chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Drug ineffective, Nasopharyngeal swab, Suspected COVID-19
Clinical narrative: Interchange of vaccine products; Horrible case of bulbous pemphigoid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 at 10:00 as dose 4 (booster), single (Lot number: Gh97036) at the age of 74 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Peritoneal dialysis" (unspecified if ongoing). The patient has no known drug allergies. The patient had not been diagnosed with COVID-19 prior vaccination. Concomitant medication(s) included: INFLUENZA taken for immunisation, on 04Oct2022 as dose 1, single; ATORVASTATIN; AMLODIPINE; LISINOPRIL; HYDRALAZINE. Vaccination history included: moderna (DOSE 1, Administration time: 11:00 AM, Lot number: 026D21A, Vaccine location: Right arm), administration date: 21Oct2021, when the patient was 73-year-old, for COVID-19 immunization; moderna (DOSE 2, Administration time: 10:00 AM, Vaccine location: Right arm), administration date: 03Nov2021, when the patient was 73-year-old, for COVID-19 immunization; moderna (DOSE 3 (BOOSTER), Administration time: 11:00 AM, Lot number: 059M21A, Vaccine location: Right arm), administration date: 04May2022, when the patient was 74-year-old, for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (hospitalization, life threatening) with onset 19Oct2022 at 10:00, outcome "recovering"; PEMPHIGOID (hospitalization, medically significant, life threatening) with onset 28Oct2022, outcome "recovering", described as "Horrible case of bulbous pemphigoid". The patient was hospitalized for pemphigoid (hospitalization duration: 2 day(s)). The event "horrible case of bulbous pemphigoid" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Nov2022) Negative. Therapeutic measures were taken as a result of pemphigoid which included steroids bi iv.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Thrombosis
Clinical narrative: Cerebral Venus Sinus Thrombosis; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), on 29Nov2021 as dose 3 (booster), single (Lot number: EW0191) at the age of 33 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: ER8736), administration date: 24Jul2021, when the patient was 33-year-old, for COVID-19 immunization, reaction(s): "COVID-19"; BNT162b2 (Dose Number: 1, Batch/Lot No: ER8733), administration date: 31Mar2021, when the patient was 32-year-old, for COVID-19 immunization. The following information was reported: THROMBOSIS (hospitalization, life threatening) with onset 20Jun2022, outcome "recovering", described as "Cerebral Venus Sinus Thrombosis"; HEADACHE (hospitalization, life threatening) with onset 20Jun2022, outcome "recovering". The patient was hospitalized for thrombosis, headache (start date: 19Jun2022, discharge date: 22Jun2022, hospitalization duration: 4 day(s)). The events "cerebral venus sinus thrombosis" and "headache" required emergency room visit. Therapeutic measures were taken as a result of thrombosis, headache.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort
Clinical narrative: experiencing gastrointestinal issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, 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: ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "experiencing gastrointestinal issues".  Additional Information: I had the covid shots thru this manufacturer and so did my husband in Apr2020. We both started experiencing gastrointestinal issues and at times severe issues. Never had these issues prior. Could. this be an alternate side effect of covid shots and booster shots.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Gastrointestinal disorder
Clinical narrative: experiencing gastrointestinal issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:  A male patient received BNT162b2 (BNT162B2), in Apr2020 as dose number unknown, 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: GASTROINTESTINAL DISORDER (non-serious), outcome "unknown", described as "experiencing gastrointestinal issues".  Additional Information: The patient had the covid shots thru this manufacturer and so did her husband in Apr2020. They both started experiencing gastrointestinal issues and at times severe issues. Never had these issues prior. Could this be an alternate side effect of covid shots and booster shots.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Back disorder
Clinical narrative: disability for her back; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s):   A 54-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, 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: BACK DISORDER (disability) with onset Mar2021, outcome "not recovered", described as "disability for her back".  Clinical course: First went on disability for her back in Mar2021, and now she was on permanent disability for her back. Company agent causality reported as Yes.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Skin rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer unknown). The following information was reported: RASH (non-serious), outcome "unknown", described as "Skin rash".  Additional information: The patient developed a skin rash within two years of receiving second vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: significant reduction in herpes simplex outbreaks after the Pfizer COVID reduction of outbreaks around 50~70% less than normal; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 16Dec2021 as dose 3 (booster), single (Lot number: FE3594) intramuscular, in arm for COVID-19 immunization. The patient's relevant medical history included: "Herpes Simplex" (ongoing), notes: Herpes labials HSV-1 Herpes HSV-2, Onset date: around 1978. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "significant reduction in herpes simplex outbreaks after the Pfizer COVID reduction of outbreaks around 50~70% less than normal".  Additional information: Family medical history relevant to Adverse Events (AES): N.A. It was noticed that a significant reduction in herpes simplex outbreaks after the Pfizer COVID vaccination(s). Reduction of outbreaks around 50 -70 percentage less than normal, if there was a herpes simplex outbreak the duration and severity was lessened. Patient's lifestyle and diet was the same prior to and after the vaccination and very beneficial side effects. Specific relevant test for thromboembolic events with thrombocytopenia was none. Note: for thromboembolic events with thrombocytopenia include specific relevant test above: N.A.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-PV202200123893 Same reporter/patient/event, different vaccine dose.;
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Illness, Influenza
Clinical narrative: got the flu; sick for 4 weeks; still fighting left over symptoms weakness; Initial information received on 08-Jan-2023 regarding an unsolicited valid social media serious case from a consumer/non-hcp.  This case is linked to case 2022SA520933(CLUSTER).  This case involves an unknown age male patient who got the flu, sick for 4 weeks and still fighting left over symptoms weakness after receiving influenza vaccine.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.     On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination (immunisation).  On an unknown date the patient developed a serious got the flu (influenza) (unknown latency) following the administration of influenza vaccine. The patient was hospitalized for this event. On an unknown date the patient developed a non-serious sick for 4 weeks (illness) and still fighting left over symptoms weakness (asthenia) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if there were lab data/results available.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown for the event got the flu and sick for 4 weeks and was Not Recovered / Not Resolved for the event still fighting left over symptoms weakness.; Sender's Comments: Sanofi company comment dated 13-Jan-2023: This case involves an unknown age male patient who got the flu, sick for 4 weeks and still fighting left over symptoms weakness after receiving influenza vaccine. Additional information regarding condition at the time of vaccination, concomitant medication, medical history would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: they administered the pentacel vaccine to patient. However the vaccine was not mixed. The caller advised the patient only received the powder portion, with no adverse event; Initial information was received on 11-Jan-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves an unknown age/gender patient who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] however the vaccine was not mixed. the caller advised the patient only received the powder portion, with no adverse event.  The patient's past medical history, medical treatment(s),concomitant medication(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (dose, formulation, strength, lot number, expiry date, route, administration site: Unknown) for prophylactic vaccination (Immunisation) was not mixed. the caller advised the patient only received the powder portion, with no adverse event (product preparation error) (same day latency).  No lab data reported.  Action taken: not applicable.  Outcome: Unknown for the event they administered the pentacel vaccine to patient. however the vaccine was not mixed. the caller advised the patient only received the powder portion, with no adverse 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 guidelines. 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: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: Received a dose of Adacel in the left deltoid, dose that was administered was expired with no reported adverse event; Initial information was received on 12-Jan-2023 regarding an unsolicited valid  non-serious case received from an other health professional.  This case involves a 11 years old male patient who received a dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] in the left deltoid, dose that was administered was expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (TET TOX) (MENQUADFI).  On 12-Jan-2023, the patient received Total 0.5 ml once dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: U6900AA, route, strength, formulation: Unknown) in the left deltoid for Immunization (Immunisation) that was administered was expired on 18-Nov-2022 with no reported adverse event (expired product administered) (Unknown latency)  It was reported that " Today about 20 minutes ago a patient received a dose of Adacel in the left deltoid. The dose that was administered was expired on 18-Nov-2022. Treatment The caller stated they would plan to call the patient back as soon as possible to repeat the dose."   No lab data reported.  Action taken: not applicable.  Outcome: Unknown for the event received a dose of adacel in the left deltoid, dose that was administered was expired with no reported adverse 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 guidelines. 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: YF
Symptoms: Condition aggravated, Multiple sclerosis relapse
Clinical narrative: patient was given the YF-VAX vaccine and it caused her MS to flare up; Initial information received on 12-Jan-2023 regarding an unsolicited valid serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who was given the YELLOW FEVER VACCINE -  [YF-VAX] and it caused her ms to flare up.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing MS.   On an unknown date, the patient received suspect YELLOW FEVER VACCINE - (strength, formulation, route, dose: unknown) (lot number and expiry date: not reported) in unknown administration site for Immunization.  On an unknown date, the patient developed a serious event of patient was given the vf-vax vaccine and it caused her ms to flare up (multiple sclerosis relapse) (unknown latency) following the administration of YELLOW FEVER VACCINE - . This event was assessed as medically significant.  Pharmacist is calling to find out if the YF-VAX has any contraindication for patients that are autoimmune compromised. The caller also stated that she is wanting to know if it is safe for a patient to get the vaccine if they have Hashimoto Thyroiditis and if it would cause an abnormal immune reaction. The pharmacist is requesting information on abnormal immune reaction with Hashimoto Thyroiditis and for any autoimmune reactions.   Action taken with YELLOW FEVER VACCINE (YF-VAX) was not applicable.  It was not reported if the patient received a corrective treatment for the event (patient was given the VF-VAX vaccine and it caused her MS to flare up).  At time of reporting, the outcome was Unknown for the event patient was given the vf-vax vaccine and it caused her ms to flare up.; Sender's Comments: Sanofi company comment dated 16-Jan-2023: This case involves an unknown age and unknown gender patient who was given the YELLOW FEVER VACCINE - [YF-VAX] and it caused her ms to flare up. Based on reported information underlying medical history remains as confounding factors for reported event. Additional information regarding additional risk factor, concomitant medications, medical treatment and family history excluding other predisposing etiologies would be needed for complete assessment of the case.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Computerised tomogram head normal, Drooling, Fall, Loss of consciousness, Posture abnormal
Clinical narrative: This occurred 1 day after influenza vaccine and per ER records: "Pt. is a 3 y.o. female who presents with a chief complaint of loss of consciousness. HPI per patient's mother and father. The mother was dressing a paper cut on the patient's left 5th finger when the patient lost consciousness, falling face first onto the tile floor. From this, she incurred a 1 cm chin laceration. The patient's mother immediately grabbed her from the ground. She hung limp with her eyes closed in her mother's arms. She then began to have an episode of seizure-like movements with extension, flexion, and drooling. This lasted less than 60 seconds. Upon waking, the patient was groggy but responsive with reactive pupils. She denies neck pain, back pain, headache, shortness of breath, or any other concerns. Upon exam, no tongue biting is evident. Bleeding from the chin laceration is mild upon presentation. She received her bivalent COVID booster one week ago and her annual influenza shot yesterday."
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Seizure like phenomena, Skin laceration, Somnolence
Clinical narrative: This occurred 1 day after influenza vaccine and per ER records: "Pt. is a 3 y.o. female who presents with a chief complaint of loss of consciousness. HPI per patient's mother and father. The mother was dressing a paper cut on the patient's left 5th finger when the patient lost consciousness, falling face first onto the tile floor. From this, she incurred a 1 cm chin laceration. The patient's mother immediately grabbed her from the ground. She hung limp with her eyes closed in her mother's arms. She then began to have an episode of seizure-like movements with extension, flexion, and drooling. This lasted less than 60 seconds. Upon waking, the patient was groggy but responsive with reactive pupils. She denies neck pain, back pain, headache, shortness of breath, or any other concerns. Upon exam, no tongue biting is evident. Bleeding from the chin laceration is mild upon presentation. She received her bivalent COVID booster one week ago and her annual influenza shot yesterday."
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood glucose increased, Glycosylated haemoglobin increased, Thirst, Type 1 diabetes mellitus, Weight decreased
Clinical narrative: Diagnosed with type 1 diabetes in July 2021 after months of weight loss, and excessive thirst which began after receiving the first vaccine in April 2021.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: Covid-19 Positive on 01/04/2023, Admitted to the medical center on 01/06/2023, Expired on 01/12/2023
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Covid-19 Positive on 01/04/2023, Admitted to the medical center on 01/06/2023, Expired on 01/12/2023
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Loss of personal independence in daily activities, Vaccination failure
Clinical narrative: It gave me shingles and I got the vaccine/suspected vaccination failure; shingles next to my hip; feels like a burning like it was electricity; couldn't put on my clothes; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, burning sensation and activities of daily living impaired. On an unknown date, the outcome of the vaccination failure, shingles, burning sensation and activities of daily living impaired were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, burning sensation and activities of daily living impaired to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 10-JAN-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received a dose of Shingles vaccine last year and had shingles next to hip and it felt like a burning like it was electricity and the patient could not put on his/her clothes. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding, primary schedule, laboratory test and time to onset confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Palpitations, Peripheral swelling, Pyrexia
Clinical narrative: Lots of fever (ER); Palpitation (ER); Arm was swollen (ER); Got very ill; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever, palpitation, swelling arm and illness. On an unknown date, the outcome of the fever, palpitation, swelling arm and illness were recovered/resolved.   The reporter considered the fever, palpitation, swelling arm and illness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 07-JAN-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter was the patient. The patient got the vaccine and got very ill. The vaccine gave high fever, palpitations and arm was swollen.  The patient had to go to the emergency room and they stabilized to patient. The doctor told to patient as it was a vaccine reaction. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal pain upper
Clinical narrative: Very strong stomach pain; This case was reported by a consumer via interactive digital media and described the occurrence of stomach pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced stomach pain. On an unknown date, the outcome of the stomach pain was unknown.   It was unknown if the reporter considered the stomach pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 08 Jan 2023 Reporter's comment: This case was reported by a consumer via interactive digital media. The patient reported after the vaccination had very strong stomach pain.
Age: 34.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Expired Twinrix  Administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 34-year-old female patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th January 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 9th January 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 10-JAN-2023 Reporter's comment: The patient received Twinrix in left deltoid. The reporter consented to follow-up. Additional supportive information: The patient was administered an expired Twinrix Vaccine inadvertently, which led to expired vaccine used.
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: she had an extreme reaction to her skin and is completely covered with red bumps all over her body; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (she had an extreme reaction to her skin and is completely covered with red bumps all over her body) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Spikevax. Past adverse reactions to the above products included No adverse event with Spikevax.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (she had an extreme reaction to her skin and is completely covered with red bumps all over her body). At the time of the report, RASH ERYTHEMATOUS (she had an extreme reaction to her skin and is completely covered with red bumps all over her body) outcome was unknown.        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 information was reported.  It was unknown patient Received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No treatment medication information was reported.   Reporter did not allow further contact
Age: 0.75
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; child recived the bivalent booster dose instead of the monovalent dose; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (child recived the bivalent booster dose instead of the monovalent dose) and NO ADVERSE EVENT (No adverse event) in a 9-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Dec-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 09-Dec-2022, the patient experienced INCORRECT DOSE ADMINISTERED (child recived the bivalent booster dose instead of the monovalent dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (child recived the bivalent booster dose instead of the monovalent dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (child recived the bivalent booster dose instead of the monovalent dose).    No relevant concomitant medications were reported.  No other adverse reactions are reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction, Vaccination site erythema, Vaccination site pain
Clinical narrative: she had an adverse reaction to the 2nd shot; her arm was sore; her arm was sore and red; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (she had an adverse reaction to the 2nd shot), VACCINATION SITE PAIN (her arm was sore) and VACCINATION SITE ERYTHEMA (her arm was sore and red) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (she had an adverse reaction to the 2nd shot), VACCINATION SITE PAIN (her arm was sore) and VACCINATION SITE ERYTHEMA (her arm was sore and red). At the time of the report, IMMUNISATION REACTION (she had an adverse reaction to the 2nd shot), VACCINATION SITE PAIN (her arm was sore) and VACCINATION SITE ERYTHEMA (her arm was sore and red) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medicine were reported. It was reported that the patient has received 4 doses of the Moderna COVID-19 vaccine so far, including 2 primary doses and 2 booster doses. No treatment medicine were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19-2
Symptoms: Eye disorder
Clinical narrative: After having a booster shot, that day had uneven eye dialation; This spontaneous case was reported by a consumer and describes the occurrence of EYE DISORDER (After having a booster shot, that day had uneven eye dialation) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EYE DISORDER (After having a booster shot, that day had uneven eye dialation). At the time of the report, EYE DISORDER (After having a booster shot, that day had uneven eye dialation) outcome was unknown.            Concomitant medications were not reported.  No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: administering only half the booster dose (0.25 ML) instead of 0.5 ml; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (administering only half the booster dose (0.25 ML) instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (administering only half the booster dose (0.25 ML) instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (administering only half the booster dose (0.25 ML) instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (administering only half the booster dose (0.25 ML) instead of 0.5 ml).    Concomitant medication was not reported. Treatment drug was not reported.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient received Moderna bivalent booster dose that had undergone a temperature excursion.; Patient received Moderna bivalent booster dose that had undergone a temperature excursion.; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent booster dose that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna bivalent booster dose that had undergone a temperature excursion.) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent booster dose that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna bivalent booster dose that had undergone a temperature excursion.) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent booster dose that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna bivalent booster dose that had undergone a temperature excursion.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent booster dose that had undergone a temperature excursion.) and POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna bivalent booster dose that had undergone a temperature excursion.).    No concomitant medications were reported.  The case was reported for 72th out of 77 adult patients who had received the vaccine as reported by the reporter.  It was reported that the vaccine was administered approximately to 77 patients before it was known if the vaccine was ok to use after the excursion.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product storage error, Product temperature excursion issue
Clinical narrative: 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion. 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; product storage error; No adverse event; This spontaneous case was reported by another health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and PRODUCT STORAGE ERROR (product storage error).    Concomitant medication was not provided. Treatment medication information was not provided by the reporter. The doses were administered before it was known if the vaccine was ok to use after the excursion. This case contains information for the 75th out of 77 adult patients described by the reporter.   This case was linked to MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2023-696122: Master case
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion. Product storage error; no adverse event; This spontaneous case was reported by another health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and PRODUCT STORAGE ERROR (product storage error).    No concomitant medicine was reported. It was reported that Approximately 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion. The doses were administered before it was known if the vaccine was ok to use after the excursion. No treatment medicine was reported.   This case was linked to MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2023-696122:Master case
Sex: M
Vaccine: COVID19-2
Symptoms: Rash
Clinical narrative: severe rash; This spontaneous case was reported by a patient family member or friend and describes the occurrence of RASH (severe rash) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (severe rash). At the time of the report, RASH (severe rash) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.   Treatment medications were not reported.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Chills, Headache, Insomnia, Pain in extremity
Clinical narrative: After several hours, the pain started in my right arm which spread to my underarm. At approximately 9:30pm I started shivering and developed a headache. The shivering was so intense that it woke my husband. I also noticed that I was unusually parched. I couldn't get enough water.   The shivering has since subsided, though I didn't get any sleep. My headache still exists as does the arm and underarm pain, and need for excessive water intake.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Thirst
Clinical narrative: After several hours, the pain started in my right arm which spread to my underarm. At approximately 9:30pm I started shivering and developed a headache. The shivering was so intense that it woke my husband. I also noticed that I was unusually parched. I couldn't get enough water.   The shivering has since subsided, though I didn't get any sleep. My headache still exists as does the arm and underarm pain, and need for excessive water intake.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Cerebrovascular accident, Death, Dyskinesia, Movement disorder, Pain
Clinical narrative: Vaccine was recieved on December 15.  Body movement and motion different. Left leg pain. Dec 22nd ER visit due to entire body pain. Jan 6  Discovered My mother dead on the floor due to stroke.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Vaccine was recieved on December 15.  Body movement and motion different. Left leg pain. Dec 22nd ER visit due to entire body pain. Jan 6  Discovered My mother dead on the floor due to stroke.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough case
Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough case  All Pfizer dose 1 1/24/21 EL9261 dose 2 2/14/21 EM9810 doe 3 10/25/21 30125BA dose 4 7/23/22 FP7137
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: have irregular menstruations; This is a spontaneous report received from contactable reporter (Physician) from a sales representative. A 12-year-old female patient received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, single; lot number: unknown), for COVID-19 immunization. The following information was reported: MENSTRUATION IRREGULAR (non-serious), outcome "not recovered", described as "have irregular menstruations". Description of Event: After second dose, the patient began to have irregular menstruations and after 1 year the problem continues. No other doses were administered.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: has experienced muscular aches; This is a spontaneous report received from contactable reporter(s) (Physician) from a representative.  A female patient in her 50's received BNT162b2 (COMIRNATY), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "has experienced muscular aches".  Additional information: After first 3 doses of vaccine, has experienced muscular aches. Decided not to be vaccinated with 4th and bivalent vaccines.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Injection site pain, Injection site swelling, Pain, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Joint Pain-Medium, Systemic: Unable to Sleep-Medium, Additional Details: Pt states he has pain in arm, unable to sleep
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Sleep disorder
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Joint Pain-Medium, Systemic: Unable to Sleep-Medium, Additional Details: Pt states he has pain in arm, unable to sleep
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Feeding disorder, Injection site erythema, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: could not eat the day after vaccine-Medium, Additional Details: Pt stated the day after vaccine (1/12/23) she felt sick all day and could not eat. Arm became painful, red, swollen, and warm beginning Friday 1/13/23. Pt is trying to schedule an appt at an urgent care. Recommended follow up with PCP as well to determine whether 2nd dose should be taken.