chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Feeling cold, Hyperhidrosis
Clinical narrative: Fever/a lot of fever/fever was 101; Tiredness/Felt tired; Severe flu symptoms; sweatiness/felt kind of like sweaty/he started to sweat and everything; Was cold when he went to bed; Was kind of low for a while; had a little bit dizziness; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Severe flu symptoms), HYPERHIDROSIS (sweatiness/felt kind of like sweaty/he started to sweat and everything), FEELING COLD (Was cold when he went to bed), VACCINATION COMPLICATION (Was kind of low for a while) and DIZZINESS (had a little bit dizziness) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 010M20A and 012LA0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-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 INFLUENZA (Severe flu symptoms), HYPERHIDROSIS (sweatiness/felt kind of like sweaty/he started to sweat and everything), FEELING COLD (Was cold when he went to bed), VACCINATION COMPLICATION (Was kind of low for a while), DIZZINESS (had a little bit dizziness), CHILLS (Chills) and FATIGUE (Tiredness/Felt tired). On an unknown date, the patient experienced PYREXIA (Fever/a lot of fever/fever was 101). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INFLUENZA (Severe flu symptoms), HYPERHIDROSIS (sweatiness/felt kind of like sweaty/he started to sweat and everything), FEELING COLD (Was cold when he went to bed), VACCINATION COMPLICATION (Was kind of low for a while), DIZZINESS (had a little bit dizziness), CHILLS (Chills), PYREXIA (Fever/a lot of fever/fever was 101) and FATIGUE (Tiredness/Felt tired) outcome was unknown.            No Concomitant product use was reported. No treatment information was provided.  The patient received a third Moderna shot on 12-Oct-2021 and believed that they got a regular Moderna shot as they experienced the same side effects post the first dose as well. The patient had severe flu symptoms, had fever, developed chills, a lot of fever, sweatiness, and tiredness.  At the vaccination place, they considered that dose was the booster and that patient was immunocompromised as the patient was over 65 years.   This case was linked to MOD-2021-353320, MOD-2021-353221 (Patient Link).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza, Pyrexia, Vaccination complication
Clinical narrative: Fever/a lot of fever/fever was 101; Tiredness/Felt tired; Severe flu symptoms; sweatiness/felt kind of like sweaty/he started to sweat and everything; Was cold when he went to bed; Was kind of low for a while; had a little bit dizziness; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Severe flu symptoms), HYPERHIDROSIS (sweatiness/felt kind of like sweaty/he started to sweat and everything), FEELING COLD (Was cold when he went to bed), VACCINATION COMPLICATION (Was kind of low for a while) and DIZZINESS (had a little bit dizziness) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 010M20A and 012LA0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-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 INFLUENZA (Severe flu symptoms), HYPERHIDROSIS (sweatiness/felt kind of like sweaty/he started to sweat and everything), FEELING COLD (Was cold when he went to bed), VACCINATION COMPLICATION (Was kind of low for a while), DIZZINESS (had a little bit dizziness), CHILLS (Chills) and FATIGUE (Tiredness/Felt tired). On an unknown date, the patient experienced PYREXIA (Fever/a lot of fever/fever was 101). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INFLUENZA (Severe flu symptoms), HYPERHIDROSIS (sweatiness/felt kind of like sweaty/he started to sweat and everything), FEELING COLD (Was cold when he went to bed), VACCINATION COMPLICATION (Was kind of low for a while), DIZZINESS (had a little bit dizziness), CHILLS (Chills), PYREXIA (Fever/a lot of fever/fever was 101) and FATIGUE (Tiredness/Felt tired) outcome was unknown.            No Concomitant product use was reported. No treatment information was provided.  The patient received a third Moderna shot on 12-Oct-2021 and believed that they got a regular Moderna shot as they experienced the same side effects post the first dose as well. The patient had severe flu symptoms, had fever, developed chills, a lot of fever, sweatiness, and tiredness.  At the vaccination place, they considered that dose was the booster and that patient was immunocompromised as the patient was over 65 years.   This case was linked to MOD-2021-353320, MOD-2021-353221 (Patient Link).
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced COVID-19 (Tested positive for COVID-19) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown and DRUG INEFFECTIVE (Lack of drug effect) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, SARS-CoV-2 test: positive (Positive) Tested positive for COVID-19.         No concomitant products were reported. The patient stated that he received monoclonal antibodies as treatment. The lab test included Monoclonal antibody test with inconclusive results. Rhinorrhoea and Nasopharyngitis are not coded as they are COVID-19 symptoms; Sender's Comments: This case concerns a 41-year-old male patient with no reported medical history, who experienced the unexpected, non-serious and AESI event of COVID-19. Drug ineffective was also reported. The event occurred approximately 5 months after second dose of Spikevax. The rechallenge was not applicable, as no additional dosing will be given The The benefit-risk relationship of Spikevax is not affected by this report.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046821A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine). On 03-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter who worked at a correctional facility was calling to report that a nurse gave the patient an expired Moderna COVID-19 vaccine. The vial was punctured for more than 12 hours and the dose was administered after the 12 hours. It was also reported that it was patient's first dose and the patient did not experience any symptoms.  No Concomitant product use was reported. No treatment information was provided.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Expired product administered, Pain, Pyrexia
Clinical narrative: Aches; Fever; Chills; Expired vaccine beyond 12 hours after first puncture was administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine beyond 12 hours after first puncture was administered), PAIN (Aches), PYREXIA (Fever) and CHILLS (Chills) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Sep-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 18-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine beyond 12 hours after first puncture was administered). On an unknown date, the patient experienced PAIN (Aches), PYREXIA (Fever) and CHILLS (Chills). On 18-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine beyond 12 hours after first puncture was administered) had resolved. At the time of the report, PAIN (Aches), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        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.  The reporter was calling to report that on 17-Sep-2021, at 3:50 PM, a vial of Moderna vaccine was used to prefill syringes for future administration and the syringes were labelled and placed in the vaccine fridge immediately. On 18-Sep-2021 one of the syringes was used to administer a Moderna vaccine dose to a patient. The expired vaccine was administered to the patient.  On 20-Sep-2021, the error was realized. On a follow-up with the patient the patient reported that thy experienced usual fever, chills, and aches similar to patient first dose experience but had done well otherwise.   This case was linked to MOD-2021-353631 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: Additional information was received on 14-OCT-2021 and contains significant information such as patient identifiers and demographics, suspect product information including lot number, dose number, additional events experienced, and description of the events.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: very sore left arm after the second vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very sore left arm after the second vaccination) 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 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced PAIN IN EXTREMITY (very sore left arm after the second vaccination). At the time of the report, PAIN IN EXTREMITY (very sore left arm after the second vaccination) outcome was unknown.            No concomitant medications were provided by the reporter.  Treatment information was not provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dizziness postural, Inappropriate schedule of product administration, Vertigo
Clinical narrative: 28DEC2020 (lot number 026L20A, expiration date unknown), and 17FEB2021; bad vertigo/sitting there and feeling the room spin; doing downward dog and getting dizzy; bending down, standing up, and getting dizzy; This spontaneous case was reported by a nurse and describes the occurrence of VERTIGO (bad vertigo/sitting there and feeling the room spin), DIZZINESS (doing downward dog and getting dizzy), DIZZINESS POSTURAL (bending down, standing up, and getting dizzy) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (28DEC2020 (lot number 026L20A, expiration date unknown), and 17FEB2021) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 026L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (suspects she still had antibodies at the time of vaccination attributing to her symptoms) in December 2019.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (28DEC2020 (lot number 026L20A, expiration date unknown), and 17FEB2021). In 2021, the patient experienced VERTIGO (bad vertigo/sitting there and feeling the room spin), DIZZINESS (doing downward dog and getting dizzy) and DIZZINESS POSTURAL (bending down, standing up, and getting dizzy). On 17-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (28DEC2020 (lot number 026L20A, expiration date unknown), and 17FEB2021) had resolved. At the time of the report, VERTIGO (bad vertigo/sitting there and feeling the room spin), DIZZINESS (doing downward dog and getting dizzy) and DIZZINESS POSTURAL (bending down, standing up, and getting dizzy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  Patient treatment information include ears cleaned, and an Epley Maneuver performed. They said they had seen similar symptoms in other patients before. She has not tried any additional treatments.  Patient has a history of covid-19 diagnosed in December 2019, and suspects she still had antibodies at the time of vaccination attributing to her symptoms.   This case was linked to MOD-2021-353425 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included Ovarian cancer (20 years).    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE REACTION (COVID arm). At the time of the report, VACCINATION SITE REACTION (COVID arm) 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 provided.  Patient race was UNKNOWN   This case was linked to MOD-2021-353887 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic taste in my mouth; This spontaneous case was reported by a nurse and describes the occurrence of DYSGEUSIA (Metallic taste in my mouth) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2019.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced DYSGEUSIA (Metallic taste in my mouth). On 28-Dec-2020, DYSGEUSIA (Metallic taste in my mouth) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication was reported. No Treatment information was reported.   This case was linked to MOD-2021-353361 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received Moderna Covid-19 vaccine after the 30 day beyond use date in the refrigerator; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Oct-2021 and was forwarded to Moderna on 14-Oct-2021.    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 (Patients received Moderna Covid-19 vaccine after the 30 day beyond use date in the refrigerator) 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.    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 (Patients received Moderna Covid-19 vaccine after the 30 day beyond use date in the refrigerator). In October 2021, EXPIRED PRODUCT ADMINISTERED (Patients received Moderna Covid-19 vaccine after the 30 day beyond use date in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not reported. Treatment information was not reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injury associated with device, Limb discomfort, Pain in extremity, Vaccination site pain
Clinical narrative: Immediately killed her arm/arm got so bad/she could not use it or anything; Maybe needle went in wrong spot/needle went pretty high; Felt like HCP stabbed a rock in her arm; Arm in pain, could not use her arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Immediately killed her arm/arm got so bad/she could not use it or anything), INJURY ASSOCIATED WITH DEVICE (Maybe needle went in wrong spot/needle went pretty high), PAIN IN EXTREMITY (Arm in pain, could not use her arm) and VACCINATION SITE PAIN (Felt like HCP stabbed a rock in her arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced PAIN IN EXTREMITY (Arm in pain, could not use her arm). On 17-Aug-2021, the patient experienced LIMB DISCOMFORT (Immediately killed her arm/arm got so bad/she could not use it or anything), INJURY ASSOCIATED WITH DEVICE (Maybe needle went in wrong spot/needle went pretty high) and VACCINATION SITE PAIN (Felt like HCP stabbed a rock in her arm). At the time of the report, LIMB DISCOMFORT (Immediately killed her arm/arm got so bad/she could not use it or anything), INJURY ASSOCIATED WITH DEVICE (Maybe needle went in wrong spot/needle went pretty high), PAIN IN EXTREMITY (Arm in pain, could not use her arm) and VACCINATION SITE PAIN (Felt like HCP stabbed a rock in her arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was reported. Patient went to see an orthopedic doctor, and doctor said her arm looks okay but may the needle went in the wrong spot, it went pretty high.   This case was linked to MOD-2021-353568 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 8 patients received doses past the expiration date; 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 (8 patients received doses past the expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (8 patients received doses past the expiration date). In 2021, EXPIRED PRODUCT ADMINISTERED (8 patients received doses past the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vaccines were administered to 8 patient and these were the dates of administration. On 24 Sep 2021 (3 patients), 1 Oct 2021 (2 patients), 8 Oct 2021 (3 patients)  No concomitant products were reported. No treatment information was reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: approximately 10 doses administered past 30 day use by date; 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 (approximately 10 doses administered past 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.    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 (approximately 10 doses administered past 30 day use by date). In October 2021, EXPIRED PRODUCT ADMINISTERED (approximately 10 doses administered past 30 day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  Treatment information was not provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Inappropriate schedule of product administration, Mass
Clinical narrative: Patient received first dose on 17Aug2021, second dose on 12Oct2021; sweats; headache, splitting headache; Fever; felt exhausted, really tired; a lump in her arm, that was red, swollen and itchy. It felt like she had a knot in her arm.; This spontaneous case was reported by a consumer and describes the occurrence of MASS (a lump in her arm, that was red, swollen and itchy. It felt like she had a knot in her arm.), HYPERHIDROSIS (sweats), HEADACHE (headache, splitting headache), PYREXIA (Fever) and FATIGUE (felt exhausted, really tired) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A and 019F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced MASS (a lump in her arm, that was red, swollen and itchy. It felt like she had a knot in her arm.). In October 2021, the patient experienced HYPERHIDROSIS (sweats), HEADACHE (headache, splitting headache), PYREXIA (Fever) and FATIGUE (felt exhausted, really tired). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 17Aug2021, second dose on 12Oct2021). In October 2021, HEADACHE (headache, splitting headache), PYREXIA (Fever) and FATIGUE (felt exhausted, really tired) had resolved. At the time of the report, MASS (a lump in her arm, that was red, swollen and itchy. It felt like she had a knot in her arm.) and HYPERHIDROSIS (sweats) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 17Aug2021, second dose on 12Oct2021) had resolved.            Treatment information was not provided. Patient developed a lump in her arm, that was red, swollen and itchy. It felt like she had a knot in her arm.   This case was linked to MOD-2021-353465 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Patient received first dose on 17Aug2021, second dose on 12Oct2021; sweats; headache, splitting headache; Fever; felt exhausted, really tired; a lump in her arm, that was red, swollen and itchy. It felt like she had a knot in her arm.; This spontaneous case was reported by a consumer and describes the occurrence of MASS (a lump in her arm, that was red, swollen and itchy. It felt like she had a knot in her arm.), HYPERHIDROSIS (sweats), HEADACHE (headache, splitting headache), PYREXIA (Fever) and FATIGUE (felt exhausted, really tired) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A and 019F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced MASS (a lump in her arm, that was red, swollen and itchy. It felt like she had a knot in her arm.). In October 2021, the patient experienced HYPERHIDROSIS (sweats), HEADACHE (headache, splitting headache), PYREXIA (Fever) and FATIGUE (felt exhausted, really tired). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 17Aug2021, second dose on 12Oct2021). In October 2021, HEADACHE (headache, splitting headache), PYREXIA (Fever) and FATIGUE (felt exhausted, really tired) had resolved. At the time of the report, MASS (a lump in her arm, that was red, swollen and itchy. It felt like she had a knot in her arm.) and HYPERHIDROSIS (sweats) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 17Aug2021, second dose on 12Oct2021) had resolved.            Treatment information was not provided. Patient developed a lump in her arm, that was red, swollen and itchy. It felt like she had a knot in her arm.   This case was linked to MOD-2021-353465 (Patient Link).
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Given the vaccine on day 31 days of expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 046C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medication were provided.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Pain in extremity, Vomiting
Clinical narrative: diarrhea; sore arm; headache; at midnight they throw up; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), PAIN IN EXTREMITY (sore arm), HEADACHE (headache) and VOMITING (at midnight they throw up) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Oct-2021, the patient experienced DIARRHOEA (diarrhea), PAIN IN EXTREMITY (sore arm), HEADACHE (headache) and VOMITING (at midnight they throw up). On 14-Oct-2021, VOMITING (at midnight they throw up) had resolved. At the time of the report, DIARRHOEA (diarrhea), PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that they didn't took any  medication and that aren't taking any concomitant medication.  No concomitant medication was reported  No treatment drug was reported.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Given the vaccine on day 31 days of expiry; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Oct-2021 and was forwarded to Moderna on 14-Oct-2021.    This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 046C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received the first and second dose of the vaccine in the left. No treatment medication was reported. No Concomitant medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: A lot of severe side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (A lot of severe side effects) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (A lot of severe side effects). At the time of the report, VACCINATION COMPLICATION (A lot of severe side effects) outcome was unknown.            The patient had a lot of severe side effects since Monday when she had the second dose of the vaccine.   No concomitant medication was provided.  No treatment medication was provided.   Reporter did not allow further contact
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Given the vaccine on day 31 days of expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 046C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Given the vaccine on day 31 days of expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: More fatigue after 3rd dose than the others; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (More fatigue after 3rd dose than the others) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (More fatigue after 3rd dose than the others). At the time of the report, FATIGUE (More fatigue after 3rd dose than the others) had resolved.            No Concomitant medications were provided No treatment medications were provided.   This case was linked to MOD-2021-353899, MOD-2021-353900 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: fatigue; light headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) and HEADACHE (light headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) 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 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue) and HEADACHE (light headache). At the time of the report, FATIGUE (fatigue) and HEADACHE (light headache) outcome was unknown.            No concomitant medication was reported . No treatment medication was reported .
Sex: M
Vaccine: COVID19
Symptoms: Vaccination error, Vaccination site reaction
Clinical narrative: pharmacist who administered the 2nd dose missed deltoid injection site and went too South; 2 inch circle at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (2 inch circle at injection site) and VACCINATION ERROR (pharmacist who administered the 2nd dose missed deltoid injection site and went too South) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A and 048F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION ERROR (pharmacist who administered the 2nd dose missed deltoid injection site and went too South). In October 2021, the patient experienced VACCINATION SITE REACTION (2 inch circle at injection site). On 11-Oct-2021, VACCINATION ERROR (pharmacist who administered the 2nd dose missed deltoid injection site and went too South) had resolved. In October 2021, VACCINATION SITE REACTION (2 inch circle at injection site) had resolved.            Concomitant medication details were not provided. Treatment details were not provided.   This case was linked to MOD-2021-354180 (Patient Link).
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: ache; fever; chills; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (ache), PYREXIA (fever) and CHILLS (chills) in an 18-year-old male patient 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 PAIN (ache), PYREXIA (fever) and CHILLS (chills). At the time of the report, PAIN (ache), PYREXIA (fever) and CHILLS (chills) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information not provided.  Treatment information not provided.   This case was linked to MOD-2021-353342.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: doses administered from vaccine stored in unmonitored freezer temperatures; 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 PRODUCT STORAGE ERROR (doses administered from vaccine stored in unmonitored freezer temperatures) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) 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 PRODUCT STORAGE ERROR (doses administered from vaccine stored in unmonitored freezer temperatures). At the time of the report, PRODUCT STORAGE ERROR (doses administered from vaccine stored in unmonitored freezer temperatures) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment information was reported by the reporter. The reporter stated that for 13 nonconsecutive days the maximum temperature ranged from -12 to -14 for an unknown period of time. The vaccine was utilized by 2/6/21.   Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: Follow-up contains non-significant information includes reporter contact details.
Sex: M
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Poor quality product administered
Clinical narrative: patient was in bed and can't call himself; one of the shots was no good/ one of the shots was not potent like it was supposed to; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (patient was in bed and can't call himself) and POOR QUALITY PRODUCT ADMINISTERED (one of the shots was no good/ one of the shots was not potent like it was supposed to) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In August 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (patient was in bed and can't call himself) and POOR QUALITY PRODUCT ADMINISTERED (one of the shots was no good/ one of the shots was not potent like it was supposed to). At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (patient was in bed and can't call himself) outcome was unknown and POOR QUALITY PRODUCT ADMINISTERED (one of the shots was no good/ one of the shots was not potent like it was supposed to) had resolved.            No Concomitant Medication was provided. No treatment  was provided.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vial was punctured for more than 12 hours, doses were administered after the 12 hours; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vial was punctured for more than 12 hours, doses were administered after the 12 hours) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046821A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included TRAZODONE for an unknown indication.    On 03-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was punctured for more than 12 hours, doses were administered after the 12 hours). On 03-Oct-2021, EXPIRED PRODUCT ADMINISTERED (The vial was punctured for more than 12 hours, doses were administered after the 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication were reported. No concomitant medication were reported. HCP  reported that a nurse gave 4 patients expired Moderna COVID-19 vaccines. The vial was punctured for more than 12 hours, doses were administered after the 12 hours.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Myalgia
Clinical narrative: feel very bad; terrible reaction; chills; vomiting; body aches; headaches; feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feel very bad), VACCINATION COMPLICATION (terrible reaction), CHILLS (chills), VOMITING (vomiting) and MYALGIA (body aches) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048cz1, 036421a and 00013m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CARVEDILOL for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (feel very bad), VACCINATION COMPLICATION (terrible reaction), CHILLS (chills), VOMITING (vomiting), MYALGIA (body aches), HEADACHE (headaches) and FATIGUE (feeling tired). At the time of the report, FEELING ABNORMAL (feel very bad), VACCINATION COMPLICATION (terrible reaction), CHILLS (chills), VOMITING (vomiting), MYALGIA (body aches), HEADACHE (headaches) and FATIGUE (feeling tired) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication included hbp medicine. No treatment medication was reported. No lab data was provided.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication, Vomiting
Clinical narrative: feel very bad; terrible reaction; chills; vomiting; body aches; headaches; feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feel very bad), VACCINATION COMPLICATION (terrible reaction), CHILLS (chills), VOMITING (vomiting) and MYALGIA (body aches) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048cz1, 036421a and 00013m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CARVEDILOL for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (feel very bad), VACCINATION COMPLICATION (terrible reaction), CHILLS (chills), VOMITING (vomiting), MYALGIA (body aches), HEADACHE (headaches) and FATIGUE (feeling tired). At the time of the report, FEELING ABNORMAL (feel very bad), VACCINATION COMPLICATION (terrible reaction), CHILLS (chills), VOMITING (vomiting), MYALGIA (body aches), HEADACHE (headaches) and FATIGUE (feeling tired) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication included hbp medicine. No treatment medication was reported. No lab data was provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal
Clinical narrative: Felt strange after second Moderna COVID-19 vaccine; Felt tired after second Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt strange after second Moderna COVID-19 vaccine) and FATIGUE (Felt tired after second Moderna COVID-19 vaccine) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 012L20A) 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. In 2021, the patient experienced FEELING ABNORMAL (Felt strange after second Moderna COVID-19 vaccine) and FATIGUE (Felt tired after second Moderna COVID-19 vaccine). At the time of the report, FEELING ABNORMAL (Felt strange after second Moderna COVID-19 vaccine) and FATIGUE (Felt tired after second Moderna COVID-19 vaccine) outcome was unknown.            Patient received Moderna vaccine at Health Department. No concomitant medication was provided. No treatment medication was provided. Patient received first Moderna Covid-19 vaccine on 15JAN2021 and had not experienced any adverse reactions to report.