chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, COVID-19, Cholecystitis, Colitis ischaemic, Computerised tomogram abdomen abnormal
Clinical narrative: PFIZER COVID VACCINE #3 GIVEN 11/20/21, LOT #FG3527; 5/31/22 pt with abdominal pain; ischemic colitis with patchy ulcerations; 6/3/22 dc'd to home; 6/5/22 pt back to ED with worsening abdominal pain, nausea, diarrhea, poor oral intake; CT showed hemicolonic colitis with ileus and cholecystitis; 6/6/22 pt positive for COVID (no mention of treatment for COVID in medical records); general surgery consult; septic shock; underwent celiac artery stent graft and superior mesenteric artery stent; pt's condition worsened; 6/22/22 pt transitioned to comfort measures; hospice consulted to assist with care; pt unable to go home due to diarrhea; pt passed away in the hospital
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Diarrhoea, General physical health deterioration, Hypophagia, Ileus
Clinical narrative: PFIZER COVID VACCINE #3 GIVEN 11/20/21, LOT #FG3527; 5/31/22 pt with abdominal pain; ischemic colitis with patchy ulcerations; 6/3/22 dc'd to home; 6/5/22 pt back to ED with worsening abdominal pain, nausea, diarrhea, poor oral intake; CT showed hemicolonic colitis with ileus and cholecystitis; 6/6/22 pt positive for COVID (no mention of treatment for COVID in medical records); general surgery consult; septic shock; underwent celiac artery stent graft and superior mesenteric artery stent; pt's condition worsened; 6/22/22 pt transitioned to comfort measures; hospice consulted to assist with care; pt unable to go home due to diarrhea; pt passed away in the hospital
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, SARS-CoV-2 test positive, Septic shock, Stent placement, Ulcer
Clinical narrative: PFIZER COVID VACCINE #3 GIVEN 11/20/21, LOT #FG3527; 5/31/22 pt with abdominal pain; ischemic colitis with patchy ulcerations; 6/3/22 dc'd to home; 6/5/22 pt back to ED with worsening abdominal pain, nausea, diarrhea, poor oral intake; CT showed hemicolonic colitis with ileus and cholecystitis; 6/6/22 pt positive for COVID (no mention of treatment for COVID in medical records); general surgery consult; septic shock; underwent celiac artery stent graft and superior mesenteric artery stent; pt's condition worsened; 6/22/22 pt transitioned to comfort measures; hospice consulted to assist with care; pt unable to go home due to diarrhea; pt passed away in the hospital
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, Off label use
Clinical narrative: SUSPECTED COVID-19 INFECTION; NAUSEA; DIARRHEA; FATIGUE; STOMACH CRAMPS; BRAIN FOG; LACK OF APPETITE; TERRIBLE LASTING TASTE IN BACK OF THROAT; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 37 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included: citrus allergy, banana allergy, generalized anxiety, depression, and high blood pressure, and other pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1808980 expiry: unknown) dose was not reported, 01 total, administered on left arm on 03-APR-2021 at 14:30 for covid-19 prophylaxis.  Age at time of vaccination 36 years old.  Concomitant medications included escitalopram oxalate for anxiety.  It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received non-company suspect vaccine tozinameran (Pfizer) (Dose number in series 2) (form of admin and route of admin were not reported, batch number: 133026801 expiry: unknown) dose was not reported, administered on left arm on 15-NOV-2021 at 18:00 for covid-19 prophylaxis.  On an unspecified date, the patient experienced suspected covid-19 infection (Dose number in series 2).  The patient received non company suspect Paxlovid (nirmatrelvir/ritonavir) (form of administration and route of admin were not reported, batch number: 1917995A, expiry: unknown) dose was not reported, administered from 10-AUG-2022 to 15-AUG-2022 for covid-19 treatment. On 10-AUG-2022 23:00, the patient experienced nausea, stomach cramps, diarrhea, fatigue, brain fog, lack of appetite, and terrible lasting taste in back of throat (Dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The patient had not recovered from nausea, stomach cramps, diarrhea, fatigue, brain fog, lack of appetite, and terrible lasting taste in back of throat, and the outcome of suspected covid-19 infection was not reported. This report was non-serious.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain upper, Decreased appetite, Diarrhoea, Dysgeusia, Fatigue
Clinical narrative: SUSPECTED COVID-19 INFECTION; NAUSEA; DIARRHEA; FATIGUE; STOMACH CRAMPS; BRAIN FOG; LACK OF APPETITE; TERRIBLE LASTING TASTE IN BACK OF THROAT; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 37 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included: citrus allergy, banana allergy, generalized anxiety, depression, and high blood pressure, and other pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1808980 expiry: unknown) dose was not reported, 01 total, administered on left arm on 03-APR-2021 at 14:30 for covid-19 prophylaxis.  Age at time of vaccination 36 years old.  Concomitant medications included escitalopram oxalate for anxiety.  It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received non-company suspect vaccine tozinameran (Pfizer) (Dose number in series 2) (form of admin and route of admin were not reported, batch number: 133026801 expiry: unknown) dose was not reported, administered on left arm on 15-NOV-2021 at 18:00 for covid-19 prophylaxis.  On an unspecified date, the patient experienced suspected covid-19 infection (Dose number in series 2).  The patient received non company suspect Paxlovid (nirmatrelvir/ritonavir) (form of administration and route of admin were not reported, batch number: 1917995A, expiry: unknown) dose was not reported, administered from 10-AUG-2022 to 15-AUG-2022 for covid-19 treatment. On 10-AUG-2022 23:00, the patient experienced nausea, stomach cramps, diarrhea, fatigue, brain fog, lack of appetite, and terrible lasting taste in back of throat (Dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The patient had not recovered from nausea, stomach cramps, diarrhea, fatigue, brain fog, lack of appetite, and terrible lasting taste in back of throat, and the outcome of suspected covid-19 infection was not reported. This report was non-serious.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling abnormal, Nausea, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; NAUSEA; DIARRHEA; FATIGUE; STOMACH CRAMPS; BRAIN FOG; LACK OF APPETITE; TERRIBLE LASTING TASTE IN BACK OF THROAT; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 37 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included: citrus allergy, banana allergy, generalized anxiety, depression, and high blood pressure, and other pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1808980 expiry: unknown) dose was not reported, 01 total, administered on left arm on 03-APR-2021 at 14:30 for covid-19 prophylaxis.  Age at time of vaccination 36 years old.  Concomitant medications included escitalopram oxalate for anxiety.  It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received non-company suspect vaccine tozinameran (Pfizer) (Dose number in series 2) (form of admin and route of admin were not reported, batch number: 133026801 expiry: unknown) dose was not reported, administered on left arm on 15-NOV-2021 at 18:00 for covid-19 prophylaxis.  On an unspecified date, the patient experienced suspected covid-19 infection (Dose number in series 2).  The patient received non company suspect Paxlovid (nirmatrelvir/ritonavir) (form of administration and route of admin were not reported, batch number: 1917995A, expiry: unknown) dose was not reported, administered from 10-AUG-2022 to 15-AUG-2022 for covid-19 treatment. On 10-AUG-2022 23:00, the patient experienced nausea, stomach cramps, diarrhea, fatigue, brain fog, lack of appetite, and terrible lasting taste in back of throat (Dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The patient had not recovered from nausea, stomach cramps, diarrhea, fatigue, brain fog, lack of appetite, and terrible lasting taste in back of throat, and the outcome of suspected covid-19 infection was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: CONFIRMED COVID-19 INFECTION; ANXIETY; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 57 year old male. The patient's height, and weight were not reported. The patient's past medical history included: head injuries, and other pre-existing medical conditions included: Patient was an athlete. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received non-company suspect vaccine included: Pfizer covid-19 vaccine (tozinameran) (dose number in series 2) (form of admin, route of admin, and batch number were not reported), dose, start therapy date were not reported for covid-19 prophylaxis. The patient also received non-company suspect drug included: Paxlovid (nirmatrelvir tablets; ritonavir tablets) (tablets, route of admin, and batch number were not reported), dose, start therapy date were not reported for unknown indication.  On an unspecified date, it was reported that, paxlovid made him ready to jump out of his skin. he wouldn't eat, he was angry and was anxious and that's no good. The anxiety that patient felt with this medication (paxlovid) was unbelievable (dose number in series 2). Patient wont take this medication and was afraid to take it. The patient was tested positive for a week almost 10 days now (confirmed covid-19 infection) (dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable and was discontinued with paxlovid. The patient had not recovered from confirmed covid-19 infection, and the outcome of anxiety was not reported. This report was non-serious.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Anxiety, COVID-19, SARS-CoV-2 test
Clinical narrative: CONFIRMED COVID-19 INFECTION; ANXIETY; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 57 year old male. The patient's height, and weight were not reported. The patient's past medical history included: head injuries, and other pre-existing medical conditions included: Patient was an athlete. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received non-company suspect vaccine included: Pfizer covid-19 vaccine (tozinameran) (dose number in series 2) (form of admin, route of admin, and batch number were not reported), dose, start therapy date were not reported for covid-19 prophylaxis. The patient also received non-company suspect drug included: Paxlovid (nirmatrelvir tablets; ritonavir tablets) (tablets, route of admin, and batch number were not reported), dose, start therapy date were not reported for unknown indication.  On an unspecified date, it was reported that, paxlovid made him ready to jump out of his skin. he wouldn't eat, he was angry and was anxious and that's no good. The anxiety that patient felt with this medication (paxlovid) was unbelievable (dose number in series 2). Patient wont take this medication and was afraid to take it. The patient was tested positive for a week almost 10 days now (confirmed covid-19 infection) (dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable and was discontinued with paxlovid. The patient had not recovered from confirmed covid-19 infection, and the outcome of anxiety was not reported. This report was non-serious.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 74.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Blister, Laboratory test, Myalgia, Paraesthesia
Clinical narrative: Vaccine given on 8/2/2022.  Patient reports developing left elbow pain on 8/14/2022.  Dull pain increased to span from shoulder to fingers.  Vesicular rash developed on 8/22/2022.    Exam on 8/24/2022 showed vesicular rash in C7 dermatome on left elbow to hand/fingers.  Hyperaesthesia noted.
Age: 74.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Arthralgia, Pain, Pain in extremity, Rash vesicular, Varicella virus test positive
Clinical narrative: Vaccine given on 8/2/2022.  Patient reports developing left elbow pain on 8/14/2022.  Dull pain increased to span from shoulder to fingers.  Vesicular rash developed on 8/22/2022.    Exam on 8/24/2022 showed vesicular rash in C7 dermatome on left elbow to hand/fingers.  Hyperaesthesia noted.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate, Heart rate increased, Pain
Clinical narrative: Had a lot of pain; can't walk; Pulse was high after the first vaccine and it's worse after the second booster; Pulse was high after the first vaccine and it's worse after the second booster; pain in head; pain in shoulders; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Had a lot of pain), GAIT INABILITY (can't walk), HEART RATE INCREASED (Pulse was high after the first vaccine and it's worse after the second booster), CONDITION AGGRAVATED (Pulse was high after the first vaccine and it's worse after the second booster) and HEADACHE (pain in head) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051B22A, 939904, 037A21B and 030A21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     .  Concurrent medical conditions included Blood pressure abnormal (takes blood pressure pills for many years).   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2022, the patient experienced PAIN (Had a lot of pain), GAIT INABILITY (can't walk), HEART RATE INCREASED (Pulse was high after the first vaccine and it's worse after the second booster), CONDITION AGGRAVATED (Pulse was high after the first vaccine and it's worse after the second booster), HEADACHE (pain in head) and ARTHRALGIA (pain in shoulders). At the time of the report, PAIN (Had a lot of pain) had not resolved and GAIT INABILITY (can't walk), HEART RATE INCREASED (Pulse was high after the first vaccine and it's worse after the second booster), CONDITION AGGRAVATED (Pulse was high after the first vaccine and it's worse after the second booster), HEADACHE (pain in head) and ARTHRALGIA (pain in shoulders) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2022, Heart rate: worse.         The patient had no other heart conditions.  The patient thought they may have gotten a higher dose as the patient experienced more pain.  The patient had not taken any medication for the pain just took a warm shower and used cool towel.   This case was linked to MOD-2022-633793 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Condition aggravated, Gait inability, Headache, Heart rate
Clinical narrative: Had a lot of pain; can't walk; Pulse was high after the first vaccine and it's worse after the second booster; Pulse was high after the first vaccine and it's worse after the second booster; pain in head; pain in shoulders; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Had a lot of pain), GAIT INABILITY (can't walk), HEART RATE INCREASED (Pulse was high after the first vaccine and it's worse after the second booster), CONDITION AGGRAVATED (Pulse was high after the first vaccine and it's worse after the second booster) and HEADACHE (pain in head) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051B22A, 939904, 037A21B and 030A21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     .  Concurrent medical conditions included Blood pressure abnormal (takes blood pressure pills for many years).   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2022, the patient experienced PAIN (Had a lot of pain), GAIT INABILITY (can't walk), HEART RATE INCREASED (Pulse was high after the first vaccine and it's worse after the second booster), CONDITION AGGRAVATED (Pulse was high after the first vaccine and it's worse after the second booster), HEADACHE (pain in head) and ARTHRALGIA (pain in shoulders). At the time of the report, PAIN (Had a lot of pain) had not resolved and GAIT INABILITY (can't walk), HEART RATE INCREASED (Pulse was high after the first vaccine and it's worse after the second booster), CONDITION AGGRAVATED (Pulse was high after the first vaccine and it's worse after the second booster), HEADACHE (pain in head) and ARTHRALGIA (pain in shoulders) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2022, Heart rate: worse.         The patient had no other heart conditions.  The patient thought they may have gotten a higher dose as the patient experienced more pain.  The patient had not taken any medication for the pain just took a warm shower and used cool towel.   This case was linked to MOD-2022-633793 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Pain
Clinical narrative: Had a lot of pain; can't walk; Pulse was high after the first vaccine and it's worse after the second booster; Pulse was high after the first vaccine and it's worse after the second booster; pain in head; pain in shoulders; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Had a lot of pain), GAIT INABILITY (can't walk), HEART RATE INCREASED (Pulse was high after the first vaccine and it's worse after the second booster), CONDITION AGGRAVATED (Pulse was high after the first vaccine and it's worse after the second booster) and HEADACHE (pain in head) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051B22A, 939904, 037A21B and 030A21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     .  Concurrent medical conditions included Blood pressure abnormal (takes blood pressure pills for many years).   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2022, the patient experienced PAIN (Had a lot of pain), GAIT INABILITY (can't walk), HEART RATE INCREASED (Pulse was high after the first vaccine and it's worse after the second booster), CONDITION AGGRAVATED (Pulse was high after the first vaccine and it's worse after the second booster), HEADACHE (pain in head) and ARTHRALGIA (pain in shoulders). At the time of the report, PAIN (Had a lot of pain) had not resolved and GAIT INABILITY (can't walk), HEART RATE INCREASED (Pulse was high after the first vaccine and it's worse after the second booster), CONDITION AGGRAVATED (Pulse was high after the first vaccine and it's worse after the second booster), HEADACHE (pain in head) and ARTHRALGIA (pain in shoulders) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2022, Heart rate: worse.         The patient had no other heart conditions.  The patient thought they may have gotten a higher dose as the patient experienced more pain.  The patient had not taken any medication for the pain just took a warm shower and used cool towel.   This case was linked to MOD-2022-633793 (Patient Link).
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient administered expired dose. No other events, treatments, outcomes noted.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient administered expired dose. No other events, treatments, outcomes noted.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient administered expired dose. No other events, treatments, outcomes noted.
Age: 37.0
Sex: M
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: Patient administered expired dose. No other events, treatments, outcomes noted.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient administered expired dose. No other events, treatments, outcomes noted.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient administered expired dose. No other events, treatments, outcomes noted.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient administered expired dose. No other events, treatments, outcomes noted.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient administered expired dose. No other events, treatments, outcomes noted.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Immune thrombocytopenia, Immunoglobulin therapy, Platelet count decreased
Clinical narrative: CHILD DEVELOPED ITP ONE WEEK AFTER RECEIVING FIRST DOSE OF  AGE  APPROPIRATED COVID-19 VACCINE
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient administered expired dose. No other events, treatments, outcomes noted.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient administered expired dose. No other events, treatments, outcomes noted.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Electrocardiogram, Electrocardiogram ambulatory, Fatigue, Palpitations
Clinical narrative: Had been feeling really exhausted and started to have heart palpitations. Went to a local medical center ER and was given an EKG. Followed up with new PCP and was given another EKG. Was given a Heart Monitor to wear and prescribed metoprolol. Before coming back in for a follow up, contracted COVID-19 and everything was delayed. Still having heart problems.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient got 5 doses of Moderna covid-19 vaccine. Dose #4 (7/14/22) and 5 (8/11/22) were given in full ( 0.5 ml). No adverse event was reported from patient. Pharmacy found out patient has gotten 5 doses upon billing processing.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Immediate post-injection reaction, Nausea, Underdose
Clinical narrative: Patient is 25 years of age, was incorrectly given pediatric formulation of Hepatitis B vaccine for ages 19 or younger.  Patient noted some nausea immediately after receiving this vaccine and other required vaccines, reported that nausea subsided within 15 minutes.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles
Sex: F
Vaccine: COVID19
Symptoms: Blood triglycerides increased, Hepatic steatosis, Malaise
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HEPATIC STEATOSIS (FATTY LIVER), BLOOD TRIGLYCERIDES INCREASED (HIGH TRIGLYCERIDES) and MALAISE (FEELING UNWELL AFTER COVID VACCINE with HUMIRA) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriasis. The patient's past medical history included Defibrillator/pacemaker insertion in 2012. Concurrent medical conditions included Psoriasis. On 18-Jan-2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Feb-2022, the patient experienced MALAISE (FEELING UNWELL AFTER COVID VACCINE with HUMIRA). In June 2022, the patient experienced HEPATIC STEATOSIS (FATTY LIVER) and BLOOD TRIGLYCERIDES INCREASED (HIGH TRIGLYCERIDES). In 2022, MALAISE (FEELING UNWELL AFTER COVID VACCINE with HUMIRA) had resolved. At the time of the report, HEPATIC STEATOSIS (FATTY LIVER) and BLOOD TRIGLYCERIDES INCREASED (HIGH TRIGLYCERIDES) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. The reporter did not have the lot number information, because the packaging was discarded. The reporter causality for the events of FATTY LIVER, HIGH TRIGLYCERIDES and FEELING UNWELL AFTER COVID VACCINE with HUMIRA was no reasonable possibility. Treatment information was not provided.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Joint range of motion decreased, Magnetic resonance imaging, Pain in extremity, X-ray
Clinical narrative: I having pain in my right arm can't rise my arm over my head it hurt when I reach for things it pain when I get out of bed shoulder to elbow I have not worked in 5months; can't rise my arm over my head; Patient received DOSE 1 on 8Aug20211 and DOSE 2 on 24Aug2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 24Aug2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 08Aug2021, for COVID-19 immunization, reaction(s): "Pain in extremity". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 24Aug2021, outcome "unknown", described as "Patient received DOSE 1 on 8Aug20211 and DOSE 2 on 24Aug2021"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "I having pain in my right arm can't rise my arm over my head it hurt when I reach for things it pain when I get out of bed shoulder to elbow I have not worked in 5months"; JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown", described as "can't rise my arm over my head". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient started that he had pain in right arm can't rise arm over head and it hurt when the patient reached for things it pain when the patient get out of bed shoulder to elbow, the patient had not worked in 5months so it's probably not job related one Doc gave a x-ray and a MRI he had changed his insurance policy   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : UM-PFIZER INC-PV202200051492 Same patient/event, different dose;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Mobility decreased, Pain in extremity, X-ray
Clinical narrative: I having pain in my right arm can't rise my arm over my head it hurt when I reach for things it pain when I get out of bed shoulder to elbow I have not worked in 5months; can't rise my arm over my head; Patient received DOSE 1 on 8Aug20211 and DOSE 2 on 24Aug2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 24Aug2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 08Aug2021, for COVID-19 immunization, reaction(s): "Pain in extremity". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 24Aug2021, outcome "unknown", described as "Patient received DOSE 1 on 8Aug20211 and DOSE 2 on 24Aug2021"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "I having pain in my right arm can't rise my arm over my head it hurt when I reach for things it pain when I get out of bed shoulder to elbow I have not worked in 5months"; JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown", described as "can't rise my arm over my head". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient started that he had pain in right arm can't rise arm over head and it hurt when the patient reached for things it pain when the patient get out of bed shoulder to elbow, the patient had not worked in 5months so it's probably not job related one Doc gave a x-ray and a MRI he had changed his insurance policy   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : UM-PFIZER INC-PV202200051492 Same patient/event, different dose;
Age: 19.0
Sex: F
Vaccine: MMRV
Symptoms: Mumps antibody test negative, Product administered to patient of inappropriate age, Varicella virus test negative
Clinical narrative: Caller reported PROQUAD administered to a 19 year old patient; Caller also reported patient had titers drawn that showed she was non immune to Varicella and Mumps; Caller also reported patient had titers drawn that showed she was non immune to Varicella and Mumps; This spontaneous report was received from registered nurse, referring to a 19-year-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 29-JUN-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (therapy type: rHA) 0.5 milliliter, lot #W004026, expiration date: 02-AUG-2023, administered intramuscularly, for prophylaxis (product administered to patient of inappropriate age).  On an unknown date in 2022, the patient had blood titers drawn that showed she was non immune to varicella and mumps (mumps antibody test negative and varicella virus test negative). No other information was provided.  At the time of reporting, the outcome of mumps antibody test negative and varicella virus test negative was unknown.   The reporter's causality assessment between mumps antibody test negative and varicella virus test negative with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; an improperly stored dose of VARIVAX was administered to a patient; This spontaneous report was received from a medical assistant referring to a patient of unspecified age and gender patient whose medical history, concurrent conditions, and previous adverse drug reaction/allergies were not provided.  On 01-AUG-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, used as directed to prevent varicella infection (lot number: W002596, with an expiration date: 24-JAN-2024, was verified to be a valid lot number; strength, dose, frequency, route of administration and anatomical injection site were not provided) (product storage error).  No additional adverse events (AE) were reported.
Age: 16.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; MMR II lot expired on 7/30/22 and was given to patient today, 8/3/22; This spontaneous report was received from a registered nurse referring to a 16-year-old male patient. The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not reported.  On 03-AUG-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rHA) (M-M-R II) (0.5 mL, once, lot #T025930 and expiration date was reported as 30-JUL-2022 (also reported as 30-JUL-2022, but upon internal validation established as 30-JUL-2022); strength, route and anatomical location were not reported) for prophylaxis (expired product administered). The patient was inquiring information pertaining to the administration of expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (M-M-R II). No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Multiple outbreaks of herpes zoster; Information has been received from a lawyer regarding a case in litigation referring to a currently 83-year-old patient (pt). The pt's pertinent medical history, concurrent conditions and concomitant medications were not provided. On or about May 2010, pt was vaccinated with zoster vaccine live (ZOSSTAVAX) at a local pharmacy (strength, dose, route of administration, anatomical location, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unknown date, pt was treated by local providers for multiple outbreaks of herpes zoster (Herpes zoster) which resulted from zoster vaccine live (ZOSTAVAX)'s use. Pt claimed damages as a result of injury to themselves and economic losses. At reporting time, the outcome of herpes zoster was unknown.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Accidental overdose, Extra dose administered, No adverse event
Clinical narrative: No additional AE details provided.; VARIVAX and PROQUAD inadvertently concomitantly administered to one patient; This spontaneous report was received from a office manager concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.  On 08-AUG-2022, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD)(dosage regimen and route of administration were not reported), lot number W016355, expiration date 29-OCT-2023, administered as prophylaxis which was diluted with sterile diluent (dosage regimen, lot#, expiration date, and route of administration were not reported), and inadvertently concomitantly the patient received a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (dosage regimen and route of administration were not reported) lot number T028304, expiration date 20-AUG-2022, administered as prophylaxis (Accidental overdose). No additional adverse events were reported (No adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events; Medical assistant calling for TE evaluation on VARIVAX that has been administered.; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender.   The patient's medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent.  On 21-JUL-2022, the patient was vaccinated with 0.5 milliliter of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #T032315, expiration date: 22-SEP-2022, for prophylaxis (strength and route of administration were not provided), after a 40 minute temperature excursion between -14 and -10 Celsius degrees (-14.04 C) (product storage error). There was no previous temperature excursion and no additional adverse event reported.  This is one of several cases received from the same source.; Sender's Comments:  US-009507513-2208USA006426:
Age: 69.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE reported; HCP reported that a patient received his 1st dose of RECOMBIVAX HB in June2021. He didn't get his 2nd dose until  July2022.; This spontaneous report was received from a nurse and refers to a 70-year-old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date in June 2021, at the age of 69 years old, the patient was vaccinated with his first dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) for prophylaxis (dose, lot #, expiry date, anatomical location and route of administration were not provided). On an unknown date in July 2022, at the age of 70 years old, the patient was vaccinated with his second dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) for prophylaxis (dose, lot #, expiry date, anatomical location and route of administration were not provided) (inappropriate schedule of product administration).   There were no adverse events reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No additional adverse event; A 26 Year Old Patient was administered PROQUAD on 08/17/2022.; This spontaneous report was received from a registered nurse concerning a 26-year-old patient of unknown gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 17-AUG-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) subcutaneous injection, lot #U029322, expiration date: 19-MAR-2023, administered for prophylaxis (anatomical location, dose, and route of administration were not provided) (Product administered to patient of inappropriate age). No additional adverse events were reported.
Sex: U
Vaccine: HEPA
Symptoms: Product administration error
Clinical narrative: No additional adverse events; patient did not receive full dose of VAQTA; inexperienced nurse who administered the dose and because of "user error"; This spontaneous report was received from a licensed practical nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.  On 18-AUG-2022, the patient was vaccinated with a dose of Hepatitis A Vaccine, Inactivated (VAQTA) pre-filled syringe (dosage regimen and route of administration were not reported) lot number U031911, expiration date: 11-NOV-2022, administered as prophylaxis. The nurse reported that it was the inexperienced nurse who administered the dose and because of "user error" (Product administration error), part of the dose was sprayed on the floor and part in the vaccine; therefore, the patient did not receive the full dose of Hepatitis A Vaccine, Inactivated (VAQTA) (Underdose). No additional adverse events were reported (No adverse event).
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Office manager calling on behalf of a Provider to report that a patient received a dose of VARIVAX was administered on Aug 11, 2022 and PROQUAD was given on 8/18/2022.  No other issues reported.  AE follow-up can be sent.   NO PQC; This spontaneous report was received from an office manager concerning a 4-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 11-AUG-2022, the patient received a dose of with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (strength, lot #, expiry date, and route of administration were not provided); and on 18-AUG-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection (strength, lot #, expiry date, and route of administration were not provided), both administered for prophylaxis (inappropriate schedule of product administration). No other issues were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE for this patient; The caller said a patient received PROQUAD after a temperature excursion; This spontaneous report has been received from a Health Care Professional concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.  On 18-AUG-2022, the patient was vaccinated with an improperly storage dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) administered as prophylaxis, lot number U022729 with expiration date of 16-JAN-2023 (dosage regimen and route of administration were not provided). The mentioned vaccine underwent a temperature excursion of 11.5 degrees Fahrenheit (F) for 53 minutes, with no previous temperature excursion. No additional adverse event was reported for this patient (No adverse event).; Sender's Comments:  US-009507513-2208USA008698:02230187 US-009507513-2208USA008719:02230189
Age: 72.0
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Pain, Vaccination failure
Clinical narrative: I got the vaccine about 10 years ago but now have the shingles; I got the vaccine about 10 years ago but now have the shingles; This spontaneous report has been received from an 82-year-old patient of unknown age and gender referring to herself/himself. The patients' concomitant medications, pertinent medical history, and drug reactions/allergies were not reported.  In approximately 2012 (reported as about 10 years ago), the patient received the shingles vaccine zoster vaccine live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were not reported) for prophylaxis. However, on an unknown date in August 2022 (reported as now), the patient had shingles (Vaccination failure). It is over 2 weeks. The patient got pain pills antibiotics and cream as treatment. The patient never experienced pain like this, which got the patient shot, and also there was a booster. The patient felt horrible. The patient's life had been on hold. The outcome of the event was unknown. The action taken was not applicable. The vaccination failure was related to zoster vaccine live (ZOSTAVAX). The causality between shingles and zoster vaccine live (ZOSTAVAX) was unknown.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: no additional AE; Nurse reporting that MMRII was administered on 8/23/2022 with a labeled expiry of 8/18/2022. No temperature excursion involved. No additional information provided. No additional AE/PQC reported at time of call.; This spontaneous report has been received from a nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, drugs reactions or allergies and concomitant medications were not provided.  On 23-AUG-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rha) (M-M-R II) subcutaneous injection, 0.5  milliliters (mL), administered subcutaneously (valid lot number T027937 with an expiration date on 18-AUG-2022) (strength, frequency, and anatomical injection site were not provided) for prophylaxis (expired product administered), and sterile diluent (STERILE DILUENT)  (valid lot number T032311 with an expiration date on 05-MAY-2023).  No additional adverse event (AE) was reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Nurse reporting that MMRII was administered on 8/23/2022 with a labeled expiry of 8/18/2022. No temperature excursion involved. No additional information provided. No additional AE/PQC reported at time of call.; This spontaneous report has been received from a nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, drugs reactions or allergies and concomitant medications were not provided.  On 23-AUG-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rha) (M-M-R II) subcutaneous injection, 0.5  milliliters (mL), administered subcutaneously (valid lot number T027937 with an expiration date on 18-AUG-2022) (strength, frequency, and anatomical injection site were not provided) for prophylaxis (expired product administered), and sterile diluent (STERILE DILUENT)  (valid lot number T032311 with an expiration date on 05-MAY-2023).  No additional adverse event (AE) was reported.