chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose has not been administered yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 01-Apr-2022 Reporter's Comments: Did not consent to follow-up. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of Shingrix yet, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Wrong solution used; Wrong solution used; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 01-APR-2022 Reporter's Comments: Quality assurance pharmacist reported that a one of his/her outlying clinics noticed a discrepancy in the number of Shingrix vials and diluent vials. They surmised that there was a possibility that sterile water stocked in the clinic might had inadvertently been used for reconstitution instead of the diluent. The reporter would like to know if there were consequences/implications to any affected patients if sterile water was used for reconstitution and asked if had any information on this. Health care professional(HCP) stated that there was no information regarding date, patient, lot/expiry date.  The reporter consented to follow up via email. Additional Supportive Information: As the patients were administered the shingrix vaccine using the sterile water diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022058850:Same reporter. FU1 - deleted.
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered only the diluent portion; administered only the diluent portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 2-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number CT44F, expiry date 10th July 2023) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 1st April 2022, the patient received Rotarix lyophilized formulation (oral) and Rotarix Oral Applicator Device. On 1st April 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-APR-2022 Reporter's comments: Registered nurse reported that a medical assistant of her office administered only the diluent portion of Rotarix to a patient without reconstituting it. Lot number and expiration date was regarding the administered diluent portion. The consent to follow-up was not asked to the health care professional(HCP) Additional Supportive Information: The patient received only diluent portion of Rotarix vaccine, which led to inappropriate preparation of medication and Inappropriate dose of vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Erythema, Injection site erythema, Injection site warmth, Skin warm
Clinical narrative: blister on his right elbow; red patch 3 inches diameter, 0.5inches below injection site; was warm to the touch; This case was reported by a consumer via call center representative and described the occurrence of skin red in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 30th March 2022, the patient received the 2nd dose of Shingrix (injection). On 30th March 2022, less than a day after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced skin red and skin warm. On 4th April 2022, the patient experienced blister. On 31st March 2022, the outcome of the skin red was recovered/resolved. On an unknown date, the outcome of the skin warm and blister were recovered/resolved.   It was unknown if the reporter considered the skin red, skin warm and blister to be related to Shingrix.     Additional Information: GSK Receipt Date: 04-APR-2022 Reporter's comment: The case was self reported by the patient. The patient received first dose of Shingrix in mid January 2022 (unspecified date) The patient reported that after second dose of Shingrix within 1-2 hours he developed a red patch 3 inches in diameter about 0.5 inches below the site of injection that was red and warm to the touch.  The patient reported that the red patch went away the following day.  The patient reported that on day of reporting, he noticed a blister on right elbow. The patient wants to know if Shingrix can cause shingles. The patient did not want to provide DOB (Date Of Birth)and HCP (health care professional) contact information. The consent not obtained to contact HCP (health care professional) and consumer for follow-up.
Age: 64.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: administered Twinrix after the expiration date; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 64-year-old female patient who received HAB (Twinrix) (batch number GG3S5, expiry date 28th February 2022) 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.   On 4th April 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 4th April 2022, 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 Information: GSK Receipt Date: 04-Apr-2022 Reporter's Comments: The reporter stated that the patient was administered Twinrix after the expiration date. The reporter consented to follow up via post.
Age: 1.58
Sex: M
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: was believed that patient received a second dose; patient received a 2nd dose of Kinrix at 21 months; patient 19 months and 16 days old, received a dose of Kinrix; This case was reported by a physician via call center representative and described the occurrence of extra dose administered in a 19-month-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis and dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd February 2022, the patient received the 2nd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 16th December 2021, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 16th December 2021, not applicable after receiving Kinrix and Kinrix Pre-Filled Syringe Device and unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On 23rd February 2022, the patient experienced extra dose administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the extra dose administered, inappropriate age at vaccine administration and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-Apr-2022 Reporter's Comments: The reporter stated that a 19 months and 16 days old patient received 1st dose Kinrix, it was believed that patient received a second dose of Kinrix as well. No prior immunization was confirmed. The reporter did not consent to follow-up.  The Vaccine Administration Facility is the same as Primary Reporter. Additional Supportive Information: The 19 months and 16 days old patient received 1st dose of Kinrix, which led to inappropriate age at vaccine administration. The patient also received 2nd dose of Kinrix at 21 months of age, which led to inappropriate age at vaccine administration and extra dose administered.
Sex: F
Vaccine: MENB
Symptoms: Intercepted product administration error
Clinical narrative: was determined by the practitioner the patient was too young to receive the dose; This case was reported by a other health professional via call center representative and described the occurrence of intercepted product administration error in a 15-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient did not receive Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced intercepted product administration error. On an unknown date, the outcome of the intercepted product administration error 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 Information: GSK Receipt Date: 04-Apr-2022 Reporter's Comments: Office manager reported that a Bexsero dose was drawn up for a patient but not given as it was determined by the practitioner the patient was too young to receive the dose. Further details were not provided to the reporter who stated she was not sure which day this occurred.  Submitting potential near-miss to safety with limited information provided.  The reporter consented to follow up from safety. Additional Supportive Information: The practitioner avoided the dose as patient's age was too young, which led to intercepted product administration error.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: expired dose was given; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB06DA, expiry date 31st March 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th April 2022, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 4th April 2022, 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 Information: GSK Receipt Date: 04-APR-2022 Reporter's comments: Registered nurse reported that, on the day of reporting the patient received an expired dose of Bexsero. The reporter consented to follow up. Additional Supportive Information: The patient received dose of Bexsero that was already got expired on 31st March 2022, which led to expired vaccine used. This case was linked with case US2021236308, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021236308:Same reporter
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Immunodeficiency, Inappropriate schedule of product administration, Injection site bruising, Off label use
Clinical narrative: IMMUNODEFICIENCY; INJECTION SITE BRUISING; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a patient via AbbVie concerned an elderly female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (dose 1) (dose number in series: 1) (suspension for injection, intramuscular, batch number was not reported, expiry: unknown) dose was not reported, 1 total administered on 15-MAR-2021 for prophylactic vaccination. On an unspecified date, the patient received covid-19 vaccine ad26.cov2.s (dose 2) (dose number in series: 1) (suspension for injection, intramuscular, batch number was not reported, expiry: unknown) dose was not reported, 1 total administered for prophylactic vaccination which was an off label use for inappropriate schedule of vaccine administered (dose number in series: 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported, expiry: unknown) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On an unspecified date, the patient experienced immunodeficiency, and injection site bruising (dose number in series: 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from injection site bruising, and the outcome of immunodeficiency, off label use and inappropriate schedule of vaccine administered was not reported. The reporter causality between covid-19 vaccine ad26.cov2.s and injection site bruising was not related.  On 15-DEC-2021, the patient received booster dose of covid-19 vaccine ad26.cov2.s (dose 3) (dose number in series: 2) (suspension for injection, intramuscular, batch number was not reported, expiry: unknown) dose was not reported, 1 total administered for prophylactic vaccination. No adverse events were reported following covid-19 vaccine ad26.cov2.s (dose number in series: 2). This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20220401843-Covid-19 vaccine ad26.CoV-2.s- -Immunodeficiency. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: CONMEDS-OTHER SUSPECT DRUGS(adalimumab). Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: SYMPTOMS EXPERIENCED SINCE RECEIVING THE VACCINE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced symptoms experienced since receiving the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of symptoms experienced since receiving the vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEAD IS ACHING; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the patient experienced head is aching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from head is aching. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Malaise, Off label use
Clinical narrative: NOT FEELING SO GOOD; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient previously received covid-19 vaccine (unspecified manufacturer) (dose number in series: 1) (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered for prophylactic vaccination. No adverse events were reported following covid-19 vaccine (dose number in series: 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 2) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total administered on 24-MAR-2021 for prophylactic vaccination which was off label use for inappropriate schedule of vaccine administered (dose number in series: 2). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 24-MAR-2021, the patient was fine all day. On 25-MAR-2021, the patient experienced not feeling so good (dose number in series 2). The nurse suggested the patient to take Tylenol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from not feeling so good, and the outcome of off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: 104 FULL FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch and lot numbers. No concomitant medications were reported.  On 08-APR-2021, the patient experienced 104 full fever. Laboratory data included: Body temperature (NR: not provided) 104. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from 104 full fever. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pain in extremity, Pyrexia
Clinical narrative: SWEATY; PAIN IN LEFT ARM; FEVER; This spontaneous report received from a patient via a company representative concerned a male of unspecified age, race and 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 (unspecified manufacturer) (dose number in series 1), (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose was not reported, 1 total administered, start therapy date were not reported for prophylactic vaccination.  No adverse events were reported following administration of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received a booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2 ) (suspension for injection, route of admin not reported, batch number: Unknown, and expiry: Unknown) dose was not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced sweaty, pain in left arm, and fever (dose number in series 2). Treatment medications (dates unspecified) included: Tylenol (paracetamol). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in left arm, sweaty, and fever. This report was non-serious. This case, involving the same patient is linked to 20220154210.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: ARMS WERE IN PAIN; This spontaneous report received from a patient via a company representative concerned an 81 year old of unspecified sex, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (unspecified manufacturer) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on an unspecified date for prophylactic vaccination. It was unknown if the patient experienced any adverse event after vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on an unspecified date for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced pain in arms (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arms were in pain was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Malaise
Clinical narrative: DIDN'T FEEL RIGHT; FEELING OF MALAISE; This spontaneous report received from a parent concerned a male of unspecified age. 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced didn't feel right, and feeling of malaise. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from didn't feel right, and feeling of malaise. This report was non-serious. This case, from the same reporter is linked to 20220406074 and 20220407562.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: NOT FEEL GOOD FOR A FEW DAYS AFTER RECEIVING THE BOOSTER SHOT; This spontaneous report received from a parent concerned a male of an unspecified age, race and ethnicity The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received first dose of covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total administered for prophylactic vaccination. On an unspecified date, following vaccination with first dose of covid-19 vaccine ad26.cov2.s, the patient experienced a feeling of malaise and just didn't feel right (Dose number in series: 1). The patient recovered from a feeling of malaise and just didn't feel right. On an unspecified date, the patient received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series: 2) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was 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 not felt good for a few days after receiving the booster shot (Dose number in series: 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of not feel good for a few days after receiving the booster shot was not reported. This report was non-serious. This case, involving the same patient is linked to 20220407558. This case, from the same reporter is linked to 20220406074.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Parosmia
Clinical narrative: WORSENING OF CHRONIC PAROSMIA; WORSENING OF ANOSMIA/LOSS OF SMELL; LOSS OF TASTE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: chronic parosmia, and chronic anosmia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry date were not reported) dose was not reported, administered on MAR-2021 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 worsening of chronic parosmia, worsening of anosmia/loss of smell, and loss of taste. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the loss of taste, worsening of anosmia/loss of smell and worsening of chronic parosmia was not reported. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Feeling cold, Injection site erythema, Injection site swelling
Clinical narrative: The injection site swelled up and is red and warm. This happened within an hour and by day 2, the welt is the size of my hand, is solid and has spread across my upper arm. I ran a fever of 99.8 and was extremely lethargic and very achy, both in my muscles and my joints. I had to spend most of the day in bed and had chills and couldn't warm up. I took Advil and felt a bit better but this welt across my arm is epic. You can see it through my clothing.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Lethargy, Mobility decreased, Myalgia, Pyrexia
Clinical narrative: The injection site swelled up and is red and warm. This happened within an hour and by day 2, the welt is the size of my hand, is solid and has spread across my upper arm. I ran a fever of 99.8 and was extremely lethargic and very achy, both in my muscles and my joints. I had to spend most of the day in bed and had chills and couldn't warm up. I took Advil and felt a bit better but this welt across my arm is epic. You can see it through my clothing.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: The injection site swelled up and is red and warm. This happened within an hour and by day 2, the welt is the size of my hand, is solid and has spread across my upper arm. I ran a fever of 99.8 and was extremely lethargic and very achy, both in my muscles and my joints. I had to spend most of the day in bed and had chills and couldn't warm up. I took Advil and felt a bit better but this welt across my arm is epic. You can see it through my clothing.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Developed some side effects after receiving the Moderna vaccines; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Developed some side effects after receiving the Moderna vaccines) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Developed some side effects after receiving the Moderna vaccines). At the time of the report, VACCINATION COMPLICATION (Developed some side effects after receiving the Moderna vaccines) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication reported. No treatment medication reported.   Reporter reported that she developed some side effects after receiving the Moderna vaccines and that she would like to receive the booster but she was nervous about it. She stated she had reported this in the past but didn't finish the process and that she would like to follow up on that.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2022: Follow-up received contained NNI-No New Information. On 31-Mar-2022: Upon internal Review on 06-Apr-2022, significant correction was made to update gender of patient to Female.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient tested positive for COVID-19; Lack of efficacy; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Patient tested positive for COVID-19) and DRUG INEFFECTIVE (Lack of efficacy) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014c21a and 022c21A) for COVID-19 vaccination.     Concurrent medical conditions included Pollen allergy (allergy to Bee pollen) and Drug allergy (allergy to Flonase).   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Dec-2021, the patient experienced COVID-19 (Patient tested positive for COVID-19) and DRUG INEFFECTIVE (Lack of efficacy). At the time of the report, COVID-19 (Patient tested positive for COVID-19) and DRUG INEFFECTIVE (Lack of efficacy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter. No treatment information was provided.  The patient had not received any other vaccines within 1 month prior to receiving Moderna COVID-19 vaccine.  Company comment: This is a spontaneous case concerning a 20-year-old, male patient with no relevant medical history, who experienced the unexpected non-serious AESI event of Covid-19 and unexpected non-serious event of lack of efficacy. The patient received 2 primary doses of mRNA-1273 vaccine with appropriate dosage interval of 27 days. The events occurred approximately 217 days after the second dose of mRNA-1273 vaccine administration with positive SARS-CoV-2 test result. No other information surrounding the events was reported. The outcome of the events was reported as unknown. The current Covid-19 pandemic remain confounder for the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-527285 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 20-year-old, male patient with no relevant medical history, who experienced the unexpected non-serious AESI event of Covid-19 and unexpected non-serious event of lack of efficacy. The patient received 2 primary doses of mRNA-1273 vaccine with appropriate dosage interval of 27 days. The events occurred approximately 217 days after the second dose of mRNA-1273 vaccine administration with positive SARS-CoV-2 test result. No other information surrounding the events was reported. The outcome of the events was reported as unknown. The current Covid-19 pandemic remain confounder for the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received some Moderna COVID19 doses that were expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received some Moderna COVID19 doses that were expired) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received some Moderna COVID19 doses that were expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received some Moderna COVID19 doses that were expired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient received booster dose.  No treatment medications were reported.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered to patient post expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient post expiry date) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient post expiry date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient post expiry date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided.  It was reported that patient received the additional dose.  No treatment medications was provided.   This case was linked to MOD-2022-531880 (Patient Link).
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered to patient post expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient post expiry date) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient post expiry date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient post expiry date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment information was reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: receiving expired doses; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving expired doses) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (receiving expired doses) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment medications were not provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired dose on 24 Sep 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose on 24 Sep 2021) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose on 24 Sep 2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose on 24 Sep 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The expiration date reported as 22 Sep 2021. No treatment medications were reported.   This case was linked to MOD-2022-531880 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment medications were reported   This case was linked to MOD-2022-531880 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired dose on 24-SEP-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose on 24-SEP-2021) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose on 24-SEP-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose on 24-SEP-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-531880 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.  On 24-Sep-2021, the patient received the booster dose of the vaccine.   This case was linked to MOD-2022-531880 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 067H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter. It was reported that number of doses/vials was 4 doses/1 vial. On 5-MAR-2022 vial was initially stored in the refrigerator. Vial did not undergone any temperature excursions.   This case was linked to MOD-2022-532744, MOD-2022-532746 (Patient Link).
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Patient received (0.5ml)  full dose from a red cap vial for the 2nd booster; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Patient received (0.5ml)  full dose from a red cap vial for the 2nd booster) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A, 939905, 030M20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022, the patient experienced ACCIDENTAL OVERDOSE (Patient received (0.5ml)  full dose from a red cap vial for the 2nd booster). At the time of the report, ACCIDENTAL OVERDOSE (Patient received (0.5ml)  full dose from a red cap vial for the 2nd booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received 2nd Booster dose on 04-APR-2021. No concomitant medications was provided. No treatment medications was provided.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 067H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Date the vial was initially stored in the refrigerator was reported as 05-Mar-2022. It was reported that vial did not undergo any temperature excursion.  No treatment medications were reported.    This case was linked to MOD-2022-532663, MOD-2022-532746 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired doses administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 067H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired doses administered) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment medications reported