chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: MI (myocardial infarction); Severe limitation in my left arm movement; Frozen Shoulder; Booster; off label use; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EN6199), in left arm, as dose 2, single (Lot number: EP7534), in left arm, as dose 3 (booster), single (Lot number: FC3184), in left arm and as dose 4 (booster), single (Lot number: F129896) at the age of 68 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of other medications the patient received within 2 weeks of vaccination For the 3rd and 4th vaccinations. The patient had no known allergies. The following information was reported: PERIARTHRITIS (hospitalization, life threatening) with onset 10Nov2021 at 17:30, outcome "recovering", described as "Frozen Shoulder"; MYOCARDIAL INFARCTION (hospitalization, medically significant, life threatening) with onset 10Nov2021 at 17:30, outcome "recovering", described as "MI (myocardial infarction)"; JOINT RANGE OF MOTION DECREASED (hospitalization, life threatening) with onset 10Nov2021 at 17:30, outcome "recovering", described as "Severe limitation in my left arm movement"; IMMUNISATION (life threatening), outcome "unknown", described as "Booster"; OFF LABEL USE (life threatening), outcome "unknown". The patient was hospitalized for myocardial infarction, joint range of motion decreased, periarthritis (hospitalization duration: 2 day(s)). The events "mi (myocardial infarction)", "severe limitation in my left arm movement" and "frozen shoulder" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Dec2021) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of myocardial infarction, joint range of motion decreased, periarthritis.  Clinical course: The patient received all four doses on 23Mar2022. The patient was a healthy individual and experienced a MI (myocardial infarction) 10Nov2021.  Shortly after that she started to experience severe limitation in my left arm movement. Was then diagnosed with Frozen Shoulder. She received blood thinners for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling, Pruritus, Rash
Clinical narrative: broke out in a rash, sores; broke out in a rash, sores; looks like a big circle of whelps or swellings on her legs and it's itchy; looks like a big circle of whelps or swellings on her legs and it's itchy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 22Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cellulitis" (unspecified if ongoing), notes: Hospitalized for cellulitis years ago and not know what causing it and had kept taking medications.; "Sulfa drug" (unspecified if ongoing), notes: Occurs with many medications such as anything classified as a NSAID or Sulfa drug.; "NSAID" (unspecified if ongoing), notes: Occurs with many medications such as anything classified as a NSAID or Sulfa drug. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Lot Number: Caller states that it is either. and Expiry date are unknown., Anatomical location: left arm.), administration date: 30Mar2021, when the patient was 65-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, Lot Number:  and Expiry date are unknown, Anatomical location: left arm.), administration date: 21Apr2021, when the patient was 65-year-old, for COVID-19 immunization; BNT162b2 (Dose 3, Lot Number:  and Expiry date are unknown, Anatomical location: left arm.), administration date: 19Nov2021, when the patient was 65-year-old, for COVID-19 immunization; Flu vaccine, for she got so ill with it; Flu vaccine, for Got real sick. The following information was reported: RASH (non-serious) with onset Apr2022, outcome "recovered" (Apr2022), PAIN (non-serious) with onset Apr2022, outcome "unknown" and all described as "broke out in a rash, sores"; PRURITUS (non-serious), PERIPHERAL SWELLING (non-serious) all with onset Apr2022, outcome "unknown" and all described as "looks like a big circle of whelps or swellings on her legs and it's itchy". Therapeutic measures were taken as a result of rash.  Additional information: Patient had no reactions to the COVID Vaccines up until her fourth shot. States she broke out in a rash, sores, whatever it was that she breaks out in. States it looks like a big circle of whelps or swellings on her legs and it's itchy. Patient stated that if she doesn't stop taking whatever medication it was at the time that causes it just gets worse. Patient stated that the rash she got after this vaccine went away in about 3-4 days. States that she had Triamcinolone Cream, she used that on the rash, and it faded away. Patient stated that her only concern now was if she needs more booster vaccines. Stated that something in the vaccine, she was reacting to now. States that once she starts reacting, if she takes the medication again, the reaction was immediate. Patient stated that she was not blaming the vaccine. Stated that she was just very rare and reacts to a lot of things.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site nodule
Clinical narrative: I have like this red knot in my arm where I got the vaccine shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient received BNT162b2 (BNT162B2), on 25Apr2022 as dose number unknown, single (Lot number: 3303686) at the age of 49 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing), notes: Diabetes; "Blood pressure high" (unspecified if ongoing), notes: Blood pressure high; "High cholesterol" (unspecified if ongoing), notes: High cholesterol. Concomitant medication(s) included: METFORMIN; ATORVASTATIN; FERROUS SULFATE. The following information was reported: VACCINATION SITE NODULE (non-serious) with onset 30Apr2022, outcome "unknown", described as "I have like this red knot in my arm where I got the vaccine shot". Therapeutic measures were not taken as a result of vaccination site nodule.  No follow up attempts are needed. No Further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I have COVID-19; I have COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Interchange of vaccine" (not ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I have COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 included Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Vaccination site pain
Clinical narrative: first dose had given it way high up on the shoulder bone and it hurt like crazy.; first dose had given it way high up on the shoulder bone and it hurt like crazy.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient received BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Lot number: EN6198) at the age of 55 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU taken for immunisation, start date: 05Oct2021, stop date: 05Oct2020. Vaccination history included: flu vaccine , administration date: 05Oct2020, when the patient was 55-year-old, for Immunization; Shingles shot (she has had other vaccines that were given high up like with her Shingles shot, and that hurt), reaction(s): "hurt". The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious), VACCINATION SITE PAIN (non-serious) all with onset Mar2021, outcome "unknown" and all described as "first dose had given it way high up on the shoulder bone and it hurt like crazy." Additional information: Caller told the person administering that second dose that the person who gave the caller her first dose had given it way high up on the shoulder bone and it hurt like crazy. Caller stated that the person give her the second dose know about that so they could get it in deltoid. Caller said she did not feel any soreness or anything at all with that second dose. Caller had no soreness afterwards.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Experiencing the same rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:   A 91-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "Experiencing the same rash".  Additional information :  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: Vaccination failure; Suspected COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL3302), in left arm, on 10Feb2021 as dose 2, single (Lot number: EM9809), in left arm and on 15Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 52 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Hashimoto's" (unspecified if ongoing), notes: Hashimoto's; "arthritis" (unspecified if ongoing); "migraine" (unspecified if ongoing). Patient had unspecified known allergies. Concomitant medication(s) included: GABAPENTIN, start date: 15Oct2021, also reported as other medication in 2 weeks. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown"; SUSPECTED COVID-19 (medically significant), outcome "unknown". Therapeutic measures were taken as a result of vaccination failure, suspected covid-19 included anti viral Paxlovid (brand=Pfizer) started on 21Apr2022 to 25Apr2022. Patient had Rebound of COVID symptoms Sore throat, head congestion, cough, exhaustion on 30Apr2022 at 18:15, and was not recovered from symptoms. Reported that, the patient previously received a COVID-19 Vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Liver disorder, Nausea, Pain, Rash
Clinical narrative: Nausea; liver problems; rashes; abdominal pain; immense body pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), in May2021 as dose 1, single (Batch/Lot number: unknown) and in Jun2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious), outcome "unknown"; LIVER DISORDER (non-serious), outcome "unknown", described as "liver problems"; RASH (non-serious), outcome "unknown", described as "rashes"; ABDOMINAL PAIN (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "immense body pain". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Additional information : Caller (UNKNOWN) a Consumer who got the two shots of the Pfizer Covid-19 vaccine last May and Jun2021. stated that he experienced side effects such as Nausea, liver problems, rashes, abdominal pain and immense body pain. He also mentioned that he sent a letter regarding the Vaccine. Medical Information : Customer and/or medical inquiry was NOT forwarded or referred. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 45-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 45 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Apr2022, outcome "not recovered" and all described as "COVID 19". The Seriousness was reported as Non-Serious. Therapeutic measures were taken as a result of suspected covid-19 which included Paxlovid from 18Apr2022 to 23Apr2022 via oral route.   Clinical Course: The events reported were Loss of sense of smell and taste starting Sunday 01May2022. Potential worsening of COVID symptoms after completion of Paxlovid (cough, fatigue).   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: EN6208), in right arm, on 09Apr2021 as dose 2, single (Lot number: ER8733), in right arm and on 14Aug2021 as dose 3 (booster), single (Lot number: FA7485) at the age of 48 years, in right arm for Covid-19 immunisation. The patient's relevant medical history included: "crohn's disease" (unspecified if ongoing); "known allergies: crustaceans" (unspecified if ongoing). Concomitant medication(s) included: ALLEGRA. Past drug history included: Venofer, reaction(s): "Allergy". The following information was reported: COVID-19 (medically significant) with onset 02May2022 at 08:30, outcome "not recovered", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "Testing positive again after negative". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02May2022) Positive; (02May2022) Negative. Therapeutic measures were not taken as a result of Covid-19, vaccination failure. Clinical course: Patient received anti viral treatment with Paxlovid (from 23Apr2022 to 28Apr2022) lot number (FY5657). Patient received any other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously receive a COVID-19 Vaccine. Patient was treated with Humira for crohn's disease.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: EN6208), in right arm, on 09Apr2021 as dose 2, single (Lot number: ER8733), in right arm and on 14Aug2021 as dose 3 (booster), single (Lot number: FA7485) at the age of 48 years, in right arm for Covid-19 immunisation. The patient's relevant medical history included: "crohn's disease" (unspecified if ongoing); "known allergies: crustaceans" (unspecified if ongoing). Concomitant medication(s) included: ALLEGRA. Past drug history included: Venofer, reaction(s): "Allergy". The following information was reported: COVID-19 (medically significant) with onset 02May2022 at 08:30, outcome "not recovered", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "Testing positive again after negative". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02May2022) Positive; (02May2022) Negative. Therapeutic measures were not taken as a result of Covid-19, vaccination failure. Clinical course: Patient received anti viral treatment with Paxlovid (from 23Apr2022 to 28Apr2022) lot number (FY5657). Patient received any other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously receive a COVID-19 Vaccine. Patient was treated with Humira for crohn's disease.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: How bad my arm hurt after getting that exact vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A 23-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "How bad my arm hurt after getting that exact vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: total time out of range is 2 days with a minimum of 9.2C and maximum of 28.3C; 30 minutes with a minimum of 12.3C and maximum of 15.6C; 1 hour with a minimum of negative 1.8C and maximum of 1.8C reported with no adverse event; Initial information received on 29-Apr-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 71 years old and unknown gender patient who experienced total time out of range is 2 days with a minimum of 9.2c and maximum of 28.3c; 30 minutes with a minimum of 12.3c and maximum of 15.6c; 1 hour with a minimum of negative 1.8c and maximum of 1.8c reported with no adverse event while receiving vaccine influenza quadrival A-B high dose hv vaccine [Fluzone high-dose quadrivalent].   The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.    On an unknown date, the patient received suspect influenza quadrival A-B high dose hv vaccine (lot UJ732AB, expiry date: 30-Jun-2022, strength: not reported) via unknown route in unknown administration site for immunisation.  On 17-Oct-2021, the patient developed a non-serious total time out of range is 2 days with a minimum of 9.2c and maximum of 28.3c; 30 minutes with a minimum of 12.3c and maximum of 15.6c; 1 hour with a minimum of negative 1.8c and maximum of 1.8c reported with no adverse event (product temperature excursion issue) (unknown latency) following the administration of influenza quadrival A-B high dose hv vaccine.  Action taken: not applicable.  Outcome: Unknown.
Sex: U
Vaccine: YF
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: incorrect route of administration, with no reported adverse event; Initial information received on 22-Apr-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who experienced incorrect route of administration, with no reported adverse event while receiving vaccine yellow fever vaccine [yf-vax].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect yellow fever vaccine solution for injection (lot number, expiry date : not reported) via unknown route in unknown administration site for immunization.  On an unknown date, the patient experienced incorrect route of administration, with no reported adverse event (incorrect route of product administration) (unknown latency) following the administration of yellow fever vaccine.  Action taken : Not applicable.  Corrective treatment : Not reported for the event (incorrect route of administration, with no reported adverse event).  Outcome : Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: TYP
Symptoms: Injury, Syringe issue
Clinical narrative: where the syringe hub of the Typhim broke and caused an injury; Initial information received on 26-Apr-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced where the syringe hub of the typhim broke and caused an injury while receiving vaccine TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE lot number not reported via unknown route and expiry date in unknown administration site for Immunisation.  On an unknown date the patient developed a non-serious where the syringe hub of the typhim broke and caused an injury (injury) (unknown latency) following the administration of TYPHOID VI POLYSACCHARIDE VACCINE.  Action taken with TYPHOID VACCINE (TYPHIM VI) was not applicable.  It was not reported if the patient received a corrective treatment for the event (where the syringe hub of the Typhim broke and caused an injury).  At time of reporting, the outcome was Unknown for the event where the syringe hub of the typhim broke and caused an injury.
Age: 29.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event
Clinical narrative: No other adverse events reported; an administered expired VARIVAX dose; This spontaneous report as received from an office manager referring to a 29-year-old male patient. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.   On 25-APR-2022, the patient was vaccinated with an expired varicella virus vaccine live (oka/merck) (VARIVAX) (1 dose, lot # T012551, expiration date 10-APR-2022; strength, route of administration and anatomical location were not reported) for prophylaxis (expired product administered). The vaccine had had never experienced temperature excursion and product supported per article. No other adverse events reported. No product quality complaints.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash
Clinical narrative: shingles; dime sized, tiny blisters, eventually crusted over; painful; rash was in his mustache area; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced shingles, blister, pain and rash. On an unknown date, the outcome of the shingles, blister, pain and rash were recovered/resolved.   It was unknown if the reporter considered the shingles, blister, pain and rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-APR-2022 Reporter's Comments: The patient reported case for herself. The patient received his first dose of Shingrix about 2.5 months ago.    The patient stated that after 3 days after his dose, he developed shingles on his face. He described it as dime sized, tiny blisters, painful and it eventually crusted over. The patient stated that it lasted for about 2 weeks and resolved.  The location of the rash was in his mustache area. The reporter consented to follow up.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: PRODUCT STORAGE ERROR; VACCINE WAS ADMINISTERED TO PATIENT DIRECTLY FROM FREEZER WITHOUT BEING STORED AT RECOMMENDED STORAGE CONDITIONS OF 2 TO 8 CELSIUS; This spontaneous report received from a health care professional concerned a 30 year old male. 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: 1822811 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2022 for prophylactic vaccination. Age at time of vaccination 30 years old. No concomitant medications were reported.  On 01-APR-2022, the patient experienced vaccine was administered to patient directly from freezer without being stored at recommended storage conditions of 2 to 8 celsius. On an unspecified date, the patient experienced product storage error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product storage error and vaccine was administered to patient directly from freezer without being stored at recommended storage conditions of 2 to 8 celsius was not reported. This report was non-serious. This case, from the same reporter is linked to 20220505340, 20220505192, 20220504995, 20220505044, 20220505162, 20220505373 and 20220505824.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: Bruising directly above the injection site (left arm); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruising directly above the injection site (left arm)) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046L21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: J and J (1st dose with lot number 1805029) on 15-Mar-2021, FLU VACCINE VII in October 2021 and PFIZER BIONTECH COVID-19 VACCINE (1st booster dose with lot number 301358A) on 29-Oct-2021. Past adverse reactions to the above products included No adverse event with FLU VACCINE VII, J and J and PFIZER COVID-19 VACCINE. Concurrent medical conditions included Diabetes (She takes metformin, glipizide and pioglita for diabetes) and Drug allergy (Allergies to Codeine, Demerol and Hydrocodone.). Concomitant products included METFORMIN, GLIMEPIRIDE (GLIPIRIDE) and PIOGLITAZONE HYDROCHLORIDE (PIOGLITA) for Diabetes.    On 15-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2022, the patient experienced VACCINATION SITE BRUISING (Bruising directly above the injection site (left arm)). At the time of the report, VACCINATION SITE BRUISING (Bruising directly above the injection site (left arm)) was resolving.            The patient had no COVID-19 diagnosis prior to or after getting the Covid-19 vaccines.   The patient reported bruising directly above the injection site on the left arm after getting the Moderna Covid-19 vaccine for her 2nd booster dose.. At the time of report it was resolving.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Renal disorder
Clinical narrative: renal disorder nos; This spontaneous case was reported by a consumer and describes the occurrence of RENAL DISORDER (renal disorder nos) in a 62-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RENAL DISORDER (renal disorder nos). At the time of the report, RENAL DISORDER (renal disorder nos) outcome was unknown.            No concomitant medications reported. No treatment reported  Patient reported that he had two, without symptoms, and is concern of getting the third. Procedure do to he had major surgery and doesn't want to contract. Two major surgery related to his kidney, and doesn't want to get infected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   vial didn't undergo any temperature excursions No Concomitant Products were reported. No Treatment information was reported.
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Eczema
Clinical narrative: Patient stated that after the second vaccine patient got eczema.; This spontaneous case was reported by a patient and describes the occurrence of ECZEMA (Patient stated that after the second vaccine patient got eczema.) in a 75-year-old patient of an unknown gender 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 and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ECZEMA (Patient stated that after the second vaccine patient got eczema.). At the time of the report, ECZEMA (Patient stated that after the second vaccine patient got eczema.) was resolving.            Patient reported that along with the initial doses patient had also taken 1 booster dose last year, but got eczema after the second dose which at the moment is calming down.Thus the patient is now reluctant to take the 2 booster dose.  Concomitant drugs were not reported.  Treatment details were not given.
Age: 0.17
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: medication error due to use of invalid vaccine since it was reconstituted with wrong diluent with no reported adverse event; Initial information received on 03-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 months old female patient who was administered an invalid vaccine since it was reconstituted with wrong diluent with no reported adverse event while receiving vaccine hib (prp/t) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (Pediarix); pneumococcal vaccine conj 7V (CRM197) (PREVNAR); and Rotavirus vaccine.  On 02-May-2022, the patient received a 0.5 mL dose of suspect HIB (PRP/T) VACCINE (lot UJ588AAA, expiry date: 24-Oct-2022) via intramuscular route in the left thigh for immunization.  On 02-MAY-2022 the patient was administered an invalid vaccine since it was reconstituted with wrong diluent with no reported adverse event (product preparation error).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Since late December she has complained of recurrent episodes of generalized itching and rashes described as raised, red, itchy whelts which can occur anywhere on her body, especially at sites of pressure or where her skin is scraped or scratched. She also notes increased lesions following hot water bathing. Lesions last less than 24 hours, affect her palms and soles, and resolve without post-inflammatory changes. She denies laryngeal, pulmonary, GI, neurologic, and cardiovascular symptoms with these episodes. Episodes not associated with exercise, sweating, cold, foods, medications, NSAIDs, IV contrast, latex exposure, infections, or insect bites/stings. She received her Moderna COVID-19 vaccine booster dose on 4 December, 2-3 weeks prior to onset of symptoms. She has used oral antihistamines with some benefit. She denies constitutional symptoms. UCT score today is 19 (0, 4, 2, 2, 4, 4, 1, 2). She feels her symptoms are gradually improving. No history of adverse reactions to prior vaccines.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Scratch, Skin lesion, Urticaria
Clinical narrative: Since late December she has complained of recurrent episodes of generalized itching and rashes described as raised, red, itchy whelts which can occur anywhere on her body, especially at sites of pressure or where her skin is scraped or scratched. She also notes increased lesions following hot water bathing. Lesions last less than 24 hours, affect her palms and soles, and resolve without post-inflammatory changes. She denies laryngeal, pulmonary, GI, neurologic, and cardiovascular symptoms with these episodes. Episodes not associated with exercise, sweating, cold, foods, medications, NSAIDs, IV contrast, latex exposure, infections, or insect bites/stings. She received her Moderna COVID-19 vaccine booster dose on 4 December, 2-3 weeks prior to onset of symptoms. She has used oral antihistamines with some benefit. She denies constitutional symptoms. UCT score today is 19 (0, 4, 2, 2, 4, 4, 1, 2). She feels her symptoms are gradually improving. No history of adverse reactions to prior vaccines.
Age: 75.0
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Chest X-ray normal, Cough, Dyspnoea, Exposure to fungus
Clinical narrative: Covid19 breakthrough.  1st vaccine received on 01/09/2021, 2nd on 01/30/2021, and 3rd on 09/03/2021.  76 y/o female with PMHx of Diabetes, HTN, and chronic renal insufficiency presents to the ED with c/o SOB, Cough, Mold Exposure, nausea, vomiting and low grade temps.  Temp 100.0, room air sat 100%.  Chest Xray-normal chest.  Pt treated with steroids.
Age: 75.0
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, SARS-CoV-2 test positive, Vaccine breakthrough infection, Vomiting
Clinical narrative: Covid19 breakthrough.  1st vaccine received on 01/09/2021, 2nd on 01/30/2021, and 3rd on 09/03/2021.  76 y/o female with PMHx of Diabetes, HTN, and chronic renal insufficiency presents to the ED with c/o SOB, Cough, Mold Exposure, nausea, vomiting and low grade temps.  Temp 100.0, room air sat 100%.  Chest Xray-normal chest.  Pt treated with steroids.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Sleep disorder
Clinical narrative: severe itching of feet and hands - even to the point it keeps you awake during the evening
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bundle branch block left, Cardiac failure congestive, Catheterisation cardiac normal, Chest X-ray, Dyspnoea
Clinical narrative: Acute new onset of CHF one week after receiving the 3rd (booster) dose of the pfizer COVID-19 Vaccine.  Initial symptom of shortness of breath.  When initially evaluated for SOB, EKG performed, showing a new left sided bundle branch block and slight LVH.  Urgent echocardiogram performed soon after EKG result, finding an Ejection Fraction of 30%.  Emergent cardiac catheterization followed the echo, and showed absolutely no blockages of heart vessels, whatsoever.  Cardiac cath was 100% clean of any blockages.  EF in heart cath was 35%.  No familial history of CHF or Cardiomyopathy.  No history of COVID-19 illness.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Echocardiogram abnormal, Ejection fraction decreased, Electrocardiogram abnormal, Left ventricular hypertrophy
Clinical narrative: Acute new onset of CHF one week after receiving the 3rd (booster) dose of the pfizer COVID-19 Vaccine.  Initial symptom of shortness of breath.  When initially evaluated for SOB, EKG performed, showing a new left sided bundle branch block and slight LVH.  Urgent echocardiogram performed soon after EKG result, finding an Ejection Fraction of 30%.  Emergent cardiac catheterization followed the echo, and showed absolutely no blockages of heart vessels, whatsoever.  Cardiac cath was 100% clean of any blockages.  EF in heart cath was 35%.  No familial history of CHF or Cardiomyopathy.  No history of COVID-19 illness.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Syringe issue
Clinical narrative: Error: Leaking from Syringe-
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Dose in Series Given Too Early-
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Pruritus
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Chills-Severe, Systemic: Fever-Severe
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Chills-Severe, Systemic: Fever-Severe
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Injection site erythema
Clinical narrative: Site: Redness at Injection Site-Mild, Error: Wrong Dose of Vaccine - Too High-
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Mental disorder
Clinical narrative: My daughter has not had a menstrual cycle since getting this vaccine. She recently confided this in me as she seems to now be having psychological struggles with the fact that as a young women she may no longer be able to bear children. She has seen her doctor and has tried some supplementary medications in the hopes these might trigger her body into normal functions once again but to no avail.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Urticaria
Clinical narrative: Approximately 24 hrs after, I experienced a rash and hives on the inner arms, wrist, chest, and neck. I first noticed the neck rash. The rash is itchy occasionally.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Client came to Facility for his COVID Pfizer #2 vaccine with his parent. Vaccinating RN reported to vaccine preparer RN that he had to waste a Pfizer Pediatric COVID vaccine dose. When vaccinating RN was about to vaccinate the client, the client moved his left arm away from him and the needle lightly grazed client?s left arm without any observed injury. Vaccine preparer RN came to report incident to PHN after vaccinating RN vaccinated client in his right arm with COVID Pfizer Pediatric COVID vaccine dose #2 (lot #: FK5618 exp. 01.09.22) at 1142 on 12.09.21. The client?s parent had already taken the client outside to calm him down for 30 minutes and left the EMT station. PHN educated vaccinating RN to elevate any needle issue or vaccine dose issue immediately to PHN lead for client?s and vaccinator?s safety in the future. Vaccinating RN verbalized understanding.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Headache, Malaise, Oropharyngeal pain
Clinical narrative: Experienced COVID symptoms: first nasal drip (two days), second sore throat (two days), third chills (one day) and body aches( three days), fifth phlegmy cough (four days), sixth  headache (on and off over seven days.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Productive cough, SARS-CoV-2 test positive, Upper-airway cough syndrome
Clinical narrative: Experienced COVID symptoms: first nasal drip (two days), second sore throat (two days), third chills (one day) and body aches( three days), fifth phlegmy cough (four days), sixth  headache (on and off over seven days.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Arteriogram coronary normal, Blood pressure increased, COVID-19, Cardiac imaging procedure abnormal
Clinical narrative: Vaccine given in August 2021, Septemper 2021- started noticing tightness in chest upon cardio exercise.   Blood pressure started going up.   Symptoms didn't go away.  In fact it was getting worse, upon only 5 min of cardio I would feel the tightness and "angina."   Positive for Covid 19 January 14th recovered after a few days. Reported to my Dr. - ordered stress test.  Nothing noted.   MRI perform MYOCARDITIS discovered.   Angiogram conducted -  No blockage and no issues found within Coronary Arteries.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac stress test normal, Chest discomfort, Myocarditis, SARS-CoV-2 test positive
Clinical narrative: Vaccine given in August 2021, Septemper 2021- started noticing tightness in chest upon cardio exercise.   Blood pressure started going up.   Symptoms didn't go away.  In fact it was getting worse, upon only 5 min of cardio I would feel the tightness and "angina."   Positive for Covid 19 January 14th recovered after a few days. Reported to my Dr. - ordered stress test.  Nothing noted.   MRI perform MYOCARDITIS discovered.   Angiogram conducted -  No blockage and no issues found within Coronary Arteries.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Confusional state, SARS-CoV-2 test positive
Clinical narrative: Weakness confusion positive COVID
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, SARS-CoV-2 test positive, Vomiting
Clinical narrative: weakness, vomiting, COVID positive
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Influenza A virus test, Influenza B virus test, Malaise, SARS-CoV-2 test positive
Clinical narrative: Breakthrough COVID infection. Unable to assess symptoms. Positive COVID test on 5/4/22
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccine breakthrough infection
Clinical narrative: Breakthrough COVID infection. Unable to assess symptoms. Positive COVID test on 5/4/22
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Angiopathy, Atrial fibrillation, Balance disorder, Blood electrolytes normal, Blood glucose normal
Clinical narrative: 5/4/22-Patient brought to Emergency Department by EMS secondary to bilateral leg weakness leading to a fall.  Reported legs feeling weak for past week, hard time getting up or standing, veering to R when walking.  No headache focal weakness or problems with speech.  Balance problems persisted and resulted in fall.  Able to get herself up.  MRI and head CT interpreted by Neurology per H&P   "...stroke had happened probably a week, and there is evidence of bleeding but more petechial hemorrhage but probably from an underlying ischemic stroke."
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Brain natriuretic peptide increased, Bundle branch block right, Cardiomegaly, Cerebrovascular accident, Chest X-ray abnormal
Clinical narrative: 5/4/22-Patient brought to Emergency Department by EMS secondary to bilateral leg weakness leading to a fall.  Reported legs feeling weak for past week, hard time getting up or standing, veering to R when walking.  No headache focal weakness or problems with speech.  Balance problems persisted and resulted in fall.  Able to get herself up.  MRI and head CT interpreted by Neurology per H&P   "...stroke had happened probably a week, and there is evidence of bleeding but more petechial hemorrhage but probably from an underlying ischemic stroke."
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chromaturia, Computerised tomogram head abnormal, Dysstasia, Electrocardiogram abnormal, Fall
Clinical narrative: 5/4/22-Patient brought to Emergency Department by EMS secondary to bilateral leg weakness leading to a fall.  Reported legs feeling weak for past week, hard time getting up or standing, veering to R when walking.  No headache focal weakness or problems with speech.  Balance problems persisted and resulted in fall.  Able to get herself up.  MRI and head CT interpreted by Neurology per H&P   "...stroke had happened probably a week, and there is evidence of bleeding but more petechial hemorrhage but probably from an underlying ischemic stroke."
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count normal, Liver function test normal, Magnetic resonance imaging head abnormal, Mobility decreased, Muscular weakness
Clinical narrative: 5/4/22-Patient brought to Emergency Department by EMS secondary to bilateral leg weakness leading to a fall.  Reported legs feeling weak for past week, hard time getting up or standing, veering to R when walking.  No headache focal weakness or problems with speech.  Balance problems persisted and resulted in fall.  Able to get herself up.  MRI and head CT interpreted by Neurology per H&P   "...stroke had happened probably a week, and there is evidence of bleeding but more petechial hemorrhage but probably from an underlying ischemic stroke."