chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Heart rate, Lethargy, Malaise
Clinical narrative: lethargic; did not feel well for a "day or so/not feeling that great; tiredness; This spontaneous case was reported by a patient and describes the occurrence of LETHARGY (lethargic), MALAISE (did not feel well for a "day or so/not feeling that great) and FATIGUE (tiredness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A, 012M20A, 051F21A and 01M21A) for COVID-19 prophylaxis.     Concomitant products included ATORVASTATIN and METOPROLOL for an unknown indication.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LETHARGY (lethargic), MALAISE (did not feel well for a "day or so/not feeling that great) and FATIGUE (tiredness). At the time of the report, LETHARGY (lethargic), MALAISE (did not feel well for a "day or so/not feeling that great) and FATIGUE (tiredness) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, Heart rate: patient documented a Pulse of 85. On 06-Feb-2021, Heart rate: had a slightly elevated pulse for 12 hours.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had a high pulse for 1 day after 1 dose of moderna primary series. On 13 January 2021 the patient documented a Pulse of 85. The patient was documenting his own pulse rates. Patient did not feel well for a day or so.  On 06 February 2021 the patient received his second Moderna primary series dose and had a slightly elevated pulse for 12 hours. Patient did not feel well for 24 to 36 hours. Patient reported not feeling that great tiredness, lethargic.  Patient reported not feeling that great tiredness and lethargic after monovalent booster first and second dose.  No treatment medication details were provided.   This case was linked to MOD-2023-694310 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: facility the patient received the bivalent booster of Moderna COVID 19 vaccine as a first dose/Patient hadn't received any other dose before; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (facility the patient received the bivalent booster of Moderna COVID 19 vaccine as a first dose/Patient hadn't received any other dose before) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (facility the patient received the bivalent booster of Moderna COVID 19 vaccine as a first dose/Patient hadn't received any other dose before) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (facility the patient received the bivalent booster of Moderna COVID 19 vaccine as a first dose/Patient hadn't received any other dose before) 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 WRONG PRODUCT ADMINISTERED (facility the patient received the bivalent booster of Moderna COVID 19 vaccine as a first dose/Patient hadn't received any other dose before).    No concomitant medications were reported.  Consultant pharmacist stated that in a facility the patient received the bivalent booster of Moderna COVID 19 vaccine as a first dose. Patient hadn't received any other dose before. Caller stated that the CDC indicates that they should get the monovalent vaccine right away.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: A patient got a dose of Moderna Covid-19 vaccine, Bivalent for their 1st dose, instead of the monovalent vaccine.; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (A patient got a dose of Moderna Covid-19 vaccine, Bivalent for their 1st dose, instead of the monovalent vaccine.) and NO ADVERSE EVENT (No Adverse Event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 052D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (A patient got a dose of Moderna Covid-19 vaccine, Bivalent for their 1st dose, instead of the monovalent vaccine.) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (A patient got a dose of Moderna Covid-19 vaccine, Bivalent for their 1st dose, instead of the monovalent 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 WRONG PRODUCT ADMINISTERED (A patient got a dose of Moderna Covid-19 vaccine, Bivalent for their 1st dose, instead of the monovalent vaccine.).    No concomitant medications were provided. No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: hypertension; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPERTENSION (hypertension) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Patient did not have any other medical states.  Previously administered products included for Drug use for unknown indication: METOPROLOL and ATORVASTATIN. Past adverse reactions to the above products included No adverse event with ATORVASTATIN and METOPROLOL.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (hypertension). At the time of the report, HYPERTENSION (hypertension) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: No adverse event; Circumstance or information capable of leading to a medication error; This spontaneous case was reported by a patient and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to a medication error) and NO ADVERSE EVENT (No adverse event) in an adult 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 prophylaxis.     No Medical History information was reported.    On 30-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 30-Nov-2022, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to a medication error). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to a medication error) 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 CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to a medication error).    No concomitant products reported.  Reporter stated that she received 5 doses of Moderna COVID-19 vaccine. She received the last dose on 30 Nov 2022 Bivalent Booster at a local pharmacy. She states that her chart medical records online showed all information except the last dose had a different lot online in her chart. The Lot  on vaccination card 021H22A  NDC 80777028299. The Lot online her chart showed 021H22AS. In the website, her chart stated that the lot  belongs to 6 to 11 year age group. She stated that the pharmacy tech ensured her that she received the correct dose and even provided her with the NDC number.   No treatment products reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Moderna was stored in the fridge on 17Aug2022 and beyond use date was on 17Sept2022; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Moderna was stored in the fridge on 17Aug2022 and beyond use date was on 17Sept2022) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 053B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Nov-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna was stored in the fridge on 17Aug2022 and beyond use date was on 17Sept2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Moderna was stored in the fridge on 17Aug2022 and beyond use date was on 17Sept2022) 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 (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Moderna was stored in the fridge on 17Aug2022 and beyond use date was on 17Sept2022).    No concomitant medications were reported.  It was reported the Moderna vaccine was stored in the fridge on 17-Aug-2022 and beyond use date was on 17-Sep-2022. Individual vials or unbroken cartons was 2 vials. The product was expired on 24-NOV-2022.  It was reported Vial size 5.5 mL with 10-dose vials.  The vial did not undergo any temperature excursions.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-679876 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-679876:Case for patient who received dose on 28Nov2022
Sex: U
Vaccine: COVID19
Symptoms: Carditis
Clinical narrative: Sufffer heart inflamation for a year now from this vacctine; This spontaneous case was reported by a patient and describes the occurrence of CARDITIS (Sufffer heart inflamation for a year now from this vacctine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDITIS (Sufffer heart inflamation for a year now from this vacctine) (seriousness criterion medically significant). At the time of the report, CARDITIS (Sufffer heart inflamation for a year now from this vacctine) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was provided by the reporter.  Company comment: This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the serious (medically significant) expected AESI carditis, after receiving, on an unknown date, an unspecified dose of mRNA-1273. Very limited information regarding this event has been provided at this time.  Further information has been requested. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: Company comment: This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the serious (medically significant) expected AESI carditis, after receiving, on an unknown date, an unspecified dose of mRNA-1273. Very limited information regarding this event has been provided at this time.  Further information has been requested. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Hemiplegia
Clinical narrative: left me paralyzed on my right side; Patient had a severe stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Patient had a severe stroke) and HEMIPLEGIA (left me paralyzed on my right side) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient had no history or stroke or risk previously.     On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jul-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Patient had a severe stroke) (seriousness criterion medically significant). On 24-Jan-2022, the patient experienced HEMIPLEGIA (left me paralyzed on my right side) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Patient had a severe stroke) and HEMIPLEGIA (left me paralyzed on my right side) outcome was unknown.            No concomitant medications were reported.  The patient believed that these might have been attributed to the vaccine.  No treatment medications were reported.  Company Comment: This is a Spontaneous case reported by a consumer, concerning a patient of unknown age and gender, with no history of stroke or risk factors, who experienced the unexpected and serious (due to medically significant) events of Cerebrovascular accident (AESI) and Hemiplegia. Cerebrovascular accident occurred approximately 3 months and a half after mRNA-1273 vaccine, administered as second dose within COVID-19 vaccination schedule. Hemiplegia occurred approximately 9 months and a half after the same dose. Patient reported having a severe stroke that left him/her paralyzed on his/her right side. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning a patient of unknown age and gender, with no history of stroke or risk factors, who experienced the unexpected and serious (due to medically significant) events of Cerebrovascular accident (AESI) and Hemiplegia. Cerebrovascular accident occurred approximately 3 months and a half after mRNA-1273 vaccine, administered as second dose within COVID-19 vaccination schedule. Hemiplegia occurred approximately 9 months and a half after the same dose. Patient reported having a severe stroke that left him/her paralyzed on his/her right side. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Crying, Depression, Dizziness, Drug interaction
Clinical narrative: pain; in a lot of distress it sounds like due to pain and mental anguish; dizzy spells; nausea; hot flashes; depression; an interaction between a steroid shot of dexamethasone and Ketorolac that Patient received on 15May2021 and Moderna Covid-19 vaccine; crying; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), ANXIETY (in a lot of distress it sounds like due to pain and mental anguish), DIZZINESS (dizzy spells), NAUSEA (nausea) and HOT FLUSH (hot flashes) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products DEXAMETHASONE for an unknown indication and KETOROLAC for an unknown indication.    Previously administered products included for Antidepressant therapy: LORAZEPAM and LEXAPRO. Past adverse reactions to the above products included No adverse event with LEXAPRO and LORAZEPAM.   On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started DEXAMETHASONE (unknown route) at an unspecified dose and KETOROLAC (unknown route) at an unspecified dose. On 15-May-2021, the patient experienced PAIN (pain), ANXIETY (in a lot of distress it sounds like due to pain and mental anguish), DIZZINESS (dizzy spells), NAUSEA (nausea), HOT FLUSH (hot flashes), DEPRESSION (depression) and DRUG INTERACTION (an interaction between a steroid shot of dexamethasone and Ketorolac that Patient received on 15May2021 and Moderna Covid-19 vaccine). In 2021, the patient experienced CRYING (crying). At the time of the report, PAIN (pain), ANXIETY (in a lot of distress it sounds like due to pain and mental anguish), DIZZINESS (dizzy spells), NAUSEA (nausea), HOT FLUSH (hot flashes), DEPRESSION (depression) and DRUG INTERACTION (an interaction between a steroid shot of dexamethasone and Ketorolac that Patient received on 15May2021 and Moderna Covid-19 vaccine) had not resolved and CRYING (crying) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Two days after receiving the vaccine the patient went to the pain clinic for a shot of dexamethasone and ketorolac. The patient life has been turned upside down and was ruined. The patient never received her second dose of the Moderna Covid-19 vaccine because had such a bad experience due to what the patient said was an interaction between a steroid shot of dexamethasone and Ketorolac that patient received on 15May2021 and Moderna Covid-19 vaccine. Treatment medications were not reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Nausea, Pain
Clinical narrative: pain; in a lot of distress it sounds like due to pain and mental anguish; dizzy spells; nausea; hot flashes; depression; an interaction between a steroid shot of dexamethasone and Ketorolac that Patient received on 15May2021 and Moderna Covid-19 vaccine; crying; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), ANXIETY (in a lot of distress it sounds like due to pain and mental anguish), DIZZINESS (dizzy spells), NAUSEA (nausea) and HOT FLUSH (hot flashes) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products DEXAMETHASONE for an unknown indication and KETOROLAC for an unknown indication.    Previously administered products included for Antidepressant therapy: LORAZEPAM and LEXAPRO. Past adverse reactions to the above products included No adverse event with LEXAPRO and LORAZEPAM.   On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started DEXAMETHASONE (unknown route) at an unspecified dose and KETOROLAC (unknown route) at an unspecified dose. On 15-May-2021, the patient experienced PAIN (pain), ANXIETY (in a lot of distress it sounds like due to pain and mental anguish), DIZZINESS (dizzy spells), NAUSEA (nausea), HOT FLUSH (hot flashes), DEPRESSION (depression) and DRUG INTERACTION (an interaction between a steroid shot of dexamethasone and Ketorolac that Patient received on 15May2021 and Moderna Covid-19 vaccine). In 2021, the patient experienced CRYING (crying). At the time of the report, PAIN (pain), ANXIETY (in a lot of distress it sounds like due to pain and mental anguish), DIZZINESS (dizzy spells), NAUSEA (nausea), HOT FLUSH (hot flashes), DEPRESSION (depression) and DRUG INTERACTION (an interaction between a steroid shot of dexamethasone and Ketorolac that Patient received on 15May2021 and Moderna Covid-19 vaccine) had not resolved and CRYING (crying) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Two days after receiving the vaccine the patient went to the pain clinic for a shot of dexamethasone and ketorolac. The patient life has been turned upside down and was ruined. The patient never received her second dose of the Moderna Covid-19 vaccine because had such a bad experience due to what the patient said was an interaction between a steroid shot of dexamethasone and Ketorolac that patient received on 15May2021 and Moderna Covid-19 vaccine. Treatment medications were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Expired vaccine was stored at room temperature; No Adverse Event; Patient was administered vaccine past the expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered vaccine past the expiration), PRODUCT STORAGE ERROR (Expired vaccine was stored at room temperature) and NO ADVERSE EVENT (No Adverse Event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 052D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 29-Dec-2022 at 8:30 AM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered vaccine past the expiration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was stored at room temperature). an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered vaccine past the expiration), PRODUCT STORAGE ERROR (Expired vaccine was stored at room temperature) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered vaccine past the expiration) and PRODUCT STORAGE ERROR (Expired vaccine was stored at room temperature).    No concomitant medications were reported.   The patient was administered vaccine past the expiration. Dose administered more than 12 hours post puncture. The size of the vial was reported as 2.5 ml. The vial was initially stored in refrigerator on 20-Dec-2022 and was punctured on 28-Dec-2022 11:20 AM and was administered on 29-Dec-2022 at 08:30. The vial was stored at room temperature post puncture. The vial did not undergo any temperature excursion. The vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) for 18 hours.  No treatment details were reported.   Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Myalgia, Peripheral swelling, Vaccination site erythema
Clinical narrative: felt a little tired; sore arm; red rash at the injection site/could feel bumps; arm was swollen; lymph nodes were swollen; red rash at the injection site/could feel bumps; red rash at the injection site/could feel bumps; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt a little tired), MYALGIA (sore arm), VACCINATION SITE RASH (red rash at the injection site/could feel bumps), PERIPHERAL SWELLING (arm was swollen) and LYMPHADENOPATHY (lymph nodes were swollen) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 036B21A and 001B21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:asthmatic, high blood pressure. Allergies: mold, ragweed, pollen, trees, grasses, smoke, dust, flowers, etc.  Concurrent medical conditions included Asthmatic, Blood pressure high, Allergy to molds, Ragweed allergy, Pollen allergy, Allergy, Dust allergy, Allergy, Allergy to plants and Grass allergy. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for Asthma, OLMESARTAN MEDOXOMIL for Blood pressure.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jul-2022, the patient experienced FATIGUE (felt a little tired), MYALGIA (sore arm), VACCINATION SITE RASH (red rash at the injection site/could feel bumps), PERIPHERAL SWELLING (arm was swollen), LYMPHADENOPATHY (lymph nodes were swollen), VACCINATION SITE ERYTHEMA (red rash at the injection site/could feel bumps) and VACCINATION SITE MASS (red rash at the injection site/could feel bumps). At the time of the report, FATIGUE (felt a little tired), MYALGIA (sore arm), VACCINATION SITE RASH (red rash at the injection site/could feel bumps), PERIPHERAL SWELLING (arm was swollen), LYMPHADENOPATHY (lymph nodes were swollen), VACCINATION SITE ERYTHEMA (red rash at the injection site/could feel bumps) and VACCINATION SITE MASS (red rash at the injection site/could feel bumps) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had a rash at the injection site, it was red and could feel bumps. patient visited a doctor and they told that lymph nodes were swollen, treatment given were only compresses. The swelling in the arm went down 8 days later, but swollen lymph nodes resolved until 2 months later.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site rash
Clinical narrative: felt a little tired; sore arm; red rash at the injection site/could feel bumps; arm was swollen; lymph nodes were swollen; red rash at the injection site/could feel bumps; red rash at the injection site/could feel bumps; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt a little tired), MYALGIA (sore arm), VACCINATION SITE RASH (red rash at the injection site/could feel bumps), PERIPHERAL SWELLING (arm was swollen) and LYMPHADENOPATHY (lymph nodes were swollen) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 036B21A and 001B21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:asthmatic, high blood pressure. Allergies: mold, ragweed, pollen, trees, grasses, smoke, dust, flowers, etc.  Concurrent medical conditions included Asthmatic, Blood pressure high, Allergy to molds, Ragweed allergy, Pollen allergy, Allergy, Dust allergy, Allergy, Allergy to plants and Grass allergy. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for Asthma, OLMESARTAN MEDOXOMIL for Blood pressure.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jul-2022, the patient experienced FATIGUE (felt a little tired), MYALGIA (sore arm), VACCINATION SITE RASH (red rash at the injection site/could feel bumps), PERIPHERAL SWELLING (arm was swollen), LYMPHADENOPATHY (lymph nodes were swollen), VACCINATION SITE ERYTHEMA (red rash at the injection site/could feel bumps) and VACCINATION SITE MASS (red rash at the injection site/could feel bumps). At the time of the report, FATIGUE (felt a little tired), MYALGIA (sore arm), VACCINATION SITE RASH (red rash at the injection site/could feel bumps), PERIPHERAL SWELLING (arm was swollen), LYMPHADENOPATHY (lymph nodes were swollen), VACCINATION SITE ERYTHEMA (red rash at the injection site/could feel bumps) and VACCINATION SITE MASS (red rash at the injection site/could feel bumps) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had a rash at the injection site, it was red and could feel bumps. patient visited a doctor and they told that lymph nodes were swollen, treatment given were only compresses. The swelling in the arm went down 8 days later, but swollen lymph nodes resolved until 2 months later.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Inappropriate schedule of product administration, Pain in extremity, Vaccination site haemorrhage
Clinical narrative: Booster 1 and booster 2 taken on 23-jan-2022 and 22-may-2022; reaction to the second booster Covid-19/injected in area affected by Hidradenitis Suppurativa that caused patient to bleed; reaction to the second booster Covid-19/felt stabbing pain in chest and feet; reaction to the second booster Covid-19/felt stabbing pain in chest and feet; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (reaction to the second booster Covid-19/injected in area affected by Hidradenitis Suppurativa that caused patient to bleed), CHEST PAIN (reaction to the second booster Covid-19/felt stabbing pain in chest and feet), PAIN IN EXTREMITY (reaction to the second booster Covid-19/felt stabbing pain in chest and feet) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster 1 and booster 2 taken on 23-jan-2022 and 22-may-2022) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Daily Dose. In May 2022, the patient experienced CHEST PAIN (reaction to the second booster Covid-19/felt stabbing pain in chest and feet) and PAIN IN EXTREMITY (reaction to the second booster Covid-19/felt stabbing pain in chest and feet). On 22-May-2022, the patient experienced VACCINATION SITE HAEMORRHAGE (reaction to the second booster Covid-19/injected in area affected by Hidradenitis Suppurativa that caused patient to bleed). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster 1 and booster 2 taken on 23-jan-2022 and 22-may-2022). In May 2022, CHEST PAIN (reaction to the second booster Covid-19/felt stabbing pain in chest and feet) and PAIN IN EXTREMITY (reaction to the second booster Covid-19/felt stabbing pain in chest and feet) had resolved. At the time of the report, VACCINATION SITE HAEMORRHAGE (reaction to the second booster Covid-19/injected in area affected by Hidradenitis Suppurativa that caused patient to bleed) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster 1 and booster 2 taken on 23-jan-2022 and 22-may-2022) outcome was unknown.      No concomitant medication was reported. No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: She only had one as it gave her a rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (She only had one as it gave her a rash) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Psoriasis (she had problems with her Psoriasis). Concomitant products included TOFACITINIB CITRATE (XELJANZ) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (She only had one as it gave her a rash). At the time of the report, RASH (She only had one as it gave her a rash) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       It was reported patient asked if patient could try another vaccine other than the Moderna vaccine. patient doctor advised not to take anymore vaccines for Covid.  No treatment medications were reported.
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood pressure measurement, Heart rate, Hypertension
Clinical narrative: high blood pressure; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPERTENSION (high blood pressure) in a 73-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7166B) for COVID-19 prophylaxis.     Concomitant products included ATORVASTATIN and METOPROLOL for an unknown indication.    On 10-Dec-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 11-Dec-2022, the patient experienced HYPERTENSION (high blood pressure). At the time of the report, HYPERTENSION (high blood pressure) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Dec-2022, Blood pressure measurement: 130/79 at 8:18 AM 130/71 at 9:30PM. On 11-Dec-2022, Heart rate: 89 at 8:18 AM 58 at 9:30PM. On 12-Dec-2022, Blood pressure measurement: 132/72 at 7:28AM 134/78 at 9:30PM. On 12-Dec-2022, Heart rate: 56 at 7:28AM 64 at 9:30 PM.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   The patient received first Moderna Covid-19 primary series vaccine on 09-Jan-2021 lot number 011L20A, second Moderna primary series dose on 6-Feb-2021 Lot 012M20A, first Monovalent booster dose 23-Oct-2021 Lot Number 051F21A and second monovalent booster dose on18-Apr-2022 Lot number 01M21A.  No treatment information was reported.   This case was linked to MOD-2023-694235 (Patient Link).
Age: 54.0
Sex: M
Vaccine: COVID19-2, UNK
Symptoms: Chest pain, Cough
Clinical narrative: Chest pain; Coughing; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain) and COUGH (Coughing) in a 54-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.   In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 24-Jun-2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced CHEST PAIN (Chest pain) and COUGH (Coughing). At the time of the report, CHEST PAIN (Chest pain) and COUGH (Coughing) outcome was unknown.            MPID number of Moderna Covid-19 vaccine was reported. The reporter's causality for the events of coughing and chest pain with Adalimumab Solution for Injection was Not Provided. No treatment medications were provided.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 at 15:00 as dose 5 (booster), single (Lot number: GH9693) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma but rarely symptomatic." (unspecified if ongoing); "Known allergies: Almonds" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Covid-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 18Dec2022 to 22Dec2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201402555 Same patient, different product and event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that patient didn't receive other medication in 2 weeks. The patient received Paxlovid treatment for covid-19 from 19Dec2022 to 25Dec2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; vaccine brand other=Moderna/vaccine dose number=4; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Jan2021 at 16:00 as dose 1, single (Lot number: EL0142), in right arm, on 04Feb2021 at 14:30 as dose 2, single (Lot number: EM9810), in left arm and on 02Dec2021 at 14:00 as dose 3 (booster), single (Lot number: FD0809) at the age of 64 years, in left arm for COVID-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 14Jul2022 at 14:30 as dose 4 (booster), single (Lot number: 016B22A), in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Osteoarthritis" (unspecified if ongoing), notes: Other medical history: Osteoarthritis. The patient's concomitant medications were not reported. Past drug history included: Nystatin, reaction(s): "Known allergies: Nystatin", notes: Known allergies: Nystatin. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 14Jul2022 at 14:30, outcome "unknown", described as "vaccine brand other=Moderna/vaccine dose number=4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 at 15:00 as dose 4 (booster), single (Lot number: GH9694) at the age of 31 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Poly cystic ovarian syndrome" (unspecified if ongoing), notes: Other medical history: Poly cystic ovarian syndrome; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: SPIRONOLACTONE, start date: 01Jun2021.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: after testing negative twice on days 6 and 8; Negative, notes: after testing negative twice on days 6 and 8; Positive, notes: Positive rapid test on day 10 post initial symptom. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Positive rapid test on day 10 post initial symptom onset after testing negative twice on days 6 and 8 post initial symptom onset. the patient received treatment with Paxlovid from 22Dec2022 to 27Dec2022 for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 74-year-old male patient received BNT162b2 (BNT162B2), on 11Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "degenerative disc disease of cervical and lumbar spine" (unspecified if ongoing), notes: degenerative disc disease of cervical and lumbar spine; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid from 24Dec2022 to 28Dec2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Drug ineffective (LOE) and COVID-19 cannot be ruled out.