chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Myalgia, Nausea
Clinical narrative: Although I'm reporting the adverse affects from the 2nd dose of SHINGRIX, I had the same affects from the first dose in October. The affects from the 2nd dose were slightly worse. Since Friday evening, December 7, I've had a temperature of 100.2, nausea, headache, sharp pains in my head, aching and weak joints, muscle pain all over, skin hurts to touch (all over), dizziness, and swelling, redness (approximately 2.5" diameter) and extreme tenderness at injection site. As of now, noon on Sunday, symptoms are thankfully fading.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin exfoliation
Clinical narrative: Although I'm reporting the adverse affects from the 2nd dose of SHINGRIX, I had the same affects from the first dose in October. The affects from the 2nd dose were slightly worse. Since Friday evening, December 7, I've had a temperature of 100.2, nausea, headache, sharp pains in my head, aching and weak joints, muscle pain all over, skin hurts to touch (all over), dizziness, and swelling, redness (approximately 2.5" diameter) and extreme tenderness at injection site. As of now, noon on Sunday, symptoms are thankfully fading.
Age: 68.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Musculoskeletal pain, Periarthritis
Clinical narrative: Patient called about a week after receiving vaccination with complaint of an abnormally shoulder. Was advised to attempt reach out to PCP about pain in shoulder if not resolved within the next few days. Patient went to PCP and was diagnosed with a frozen shoulder.
Age: 68.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Mobility decreased, Pain in extremity, Periarthritis, X-ray limb
Clinical narrative: Patient called about a week after receiving vaccination with complaint of an abnormally shoulder. Was advised to attempt reach out to PCP about pain in shoulder if not resolved within the next few days. Patient went to PCP and was diagnosed with a frozen shoulder.
Age: 49.0
Sex: F
Vaccine: HEPA
Symptoms: Pain in extremity
Clinical narrative: Soreness and pain in her arm.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash erythematous, Rash generalised, Rash macular
Clinical narrative: Approximately two days after receiving the vaccine, patient and his wife report that he broke out in a wide-spread rash. Presented as blotchy redness and itching that lasted for about 7 to 10 days.  Per patient, the rash wasn't raised (doesn't sound like they were hives) and denies using anything to alleviate the symptoms. No reports of fever or additional swelling.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Chills, Malaise, Vomiting
Clinical narrative: 4-5 hours after the shot, started feeling ill. Got violent chills, added clothing, turned up heat in the house and went to bed. No fever noted but did throw up about 9pm. Went back to bed and stayed there until 8 am the next morning (15 hrs total) drinking a lot of water along the way. Got up; not a lot of energy but was fine. Took it easy all day.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Fever, Chills, painful joints, sore injection site, red and edematous (approximately 8 cm diameter and 1 cm raised).
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever, Chills, painful joints, sore injection site, red and edematous (approximately 8 cm diameter and 1 cm raised).
Age: 18.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Dizziness, Syncope
Clinical narrative: Patient received the flu vaccination and complained of being light headed. She said she gets nervous with shots. I offered to give her time to collect herself, but she stated she was fine and ready for the HPV vaccination. Just a few seconds after receiving the HPV vaccine, the patient fainted. She was seated so she slumped forward and did not sustain any injuries. She regained consciousness after approximately ten seconds and was answering questions within approximately a minute. The patient was not exhibiting any other signs or symptoms of distress. She was given a beverage, and was supervised for the next approximately 30 minutes. She did not have any problems the rest of the day.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Injection site erythema, Pyrexia, Swelling
Clinical narrative: Swelling, redness at site, fever, vomiting, severe headache, diarrhea.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Swelling, redness at site, fever, vomiting, severe headache, diarrhea.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Apathy, Blood test normal, Fatigue, Feeling abnormal, Impaired work ability
Clinical narrative: Most recent flu shot was FLUCELVAX-IIV-4 (0.5 mL). Shortly after receiving the flu shot prior to this one, I began to have a number of symptoms I had never had before, including vertigo (hospitalized twice for - after much testing, no cause found), fatigue, muscle weakness not improved by exercise, increased need for sleep (7 hrs/night was norm, became 10 -12), low motivation, general malaise, foggy brain...Then when I had this injection, symptoms worsened considerably and I resigned from work December 8, 2017. Filed for and received disability January 2018.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Malaise, Muscular weakness, Nuclear magnetic resonance imaging normal, Somnolence, Vertigo
Clinical narrative: Most recent flu shot was FLUCELVAX-IIV-4 (0.5 mL). Shortly after receiving the flu shot prior to this one, I began to have a number of symptoms I had never had before, including vertigo (hospitalized twice for - after much testing, no cause found), fatigue, muscle weakness not improved by exercise, increased need for sleep (7 hrs/night was norm, became 10 -12), low motivation, general malaise, foggy brain...Then when I had this injection, symptoms worsened considerably and I resigned from work December 8, 2017. Filed for and received disability January 2018.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal discomfort, Asthenia, Back pain, Blood test normal, Chest pain
Clinical narrative: ADACEL TDAP booster received (8/28). Onset muscle weakness 2 days after shot (8/30/18), diarrhea, fatigue, weakness. Reported to pharmacist. On (10/4/18) received flu vaccine. On 10/27-10/28, back pain, muscle weakness, tingling in arms, tingling in feet and legs. burning sensation in chest and abdomen. Extreme weakness. Ears ringing. Left Eye ball pain when looking sideways. On 11/2/18 went to primary care physician to report symptoms. Had MRI of thoracic and lumbar on 11/2/18. Know significant disc issues reported on MRI. Referred to Neurologist (12/4/18). Legs and feet continue to tingle. Received brain and c-spine MRi on 12/8/2018.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Diarrhoea, Eye pain, Fatigue, Muscular weakness, Nervous system disorder
Clinical narrative: ADACEL TDAP booster received (8/28). Onset muscle weakness 2 days after shot (8/30/18), diarrhea, fatigue, weakness. Reported to pharmacist. On (10/4/18) received flu vaccine. On 10/27-10/28, back pain, muscle weakness, tingling in arms, tingling in feet and legs. burning sensation in chest and abdomen. Extreme weakness. Ears ringing. Left Eye ball pain when looking sideways. On 11/2/18 went to primary care physician to report symptoms. Had MRI of thoracic and lumbar on 11/2/18. Know significant disc issues reported on MRI. Referred to Neurologist (12/4/18). Legs and feet continue to tingle. Received brain and c-spine MRi on 12/8/2018.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal normal, Paraesthesia, Tinnitus
Clinical narrative: ADACEL TDAP booster received (8/28). Onset muscle weakness 2 days after shot (8/30/18), diarrhea, fatigue, weakness. Reported to pharmacist. On (10/4/18) received flu vaccine. On 10/27-10/28, back pain, muscle weakness, tingling in arms, tingling in feet and legs. burning sensation in chest and abdomen. Extreme weakness. Ears ringing. Left Eye ball pain when looking sideways. On 11/2/18 went to primary care physician to report symptoms. Had MRI of thoracic and lumbar on 11/2/18. Know significant disc issues reported on MRI. Referred to Neurologist (12/4/18). Legs and feet continue to tingle. Received brain and c-spine MRi on 12/8/2018.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling in upper right arm, itching, redness in upper right arm.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Extreme/severe pain upper arm. Unable to lift elbow level Above shoulder until December 7th. Unable to lift elbow period until Thursday. Took ADVIL for pain.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient states she has chronic pain from shoulder thru elbow.
Age: 35.0
Sex: M
Vaccine: FLU4
Symptoms: Hyperhidrosis, Seizure like phenomena, Syncope
Clinical narrative: Patient fainted. Sweating, he stated it felt like seizure.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Lingering shoulder pain, unable to lift my arm without severe pain that has been getting progressively worse.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Musculoskeletal pain
Clinical narrative: Lingering shoulder pain that has been getting progressively worse.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Musculoskeletal pain
Clinical narrative: Shoulder pain, she is unable to sleep on the side where her shot was administered, and cannot lift with that arm.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Lingering shoulder pain, unable to lift my arm without severe pain that has been getting progressively worse.
Age: 27.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy, Premature labour, Prenatal screening test
Clinical narrative: This is a serious observational study case, initially received from other health care-professional on 26-Nov-2018, concerns a 27-year-old, adult, female pregnant subject of body weight 96 lbs, height 60 cm and body mass index (BMI) 18.7, enrolled in a prospective observational safety study. The subject's historical drug included SYNTHROID for thyroid. The subject's historical condition included thyroid (from 01-Aug-2018 to 31-Aug-2018). The subject had one previous pregnancy with full term live birth. The subject had no history of offspring with major congenital malformations. The subject had no relevant maternal and paternal medical history with major congenital malformations. The subject did not use tobacco, alcohol and illicit drugs during pregnancy. The subject's current condition included low iron (since an unspecified date). The subject's concomitant medications included OB complete one (as reported) for healthy pregnancy and Ferrous sulfate (reported ferrouSul) for low iron. The subject's last menstrual period (LMP) date was 12-Aug-2018. The type of pregnancy was singleton. On 16-Jul-2018, the subject underwent first trimester screening and no major congenital malformations were noted. On 18-Jul-2018, the subject underwent fibrosis mutation analysis and no major congenital malformations were noted. On 31-Aug-2018, the subject underwent third trimester screening and no major congenital malformations were noted. On 16-Oct-2018, at gestational age of 25-weeks (second trimester of pregnancy) the subject was administered influenza vaccine (batch number: 252232, dose, route of administration, anatomical location, and expiry date: not reported]. On an unspecified date, after vaccination, the subject had preterm labor with not resulting in live birth. The subject's estimated delivery date (EED) was reported as 29-Jan-2019.
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthma, Exposure during pregnancy, Prenatal screening test
Clinical narrative: This is a serious observational study case, initially received from other health professional on 26-Nov-2018, concerns a 39-year-old, adult, female pregnant subject with weight 190 lbs, 64.4 inches, and body mass index (BMI) as 32.2, enrolled in a prospective observational safety study. The subject had two previous pregnancies in which first pregnancy was full term live birth and second pregnancy was elective abortion. The subject had no family history of offspring with major congenital malformation. No relevant maternal and paternal medical history with major congenital malformation. The subject did not use tobacco, alcohol and illicit drugs during pregnancy. The subject's current condition included urinary tract infection (since an unspecified date). Concomitant medications included VITAFOL ONE for healthy pregnancy and MACROBID for urinary tract infection. The subject's last menstrual period date (LMP) was 02-Jun-2018. On 04-Sep-2018, non-invasive prenatal test and first trimester screening test were performed, and no congenital malformations were noted. On 08-Oct-2018, at gestational age of 18-weeks (second trimester of pregnancy) the subject was administered influenza vaccine [batch number: 252232, dose, route of administration, anatomical location, and expiry date: not reported]. On an unspecified date in 2018, after vaccination, the subject developed asthma. At the time of this report, the subject had not recovered from asthma. The subject's estimated delivery date (EDD) was 09-Mar-2019.
Age: 72.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient reported redness, itching, swelling and mild pain at the injection site. Followed up on the next day and she mentioned she was improving. Administered on 12/7/18 by another pharmacist. I received call on Saturday and informed the patient to take OTC BENADRYL and Ibuprofen (or NSAID) for a few days to help fever and her symptoms of redness, swelling, and pain at injection site. I also recommended to the patient to contact her primary care provider if her condition doesn't improve and still follow-up with her physician. Followed up on Sunday with patient and she mentioned that she was improving as the swelling and pain had decreased.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Dizziness, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Act. After receiving 4 vaccines patient began to get lightheaded and faint. Patient was assisted to lie down, given cold washcloth, crackers and juice. Patient stated she hadn't eaten breakfast. Follow information was received on 05-NOV-2018. Information was received regarding 12 year old female patient. Concurrently patient had amoxicillin and ginger allergy. On 23-AUG-2017 the patient was vaccinated with GARDASIL 9 lot # N013695 dose 1, intramuscular in the left deltoid for prophylaxis. Other suspect therapies included BOOSTRIX, HAVRIX and MENVEO. Concomitant therapies included vitamins (unspecified) and hydrocortisone. On 23-AUG-2017, the patient experienced lightheaded and faint. The outcome of dizziness and syncope was reported as resolved. Follow up information has been received from the clinic manager on 03-DEC-2018. It was reported that the clinic manager was unfamiliar with the report. Additional details about the case were provided to the clinic manager so that she could attempt to obtain further information regarding the reported events of dizziness and syncope following the administration of the vaccine, GARDASIL 9.
Age: 68.0
Sex: F
Vaccine: FLU4, PPV, FLU3
Symptoms: Bone pain, Hypoaesthesia, Injected limb mobility decreased
Clinical narrative: Deep burning sensation at time of flu shot injection in left arm, within 30 minutes excruciating pain radiating from shoulder to hand. Swelling sensation in left shoulder and left arm paralyzed sensation and unable to lift arm away from my body. Pain radiated from shoulder to into my armpit, down my forearm and into wrist with tingling in all fingers. The pain experienced was the most significant endured in my lifetime and continued to next day. I contacted my GP immediately and was seen immediately. Based on the my symptoms, my GP immediately contacted neurologist directly for further collaboration and was seen the same day. The neurologist early diagnosis was SIRVA who took a photo of the injection site and indicated that it was incorrect injection technique. The neurologist prescribed Methylprednisolone Dosepack which helped take the edge off but was still unable to lift arm away from body. Within 24 hours of the last pill, the severe pain had returned. I was prescribed a second round of Methylprednisolone Dosepack. During this time my arm was in a sling as any slight movement would cause severe discomfort. I could not use my left arm at all. As the symptoms were not getting significantly better, the neurologist ordered an EMG and was tested on November 20th. The test conclusion indicated moderate radial neuropathy. Dr. prescribed physical therapy which I started last week. It has now been 2 months and am still unable to sleep on my left side without pain going all the way down my forearm. Generally there is still a throbbing discomfort between my shoulder and my elbow and burning sensation in my forearm. Certain movements cause a sharp stabbing pain jolt. One day last week there was significant pain in wrist and thumb which felt like something was broken. The pain seems to be worse in my shoulder and arm first thing in the morning having difficulty just lifting my arm. I have been told that when the radial nerve is involved it can manifest pain in many ways and take a long time to resolve which is frustrating with the unknown length of time to return to normal pre flu shot.
Age: 68.0
Sex: F
Vaccine: FLU4, PPV, FLU3
Symptoms: Burning sensation, Electromyogram abnormal, Injection site pain, Injection site swelling, Mobility decreased
Clinical narrative: Deep burning sensation at time of flu shot injection in left arm, within 30 minutes excruciating pain radiating from shoulder to hand. Swelling sensation in left shoulder and left arm paralyzed sensation and unable to lift arm away from my body. Pain radiated from shoulder to into my armpit, down my forearm and into wrist with tingling in all fingers. The pain experienced was the most significant endured in my lifetime and continued to next day. I contacted my GP immediately and was seen immediately. Based on the my symptoms, my GP immediately contacted neurologist directly for further collaboration and was seen the same day. The neurologist early diagnosis was SIRVA who took a photo of the injection site and indicated that it was incorrect injection technique. The neurologist prescribed Methylprednisolone Dosepack which helped take the edge off but was still unable to lift arm away from body. Within 24 hours of the last pill, the severe pain had returned. I was prescribed a second round of Methylprednisolone Dosepack. During this time my arm was in a sling as any slight movement would cause severe discomfort. I could not use my left arm at all. As the symptoms were not getting significantly better, the neurologist ordered an EMG and was tested on November 20th. The test conclusion indicated moderate radial neuropathy. Dr. prescribed physical therapy which I started last week. It has now been 2 months and am still unable to sleep on my left side without pain going all the way down my forearm. Generally there is still a throbbing discomfort between my shoulder and my elbow and burning sensation in my forearm. Certain movements cause a sharp stabbing pain jolt. One day last week there was significant pain in wrist and thumb which felt like something was broken. The pain seems to be worse in my shoulder and arm first thing in the morning having difficulty just lifting my arm. I have been told that when the radial nerve is involved it can manifest pain in many ways and take a long time to resolve which is frustrating with the unknown length of time to return to normal pre flu shot.
Age: 68.0
Sex: F
Vaccine: FLU4, PPV, FLU3
Symptoms: Pain in extremity, Paraesthesia, Radial nerve injury, Wrong technique in product usage process
Clinical narrative: Deep burning sensation at time of flu shot injection in left arm, within 30 minutes excruciating pain radiating from shoulder to hand. Swelling sensation in left shoulder and left arm paralyzed sensation and unable to lift arm away from my body. Pain radiated from shoulder to into my armpit, down my forearm and into wrist with tingling in all fingers. The pain experienced was the most significant endured in my lifetime and continued to next day. I contacted my GP immediately and was seen immediately. Based on the my symptoms, my GP immediately contacted neurologist directly for further collaboration and was seen the same day. The neurologist early diagnosis was SIRVA who took a photo of the injection site and indicated that it was incorrect injection technique. The neurologist prescribed Methylprednisolone Dosepack which helped take the edge off but was still unable to lift arm away from body. Within 24 hours of the last pill, the severe pain had returned. I was prescribed a second round of Methylprednisolone Dosepack. During this time my arm was in a sling as any slight movement would cause severe discomfort. I could not use my left arm at all. As the symptoms were not getting significantly better, the neurologist ordered an EMG and was tested on November 20th. The test conclusion indicated moderate radial neuropathy. Dr. prescribed physical therapy which I started last week. It has now been 2 months and am still unable to sleep on my left side without pain going all the way down my forearm. Generally there is still a throbbing discomfort between my shoulder and my elbow and burning sensation in my forearm. Certain movements cause a sharp stabbing pain jolt. One day last week there was significant pain in wrist and thumb which felt like something was broken. The pain seems to be worse in my shoulder and arm first thing in the morning having difficulty just lifting my arm. I have been told that when the radial nerve is involved it can manifest pain in many ways and take a long time to resolve which is frustrating with the unknown length of time to return to normal pre flu shot.
Sex: U
Vaccine: PNC13, PNC13
Symptoms: Cellulitis, Injection site erythema, Local reaction, Rash erythematous, Vaccination site reaction
Clinical narrative: This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported similar events for two patients. This is first of two reports. A patient of unspecified age and gender received PREVNAR 13, (Lot number: W51924, expiry date: Jul2020), via an unspecified route of administration on 01Oct2018 at single dose for immunization. The patient's medical history and concomitant medications were not reported. In 2018, the patient experienced cellulitis with outcome of unknown. Sender's Comments: The current information is very limited to allow a full medically meaningful assessment, especially lack of the following: complete medical history, concomitant medications, vaccination details and event description including onset date and location of the event. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Linked Report(s): US-PFIZER INC-2018501708 same product and event, different patient.
Sex: U
Vaccine: PNC13, PNC13
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported similar events for two patients. This is first of two reports. A patient of unspecified age and gender received PREVNAR 13, (Lot number: W51924, expiry date: Jul2020), via an unspecified route of administration on 01Oct2018 at single dose for immunization. The patient's medical history and concomitant medications were not reported. In 2018, the patient experienced cellulitis with outcome of unknown. Sender's Comments: The current information is very limited to allow a full medically meaningful assessment, especially lack of the following: complete medical history, concomitant medications, vaccination details and event description including onset date and location of the event. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Linked Report(s): US-PFIZER INC-2018501708 same product and event, different patient.
Sex: U
Vaccine: PNC13, PNC13
Symptoms: Cellulitis
Clinical narrative: This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported similar events for two patients. This is first of two reports. A patient of unspecified age and gender received PREVNAR 13, (Lot number: W51924, expiry date: Jul2020), via an unspecified route of administration on 01Oct2018 at single dose for immunization. The patient's medical history and concomitant medications were not reported. In 2018, the patient experienced cellulitis with outcome of unknown. Sender's Comments: The current information is very limited to allow a full medically meaningful assessment, especially lack of the following: complete medical history, concomitant medications, vaccination details and event description including onset date and location of the event. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Linked Report(s): US-PFIZER INC-2018501708 same product and event, different patient.
Age: 67.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Uterine leiomyoma
Clinical narrative: This is a spontaneous case reported by other non-health professional on 27-Nov-2018, concerning a 67-year-old, elderly female patient of weight: 213 lbs, height: 68.5 inches and body mass index (BMI): 31.92. The patient's historical condition included dysphagia, constipation, oesophageal spasm, urinary retention and presbyesophagus. The current conditions included weakness, gastroesophageal reflux disease, hypertensive cardiovascular disease, atherosclerotic cardiovascular disease, diabetes mellitus, obesity, colonic diverticulosis and leiomyoma uteri. The patient was allergic to sumatriptan and Ciprofloxacin. The concomitant medications included aspirin, gabapentin, lactobacillus acidophilus, Linaclotide, lorazepam, metformin, Vitamins, omeprazole, pramipexole, simvastatin and warfarin for unknown indications. On 23-Oct-2018, the patient was scheduled to drink the preparation prior to her colonoscopy. Around 2:30 pm on the same day, patient began drinking the preparation and began to experience weakness and syncope around 4:30 pm. The patient went to the emergency room and was treated for hypotension. The patient was admitted in the emergency room overnight. On 24-Oct-2018, the physician performed the colonoscopy within the hospital without any issues and at 4 pm, patient was ready to be discharged. On 24-Oct 2018, the patient was administered AFLURIA QUADRIVALENT (dose, route of administration, anatomical location, batch number and expiry date: not reported). On the same day, about 3 hours after vaccination, the patient felt extremely cold, tired and had a fever of 100.3. The patient was given TYLENOL to treat the fever and chills. The patient took some of her medications (warfarin, gabapentin, simvastatin, and metformin) and went to bed. On 25-Oct-2018, around 5 am in the morning, the husband of the patient found her snoring. When he returned to the patient about 30 minutes later, he found that the patient was not breathing and had no pulse. CPR was performed but later, the patient was pronounced dead. On an unspecified date, autopsy was performed, and revealed an anterior fracture of the second through eight ribs and the sternum at the level of the fourth ribs. The purple contusions of the left forearm measuring 4x 3 cm in greatest dimension was noted. The final diagnosis was reported as hypertensive and atherosclerotic cardiovascular disease (cardiac hypertrophy: 600 grams, left ventricular hypertrophy: 1.5 cm, slight coronary atherosclerosis, moderate aortic atherosclerosis, slight cerebral atherosclerosis and nephrosclerosis were noted), diabetes mellitus (glucose: 436 mg/dl), obesity (BMI: 31.92), colonic diverticulosis and leiomyomata uteri. The cause of death was reported as hypertensive and atherosclerotic cardiovascular disease and the contributing factor was diabetes mellitus and obesity. The outcome of the events feeling cold, fever, chills, fatigue was fatal and the outcome of the events rib fracture, sternum fracture and contusion was not reported. The reporter assessed the serious (death).
Age: 4.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Anaphylactic reaction, Erythema, Hypersensitivity, Lip swelling, Rash
Clinical narrative: This spontaneous report was received from a registered nurse concerning to a 4 year old female patient. The patient's medical history included hydrocephalus. Her concomitant medications included ZANTAC, albuterol inhaler, KEPPRA, PULMICORT and cetirizine hydrochloride. She had no drug reaction or allergies. On 28-NOV-2018, the patient was vaccinated with the second (2nd) dose of PROQUAD injection (lot # R015742, expiration date: 02-DEC-2019), subcutaneously, as prophylaxis (indication reported as 2nd MMR and Varicella vaccination) (strength, dose and anatomical location were not reported). On the same day, the patient experienced anaphylaxis reaction, hives and swelling of the face. In consequence, she was referred to the emergency room of a hospital. Over there, she was treated with BENADRYL, PEPCID and epinephrine. The patient was having a hard time breathing; therefore, she was placed on treatment with oxygen and admitted to the hospital to overnight monitoring. On an unspecified date in November 2018, the patient recovered from the event and on 29-NOV-2018, she was discharged from hospital. The causality between the event of anaphylactic reaction and PROQUAD was determined to be related. Upon internal review, the patient's anaphylactic reaction was considered to be medically significant. The reporter considered the event to be life threatening as the patient was having hard time breathing.
Age: 4.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Swelling, Swelling face, Urticaria
Clinical narrative: This spontaneous report was received from a registered nurse concerning to a 4 year old female patient. The patient's medical history included hydrocephalus. Her concomitant medications included ZANTAC, albuterol inhaler, KEPPRA, PULMICORT and cetirizine hydrochloride. She had no drug reaction or allergies. On 28-NOV-2018, the patient was vaccinated with the second (2nd) dose of PROQUAD injection (lot # R015742, expiration date: 02-DEC-2019), subcutaneously, as prophylaxis (indication reported as 2nd MMR and Varicella vaccination) (strength, dose and anatomical location were not reported). On the same day, the patient experienced anaphylaxis reaction, hives and swelling of the face. In consequence, she was referred to the emergency room of a hospital. Over there, she was treated with BENADRYL, PEPCID and epinephrine. The patient was having a hard time breathing; therefore, she was placed on treatment with oxygen and admitted to the hospital to overnight monitoring. On an unspecified date in November 2018, the patient recovered from the event and on 29-NOV-2018, she was discharged from hospital. The causality between the event of anaphylactic reaction and PROQUAD was determined to be related. Upon internal review, the patient's anaphylactic reaction was considered to be medically significant. The reporter considered the event to be life threatening as the patient was having hard time breathing.
Age: 4.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Anaphylactic reaction, Dyspnoea, Swelling face, Urticaria
Clinical narrative: This spontaneous report was received from a registered nurse concerning to a 4 year old female patient. The patient's medical history included hydrocephalus. Her concomitant medications included ZANTAC, albuterol inhaler, KEPPRA, PULMICORT and cetirizine hydrochloride. She had no drug reaction or allergies. On 28-NOV-2018, the patient was vaccinated with the second (2nd) dose of PROQUAD injection (lot # R015742, expiration date: 02-DEC-2019), subcutaneously, as prophylaxis (indication reported as 2nd MMR and Varicella vaccination) (strength, dose and anatomical location were not reported). On the same day, the patient experienced anaphylaxis reaction, hives and swelling of the face. In consequence, she was referred to the emergency room of a hospital. Over there, she was treated with BENADRYL, PEPCID and epinephrine. The patient was having a hard time breathing; therefore, she was placed on treatment with oxygen and admitted to the hospital to overnight monitoring. On an unspecified date in November 2018, the patient recovered from the event and on 29-NOV-2018, she was discharged from hospital. The causality between the event of anaphylactic reaction and PROQUAD was determined to be related. Upon internal review, the patient's anaphylactic reaction was considered to be medically significant. The reporter considered the event to be life threatening as the patient was having hard time breathing.
Age: 24.0
Sex: M
Vaccine: HEPA, HEPA, HEPA
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Inflammatory nodule that is red and tender to the touch.
Age: 24.0
Sex: M
Vaccine: HEPA, HEPA, HEPA
Symptoms: Erythema, Inflammation, Nodule, Tenderness
Clinical narrative: Inflammatory nodule that is red and tender to the touch.
Age: 24.0
Sex: M
Vaccine: HEPA, HEPA, HEPA
Symptoms: Arthralgia, Corynebacterium test positive, Injection site swelling, Musculoskeletal pain, Pain in extremity
Clinical narrative: Inflammatory nodule that is red and tender to the touch.
Age: 35.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site nodule, Pain in extremity
Clinical narrative: Left arm pain, left arm weakness, left arm limited range of motion, left arm shoulder pain, knot in arm. Simple tasks like putting clothes on, sleeping on left side, and driving painful.
Age: 35.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site nodule, Injection site pain, Joint range of motion decreased, Muscular weakness, Pain in extremity
Clinical narrative: Left arm pain, left arm weakness, left arm limited range of motion, left arm shoulder pain, knot in arm. Simple tasks like putting clothes on, sleeping on left side, and driving painful.
Age: 35.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Soft tissue swelling, X-ray abnormal
Clinical narrative: Left arm pain, left arm weakness, left arm limited range of motion, left arm shoulder pain, knot in arm. Simple tasks like putting clothes on, sleeping on left side, and driving painful.
Age: 68.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Musculoskeletal pain, Periarthritis
Clinical narrative: FROZEN SHOULDER (Severe Pain Moving Arm in Extended or Raised Positions).
Age: 68.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Mobility decreased, Pain in extremity, Periarthritis, X-ray limb
Clinical narrative: FROZEN SHOULDER (Severe Pain Moving Arm in Extended or Raised Positions).
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Tremor
Clinical narrative: Extreme shaking, low grade fever. I took 800 mg ibuprofen. Symptoms lessened but went away after 2-3 days.
Age: 8.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal pain upper, Cough, Heart rate increased, Lethargy, Pain
Clinical narrative: Fever of 103, Fast heart beat, Aches pains, Stomach ache, Lethargic, Cough, Runny nose.
Age: 8.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: Fever of 103, Fast heart beat, Aches pains, Stomach ache, Lethargic, Cough, Runny nose.
Age: 38.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Dehydration, Mobility decreased, Musculoskeletal pain, Pyrexia
Clinical narrative: Severe pain immobilizing shoulder/arm 48 plus hours of mid-grade fever signs of dehydration.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: NO adverse event. Patient has not had any side effects. Patient was due for Tdap (BOOSTRIX by GSK); nurse accidentally gave a DTaP (INFANRIX by GSK). Called GSK and states not to administer a Tdap but consider this 6th dose of DTaP as Patient's Tdap booster. Re-dose a Td in 10 years from 10/16/18.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Pain in site of vaccine injection, started on the day of vaccine and continued through the date of this report (4 weeks later).
Age: 15.0
Sex: U
Vaccine: VARCEL
Symptoms: Extra dose administered, Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician (pediatrician) concerning a 15-year-old patient of unknown gender. The patients historical conditions, concurrent conditions, concomitant therapies, historical drugs, allergies and concomitant therapies were not reported. On 28-NOV-2018, the patient was vaccinated with VARIVAX reported lot number N028713, expiration date: 13-OCT-2019, for prophylaxis (strength, dose, and frequency were not reported); one dose was administered subcutaneously, and the other dose was administered intramuscularly (overdose, incorrect route of product administration). No adverse effects were reported.  No product quality complaint was filed.   At the time of reporting, the outcome of the events was unknown.
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative, Decreased immune responsiveness
Clinical narrative: This spontaneous report was received from a pharmacist referring to an adult female patient of unknown age. Information about pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medication was not reported. On an unknown date (reported as when the patient was a child), the patient was vaccinated with M-M-R II injection (dose detail, route, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient had titers drawn, which showed her immunity had waned (antibody test negative and decreased immune responsiveness). The outcome of events and the causality assessments between events and M-M-R II injection were not reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse, referring to a patient of unknown age. Information of concurrent condition, medical history and concomitant therapy was not provided. On 27-NOV-2018, the patient was inadvertently administered a dose of M-M-R II (strength, route were unknown; lot # M045402 and expiration date 14-NOV-2018) which was expired (expired product administered) for prophylaxis. No adverse effects reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received by a nurse, referring to a patient of an unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies was provided. On 30-JAN-2018, the patient was vaccinated with an improperly stored dose of VARIXAX injection, subcutaneously (lot number N010107, expiration date 28-MAR-2019) for prophylaxis. (Product storage error) (Poor quality product administered). No adverse effects were reported. The administered dose of vaccine experienced a temperature excursion of 2.5 degrees Celsius (-9°C to 8°C) for 18 hours 11 minutes. There was a previous temperature excursion of -9°C to 8°C for 3 hours 19 minutes. It was reported that sterile diluent administered concomitantly was properly stored. A data logger was involved. This is one of several reports received from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received by a nurse, referring to a patient of an unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies was provided. On 14-AUG-2018, the patient was vaccinated with an improperly stored dose of VARIXAX injection, subcutaneously (lot number N010107, expiration date 28-MAR-2019) for prophylaxis. (Product storage error) (Poor quality product administered). No adverse effects were reported. The administered dose of vaccine experienced a temperature excursion of 2.5 degrees Celsius (-9°C to 8°C) for 18 hours 11 minutes. There was a previous temperature excursion of -9°C to 8°C for 3 hours 19 minutes. It was reported that sterile diluent administered concomitantly was properly stored. A data logger was involved. This is one of several reports received from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received by a nurse, referring to a patient of an unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies was provided. On 02-OCT-2018, the patient was vaccinated with an improperly stored dose of VARIXAX injection, subcutaneously (lot number N010107, expiration date 28-MAR-2019) for prophylaxis. (Product storage error) (Poor quality product administered). No adverse effects were reported. The administered dose of vaccine experienced a temperature excursion of 2.5 degrees Celsius (-9°C to 8°C) for 18 hours 11 minutes. There was a previous temperature excursion of -9°C to 8°C for 3 hours 19 minutes. It was reported that sterile diluent administered concomitantly was properly stored. A data logger was involved. This is one of several reports received from the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown demographics. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date in 2011, the patient was inoculated with ZOSTAVAX by a healthcare provider as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, lot # and expiration date not provided). On an unknown date, the patient was diagnosed with shingles and/or zoster related injuries after and despite being inoculated with ZOSTAVAX vaccine (vaccination failure, herpes zoster). On an unknown date in 2016, the patient was treated by a healthcare provider for shingles. As a further proximate result, the patient had suffered and will continue to suffer ongoing injuries, including by not limited to mental and physical pain and suffering, and other medical related expenses which includes but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies. The outcome of the events was unknown. The reporter considered vaccination failure, pain, injury, emotional distress and herpes zoster to be related to ZOSTAVAX.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On 22-AUG-2012 the patient was inoculated with ZOSTAVAX by a pharmacist to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot #, expiry date not provided). On an unknown date, the patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, (vaccination failure) and suffered serious physical, emotional, and economic damages as a result of patient's injuries. The patient was treated by a healthcare provider for shingles on an unknown date in 2016. The lawyer reported that as a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death- aggravation of preexisting conditions and activation-of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not reported. The events were considered to be related to ZOSTAVAX.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown demographics. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date in 2012, the patient was inoculated with ZOSTAVAX by a physician as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or zoster related injuries after and despite being inoculated with ZOSTAVAX vaccine and suffered serious mental and physical pain and suffering and required extensive medical care and treatment. On an unknown date in 2015, the patient was treated by a physician for shingles. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. Outcome of the events was unknown. Causality assessment was related.