chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect dose administered, Needle issue, No adverse event
Clinical narrative: No other AE reported.; does not think the patient received the full dose; Needle leak; This spontaneous report has been received from a licensed practical nurse, referring to a 12 months old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On 13-OCT-2021, the patient was receiving a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, strength, route, lot number and expiration date were unknown) for prophylaxis and the needle was not attached properly so some of the vaccine leaked out (incorrect dose administered and needle issue). The reporter did not think the patient received the full dose. No other adverse event (AE) reported. No other issues or concerns.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Injection site rash
Clinical narrative: negative titer; rash at the injection site; This spontaneous report as received from a physician referring to a 20-year-old female patient. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.       On an unspecified date,  the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis (dose, frequency, administration route, lot number and expiry date were not reported) .  On an unknown day reported as recent, the patient performed a test that showed  negative titers so on 13-OCT-2021, she received a dose of  varicella virus vaccine live (oka/merck)(VARIVAX) booster  and she experienced vaccination site rash.    The outcome of antibody test negative and vaccination site rash was unknown.  and the reporter did not assess the causal relatedness between the events and the suspect vaccine.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Expired product administered
Clinical narrative: No other issues or concerns noted.; VARIVAX and MMR II were administered to a patient past expiration date; This spontaneous report has been received from an office manager, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.   On 18-OCT-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S028925 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 16-SEP-2021, dose, route and strength were unknown) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) (lot # S032825 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 16-OCT-2021, route and strength were unknown), both for prophylaxis (expired product administered). No other issues or concerns noted.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No further information was provided; PNEUMOVAX 23 was administered to three patients after the excursion occurred; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 13-OCT-2021, the patient was vaccinated with improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # T039322, (dose, route of administration and anatomical location were not provided) for prophylaxis. Administered vaccine experienced temperature excursion of 23.9 degrees Celsius for 31 minutes on 11-OCT-2021. There were no previous excursions reported. No additional adverse event was reported.  This is one of tree reports from the same reporter. ; Sender's Comments:  US-009507513-2110USA005005: US-009507513- 2110USA004979:
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; an expired dose of MMR II was administered to a 28 year old female patient; This spontaneous report was received from an office manager concerning a 28-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.    On 18-OCT-2021, the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) 0.5 milliliters, lot # S031482, expiration date 07-OCT-2021 (route not reported) for prophylaxis (expired product administered). No additional adverse event was reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No further information was provided; PNEUMOVAX 23 was administered to three patients after the excursion occurred; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 13-OCT-2021, the patient was vaccinated with improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # T039322, (dose, route of administration and anatomical location were not provided) for prophylaxis. Administered vaccine experienced temperature excursion of 23.9 degrees Celsius for 31 minutes on 11-OCT-2021. There were no previous excursions reported. No additional adverse event was reported.  This is one of tree reports from the same reporter. ; Sender's Comments:  US-009507513-2110USA005005: US-009507513-2110USA004952:
Age: 17.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No other issues or concerns noted; PROQUAD was given to 17 year old patient; This spontaneous report has been received from a nurse prescriber referring to a 17-year-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and previous drug reactions or allergies were not reported.   On 18-OCT-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (product administered to patient of inappropriate age) as prophylaxis (dose, route of administration, anatomical site of vaccination, lot number and expiration date were not reported). No other issues or concerns reported (not adverse event).
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, Maternal exposure before pregnancy, Medication error
Clinical narrative: She mentioned she will be receiving her 3rd vaccination this Saturday; No additional adverse effects reported; she found out she was pregnant on Oct 15, 2021; She mentioned she will be receiving her 3rd vaccination this Saturday; This spontaneous prospective pregnancy report was received from a consumer referring to herself, a female patient who was 30 years old at the time of the report.  The patient pertinent medical history, previous drug reactions or allergies, and concurrent conditions were not reported. The patient's concomitant vaccines included COVID-19 vaccine (manufacturer: Pfizer).  On 02-JUL-2021, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, anatomical site of vaccination, lot number and expiration date were not reported) for human papillomavirus (HPV) prevention.  On 15-OCT-2021, the patient found out she was pregnant (maternal exposure before pregnancy). Moreover, the patient mentioned that she would receive the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) on 22-OCT-2021 (circumstance or information capable of leading to medication error, exposure during pregnancy).   The pregnancy gestation or last menstrual period was in October 2021 (reported as "less than a week"). The estimated date of delivery was not reported. The pregnancy outcome is pending, and the fetal outcome is unknown. No additional adverse effects reported (no adverse event).
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; PROQUAD involved in multiple recent temperature excursions; This spontaneous report was received from a medical assistant and refers to a 12 months old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 18-OCT-2021, the patient was administered one dose of improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot # T014388, expiration date 24-OCT-2021 (strength, route of administration and anatomical location were not provided) for prophylaxis.   The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) had underwent a temperature excursion of 6.9 Fahrenheit degrees (F) for 1 hour and 31 minutes on 15-OCT-2021, 5.5 F for 1 hour and 59 minutes on 16-OCT-2021, 5.5 F for 1 hour and 24 minutes on 17-OCT-2021, 5.9 F for 1 hour and 31 minutes on 18-OCT-2021. There were no previous excursions reported. No additional adverse event was reported.
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE; Vaccines were administered after experiencing temperature excursion; This spontaneous report was received from medical assistant concerning a 15 months old patient. No information about the patient's current condition, medical history or concomitant therapy was reported.       On 30-SEP-2021, medical assistant reported varicella virus vaccine live (oka/merck)(VARIVAX) was administered (dose and route were not reported; lot# T032317, expiry date: 22-SEP-2022) after experiencing temperature excursion as prophylaxis (product storage error). The vaccine was stored at 6 Fahrenheit to 14 Fahrenheit for 18 minutes and 6 Fahrenheit to 14 Fahrenheit (11.9 Fahrenheit) for 1 hour. Total time frame was 1 hour and 18 minutes. No previous temperature excursion was reported. No additional adverse event details were available.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was admnistered after experiencing temperature excursion; no additonal AE; This spontaneous report was received from medical assistant concerning a 12 months old patient. No information about the patient's current condition, medical history or concomitant therapy was reported.       On 29-SEP-2021, medical assistant reported varicella virus vaccine live (oka/merck)(VARIVAX) was administered (dose and route were not reported; lot# T032317, expiry date: 22-SEP-2022) after experiencing temperature excursion as prophylaxis (product storage error). The vaccine was stored at 6 Fahrenheit to 14 Fahrenheit for 18 minutes and 6 Fahrenheit to 14 Fahrenheit (11.9 Fahrenheit) for 1 hour. Total time frame was 1 hour and 18 minutes. No previous temperature excursion was reported. No additional adverse event details were available.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; was administered after improperly stored; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot# U002534, expiration date 27-JUL-2022, experienced the temperature excursion of (6 degrees Fahrenheit (F) to 14 F) (8.5 F) for 0 hours 18 minutes and 0 seconds; 6 F to 14 F (11.9 F) for 1 hour 0 minutes. Cumulative timeframe: 1 hour and 18 minutes. On 19-SEP-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 ml (formulation, concentration, dose number, route of administration and anatomical location were not reported) for prophylaxis (product storage error). There were no previous excursions reported. No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE details; vaccines were administered after experiencing temperature excursion.; This spontaneous report was received from a medical assistant and refers to a patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the varicella virus vaccine live (oka/merck) (VARIVAX) lot # T032317, expiration date 22-SEP-2022, experienced the temperature excursion of (6 degrees Fahrenheit (F) to 14 F) (8.5 F) for 0 hours 18 minutes and 0 seconds; 6 F to 14 F (11.9 F) for 1 hour 0 minutes. Cumulative timeframe: 1 hour and 18 minutes. On 04-OCT-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T032317 (formulation, concentration, exact dose, dose number, route of administration and anatomical location were not reported) for prophylaxis (product storage error). No additional adverse event details were provided. There were no previous excursions reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; VARlVAX that was administered after improperly stored.; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the varicella virus vaccine live (oka/merck) (VARIVAX) lot # T027303, expiration date 12-AUG-2022, experienced the temperature excursion of (6 degrees Fahrenheit (F) to 14 F) (8.5 F) for 0 hours 18 minutes and 0 seconds; 6 F to 14 F (11.9 F) for 1 hour 0 minutes. Cumulative timeframe: 1 hour and 18 minutes. On 22-SEP-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml, lot # T032317 (formulation, concentration, dose number, route of administration and anatomical location were not reported) for prophylaxis (product storage error). There were no previous excursions reported. No additional adverse event was reported (No adverse event).
Sex: F
Vaccine: HPV9
Symptoms: Injection site mass, Injection site nodule
Clinical narrative: felt mass or nodule near the injection site; felt mass or nodule near the injection site; This spontaneous report was received from a physician concerning a female patient of unknown age. No concurrent condition, medical history, or concomitant therapy was reported.    On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, lot # and expiration date were unknown), intramuscularly for prophylaxis.         On an unknown date, about one or two months after hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) vaccination, the patient felt mass or nodule near the injection site. The patient came back to the office and was seen by the physician about the AE. The treatment given for the events was unknown. The outcome of the events was unknown. The causality assessment was not provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2111USA001338: US-009507513-2111USA001337: US-009507513-2111USA001339: US-009507513-2111USA001336:
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Accidental overdose, No adverse event
Clinical narrative: No additional AE reported; PROQUAD and VARlVAX were inadvertently administered; This spontaneous report was received from a medical assistant concerning a patient of unknown age. No concurrent condition, medical history, or concomitant therapy was reported.  On 21-OCT-2021, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength and route were unknown; recombinant Human albumin; 0.5 (unit not provided), lot # T032147 has been verified to be a valid lot number, expiration date reported and confirm upon internal validation as 20-MAR-2022) and varicella virus vaccine live (oka/merck)(VARIVAX) (strength and route were unknown; 0.5 (unit not provided), lot # T41503 was evaluated and changed to the valid lot # T041503, expiration date reported and confirm upon internal validation as 09-DEC-2022) for prophylaxis (accidental overdose).  No adverse event was reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: not signs or symptoms reported. No other AE or PQC reported; a temperature excursion on ROTATEQ, ROTATEQ was administered; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender.  The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.   On 27-OCT-2021, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (strength was not reported, lot # T040208, expiration date was 19-JUL-2022)  1 time dose, orally for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to a temperature of 34.03 F for a time frame of 5 minutes (occurred on 26-OCT-2021). There were no previous temperature excursions. No digital data logger was reported. There was no not signs or symptoms reported. No further adverse event (AE) information was provided (no adverse event).   This is one of the several reports reported by the same reporter.; Sender's Comments:  US-009507513-2111USA000689: US-009507513-2111USA000286:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: not signs or symptoms reported. No other AE or PQC reported; a temperature excursion on ROTATEQ, ROTATEQ was administered; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender.  The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.   On 27-OCT-2021, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (strength was not reported, lot # T040208, expiration date was 19-JUL-2022)  1 time dose, orally for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to a temperature of 34.03 F for a time frame of 5 minutes (occurred on 26-OCT-2021). There were no previous temperature excursions. No digital data logger was reported. There was no not signs or symptoms reported. No further adverse event (AE) information was provided (no adverse event).   This is one of the several reports reported by the same reporter.; Sender's Comments:  US-009507513-2111USA000688: US-009507513-2111USA000286:
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE was reported; an expired PROQUAD vaccine that was administered to a patient; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies and drug allergy or reactions were not reported.      On 02-NOV-2021, the patient was vaccinated with the expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose and route were not reported; lot # T013541, expiration date; 17-OCT-2021) used as directed for the prevention of Measles, Mumps, rubella and varicella (expired product administered). No additional adverse event (AE) was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE details or PQC.; 33 year old patient who received PROQUAD; This spontaneous report was received from a medical assistant and refers to a 33-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 29-OCT-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot # T032148, expiration date 20-MAR-2022, 0.5 milliliter (formulation, concentration, dose number, route of administration and anatomical location were not reported) for prophylaxis (product administered to patient of inappropriate age). No additional adverse event was reported.
Sex: F
Vaccine: HPV9
Symptoms: Injection site mass, Injection site nodule
Clinical narrative: felt mass or nodule near the injection site; felt mass or nodule near the injection site; This spontaneous report was received from a physician concerning a female patient of unknown age. No concurrent condition, medical history, or concomitant therapy was reported.    On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, lot # and expiration date were unknown), intramuscularly for prophylaxis.         On an unknown date, about one or two months after hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) vaccination, the patient felt mass or nodule near the injection site. The physician did not see the patient. The treatment given for the events was unknown. The outcome of the events was unknown. The causality assessment was not provided.      This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA008168:
Sex: F
Vaccine: HPV9
Symptoms: Injection site nodule
Clinical narrative: felt mass or nodule near the injection site; felt mass or nodule near the injection site; This spontaneous report was received from a physician concerning a female patient of unknown age. No concurrent condition, medical history, or concomitant therapy was reported.    On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, lot # and expiration date were unknown), intramuscularly for prophylaxis.         On an unknown date, about one or two months after hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) vaccination, the patient felt mass or nodule near the injection site. The physician did not see the patient. The treatment given for the events was unknown. The outcome of the events was unknown. The causality assessment was not provided.      This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA008168:
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose given less than 2 months; This case was reported by a nurse and described the occurrence of drug dose administration interval too short in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 21st October 2021, the patient received the 2nd dose of Shingrix. On 21st October 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: Nurse reported patient was administered the 2nd dose of Shingrix less than 2 months interval after dose one. Earlier than the recommended interval, which led to shortening of vaccination schedule. The reporter consented to follow up. No other vaccine details was provided.
Age: 62.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: received an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 62-year-old female patient who received HAB (Twinrix) (batch number 5B22F, expiry date 27th April 2021) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix  (received 1st dose on an unknown date ).   On 29th October 2021, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 29th October 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided are as follows: The nurse reported a patient received an expired dose of Twinrix which expired on 27th April 2021, which led to expired vaccine used. The reporter consented to follow-up via email.
Sex: U
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: received and expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number unknown, expiry date 31st October 2021) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe (batch number unknown, expiry date 31st October 2021) for prophylaxis.   On 1st November 2021, the patient received Bexsero. On an unknown date, the patient started Bexsero Pre-Filled Syringe Device. On 1st November 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: Age at vaccination were not reported. Medical Assistant reported that a patient received an expired dose of Bexsero. The reporter did not consent to follow-up.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, Product storage error
Clinical narrative: The patient received a dose from a vial more than 30 days on the fridge; Inappropriate Schedule of vaccine administered; The patient received a dose from a vial more than 30 days on the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate Schedule of vaccine administered) and PRODUCT STORAGE ERROR (The patient received a dose from a vial more than 30 days on the fridge) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate Schedule of vaccine administered) and PRODUCT STORAGE ERROR (The patient received a dose from a vial more than 30 days on the fridge). On 14-Jul-2021, EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate Schedule of vaccine administered) and PRODUCT STORAGE ERROR (The patient received a dose from a vial more than 30 days on the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  Date the vial was initially stored in the refrigerator 20 Apr 2021. Patient had no adverse events.  No treatment information was provided.  The reporter stated that they received some vaccines on 20-Apr-2021 and on the same day they moved the vaccine and stored the vial into the fridge. On 14-Jul-2021, a patient received their second dose from the same vial which was stored more than 30 days in the refrigerator. The vial did not undergo any temperature excursions. HCP mentioned that there were 14 patients instead of 18 because of some duplicates.   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Added reporter's fax number and no adverse events were updated.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis
Clinical narrative: FACIAL CELLULITIS ON RIGHT CHEEK SIDE; This spontaneous report received from a patient concerned a 46 year old  female. The patient's height, and weight were not reported. The patient's past medical history included: COVID-19 antibody test, and COVID-19 in DEC-2019, and concurrent conditions included: epilepsy, and thyroid abnormality. The patient never had facial cellulitis before the vaccination. The patient was not pregnant at the time of report. The patient experienced drug allergy when treated with phenobarbital, and ethosuximide.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, expiry: Unknown) dose was not reported, 1 total, administered on 02-OCT-2021 to left arm for prophylactic vaccination. Concomitant medications included carbamazepine for epilepsy, and armour natural desiccated thyroid hormone for thyroid abnormality.  On 09-OCT-2021, the patient experienced facial cellulitis on right cheek side and went to the urgent care physician. On 11-OCT-2021, patient had an appointment with regular provider. The patient was prescribed with clindamycin 300 mg three times a day for 15 days and ibuprofen 800 mg one tablet every 6-8 hours as needed for pain. After completing the therapy, facial cellulitis was resolved. The patient had no other symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from facial cellulitis on right cheek side on 23-OCT-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211110578-covid-19 vaccine ad26.cov2.s-facial cellulitis on right cheek side . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: MULTIPLE MINI STROKES; This spontaneous report received from a patient via a company representative concerned a 5 decade (around 41 years) old male of unknown ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced multiple mini strokes. The timing between the vaccine and the stroke was unknown, and that the patient still had troubled speaking today. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from multiple mini strokes. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211112429-Covid-19 vaccine ad26.cov2.s-Multiple mini strokes. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine given to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 500E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications, Lab data details and Treatment information were not provided. There are no adverse advents reported for the patient.   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Follow up received contains reporter alternate  contact details . No adverse events found
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vaccination site erythema, Vaccination site pain
Clinical narrative: Incredible red site at injection part; Severe nausea; soreness at injection side; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Incredible red site at injection part), NAUSEA (Severe nausea), VACCINATION SITE PAIN (soreness at injection side) and HEADACHE (Headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E219) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Asthma, Drug allergy (Allergic to Sulfa) and Drug allergy (Allergic to Cephalosporins).    On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Incredible red site at injection part), NAUSEA (Severe nausea), VACCINATION SITE PAIN (soreness at injection side) and HEADACHE (Headache). At the time of the report, VACCINATION SITE ERYTHEMA (Incredible red site at injection part) and NAUSEA (Severe nausea) had not resolved and VACCINATION SITE PAIN (soreness at injection side) and HEADACHE (Headache) was resolving.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter. Patient confirmed the correct spelling of their email address since previously documented was incorrect. Patient would like a follow up from Safety.   This case was linked to MOD-2021-364875 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2021: Follow-up document received on NOV-1,contains non significant information -Contact info updated
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Moderna COVID19 Vaccine vial was taken out of the fridge and left at room temperature; Administered dose past the 12-hour mark; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Moderna COVID19 Vaccine vial was taken out of the fridge and left at room temperature) and EXPIRED PRODUCT ADMINISTERED (Administered dose past the 12-hour mark) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (Moderna COVID19 Vaccine vial was taken out of the fridge and left at room temperature) and EXPIRED PRODUCT ADMINISTERED (Administered dose past the 12-hour mark). On 22-Oct-2021, PRODUCT STORAGE ERROR (Moderna COVID19 Vaccine vial was taken out of the fridge and left at room temperature) and EXPIRED PRODUCT ADMINISTERED (Administered dose past the 12-hour mark) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided. This is first patient. Lot number(s): 037F21A Number of doses/vials: one vial, 4 doses administered. Date(s) and time(S) vial was first punctured: 21Oct2021 at 9:15 AM. How was the vial stored post puncture? room temperature Did the vial undergo any temperature excursions? No Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): 27.5 hours.   This case was linked to MOD-2021-363303, MOD-2021-365032, MOD-2021-364190 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Non-significant follow up Appended - reporter details and narrative updated.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Feeling hot, Headache
Clinical narrative: 3 severe hot flashes from head to toes, like for a minute; rash; extreme fatigue; massive/severe headache; chills; fever:soaking wet; sweating; heat; swollen arm; itchy arm; redness/red arm; arm hot to the touch; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of SWEATING FEVER (fever:soaking wet) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939903) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Menopause (when she was 40.).    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced SWEATING FEVER (fever:soaking wet) (seriousness criterion medically significant), HYPERHIDROSIS (sweating), FEELING HOT (heat), PERIPHERAL SWELLING (swollen arm), PRURITUS (itchy arm), ERYTHEMA (redness/red arm), VACCINATION SITE WARMTH (arm hot to the touch), PAIN IN EXTREMITY (sore arm), FATIGUE (extreme fatigue), HEADACHE (massive/severe headache) and CHILLS (chills). On 26-Oct-2021, the patient experienced RASH (rash). On 27-Oct-2021, the patient experienced HOT FLUSH (3 severe hot flashes from head to toes, like for a minute). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency and CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) for Adverse event, at an unspecified dose and frequency. On 26-Oct-2021, RASH (rash) had resolved. On 27-Oct-2021, HOT FLUSH (3 severe hot flashes from head to toes, like for a minute) had resolved. At the time of the report, SWEATING FEVER (fever:soaking wet), HYPERHIDROSIS (sweating), FEELING HOT (heat), PERIPHERAL SWELLING (swollen arm), PRURITUS (itchy arm), ERYTHEMA (redness/red arm), VACCINATION SITE WARMTH (arm hot to the touch), PAIN IN EXTREMITY (sore arm), FATIGUE (extreme fatigue), HEADACHE (massive/severe headache) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information included cold packs.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was Not applicable.   This case was linked to MOD-2021-366002, MOD-2021-366003 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Hyperhidrosis, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: 3 severe hot flashes from head to toes, like for a minute; rash; extreme fatigue; massive/severe headache; chills; fever:soaking wet; sweating; heat; swollen arm; itchy arm; redness/red arm; arm hot to the touch; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of SWEATING FEVER (fever:soaking wet) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939903) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Menopause (when she was 40.).    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced SWEATING FEVER (fever:soaking wet) (seriousness criterion medically significant), HYPERHIDROSIS (sweating), FEELING HOT (heat), PERIPHERAL SWELLING (swollen arm), PRURITUS (itchy arm), ERYTHEMA (redness/red arm), VACCINATION SITE WARMTH (arm hot to the touch), PAIN IN EXTREMITY (sore arm), FATIGUE (extreme fatigue), HEADACHE (massive/severe headache) and CHILLS (chills). On 26-Oct-2021, the patient experienced RASH (rash). On 27-Oct-2021, the patient experienced HOT FLUSH (3 severe hot flashes from head to toes, like for a minute). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency and CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) for Adverse event, at an unspecified dose and frequency. On 26-Oct-2021, RASH (rash) had resolved. On 27-Oct-2021, HOT FLUSH (3 severe hot flashes from head to toes, like for a minute) had resolved. At the time of the report, SWEATING FEVER (fever:soaking wet), HYPERHIDROSIS (sweating), FEELING HOT (heat), PERIPHERAL SWELLING (swollen arm), PRURITUS (itchy arm), ERYTHEMA (redness/red arm), VACCINATION SITE WARMTH (arm hot to the touch), PAIN IN EXTREMITY (sore arm), FATIGUE (extreme fatigue), HEADACHE (massive/severe headache) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information included cold packs.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was Not applicable.   This case was linked to MOD-2021-366002, MOD-2021-366003 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Sweating fever, Vaccination site warmth
Clinical narrative: 3 severe hot flashes from head to toes, like for a minute; rash; extreme fatigue; massive/severe headache; chills; fever:soaking wet; sweating; heat; swollen arm; itchy arm; redness/red arm; arm hot to the touch; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of SWEATING FEVER (fever:soaking wet) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939903) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Menopause (when she was 40.).    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced SWEATING FEVER (fever:soaking wet) (seriousness criterion medically significant), HYPERHIDROSIS (sweating), FEELING HOT (heat), PERIPHERAL SWELLING (swollen arm), PRURITUS (itchy arm), ERYTHEMA (redness/red arm), VACCINATION SITE WARMTH (arm hot to the touch), PAIN IN EXTREMITY (sore arm), FATIGUE (extreme fatigue), HEADACHE (massive/severe headache) and CHILLS (chills). On 26-Oct-2021, the patient experienced RASH (rash). On 27-Oct-2021, the patient experienced HOT FLUSH (3 severe hot flashes from head to toes, like for a minute). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency and CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) for Adverse event, at an unspecified dose and frequency. On 26-Oct-2021, RASH (rash) had resolved. On 27-Oct-2021, HOT FLUSH (3 severe hot flashes from head to toes, like for a minute) had resolved. At the time of the report, SWEATING FEVER (fever:soaking wet), HYPERHIDROSIS (sweating), FEELING HOT (heat), PERIPHERAL SWELLING (swollen arm), PRURITUS (itchy arm), ERYTHEMA (redness/red arm), VACCINATION SITE WARMTH (arm hot to the touch), PAIN IN EXTREMITY (sore arm), FATIGUE (extreme fatigue), HEADACHE (massive/severe headache) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information included cold packs.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was Not applicable.   This case was linked to MOD-2021-366002, MOD-2021-366003 (Patient Link).
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Unable to sleep at all/way too much energy/beyond wired; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (unable to sleep at all/way too much energy/beyond wired) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced INSOMNIA (unable to sleep at all/way too much energy/beyond wired). At the time of the report, INSOMNIA (unable to sleep at all/way too much energy/beyond wired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided.  Concomitant medication was not provided.