chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This was 9 months after his last booster of Moderna Covid-19 vaccine, he got Covid-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (This was 9 months after his last booster of Moderna Covid-19 vaccine, he got Covid-19) in a 93-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Aortic surgery (Aortic repair). Concurrent medical conditions included Stroke (He's on Eliquis.). Concomitant products included APIXABAN (ELIQUIS) for Stroke.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, 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 COVID-19 (This was 9 months after his last booster of Moderna Covid-19 vaccine, he got Covid-19). At the time of the report, COVID-19 (This was 9 months after his last booster of Moderna Covid-19 vaccine, he got Covid-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         The AE reported caused patient to seek medical care. Patient took primary regimen with full doses on unknown dates and also first booster on unknown date. Batch numbers were not known. There were no events reported with these three doses of Moderna. It was unknown if the patient experienced a similar event in the past.  It was unknown if the patient received any other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Treatment information was not reported. Company comment: This is a spontaneous case concerning a 93-year-old male patient, with no relevant medical history, who experienced the unexpected and non-serious AESI of COVID-19 after his last booster of mRNA-1273. Patient got full doses of mRNA-1273 vaccine on unknown dates (primary schedule and 2 booster doses); hence, latency could not properly assess. No information disclosed about lab tests or treatments received. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.    Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a 93-year-old male patient, with no relevant medical history, who experienced the unexpected and non-serious AESI of COVID-19 after his last booster of mRNA-1273. Patient got full doses of mRNA-1273 vaccine on unknown dates (primary schedule and 2 booster doses); hence, latency could not properly assess. No information disclosed about lab tests or treatments received. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product leakage, Underdose
Clinical narrative: No adverse event; Patient did not receive the full dose of the Bivalent booster; A lot of the liquid vaccine leaked out of the syringe while administering the Bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Patient did not receive the full dose of the Bivalent booster), PRODUCT LEAKAGE (A lot of the liquid vaccine leaked out of the syringe while administering the Bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 73-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7145B) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 20-Sep-2022, the patient experienced UNDERDOSE (Patient did not receive the full dose of the Bivalent booster) and PRODUCT LEAKAGE (A lot of the liquid vaccine leaked out of the syringe while administering the Bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient did not receive the full dose of the Bivalent booster), PRODUCT LEAKAGE (A lot of the liquid vaccine leaked out of the syringe while administering the Bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for UNDERDOSE (Patient did not receive the full dose of the Bivalent booster) and PRODUCT LEAKAGE (A lot of the liquid vaccine leaked out of the syringe while administering the Bivalent booster).    No concomitant medications were provided.  No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; Patient received a Monovalent vaccine from age group of 6 months to 5 years for a booster dose/Patient received 0.5ml of the 6 month to 5 year old vaccine; Patient received 0.5ml of the 6 month to 5 year old vaccine; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT DOSE ADMINISTERED (Patient received a Monovalent vaccine from age group of 6 months to 5 years for a booster dose/Patient received 0.5ml of the 6 month to 5 year old vaccine), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received 0.5ml of the 6 month to 5 year old vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Sep-2022, the patient experienced INCORRECT DOSE ADMINISTERED (Patient received a Monovalent vaccine from age group of 6 months to 5 years for a booster dose/Patient received 0.5ml of the 6 month to 5 year old vaccine) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received 0.5ml of the 6 month to 5 year old vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Patient received a Monovalent vaccine from age group of 6 months to 5 years for a booster dose/Patient received 0.5ml of the 6 month to 5 year old vaccine), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received 0.5ml of the 6 month to 5 year old vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INCORRECT DOSE ADMINISTERED (Patient received a Monovalent vaccine from age group of 6 months to 5 years for a booster dose/Patient received 0.5ml of the 6 month to 5 year old vaccine) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received 0.5ml of the 6 month to 5 year old vaccine).    No concomitant medications were reported.    The patient received a Monovalent vaccine from age group of 6 months to 5 years for a booster dose. Patient received 0.5ml of the 6 month to 5 year old vaccine. The reporter (nurse) did not give permission for Safety to contact.  No treatment information was reported.   Reporter did not allow further contact
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Dizziness, Dyspnoea, Erythema
Clinical narrative: body aches/body is aching/sore/all his body very painful; couldn't breath; itchiness; light headed feeling; feeling weak/weakness; can't walk; redness; joint pain; vomiting; nausea; hives all over his body; shot area was very painful; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches/body is aching/sore/all his body very painful), DYSPNOEA (couldn't breath), PRURITUS (itchiness), DIZZINESS (light headed feeling) and ASTHENIA (feeling weak/weakness) in a 34-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (body aches/body is aching/sore/all his body very painful), DYSPNOEA (couldn't breath), PRURITUS (itchiness), DIZZINESS (light headed feeling), ASTHENIA (feeling weak/weakness), GAIT DISTURBANCE (can't walk), ERYTHEMA (redness), ARTHRALGIA (joint pain), VOMITING (vomiting), NAUSEA (nausea), URTICARIA (hives all over his body) and VACCINATION SITE PAIN (shot area was very painful). At the time of the report, PAIN (body aches/body is aching/sore/all his body very painful), DYSPNOEA (couldn't breath), PRURITUS (itchiness), DIZZINESS (light headed feeling), ASTHENIA (feeling weak/weakness), GAIT DISTURBANCE (can't walk), ERYTHEMA (redness), ARTHRALGIA (joint pain), VOMITING (vomiting), NAUSEA (nausea), URTICARIA (hives all over his body) and VACCINATION SITE PAIN (shot area was very painful) had not resolved.            No allergies were reported. No concomitant medication information was provided. It was reported that the patient experienced following vaccination: hives all over his body, body aches until now, on last Sunday went to the ER. The second day after vaccination his shot area was very painful, he complained that he was so weak and after a couple of days he had hives and then he went to the ER.  The symptoms were the same and he had not been going to work for almost 2 weeks. For treatment, patient received allergy medication after 6 hours the hives come out again.  Patient has not had COVID + test or diagnosis. Patient did not experience similar event in past. Reporter did not know how many doses the patient had received.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Nausea, Pain, Pruritus, Urticaria
Clinical narrative: body aches/body is aching/sore/all his body very painful; couldn't breath; itchiness; light headed feeling; feeling weak/weakness; can't walk; redness; joint pain; vomiting; nausea; hives all over his body; shot area was very painful; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches/body is aching/sore/all his body very painful), DYSPNOEA (couldn't breath), PRURITUS (itchiness), DIZZINESS (light headed feeling) and ASTHENIA (feeling weak/weakness) in a 34-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (body aches/body is aching/sore/all his body very painful), DYSPNOEA (couldn't breath), PRURITUS (itchiness), DIZZINESS (light headed feeling), ASTHENIA (feeling weak/weakness), GAIT DISTURBANCE (can't walk), ERYTHEMA (redness), ARTHRALGIA (joint pain), VOMITING (vomiting), NAUSEA (nausea), URTICARIA (hives all over his body) and VACCINATION SITE PAIN (shot area was very painful). At the time of the report, PAIN (body aches/body is aching/sore/all his body very painful), DYSPNOEA (couldn't breath), PRURITUS (itchiness), DIZZINESS (light headed feeling), ASTHENIA (feeling weak/weakness), GAIT DISTURBANCE (can't walk), ERYTHEMA (redness), ARTHRALGIA (joint pain), VOMITING (vomiting), NAUSEA (nausea), URTICARIA (hives all over his body) and VACCINATION SITE PAIN (shot area was very painful) had not resolved.            No allergies were reported. No concomitant medication information was provided. It was reported that the patient experienced following vaccination: hives all over his body, body aches until now, on last Sunday went to the ER. The second day after vaccination his shot area was very painful, he complained that he was so weak and after a couple of days he had hives and then he went to the ER.  The symptoms were the same and he had not been going to work for almost 2 weeks. For treatment, patient received allergy medication after 6 hours the hives come out again.  Patient has not had COVID + test or diagnosis. Patient did not experience similar event in past. Reporter did not know how many doses the patient had received.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vomiting
Clinical narrative: body aches/body is aching/sore/all his body very painful; couldn't breath; itchiness; light headed feeling; feeling weak/weakness; can't walk; redness; joint pain; vomiting; nausea; hives all over his body; shot area was very painful; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches/body is aching/sore/all his body very painful), DYSPNOEA (couldn't breath), PRURITUS (itchiness), DIZZINESS (light headed feeling) and ASTHENIA (feeling weak/weakness) in a 34-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (body aches/body is aching/sore/all his body very painful), DYSPNOEA (couldn't breath), PRURITUS (itchiness), DIZZINESS (light headed feeling), ASTHENIA (feeling weak/weakness), GAIT DISTURBANCE (can't walk), ERYTHEMA (redness), ARTHRALGIA (joint pain), VOMITING (vomiting), NAUSEA (nausea), URTICARIA (hives all over his body) and VACCINATION SITE PAIN (shot area was very painful). At the time of the report, PAIN (body aches/body is aching/sore/all his body very painful), DYSPNOEA (couldn't breath), PRURITUS (itchiness), DIZZINESS (light headed feeling), ASTHENIA (feeling weak/weakness), GAIT DISTURBANCE (can't walk), ERYTHEMA (redness), ARTHRALGIA (joint pain), VOMITING (vomiting), NAUSEA (nausea), URTICARIA (hives all over his body) and VACCINATION SITE PAIN (shot area was very painful) had not resolved.            No allergies were reported. No concomitant medication information was provided. It was reported that the patient experienced following vaccination: hives all over his body, body aches until now, on last Sunday went to the ER. The second day after vaccination his shot area was very painful, he complained that he was so weak and after a couple of days he had hives and then he went to the ER.  The symptoms were the same and he had not been going to work for almost 2 weeks. For treatment, patient received allergy medication after 6 hours the hives come out again.  Patient has not had COVID + test or diagnosis. Patient did not experience similar event in past. Reporter did not know how many doses the patient had received.
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; He entered the lot number and it says this vaccine is expired; This spontaneous case was reported by a patient and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (He entered the lot number and it says this vaccine is expired) and NO ADVERSE EVENT (No adverse event) in a 63-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 21-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (He entered the lot number and it says this vaccine is expired). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (He entered the lot number and it says this vaccine is expired) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant information provided  It was reported that The patient states he just got a booster vaccine on 21Sep2022 about 20 minutes ago. patient entered the lot number and it said the vaccine was expired. He was trying to check if he got the bivalent. The lot was 005M21A.Then the patient realized he might have given the lot number from a previous dose that he received back in April. He was unsure of the lot number of the dose that he received on 21Sep2022 because he could not read the writing on his card.  On 28Mar2021 patient received first dose of Moderna vaccine with lot number 008B21-2A On 26Arp2021 patient received second dose of Moderna vaccine with lot number 014C21A On 18Nov2021 patient received 1st booster dose of Moderna vaccine of 0.25 ml with lot number 027H21B  On 14Apr2022 patient received 2nd booster dose of Moderna vaccine of 0.25 ml with lot number 005M21A   No treatment information provided
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeding disorder, Nausea, Pain in extremity, Pruritus
Clinical narrative: Couldn't eat; Arm was itchy; Dizzy; Nauseous; Fever; Arm was itchy and a bit sore; This spontaneous case was reported by a patient and describes the occurrence of FEEDING DISORDER (Couldn't eat), PRURITUS (Arm was itchy), DIZZINESS (Dizzy), NAUSEA (Nauseous) and PYREXIA (Fever) in a 55-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient did not had any allergies to any food or medications.    On 08-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 20-Sep-2022, the patient experienced FEEDING DISORDER (Couldn't eat), PRURITUS (Arm was itchy), DIZZINESS (Dizzy), NAUSEA (Nauseous), PYREXIA (Fever) and PAIN IN EXTREMITY (Arm was itchy and a bit sore). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEEDING DISORDER (Couldn't eat), PRURITUS (Arm was itchy), NAUSEA (Nauseous), PYREXIA (Fever) and PAIN IN EXTREMITY (Arm was itchy and a bit sore) was resolving and DIZZINESS (Dizzy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Sep-2022, SARS-CoV-2 test: (Negative) Negative.  No concomitant medications were reported.  Patient received first dose on 26-Aug-2021 lot number 036A21A, second dose on 25-Sep-2021 lot number 038B21A, first booster dose on 05-Dec-2021 lot number 011F21A and second booster dose on 04-Apr-2022.  It was reported that the patient had a whole roster of symptoms that seemed like the coronavirus or booster side effects. It took a long time. Patient wanted to know if that was something that usually happen. Reportedly, the patient stated that the symptoms had improved. Patient felt better on that day 21-Sep-2022.   This case was linked to MOD-2022-648677 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Couldn't eat; Arm was itchy; Dizzy; Nauseous; Fever; Arm was itchy and a bit sore; This spontaneous case was reported by a patient and describes the occurrence of FEEDING DISORDER (Couldn't eat), PRURITUS (Arm was itchy), DIZZINESS (Dizzy), NAUSEA (Nauseous) and PYREXIA (Fever) in a 55-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient did not had any allergies to any food or medications.    On 08-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 20-Sep-2022, the patient experienced FEEDING DISORDER (Couldn't eat), PRURITUS (Arm was itchy), DIZZINESS (Dizzy), NAUSEA (Nauseous), PYREXIA (Fever) and PAIN IN EXTREMITY (Arm was itchy and a bit sore). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEEDING DISORDER (Couldn't eat), PRURITUS (Arm was itchy), NAUSEA (Nauseous), PYREXIA (Fever) and PAIN IN EXTREMITY (Arm was itchy and a bit sore) was resolving and DIZZINESS (Dizzy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Sep-2022, SARS-CoV-2 test: (Negative) Negative.  No concomitant medications were reported.  Patient received first dose on 26-Aug-2021 lot number 036A21A, second dose on 25-Sep-2021 lot number 038B21A, first booster dose on 05-Dec-2021 lot number 011F21A and second booster dose on 04-Apr-2022.  It was reported that the patient had a whole roster of symptoms that seemed like the coronavirus or booster side effects. It took a long time. Patient wanted to know if that was something that usually happen. Reportedly, the patient stated that the symptoms had improved. Patient felt better on that day 21-Sep-2022.   This case was linked to MOD-2022-648677 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Patient contracted COVID-19 twice after receiving Moderna COVID-19 vaccine; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient contracted COVID-19 twice after receiving Moderna COVID-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient contracted COVID-19 twice after receiving Moderna COVID-19 vaccine). At the time of the report, COVID-19 (Patient contracted COVID-19 twice after receiving Moderna COVID-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter.  Reportedly, event took place after use of product.  Treatment details were not reported by the reporter. Company comment: This is a spontaneous case concerning a female patient of an unknown age, with no reported medical history, who experienced the unexpected and non-serious AESI of COVID-19 after an unspecified dose of mRNA-1273 vaccine. The onset date of the event and the vaccination date were not reported; hence, latency could not be assessed. No information disclosed about clinical course, lab tests or treatments received. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a female patient of an unknown age, with no reported medical history, who experienced the unexpected and non-serious AESI of COVID-19 after an unspecified dose of mRNA-1273 vaccine. The onset date of the event and the vaccination date were not reported; hence, latency could not be assessed. No information disclosed about clinical course, lab tests or treatments received. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Oropharyngeal pain, Somnolence
Clinical narrative: had a sore throat; slept for a while; got tired; first dose on 6FEB2021 and second dose on 28MAR2021, more than 35 days between Moderna Covid-19 vaccine primary series; This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL PAIN (had a sore throat), SOMNOLENCE (slept for a while), FATIGUE (got tired) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 6FEB2021 and second dose on 28MAR2021, more than 35 days between Moderna Covid-19 vaccine primary series) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 prophylaxis.     Concomitant products included FAMOTIDINE, ATORVASTATIN, ESCITALOPRAM and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 28-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (had a sore throat), SOMNOLENCE (slept for a while), FATIGUE (got tired) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 6FEB2021 and second dose on 28MAR2021, more than 35 days between Moderna Covid-19 vaccine primary series). At the time of the report, OROPHARYNGEAL PAIN (had a sore throat), SOMNOLENCE (slept for a while), FATIGUE (got tired) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 6FEB2021 and second dose on 28MAR2021, more than 35 days between Moderna Covid-19 vaccine primary series) outcome was unknown.            No medical history was provided by the reporter.  Patient does not remember which arm that she received the vaccine No treatment information was provided by the reporter.   This case was linked to MOD-2022-648652, MOD-2022-648682 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: CD4 lymphocytes, Illness
Clinical narrative: Patient experienced sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Patient experienced sick) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for an unknown indication.    Co-suspect product included non-company product BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY) tablet for an unknown indication.    No Medical History information was reported.   In July 2022, the patient started BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY) (unknown route) at an unspecified dose. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Patient experienced sick). At the time of the report, ILLNESS (Patient experienced sick) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2022, CD4 lymphocytes: 46.         No concomitant medication information was provided. No treatment medication were provided.  Reporter causality for co-suspect drug(BIKTARVY) was reported as Not Reported.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick for 3 days; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (sick for 3 days) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick for 3 days). At the time of the report, ILLNESS (sick for 3 days) had resolved.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       No concomitant medication was provided by reporter. No treatment medication was provided by reporter.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Maternal exposure during breast feeding
Clinical narrative: Tired; Small headache; Patient was nursing her baby when she received this vaccine; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Tired), HEADACHE (Small headache) and MATERNAL EXPOSURE DURING BREAST FEEDING (Patient was nursing her baby when she received this vaccine) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032FF21A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna Covid-19 (Dose 1: The patient was in her first Trimester of Pregnancy. Patient received in right arm and had a "little headache") on 20-Jan-2021, Moderna Covid-19 (Dose 2- Patient had a low grade fever for 12 hours, the chills and and the patient vomited the day after. Patient was in her first trimester of pregnancy.) on 17-Feb-2021. Past adverse reactions to the above products included No adverse event with Moderna Covid-19 and Moderna Covid-19.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced FATIGUE (Tired), HEADACHE (Small headache) and MATERNAL EXPOSURE DURING BREAST FEEDING (Patient was nursing her baby when she received this vaccine). On 09-Nov-2021, MATERNAL EXPOSURE DURING BREAST FEEDING (Patient was nursing her baby when she received this vaccine) had resolved. At the time of the report, FATIGUE (Tired) and HEADACHE (Small headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication were reported.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; Received  0.25ml  instead of 0.5ml for bivalent booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Received  0.25ml  instead of 0.5ml for bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 15-Sep-2022, the patient experienced UNDERDOSE (Received  0.25ml  instead of 0.5ml for bivalent booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Received  0.25ml  instead of 0.5ml for bivalent booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Received  0.25ml  instead of 0.5ml for bivalent booster dose).    Concomitant drugs were not reported. It was reported that patient received bivalent booster dose. It was reported that patient received Dose 1, Dose 2, 1st booster and 2nd booster of monovalent Moderna COVID-19 vaccines. Treatment medications were not provided. This case was reported for Patient 1.   This case was linked to US-MODERNATX, INC.-MOD-2022-648802, US-MODERNATX, INC.-MOD-2022-648805, US-MODERNATX, INC.-MOD-2022-648807, US-MODERNATX, INC.-MOD-2022-648808, US-MODERNATX, INC.-MOD-2022-648809, US-MODERNATX, INC.-MOD-2022-648812 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-648802:same reporter US-MODERNATX, INC.-MOD-2022-648805:same reporter US-MODERNATX, INC.-MOD-2022-648807:same reporter US-MODERNATX, INC.-MOD-2022-648808:same reporter US-MODERNATX, INC.-MOD-2022-648809:same reporter US-MODERNATX, INC.-MOD-2022-648812:same reporter
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; Received  0.25ml  instead of 0.5ml for bivalent booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Received  0.25ml  instead of 0.5ml for bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 15-Sep-2022, the patient experienced UNDERDOSE (Received  0.25ml  instead of 0.5ml for bivalent booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Received  0.25ml  instead of 0.5ml for bivalent booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Received  0.25ml  instead of 0.5ml for bivalent booster dose).    No concomitant medications were reported. The age of patient was more than 18 years. The patient had received 2 primary and 2 monovalent booster of Moderna COVID-19 Vaccine. No treatment medications were reported.  This case contains information for the 4 of 7 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-648798 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-648798: US-MODERNATX, INC.-MOD-2022-648812:same reporter
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; Received  0.25ml  instead of 0.5ml for bivalent booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Received  0.25ml  instead of 0.5ml for bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 15-Sep-2022, the patient experienced UNDERDOSE (Received  0.25ml  instead of 0.5ml for bivalent booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Received  0.25ml  instead of 0.5ml for bivalent booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Received  0.25ml  instead of 0.5ml for bivalent booster dose).    No concomitant medications were reported. The age of patient was more than 18 years. The patient had received 2 primary and 2 monovalent booster of Moderna COVID-19 Vaccine. No treatment medications were reported.  This case contains information for the 2nd of 7 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-648798 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-648798:
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; Received  0.25ml  instead of 0.5ml for bivalent booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Received  0.25ml  instead of 0.5ml for bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 15-Sep-2022, the patient experienced UNDERDOSE (Received  0.25ml  instead of 0.5ml for bivalent booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Received  0.25ml  instead of 0.5ml for bivalent booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Received  0.25ml  instead of 0.5ml for bivalent booster dose).    The age of patient was more than 18 years.  No concomitant medications were reported.  The patient had 2 primary and 2 monovalent booster of Moderna COVID-19 Vaccine.  No treatment medications were reported.  This case contains information for the 6th of 7 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-648798, US-MODERNATX, INC.-MOD-2022-648812 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-648798:same reporter US-MODERNATX, INC.-MOD-2022-648812:same reporter
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; Received 0.25ml  instead of 0.5ml for bivalent booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Received 0.25ml  instead of 0.5ml for bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Sep-2022, the patient experienced UNDERDOSE (Received 0.25ml  instead of 0.5ml for bivalent booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Received 0.25ml  instead of 0.5ml for bivalent booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Received 0.25ml  instead of 0.5ml for bivalent booster dose).    No concomitant medications were reported. Patient received primary series two doses of Moderna vaccine (monovalent). Patient received two booster dose of Moderna vaccine (monovalent). No treatment medications were reported. This case contains information for the 7th of 7 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-648798, US-MODERNATX, INC.-MOD-2022-648802, US-MODERNATX, INC.-MOD-2022-648805, US-MODERNATX, INC.-MOD-2022-648807, US-MODERNATX, INC.-MOD-2022-648808, US-MODERNATX, INC.-MOD-2022-648809 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-648798:same reporter US-MODERNATX, INC.-MOD-2022-648802:same reporter US-MODERNATX, INC.-MOD-2022-648805:same reporter US-MODERNATX, INC.-MOD-2022-648807:same reporter US-MODERNATX, INC.-MOD-2022-648808:same reporter US-MODERNATX, INC.-MOD-2022-648809:same reporter
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: fever; headache; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever) and HEADACHE (headache) in a 47-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No acute illnesses at the time of vaccination and up to one month before. No chronic or long-standing health conditions. Patient had no allergies to medications, food, and other products.  The patient's past medical history included COVID-19 (tested positive for COVID-19, through PCR, rapid test.) on 01-Jan-2022.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever) and HEADACHE (headache). At the time of the report, PYREXIA (fever) and HEADACHE (headache) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2022-647149 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: started developing urticaria, which is now chronic 9 months later; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (started developing urticaria, which is now chronic 9 months later) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 prophylaxis.     No Medical History information was reported.   In December 2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced URTICARIA (started developing urticaria, which is now chronic 9 months later). At the time of the report, URTICARIA (started developing urticaria, which is now chronic 9 months later) had not resolved.            No concomitant medication were reported.  Shortly after receiving the vaccine patient started developing urticaria, which is now chronic 9 months later.  Patient's dermatologist suspects this as a side effect to the vaccine given that it started shortly after receiving the third dose (she has seen this in other patients as well) No treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Oral mucosal blistering
Clinical narrative: large blisters around mouth after recently receiving a fourth dose of the Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of ORAL MUCOSAL BLISTERING (large blisters around mouth after recently receiving a fourth dose of the Moderna vaccine) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ORAL MUCOSAL BLISTERING (large blisters around mouth after recently receiving a fourth dose of the Moderna vaccine). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, ORAL MUCOSAL BLISTERING (large blisters around mouth after recently receiving a fourth dose of the Moderna vaccine) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not reported.  It was reported that patient had no problem at all with her previous Moderna shots.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Erythema, Inappropriate schedule of product administration, Loss of personal independence in daily activities, Pyrexia
Clinical narrative: couldn't do anything; huge red mark from shoulder to elbow; patient received third booster; fever for 102 for 3 days; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (couldn't do anything), ERYTHEMA (huge red mark from shoulder to elbow), PYREXIA (fever for 102 for 3 days) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received third booster) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (couldn't do anything), ERYTHEMA (huge red mark from shoulder to elbow), PYREXIA (fever for 102 for 3 days) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received third booster). At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (couldn't do anything), ERYTHEMA (huge red mark from shoulder to elbow) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received third booster) outcome was unknown and PYREXIA (fever for 102 for 3 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.         Concomitant drugs were not reported. It was reported that patient received a half dose for third booster dose. It was also reported that patient had a terrible time with the vaccine. Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-649254 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-649254:Second booster