chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fluid retention, Head discomfort, Hypoaesthesia, Lymphadenopathy, Oedema peripheral
Clinical narrative: The day of vaccine I had tingling and numbness in arm down to hand and had chest pains. This continued to next day and I went to urgent care for chest pain. I was told lymph node was swollen and it was normal.  Since then, I?ve had a pocket of fluid swelling in my arm pit. I?ve been diagnosed with Chondritis in my left chest area as a reason for my continued chest pain.  As of June 9th 2022, a sudden wave of vertigo and lightheadedness, head pressure, ringing and fullness in ears, palpitations, etc which resulted in many tests - and so far one diagnosis is POTS. I continue to have these debilitating symptoms.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Paraesthesia, Postural orthostatic tachycardia syndrome, Tilt table test, Tinnitus
Clinical narrative: The day of vaccine I had tingling and numbness in arm down to hand and had chest pains. This continued to next day and I went to urgent care for chest pain. I was told lymph node was swollen and it was normal.  Since then, I?ve had a pocket of fluid swelling in my arm pit. I?ve been diagnosed with Chondritis in my left chest area as a reason for my continued chest pain.  As of June 9th 2022, a sudden wave of vertigo and lightheadedness, head pressure, ringing and fullness in ears, palpitations, etc which resulted in many tests - and so far one diagnosis is POTS. I continue to have these debilitating symptoms.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: The day of vaccine I had tingling and numbness in arm down to hand and had chest pains. This continued to next day and I went to urgent care for chest pain. I was told lymph node was swollen and it was normal.  Since then, I?ve had a pocket of fluid swelling in my arm pit. I?ve been diagnosed with Chondritis in my left chest area as a reason for my continued chest pain.  As of June 9th 2022, a sudden wave of vertigo and lightheadedness, head pressure, ringing and fullness in ears, palpitations, etc which resulted in many tests - and so far one diagnosis is POTS. I continue to have these debilitating symptoms.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody increased, Discomfort, Pain
Clinical narrative: pt with increase in chronic pain
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Vial of pediatric vaccine was not diluted before administration so a larger than recommended dose was given
Age: 1.08
Sex: M
Vaccine: COVID19
Symptoms: Cardiac telemetry abnormal, Cyanosis, Diarrhoea, Discomfort, Faeces discoloured
Clinical narrative: Patient had his second covid vaccine on Thursday afternoon, July 28. He had worsening diarrhea (turned liquid from being soft and was darker) the next day on July 29. On Saturday morning July 30, he woke up at 4:30 in the morning with a fever of 103.5. He seemed pretty draggy and uncomfortable all morning, although his fever was responsive to Tylenol. A little later that morning he looked a little blue around his lips, and his hands and feet were dusky with slow capillary refill. He was not in distress, just continued to seem under the weather and have fevers when the medicine wore off.  We took him to an Emergency Room because of lack of availability of a dr's office appointment on Saturday.  They checked his vitals which were normal other than a slightly elevated HR and the fever (back up at 103.4), gave some Motrin, and think he probably had a viral GI bug. They would have tested his stool but he didn't have an episode while we were there. They did a covid and respiratory panel which was negative.  patient's fever and diarrhea resolved over the next couple days and he was quickly back to his normal self.
Age: 1.08
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Heart rate increased, Influenza virus test negative, Pyrexia, Respiratory syncytial virus test negative
Clinical narrative: Patient had his second covid vaccine on Thursday afternoon, July 28. He had worsening diarrhea (turned liquid from being soft and was darker) the next day on July 29. On Saturday morning July 30, he woke up at 4:30 in the morning with a fever of 103.5. He seemed pretty draggy and uncomfortable all morning, although his fever was responsive to Tylenol. A little later that morning he looked a little blue around his lips, and his hands and feet were dusky with slow capillary refill. He was not in distress, just continued to seem under the weather and have fevers when the medicine wore off.  We took him to an Emergency Room because of lack of availability of a dr's office appointment on Saturday.  They checked his vitals which were normal other than a slightly elevated HR and the fever (back up at 103.4), gave some Motrin, and think he probably had a viral GI bug. They would have tested his stool but he didn't have an episode while we were there. They did a covid and respiratory panel which was negative.  patient's fever and diarrhea resolved over the next couple days and he was quickly back to his normal self.
Age: 1.08
Sex: M
Vaccine: COVID19
Symptoms: Respiratory viral panel, SARS-CoV-2 test negative, Skin discolouration, Ventricular extrasystoles
Clinical narrative: Patient had his second covid vaccine on Thursday afternoon, July 28. He had worsening diarrhea (turned liquid from being soft and was darker) the next day on July 29. On Saturday morning July 30, he woke up at 4:30 in the morning with a fever of 103.5. He seemed pretty draggy and uncomfortable all morning, although his fever was responsive to Tylenol. A little later that morning he looked a little blue around his lips, and his hands and feet were dusky with slow capillary refill. He was not in distress, just continued to seem under the weather and have fevers when the medicine wore off.  We took him to an Emergency Room because of lack of availability of a dr's office appointment on Saturday.  They checked his vitals which were normal other than a slightly elevated HR and the fever (back up at 103.4), gave some Motrin, and think he probably had a viral GI bug. They would have tested his stool but he didn't have an episode while we were there. They did a covid and respiratory panel which was negative.  patient's fever and diarrhea resolved over the next couple days and he was quickly back to his normal self.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Undiluted vial of pediatric Pfizer COVID-19 vaccine given; therefore a larger than recommended dose administered.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation error
Clinical narrative: Failed to dilute Pfizer pediatric vaccine. Tried numerous times to call patient. No answer. No return call.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation error
Clinical narrative: Failed to dilute Pfizer pediatric vaccine. No known reaction at this time. Called patient numerous times. Patient has not returned our calls.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial septal defect, Basilar artery thrombosis, Dizziness, Hemiparesis, Paraesthesia
Clinical narrative: Patient with a 2 week history of subacute vertiginous dizziness, right arm paresthesias, and right-sided weakness, found to have acute basilar artery thrombus in setting of PFO.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Patient with a 2 week history of subacute vertiginous dizziness, right arm paresthesias, and right-sided weakness, found to have acute basilar artery thrombus in setting of PFO.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration
Clinical narrative: MCV 4 dose #2 given to Pt too early. Pt and his mother notified of incident on 08/12/22. Pt has no apparent adverse effects.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: Extra dose of HPV given when not needed
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Pain in extremity, Tinnitus
Clinical narrative: Patient reported feeling dizziness, having ringing in her ears and sweating 3 minutes after vaccination. She also reported having pain in her arm.  She was given water and cool rag to help cool her down.  She also reported not eating since 2pm today so she drank some orange juice and crackers.  After 15 minutes she was feeling better and was able to leave on her own/
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: extra dose of shingrix given when not needed
Age: 1.5
Sex: M
Vaccine: MMR
Symptoms: Irritability, Pallor, Rash, Rash macular, Rash papular
Clinical narrative: Onset of generalized rash on 8/9/22  with mild congestion, rhinorrhea, Fussiness. Rash worsened by 8/12/22, generalized including palms and soles, but more severe over torso & face where papules & macules are pale
Age: 1.5
Sex: M
Vaccine: MMR
Symptoms: Respiratory tract congestion, Respiratory viral panel, Rhinorrhoea
Clinical narrative: Onset of generalized rash on 8/9/22  with mild congestion, rhinorrhea, Fussiness. Rash worsened by 8/12/22, generalized including palms and soles, but more severe over torso & face where papules & macules are pale
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse etfects reported; patient received improperly stored dose of MMR II; This spontaneous report was received from a nurse and refers to a 4-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 09-SEP-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) albumin status rHA (lot # S004120 has been verified to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), expiration date reported as 11-JAN-2021, but upon internal validation established as 11-FEB-2021) (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of above 47 degrees Fahrenheit (54 degrees Fahrenheit) for 1 hour. Data logger was involved. There were no previous excursions reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1912USA000782: US-009507513-1912USA000780: US-009507513-1912USA000777: US-009507513-1912USA000778: US-009507513-1912USA000779: US-009507513-1912USA000781: US-009507513-1912USA000785: US-009507513-1912USA000784: US-009507513-1912USA000783:
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Induration, Vaccination site induration
Clinical narrative: The patient developed a large indurated area at the vaccination site as well as indurated distal to right arm.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Inflammation, Pain, Skin warm
Clinical narrative: Inflammation of the neck,  shoulder and armpit,  Pain on palpation and hot area to the touch
Age: 29.0
Sex: M
Vaccine: FLUC3
Symptoms: Anxiety, Blindness transient, Blood glucose normal, Dizziness, Lethargy
Clinical narrative: Complained about not being able to see or loss of vision; Pupils were dilated; Skin color was pale; Skin temperature was warm; Lethargic; Felt faint; This spontaneous case was retrieved on 04-Aug-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 0882268-1), reported by other healthcare professional and concerned 29-year-old, male patient.  The patient's medical history and concomitant medications were not reported.  On 05-Sep-2020, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: reported as 'one', route of administration: intramuscular, anatomical location: right arm (RA), indication: not reported). The batch number reported was 276531 (reported batch number was identified by Seqirus to be linked to new suspect product Flucelvax QIV).   On the same date, after receiving Flucelvax Quadrivalent, the patient felt faint and complained about not being able to see or loss of vision. Pupils were dilated. The patient's skin colour was pale, skin temperature was warm. and he was lethargic. Blood glucose was 82 (units were not provided). He was treated with one dose of Epipen (epinephrine). Within minutes symptoms were reversed and patient recovered.  The reporter did not provide causality assessment.  All events were considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  Company comment: A 29-year-old patient experienced temporary vision loss, mydriasis, pallor, skin warmth, lethargy, and dizziness on the same day after receiving the suspect product Flucelvax Quadrivalent. Reportedly, the patient was treated with one dose of Epipen (epinephrine) and was recovered within minutes. The patient's medical history and concomitant drugs were not provided. Temporal relationship is plausible. The events suggest anxiety related reaction. Causality is assessed as possibly related for all events.; Sender's Comments: A 29-year-old patient experienced temporary vision loss, mydriasis, pallor, skin warmth, lethargy, and dizziness on the same day after receiving the suspect product Flucelvax Quadrivalent. Reportedly, the patient was treated with one dose of Epipen (epinephrine) and was recovered within minutes. The patient's medical history and concomitant drugs were not provided. Temporal relationship is plausible. The events suggest anxiety related reaction. Causality is assessed as possibly related for all events.
Age: 29.0
Sex: M
Vaccine: FLUC3
Symptoms: Mydriasis, Pallor, Skin warm
Clinical narrative: Complained about not being able to see or loss of vision; Pupils were dilated; Skin color was pale; Skin temperature was warm; Lethargic; Felt faint; This spontaneous case was retrieved on 04-Aug-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 0882268-1), reported by other healthcare professional and concerned 29-year-old, male patient.  The patient's medical history and concomitant medications were not reported.  On 05-Sep-2020, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: reported as 'one', route of administration: intramuscular, anatomical location: right arm (RA), indication: not reported). The batch number reported was 276531 (reported batch number was identified by Seqirus to be linked to new suspect product Flucelvax QIV).   On the same date, after receiving Flucelvax Quadrivalent, the patient felt faint and complained about not being able to see or loss of vision. Pupils were dilated. The patient's skin colour was pale, skin temperature was warm. and he was lethargic. Blood glucose was 82 (units were not provided). He was treated with one dose of Epipen (epinephrine). Within minutes symptoms were reversed and patient recovered.  The reporter did not provide causality assessment.  All events were considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  Company comment: A 29-year-old patient experienced temporary vision loss, mydriasis, pallor, skin warmth, lethargy, and dizziness on the same day after receiving the suspect product Flucelvax Quadrivalent. Reportedly, the patient was treated with one dose of Epipen (epinephrine) and was recovered within minutes. The patient's medical history and concomitant drugs were not provided. Temporal relationship is plausible. The events suggest anxiety related reaction. Causality is assessed as possibly related for all events.; Sender's Comments: A 29-year-old patient experienced temporary vision loss, mydriasis, pallor, skin warmth, lethargy, and dizziness on the same day after receiving the suspect product Flucelvax Quadrivalent. Reportedly, the patient was treated with one dose of Epipen (epinephrine) and was recovered within minutes. The patient's medical history and concomitant drugs were not provided. Temporal relationship is plausible. The events suggest anxiety related reaction. Causality is assessed as possibly related for all events.
Age: 70.0
Sex: M
Vaccine: FLUA3, VARZOS
Symptoms: Arthralgia
Clinical narrative: Pain in the left shoulder; This spontaneous case was retrieved on 04-Aug-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 0885073-1), reported by other healthcare professional and concerned a 70-year-old, male patient.  The patient's concurrent condition included prostate cancer. The patient had no known allergies. The patient's concomitant medication included Xanax (alprazolam) used for unreported indication.   On 20-Dec-2019, the patient was vaccinated with Fluad TIV (influenza vaccine inact sag 3v; dose: reported as 'one', route of administration: intramuscular, anatomical location: right arm, indication: not reported). The batch number reported was 263074 (reported batch number was identified by Seqirus to be linked to new suspect product Fluad TIV).  On the same date, the patient was also vaccinated with non-company co-suspect Shingrix (varicella zoster vaccine rge (cho); dose: reported as 'one', route of administration: intramuscular, anatomical location: left arm, indication: not reported). The batch number reported was 7l27G. The patient heard a 'weird' noise during the vaccination that sounded like a squeegee.  On the same date, after receiving Fluad TIV and non-company co-suspect Shingrix, the patient experienced pain in the left shoulder. Pain came and went. The patient had not received any treatment for this condition.  On an unspecified date, the patient visited the physician's office.   At the time of initial reporting, the patient had not recovered from the event of 'shoulder pain'.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: Based on information regarding anatomical location of both vaccines, causality for the event 'shoulder pain' is assessed as not related to Fluad TIV.; Sender's Comments: Based on information regarding anatomical location of both vaccines, causality for the event 'shoulder pain' is assessed as not related to Fluad TIV.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, Drug ineffective, Liver function test, Renal function test, SARS-CoV-2 test
Clinical narrative: had Covid in May2022/ had her first booster last Oct2021; had Covid in May2022/ had her first booster last Oct2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown), in 2021 as dose 2, single (Batch/Lot number: unknown) and in Oct2021 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "recovered" (26Jun2022) and all described as "had Covid in May2022/ had her first booster last Oct2021". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive, notes: She had Covid in May2022; (26Jun2022) Negative, notes: She tested negative for Covid on 26Jun. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The reporter had Covid in May2022 and completed a course of Paxlovid. She tested negative for Covid on 26Jun. She was due for a booster dose of the Covid-19 vaccine and wants to know if there is any guidance on how long after Covid she should have the booster. she completed two doses of the Pfizer vaccine on 2021 and had her first booster last Oct2021. Her primary doctor prescribed her with Paxlovid when she got Covid. She was also prescribed with "a lot of floxins" like quinolone and ciprofloxacin antibiotics. She has not experienced any rebounds after that. When she had Covid, her symptoms were mild. She only had cough, constant sneezing, runny nose and loss of smell which got right back after 2-3 hours. She tested negative and that was 2-3 months ago. She was then booked for a second booster shot on Monday. She wanted to know if she should get the booster, if she should take the second booster or wait for the new vaccine that is going to come out on Sep. She was also hesitant for the booster because she might have Covid again, the second booster contains anything that will react or activate the virus. She thinks that because she had Covid, she will have the virus in her and will have antibodies that make her immune to the virus. If she gets the booster, she might have Covid after this. She wants to know if it was true.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Suspected COVID-19
Clinical narrative: had Covid in May2022/ had her first booster last Oct2021; had Covid in May2022/ had her first booster last Oct2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown), in 2021 as dose 2, single (Batch/Lot number: unknown) and in Oct2021 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "recovered" (26Jun2022) and all described as "had Covid in May2022/ had her first booster last Oct2021". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive, notes: She had Covid in May2022; (26Jun2022) Negative, notes: She tested negative for Covid on 26Jun. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The reporter had Covid in May2022 and completed a course of Paxlovid. She tested negative for Covid on 26Jun. She was due for a booster dose of the Covid-19 vaccine and wants to know if there is any guidance on how long after Covid she should have the booster. she completed two doses of the Pfizer vaccine on 2021 and had her first booster last Oct2021. Her primary doctor prescribed her with Paxlovid when she got Covid. She was also prescribed with "a lot of floxins" like quinolone and ciprofloxacin antibiotics. She has not experienced any rebounds after that. When she had Covid, her symptoms were mild. She only had cough, constant sneezing, runny nose and loss of smell which got right back after 2-3 hours. She tested negative and that was 2-3 months ago. She was then booked for a second booster shot on Monday. She wanted to know if she should get the booster, if she should take the second booster or wait for the new vaccine that is going to come out on Sep. She was also hesitant for the booster because she might have Covid again, the second booster contains anything that will react or activate the virus. She thinks that because she had Covid, she will have the virus in her and will have antibodies that make her immune to the virus. If she gets the booster, she might have Covid after this. She wants to know if it was true.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had Covid in May2022/ had her first booster last Oct2021; had Covid in May2022/ had her first booster last Oct2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown), in 2021 as dose 2, single (Batch/Lot number: unknown) and in Oct2021 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "recovered" (26Jun2022) and all described as "had Covid in May2022/ had her first booster last Oct2021". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive, notes: She had Covid in May2022; (26Jun2022) Negative, notes: She tested negative for Covid on 26Jun. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The reporter had Covid in May2022 and completed a course of Paxlovid. She tested negative for Covid on 26Jun. She was due for a booster dose of the Covid-19 vaccine and wants to know if there is any guidance on how long after Covid she should have the booster. she completed two doses of the Pfizer vaccine on 2021 and had her first booster last Oct2021. Her primary doctor prescribed her with Paxlovid when she got Covid. She was also prescribed with "a lot of floxins" like quinolone and ciprofloxacin antibiotics. She has not experienced any rebounds after that. When she had Covid, her symptoms were mild. She only had cough, constant sneezing, runny nose and loss of smell which got right back after 2-3 hours. She tested negative and that was 2-3 months ago. She was then booked for a second booster shot on Monday. She wanted to know if she should get the booster, if she should take the second booster or wait for the new vaccine that is going to come out on Sep. She was also hesitant for the booster because she might have Covid again, the second booster contains anything that will react or activate the virus. She thinks that because she had Covid, she will have the virus in her and will have antibodies that make her immune to the virus. If she gets the booster, she might have Covid after this. She wants to know if it was true.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hot flush, Nausea, Oropharyngeal pain, Photopsia
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Headache-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Throat tightness, Tremor
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Headache-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Dizziness, Dysphagia, Dyspnoea
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Headache-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Headache-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site swelling, Pain, Rash, Throat tightness, Visual impairment
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Headache-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium
Age: 1.08
Sex: U
Vaccine: MMR, MMRV
Symptoms: Accidental overdose, No adverse event
Clinical narrative: Caller is a nurse who reports inadvertent concomitant administration of PROQUAD and M-M-R II.; Patient received the dose today and has not had any adverse effects or symptoms from this dose. No other information available; no other AE/no PQC.; This spontaneous report has been received from a registered nurse concerning a 13-month-old patient. No information regarding the patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was provided.  On 20-JUL-2022, the patient was inadvertently vaccinated with with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II), 0.5 mililiter (ml)/once, (lot number U006488, who had been verified to be a valid number, expiration date reported and established as: 26-FEB-2023) administered for prophylaxis, concomitant with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0.5 ml/once, (lot number U017140, who had been verified to be a valid number, expiration date reported and established as: 28-NOV-2022) administered for prophylaxis, plus sterile diluent (DILUENT MRK) (strength, dose description, lot number, expiration date, were not provided) (accidental overdose). It was reported that, the patient did not experienced any adverse effects or symptoms for this dose.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE; A pharmacist reported that an improperly stored VARIVAX vaccine was administered to a patient.; This spontaneous report has been received from a pharmacist, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions and allergies were not provided.   On 27-JUL-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, to prevent varicella infection (lot number W011622 which has been verified to be valid, expiration date reported and validated as 06-APR-2024). Lot number A011622 is an invalid lot number for varicella virus vaccine live (Oka/Merck) (VARIVAX). (dose, route of administration, and anatomical site of injection were not provided). The administered dose of the vaccine was stored at a temperature of 5.67 degrees Fahrenheit (F), during a time frame of 3 hours and 45 minutes. There was a previous temperature excursion reported as 7.81 F, during a time frame of 1 hour and 5 seconds (product storage error). No additional adverse events were reported in the patient.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional AE reported; A medical assistant called to report an expired dose of MMR II that was administered to a patient. on 8/1/2022.  No additional AE's and no PQC's were reported.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-AUG-2022, the patient was vaccinated with a expired dose of measles, mumps, and rubella (WISTAR RA 27-3) virus vaccine, live (M-M-R II) (valid lot #T025927, expiration date: 30-JUL-2022) use as directed to prevent measles, mumps, and rubella infection. No additional adverse event was reported.
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse event; patient was administered 3rd dose of VARIVAX; This spontaneous report was received from a nurse practitioner and refers to a female patient of unknown age.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 09-SEP-2019, the patient was vaccinated with the second dose of varicella virus vaccine (manufacturer unknown)(strength, anatomical location, lot #, expiry date, and route of administration were not provided). On 02-AUG-2022, she was vaccinated with a 3rd dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliter (strength, anatomical location, lot #, expiry date, and route of administration were not provided) (extra dose administered). All vaccines were administered as prophylaxis. There was no adverse event reported.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Temperature stability evaluation of vaccines and reported that pediatric patients received PROQUAD vaccine since excursion date on 14-JUL-2022.; This spontaneous report has been received from a medical assistant referring to a 1-year-old female patient. The patient pertinent medical history, historical drugs, previous drugs reactions or allergies, and concomitant medications were not reported.    On an unspecified date in 2022, the patient was vaccinated with measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (PROQUAD) at dose of 1.5 milliliter (ml) for prophylaxis (lot number W002781 had been verified to be a valid number; expiration date  24-JUL-2023; strength, route of administration and antomical location was not reported). It was reported the temperature stability of vaccines was summited on an evaluation after excursion date on 14-JUL-2022 (product storage error).; Sender's Comments:  US-009507513-2208USA004135:
Sex: U
Vaccine: COVID19
Symptoms: Gingival pain
Clinical narrative: My mouth gums still hurts what can I do to ease the pain; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVAL PAIN (My mouth gums still hurts what can I do to ease the pain) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced GINGIVAL PAIN (My mouth gums still hurts what can I do to ease the pain). At the time of the report, GINGIVAL PAIN (My mouth gums still hurts what can I do to ease the pain) had not resolved.      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   No concomitant drug information was provided.  Patient had adverse reaction from 2 weeks.  No treatment drug information was provided.
Age: 48.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Fatigue, Pain, Vaccination site pain
Clinical narrative: Pain; INJECTION SITE PAIN OF COVID VACCINE; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), VACCINATION SITE PAIN (INJECTION SITE PAIN OF COVID VACCINE) and FATIGUE (Fatigue) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    There was no reported medical history.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-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) Citrate Free Discontinued. On 21-Jan-2021, the patient experienced VACCINATION SITE PAIN (INJECTION SITE PAIN OF COVID VACCINE) and FATIGUE (Fatigue). On an unknown date, the patient experienced PAIN (Pain). At the time of the report, PAIN (Pain) had not resolved and VACCINATION SITE PAIN (INJECTION SITE PAIN OF COVID VACCINE) and FATIGUE (Fatigue) outcome was unknown.            Concomitant medications were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Treatment medications were not reported.
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Concomitant products were not reported.  It was reported that primary reporter did not have the lot number information, because the packing was discarded. The causality for Humira was reported as not related.  Treatment medications were not reported.  Company Comment: This is a spontaneous case concerning a 52-year-old female patient, with no relevant medical history reported, who experienced the unexpected non-serious AESI COVID-19 which occurred unknown number of days after a dose of mRNA-1273 COVID-19 vaccine, dose number unknown. On an unknown date, COVID-19 TEST was positive. There is no available information regarding clinical course and treatment medication. Outcome of COVID-19 was reported as not recovered. Use of non-company co-suspect drug Humira was also reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 52-year-old female patient, with no relevant medical history reported, who experienced the unexpected non-serious AESI COVID-19 which occurred unknown number of days after a dose of mRNA-1273 COVID-19 vaccine, dose number unknown. On an unknown date, COVID-19 TEST was positive. There is no available information regarding clinical course and treatment medication. Outcome of COVID-19 was reported as not recovered. Use of non-company co-suspect drug Humira was also reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022; No adverse event; Dose administered after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (No adverse event) in a 73-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 003K21-2A, 012H21B, 018B21A and 036A21A) for COVID-19 prophylaxis.     Patient was never diagnosed with or tested positive for COVID-19.  The patient's past medical history included Hepatobiliary disorder prophylaxis (HPB). Concurrent medical conditions included Allergy to antibiotic (Septra). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), METOPROLOL, LISINOPRIL and HYDROCHLOROTHIAZIDE for an unknown indication.   On 05-Mar-2021 at 12:09 PM, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 18-Nov-2021 at 9:32 AM, received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .25 milliliter. On 05-Apr-2022 at 3:22 PM, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .5 milliliter. On 26-May-2022 at 10:47 AM, received fourth dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .25 milliliter. On 26-May-2022,  after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date) and PRODUCT STORAGE ERROR (vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022).    Date(s) of administration of vaccine were reported as 19-May-2022, 26-May-2022, 02-Jun2022, 07-Jun-2022 and 08-Jun-2022. The used vials were placed in the refrigerator on the same day of administration (26-May-2022). No temperature excursions were reported. No treatment medication was provided.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022; No adverse event; Dose administered after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (No adverse event) in a 64-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 003K21-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-May-2022 at 2:25 PM, the patient received fourth dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .25 milliliter. On 26-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related and EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date) to have an unknown relationship. No further causality assessment was provided for PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022).    Concomitant medications were not reported. Patient race was reported as other. Patient received Moderna covid 19 vaccine Dose 3 on 23 Nov 2021 on 8 47 am with batch lot number 077C21B, intramuscular as 025 ml dose. The event did not cause the patient to seek medical care. It was unknown if there was any other potential cause. It was unknown if the patient experienced a similar event in the past. Vial was initially stored in refrigerator on 21Jan2022 and the used vial was again stored in refrigerator on 7jun2022. Treatment information was not reported.