chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Interchange of vaccine products, Swelling
Clinical narrative: Swelling under my left arm pit the size of a lemon assumed lymph node; Interchange of vaccine products; Revaccination with different COVID-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of SWELLING (Swelling under my left arm pit the size of a lemon assumed lymph node), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 65081186-1221) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for Vaccination.    The patient had no allergy.  The patient's past medical history included Psoriasis. Previously administered products included for Vaccination: Pfizer-biotech Covid -19 (Dose Number: 1 Batch/Lot No: .03). Past adverse reactions to the above products included No adverse event with Pfizer-biotech Covid -19. Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), FISH OIL and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 05-Nov-2021 at 1:00 PM, the patient received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. 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 SWELLING (Swelling under my left arm pit the size of a lemon assumed lymph node), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). At the time of the report, SWELLING (Swelling under my left arm pit the size of a lemon assumed lymph node), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 38.0
Sex: M
Vaccine: FLUC3
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Tingling sensation in bottom of both of feet / numbness and tingling in my calves; Sharp pains in tips of my big toes; Tingling sensation in bottom of both of feet / numbness and tingling in my calves; This spontaneous case  retrieved on 29-Aug-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 1915835-1), reported by other non-healthcare professional (consumer) and concerned a 38-year-old, male patient.  The patient's concurrent condition included inflammatory arthritis and allergy to sulfanomides and sesames seeds. The patient's concomitant medications included bromelain, Boswellia (boswellia serrata), Curcumen (curcuma zanthorrhiza) and quercetin, all used for unreported indication.   On 01-Dec-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: reported as '1', route of administration: intramuscular (IM), anatomical location: left arm (LA), indication: not reported). The batch number reported was 308483 (reported batch number was identified by Seqirus to be linked to suspect product Flucelvax Quadrivalent instead of reported suspect product Fluad Quadrivalent).  On the same date, approximately 15 minutes after receiving Flucelvax Quadrivalent, the patient experienced tingling sensation in bottom of both feet. Ten hours later, sensation had grown more intense. Patient experienced sharp pains in tips of his big toes. Additionally, patient was also felt numbness and tingling in his calves. Patient did not receive any treatment yet. Patient was watching and waiting while keeping doctor's office apprised. The patient plan was to go to emergency room if muscle weakness or any loss of motor control occurs.  At the time of initial reporting, the patient had not recovered from all events.    The reporter did not provide a causality assessment.   The case was assessed as non-serious.  Company comment: A 38-year-old patient experienced hypoaesthesia in bottom of both of feet and calves, pain in toes, and paraesthesia of calves on the same date after receiving the suspect product Flucelvax Quadrivalent. Based on suggestive temporal relationship and the absence of confounders, causality for the reported events is assessed as probably related.; Sender's Comments: A 38-year-old patient experienced hypoaesthesia in bottom of both of feet and calves, pain in toes, and paraesthesia of calves on the same date after receiving the suspect product Flucelvax Quadrivalent. Based on suggestive temporal relationship and the absence of confounders, causality for the reported events is assessed as probably related.
Age: 67.0
Sex: F
Vaccine: FLUC3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Cannot lift their left arm; Soreness in arm; This spontaneous case was retrieved on 29-Aug-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 1924816-1), reported by other healthcare professional and concerned a 67-year-old, female patient.  The patient's concurrent condition included high blood pressure, osteoporosis and allergy to Tylenol (paracetamol), codeine and Motrin (ibuprofen). The patient's concomitant medications included Risedronate (risedronate sodium), Aldactone (spironolactone), Coreg (carvedilol), buspirone and lactulose, all used for an unreported indication.   On 20-Nov-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: reported as '1', route of administration: intramuscular (IM), anatomical location: left arm (LA), indication: not reported). The batch number reported was 308460 (reported batch number was identified by Seqirus to be linked to suspect product Flucelvax Quadrivalent instead of reported suspect product Fluad Quadrivalent).    On the same day, after receiving Flucelvax Quadrivalent, the patient developed soreness in arm which persisted  two weeks later. Patient claimed that couldn't lift her left arm as a result of the vaccine.   At the time of initial reporting, the patient had not recovered from the events.  The reporter did not provide causality assessment. Patient considered event 'injected limb mobility decreased' as related to Flucelvax Quadrivalent, as it was reported that patient couldn't lift left arm as a result of the vaccine.  The case was assessed as non-serious.  Company comment: A 67-year-old patient experienced pain and decreased mobility of arm on the same day, after receiving the suspect product Flucelvax Quadrivalent. Based on suggestive temporal relationship and the absence of confounders, causality for the reported events is assessed as probably related.; Reporter's Comments: Patient considered event 'injected limb mobility decreased' as related to Flucelvax Quadrivalent, as it was reported that patient couldn't lift left arm as a result of the vaccine.; Sender's Comments: A 67-year-old patient experienced pain and decreased mobility of arm on the same day, after receiving the suspect product Flucelvax Quadrivalent. Based on suggestive temporal relationship and the absence of confounders, causality for the reported events is assessed as probably related.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Body temperature, Chills, Dyskinesia, Fatigue
Clinical narrative: I just have had COVID; I just have had COVID; 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 24Sep2021 as dose 1, single (Lot number: EW0167), in left arm and on 15Oct2021 as dose 2, single (Lot number: EW0167) at the age of 65 years, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: drug ineffective (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I just have had COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101540000 same patient/drug, different event/dose.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Mobility decreased, Pain, Pain in extremity, Pyrexia
Clinical narrative: I just have had COVID; I just have had COVID; 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 24Sep2021 as dose 1, single (Lot number: EW0167), in left arm and on 15Oct2021 as dose 2, single (Lot number: EW0167) at the age of 65 years, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: drug ineffective (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I just have had COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101540000 same patient/drug, different event/dose.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thinking abnormal
Clinical narrative: I just have had COVID; I just have had COVID; 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 24Sep2021 as dose 1, single (Lot number: EW0167), in left arm and on 15Oct2021 as dose 2, single (Lot number: EW0167) at the age of 65 years, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: drug ineffective (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I just have had COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101540000 same patient/drug, different event/dose.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I just have had COVID; I just have had COVID; 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 24Sep2021 as dose 1, single (Lot number: EW0167), in left arm and on 15Oct2021 as dose 2, single (Lot number: EW0167) at the age of 65 years, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: drug ineffective (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I just have had COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101540000 same patient/drug, different event/dose.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anosmia, COVID-19, Cough, Dizziness, Headache
Clinical narrative: This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. Initial information was processed along with the additional information received on 22-SEP-2022.  The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (polyethylene glycol). The patient previously received dose 1 with covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered on 28-APR-2021  for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination (Dose number in series 1). The patient previously received dose 2 with covid-19 vaccine ad26.cov2.s (Dose number in series 2), (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered on 25-OCT-2021  for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination (Dose number in series 2). The patient received dose 3 with covid-19 vaccine ad26.cov2.s (Dose number in series 3), (suspension for injection, route of admin not reported, batch number: 1855191 expiry: UNKNOWN) dose was not reported, 1 total administered on 02-MAY-2022 for covid-19 prophylaxis which was an off label dosing frequency (Dose number in series 3). The drug was associated with Off label use. No concomitant medications were reported. On 01-JUL-2022, 2 months after dose 3, the patient experienced suspected covid-19 infection (Dose number in series 3), and went to hospital for an infusion of monoclonal antibodies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label dosing frequency and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000252542. Sender's Comments: V0-20220943780-covid-19 vaccine ad26.cov2.s-Suspected Covid-19 infection. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. Initial information was processed along with the additional information received on 22-SEP-2022.  The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (polyethylene glycol). The patient previously received dose 1 with covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered on 28-APR-2021  for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination (Dose number in series 1). The patient previously received dose 2 with covid-19 vaccine ad26.cov2.s (Dose number in series 2), (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered on 25-OCT-2021  for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination (Dose number in series 2). The patient received dose 3 with covid-19 vaccine ad26.cov2.s (Dose number in series 3), (suspension for injection, route of admin not reported, batch number: 1855191 expiry: UNKNOWN) dose was not reported, 1 total administered on 02-MAY-2022 for covid-19 prophylaxis which was an off label dosing frequency (Dose number in series 3). The drug was associated with Off label use. No concomitant medications were reported. On 01-JUL-2022, 2 months after dose 3, the patient experienced suspected covid-19 infection (Dose number in series 3), and went to hospital for an infusion of monoclonal antibodies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label dosing frequency and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000252542. Sender's Comments: V0-20220943780-covid-19 vaccine ad26.cov2.s-Suspected Covid-19 infection. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Off label use, Suspected COVID-19
Clinical narrative: This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. Initial information was processed along with the additional information received on 22-SEP-2022.  The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (polyethylene glycol). The patient previously received dose 1 with covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered on 28-APR-2021  for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination (Dose number in series 1). The patient previously received dose 2 with covid-19 vaccine ad26.cov2.s (Dose number in series 2), (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered on 25-OCT-2021  for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination (Dose number in series 2). The patient received dose 3 with covid-19 vaccine ad26.cov2.s (Dose number in series 3), (suspension for injection, route of admin not reported, batch number: 1855191 expiry: UNKNOWN) dose was not reported, 1 total administered on 02-MAY-2022 for covid-19 prophylaxis which was an off label dosing frequency (Dose number in series 3). The drug was associated with Off label use. No concomitant medications were reported. On 01-JUL-2022, 2 months after dose 3, the patient experienced suspected covid-19 infection (Dose number in series 3), and went to hospital for an infusion of monoclonal antibodies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label dosing frequency and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000252542. Sender's Comments: V0-20220943780-covid-19 vaccine ad26.cov2.s-Suspected Covid-19 infection. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, Fatigue, Nausea, Pyrexia
Clinical narrative: Fever 101; Tired; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever 101) and FATIGUE (Tired) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 029A21A) for COVID-19 vaccination.     Patient had no allergies. Patient never had COVID positive test or diagnosis. Patient was not given other vaccines within 1 month prior to Moderna COVID-19 vaccine.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced PYREXIA (Fever 101) and FATIGUE (Tired). In April 2021, PYREXIA (Fever 101) and FATIGUE (Tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Body temperature: Fever 101.         Concomitant product use was not provided by the reporter. On 02-Apr-2021, patient reported fever 101 and was tired. The symptoms were 36-48 hours. Patient stated that his symptoms were less and less with each dose. Treatment information was not provided.   This case was linked to MOD-2022-648106, MOD-2022-648153, MOD-2022-648275, MOD-2022-648157 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Fever 101; Tired; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever 101) and FATIGUE (Tired) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 029A21A) for COVID-19 vaccination.     Patient had no allergies. Patient never had COVID positive test or diagnosis. Patient was not given other vaccines within 1 month prior to Moderna COVID-19 vaccine.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced PYREXIA (Fever 101) and FATIGUE (Tired). In April 2021, PYREXIA (Fever 101) and FATIGUE (Tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Body temperature: Fever 101.         Concomitant product use was not provided by the reporter. On 02-Apr-2021, patient reported fever 101 and was tired. The symptoms were 36-48 hours. Patient stated that his symptoms were less and less with each dose. Treatment information was not provided.   This case was linked to MOD-2022-648106, MOD-2022-648153, MOD-2022-648275, MOD-2022-648157 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, Fatigue, Pyrexia
Clinical narrative: Fever 101; Tired; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever 101) and FATIGUE (Tired) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 029A21A) for COVID-19 vaccination.     Patient had no allergies. Patient never had COVID positive test or diagnosis. Patient was not given other vaccines within 1 month prior to Moderna COVID-19 vaccine.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced PYREXIA (Fever 101) and FATIGUE (Tired). In April 2021, PYREXIA (Fever 101) and FATIGUE (Tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Body temperature: Fever 101.         Concomitant product use was not provided by the reporter. On 02-Apr-2021, patient reported fever 101 and was tired. The symptoms were 36-48 hours. Patient stated that his symptoms were less and less with each dose. Treatment information was not provided.   This case was linked to MOD-2022-648106, MOD-2022-648153, MOD-2022-648275, MOD-2022-648157 (Patient Link).
Age: 28.0
Sex: M
Vaccine: SMALLMNK, SMALLMNK
Symptoms: No adverse event, Vaccination error
Clinical narrative: Patient is a 28 year old male, arrives to location for his second shot of Jynneos. Per patient, his first dose was subcutaneous. RN administered 0.1cc dose of Jynneos vaccine Lot # FDP00014 exp 11/3/2022 via intradermal route to right arm of patient, and a wheal was not produced.  Another RN re-administered another dose of 0.1cc of Jynneos Lot # FDP00014 exp 11/3/2022 at 12:19PM to the left arm and a wheal was produced. At 12:26pm, patient who is still at vaccination table, reported to RN that he feels lightheaded. Clinic lead nurses PHN and another PHN approached patient, and observed that he was pale and diaphoretic. Patient stated that he is only lightheaded during assessment by Dr. RN assisted patient to sit down on cot, and patient is assisted to lay down. At 12:30PM, RN held patient's feet elevated, as Dr. went to grab patient a cold rag or ice pack. Vital signs were taken by PHN at 12:32 PM, and resulted: BP: 110/60, R:22, T:98.4, P:64. Incident Commander arrives with cold water, a banana, and orange at 12:33 PM. Patient eats the banana sitting up, and lays back down with assistance. RN and PHN assisted patient to sit up and stood near patient when patient laid back down. At 12:35PM, Dr. offers patient an ice rag for his forehead and a cold water bottle for behind his neck. At 12:35PM, patient appears less diaphoretic and is no longer pale. Patient states at 12:36 PM that he took a transport car to the vaccination site, and plans to take transport car home. At 12:37PM, vital signs were taken by PHN and resulted: BP: 110/60, R: 20, P:70. Temperature was not taken as it was within normal limits the first set of vital signs. At 12:39PM, patient's feet are elevated by RN while patient is laying down. Patient states at this time that he is not lightheaded. At 12:42PM, RN and and another RN assist patient to sit up and patient states, "I feel okay now. I have had a panic attack before and this was a panic attack, but this time it felt different. The other times I had chest pain and this time I didn't." Patient requested to stand and stated that he would like to wait in observation area. At 12:45 PM, a final set of vital signs were taken by RN and resulted: BP: 104/60, R:18, and P:60. At this time, patient reported that he is not lightheaded, and denies nausea, chest pain, and shortness of breath. RN stood behind patient as he stood up, and patient was instructed to wait 30 minutes in observation area before leaving site. At 1:30PM, patient stood up and left the vaccination site in stable condition.
Age: 28.0
Sex: M
Vaccine: SMALLMNK, SMALLMNK
Symptoms: Dizziness, Panic attack
Clinical narrative: Patient is a 28 year old male, arrives to location for his second shot of Jynneos. Per patient, his first dose was subcutaneous. RN administered 0.1cc dose of Jynneos vaccine Lot # FDP00014 exp 11/3/2022 via intradermal route to right arm of patient, and a wheal was not produced.  Another RN re-administered another dose of 0.1cc of Jynneos Lot # FDP00014 exp 11/3/2022 at 12:19PM to the left arm and a wheal was produced. At 12:26pm, patient who is still at vaccination table, reported to RN that he feels lightheaded. Clinic lead nurses PHN and another PHN approached patient, and observed that he was pale and diaphoretic. Patient stated that he is only lightheaded during assessment by Dr. RN assisted patient to sit down on cot, and patient is assisted to lay down. At 12:30PM, RN held patient's feet elevated, as Dr. went to grab patient a cold rag or ice pack. Vital signs were taken by PHN at 12:32 PM, and resulted: BP: 110/60, R:22, T:98.4, P:64. Incident Commander arrives with cold water, a banana, and orange at 12:33 PM. Patient eats the banana sitting up, and lays back down with assistance. RN and PHN assisted patient to sit up and stood near patient when patient laid back down. At 12:35PM, Dr. offers patient an ice rag for his forehead and a cold water bottle for behind his neck. At 12:35PM, patient appears less diaphoretic and is no longer pale. Patient states at 12:36 PM that he took a transport car to the vaccination site, and plans to take transport car home. At 12:37PM, vital signs were taken by PHN and resulted: BP: 110/60, R: 20, P:70. Temperature was not taken as it was within normal limits the first set of vital signs. At 12:39PM, patient's feet are elevated by RN while patient is laying down. Patient states at this time that he is not lightheaded. At 12:42PM, RN and and another RN assist patient to sit up and patient states, "I feel okay now. I have had a panic attack before and this was a panic attack, but this time it felt different. The other times I had chest pain and this time I didn't." Patient requested to stand and stated that he would like to wait in observation area. At 12:45 PM, a final set of vital signs were taken by RN and resulted: BP: 104/60, R:18, and P:60. At this time, patient reported that he is not lightheaded, and denies nausea, chest pain, and shortness of breath. RN stood behind patient as he stood up, and patient was instructed to wait 30 minutes in observation area before leaving site. At 1:30PM, patient stood up and left the vaccination site in stable condition.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: tested positive for Covid-19.; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for Covid-19.) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001M21A, 067F21A, 019B21A and 012A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (tested positive for Covid-19.) (seriousness criterion hospitalization). At the time of the report, COVID-19 (tested positive for Covid-19.) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jul-2022, SARS-CoV-2 test: (Positive) Positive.         No concomitant and treatment drug was reported. It was reported that the patient had not diagnosed with COVID-19 in the past. Event outcome was reported as residual effects and symptoms improved.  Company comment: This is a spontaneous case regarding a 70-year-old female patient, with no medical history reported, who received four doses of mRNA-1273 vaccine and experienced serious event of COVID-19 82 days after receiving the last dose. Patient was hospitalized; no further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Event outcome was reported as residual effects. Patient received first and second dose with an interval of 13 days, an additional event of inappropriate schedule of vaccine administered was considered. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-648568 (Patient Link).; Sender's Comments: This is a spontaneous case regarding a 70-year-old female patient, with no medical history reported, who received four doses of mRNA-1273 vaccine and experienced serious event of COVID-19 82 days after receiving the last dose. Patient was hospitalized; no further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Event outcome was reported as residual effects. Patient received first and second dose with an interval of 13 days, an additional event of inappropriate schedule of vaccine administered was considered. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid-19.; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for Covid-19.) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001M21A, 067F21A, 019B21A and 012A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (tested positive for Covid-19.) (seriousness criterion hospitalization). At the time of the report, COVID-19 (tested positive for Covid-19.) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jul-2022, SARS-CoV-2 test: (Positive) Positive.         No concomitant and treatment drug was reported. It was reported that the patient had not diagnosed with COVID-19 in the past. Event outcome was reported as residual effects and symptoms improved.  Company comment: This is a spontaneous case regarding a 70-year-old female patient, with no medical history reported, who received four doses of mRNA-1273 vaccine and experienced serious event of COVID-19 82 days after receiving the last dose. Patient was hospitalized; no further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Event outcome was reported as residual effects. Patient received first and second dose with an interval of 13 days, an additional event of inappropriate schedule of vaccine administered was considered. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-648568 (Patient Link).; Sender's Comments: This is a spontaneous case regarding a 70-year-old female patient, with no medical history reported, who received four doses of mRNA-1273 vaccine and experienced serious event of COVID-19 82 days after receiving the last dose. Patient was hospitalized; no further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Event outcome was reported as residual effects. Patient received first and second dose with an interval of 13 days, an additional event of inappropriate schedule of vaccine administered was considered. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Maternal exposure during pregnancy
Clinical narrative: Little headache; Patient was in her first trimester of pregnancy; This spontaneous retrospective pregnancy case was reported by a patient and describes the occurrence of HEADACHE (Little headache) and MATERNAL EXPOSURE DURING PREGNANCY (Patient was in her first trimester of pregnancy) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 20-Jan-2021, the patient experienced HEADACHE (Little headache) and MATERNAL EXPOSURE DURING PREGNANCY (Patient was in her first trimester of pregnancy). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Delivered NOS. On 20-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Patient was in her first trimester of pregnancy) had resolved. At the time of the report, HEADACHE (Little headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported. Company comment: This is a spontaneous case of maternal exposure during pregnancy, concerning a 29-year-old female patient, with no reported medical history, who experienced the expected and non-serious event of headache on the same day of the first dose of mRNA-1273 vaccine. The vaccination occurred in her first trimester of pregnancy. Last menstrual period was not provided; hence, weeks of gestation at the time of vaccination could not be assessed. The delivery occurred on an unknown date. No further clinical information was provided for medical reviewing. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.    This case was linked to MOD-2022-648794, MOD-2022-648795 (Patient Link).; Sender's Comments: This is a spontaneous case of maternal exposure during pregnancy, concerning a 29-year-old female patient, with no reported medical history, who experienced the expected and non-serious event of headache on the same day of the first dose of mRNA-1273 vaccine. The vaccination occurred in her first trimester of pregnancy. Last menstrual period was not provided; hence, weeks of gestation at the time of vaccination could not be assessed. The delivery occurred on an unknown date. No further clinical information was provided for medical reviewing. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Breast mass, Fatigue, Immunisation reaction, Productive cough
Clinical narrative: Tiredness; ball like lump on right breast; chest phlegm, cough due to phlegm; reaction to covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of BREAST MASS (ball like lump on right breast), PRODUCTIVE COUGH (chest phlegm, cough due to phlegm), IMMUNISATION REACTION (reaction to covid-19 vaccine) and FATIGUE (Tiredness) in a female patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriasis.    Concurrent medical conditions included Psoriasis.   On 03-Jun-2016, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. In March 2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In March 2021, the patient experienced BREAST MASS (ball like lump on right breast) and PRODUCTIVE COUGH (chest phlegm, cough due to phlegm). In April 2021, the patient experienced FATIGUE (Tiredness). In 2021, the patient experienced IMMUNISATION REACTION (reaction to covid-19 vaccine). In 2021, BREAST MASS (ball like lump on right breast) and FATIGUE (Tiredness) had resolved. At the time of the report, PRODUCTIVE COUGH (chest phlegm, cough due to phlegm) had not resolved and IMMUNISATION REACTION (reaction to covid-19 vaccine) outcome was unknown.            Concomitant medication was not reported.  Treatment drug was not reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation reaction, Pain, Pyrexia
Clinical narrative: Vaccination adverse reaction; Fatigability generalized; Fever; Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), IMMUNISATION REACTION (Vaccination adverse reaction), FATIGUE (Fatigability generalized) and PYREXIA (Fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 12-Jun-2017, the patient received dose of ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, the patient experienced PAIN (Pain), FATIGUE (Fatigability generalized) and PYREXIA (Fever). On an unknown date, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, PAIN (Pain), FATIGUE (Fatigability generalized) and PYREXIA (Fever) was resolving and IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication information was provided.  Primary reporter did not have the lot number information, because the packaging was discarded.   The reporter's causality for the event(s) of FEVER, PAIN, GENERALIZED TIREDNESS and REACTION TO COVID-19 VACCINE with HUMIRA 40MG/0.8ML(ADALIMUMAB) was no reasonable possibility.  No treatment medication information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma
Clinical narrative: Asthma; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (Asthma) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Psoriatic arthritis and ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    The patient's past medical history included Psoriatic arthritis.   On 07-Nov-2012, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. In November 2021, the patient experienced ASTHMA (Asthma). At the time of the report, ASTHMA (Asthma) had not resolved.            No concomitant medications were reported. No treatment drugs were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 28.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Fatigue, Immunisation reaction
Clinical narrative: Vaccination adverse reaction; Tiredness; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction), the first episode of FATIGUE (Tiredness) and the second episode of FATIGUE (Tiredness) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriasis.    Concurrent medical conditions included Psoriasis.   On 16-Oct-2020, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 150 milligram every three months. On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2020, the patient experienced the first episode of FATIGUE (Tiredness). On 30-Aug-2021, the patient experienced the second episode of FATIGUE (Tiredness). In September 2021, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) and the last episode of FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There was no reported medical history.  Concomitant medications details were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   It was reported that the patient had reaction to covid-19 vaccine and tiredness.  Primary reporter did not have the lot number information, because the packaging was discarded. The reporter's causality for the events of Vaccination adverse reaction was not reported and for Tiredness was possibly related. No treatment medication were provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Subcutaneous abscess
Clinical narrative: Axillary abscess/Abscess in left armpit; This spontaneous case was reported by a consumer and describes the occurrence of SUBCUTANEOUS ABSCESS (Axillary abscess/Abscess in left armpit) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis. Patient had no known allergies. Concurrent medical conditions included Diabetes since 2011, Blood pressure high since 2011 and Psoriatic arthritis. Concomitant products included LOSARTAN, HYDRALAZINE and METOPROLOL for Blood pressure high, METFORMIN for Diabetes, ATORVASTATIN CALCIUM (LIPITOR) for High cholesterol.   In 2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Dec-2021, the patient experienced SUBCUTANEOUS ABSCESS (Axillary abscess/Abscess in left armpit). At the time of the report, SUBCUTANEOUS ABSCESS (Axillary abscess/Abscess in left armpit) had not resolved. On 20 Dec 2021, the patient experienced abscess in left armpit after covid-19 vaccine. MRNA 1273 was also considered suspect. It was unknown if patient was enrolled in a COVID-19 vaccine trial. No treatment medication was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymph nodes in left arm; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph nodes in left arm) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis and ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis.    No Medical History information was reported.   On 06-Jul-2016, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Dec-2021, the patient experienced LYMPHADENOPATHY (Lymph nodes in left arm). At the time of the report, LYMPHADENOPATHY (Lymph nodes in left arm) had not resolved.            No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.