chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Bedridden, Fatigue
Clinical narrative: went to bed for a couple of days; Tired/wiped out; This spontaneous case was reported by a nurse and describes the occurrence of BEDRIDDEN (went to bed for a couple of days) and FATIGUE (Tired/wiped out) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 032M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced BEDRIDDEN (went to bed for a couple of days) and FATIGUE (Tired/wiped out). In April 2021, BEDRIDDEN (went to bed for a couple of days) had resolved. At the time of the report, FATIGUE (Tired/wiped out) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2022-663083, MOD-2022-663104, MOD-2022-663113, MOD-2022-663126 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, Fatigue, Vaccination site pain
Clinical narrative: went to bed for a couple of days; Tired/wiped out; This spontaneous case was reported by a nurse and describes the occurrence of BEDRIDDEN (went to bed for a couple of days) and FATIGUE (Tired/wiped out) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 032M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced BEDRIDDEN (went to bed for a couple of days) and FATIGUE (Tired/wiped out). In April 2021, BEDRIDDEN (went to bed for a couple of days) had resolved. At the time of the report, FATIGUE (Tired/wiped out) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2022-663083, MOD-2022-663104, MOD-2022-663113, MOD-2022-663126 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: went to bed for a couple of days; Tired/wiped out; This spontaneous case was reported by a nurse and describes the occurrence of BEDRIDDEN (went to bed for a couple of days) and FATIGUE (Tired/wiped out) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 032M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced BEDRIDDEN (went to bed for a couple of days) and FATIGUE (Tired/wiped out). In April 2021, BEDRIDDEN (went to bed for a couple of days) had resolved. At the time of the report, FATIGUE (Tired/wiped out) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2022-663083, MOD-2022-663104, MOD-2022-663113, MOD-2022-663126 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: went to bed for a couple of days; Tired/wiped out; This spontaneous case was reported by a nurse and describes the occurrence of BEDRIDDEN (went to bed for a couple of days) and FATIGUE (Tired/wiped out) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 032M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced BEDRIDDEN (went to bed for a couple of days) and FATIGUE (Tired/wiped out). In April 2021, BEDRIDDEN (went to bed for a couple of days) had resolved. At the time of the report, FATIGUE (Tired/wiped out) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2022-663083, MOD-2022-663104, MOD-2022-663113, MOD-2022-663126 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Bedridden, Fatigue
Clinical narrative: Washed out; Tired; Sore right arm; This spontaneous case was reported by a nurse and describes the occurrence of ASTHENIA (Washed out), FATIGUE (Tired) and VACCINATION SITE PAIN (Sore right arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 prophylaxis.     No Medical History information was reported. On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced ASTHENIA (Washed out), FATIGUE (Tired) and VACCINATION SITE PAIN (Sore right arm). At the time of the report, ASTHENIA (Washed out), FATIGUE (Tired) and VACCINATION SITE PAIN (Sore right arm) 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. No relevant concomitant medications were reported. Treatment medication was not provided by the reporter. This case was linked to MOD-2022-663083, MOD-2022-663104, MOD-2022-663113, MOD-2022-663121 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, Fatigue, Vaccination site pain
Clinical narrative: Washed out; Tired; Sore right arm; This spontaneous case was reported by a nurse and describes the occurrence of ASTHENIA (Washed out), FATIGUE (Tired) and VACCINATION SITE PAIN (Sore right arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 prophylaxis.     No Medical History information was reported. On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced ASTHENIA (Washed out), FATIGUE (Tired) and VACCINATION SITE PAIN (Sore right arm). At the time of the report, ASTHENIA (Washed out), FATIGUE (Tired) and VACCINATION SITE PAIN (Sore right arm) 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. No relevant concomitant medications were reported. Treatment medication was not provided by the reporter. This case was linked to MOD-2022-663083, MOD-2022-663104, MOD-2022-663113, MOD-2022-663121 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Washed out; Tired; Sore right arm; This spontaneous case was reported by a nurse and describes the occurrence of ASTHENIA (Washed out), FATIGUE (Tired) and VACCINATION SITE PAIN (Sore right arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 prophylaxis.     No Medical History information was reported. On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced ASTHENIA (Washed out), FATIGUE (Tired) and VACCINATION SITE PAIN (Sore right arm). At the time of the report, ASTHENIA (Washed out), FATIGUE (Tired) and VACCINATION SITE PAIN (Sore right arm) 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. No relevant concomitant medications were reported. Treatment medication was not provided by the reporter. This case was linked to MOD-2022-663083, MOD-2022-663104, MOD-2022-663113, MOD-2022-663121 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: Washed out; Tired; Sore right arm; This spontaneous case was reported by a nurse and describes the occurrence of ASTHENIA (Washed out), FATIGUE (Tired) and VACCINATION SITE PAIN (Sore right arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 prophylaxis.     No Medical History information was reported. On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced ASTHENIA (Washed out), FATIGUE (Tired) and VACCINATION SITE PAIN (Sore right arm). At the time of the report, ASTHENIA (Washed out), FATIGUE (Tired) and VACCINATION SITE PAIN (Sore right arm) 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. No relevant concomitant medications were reported. Treatment medication was not provided by the reporter. This case was linked to MOD-2022-663083, MOD-2022-663104, MOD-2022-663113, MOD-2022-663121 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Illness
Clinical narrative: laid  in bed for two days; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (laid  in bed for two days) and FATIGUE (Tiredness) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 032M20A) for COVID-19 prophylaxis.     Concomitant products included SILDENAFIL and OMEPRAZOLE for an unknown indication.   On 03-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2022, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced ILLNESS (laid  in bed for two days) and FATIGUE (Tiredness). In April 2021, ILLNESS (laid  in bed for two days) and FATIGUE (Tiredness) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.   This case was linked to MOD-2022-663250, MOD-2022-663266 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: felt crummy after receiving all previous Moderna doses for 3 days; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (felt crummy after receiving all previous Moderna doses for 3 days) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     Patient had no allergies. Patient did not have COVID-19 in the past. No vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Arthritis (15 years ago, worsening, but patient attribute it to a lot more walking than normal.), Blood pressure abnormal and Insomnia. Concomitant products included LISINOPRIL for Blood pressure abnormal, GABAPENTIN and TRAZODONE for Insomnia.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (felt crummy after receiving all previous Moderna doses for 3 days). At the time of the report, FEELING ABNORMAL (felt crummy after receiving all previous Moderna doses for 3 days) had resolved.            Patient reported that she had gotten a list of excipients and additives when she had received the first doses. Patient did not seek medical care for AE. Patient concomitant medication included thyroid medicines (unspecified). No treatment medications were reported. The patient reported that she felt crummy after all Moderna vaccinations.   This case was linked to MOD-2022-663115 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Headache, Nasal congestion, SARS-CoV-2 test
Clinical narrative: Had a bad sinus infection post Covid/X-ray showed sinuses were totally blocked; Nose completely blocked/congestion; Coughing; Severe headache; Tested positive for Covid-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for Covid-19), SINUSITIS (Had a bad sinus infection post Covid/X-ray showed sinuses were totally blocked), NASAL CONGESTION (Nose completely blocked/congestion), COUGH (Coughing) and HEADACHE (Severe headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 038A21A and 027A21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu vaccine (Interval of a couple of weeks with the COVID-19 Vaccine) in October 2021. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Soy allergy (Soy intolerance), Drug allergy (keflex), Sulfonamide allergy (Sulfa drugs) and Type 2 diabetes mellitus. Concomitant products included METFORMIN for Type 2 diabetes mellitus.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2022, the patient experienced COVID-19 (Tested positive for Covid-19). On an unknown date, the patient experienced SINUSITIS (Had a bad sinus infection post Covid/X-ray showed sinuses were totally blocked), NASAL CONGESTION (Nose completely blocked/congestion), COUGH (Coughing) and HEADACHE (Severe headache). The patient was treated with CEFPROZIL at an unspecified dose and frequency and IVERMECTIN at an unspecified dose and frequency. On 21-Oct-2022, HEADACHE (Severe headache) had resolved. At the time of the report, COVID-19 (Tested positive for Covid-19), SINUSITIS (Had a bad sinus infection post Covid/X-ray showed sinuses were totally blocked), NASAL CONGESTION (Nose completely blocked/congestion) and COUGH (Coughing) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Aug-2022, SARS-CoV-2 test: Positive. In October 2022, X-ray: Sinuses were totally blocked.  She was prescribed with another nasal spray. She had a teledoc on 24Aug2022. Patient had not experienced similar events in the past.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis, X-ray
Clinical narrative: Had a bad sinus infection post Covid/X-ray showed sinuses were totally blocked; Nose completely blocked/congestion; Coughing; Severe headache; Tested positive for Covid-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for Covid-19), SINUSITIS (Had a bad sinus infection post Covid/X-ray showed sinuses were totally blocked), NASAL CONGESTION (Nose completely blocked/congestion), COUGH (Coughing) and HEADACHE (Severe headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 038A21A and 027A21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu vaccine (Interval of a couple of weeks with the COVID-19 Vaccine) in October 2021. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Soy allergy (Soy intolerance), Drug allergy (keflex), Sulfonamide allergy (Sulfa drugs) and Type 2 diabetes mellitus. Concomitant products included METFORMIN for Type 2 diabetes mellitus.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2022, the patient experienced COVID-19 (Tested positive for Covid-19). On an unknown date, the patient experienced SINUSITIS (Had a bad sinus infection post Covid/X-ray showed sinuses were totally blocked), NASAL CONGESTION (Nose completely blocked/congestion), COUGH (Coughing) and HEADACHE (Severe headache). The patient was treated with CEFPROZIL at an unspecified dose and frequency and IVERMECTIN at an unspecified dose and frequency. On 21-Oct-2022, HEADACHE (Severe headache) had resolved. At the time of the report, COVID-19 (Tested positive for Covid-19), SINUSITIS (Had a bad sinus infection post Covid/X-ray showed sinuses were totally blocked), NASAL CONGESTION (Nose completely blocked/congestion) and COUGH (Coughing) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Aug-2022, SARS-CoV-2 test: Positive. In October 2022, X-ray: Sinuses were totally blocked.  She was prescribed with another nasal spray. She had a teledoc on 24Aug2022. Patient had not experienced similar events in the past.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Breakthrough covid infection 37 days after bivalent booster; This spontaneous case was reported by a consumer and describes the occurrence of BREAKTHROUGH COVID-19 (Breakthrough covid infection 37 days after bivalent booster) in a 56-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. A57140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 50 milliliter. On 16-Oct-2022, the patient experienced BREAKTHROUGH COVID-19 (Breakthrough covid infection 37 days after bivalent booster). At the time of the report, BREAKTHROUGH COVID-19 (Breakthrough covid infection 37 days after bivalent booster) was resolving.            No concomitant medication was provided.  Reportedly, patient 2 parents and mother-in-la were having breakthrough infections, all also bivalent boostered, elderly and with no means of reporting and not sure of lot but all received Moderna bivalent booster the second week of September 2022.   It was unknown if the patient experienced any additional symptoms/events.  Treatment medication was not provided by the reporter.   Reporter did not allow further contact
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; Administration error: 7 patients received 0.25 mL doses instead of 0.50 mL of bivalent; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Administration error: 7 patients received 0.25 mL doses instead of 0.50 mL of bivalent) and NO ADVERSE EVENT (No adverse event) in a 78-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 21-Oct-2022, the patient experienced UNDERDOSE (Administration error: 7 patients received 0.25 mL doses instead of 0.50 mL of bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Administration error: 7 patients received 0.25 mL doses instead of 0.50 mL of bivalent) 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 (Administration error: 7 patients received 0.25 mL doses instead of 0.50 mL of bivalent).    Concomitant medications were not reported. It was unknown if patients reported any AEs. No treatment information was provided by the reporter.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Administration error: 7 patients received 0.25 mL doses instead of 0.50 mL of bivalent; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Administration error: 7 patients received 0.25 mL doses instead of 0.50 mL of bivalent) and NO ADVERSE EVENT (No adverse event) in a 75-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 21-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Administration error: 7 patients received 0.25 mL doses instead of 0.50 mL of bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Administration error: 7 patients received 0.25 mL doses instead of 0.50 mL of bivalent) 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 ACCIDENTAL UNDERDOSE (Administration error: 7 patients received 0.25 mL doses instead of 0.50 mL of bivalent).    No concomitant medications were reported. No treatment medications were reported. 7 patients received 0.25 mL doses instead of 0.50 mL of Moderna COVID-19 Vaccine Bivalent on 21Oct2022.   This case was linked to US-MODERNATX, INC.-MOD-2022-663507, US-MODERNATX, INC.-MOD-2022-663578 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-663578: US-MODERNATX, INC.-MOD-2022-663507:
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Administration error: Patient received 0.25 mL dose instead of 0.50 mL of bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Administration error: Patient received 0.25 mL dose instead of 0.50 mL of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 76-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 21-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Administration error: Patient received 0.25 mL dose instead of 0.50 mL of bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Administration error: Patient received 0.25 mL dose instead of 0.50 mL of bivalent vaccine) 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 ACCIDENTAL UNDERDOSE (Administration error: Patient received 0.25 mL dose instead of 0.50 mL of bivalent vaccine).    No concomitant medications were reported. It was unknown if patient experienced any AE. Total 7 patients received 0.25 mL doses instead of 0.50 mL of Moderna COVID-19 Vaccine Bivalent vaccine. No treatment details were reported.
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; Administration error: Patient received 0.25 mL dose instead of 0.50 mL of bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Administration error: Patient received 0.25 mL dose instead of 0.50 mL of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 59-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 21-Oct-2022, the patient experienced UNDERDOSE (Administration error: Patient received 0.25 mL dose instead of 0.50 mL of bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Administration error: Patient received 0.25 mL dose instead of 0.50 mL of bivalent vaccine) 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 (Administration error: Patient received 0.25 mL dose instead of 0.50 mL of bivalent vaccine).    Concomitant product use was not provided by the reporter.  Patient received 0.25 mL doses instead of 0.50 mL of Moderna COVID-19 Vaccine Bivalent vaccine.  It was unknown if patient experienced any AE.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-663507, US-MODERNATX, INC.-MOD-2022-663474, US-MODERNATX, INC.-MOD-2022-663502, US-MODERNATX, INC.-MOD-2022-663552, US-MODERNATX, INC.-MOD-2022-663563, US-MODERNATX, INC.-MOD-2022-663577 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-663507:Same reporter US-MODERNATX, INC.-MOD-2022-663474:Same reporter US-MODERNATX, INC.-MOD-2022-663502:Same reporter US-MODERNATX, INC.-MOD-2022-663552:Same reporter US-MODERNATX, INC.-MOD-2022-663563:Same reporter US-MODERNATX, INC.-MOD-2022-663577:Same reporter
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Pain in extremity
Clinical narrative: left arm was a little sore; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (left arm was a little sore) in a male 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.    Co-suspect product included non-company product INFLUENZA VACCINE (INFLUENZA) for an unknown indication.    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 and dose of INFLUENZA VACCINE (INFLUENZA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (left arm was a little sore). At the time of the report, PAIN IN EXTREMITY (left arm was a little sore) outcome was unknown.            No relevant concomitant medications were reported.  Patient received annual flu shot and COVID-19 Moderna updated booster. No treatment information was provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Breast swelling, Constipation, Lymphadenopathy, Muscle spasms
Clinical narrative: Severe abdominal pain; cramping with constipation; cramping with constipation; lymphadenopathy; breast swelling; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 at 10:00 as dose 4 (booster), single (Lot number: G32525610123) at the age of 56 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Yes-I have predicatable immune responses to all vaccines" (unspecified if ongoing), notes: Yes- I have predicatable immune responses to all, vaccines. This is different. Environmental; "Environmental" (unspecified if ongoing), notes: Yes- I have predicatable immune responses to all, vaccines. This is different. Environmental. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, on 10Oct2022; ZOCOR. Vaccination history included: BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot number: FH8028212822), administration date: 29Nov2021, when the patient was 55-year-old, for Covid-19 immunization, reaction(s): "breast swelling"; BNT162b2 (DOSE 2, SINGLE, Lot number: EL3248), administration date: 12Jan2021, when the patient was 55-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 1, SINGLE, Lot number: EJ1685), administration date: 22Dec2020, for COVID-19 Immunization. The following information was reported: ABDOMINAL PAIN (non-serious) with onset 21Oct2022 at 03:00, outcome "recovering", described as "Severe abdominal pain"; BREAST SWELLING (non-serious) with onset 21Oct2022 at 03:00, outcome "recovering"; MUSCLE SPASMS (non-serious), CONSTIPATION (non-serious) all with onset 21Oct2022 at 03:00, outcome "recovering" and all described as "cramping with constipation"; LYMPHADENOPATHY (non-serious) with onset 21Oct2022 at 03:00, outcome "recovering". Therapeutic measures were not taken as a result of abdominal pain, muscle spasms, constipation, lymphadenopathy, breast swelling.  Follow-up (26Oct2022): Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Confusional state, Diarrhoea, Fatigue
Clinical narrative: high fever; chills; uncontrolled shivering; diarrhea; fatigue; malaise; confusion; upset stomach; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Oct2022 at 17:45 as dose 5 (booster), single (Lot number: GH9693) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "MEDICATED BP" (unspecified if ongoing); "HYPOTHYROID" (unspecified if ongoing); "UNPROVOKED DVT" (unspecified if ongoing). Concomitant medication(s) included: XARELTO; SYNTHROID; BENICAR; VALACYCLOVIR [VALACICLOVIR]; AREDS; VITAMIN B12 NOS. Past drug history included: Doxycyclin, reaction(s): "Known allergies: DOXYCYCLIN". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: PAA156051; Location of injection: Arm Left; Vaccine Administration Time: 09:30 AM), administration date: Jan2021, when the patient was 72 years old, for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE; Lot number: Unknown; Location of injection: Arm Left; Vaccine Administration Time: 10:30 AM), administration date: Feb2021, when the patient was 72 years old, for Covid-19 immunization; Bnt162b2 (DOSE 3, SINGLE; Lot Number: FD8448; Location of injection: Arm Left; Vaccine Administration Time: 02:30 PM), administration date: Aug2021, when the patient was 73 years old, for Covid-19 immunization; Bnt162b2 (DOSE 4, SINGLE; Lot Number: FM7553; Location of injection: Arm Left; Vaccine Administration Time: 02:30 PM), administration date: May2022, when the patient was 73 years old, for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 18Oct2022 at 22:00, outcome "recovering"; CONFUSIONAL STATE (non-serious) with onset 18Oct2022 at 22:00, outcome "recovering", described as "confusion"; DIARRHOEA (non-serious) with onset 18Oct2022 at 22:00, outcome "recovering", described as "diarrhea"; FATIGUE (non-serious) with onset 18Oct2022 at 22:00, outcome "recovering"; PYREXIA (non-serious) with onset 18Oct2022 at 22:00, outcome "recovering", described as "high fever"; MALAISE (non-serious) with onset 18Oct2022 at 22:00, outcome "recovering"; CHILLS (non-serious) with onset 18Oct2022 at 22:00, outcome "recovering", described as "uncontrolled shivering"; ABDOMINAL DISCOMFORT (non-serious) with onset 18Oct2022 at 22:00, outcome "recovering", described as "upset stomach". Therapeutic measures were not taken as a result of pyrexia, chills, chills, diarrhoea, fatigue, malaise, confusional state, abdominal discomfort.   Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: high fever; chills; uncontrolled shivering; diarrhea; fatigue; malaise; confusion; upset stomach; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Oct2022 at 17:45 as dose 5 (booster), single (Lot number: GH9693) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "MEDICATED BP" (unspecified if ongoing); "HYPOTHYROID" (unspecified if ongoing); "UNPROVOKED DVT" (unspecified if ongoing). Concomitant medication(s) included: XARELTO; SYNTHROID; BENICAR; VALACYCLOVIR [VALACICLOVIR]; AREDS; VITAMIN B12 NOS. Past drug history included: Doxycyclin, reaction(s): "Known allergies: DOXYCYCLIN". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: PAA156051; Location of injection: Arm Left; Vaccine Administration Time: 09:30 AM), administration date: Jan2021, when the patient was 72 years old, for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE; Lot number: Unknown; Location of injection: Arm Left; Vaccine Administration Time: 10:30 AM), administration date: Feb2021, when the patient was 72 years old, for Covid-19 immunization; Bnt162b2 (DOSE 3, SINGLE; Lot Number: FD8448; Location of injection: Arm Left; Vaccine Administration Time: 02:30 PM), administration date: Aug2021, when the patient was 73 years old, for Covid-19 immunization; Bnt162b2 (DOSE 4, SINGLE; Lot Number: FM7553; Location of injection: Arm Left; Vaccine Administration Time: 02:30 PM), administration date: May2022, when the patient was 73 years old, for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 18Oct2022 at 22:00, outcome "recovering"; CONFUSIONAL STATE (non-serious) with onset 18Oct2022 at 22:00, outcome "recovering", described as "confusion"; DIARRHOEA (non-serious) with onset 18Oct2022 at 22:00, outcome "recovering", described as "diarrhea"; FATIGUE (non-serious) with onset 18Oct2022 at 22:00, outcome "recovering"; PYREXIA (non-serious) with onset 18Oct2022 at 22:00, outcome "recovering", described as "high fever"; MALAISE (non-serious) with onset 18Oct2022 at 22:00, outcome "recovering"; CHILLS (non-serious) with onset 18Oct2022 at 22:00, outcome "recovering", described as "uncontrolled shivering"; ABDOMINAL DISCOMFORT (non-serious) with onset 18Oct2022 at 22:00, outcome "recovering", described as "upset stomach". Therapeutic measures were not taken as a result of pyrexia, chills, chills, diarrhoea, fatigue, malaise, confusional state, abdominal discomfort.   Follow-up attempts are completed. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19, FLUC3
Symptoms: Erythema multiforme, Product use issue, Rash, SARS-CoV-2 test
Clinical narrative: Diagnosed as erythema multiforme; Developed an all over body rash 9 days after vaccine; Other vaccine same date product: Flucelvax Quadrivalent Serqirus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 at 20:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 12 years, in right arm for covid-19 immunisation; influenza vaccine inact sag 4v (FLUCELVAX QUADRIVALENT), on 10Oct2022 as dose 1, single (Batch/Lot number: unknown), in right deltoid for immunisation. The patient's relevant medical history included: "If COVID prior vaccination: Yes" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. Patient did not have any known allergies. Concomitant medication(s) included: AMOXICILLIN. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EW0153, Location of injection: Arm Right), administration date: 18Jun2021, when the patient was 11-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EW0187, Location of injection: Arm Right), administration date: 28May2021, when the patient was 11-year-old, for COVID-19 immunization Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 10Oct2022, outcome "unknown", described as "Other vaccine same date product: Flucelvax Quadrivalent Serqirus"; RASH (medically significant) with onset 19Oct2022 at 06:00, outcome "not recovered", described as "Developed an all over body rash 9 days after vaccine"; ERYTHEMA MULTIFORME (medically significant) with onset 19Oct2022 at 06:00, outcome "not recovered", described as "Diagnosed as erythema multiforme". The events "diagnosed as erythema multiforme" and "developed an all over body rash 9 days after vaccine" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Oct2022) Negative, notes: COVID test type post vaccination: Nasal Swab. Therapeutic measures were taken as a result of erythema multiforme, rash with Medrol dose pack- d/c after day 1 and Benadryl.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: shot done in the left arm and between my shoulder and my heart, I was getting shooting pain every once in a while; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset Oct2022, outcome "recovered" (Oct2022), described as "shot done in the left arm and between my shoulder and my heart, I was getting shooting pain every once in a while". The events "shot done in the left arm and between my shoulder and my heart, I was getting shooting pain every once in a while" required emergency room visit.  Additional information: The patient stated, "In Oct2022 (Monday) the patient got the Booster shot (Clarified as Pfizer COVID-19 Vaccine) and 21Oct2022 (yesterday) morning the patient had a shot done in the left arm and between shoulder and heart the patient was getting shooting pain every once in a while. So, the patient went to the emergency room, the patient figured may be something was with the heart, but they checked out everything, heart was fine, there was no problem. The patient asked them if this could have been because of the shot, again the patient got it into the left arm and Oct2022 (Friday) the patient started to get that shooting pain that only left for couple of second then go away, so the patient don't know if certainly to do with shot or not. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Gait disturbance, Heart rate, Heart rate increased, Hypoaesthesia, Pallor
Clinical narrative: the ground started feeling like it was moving; pale; trouble walking; heart rate while napping was 136-173; face felt numb and pins and needles on the left side/whole left arm went numb; face felt numb and pins and needles on the left side; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 14:00 as dose 4 (booster), single (Lot number: GH9702) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ehlers Danlos Syndrome" (unspecified if ongoing); "Allergy: Penicillin" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for Covid-19 immunisation. The following information was reported: PARAESTHESIA (non-serious) with onset 10Sep2022 at 13:30, outcome "recovering", described as "face felt numb and pins and needles on the left side"; HYPOAESTHESIA (non-serious) with onset 10Sep2022 at 13:30, outcome "recovering", described as "face felt numb and pins and needles on the left side/whole left arm went numb"; HEART RATE INCREASED (non-serious) with onset 10Sep2022 at 13:30, outcome "recovering", described as "heart rate while napping was 136-173"; PALLOR (non-serious) with onset 10Sep2022 at 13:30, outcome "recovering", described as "pale"; VERTIGO (non-serious) with onset 10Sep2022 at 13:30, outcome "recovering", described as "the ground started feeling like it was moving"; GAIT DISTURBANCE (non-serious) with onset 10Sep2022 at 13:30, outcome "recovering", described as "trouble walking". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vertigo, pallor, gait disturbance, heart rate increased, hypoaesthesia, paraesthesia.  Additional information: There was no other vaccine in 4 weeks. About 24 hours after the bivalent vaccine the ground started feeling like it was moving and the patient became pale and had trouble walking. The patient got to bed and felt asleep. According to her watch the patient's heart rate while napping was 136-173. The patient's normal resting heart rate was in the 60s. The patient woke up about 2-3 hours later and face felt numb and pins and needles on the left side and whole left arm went numb. The patient felt back asleep. This time heart rate was 78-164 bpm. When the patient woke up again, started feeling better by about an hour later.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paraesthesia, Vertigo
Clinical narrative: the ground started feeling like it was moving; pale; trouble walking; heart rate while napping was 136-173; face felt numb and pins and needles on the left side/whole left arm went numb; face felt numb and pins and needles on the left side; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 14:00 as dose 4 (booster), single (Lot number: GH9702) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ehlers Danlos Syndrome" (unspecified if ongoing); "Allergy: Penicillin" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for Covid-19 immunisation. The following information was reported: PARAESTHESIA (non-serious) with onset 10Sep2022 at 13:30, outcome "recovering", described as "face felt numb and pins and needles on the left side"; HYPOAESTHESIA (non-serious) with onset 10Sep2022 at 13:30, outcome "recovering", described as "face felt numb and pins and needles on the left side/whole left arm went numb"; HEART RATE INCREASED (non-serious) with onset 10Sep2022 at 13:30, outcome "recovering", described as "heart rate while napping was 136-173"; PALLOR (non-serious) with onset 10Sep2022 at 13:30, outcome "recovering", described as "pale"; VERTIGO (non-serious) with onset 10Sep2022 at 13:30, outcome "recovering", described as "the ground started feeling like it was moving"; GAIT DISTURBANCE (non-serious) with onset 10Sep2022 at 13:30, outcome "recovering", described as "trouble walking". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vertigo, pallor, gait disturbance, heart rate increased, hypoaesthesia, paraesthesia.  Additional information: There was no other vaccine in 4 weeks. About 24 hours after the bivalent vaccine the ground started feeling like it was moving and the patient became pale and had trouble walking. The patient got to bed and felt asleep. According to her watch the patient's heart rate while napping was 136-173. The patient's normal resting heart rate was in the 60s. The patient woke up about 2-3 hours later and face felt numb and pins and needles on the left side and whole left arm went numb. The patient felt back asleep. This time heart rate was 78-164 bpm. When the patient woke up again, started feeling better by about an hour later.