chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccines placed in refrigerator on 13-Jan-2022 and dose admistered to patient on 17-Feb-2022; patients who received expired doses of the Moderna COVID vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients who received expired doses of the Moderna COVID vaccine) and PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 13-Jan-2022 and dose admistered to patient on 17-Feb-2022) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients who received expired doses of the Moderna COVID vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 13-Jan-2022 and dose admistered to patient on 17-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients who received expired doses of the Moderna COVID vaccine) and PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 13-Jan-2022 and dose admistered to patient on 17-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the vaccines were placed in refrigerator on 13-Jan-2022. Expiration date placed on vial was12-Feb-2022.  No concomitant medication was reported by the reporter. No treatment medication was reported by the reporter.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: received expired doses of the Moderna COVID vaccine; Vaccines placed in refrigerator on 13-Jan-2022 and dose administered to patient on 17-Feb-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired doses of the Moderna COVID vaccine) and PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 13-Jan-2022 and dose administered to patient on 17-Feb-2022) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired doses of the Moderna COVID vaccine) and PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 13-Jan-2022 and dose administered to patient on 17-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received expired doses of the Moderna COVID vaccine) and PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 13-Jan-2022 and dose administered to patient on 17-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter.  The vaccines were placed in refrigerator on 13-Jan-2022. Expiration date placed on vial was 12-Feb-2022.  No treatment medication was reported by the reporter.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: received expired doses of the Moderna COVID vaccine; Vaccines placed in refrigerator on 13-Jan-2022 and dose administered to patient on 17-Feb-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired doses of the Moderna COVID vaccine) and PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 13-Jan-2022 and dose administered to patient on 17-Feb-2022) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired doses of the Moderna COVID vaccine) and PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 13-Jan-2022 and dose administered to patient on 17-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received expired doses of the Moderna COVID vaccine) and PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 13-Jan-2022 and dose administered to patient on 17-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter.  The vaccines were placed in refrigerator on 13-Jan-2022. Expiration date placed on vial was 12-Feb-2022.  No treatment medication was reported by the reporter.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccines placed in refrigerator on 13 Jan 2022 and dose administered on 17 Feb 2022; patient received expired doses of the Moderna COVID vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired doses of the Moderna COVID vaccine) and PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 13 Jan 2022 and dose administered on 17 Feb 2022) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received expired doses of the Moderna COVID vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 13 Jan 2022 and dose administered on 17 Feb 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received expired doses of the Moderna COVID vaccine) and PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 13 Jan 2022 and dose administered on 17 Feb 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Drug details were reported.  No Treatment information was provided.   This case was linked to MOD-2022-491752 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccines placed in refrigerator on 13 Jan 2022 and dose administered on 17 Feb 2022; patient received expired doses of the Moderna COVID vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired doses of the Moderna COVID vaccine) and PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 13 Jan 2022 and dose administered on 17 Feb 2022) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received expired doses of the Moderna COVID vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 13 Jan 2022 and dose administered on 17 Feb 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received expired doses of the Moderna COVID vaccine) and PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 13 Jan 2022 and dose administered on 17 Feb 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Drug details were reported.  No Treatment information was provided.   This case was linked to MOD-2022-491752 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: I lost part of my smell and taste about a week after taking the shot; I lost part of my smell and taste about a week after taking the shot; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 69-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 (Lot number: ER8730) at the age of 69 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Heart attack" start date: an unknown date in 2005 (unspecified if ongoing); "Sulfonamide allergy" (unspecified if ongoing), notes: Known allergies: Sulfa and "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19: Yes. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: EN6202; Anatomical site: Left arm; Route of administration: unspecified), administration date: 24Feb2021, when the patient was 69 years old, for COVID-19 immunisation.  The following information was reported: ANOSMIA (non-serious), AGEUSIA (non-serious) all with onset 31Mar2021, outcome "not recovered", and all described as "I lost part of my smell and taste about a week after taking the shot". Therapeutic measures were not taken as a result of anosmia and ageusia.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. It was reported that the smell and taste had not returned to date almost a year later, 01Mar2022. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.
Age: 53.0
Sex: F
Vaccine: COVID19, VARZOS, COVID19
Symptoms: Polyneuropathy
Clinical narrative: Polyneuropathy; Inappropriate schedule of vaccine administered; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 19Mar2021 (Lot number: ER2613) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "UC" (unspecified if ongoing), notes: Other medical history: UC, anxiety, Retinitis Pigmentosa, Fuch's Dystrophy; "anxiety" (unspecified if ongoing), notes: Other medical history: UC, anxiety, Retinitis Pigmentosa, Fuch's Dystrophy; "Retinitis Pigmentosa" (unspecified if ongoing), notes: Other medical history: UC, anxiety, Retinitis Pigmentosa, Fuch's Dystrophy; "Fuch's Dystrophy" (unspecified if ongoing), notes: Other medical history: UC, anxiety, Retinitis Pigmentosa, Fuch's Dystrophy; "if COVID prior vaccination: Yes" (unspecified if ongoing), notes: if COVID prior vaccination: Yes. Concomitant medication(s) included: ELAVIL [ALLOPURINOL]; TRAMADOL; AMBIEN; GABAPIN. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine", notes: Known allergies: Codeine. Vaccination history included: Bnt162b2 (Prev dose product: COVID 19,, Prev dose brand: Pfizer,, Prev dose brand unknown: False,, Prev dose lot number: FJ1511,, Prev dose lot unknown: False,, Prev dose administration date: 04Jan2021, Prev dose dose number: 1), administration date: 04Jan2021, when the patient was 53 years old, for COVID-19 Immunization. The patient did not received other vaccine in four weeks. The following information was reported: POLYNEUROPATHY (disability, medically significant) with onset 01Apr2021, outcome "not recovered", described as "Polyneuropathy"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 19Mar2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered". The event "polyneuropathy" was evaluated at the physician office visit. Therapeutic measures were taken as a result of polyneuropathy: Medication, Neurologist Visits.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events.
Age: 53.0
Sex: F
Vaccine: COVID19, VARZOS, COVID19
Symptoms: Inappropriate schedule of product administration, Polyneuropathy
Clinical narrative: Polyneuropathy; Inappropriate schedule of vaccine administered; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 19Mar2021 (Lot number: ER2613) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "UC" (unspecified if ongoing), notes: Other medical history: UC, anxiety, Retinitis Pigmentosa, Fuch's Dystrophy; "anxiety" (unspecified if ongoing), notes: Other medical history: UC, anxiety, Retinitis Pigmentosa, Fuch's Dystrophy; "Retinitis Pigmentosa" (unspecified if ongoing), notes: Other medical history: UC, anxiety, Retinitis Pigmentosa, Fuch's Dystrophy; "Fuch's Dystrophy" (unspecified if ongoing), notes: Other medical history: UC, anxiety, Retinitis Pigmentosa, Fuch's Dystrophy; "if COVID prior vaccination: Yes" (unspecified if ongoing), notes: if COVID prior vaccination: Yes. Concomitant medication(s) included: ELAVIL [ALLOPURINOL]; TRAMADOL; AMBIEN; GABAPIN. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine", notes: Known allergies: Codeine. Vaccination history included: Bnt162b2 (Prev dose product: COVID 19,, Prev dose brand: Pfizer,, Prev dose brand unknown: False,, Prev dose lot number: FJ1511,, Prev dose lot unknown: False,, Prev dose administration date: 04Jan2021, Prev dose dose number: 1), administration date: 04Jan2021, when the patient was 53 years old, for COVID-19 Immunization. The patient did not received other vaccine in four weeks. The following information was reported: POLYNEUROPATHY (disability, medically significant) with onset 01Apr2021, outcome "not recovered", described as "Polyneuropathy"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 19Mar2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered". The event "polyneuropathy" was evaluated at the physician office visit. Therapeutic measures were taken as a result of polyneuropathy: Medication, Neurologist Visits.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Allergy to vaccine, Impaired healing, Muscle spasms, Peripheral coldness, Pruritus
Clinical narrative: Slow healing (cuts, wounds, injuries)/ Worsened; Ongoing muscle cramps / Worsened; Cold feet / worsened; Ridiculous itch / Worsened; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED HEALING (Slow healing (cuts, wounds, injuries)/ Worsened), MUSCLE SPASMS (Ongoing muscle cramps / Worsened), PERIPHERAL COLDNESS (Cold feet / worsened) and PRURITUS (Ridiculous itch / Worsened) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 045B21A and 039A21A) for COVID-19 vaccination.     The patient's past medical history included Injury (Acupuncture), Nail injury (Cut under fingernail took 6 months to heal.) and Muscle cramps. Previously administered products included for Allergic reaction: Decadron (Years ago). Past adverse reactions to the above products included No adverse event with Decadron. Concurrent medical conditions included Neuropathy peripheral (Started 22 years ago from an acupuncture injury.), Groin strain (Stated it still hurts today (ongoing)) since April 2020, Rotator cuff injury (Right rotator cuff injury that had not healed completely and hurts every day) since November 2020, Impaired work ability (because of the rotator cuff injuy) and Reaction to preservatives (Any product containing Thimerosal preservative).   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient experienced IMPAIRED HEALING (Slow healing (cuts, wounds, injuries)/ Worsened), MUSCLE SPASMS (Ongoing muscle cramps / Worsened), PERIPHERAL COLDNESS (Cold feet / worsened) and PRURITUS (Ridiculous itch / Worsened). At the time of the report, IMPAIRED HEALING (Slow healing (cuts, wounds, injuries)/ Worsened), MUSCLE SPASMS (Ongoing muscle cramps / Worsened) and PERIPHERAL COLDNESS (Cold feet / worsened) had not resolved and PRURITUS (Ridiculous itch / Worsened) had resolved.            Patient was not a diabetic. Patient stated the rotator cuff area is sensitive and feels like it could be sprained easily since the injury. Patient's symptoms have worsened. Patient takes several concomitant medications to treat foot neuropathy. Patient sees two regular doctors on a regular basis: a neurologist and a general practitioner. Patient recently had a physical by his general practitioner and the results showed he is fine. Patient not had COVID test or diagnosis previously. Reported none for Other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Treatment information was not provided.   This case was linked to MOD-2022-495246, MOD-2022-494845 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Impaired healing, Muscle spasms, Peripheral coldness, Pruritus
Clinical narrative: Slow healing (cuts, wounds, injuries)/ Worsened; Ongoing muscle cramps / Worsened; Cold feet / worsened; Ridiculous itch / Worsened; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED HEALING (Slow healing (cuts, wounds, injuries)/ Worsened), MUSCLE SPASMS (Ongoing muscle cramps / Worsened), PERIPHERAL COLDNESS (Cold feet / worsened) and PRURITUS (Ridiculous itch / Worsened) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 045B21A and 039A21A) for COVID-19 vaccination.     The patient's past medical history included Injury (Acupuncture), Nail injury (Cut under fingernail took 6 months to heal.) and Muscle cramps. Previously administered products included for Allergic reaction: Decadron (Years ago). Past adverse reactions to the above products included No adverse event with Decadron. Concurrent medical conditions included Neuropathy peripheral (Started 22 years ago from an acupuncture injury.), Groin strain (Stated it still hurts today (ongoing)) since April 2020, Rotator cuff injury (Right rotator cuff injury that had not healed completely and hurts every day) since November 2020, Impaired work ability (because of the rotator cuff injuy) and Reaction to preservatives (Any product containing Thimerosal preservative).   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient experienced IMPAIRED HEALING (Slow healing (cuts, wounds, injuries)/ Worsened), MUSCLE SPASMS (Ongoing muscle cramps / Worsened), PERIPHERAL COLDNESS (Cold feet / worsened) and PRURITUS (Ridiculous itch / Worsened). At the time of the report, IMPAIRED HEALING (Slow healing (cuts, wounds, injuries)/ Worsened), MUSCLE SPASMS (Ongoing muscle cramps / Worsened) and PERIPHERAL COLDNESS (Cold feet / worsened) had not resolved and PRURITUS (Ridiculous itch / Worsened) had resolved.            Patient was not a diabetic. Patient stated the rotator cuff area is sensitive and feels like it could be sprained easily since the injury. Patient's symptoms have worsened. Patient takes several concomitant medications to treat foot neuropathy. Patient sees two regular doctors on a regular basis: a neurologist and a general practitioner. Patient recently had a physical by his general practitioner and the results showed he is fine. Patient not had COVID test or diagnosis previously. Reported none for Other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Treatment information was not provided.   This case was linked to MOD-2022-495246, MOD-2022-494845 (Patient Link).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Blood test, Dizziness, Panic attack
Clinical narrative: anxiety attack; panic attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 19Apr2021 11:30 (Lot number: ER8733) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism", start date: 2010 (ongoing). Concomitant medication(s) included: SYNTHROID taken for hypothyroidism, start date: 2010 (ongoing). Vaccination history included: Bnt162b2 (Dose: 1st , Time:11:30am, Site and route of injection:, Anatomical site of injection: left arm, Route of administration: Intramuscular, Batch and lot number: Pfizer ER8733), administration date: 29Mar2021, for COVID-19 Immunization. The following information was reported: ANXIETY (non-serious) with onset 19Apr2021 01:00, outcome "not recovered", described as "anxiety attack"; PANIC ATTACK (non-serious) with onset 19Apr2021 01:00, outcome "not recovered", described as "panic attack". The events "anxiety attack" and "panic attack" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of anxiety, panic attack.  Additional information included: It was reported that patient had feelings of panic began on drive home after 2nd dose. No known causes for them. Primary care ran a blood panel to check for normal levels, but all is within range. No other cause of sudden onset and ongoing symptoms have been determined. Patient was treated with Buspar. No prior vaccination was received by patient. No relevant test had been done.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Blood test, Panic attack
Clinical narrative: anxiety attack; panic attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 19Apr2021 11:30 (Lot number: ER8733) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism", start date: 2010 (ongoing). Concomitant medication(s) included: SYNTHROID taken for hypothyroidism, start date: 2010 (ongoing). Vaccination history included: Bnt162b2 (Dose: 1st , Time:11:30am, Site and route of injection:, Anatomical site of injection: left arm, Route of administration: Intramuscular, Batch and lot number: Pfizer ER8733), administration date: 29Mar2021, for COVID-19 Immunization. The following information was reported: ANXIETY (non-serious) with onset 19Apr2021 01:00, outcome "not recovered", described as "anxiety attack"; PANIC ATTACK (non-serious) with onset 19Apr2021 01:00, outcome "not recovered", described as "panic attack". The events "anxiety attack" and "panic attack" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of anxiety, panic attack.  Additional information included: It was reported that patient had feelings of panic began on drive home after 2nd dose. No known causes for them. Primary care ran a blood panel to check for normal levels, but all is within range. No other cause of sudden onset and ongoing symptoms have been determined. Patient was treated with Buspar. No prior vaccination was received by patient. No relevant test had been done.  Follow-up attempts are completed. No further information is expected.
Age: 90.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Cerebrovascular accident, Chest X-ray abnormal, Pneumonia, SARS-CoV-2 test positive
Clinical narrative: Patient admitted to the hospital on 01/08/2022 .  Daughter interviewed on 01/14, said mother was still in the hospital, she had a stroke on 01/01/22 and contracted the virus at the hospital.  Patient was still in the hospital on 01/14/2022.  No underlying health conditions charted in System, nor the symptoms patient was experiencing.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: RN administered Pfizer 0.2ml pediatric dose to a 12-Year-old client. The client should have received 0.3 Pfizer adult dose. The nurse verified this was the dose given. Education provided to the staff.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling cold, Headache, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Second shot- Fever, chills, headache, redness and swelling a site of injection.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoacusis, Tinnitus
Clinical narrative: Tinnitus. Loud ringing in ear. Decreased hearing.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: patient's upper arm starting swelling from shoulder to elbow, no other symptoms reported.  advised patient to apply ice pack, take benadryl and ibuprofen, and monitor for improvement in the next 30-60 minutes.  patient called back 30-60 minutes later stating swelling was worsening.  advised patient to seek medical attention.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Audiogram, Deafness, Tinnitus
Clinical narrative: Tinnitus and noticeable hearing loss.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 antibody test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Dec2020 13:15 (Lot number: EL1284) at the age of 64 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "hypertension" (unspecified if ongoing); "CHOLESTEROL" (unspecified if ongoing), notes: COLESTEROL. There were no concomitant medications. The following information was reported: PAIN (non-serious) with onset 01Feb2021 15:00, outcome "not recovered", described as "Painful stabbing sensation in the area". The event "painful stabbing sensation in the area" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain. Additional information: Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. No any other medications were received within 2 weeks of vaccination. Patient received Pfizer vaccine, administration date 28Dec2020 (Lot number: EL9261) at the age of 64 years as dose 2. No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Aug2021 12:00 (Lot number: FC3181) at the age of 33 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "penicillin and skin allergies" (unspecified if ongoing), notes: known allergies: penicillin and skin allergies; "penicillin and skin allergies" (unspecified if ongoing), notes: known allergies: penicillin and skin allergies. Concomitant medication(s) included: MOTRIN [IBUPROFEN]. The following information was reported: HEADACHE (non-serious) with onset 13Aug2021, outcome "not recovered", described as "I've had a headache all week, day after day". Therapeutic measures were taken as a result of headache. Additional information: The patient had a headache all week, day after day, and headache. She expected it for the first she was expecting it for the first few days, but on day one. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 42 years as dose 2, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Product: COVID-19, Brand: Pfizer BioNTech, Lot number: EW0198, Lot unknown: False, Administration date: 16Jul2021,, Administration time: 07:15 PM,, Vaccine location: Right arm, Dose number: 1), administration date: 16Jul2021, when the patient was 42 years old, for COVID-19 immunisation, reaction(s): "Headache", "pain in the arm and a feeling of heaviness", "pain in the arm and a feeling of heaviness", "fatigue", "itching feeling of heaviness", "tiredness", "itchiness in the injection area", "chills", "fever", "pain under the arms (armpits) and part of the side area". The following information was reported: AXILLARY PAIN (non-serious) with onset 2021, outcome "recovered with sequelae" (2021), described as "after the second dose and weeks later I get pain under the arms, armpits and side.". Therapeutic measures were taken as a result of axillary pain. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Expired dose of M-M-R II was administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug allergies or reactions, and concomitant medications were not reported.  On 31-JAN-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) at a dose of  0.5 milligram subcutaneously (SQ) as prophylaxis (vaccination scheme frequency, anatomical location; lot number S039316 was verified to be a valid lot number, expiration date reported as 04-DEC-2021) (expired product administered). No adverse event was reported.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: Patient was administered VARIVAX while she was 17 weeks gestation; This spontaneous report was received from a physician concerning a female patient who was currently 26 years old. The patient historical conditions included anxiety and pyelonephritis, the patient reported that was allergic to latex. Information regarding the patient's historical drug was not provided.   Concomitant therapies included acetylsalicylic acid (BABY ASPIRIN)  On an unspecified date, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (dosage regimen, route of administration, lot number and expiration date were not provided) for prophylaxis.  The patient was pregnant at the time of vaccination. During a 20 week prenatal appointment, the patient informed the HCP what occurred. Initial exposure to varicella virus vaccine live (oka/merck)(VARIVAX) was at 17 week(s). The LMP and EDD was not reported. The pregnancy outcome was pending.   The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the Oka/Merck vaccine strain. However, information arrived incomplete. It was only reported that the patient had not been exposed or presented chickenpox or shingles.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; VARlVAX expired on 23-JAN-2022 and was administered on 27-JAN-2022; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information about the patient's medical history, concomitant medications and concurrent conditions was reported.  On 27-JAN-2022, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 (no units provided), lot #T002843, expiration date: 23-JAN-2022 (site and route of administration were not provided) for prophylaxis (expired product administered). The varicella virus vaccine live (oka/merck) (VARIVAX) had no previous temperature excursions. No additional adverse event was reported (no adverse event).
Age: 14.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional AE reported; patient was administered PROQUAD and VARlVAX on 27JAN2022 instead of MMR II and VARlVAX; a 14 year old patient was administered PROQUAD; This spontaneous report was received from a pharmacist and refers to a 14-year-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 27-JAN-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and varicella virus vaccine live (oka/merck) (VARIVAX) (dose/frequency reported as 1) instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (exact dose, dose number, route of administration, vaccination site, lot # and expiration date were not provided). No additional adverse event (AE) reported.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Product was administered to patient after temperature excursions; This spontaneous report was received from a certified medical assistant and refers to a 4-year-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 21-JAN-2022, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), dose/frequency reported as once, lot # T0235408 (invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), and does not match any Company product as confirmed by Lot Verification team), expiration date 14-APR-2022 (exact dose, dose number, route of administration and vaccination site were not provided) for prophylaxis.  Administered dose of vaccine was exposed to the temperature excursion of 7.4 degrees Fahrenheit for 25 minutes, 6.4 degrees Fahrenheit for 20 minutes and 5.9 degrees Fahrenheit for 15 minutes. There were previous temperature excursions, 31.3 degrees Fahrenheit for 10 hours 28 minutes, between range of 6 to 14 degrees Fahrenheit (no exact temperature was provided) for 1 hour 15 minutes and 11 degrees Fahrenheit for 4 hours 6 minutes.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported.; Nurse reporting a dose of Improperly stored V ARIV AX has been administered; This spontaneous report was received from a registered nurse referring to a 12 month old patient of unreported gender.      No information regarding the patient's pertinent medical history, drug reactions or allergies or concomitant therapies was provided.  On 19-JAN-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (product storage error) at a dose of 0.5 milliliter for prophylaxis (lot number U020244, expiration date 28-JUN-2023; route of administration, vaccination scheme frequency, concentration and anatomical location were not reported). It was later found that the administered dose of the vaccine experienced a temperature excursion of  6 Fahrenheit degrees up to 14 Fahrenheit degrees (13.8 Fahrenheit degrees) for 1 hour 45 minutes and 0 seconds and of 14 Fahrenheit degrees up to 46 Fahrenheit degrees (14.4 Fahrenheit degrees) for 0 hours 25 minutes and 0 seconds. There were no previous temperature excursions. No additional adverse events reported.    This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2202USA000685: US-009507513-2202USA000846:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; Nurse reporting a dose of improperly stored VARIVAX has been administered to a patient on 28JAN2022; This spontaneous report was received from a registered nurse and refers to a 12-months-old patient of unknown gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 28-JAN-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliter (route of administration was not reported, lot # U020244 and expiration date 28-JUN-2023 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of 6 degree fahrenheit (°f) up to 14°F (13.8°F) for 1 hour an 45 minutes, and 14°F up to 46°F (14.4°F) for 25 minutes; no previous temperature excursions were reported.  No adverse symptoms were reported.
Age: 1.08
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; Nurse reporting a dose of improperly stored VARIVAX has been administered to a patient on 18JAN2022; This spontaneous report was received from a registered nurse and refers to a 13-month-old patient of unknown gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 18-JAN-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliter (route of administration was not reported, lot # U020244 and expiration date 28-JUN-2023 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of 6 degree fahrenheit (°f) up to 14°F (31.8°F) for 1 hour an 45 minutes, and 14°F up to 46°F (14.4°F) for 25 minutes; no previous temperature excursions were reported.  No adverse symptoms were reported.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; incorrect product storage; This spontaneous report was received from other health professional and refers to 12-months-old patient of unknown gender. There were no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 26-JAN-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (VARIVAX), lot #: U020238, expiration date: 28-JUN-2023, dose: 0,5 milliliter (route of administration and dose number were not reported) for prophylaxis (product storage error). Administered dose of vaccine experienced the temperature excursion between 6 degrees Fahrenheit (F) up to 14 degrees Fahrenheit (F) (13.8 F) for 1 hour, 45 minutes and between of 14 degrees Fahrenheit up to 46 degrees Fahrenheit for (14.4 F) for 25 minutes.   There were no previous temperature excursions. No adverse event was reported (no adverse event).
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/none of these patients had any type of adverse reaction.; Vaccines had temperature excursion on 12/14/2021/who was given VARIVAX in the right arm on 22-DEC-2021.; This spontaneous report was received from a certified medical assistant and refers to a 5-year-old patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 14-DEC-2021, the vaccine experienced temperature excursion of 21 degrees Fahrenheit for 3 hours and 32 minutes. There was no previous excursion reported.  On 22-DEC-2021, the patient was administered a dose of an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # U019908, expiration date: 24-JUN-2023, in the right arm for prophylaxis (strength, dose, formulation and route of administration were not provided) (Improper storage of product in use).  No additional adverse event was reported - it was reported that none of the patients had any type of adverse reaction (No adverse reaction). No further information is available.  This is one of several reports received from the same reporter.  Lot Number U019908 is valid for varicella virus vaccine live (oka/merck) (VARIVAX).; Sender's Comments:  US-009507513-2202USA000907: US-009507513-2112USA007215:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; patient was administered an expired dose of VAQTA; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding patient's medical history, concurrent conditions and concomitant therapies was provided.  On 03-FEB-2022, the patient was vaccinated with expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 milliliter, lot #T020442, expiration date: 26-JAN-2022 (strength, dose number, route and site of administration were not provided) for prophylaxis (Expired product administered).  No adverse event were reported (No adverse event).
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Accidental overdose, No adverse event, Product label confusion
Clinical narrative: No further AE's reported; Employee reported that both PROQUAD and V ARlV AX were administered to a patient; Employee reports that the product labels "look too similar."; This spontaneous report as received who was an executive refers to a 12 months old male patient. The patient's concurrent conditions, concomitant therapies and medical history was not provided.  On 03-FEB-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (dose, formulation, route of administration, site of administration, lot # and expiration date were not provided) for prophylaxis. On the same day since the products labels looked too similar (product label confusion), the patient was also vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant Human albumin (PROQUAD) lot # U002539, expiration date not reported, but upon internal validation established as 24-JUL-2022 (dose, formulation, route of administration and site of administration were not provided) for prophylaxis (accidental overdose). No further adverse events were reported.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs were reported; Medical assistant is reporting that an expired GARDASIL 9 was given to a patient; This spontaneous report as revived from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, concomitant therapies and medical history were not provided.  On 02-FEB-2022, the patient was vaccinated with one dose of expired hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) prefilled syringe, lot # S011719, expiration date 04-DEC-2021 (route and site of administration were not reported) for prophylaxis (Expired product administered). No additional adverse events were reported (No adverse event).
Sex: F
Vaccine: HPV4, HPV9, HPV9
Symptoms: Circumstance or information capable of leading to medication error, Interchange of vaccine products
Clinical narrative: No additional AEs; Patient has one GARDASIL vaccine - unknown valent - at an unknown age; Patient has one GARDASIL vaccine - unknown valent - at an unknown age; This spontaneous report was received from a registered nurse and refers to a 31-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was administered first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (strength, dose, lot #, expiry date and route of administration were not provided) for prophylaxis. It was reported she had Merck hpv vaccine unknown valent. The patient thought she may also received second vaccination, but she was not sure. On 06-NOV-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml administered intramuscularly, lot # 1637642, expiration date: 28-MAY-2022 (strength and anatomical location were not provided) for prophylaxis (Circumstance or information capable of leading to medication error, interchange of vaccine products).  No additional adverse event reported.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Medical assistant called to report that an expired dose of ROTATEQ was administered.; This spontaneous report was received from a medical assistant, referring to a 6-month-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 24-JAN-2022, the patient was vaccinated with expired dose (expired product administered) of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) administered orally, lot #: U007860, expiration date: 14-JAN-2022 (exact dose and strength were not provided) for prophylaxis. No additional adverse event was reported.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: No additional AE/PQC reported; an expired dose of ROTATEQ was administered; This spontaneous report was received from a medical assistant and refers to a 6-month-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 19-JAN-2022, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot # U007860, expiration date 14-JAN-2022 (exact dose and dose number were not provided) for prophylaxis.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; an expired dose of ROT ATEQ was administered; This spontaneous report was received from a medical assistant and refers to an 8-week-old patient of unknown gender. No information about the patient's medical history, concomitant medications and concurrent conditions was reported.  On 21-JAN-2022, the patient was vaccinated an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #U007860, expiration date: 14-JAN-2022 (exact dose and frequency were not reported) orally for prophylaxis (expired product administered). No additional adverse event was reported (no adverse event).