chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dysphagia, Pyrexia, Rash
Clinical narrative: A spontaneous report was received from a healthcare facility staff member concerning a female patient of unknown age, unknown race and ethnic group, who received Modern's COVID-19 vaccine (mRNA-1273)  and experienced anaphylactic reaction, rash all over body, fever and difficulty in swallowing. The patient's medical history was not reported. No relevant concomitant medications were reported. On 30 JAN 2021, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (lot/batch: 041L20A) intramuscularly for prophylaxis of COVID-19 infection. On the same day had fever and trouble swallowing, the reporter mentioned it was almost anaphylaxis reaction. On 31 JAN 2021, the patient developed rash and is still ongoing. On 01 Feb 2021, the patient was treated at urgent care. Treatment information provided was Ibuprofen, Benadryl, and steroids. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events is not applicable. The events, anaphylactic reaction, rash, fever and difficulty in swallowing were considered not resolved or non recovered. Reporter's Comments: This case concerns a female of unknown age who had a serious expected event of anaphylactic reaction along with non-serious unexpected events of dysphagia, rash and a non-serious expected event of fever. Event onset 10 hours after the first dose of mRNA-1273. Treated with Benadryl, ibuprofen, steroids. Events not resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Pain in jaw
Clinical narrative: A spontaneous report was received from a physician concerning a 28-year old male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced anaphylactic episode and Pain in jaws. The patient's medical history was not provided. No relevant concomitant medications were reported. On 26 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (batch unknown) intramuscularly for prophylaxis of COVID-19 infection. On 26 Feb 2021, after the administration of the vaccine, the patient began to experience severe throat swelling and pain in jaw. It was believed that the patient was experiencing an anaphylactic episode and Benadryl (Diphenhydramine) was given as a treatment. The adverse event of anaphylactic episode was assessed as medically significant. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, anaphylactic episode and Pain in Jaws were unknown. Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded. Further information has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: A spontaneous report was received from physician concerning a 56-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylactic reaction. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On an unknown date, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient could not breathe and experienced anaphylactic reaction for which was hospitalized. Treatment for the event included epinephrine. Action taken with mRNA-1273 in response to the event was not provided. At the time of the report, the outcome of the event was recovering. Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic shock, Dyspnoea, Headache, Pruritus, Rash
Clinical narrative: Itching all over body, face and ass; Feeling drowsy because of medication; Rash all over the body and on face going down; Little congested in throat; Extremely bad headache; Anaphylactic shock; Trouble in breathing; Face swollen; A spontaneous report was received from a consumer concerning a 50-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylactic shock, face was swelling, trouble in breathing, bad headache, itching all over body, face and ass, and feeling drowsy because of medication, rash all over the body and on face going down, feeling little congested in her throat.   The patient's medical history, was not provided by the reporter. Concomitant medications were not reported.   On 25 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 040A21A) intramuscularly in left hand for prophylaxis of COVID-19 infection.   On 25 Mar 2021, after 15 to 20 minutes after vaccination she got anaphylactic shock. Her pharmacist noticed that her face was swelling, she was trouble in breathing. Pharmacist gave her diphenhydramine and inject her epinephrine pen in her right thigh and send her to hospital. In the ambulance they gave her diphenhydramine through IM and she got discharged from hospital on 25 Mar 2021 in night.  On 26 Mar 2021 she woke up with extremely bad headache, itching all over body, face and ass and feeling drowsy because of medication, rash all over the body and on face going down, she was feeling little congested in her throat.  Treatment for the events included epinephrine, diphenhydramine, prednisolone, and famotidine.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, anaphylactic shock, face was swelling, trouble in breathing, bad headache, itching all over body, face and ass, and feeling drowsy because of medication, rash all over the body and on face going down, and feeling little congested in her throat were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Swelling face, Upper respiratory tract congestion
Clinical narrative: Itching all over body, face and ass; Feeling drowsy because of medication; Rash all over the body and on face going down; Little congested in throat; Extremely bad headache; Anaphylactic shock; Trouble in breathing; Face swollen; A spontaneous report was received from a consumer concerning a 50-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylactic shock, face was swelling, trouble in breathing, bad headache, itching all over body, face and ass, and feeling drowsy because of medication, rash all over the body and on face going down, feeling little congested in her throat.   The patient's medical history, was not provided by the reporter. Concomitant medications were not reported.   On 25 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 040A21A) intramuscularly in left hand for prophylaxis of COVID-19 infection.   On 25 Mar 2021, after 15 to 20 minutes after vaccination she got anaphylactic shock. Her pharmacist noticed that her face was swelling, she was trouble in breathing. Pharmacist gave her diphenhydramine and inject her epinephrine pen in her right thigh and send her to hospital. In the ambulance they gave her diphenhydramine through IM and she got discharged from hospital on 25 Mar 2021 in night.  On 26 Mar 2021 she woke up with extremely bad headache, itching all over body, face and ass and feeling drowsy because of medication, rash all over the body and on face going down, she was feeling little congested in her throat.  Treatment for the events included epinephrine, diphenhydramine, prednisolone, and famotidine.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, anaphylactic shock, face was swelling, trouble in breathing, bad headache, itching all over body, face and ass, and feeling drowsy because of medication, rash all over the body and on face going down, and feeling little congested in her throat were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (Anaphylaxis) outcome was unknown. not provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Dyspnoea, Pyrexia, Tremor
Clinical narrative: just hit me, it comes real quick and make me breath kinda short; tight around the chest; CHILLS; fever (around 100); shaking; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (just hit me, it comes real quick and make me breath kinda short) and CHEST DISCOMFORT (tight around the chest) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced CHEST DISCOMFORT (tight around the chest) (seriousness criterion medically significant), CHILLS (CHILLS), PYREXIA (fever (around 100)) and TREMOR (shaking). On 02-Apr-2021, the patient experienced DYSPNOEA (just hit me, it comes real quick and make me breath kinda short) (seriousness criterion medically significant). At the time of the report, DYSPNOEA (just hit me, it comes real quick and make me breath kinda short), CHEST DISCOMFORT (tight around the chest), CHILLS (CHILLS), PYREXIA (fever (around 100)) and TREMOR (shaking) was resolving.            Concomitant product use was not provided by the reporter. No treatment information was provided.  This case concerns a male of unknown age with serious unexpected events of chest discomfort and dyspnea, along with nonserious unexpected tremor and expected pyrexia and chills. Event onset on Day 1 after first dose of mRNA-1273. Event resolving. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a male of unknown age with serious unexpected events of chest discomfort and dyspnea, along with nonserious unexpected tremor and expected pyrexia and chills. Event onset on Day 1 after first dose of mRNA-1273. Event resolving. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic reaction; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion hospitalization). At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ANAPHYLACTIC REACTION (Anaphylactic reaction) to be not related.    No concomitant medication reported. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, causal relationship cannot be excluded.  Doctor stated event was totally unrelated to the vaccine.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Asthenia, Discomfort, Dysgeusia, Feeding disorder
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction within 3-4 minutes after) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for an unknown indication. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Immunocompromised. Previously administered products included for an unreported indication: METHOTREXATE (Stopped 1 week before Vaccination). Concurrent medical conditions included Drug allergy (Anaphylactic reaction, mild, swollen lips). On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction within 3-4 minutes after) (seriousness criteria hospitalization and medically significant), DYSGEUSIA (Metallic taste), PHARYNGEAL SWELLING (Throat started to feel like it was closing/swelling), FEEDING DISORDER (Could not eat), FLUSHING (Whole upper body was flushed), DISCOMFORT (Whole upper body felt like it got heavy), SWOLLEN TONGUE (Tongue was swollen) and ASTHENIA (Left side was so weak). The patient was hospitalized from 30-Mar-2021 to 31-Mar-2021 due to ANAPHYLACTIC REACTION. At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic reaction within 3-4 minutes after), DYSGEUSIA (Metallic taste), PHARYNGEAL SWELLING (Throat started to feel like it was closing/swelling), FEEDING DISORDER (Could not eat), FLUSHING (Whole upper body was flushed), DISCOMFORT (Whole upper body felt like it got heavy), SWOLLEN TONGUE (Tongue was swollen), ASTHENIA (Left side was so weak) and HEADACHE (Headache) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Sender's Comments: This case concerns a 53-year-old female hospitalized with a serious expected event of anaphylactic reaction, and non-serious unexpected pharyngeal swelling, swollen tongue, dysgeusia, feeding disorder, flushing, discomfort, asthenia and expected headache. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Headache, Pharyngeal swelling, Swollen tongue
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction within 3-4 minutes after) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for an unknown indication. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Immunocompromised. Previously administered products included for an unreported indication: METHOTREXATE (Stopped 1 week before Vaccination). Concurrent medical conditions included Drug allergy (Anaphylactic reaction, mild, swollen lips). On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction within 3-4 minutes after) (seriousness criteria hospitalization and medically significant), DYSGEUSIA (Metallic taste), PHARYNGEAL SWELLING (Throat started to feel like it was closing/swelling), FEEDING DISORDER (Could not eat), FLUSHING (Whole upper body was flushed), DISCOMFORT (Whole upper body felt like it got heavy), SWOLLEN TONGUE (Tongue was swollen) and ASTHENIA (Left side was so weak). The patient was hospitalized from 30-Mar-2021 to 31-Mar-2021 due to ANAPHYLACTIC REACTION. At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic reaction within 3-4 minutes after), DYSGEUSIA (Metallic taste), PHARYNGEAL SWELLING (Throat started to feel like it was closing/swelling), FEEDING DISORDER (Could not eat), FLUSHING (Whole upper body was flushed), DISCOMFORT (Whole upper body felt like it got heavy), SWOLLEN TONGUE (Tongue was swollen), ASTHENIA (Left side was so weak) and HEADACHE (Headache) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Sender's Comments: This case concerns a 53-year-old female hospitalized with a serious expected event of anaphylactic reaction, and non-serious unexpected pharyngeal swelling, swollen tongue, dysgeusia, feeding disorder, flushing, discomfort, asthenia and expected headache. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue, Underdose
Clinical narrative: doses administered after excursion , Temperature excursion on 22-Aug-2022 to 04-Sep-2022; No Adverse event; Administered 3 doses that experienced the excursions; Patient received 0.25 ml as a first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered 3 doses that experienced the excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion , Temperature excursion on 22-Aug-2022 to 04-Sep-2022), UNDERDOSE (Patient received 0.25 ml as a first dose) and NO ADVERSE EVENT (No Adverse event) in a 70-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 014B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Aug-2022 at 10:00 AM, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .25 milliliter. On 22-Aug-2022 at 10:00 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered 3 doses that experienced the excursions) and UNDERDOSE (Patient received 0.25 ml as a first dose). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion , Temperature excursion on 22-Aug-2022 to 04-Sep-2022) and NO ADVERSE EVENT (No Adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered 3 doses that experienced the excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion , Temperature excursion on 22-Aug-2022 to 04-Sep-2022), UNDERDOSE (Patient received 0.25 ml as a first dose) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Administered 3 doses that experienced the excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion , Temperature excursion on 22-Aug-2022 to 04-Sep-2022) and UNDERDOSE (Patient received 0.25 ml as a first dose).    No concomitant medications were reported.  Vaccine was stored in fridge at the time of excursion. The maximum temperature reached was 52.8 Fahrenheit and the excursion duration was 8 days, 16 hours, and 30 minutes. on 22-Aug-2022 the vial was moved from freezer to refrigerator and vaccine was stored in fridge as of now. Total 3 doses were impacted from the vial. A total of 3 doses were administered with no previous excursions. On 05-Sep-2022 fridge died, ever since the fridge went out of range that past weekend and no doses was administered. The temperature went up to 70 degree and the vaccine in that fridge were moved to another fridge.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2022: Follow Up received included- Case became valid. Patient information, Dosage information updated. On 15-Sep-2022: Non Significant follow up appended
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; may not have completed a primary vaccination series prior to receiving the bivalent product; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (may not have completed a primary vaccination series prior to receiving the bivalent product) and NO ADVERSE EVENT (No adverse event) in a 39-year-old female 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 prophylaxis.     No Medical History information was reported.    On 08-Sep-2022, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 08-Sep-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (may not have completed a primary vaccination series prior to receiving the bivalent product). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (may not have completed a primary vaccination series prior to receiving the bivalent product) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (may not have completed a primary vaccination series prior to receiving the bivalent product).    No concomitant medications were reported.  It was reported that patient received the first dose of the Moderna COVID-19 vaccine by intramuscular injection on 8-Feb-2022 (lot number 083J21A, expiration date 3-May-2022, monovalent product).  It was reported that patient had not reported any symptoms. No additional doses, medications had been administered at this time.  No treatment medications were reported.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; patient was administer half the dosage of the bivalent vaccine; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (patient was administer half the dosage of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 68-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for an unknown indication.     The patient's past medical history included Dental cavity. Previously administered products included for Product used for unknown indication: Flu shot in December 2020. Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Drug allergy, Drug allergy, Drug allergy, Heart disease, unspecified, Atrial fibrillation, Type 2 diabetes mellitus, High cholesterol and Blood pressure high. Concomitant products included WARFARIN SODIUM (COUMADIN), METFORMIN HYDROCHLORIDE (METFORMIN HCL), METOPROLOL and GABAPENTIN for an unknown indication.    On 12-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 12-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (patient was administer half the dosage of the bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (patient was administer half the dosage of the 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (patient was administer half the dosage of the bivalent vaccine).    Patient only received half the dose 0.25ml and patient wanted to know when the patient should receive the other 0.25 ml shot to complete the shot. Patient was taking other medication.  On 05Feb2021, patient received first dose of Moderna vaccine 0.5 milliliters, batch lot no 015N20A on Left Deltoid. On 05Mar2021, patient received second dose of Moderna vaccine 0.5 milliliters, batch lot no 032M20A on Left Deltoid. On 23Aug2021, patient received first booster dose of Moderna vaccine batch lot no 091D on Left Deltoid. Treatment medications were not reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: some arm soreness; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (some arm soreness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020L20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Neuromuscular disorder NOS and Bronchiectasis (Bronchiectasis in one of the lobes of her lungs). Concomitant products included BUPROPION HYDROCHLORIDE (BUPROPION XR 150 ADCO), DULOXETINE and AZELASTINE for an unknown indication. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (some arm soreness). At the time of the report, PAIN IN EXTREMITY (some arm soreness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment medication was not provided by the reporter.  It was reported that the patient was exposed to Family members who tested positive for Covid-19. The patient had not tested positive for Covid-19 and the patient did not have any Covid-19 Symptoms.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: Second dose administered more than 35 days of Primary dose; No adverse event; Vaccine was administered beyond use by date to 1 patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond use by date to 1 patient), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered more than 35 days of Primary dose) and NO ADVERSE EVENT (No adverse event) in a 32-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 061B22A and 052E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 09-Sep-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond use by date to 1 patient). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered more than 35 days of Primary dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond use by date to 1 patient), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered more than 35 days of Primary dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond use by date to 1 patient) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered more than 35 days of Primary dose).    Individual vials or unbroken cartons: 1 vial. Vial size: 5 ml. The vial was initially stored in the refrigerator on 1-Aug-2022. The vial had not undergone any temperature excursion. No concomitant medications was reported. No treatment medications was reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Patient administered with 0.25 mL of bivalent booster instead of 0.5 mL; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient administered with 0.25 mL of bivalent booster instead of 0.5 mL) and NO ADVERSE EVENT (No adverse event) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-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) .25 milliliter. On 14-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient administered with 0.25 mL of bivalent booster instead of 0.5 mL). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient administered with 0.25 mL of bivalent booster instead of 0.5 mL) 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 (Patient administered with 0.25 mL of bivalent booster instead of 0.5 mL).    No concomitant medication was reported.    Patient did not report any adverse events after the vaccine was administered.  No treatment information was reported.
Age: 86.0
Sex: M
Vaccine: COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Patient administered with 0.25 mL of bivalent booster instead of 0.5 mL; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient administered with 0.25 mL of bivalent booster instead of 0.5 mL) and NO ADVERSE EVENT (No adverse event) in an 86-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis. No Medical History information was reported. On 14-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) .25 milliliter. On 14-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient administered with 0.25 mL of bivalent booster instead of 0.5 mL). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient administered with 0.25 mL of bivalent booster instead of 0.5 mL) 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 (Patient administered with 0.25 mL of bivalent booster instead of 0.5 mL).    No concomitant medications were reported.  Reported that patient did not report any AEs after the vaccine was administered.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache after the 1st dose; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (headache after the 1st dose) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache after the 1st dose). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (headache after the 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter.   This case was linked to MOD-2022-645572, MOD-2022-645571.   Reporter did not allow further contact
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Administration error: 6 patients administered with 0.25 mL of bivalent booster instead of 0.5 mL; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Administration error: 6 patients administered with 0.25 mL of bivalent booster instead of 0.5 mL) and NO ADVERSE EVENT (No adverse event) in a 77-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-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) .25 milliliter. On 14-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (Administration error: 6 patients administered with 0.25 mL of bivalent booster instead of 0.5 mL). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). On 14-Sep-2022, ACCIDENTAL UNDERDOSE (Administration error: 6 patients administered with 0.25 mL of bivalent booster instead of 0.5 mL) outcome was unknown. At the time of the report, 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: 6 patients administered with 0.25 mL of bivalent booster instead of 0.5 mL).    No concomitant medication was provided by reporter.  Patient stated he administered doses of 0.25 mL instead of 0.5 mL of the Moderna COVID-19 Vaccine, Bivalent to 6 patients on 14Sep2022. Patients did not report any AEs after the vaccine was administered.  No treatment medication was provided by reporter.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Incorrect dose administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 03-AUG-2022 and administered on 08-Sep-2022; No adverse event; Dose administered after 30-day Use By Date; Received Monovalent booster instead of Bivalent booster; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), INCORRECT DOSE ADMINISTERED (Received Monovalent booster instead of Bivalent booster), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 03-AUG-2022 and administered on 08-Sep-2022) and NO ADVERSE EVENT (No adverse event) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and INCORRECT DOSE ADMINISTERED (Received Monovalent booster instead of Bivalent booster). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 03-AUG-2022 and administered on 08-Sep-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), INCORRECT DOSE ADMINISTERED (Received Monovalent booster instead of Bivalent booster), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 03-AUG-2022 and administered on 08-Sep-2022) 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 EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), INCORRECT DOSE ADMINISTERED (Received Monovalent booster instead of Bivalent booster) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 03-AUG-2022 and administered on 08-Sep-2022).    No concomitant information was reported. It was reported that patient received monovalent first booster of Moderna COVID-19 vaccine. The vial was individual vial and size of the vial was 5.5ml red cap. The vial did not underwent any temperature excursions. No treatment information was provided.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: On 18-Apr-2022 the vial was initially stored in the refrigerator and administered on 16-Aug-2022; No adverse event; We gave expired Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave expired Moderna Covid-19 vaccine), PRODUCT STORAGE ERROR (On 18-Apr-2022 the vial was initially stored in the refrigerator and administered on 16-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 057M21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: COVID-19 (Dose 1). Past adverse reactions to the above products included No adverse event with COVID-19.    On 16-Aug-2022 at 4:14 PM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 16-Aug-2022 at 4:14 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave expired Moderna Covid-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (On 18-Apr-2022 the vial was initially stored in the refrigerator and administered on 16-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave expired Moderna Covid-19 vaccine), PRODUCT STORAGE ERROR (On 18-Apr-2022 the vial was initially stored in the refrigerator and administered on 16-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (We gave expired Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (On 18-Apr-2022 the vial was initially stored in the refrigerator and administered on 16-Aug-2022).    Concomitant medication information was not provided by the reporter.  The vaccine was delivered and placed into the freezer on 18-Apr-2022.  Vaccines were only offered on Tuesdays from Mar-2022 forward. For each Tuesday vaccine date, only one vial was removed from the freezer to place in the refrigerator the day before it was used (each Monday, one vial was removed from the freezer and placed into the refrigerator).  The vial did not undergo any temperature excursion.  Treatment information was not provided by the reporter.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vaccination site erythema
Clinical narrative: dispersed red spot that lasted for 2 days on her left arm.; patient had a temperature of 104 degrees Farenheight.The fever lasted for a day; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (dispersed red spot that lasted for 2 days on her left arm.) and PYREXIA (patient had a temperature of 104 degrees Farenheight.The fever lasted for a day) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001M21A, 012F21A, 013L20A and 026L20A) for COVID-19 prophylaxis.     Patient had several surgeries.  The patient's past medical history included COVID-19 in March 2020, Back surgery and Knee surgery NOS.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2022, the patient experienced VACCINATION SITE ERYTHEMA (dispersed red spot that lasted for 2 days on her left arm.) and PYREXIA (patient had a temperature of 104 degrees Farenheight.The fever lasted for a day). In April 2022, VACCINATION SITE ERYTHEMA (dispersed red spot that lasted for 2 days on her left arm.) and PYREXIA (patient had a temperature of 104 degrees Farenheight.The fever lasted for a day) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2022, Body temperature: 104 degree Fahrenheit.         No concomitant medication was reported. The patient had received her Moderna Covid-19 vaccine primary series and two monovalent Moderna COVID-19 vaccine booster doses. It was reported that patient was on several medications and did not wish to discuss her medications. No treatment medication was reported.   This case was linked to MOD-2022-646120, MOD-2022-646131 (Patient Link).
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: On 09-AUG-2022, the vial was initially stored in the refrigerator and on 15-Sep-2022 the vaccine administared to the patient; No adverse event; Patient received vaccine past the 30 days use by date; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past the 30 days use by date), PRODUCT STORAGE ERROR (On 09-AUG-2022, the vial was initially stored in the refrigerator and on 15-Sep-2022 the vaccine administared to the patient) and NO ADVERSE EVENT (No adverse event) in a 12-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 082B22A and 082B22A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Sep-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past the 30 days use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (On 09-AUG-2022, the vial was initially stored in the refrigerator and on 15-Sep-2022 the vaccine administared to the patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past the 30 days use by date), PRODUCT STORAGE ERROR (On 09-AUG-2022, the vial was initially stored in the refrigerator and on 15-Sep-2022 the vaccine administared to the patient) 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 EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past the 30 days use by date) and PRODUCT STORAGE ERROR (On 09-AUG-2022, the vial was initially stored in the refrigerator and on 15-Sep-2022 the vaccine administared to the patient).    No concomitant medications was reported.  On 09-Aug-2022, the vial was initially stored in the refrigerator and 3 vials were in a carton and one was selected with a dose administered to a patient on 15-Sep-2022.  The patient received the vaccine in her right arm shoulder deltoid muscle. The vial did not undergo any temperature excursions. Vial size was 5.5ml.  No treatment drug details was reported.