chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Breast mass
Clinical narrative: Large lump on the left side of breast; This is a spontaneous report from a contactable Consumer(patient). A 14-year-old male patient received bnt162b2 (COMIRNATY, solution for injection), via an unspecified route of administration, administered in Left arm on 20Aug2021 at 12:00 PM (Batch/Lot Number: FO3182) as dose 1, single for COVID-19 immunization. The patients medical history included COVID-19. The patient had no known allergies. The patients concomitant medications were not reported. On 22Aug2021 at 06:00 AM the patient experienced large lump on the left side of breast. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The outcome of event was not recovered.  Follow-Up (08Sep2021): Follow-up attempts are completed. No further information is expected.  Follow-up (24Sep2021): The following information was received from a contactable Other health professional, Health Care Professional Questionnaire received: patient not provide information to you regarding the reported adverse events with the use of the product  No follow-up attempts are needed. No further information is expected
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, SARS-CoV-2 test
Clinical narrative: Lump near my left collarbone same side as injection; This is a spontaneous report from a contactable consumer (patient herself). A 32-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0186, Expiration date: Unknown), via an unspecified route of administration in left arm on 14Aug2021 at 13:00 as dose 1, single (at the age of 32-years old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient did not receive any other vaccine in four weeks of vaccination. The patient did not receive any other medications in two weeks of vaccination. The patient's medical history included anaemia from an unknown date and unknown if ongoing. The patient's concomitant medications none. On 17Aug2021, the patient experienced lump near her left collarbone same side as injection. The patient underwent lab tests and procedures which included U of I saliva-based RT-PCR COVID-19 tested: negative on 24Aug2021. The patient received no treatment in response to the event. The outcome of the event was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Rash pruritic, SARS-CoV-2 test
Clinical narrative: Itchy rash; Red liquid filled bumps all over both arms, legs and feet; This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21Jul2021 (at the age of 42-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in 2021, the patient experienced itchy rash and red liquid filled bumps all over both arms, legs and feet. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in 2021, the patient underwent lab tests and procedures which included COVID-19 virus test via nasal swab and the result was negative. The clinical outcome of the events itchy rash and red liquid filled bumps all over both arms, legs and feet was not resolved at the time of this report.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Above  colarbone lymph node swollen; This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Aug2021 at 09:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Aug2021 at 15:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. On 28Aug2021 at 02:00, the patient experienced above colarbone lymph node swollen. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event above colarbone lymph node swollen was resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This is a spontaneous report from a contactable physician. A 13-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration on 27Aug2021 (at the age of 13-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known medication allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Concomitant medications were not reported. It was not reported if the patient received any other vaccines within four weeks prior to the vaccination. The patient experienced hives on 29Aug2021, 48 hours after first dose of Pfizer COVID vaccine. The event resulted in emergency room/department or urgent care. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. Therapeutic measures were taken as a hives and included treatment with fexofenadine hydrochloride (ALLEGRA). The clinical outcome of the event hives 48 hours after first dose of Pfizer COVID vaccine was resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: Body pain/aches; Muscle stiffness; This is a spontaneous report from a non-contactable consumer, the patient. A 22-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 13Aug2021 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included postural orthostatic tachycardia syndrome, asthma, celiac disease and allergies to red food coloring and gluten. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included sertraline (MANUFACTURER UNKNOWN), bupropion hydrochloride (WELLBUTRIN), nebivolol hydrochloride (BYSTOLIC) and omeprazole (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. On 13Aug2021, the patient experienced body pain, muscle stiffness and aches. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body pain/aches and muscle stiffness was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at injection site immediately lasting 2 days; This is a spontaneous report from a non-contactable consumer, the patient. A 23-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 27Aug2021 at 11:00 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included unspecified women's vitamin supplement for unknown indication on an unknown date and unknown if ongoing. On 27Aug2021 at 11:15, the patient experienced pain at injection site immediately lasting 2 days. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pain at injection site immediately lasting 2 days was resolved on 29Aug2021 at 11:15.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Fatigue; Body aches; Fever; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 25-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 18Aug2021 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19, which was diagnosed prior to vaccination. Concomitant medications were not reported. On an unknown date in Aug2021, the patient experienced fatigue, body aches and fever. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, body aches and fever was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Sensitive skin
Clinical narrative: Tired; Headache; Body ache; Sensitive skin; This is a spontaneous report from a contactable consumer, pfizer colleague. A 44-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 29Aug2021 at 14:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications were not reported. On 30Aug2021, the patient experienced tired, headache, body ache and sensitive skin. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tired, headache, body ache and sensitive skin were resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: VARZOS
Symptoms: Allergy to vaccine, Blister, Neuralgia
Clinical narrative: allergic to it; blisters; nerve pain; This case was reported by a consumer via interactive digital media and described the occurrence of allergy to vaccine in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles all the time they started on one arm and had suffered misdiagnosed for 5 years).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced allergy to vaccine, blister and nerve pain. The patient was treated with antivirals nos. On an unknown date, the outcome of the allergy to vaccine, blister and nerve pain were unknown.   It was unknown if the reporter considered the allergy to vaccine, blister and nerve pain to be related to Shingles vaccine.  Additional details were provided are as follows: The age at vaccination was not reported. The patient received a dose of Shingles vaccine and was allergic to it and could not receive the 2nd dose.  But the patient had minimal blisters like one to five and lots of nerve pain.  The patient used an antiviral medicine his/her doctor gave him/her to help and frozen peas were wonderful! The follow-up could not be possible as no contact details were available.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hypersensitivity, Lip pruritus, Nasal pruritus
Clinical narrative: her face turned red; had itch around her lips and nose; had itch around her lips and nose; allergic reaction; This case was reported by a nurse via call center representative and described the occurrence of allergic reaction in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th October 2021, the patient received the 1st dose of Shingrix. In October 2021, less than a week after receiving Shingrix, the patient experienced allergic reaction, lip pruritus and nasal itching. On an unknown date, the patient experienced red face. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the allergic reaction, red face, lip pruritus and nasal itching were recovered/resolved.   It was unknown if the reporter considered the allergic reaction, red face, lip pruritus and nasal itching to be related to Shingrix.  Additional details were provided are as follows: Registered nurse reported that a patient received a dose of Shingrix on Saturday and had an allergic reaction, her face turned red, had itch around her lips and nose. The patient to pharmacist and after taking Benadryl, the reaction were gone. The reporter consented to follow-up and requested to call the physician.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: not yet received second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chemotherapy (gone through chemo back then). Previously administered products included Shingrix (1st dose received intramuscularly on 27th April 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided are as follows: The case was reported by patient for himself. The age at vaccination was not applicable for this report. Till the time of reporting, the patient never went back to get the second dose, which led to incomplete course of vaccination. The patient called to inquired that what to do about the 2nd dose of Shingrix. The reporter consented to follow-up.
Age: 20.0
Sex: M
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: administered Menveo but he wanted to receive Bexsero.; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 20-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 24th October 2021, the patient received Menveo. On 24th October 2021, unknown after receiving Menveo, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.  Additional details were provided are as follows: Pharmacy manager reported that a patient was administered Menveo but he wanted to receive Bexsero. which led to wrong vaccine administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter did not have had details of lot and expiry date of Menveo. The reporter consented to follow-up.
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 5 months old patient received Kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received DTPa-IPV (Kinrix) (batch number D24G7, expiry date 4th June 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st September 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 21st September 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Nurse reported that a 4 months old patient received vaccination with Kinrix vaccine, indicated for patients 4 to 6 years old, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer concerned a 35 year old male of unspecified race and ethnicity. Initial information was processed along with the additional information received on 26-OCT-2021. The patient's height and weight were not reported. The patient was healthy as an Olympian before vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: L17021UA1 and 51737 and expiry: 28-FEB-2023 and 31-AUG-2023) dose, start therapy date were not reported,1 total administered for prophylactic vaccination. Concomitant medications included azathioprine, Inflectra, prednisone, caffeine, Neutrogena clear liquid lotion sunscreen SPF30/sunblock unspecified and Neutrogena ultra sheer mist sunscreen broad spectrum SPF70 5OZ for unspecified indication. It was reported that on an unspecified date, the patient was died days after the J and J (Johnson and Johnson ) shot. The cause of death was unknown. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of unknown cause. This report was serious (Death). This case, from the same reporter is linked to 20211049317 and 20211043304.; Sender's Comments: V0: 20211045102-covid-19 vaccine ad26.cov2.s -Death. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: Deep vein thrombosis; This spontaneous report received from a patient concerned a 61 year old. The patient's height, and weight were not reported.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A and expiry: 21-JUL-2021) dose was not reported, frequency one total, at left arm, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-AUG-2021, the patient experienced calf muscles were tight. On 08-AUG-2021, the patient went to the emergency room and was diagnosed with deep vein thrombosis. Multiple locations from calf up to behind the knee. Treatment medications (dates unspecified) included: rivaroxaban. The hematologist were running tests because the cause was unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from deep vein thrombosis. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211055705-covid-19 vaccine ad26.cov2.s-deep vein thrombosis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Mass
Clinical narrative: dizziness; red knot in her arm; arm turning red; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), MASS (red knot in her arm) and ERYTHEMA (arm turning red) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066d21a) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness), MASS (red knot in her arm) and ERYTHEMA (arm turning red). The patient was treated with CINCHOCAINE HYDROCHLORIDE, DIBROMSALAN, DIPHENHYDRAMINE HYDROCHLORIDE, HYDROCORTISONE, TRIBROMSALAN (CORTISONE B.G) at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness), MASS (red knot in her arm) and ERYTHEMA (arm turning red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was provided by the reporter.   This case was linked to MOD-2021-359259 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Melanoderma, Pain, Pruritus
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain (really hurting), melanoderma (black spots under her arm), pruritus (itching real bad) and feeling abnormal (breaking-out) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 066D21A and 959902) for COVID-19 immunization. No medical history provided. On Aug 4, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Sep 1, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pain (really hurting), melanoderma (black spots under her arm), pruritus (itching real bad) and feeling abnormal (breaking-out). Patient treated with topical cortisone for the adverse events, at an unspecified dose and frequency. At the time of the report, pain (really hurting), melanoderma (black spots under her arm), pruritus (itching real bad) and feeling abnormal (breaking-out): not resolved. No concomitant medications provided. This case linked to MOD-2021-359249 (patient link).
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Nasopharyngitis
Clinical narrative: head cold; Lack of drug effect; Diagnosed with Covid; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (head cold), DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (Diagnosed with Covid) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 013AZ1A) for COVID-19 vaccination.     Concomitant products included VITAMIN B [VITAMIN B NOS], VITAMIN C [ASCORBIC ACID] and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In July 2021, the patient experienced NASOPHARYNGITIS (head cold), DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (Diagnosed with Covid). At the time of the report, NASOPHARYNGITIS (head cold), DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (Diagnosed with Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Antibody test: no antibodies (Negative) Negative. In September 2021, Antibody test: no antibodies (Negative) Negative.         Labs performed in SEP 2021 revealed that the patient had no antibodies. The test was repeated a few weeks later with the same result.  No treatment information was provided by the reporter.  This case concerns a 83-year-old female patient with no medical history reported, who experienced the unexpected events of COVID-19 and nasopharyngitis. Drug ineffective was considered as an additional event. The events occurred unknown number of days after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the events occurred after the second dose and no additional dosing will be given. The benefit-risk relationship of vaccine is not affected by this report. The case was assessed as non-serious based on reported seriousness and medical judgement.; Sender's Comments: This case concerns a 83-year-old female patient with no medical historyreported, who experienced the unexpected events of COVID-19 and nasopharyngitis. Drug ineffective was considered as an additional event. The events occurred unknown number of days after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the events occured after the second dose and no additional dosing will be given. The benefit-risk relationship of vaccine is not affected by this report. The case was assessed as non-serious based on reported seriousness and medical judgement.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was used for doses after expired date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was used for doses after expired date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was used for doses after expired date). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine was used for doses after expired date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitants and Treatment medication were reported.   This case was linked to MOD-2021-359475 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: hundred patients received a dose from expired vial; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (hundred patients received a dose from expired vial) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (hundred patients received a dose from expired vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (hundred patients received a dose from expired vial) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03T20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore left injection site arm). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD-2021-360193 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Tinnitus
Clinical narrative: Ringing in her ears; received the Pfizer vaccine/first dose of the Moderna Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in her ears) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the Pfizer vaccine/first dose of the Moderna Covid-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On 22-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On an unknown date, the patient experienced TINNITUS (Ringing in her ears) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the Pfizer vaccine/first dose of the Moderna Covid-19). At the time of the report, TINNITUS (Ringing in her ears) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the Pfizer vaccine/first dose of the Moderna Covid-19) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. No treatment medication were reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: After 1st dose of the vaccine she had a sore arm; 1st dose of the vaccine she had a sore arm that was a little swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (After 1st dose of the vaccine she had a sore arm) and VACCINATION SITE SWELLING (1st dose of the vaccine she had a sore arm that was a little swollen) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (After 1st dose of the vaccine she had a sore arm) and VACCINATION SITE SWELLING (1st dose of the vaccine she had a sore arm that was a little swollen). At the time of the report, VACCINATION SITE PAIN (After 1st dose of the vaccine she had a sore arm) and VACCINATION SITE SWELLING (1st dose of the vaccine she had a sore arm that was a little swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was taking blood thinners concomitantly.   This case was linked to MOD-2021-359999, MOD-2021-359939 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Follow up received and contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered  past the expiration date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered  past the expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered  past the expiration date). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administered  past the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-359738 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Doses administered out of vial that went through excursion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Doses administered out of vial that went through excursion) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Doses administered out of vial that went through excursion). At the time of the report, PRODUCT STORAGE ERROR (Doses administered out of vial that went through excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided    Reporter did not allow further contact
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: injection site is still pretty red; injection site is still swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (injection site is still pretty red) and VACCINATION SITE SWELLING (injection site is still swollen) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pulmonary hypertension. Concomitant products included INSULIN for an unknown indication.    On 09-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site is still pretty red) and VACCINATION SITE SWELLING (injection site is still swollen). At the time of the report, VACCINATION SITE ERYTHEMA (injection site is still pretty red) and VACCINATION SITE SWELLING (injection site is still swollen) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient also takes other unspecified concomitant medications. Treatment information was not reported.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Tendon injury, Tendon pain
Clinical narrative: Achilles tendon hurts like hell; tingling in chest & left arm; Achilles tendon locked up. bottom 2 inches inches; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in chest & left arm), TENDON INJURY (Achilles tendon locked up. bottom 2 inches inches) and TENDON PAIN (Achilles tendon hurts like hell) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hypercholesteraemia (10 years ago) in 2011 and Achilles tendon injury (due to statins intake).   In September 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced PARAESTHESIA (tingling in chest & left arm) and TENDON INJURY (Achilles tendon locked up. bottom 2 inches inches). On 21-Oct-2021, the patient experienced TENDON PAIN (Achilles tendon hurts like hell). At the time of the report, PARAESTHESIA (tingling in chest & left arm), TENDON INJURY (Achilles tendon locked up. bottom 2 inches inches) and TENDON PAIN (Achilles tendon hurts like hell) outcome was unknown.            Patient had taken unspecified statins 10 yrs ago for cholesterol. Concomitant information was not reported.  No treatment information was reported.
Age: 89.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Asthenia, Diarrhoea, Dyspnoea, Fatigue, Hypotension
Clinical narrative: feeling lousy; increased shortness of breath for 2 days, higher than the baseline; occasional diarrhea; Hypotension; weakness; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (feeling lousy), DYSPNOEA (increased shortness of breath for 2 days, higher than the baseline), DIARRHOEA (occasional diarrhea), HYPOTENSION (Hypotension) and ASTHENIA (weakness) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TREPROSTINIL SODIUM (TYVASO) inhalation gas for Primary pulmonary hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included TADALAFIL and RIVAROXABAN (XARELTO) for an unknown indication.   On 06-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started TREPROSTINIL SODIUM (TYVASO) (unknown route) at an unspecified dose. In October 2021, the patient experienced VACCINATION COMPLICATION (feeling lousy), DYSPNOEA (increased shortness of breath for 2 days, higher than the baseline), DIARRHOEA (occasional diarrhea), HYPOTENSION (Hypotension), ASTHENIA (weakness), FATIGUE (Fatigue) and NAUSEA (Nausea). At the time of the report, VACCINATION COMPLICATION (feeling lousy), DYSPNOEA (increased shortness of breath for 2 days, higher than the baseline), DIARRHOEA (occasional diarrhea), HYPOTENSION (Hypotension), ASTHENIA (weakness), FATIGUE (Fatigue) and NAUSEA (Nausea) outcome was unknown.            No Treatment medications reported
Age: 89.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Nausea, Vaccination complication
Clinical narrative: feeling lousy; increased shortness of breath for 2 days, higher than the baseline; occasional diarrhea; Hypotension; weakness; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (feeling lousy), DYSPNOEA (increased shortness of breath for 2 days, higher than the baseline), DIARRHOEA (occasional diarrhea), HYPOTENSION (Hypotension) and ASTHENIA (weakness) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TREPROSTINIL SODIUM (TYVASO) inhalation gas for Primary pulmonary hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included TADALAFIL and RIVAROXABAN (XARELTO) for an unknown indication.   On 06-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started TREPROSTINIL SODIUM (TYVASO) (unknown route) at an unspecified dose. In October 2021, the patient experienced VACCINATION COMPLICATION (feeling lousy), DYSPNOEA (increased shortness of breath for 2 days, higher than the baseline), DIARRHOEA (occasional diarrhea), HYPOTENSION (Hypotension), ASTHENIA (weakness), FATIGUE (Fatigue) and NAUSEA (Nausea). At the time of the report, VACCINATION COMPLICATION (feeling lousy), DYSPNOEA (increased shortness of breath for 2 days, higher than the baseline), DIARRHOEA (occasional diarrhea), HYPOTENSION (Hypotension), ASTHENIA (weakness), FATIGUE (Fatigue) and NAUSEA (Nausea) outcome was unknown.            No Treatment medications reported
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Fatigue, Hyperhidrosis, Myalgia
Clinical narrative: Muscle soreness all over body after first shot / Achy all over the body after first shot; Tired after first shot; Cold sweats after first shot; Hot sweat after first shot; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (Cold sweats after first shot), HYPERHIDROSIS (Hot sweat after first shot), MYALGIA (Muscle soreness all over body after first shot / Achy all over the body after first shot) and FATIGUE (Tired after first shot) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced COLD SWEAT (Cold sweats after first shot) and HYPERHIDROSIS (Hot sweat after first shot). On 24-Apr-2021, the patient experienced MYALGIA (Muscle soreness all over body after first shot / Achy all over the body after first shot) and FATIGUE (Tired after first shot). On 01-Oct-2021, COLD SWEAT (Cold sweats after first shot) and HYPERHIDROSIS (Hot sweat after first shot) had resolved. At the time of the report, MYALGIA (Muscle soreness all over body after first shot / Achy all over the body after first shot) and FATIGUE (Tired after first shot) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter. It was reported that the patient took steroids shot as a treatment which helped tremendously to the patient.  Patient took second dose of Moderna COVID-19 vaccine on 23MAY2021 and batch no is 033B21A.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Breakthrough COVID 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Breakthrough COVID 19) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced COVID-19 (Breakthrough COVID 19). At the time of the report, COVID-19 (Breakthrough COVID 19) outcome was unknown.            No treatment medication was reported. No Concomitant medication was reported.  This is a spontaneous case concerning a 75-year-old male patient with no relevant medical history reported, who experienced AESI, non-serious, unexpected event of COVID-19. The event occurred on an unknown date after receiving two doses of mRNA-1273. Rechallenge is not applicable since it cannot be assessed. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-360264 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 75-year-old male patient with no relevant medical history reported, who experienced AESI, non-serious, unexpected event of COVID-19. The event occurred on an unknown date after receiving two doses of mRNA-1273. Rechallenge is not applicable since it cannot be assessed. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: Patient received third dose without being immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Patient received third dose without being immunocompromised) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.   In January 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, received second 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. In 2021, the patient experienced OFF LABEL USE (Patient received third dose without being immunocompromised). At the time of the report, OFF LABEL USE (Patient received third dose without being immunocompromised) had resolved.            No Concomitant product use was reported. No treatment information was provided  It was reported that the patient received their first dose of the Moderna vaccine in Jan-2021 and second dose in Feb-2021 and received the third dose without consulting their healthcare provider on whether the patient was immunocompromised or not. Reportedly, the patient had diabetes.