chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: COVID19, FLUC4, COVID19, FLU4
Symptoms: COVID-19, Cough, Pain, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: Breakthrough covid case; Body aches; Sinus drainage; Cough; This spontaneous case from the United States was retrieved on 14-Jul-2022 from Vaccine Adverse Event Reporting System (reference number: 2339209-1) with additional information received from PTC Reporting on 18-Jul-2022 (being processed together), reported by other healthcare professional and concerned a 64-year-old, male patient.  The patient's medical history and concomitant medications were not reported. The patient had no know allergies. The patient's historical vaccine included two doses of Pfizer-BioNTech COVID-19 vaccine (tozinameran).  On 29-Oct-2021, the patient was vaccinated with Afluria Quadrivalent (Influenza vaccine inact split 4v; dose: reported as 'one'; route of administration: intramuscular; anatomical location: right arm; indication: not reported). The batch number reported was P10035853 ((reported batch number was identified by Seqirus to be most likely batch: P100358553).  On the same date, the patient was also vaccinated with non-company co-suspect Pfizer-BioNTech COVID-19 vaccine (tozinameran; dose: reported as 'three'; route of administration: intramuscular; anatomical location: left arm; indication: not reported). The batch number reported was 30155BA.  On 24-Jun-2022, seven months and 26 days after receiving Afluria Quadrivalent and non-company co-suspect Pfizer-BioNTech COVID-19 vaccine, the patient experienced breakthrough covid. He was presented to emergency room (ER) with complaints of sinus drainage, cough and body aches. It was reported that the patient recently traveled. He underwent cepheid covid test, but the results were not reported. The patient was discharged home.  The outcome of all events was unknown.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 64-year-old patient experienced breakthrough COVID-19 seven months and 26 days after receiving the suspect product Afluria Quadrivalent and non-company co-suspect Pfizer-BioNTech COVID-19 vaccine. The patient was presented to emergency room (ER) with complaints of sinus drainage, cough, and body aches. More information regarding patient's diagnostic findings, medical history, and concomitant drugs is needed. Based on biological (COVID-19) and chronological implausibility (remaining events), causality for the reported events is assessed as not related.; Sender's Comments: A 64-year-old patient experienced COVID-19 Breakthrough seven months and 26 days after receiving the suspect product Afluria Quadrivalent and non-company co-suspect Pfizer-BioNTech COVID-19 vaccine. The patient was presented to emergency room (ER) with complaints of sinus drainage, cough, and body aches. More information regarding patient's diagnostic findings, medical history, and concomitant drugs is needed. Based on biological (COVID-19) and chronological implausibility (remaining events), causality for the reported events is assessed as not related.
Age: 64.0
Sex: M
Vaccine: COVID19, FLUC4, COVID19, FLU4
Symptoms: Vaccine breakthrough infection
Clinical narrative: Breakthrough covid case; Body aches; Sinus drainage; Cough; This spontaneous case from the United States was retrieved on 14-Jul-2022 from Vaccine Adverse Event Reporting System (reference number: 2339209-1) with additional information received from PTC Reporting on 18-Jul-2022 (being processed together), reported by other healthcare professional and concerned a 64-year-old, male patient.  The patient's medical history and concomitant medications were not reported. The patient had no know allergies. The patient's historical vaccine included two doses of Pfizer-BioNTech COVID-19 vaccine (tozinameran).  On 29-Oct-2021, the patient was vaccinated with Afluria Quadrivalent (Influenza vaccine inact split 4v; dose: reported as 'one'; route of administration: intramuscular; anatomical location: right arm; indication: not reported). The batch number reported was P10035853 ((reported batch number was identified by Seqirus to be most likely batch: P100358553).  On the same date, the patient was also vaccinated with non-company co-suspect Pfizer-BioNTech COVID-19 vaccine (tozinameran; dose: reported as 'three'; route of administration: intramuscular; anatomical location: left arm; indication: not reported). The batch number reported was 30155BA.  On 24-Jun-2022, seven months and 26 days after receiving Afluria Quadrivalent and non-company co-suspect Pfizer-BioNTech COVID-19 vaccine, the patient experienced breakthrough covid. He was presented to emergency room (ER) with complaints of sinus drainage, cough and body aches. It was reported that the patient recently traveled. He underwent cepheid covid test, but the results were not reported. The patient was discharged home.  The outcome of all events was unknown.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 64-year-old patient experienced breakthrough COVID-19 seven months and 26 days after receiving the suspect product Afluria Quadrivalent and non-company co-suspect Pfizer-BioNTech COVID-19 vaccine. The patient was presented to emergency room (ER) with complaints of sinus drainage, cough, and body aches. More information regarding patient's diagnostic findings, medical history, and concomitant drugs is needed. Based on biological (COVID-19) and chronological implausibility (remaining events), causality for the reported events is assessed as not related.; Sender's Comments: A 64-year-old patient experienced COVID-19 Breakthrough seven months and 26 days after receiving the suspect product Afluria Quadrivalent and non-company co-suspect Pfizer-BioNTech COVID-19 vaccine. The patient was presented to emergency room (ER) with complaints of sinus drainage, cough, and body aches. More information regarding patient's diagnostic findings, medical history, and concomitant drugs is needed. Based on biological (COVID-19) and chronological implausibility (remaining events), causality for the reported events is assessed as not related.
Age: 64.0
Sex: M
Vaccine: COVID19, FLUC4, COVID19, FLU4
Symptoms: COVID-19, Cough, Pain, Paranasal sinus hypersecretion
Clinical narrative: Breakthrough covid case; Body aches; Sinus drainage; Cough; This spontaneous case from the United States was retrieved on 14-Jul-2022 from Vaccine Adverse Event Reporting System (reference number: 2339209-1) with additional information received from PTC Reporting on 18-Jul-2022 (being processed together), reported by other healthcare professional and concerned a 64-year-old, male patient.  The patient's medical history and concomitant medications were not reported. The patient had no know allergies. The patient's historical vaccine included two doses of Pfizer-BioNTech COVID-19 vaccine (tozinameran).  On 29-Oct-2021, the patient was vaccinated with Afluria Quadrivalent (Influenza vaccine inact split 4v; dose: reported as 'one'; route of administration: intramuscular; anatomical location: right arm; indication: not reported). The batch number reported was P10035853 ((reported batch number was identified by Seqirus to be most likely batch: P100358553).  On the same date, the patient was also vaccinated with non-company co-suspect Pfizer-BioNTech COVID-19 vaccine (tozinameran; dose: reported as 'three'; route of administration: intramuscular; anatomical location: left arm; indication: not reported). The batch number reported was 30155BA.  On 24-Jun-2022, seven months and 26 days after receiving Afluria Quadrivalent and non-company co-suspect Pfizer-BioNTech COVID-19 vaccine, the patient experienced breakthrough covid. He was presented to emergency room (ER) with complaints of sinus drainage, cough and body aches. It was reported that the patient recently traveled. He underwent cepheid covid test, but the results were not reported. The patient was discharged home.  The outcome of all events was unknown.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 64-year-old patient experienced breakthrough COVID-19 seven months and 26 days after receiving the suspect product Afluria Quadrivalent and non-company co-suspect Pfizer-BioNTech COVID-19 vaccine. The patient was presented to emergency room (ER) with complaints of sinus drainage, cough, and body aches. More information regarding patient's diagnostic findings, medical history, and concomitant drugs is needed. Based on biological (COVID-19) and chronological implausibility (remaining events), causality for the reported events is assessed as not related.; Sender's Comments: A 64-year-old patient experienced COVID-19 Breakthrough seven months and 26 days after receiving the suspect product Afluria Quadrivalent and non-company co-suspect Pfizer-BioNTech COVID-19 vaccine. The patient was presented to emergency room (ER) with complaints of sinus drainage, cough, and body aches. More information regarding patient's diagnostic findings, medical history, and concomitant drugs is needed. Based on biological (COVID-19) and chronological implausibility (remaining events), causality for the reported events is assessed as not related.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 65-year-old female patient received BNT162b2 (BNT162B2), on 15Apr2022 at 11:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 65 years intramuscular, in left arm for covid-19 immunization. The patient's relevant medical history included: "Artificial knee" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EN6208; Time of administration: 11:00; Route of administration: Intramuscular; Anatomical site: Left arm; Expiration date: 30Jun2021), administration date: 16Mar2021, when the patient was 64-year-old, for Covid-19 Immunization, reaction(s): "COVID-19", "Vaccination failure"; BNT162b2 (DOSE 2, SINGLE; Lot number: EP7533; Time of administration: 11:00; Route of administration: Intramuscular; Anatomical site: Left arm), administration date: 06Apr2021, when the patient was 64-year-old, for Covid-19 Immunization, reaction(s): "COVID-19", "Vaccination failure"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: FF2588; Time of administration: 11:00; Route of administration: Intramuscular; Anatomical site: Left arm), administration date: 08Oct2021, when the patient was 65-year-old, for Covid-19 Immunization, reaction(s): "COVID-19", "Vaccination failure". The following information was reported: MUSCLE DISORDER (non-serious), outcome "unknown", described as "Muscle relaxant for artificial knee". Therapeutic measures were taken as a result of muscle disorder which included Cyclobenzaprine. Additional Information: On 09Jun2022, the patient took Cyclobenzaprine pill via mouth as a muscle relaxant for artificial knee. It was reported as sporadic. Stop date for Cyclobenzaprine was 09Jun2022. Patient's medical history was also reported as none.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle disorder
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 65-year-old female patient received BNT162b2 (BNT162B2), on 15Apr2022 at 11:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 65 years intramuscular, in left arm for covid-19 immunization. The patient's relevant medical history included: "Artificial knee" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EN6208; Time of administration: 11:00; Route of administration: Intramuscular; Anatomical site: Left arm; Expiration date: 30Jun2021), administration date: 16Mar2021, when the patient was 64-year-old, for Covid-19 Immunization, reaction(s): "COVID-19", "Vaccination failure"; BNT162b2 (DOSE 2, SINGLE; Lot number: EP7533; Time of administration: 11:00; Route of administration: Intramuscular; Anatomical site: Left arm), administration date: 06Apr2021, when the patient was 64-year-old, for Covid-19 Immunization, reaction(s): "COVID-19", "Vaccination failure"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: FF2588; Time of administration: 11:00; Route of administration: Intramuscular; Anatomical site: Left arm), administration date: 08Oct2021, when the patient was 65-year-old, for Covid-19 Immunization, reaction(s): "COVID-19", "Vaccination failure". The following information was reported: MUSCLE DISORDER (non-serious), outcome "unknown", described as "Muscle relaxant for artificial knee". Therapeutic measures were taken as a result of muscle disorder which included Cyclobenzaprine. Additional Information: On 09Jun2022, the patient took Cyclobenzaprine pill via mouth as a muscle relaxant for artificial knee. It was reported as sporadic. Stop date for Cyclobenzaprine was 09Jun2022. Patient's medical history was also reported as none.
Age: 1.33
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: a 16-months-old male patient. The patient was inadvertently administered a dose of the Pfizer-BioNTech COVID-19 Vaccine, gray cap; Sleepy; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 16-month-old male patient received BNT162b2 (BNT162B2), on 11Jul2022 at 10:00 as dose 1, 0.3 ml single (Lot number: FP7150, Expiration Date: 30Nov2022) at the age of 16 months, in right thigh for covid-19 immunisation. The patient's relevant medical history included: "Jaundice Had Jaundice when he was born" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: varicella (Vaccine Name: Varicella Manufacturer: Merck; Lot Number: U033046; EXP: 21Oct2023; NDC: 406482700; Anatomical Location: right thigh), administration date: 06Jun2022, when the patient was 1-year-old, for immunisation; mmr vaccine (Lot Number: U006487; Anatomical Location: left thigh; EXP: 26Feb2023; NDC: 406468100), administration date: 06Jun2022, when the patient was 1-year-old, for immunisation; hepatitis a (Lot Number: U038841; Anatomical Location: left thigh; Route of administration: vastus lateralis; EXP: 26Feb2023; NDC: 406409502), administration date: 06Jun2022, when the patient was 1-year-old, for immunisation. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 11Jul2022 at 10:00, outcome "unknown", described as "a 16-months-old male patient. The patient was inadvertently administered a dose of the Pfizer-BioNTech COVID-19 Vaccine, gray cap"; SOMNOLENCE NEONATAL (non-serious) with onset Jul2022, outcome "recovered" (Jul2022), described as "Sleepy".  Additional information: The reporter stated they spoke with the mother yesterday for an update. The mother said the patient was sleepy for the first two days after the overdose event, but that has resolved. Currently (at the time of the report) the patient looks normal and was playing, eating OK, and was acting well again.  Follow (13Jul2022): This is a spontaneous follow-up report received in response to the mail trail sent regarding the confirmation of reporter's occupation. The response included: reporter's occupation.  No follow-up attempts are possible. No further information is expected.  Follow-up (19Jul2022): This is a spontaneous follow-up report received from a contactable other HCP.  Updated information: New event of Somnolence neonatal and additional information added.
Age: 1.33
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age, Somnolence neonatal
Clinical narrative: a 16-months-old male patient. The patient was inadvertently administered a dose of the Pfizer-BioNTech COVID-19 Vaccine, gray cap; Sleepy; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 16-month-old male patient received BNT162b2 (BNT162B2), on 11Jul2022 at 10:00 as dose 1, 0.3 ml single (Lot number: FP7150, Expiration Date: 30Nov2022) at the age of 16 months, in right thigh for covid-19 immunisation. The patient's relevant medical history included: "Jaundice Had Jaundice when he was born" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: varicella (Vaccine Name: Varicella Manufacturer: Merck; Lot Number: U033046; EXP: 21Oct2023; NDC: 406482700; Anatomical Location: right thigh), administration date: 06Jun2022, when the patient was 1-year-old, for immunisation; mmr vaccine (Lot Number: U006487; Anatomical Location: left thigh; EXP: 26Feb2023; NDC: 406468100), administration date: 06Jun2022, when the patient was 1-year-old, for immunisation; hepatitis a (Lot Number: U038841; Anatomical Location: left thigh; Route of administration: vastus lateralis; EXP: 26Feb2023; NDC: 406409502), administration date: 06Jun2022, when the patient was 1-year-old, for immunisation. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 11Jul2022 at 10:00, outcome "unknown", described as "a 16-months-old male patient. The patient was inadvertently administered a dose of the Pfizer-BioNTech COVID-19 Vaccine, gray cap"; SOMNOLENCE NEONATAL (non-serious) with onset Jul2022, outcome "recovered" (Jul2022), described as "Sleepy".  Additional information: The reporter stated they spoke with the mother yesterday for an update. The mother said the patient was sleepy for the first two days after the overdose event, but that has resolved. Currently (at the time of the report) the patient looks normal and was playing, eating OK, and was acting well again.  Follow (13Jul2022): This is a spontaneous follow-up report received in response to the mail trail sent regarding the confirmation of reporter's occupation. The response included: reporter's occupation.  No follow-up attempts are possible. No further information is expected.  Follow-up (19Jul2022): This is a spontaneous follow-up report received from a contactable other HCP.  Updated information: New event of Somnolence neonatal and additional information added.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Burning sensation, Dermatitis, Pruritus
Clinical narrative: Within 24 hours started itching intensely all over (head, feet, arms, even groin area) and burning; Within 24 hours started itching intensely all over (head, feet, arms, even groin area) and burning; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26May2021 at 08:00 as dose 2, single (Lot number: EP7534) at the age of 51 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19 prior to vaccination" (unspecified if ongoing); "Almond nut allergy" (unspecified if ongoing); "pineapple allergy" (unspecified if ongoing); "butter allergy" (unspecified if ongoing); "Erythromycin allergy" (unspecified if ongoing), notes: Caused itching, break out and hives. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, Lot No: EP7534, Anatomical location: Arm Right, Time of Administration: 03:00 PM), administration date: 05May2021, when the patient was 51-year-old, for COVID-19 Immunization. The following information was reported: PRURITUS (non-serious), BURNING SENSATION (non-serious) all with onset 27May2021 at 03:00, outcome "not recovered" and all described as "Within 24 hours started itching intensely all over (head, feet, arms, even groin area) and burning". The events "within 24 hours started itching intensely all over (head, feet, arms, even groin area) and burning" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pruritus, burning sensation.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received over the counter allergy medicine Allegra within 2 weeks of vaccination. Within 24 hours of taking second shot, the patient started itching intensely all over and burning. Her head, feet, arms and even groin area had an itch just all over. The patient had no breathing problems, so she took Benadryl and side effects subsided for 24 hours but started back up again. The patient suffered for several weeks and was taking only Benadryl and Allegra (not together though), and finally went to her doctor. She was placed on steroid pack and found relief for 30 days, but the itching started back up after 30 days, so she went back on Allegra and see her doctor. That time she was given 25mg of Hydroxyzine and was referred to a skin allergist. Since she could not go beyond 48 hours of taking an antihistamine because of itch and burn all over, it had been difficult getting to see an Allergist. However, her appointment was on 21Jul2022 and she was hoping for a breakthrough. She never had this all over itch and burn prior to taking the 2nd dose vaccine. The patient did not notice any changes, not severe anyway, upon taking the first vaccine. This report was not serious. Device time stamp: 20Jul2022.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Pruritus, SARS-CoV-2 test
Clinical narrative: Within 24 hours started itching intensely all over (head, feet, arms, even groin area) and burning; Within 24 hours started itching intensely all over (head, feet, arms, even groin area) and burning; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26May2021 at 08:00 as dose 2, single (Lot number: EP7534) at the age of 51 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19 prior to vaccination" (unspecified if ongoing); "Almond nut allergy" (unspecified if ongoing); "pineapple allergy" (unspecified if ongoing); "butter allergy" (unspecified if ongoing); "Erythromycin allergy" (unspecified if ongoing), notes: Caused itching, break out and hives. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, Lot No: EP7534, Anatomical location: Arm Right, Time of Administration: 03:00 PM), administration date: 05May2021, when the patient was 51-year-old, for COVID-19 Immunization. The following information was reported: PRURITUS (non-serious), BURNING SENSATION (non-serious) all with onset 27May2021 at 03:00, outcome "not recovered" and all described as "Within 24 hours started itching intensely all over (head, feet, arms, even groin area) and burning". The events "within 24 hours started itching intensely all over (head, feet, arms, even groin area) and burning" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pruritus, burning sensation.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received over the counter allergy medicine Allegra within 2 weeks of vaccination. Within 24 hours of taking second shot, the patient started itching intensely all over and burning. Her head, feet, arms and even groin area had an itch just all over. The patient had no breathing problems, so she took Benadryl and side effects subsided for 24 hours but started back up again. The patient suffered for several weeks and was taking only Benadryl and Allegra (not together though), and finally went to her doctor. She was placed on steroid pack and found relief for 30 days, but the itching started back up after 30 days, so she went back on Allegra and see her doctor. That time she was given 25mg of Hydroxyzine and was referred to a skin allergist. Since she could not go beyond 48 hours of taking an antihistamine because of itch and burn all over, it had been difficult getting to see an Allergist. However, her appointment was on 21Jul2022 and she was hoping for a breakthrough. She never had this all over itch and burn prior to taking the 2nd dose vaccine. The patient did not notice any changes, not severe anyway, upon taking the first vaccine. This report was not serious. Device time stamp: 20Jul2022.
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis atopic, Feeling abnormal, Feeling of body temperature change, Scratch, Skin haemorrhage
Clinical narrative: bad sunburn; Feeling hot and cold; Like someone dropped bugs on you; Bleeding; like someone dropped bugs on you and you can't scratch hard enough; Atopic dermatitis/ Eczema; This spontaneous case was reported by a consumer and describes the occurrence of SUNBURN (bad sunburn), FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold), DERMATITIS ATOPIC (Atopic dermatitis/ Eczema), FEELING ABNORMAL (Like someone dropped bugs on you) and SKIN HAEMORRHAGE (Bleeding) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In December 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced DERMATITIS ATOPIC (Atopic dermatitis/ Eczema). On an unknown date, the patient experienced SUNBURN (bad sunburn), FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold), FEELING ABNORMAL (Like someone dropped bugs on you), SKIN HAEMORRHAGE (Bleeding) and SCRATCH (like someone dropped bugs on you and you can't scratch hard enough). At the time of the report, SUNBURN (bad sunburn), FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold), DERMATITIS ATOPIC (Atopic dermatitis/ Eczema), FEELING ABNORMAL (Like someone dropped bugs on you), SKIN HAEMORRHAGE (Bleeding) and SCRATCH (like someone dropped bugs on you and you can't scratch hard enough) outcome was unknown.            No Concomitant medication information provided.  Patient received Moderna COVID-19 Booster vaccination on December when it came out.  Patient was diagnosed with atopic dermatitis and the symptoms included pruritus/itches a lot and is worse in bed and rash erythematous/one solid red rash, like patient was scalded or had a bad sunburn.  No treatment medication information provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-610560, US-MODERNATX, INC.-MOD-2022-610542 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-610560:Relative's case US-MODERNATX, INC.-MOD-2022-610542:Master case (Reporter's case)
Sex: M
Vaccine: COVID19
Symptoms: Sunburn
Clinical narrative: bad sunburn; Feeling hot and cold; Like someone dropped bugs on you; Bleeding; like someone dropped bugs on you and you can't scratch hard enough; Atopic dermatitis/ Eczema; This spontaneous case was reported by a consumer and describes the occurrence of SUNBURN (bad sunburn), FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold), DERMATITIS ATOPIC (Atopic dermatitis/ Eczema), FEELING ABNORMAL (Like someone dropped bugs on you) and SKIN HAEMORRHAGE (Bleeding) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In December 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced DERMATITIS ATOPIC (Atopic dermatitis/ Eczema). On an unknown date, the patient experienced SUNBURN (bad sunburn), FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold), FEELING ABNORMAL (Like someone dropped bugs on you), SKIN HAEMORRHAGE (Bleeding) and SCRATCH (like someone dropped bugs on you and you can't scratch hard enough). At the time of the report, SUNBURN (bad sunburn), FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold), DERMATITIS ATOPIC (Atopic dermatitis/ Eczema), FEELING ABNORMAL (Like someone dropped bugs on you), SKIN HAEMORRHAGE (Bleeding) and SCRATCH (like someone dropped bugs on you and you can't scratch hard enough) outcome was unknown.            No Concomitant medication information provided.  Patient received Moderna COVID-19 Booster vaccination on December when it came out.  Patient was diagnosed with atopic dermatitis and the symptoms included pruritus/itches a lot and is worse in bed and rash erythematous/one solid red rash, like patient was scalded or had a bad sunburn.  No treatment medication information provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-610560, US-MODERNATX, INC.-MOD-2022-610542 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-610560:Relative's case US-MODERNATX, INC.-MOD-2022-610542:Master case (Reporter's case)
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: COVID-19 Booster Reaction; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (COVID-19 Booster Reaction) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Multiple sclerosis exacerbation. Concurrent medical conditions included Dementia, Obesity, Wheeze and Memory disturbance. Concomitant products included OCRELIZUMAB (OCREVUS), ALBUTEROL [SALBUTAMOL] and MONOCLONAL ANTIBODIES, GRANULOCYTE for an unknown indication.    On 15-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2022, the patient experienced IMMUNISATION REACTION (COVID-19 Booster Reaction). At the time of the report, IMMUNISATION REACTION (COVID-19 Booster Reaction) had resolved.            Patient took booster dose.  No treatment medication were provided.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Antinuclear antibody, Antinuclear antibody increased
Clinical narrative: Elevated ANA levels; This spontaneous case was reported by a patient and describes the occurrence of ANTINUCLEAR ANTIBODY INCREASED (Elevated ANA levels) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054A22A) for COVID-19 prophylaxis.     Patient did not had allergies and has never tested/diagnosed with COVID-19. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  Previously administered products included for Drug use for unknown indication: JANSSEN COVID-19 VACCINE (Dose 1 , Lot 1805029) on 11-Mar-2021, JANSSEN COVID-19 VACCINE (Dose 2 and Lot 211D21A) on 01-Dec-2021. Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE and JANSSEN COVID-19 VACCINE. Concurrent medical conditions included Lung disorder NOS (Being evaluated for a lung transplant).    On 01-Jun-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jul-2022, the patient experienced ANTINUCLEAR ANTIBODY INCREASED (Elevated ANA levels). At the time of the report, ANTINUCLEAR ANTIBODY INCREASED (Elevated ANA levels) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2022, Antinuclear antibody: First ANA test was normal. On 20-Jul-2022, Antinuclear antibody: Came back elevated.         No Concomitant medications were provided.  It was reported that patient was being evaluated for a lung transplant. Patient elevated ANA may cause a potential disqualification for lung transplant as case was being evaluated by a clinical team.  Patient received Moderna booster and had no other side effects.  There were recent change in patient status such as improvement or worsening.  No treatment medications were provided.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Received a 3rd booster instead of a Shingles vaccine; This spontaneous case was reported by an other caregiver and describes the occurrence of EXTRA DOSE ADMINISTERED (Received a 3rd booster instead of a Shingles vaccine) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2022, the patient experienced EXTRA DOSE ADMINISTERED (Received a 3rd booster instead of a Shingles vaccine). At the time of the report, EXTRA DOSE ADMINISTERED (Received a 3rd booster instead of a Shingles vaccine) outcome was unknown.            Reporter asked if it's safe that patient received that close another 3rd booster dose or not. It was reported that patient does not have any side effects. No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever for 8 days; This spontaneous case was reported by a pharmacist and describes the occurrence of PYREXIA (Fever for 8 days) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient has never tested positive for COVID 19.  Concurrent medical conditions included Allergy to chemicals (Sulfur) and Blood pressure high.    On 12-Jul-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jul-2022, the patient experienced PYREXIA (Fever for 8 days). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever for 8 days) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient took concomitant medication for high blood pressure. The patient was administered with 4th dose of the Moderna COVID 19 vaccine. Patient had already visited his HP and they could not do anything. Patient was very worried because the fevers do not stop since 8 days.  Patient did not have any issues with doses 1,2 or 3 .
Age: 5.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product preparation error
Clinical narrative: Pfizer orange top vaccine for the 5 to 11 age group that was diluted with the Moderna Covid-19 vaccine for ages 6 months to 5 years; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT PREPARATION ERROR (Pfizer orange top vaccine for the 5 to 11 age group that was diluted with the Moderna Covid-19 vaccine for ages 6 months to 5 years) in a 5-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Previously administered products included for Drug use for unknown indication: Pfizer Covid-19 Vaccine (Dose 1). Past adverse reactions to the above products included No adverse event with Pfizer Covid-19 Vaccine.   On 20-Jul-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 20-Jul-2022, the patient experienced PRODUCT PREPARATION ERROR (Pfizer orange top vaccine for the 5 to 11 age group that was diluted with the Moderna Covid-19 vaccine for ages 6 months to 5 years). At the time of the report, PRODUCT PREPARATION ERROR (Pfizer orange top vaccine for the 5 to 11 age group that was diluted with the Moderna Covid-19 vaccine for ages 6 months to 5 years) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that pfizer orange top vaccine for the 5 to 11 age group (lot FL8094) that was diluted with the Moderna Covid-19 Vaccine for ages 6 months to 5 years (lot AS1414B). No treatment medications were reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 17-Jun-2022 and was administered on 18-Jul-2022; Received a dose after its Beyond use; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a dose after its Beyond use) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 17-Jun-2022 and was administered on 18-Jul-2022) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058a22-2a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a dose after its Beyond use). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 17-Jun-2022 and was administered on 18-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received a dose after its Beyond use) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 17-Jun-2022 and was administered on 18-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided.  The dose was administered after 30-day Use By Date or after manufacturer date of expiry.  The vial was initially stored in the refrigerator on 17-Jun-2022.  The vial did not undergo any temperature excursion.  No treatment medication was provided.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Product use issue
Clinical narrative: patient was given booster dose from a Moderna 6 months through 5 years vial presentation; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT USE ISSUE (patient was given booster dose from a Moderna 6 months through 5 years vial presentation) in a 12-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Second primary dose) and Pfizer (First primary dose). Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    In July 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 25 microgram. In July 2022, the patient experienced PRODUCT USE ISSUE (patient was given booster dose from a Moderna 6 months through 5 years vial presentation). At the time of the report, PRODUCT USE ISSUE (patient was given booster dose from a Moderna 6 months through 5 years vial presentation) 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 patient was given booster dose from a Moderna 6 months through 5 years vial presentation. The patient was not immunocompromised.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was 1st punctured on 18-Jul-2022 at 9:30am and administered on 19-Jul-2022 at 10:28am.; Administered with vaccine from a vial punctured for more than 24 hours; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with vaccine from a vial punctured for more than 24 hours) and PRODUCT STORAGE ERROR (Vial was 1st punctured on 18-Jul-2022 at 9:30am and administered on 19-Jul-2022 at 10:28am.) in a 9-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jul-2022 at 10:28 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2022 at 10:28 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with vaccine from a vial punctured for more than 24 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was 1st punctured on 18-Jul-2022 at 9:30am and administered on 19-Jul-2022 at 10:28am.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with vaccine from a vial punctured for more than 24 hours) and PRODUCT STORAGE ERROR (Vial was 1st punctured on 18-Jul-2022 at 9:30am and administered on 19-Jul-2022 at 10:28am.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Date and time vial was first punctured 18-Jul-2022 at 9:30am. Nurse in a regional health center reported that they administered a pediatric dose of the Moderna Covid-19 which had been punctured for more that 24 hours (vial was 1st punctured on 18Jul2022 at 9:30am) to a 9-month old patient on 19Jul2022 at 10:28am. Dose administered greater than 12/24 hours post puncture. It was reported that number of vials/doses was 1 dose. Post puncture vial was stored in refrigerator. Vial did not undergone any temperature excursions.
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: One of our Medical Assistants gave a dose of expired Moderna Covid-19 vaccine.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (One of our Medical Assistants gave a dose of expired Moderna Covid-19 vaccine.) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (One of our Medical Assistants gave a dose of expired Moderna Covid-19 vaccine.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (One of our Medical Assistants gave a dose of expired Moderna Covid-19 vaccine.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Patient received second booster dose on 16-Jul-2022. Number of doses/vials were reported as 1 dose. The vial did not undergo any temperature excursions. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Exposure to toxic agent
Clinical narrative: Exposed to poison ivy bad case of poison ivy; This spontaneous case was reported by a patient and describes the occurrence of EXPOSURE TO TOXIC AGENT (Exposed to poison ivy bad case of poison ivy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jun-2022, the patient experienced EXPOSURE TO TOXIC AGENT (Exposed to poison ivy bad case of poison ivy). The patient was treated with PREDNISONE from 29-Jun-2022 to July 2022 for Exposure to poison ivy, at an unspecified dose and frequency. At the time of the report, EXPOSURE TO TOXIC AGENT (Exposed to poison ivy bad case of poison ivy) was resolving.            No concomitant medication were reported. Patient had bad case of poison ivy on 29Jun2022.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: 11-year-old patient received a 0.5 ml of the vaccine 6 month to 5 years; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (11-year-old patient received a 0.5 ml of the vaccine 6 month to 5 years) in an 11-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination.     Patient had no allergies to medications, food and other products.     On 20-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Jul-2022, the patient experienced INCORRECT DOSE ADMINISTERED (11-year-old patient received a 0.5 ml of the vaccine 6 month to 5 years). At the time of the report, INCORRECT DOSE ADMINISTERED (11-year-old patient received a 0.5 ml of the vaccine 6 month to 5 years) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient height was reported as 53.5 inches. No concomitant medications were provided by the reporter. The vaccine was stored in the fridge and the beyond use date was 22-Sep-2022. It was reported that patient is not immunocompromise. Patient was not taking other medications. Patient do not had side effect. No treatment information was provided.