chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Vaccination complication
Clinical narrative: Patient received shots at approximately 1:50pm on 4/11/19, that evening at 6pm spiked fever to 102. Brought in to office. Did have some respiratory symptoms though flu and rsv negative. Considered URI vs. vaccine reaction. Fever resolved within 48hrs and pt was back to baseline
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Infection, Rash erythematous, Skin warm
Clinical narrative: The patient had a bruise develop the night she received the vaccine. The next day and the day after that two red circles developed on each side of the bruise. The bruise when I saw it on 04/18/2019 was dark black/blue in color and the size of a half dollar. The red spots on each side of this bruise were very red and the size of a baseball. They were also warm to the touch. She did go see a NP who said an infection had developed from the vaccine and was prescribed a 10 day course of BACTRIM DS for this infection.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash, Rash erythematous, Vaccination site bruising, Vaccination site discolouration, Vaccination site pain
Clinical narrative: Patient reported a localized rash on her right arm where she received a Prevnar vaccination. The area of the vaccination was bruised and blue and the surrounding rash was red. She reported it being painful and warm to the touch.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Vaccination site warmth
Clinical narrative: Patient reported a localized rash on her right arm where she received a Prevnar vaccination. The area of the vaccination was bruised and blue and the surrounding rash was red. She reported it being painful and warm to the touch.
Age: 14.0
Sex: M
Vaccine: TDAP
Symptoms: Amnesia, Anal incontinence, Aphasia, Blindness, Blood heavy metal test
Clinical narrative: After shot, he said he felt his brain tearing or ripping apart and developed headache. Kept wetting head with water. Lost short-term memory. Unable to study, lost binocular vision to read or write.  Irritable Bowel Syndrome, Leaky gut, developed multiple Food allergies, Kidney failure, liver toxicity, spleen enlarged, became paralyzed - widespread from nose (mouth breather), Bell's palsy, to loss of urinary and bowel control, walked with a stroke shuffle at 16 years old, hypersensitive to sound, chronic insomnia, high cortisol during day and night. Lost weight, stopped growing, almost died in 2010 due to inability to swallow whole food. Lost all speech for 3 years.
Age: 14.0
Sex: M
Vaccine: TDAP
Symptoms: Cortisol increased, Dysphagia, Electroencephalogram, Facial paralysis, Feeling abnormal
Clinical narrative: After shot, he said he felt his brain tearing or ripping apart and developed headache. Kept wetting head with water. Lost short-term memory. Unable to study, lost binocular vision to read or write.  Irritable Bowel Syndrome, Leaky gut, developed multiple Food allergies, Kidney failure, liver toxicity, spleen enlarged, became paralyzed - widespread from nose (mouth breather), Bell's palsy, to loss of urinary and bowel control, walked with a stroke shuffle at 16 years old, hypersensitive to sound, chronic insomnia, high cortisol during day and night. Lost weight, stopped growing, almost died in 2010 due to inability to swallow whole food. Lost all speech for 3 years.
Age: 14.0
Sex: M
Vaccine: TDAP
Symptoms: Food allergy, Gait disturbance, Gastric disorder, Growth retardation, Headache
Clinical narrative: After shot, he said he felt his brain tearing or ripping apart and developed headache. Kept wetting head with water. Lost short-term memory. Unable to study, lost binocular vision to read or write.  Irritable Bowel Syndrome, Leaky gut, developed multiple Food allergies, Kidney failure, liver toxicity, spleen enlarged, became paralyzed - widespread from nose (mouth breather), Bell's palsy, to loss of urinary and bowel control, walked with a stroke shuffle at 16 years old, hypersensitive to sound, chronic insomnia, high cortisol during day and night. Lost weight, stopped growing, almost died in 2010 due to inability to swallow whole food. Lost all speech for 3 years.
Age: 14.0
Sex: M
Vaccine: TDAP
Symptoms: Hepatotoxicity, Hyperacusis, Insomnia, Irritable bowel syndrome, Loss of personal independence in daily activities
Clinical narrative: After shot, he said he felt his brain tearing or ripping apart and developed headache. Kept wetting head with water. Lost short-term memory. Unable to study, lost binocular vision to read or write.  Irritable Bowel Syndrome, Leaky gut, developed multiple Food allergies, Kidney failure, liver toxicity, spleen enlarged, became paralyzed - widespread from nose (mouth breather), Bell's palsy, to loss of urinary and bowel control, walked with a stroke shuffle at 16 years old, hypersensitive to sound, chronic insomnia, high cortisol during day and night. Lost weight, stopped growing, almost died in 2010 due to inability to swallow whole food. Lost all speech for 3 years.
Age: 14.0
Sex: M
Vaccine: TDAP
Symptoms: Mouth breathing, Nuclear magnetic resonance imaging, Paralysis, Renal failure, Scan with contrast
Clinical narrative: After shot, he said he felt his brain tearing or ripping apart and developed headache. Kept wetting head with water. Lost short-term memory. Unable to study, lost binocular vision to read or write.  Irritable Bowel Syndrome, Leaky gut, developed multiple Food allergies, Kidney failure, liver toxicity, spleen enlarged, became paralyzed - widespread from nose (mouth breather), Bell's palsy, to loss of urinary and bowel control, walked with a stroke shuffle at 16 years old, hypersensitive to sound, chronic insomnia, high cortisol during day and night. Lost weight, stopped growing, almost died in 2010 due to inability to swallow whole food. Lost all speech for 3 years.
Age: 14.0
Sex: M
Vaccine: TDAP
Symptoms: Splenomegaly, Urinary incontinence, Weight decreased
Clinical narrative: After shot, he said he felt his brain tearing or ripping apart and developed headache. Kept wetting head with water. Lost short-term memory. Unable to study, lost binocular vision to read or write.  Irritable Bowel Syndrome, Leaky gut, developed multiple Food allergies, Kidney failure, liver toxicity, spleen enlarged, became paralyzed - widespread from nose (mouth breather), Bell's palsy, to loss of urinary and bowel control, walked with a stroke shuffle at 16 years old, hypersensitive to sound, chronic insomnia, high cortisol during day and night. Lost weight, stopped growing, almost died in 2010 due to inability to swallow whole food. Lost all speech for 3 years.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; Products liability: manufacturing defect/defective design; Information has been received regarding a case in litigation from a lawyer and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On approximately 19-AUG-2014 (reported as on or about 19-AUG-2014), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) injection (strength, dose, route of administration, lot number and expiry date were not reported) for long-term prevention of shingles and zoster-related conditions.  On an unknown date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by the physician due to the event. The patient claimed damages as a result of: Injury to themselves; Loss of consortium; Loss of services; Economic losses. The following claims were asserted: negligence; products liability - defective design; products liability - manufacturing defect; products liability-failure to warn; breach of express warranty; breach of implied warranty; fraudulent misrepresentation; fraudulent concealment; negligent misrepresentation; unjust enrichment; strict liability; consumer fraud; loss of consortium; punitive damages. The outcome of the events was not provided.  The reporter consider the event of herpes zoster to be related to the suspected vaccine. The causality between the product quality issue and zoster vaccine live (ZOSTAVAX) was not provided.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster; Products liability: manufacturing defect/defective design; Information has been received regarding a case in litigation from a lawyer and refers to a currently 73-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On approximately 17-SEP-2012 (reported as on or about 17-SEP-2012), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) injection(strength, dose, route of administration, lot number and expiry date were not reported) for long-term prevention of shingles and zoster-related conditions.  On an unknown date, the patient experienced herpes zoster.On an unspecified date, the patient was treated by the physician due to the event. The patient claimed damages as a result of: Injury to themselves; Loss of consortium; Loss of services; Economic losses. The following claims were asserted: negligence; products liability - defective design; products liability - manufacturing defect; products liability-failure to warn; breach of express warranty; breach of implied warranty; fraudulent misrepresentation; fraudulent concealment; negligent misrepresentation; unjust enrichment; strict liability; consumer fraud; loss of consortium; punitive damages. The outcome of the events was not provided.  The reporter consider the event of herpes zoster to be related to the suspected vaccine. The causality between the product quality issue and zoster vaccine live (ZOSTAVAX) was not provided.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Products liability: manufacturing defect/defective design; Information has been received regarding a case in litigation from a lawyer and refers to a currently 71-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On approximately 17-JAN-2013 (reported as on or about 17-JAN-2013), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) injection (strength, dose, route of administration, lot number and expiry date were not reported) for long-term prevention of shingles and zoster-related conditions.  On an unknown date, the patient experienced shingles. On an unspecified date, the patient was treated by the physician due to the event. The patient claimed damages as a result of: Injury to themselves; Loss of consortium; Loss of services; Economic losses. The following claims were asserted: negligence; products liability - defective design; products liability - manufacturing defect; products liability-failure to warn; breach of express warranty; breach of implied warranty; fraudulent misrepresentation; fraudulent concealment; negligent misrepresentation; unjust enrichment; strict liability; consumer fraud; loss of consortium; punitive damages. The outcome of the events was not provided.  The reporter consider the event of shingles to be related to the  suspected vaccine.  The causality between the product quality issue and zoster vaccine live (ZOSTAVAX) was not provided.
Age: 74.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 84-year-old patient of unknown gender. No information was received regarding medical history, concurrent conditions or concomitant medications.  On approximately 22-JUL-2009, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose and route of administration were not provided) for long-term prevention of shingles and zoster-related conditions. The vaccine was administered by a healthcare provider. The patient was approximately 74 years old at the time of the vaccination. On an unknown date, the patient experienced shingles and was treated by a healthcare provider. The outcome of the event was unknown.  The reporter considered the event to be related to the zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Rash
Clinical narrative: Information has been received regarding a case in litigation from a lawyer, a female patient of unknown age, and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 17-OCT-2017, the patient was inoculated with the ZOSTAVAX vaccine for routine health maintenance and for its intended purpose: the prevention of shingles (lot number, dosage and route of administration not provided). Less than one month after receiving the ZOSTAVAX, the patient suffered a shingles rash on her right forehead and down to her eye and nose. The patient was diagnosed with herpes zoster with ophthalmic complication, herpes zoster eye disease. As a direct and proximate result of zoster ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using the ZOSTAVAX. The patient also experienced mental and emotional distress due to resulting physical limitations and the seriousness of the patient's condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the ZOSTAVAX, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered to be not recovered. Upon internal review, herpes zoster with ophthalmic complication/herpes zoster eye disease was determined to be medically significant. Herpes zoster with ophthalmic complication/herpes zoster eye disease was considered to be disabling. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse effects; A 21 year old patient, name and other demographics unknown to the reporter, received a pediatric dose of VAQTA on an unknown date in 2018 when she was approximately 20 years old; This spontaneous report was received from a registered pharmacist refers to currently 21 year old female patient. The patient's pertinent medical history, concomitant medication and drug reactions or allergies were not reported.  On an unknown date in 2018, the patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) vial 25/0.5 (unknown units), intramuscularly for prophylaxis (lot# and expiry date were not reported) when she was approximately 20 years old (product administered to patient of inappropriate age). The patient did not experience any adverse effects. No product quality complaint (PQC) was involved.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Influenza like illness, Injection site erythema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in an unspecified number of adult patients who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced influenza-like symptoms, injection site pain, injection site swelling, injection site erythema, fatigue, shivering and weakness. On an unknown date, the outcome of the influenza-like symptoms, injection site pain, injection site swelling, injection site erythema, fatigue, shivering and weakness were unknown. It was unknown if the reporter considered the influenza-like symptoms, injection site pain, injection site swelling, injection site erythema, fatigue, shivering and weakness to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected adult as per vaccine indication. The reporter listed several patients not quantified experienced multiple adverse reactions stated in the prescribing information after receiving SHINGRIX. The reporter stated pain, redness and swelling at the injection site and also reported flu-like symptoms, weakness and shivering. The reporter stated she did not have the specific data but spoke from experienced with patients at the time of the call. No additional information provided.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in an unspecified number of adult patients who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced influenza-like symptoms, injection site pain, injection site swelling, injection site erythema, fatigue, shivering and weakness. On an unknown date, the outcome of the influenza-like symptoms, injection site pain, injection site swelling, injection site erythema, fatigue, shivering and weakness were unknown. It was unknown if the reporter considered the influenza-like symptoms, injection site pain, injection site swelling, injection site erythema, fatigue, shivering and weakness to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected adult as per vaccine indication. The reporter listed several patients not quantified experienced multiple adverse reactions stated in the prescribing information after receiving SHINGRIX. The reporter stated pain, redness and swelling at the injection site and also reported flu-like symptoms, weakness and shivering. The reporter stated she did not have the specific data but spoke from experienced with patients at the time of the call. No additional information provided.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 61-year-old female patient who received SHINGRIX (batch number 424A7, expiry date 18th April 2021) for prophylaxis. On 15th November 2018 15:00, the patient received the 1st dose of SHINGRIX. In November 2018, 9 hrs after receiving SHINGRIX, the patient experienced chills, fever, nausea and pain. In November 2018, the outcome of the chills, fever, nausea and pain were recovered/resolved. The reporter considered the chills, fever, nausea and pain to be related to SHINGRIX. Additional details were provided as follows: The pharmacist stated the patient got her first dose of SHINGRIX at 3:00pm. On 16th November 2018, around midnight at 12:00 am, she started to experience chills, fever, nausea, aches and pain for the next 36 hours. The patient was in bed for 3 days. There was consent to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Circumstance or information capable of leading to medication error, Fatigue, Injection site pain, Malaise, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 63-year-old female patient who received SHINGRIX (batch number 7447A, expiry date 25th April 2020) for prophylaxis. On 12th April 2019, the patient received SHINGRIX. On 12th April 2019, unknown after receiving SHINGRIX, the patient experienced accidental underdose. In April 2019, the patient experienced pain, injection site pain, malaise and fatigue. On an unknown date, the outcome of the pain, injection site pain, malaise and fatigue were recovered/resolved and the outcome of the accidental underdose was unknown. It was unknown if the reporter considered the pain, injection site pain, malaise and fatigue to be related to SHINGRIX. Additional details were provided as follows: The reporter stated that, the patient jerked while administering SHINGRIX and fluid leaked out which led to accidental underdose. The patient experienced pain, injection site pain, malaise and fatigue. On 15th April 2019, the reporter followed up with the patient and patient stated that she had aches, pain, malaise, and fatigue and now all resolved.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Underdose
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 63-year-old female patient who received SHINGRIX (batch number 7447A, expiry date 25th April 2020) for prophylaxis. On 12th April 2019, the patient received SHINGRIX. On 12th April 2019, unknown after receiving SHINGRIX, the patient experienced accidental underdose. In April 2019, the patient experienced pain, injection site pain, malaise and fatigue. On an unknown date, the outcome of the pain, injection site pain, malaise and fatigue were recovered/resolved and the outcome of the accidental underdose was unknown. It was unknown if the reporter considered the pain, injection site pain, malaise and fatigue to be related to SHINGRIX. Additional details were provided as follows: The reporter stated that, the patient jerked while administering SHINGRIX and fluid leaked out which led to accidental underdose. The patient experienced pain, injection site pain, malaise and fatigue. On 15th April 2019, the reporter followed up with the patient and patient stated that she had aches, pain, malaise, and fatigue and now all resolved.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: PATIENT REPORTS THAT HIS ARM STILL HURTS (REPORTED TO PHARMACIST ON 4/19/19) AFTER GETTING THE FLU SHOT. PATIENT RECEIVED THE FLU SHOT ON 03/23/2019
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Tremor, Vomiting
Clinical narrative: patient reported uncontrollable shaking, vomiting 3 times, body aches
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Patient reported pain at the injection site within the first 24 hours of administration. She also has a red rash in the vicinity of the injection site that she noticed on Thursday (vaccine administered on Monday). She reports that the rash does not itch and it did not appear swollen.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Injection site pain, Rash vesicular
Clinical narrative: Patient reported develop a mark on her body similar to chicken pox. She reported pain at the site and inflammation and redness around the face. This occurred 2 months after her initial shot.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Pain, 3"x 3" redness by injection area, soreness, swelling, fever, headache, muscle aches, shivering, fatigue.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain, Pyrexia, Swelling
Clinical narrative: Pain, 3"x 3" redness by injection area, soreness, swelling, fever, headache, muscle aches, shivering, fatigue.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: SWELLING, PAIN, AND REDNESS AROUND INJECTION SITE INTO UNDERARM; FEVER, FATIGUE.
Age: 1.42
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Induration, Local reaction
Clinical narrative: Local erythematous reaction to Dtap. Developed large (10cm) erythematous skin and firmness approximately 48 hrs after vaccine. Examine 72 hourse after vaccine administration and erythema was starting to clear. No fever, no weakness, no difficulty bearing weight on affected extremity.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Patient presented two days after receiving his 2nd dose of his shingles vaccine with a red rash that was warm to the touch on the arm he received his vaccination on. The rash was about 5-6 inches long and about 1-2 inches below where the vaccine was actually administered. Patient stated he did not have this reaction after receiving his first dose. No treatment had been pursued.
Age: 18.0
Sex: F
Vaccine: HEP, TDAP, VARCEL
Symptoms: Fall, Fatigue, Nausea, Seizure like phenomena
Clinical narrative: Pt began to feel nauseated and fainted, Pt fell to the floor and had convulsive like behavior for less than one minute. Pt responsive and answering questions. Pt, head supported and evaluated. Pt assisted to one of the giving stations and then layed down on ground with legs elevated. Pt given water to drink. pt waited in room until she felt better.
Age: 38.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site pain, Injection site reaction, Lip swelling, Paraesthesia oral, Rash erythematous
Clinical narrative: pain at injection site about 5 minutes later, injection site had a 1 inch red raised rash that resolved within an hour after taking ibuprofen 400 mg (taken 5 minutes after vaccine). Lip tingling and swelling occured within 15 minutes; lower area of face/ lips were slightly puffy for one week after treating with ranitidine, antihistamines, and ibuprofen  Treated with ranitidine 400 mg to 600 mg daily, Zyrtec 10 mg tablet at night, Allegra 180 mg tablet in the morning, ibuprofen 400 mg every 4 hours during the day, Aleve 220 mg 2 tablets at bedtime, chlorpheniramine every 4 hours at night for 1 week. Continued ranitidine 150 mg twice daily during the second week along with Zyrtec 10 mg tablet in the evening and Allegra 180 mg tablet in the morning that was usually taken.
Age: 38.0
Sex: F
Vaccine: HEPA
Symptoms: Swelling face
Clinical narrative: pain at injection site about 5 minutes later, injection site had a 1 inch red raised rash that resolved within an hour after taking ibuprofen 400 mg (taken 5 minutes after vaccine). Lip tingling and swelling occured within 15 minutes; lower area of face/ lips were slightly puffy for one week after treating with ranitidine, antihistamines, and ibuprofen  Treated with ranitidine 400 mg to 600 mg daily, Zyrtec 10 mg tablet at night, Allegra 180 mg tablet in the morning, ibuprofen 400 mg every 4 hours during the day, Aleve 220 mg 2 tablets at bedtime, chlorpheniramine every 4 hours at night for 1 week. Continued ranitidine 150 mg twice daily during the second week along with Zyrtec 10 mg tablet in the evening and Allegra 180 mg tablet in the morning that was usually taken.
Age: 25.0
Sex: F
Vaccine: ANTH, SMALL, YF
Symptoms: Blister, Eczema
Clinical narrative: Both hands and feet became covered in fluid filled blisters.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Dizziness, Headache, Hypotension, Influenza virus test negative
Clinical narrative: Body aches, Headaches, Vomiting, Diarrhea, Hypotension and lightheadedness.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Vomiting
Clinical narrative: Body aches, Headaches, Vomiting, Diarrhea, Hypotension and lightheadedness.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pruritus, Skin warm, Tenderness, Urticaria
Clinical narrative: There was a lot of soreness at the site of the shot for a  couple of days, but it was not unexpected. The next evening, as the shot spread through my system, hives appeared on my trunk from chin to groin. It was hot and tender at first, then got itchy as it faded. There was no difficulty breathing or I would have gone to the ER. Treated with OTC CLARITIN and BENADRYL after calling Dr.'s office on April 16. It took about a week to totally clear my system.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Initial Report Received on 10-Apr-2019. A reporter from an infectious disease clinic (unknown title) reported that a patient (gender, age, and race not provided) was administered with HEPLISAV-B for hepatitis B immunization that was an expired dose. Relevant medical history and concomitant medications were not provided. On an unknown date, the patient received an expired dose of HEPLISAV-B that expired on 06-Apr-2019 (lot # and NDC # not provided). On 10-Apr-2019, the reporter stated that a patient was given an expired dose of HEPLISAV-B. When the reporter was informed that additional information would need to be collected for a report, she stated that a doctor would call back and she ended her inquiry and ended the call. A case number was given to her for reference. No call was received (from the doctor). On 11-Apr-2019, the reporter was called back and a message was left that it was urgent and to call back as soon as possible. The reporter's information from her recording on the phone call was located via a search on the internet and the reporter's clinic information was able to be located. At the time of this report, the individual collecting the report was awaiting for a call back. Additional information regarding the incident or medication lot number was unable to be obtained. No further information was provided. At the time of the report, the outcome of the event was unknown. The reporter did not provide a seriousness assessment for the event. Company comment: The company assessed the event of expired product administered as non-serious. The event of expired product administered is unlisted per HEPLISAV-B USPI. Sender's Comments: The company assessed the event of expired product administered as non-serious. The event of expired product administered is unlisted per HEPLISAV-B USPI.
Age: 67.0
Sex: M
Vaccine: FLUX
Symptoms: Abdominal distension, Areflexia, Asthenia, Ataxia, CSF test normal
Clinical narrative: This is a literature case, initially received on 08-Apr-2019, concerning a 67-year-old, elderly male patient. The purpose of the study was to recognize that, annually, one to two cases of GBS are reported per million of patients vaccinated with influenza. The patient's historical condition included unspecified gastroesophageal reflux disease (unspecified date). The patient's current condition included hypertension, hyperlipidemia, emphysema (since an unspecified date). On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (route of administration: intramuscular, dose, anatomical location, batch number, expiry date, trade name and manufacturer: not reported) for unknown indication. On an unspecified date, after the vaccination (reported as one day prior to hospital admission), the patient experienced abdominal distention and tingling sensation of all extremities. On an unspecified date, the patient was hospitalized. The patient underwent physical examination which demonstrated diminished motor strength in all extremities and areflexia, with subsequent ataxia and generalized weakness. The patient also developed respiratory muscle weakness requiring endotracheal intubation. On an unspecified date, the patient underwent head computerised tomogram (CT) scan which was unremarkable and CSF analysis, which failed to reveal albuminocytologic dissociation or infectious process. The patient also underwent electromyography test, which was suggestive of acute demyelinating polyneuropathy. The patient was treated with intravenous immunoglobulins (IVIGs) for 5 days and there was a failure to wean from mechanical ventilation and tracheostomy was performed, along with a percutaneous endoscopic gastrostomy. Two courses of IVIGs and one course of plasmapheresis were administered which led to weaning of mechanical ventilation and improvement of motor function. On an unspecified date, the patient was discharged on physical rehabilitation. It was reported that, the only risk factor identified was the administration of influenza vaccine two weeks prior to admission. The outcome of the event was not reported. The reporter stated that, development of Guillain-Barré Syndrome (GBS) was a potential complication of the Influenza vaccine (causality: related). The reporter assessed the case as serious (hospitalization). Reporter's Comments: A 67-year-old, male patient with underlying conditions (hypertension, hyperlipidemia, emphysema) developed Guillain Barre syndrome, approximately 2 weeks after administration of INN Flu Vaccine. Considering the plausible temporal relationship between vaccination and reported event, plausible biological mechanism and lack of any underlying conditions or alternative more plausible causes, the company assessed the events as possibly related to suspect vaccine. The case meets level 4 of Brighton Collaboration criteria of diagnostic certainty. The company assessed this case as serious (medically significant).
Age: 67.0
Sex: M
Vaccine: FLUX
Symptoms: Computerised tomogram head normal, Demyelinating polyneuropathy, Electromyogram abnormal, Endotracheal intubation, Gastrostomy
Clinical narrative: This is a literature case, initially received on 08-Apr-2019, concerning a 67-year-old, elderly male patient. The purpose of the study was to recognize that, annually, one to two cases of GBS are reported per million of patients vaccinated with influenza. The patient's historical condition included unspecified gastroesophageal reflux disease (unspecified date). The patient's current condition included hypertension, hyperlipidemia, emphysema (since an unspecified date). On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (route of administration: intramuscular, dose, anatomical location, batch number, expiry date, trade name and manufacturer: not reported) for unknown indication. On an unspecified date, after the vaccination (reported as one day prior to hospital admission), the patient experienced abdominal distention and tingling sensation of all extremities. On an unspecified date, the patient was hospitalized. The patient underwent physical examination which demonstrated diminished motor strength in all extremities and areflexia, with subsequent ataxia and generalized weakness. The patient also developed respiratory muscle weakness requiring endotracheal intubation. On an unspecified date, the patient underwent head computerised tomogram (CT) scan which was unremarkable and CSF analysis, which failed to reveal albuminocytologic dissociation or infectious process. The patient also underwent electromyography test, which was suggestive of acute demyelinating polyneuropathy. The patient was treated with intravenous immunoglobulins (IVIGs) for 5 days and there was a failure to wean from mechanical ventilation and tracheostomy was performed, along with a percutaneous endoscopic gastrostomy. Two courses of IVIGs and one course of plasmapheresis were administered which led to weaning of mechanical ventilation and improvement of motor function. On an unspecified date, the patient was discharged on physical rehabilitation. It was reported that, the only risk factor identified was the administration of influenza vaccine two weeks prior to admission. The outcome of the event was not reported. The reporter stated that, development of Guillain-Barré Syndrome (GBS) was a potential complication of the Influenza vaccine (causality: related). The reporter assessed the case as serious (hospitalization). Reporter's Comments: A 67-year-old, male patient with underlying conditions (hypertension, hyperlipidemia, emphysema) developed Guillain Barre syndrome, approximately 2 weeks after administration of INN Flu Vaccine. Considering the plausible temporal relationship between vaccination and reported event, plausible biological mechanism and lack of any underlying conditions or alternative more plausible causes, the company assessed the events as possibly related to suspect vaccine. The case meets level 4 of Brighton Collaboration criteria of diagnostic certainty. The company assessed this case as serious (medically significant).
Age: 67.0
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Mechanical ventilation, Paraesthesia, Plasmapheresis
Clinical narrative: This is a literature case, initially received on 08-Apr-2019, concerning a 67-year-old, elderly male patient. The purpose of the study was to recognize that, annually, one to two cases of GBS are reported per million of patients vaccinated with influenza. The patient's historical condition included unspecified gastroesophageal reflux disease (unspecified date). The patient's current condition included hypertension, hyperlipidemia, emphysema (since an unspecified date). On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (route of administration: intramuscular, dose, anatomical location, batch number, expiry date, trade name and manufacturer: not reported) for unknown indication. On an unspecified date, after the vaccination (reported as one day prior to hospital admission), the patient experienced abdominal distention and tingling sensation of all extremities. On an unspecified date, the patient was hospitalized. The patient underwent physical examination which demonstrated diminished motor strength in all extremities and areflexia, with subsequent ataxia and generalized weakness. The patient also developed respiratory muscle weakness requiring endotracheal intubation. On an unspecified date, the patient underwent head computerised tomogram (CT) scan which was unremarkable and CSF analysis, which failed to reveal albuminocytologic dissociation or infectious process. The patient also underwent electromyography test, which was suggestive of acute demyelinating polyneuropathy. The patient was treated with intravenous immunoglobulins (IVIGs) for 5 days and there was a failure to wean from mechanical ventilation and tracheostomy was performed, along with a percutaneous endoscopic gastrostomy. Two courses of IVIGs and one course of plasmapheresis were administered which led to weaning of mechanical ventilation and improvement of motor function. On an unspecified date, the patient was discharged on physical rehabilitation. It was reported that, the only risk factor identified was the administration of influenza vaccine two weeks prior to admission. The outcome of the event was not reported. The reporter stated that, development of Guillain-Barré Syndrome (GBS) was a potential complication of the Influenza vaccine (causality: related). The reporter assessed the case as serious (hospitalization). Reporter's Comments: A 67-year-old, male patient with underlying conditions (hypertension, hyperlipidemia, emphysema) developed Guillain Barre syndrome, approximately 2 weeks after administration of INN Flu Vaccine. Considering the plausible temporal relationship between vaccination and reported event, plausible biological mechanism and lack of any underlying conditions or alternative more plausible causes, the company assessed the events as possibly related to suspect vaccine. The case meets level 4 of Brighton Collaboration criteria of diagnostic certainty. The company assessed this case as serious (medically significant).
Age: 67.0
Sex: M
Vaccine: FLUX
Symptoms: Respiratory muscle weakness, Tracheostomy, Weaning failure
Clinical narrative: This is a literature case, initially received on 08-Apr-2019, concerning a 67-year-old, elderly male patient. The purpose of the study was to recognize that, annually, one to two cases of GBS are reported per million of patients vaccinated with influenza. The patient's historical condition included unspecified gastroesophageal reflux disease (unspecified date). The patient's current condition included hypertension, hyperlipidemia, emphysema (since an unspecified date). On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (route of administration: intramuscular, dose, anatomical location, batch number, expiry date, trade name and manufacturer: not reported) for unknown indication. On an unspecified date, after the vaccination (reported as one day prior to hospital admission), the patient experienced abdominal distention and tingling sensation of all extremities. On an unspecified date, the patient was hospitalized. The patient underwent physical examination which demonstrated diminished motor strength in all extremities and areflexia, with subsequent ataxia and generalized weakness. The patient also developed respiratory muscle weakness requiring endotracheal intubation. On an unspecified date, the patient underwent head computerised tomogram (CT) scan which was unremarkable and CSF analysis, which failed to reveal albuminocytologic dissociation or infectious process. The patient also underwent electromyography test, which was suggestive of acute demyelinating polyneuropathy. The patient was treated with intravenous immunoglobulins (IVIGs) for 5 days and there was a failure to wean from mechanical ventilation and tracheostomy was performed, along with a percutaneous endoscopic gastrostomy. Two courses of IVIGs and one course of plasmapheresis were administered which led to weaning of mechanical ventilation and improvement of motor function. On an unspecified date, the patient was discharged on physical rehabilitation. It was reported that, the only risk factor identified was the administration of influenza vaccine two weeks prior to admission. The outcome of the event was not reported. The reporter stated that, development of Guillain-Barré Syndrome (GBS) was a potential complication of the Influenza vaccine (causality: related). The reporter assessed the case as serious (hospitalization). Reporter's Comments: A 67-year-old, male patient with underlying conditions (hypertension, hyperlipidemia, emphysema) developed Guillain Barre syndrome, approximately 2 weeks after administration of INN Flu Vaccine. Considering the plausible temporal relationship between vaccination and reported event, plausible biological mechanism and lack of any underlying conditions or alternative more plausible causes, the company assessed the events as possibly related to suspect vaccine. The case meets level 4 of Brighton Collaboration criteria of diagnostic certainty. The company assessed this case as serious (medically significant).
Sex: F
Vaccine: FLU4
Symptoms: Foetal exposure during pregnancy, Jaundice neonatal
Clinical narrative: This is a serious spontaneous case, initially received from other non-health professional on 09-Apr-2019, concerning a female neonate patient. The patient's mother was a 25-years-old female of height 152.4 cm and body weight 64.399 kg. The patient's mother had 1 previous pregnancy with no still birth, miscarriage, birth defect or congenital anomaly. The last menstrual period (LMP) date of the patient's mother was 28-Apr-2018. The type of pregnancy was singleton. On 08-Oct-2018, at 13:50 hours, at gestational age of 23 weeks, the patient's mother received AFLURIA QUADRIVALENT [influenza vaccine, batch number: 02444611A, expiry date: 06-Jun-2018, dose, anatomical location and route of administration: not reported] for influenza prophylaxis and the fetus was exposed to AFLURIA QUADRIVALENT via transplacental route (explicitly coded as fetal exposure during pregnancy). There was no evidence of a defect or adverse event finding from a prenatal test. On 3 months and 11 days after vaccination, the patient's mother gave normal vaginal live birth to a female baby at 38.1 gestational week. The neonate (patient) weighed 3543.69 grams (reported as 7 lb 13 oz), body length was 52.07 cm (reported as 20.5 inches) and head circumference was 34.29 cm (reported as 13.5 inches). The reporter did not have the APGAR (appearance, pulse, grimace, activity, and respiration) scores at 1 minute, 5 minute and 10 minutes. There was no adverse pregnancy outcome, birth defect or congenital anomalies. It was reported that the patient was born very jaundice (as reported). The mother's estimated delivery date (EDD) was reported as 02-Feb-2019. The outcome of the event was not reported. This case is linked to 201804385 (mother case). Reporter's Comments: A female neonate experienced Jaundice neonatal, 3 months 11 days after administration of AFLURIA QUADRIVALENT administered to mother at gestational age of 23 weeks (explicitly coded as foetal exposure during pregnancy). Considering the implausible temporal relationship between vaccination and reported event (Jaundice neonatal), no evidence for a biological mechanism/investigation suggesting a causal role, the event was assessed as not related to the vaccination. The decision to administer a vaccine during pregnancy is related to medical decision making by the mother and her physician and is not related to any property of the medication. The event of foetal exposure during pregnancy was assessed as not related considering the intended use of the vaccine. This company assessed this case as serious (medically significant).
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Facial pain, Malaise, Pyrexia
Clinical narrative: Started with chills, fever, malaise the night of administration. At bedtime on night of administration patient had severe facial pain in the trigeminal nerve. Patient can't even touch face or lay down on pillow due to facial pain. Patient has been taking TYLENOL for pain and it is getting better every day.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Facial neuralgia, Influenza like illness, Pyrexia
Clinical narrative: Started with chills, fever, malaise the night of administration. At bedtime on night of administration patient had severe facial pain in the trigeminal nerve. Patient can't even touch face or lay down on pillow due to facial pain. Patient has been taking TYLENOL for pain and it is getting better every day.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Loss of consciousness, Paraesthesia
Clinical narrative: Patient passed out directly after being given the injection. She was placed on the floor to recover.  She came to fairly quickly and said she was experiencing tingling in her arms and legs. She was given a Coke and she said she was feeling better. She was sent to the Care Center because she already had a cough but no fever. She came back to the pharmacy after her visit and was given prednisone, ALLEGRA, and PROAIR due to her current illness.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Feeling abnormal, Headache, Insomnia, Lethargy
Clinical narrative: 36 plus hours of arm pain, bad headache, joint pain, muscle pain, lethargy, unable to sleep, just felt awful! My husband got his shot at the same time and he had the same symptoms except his arm hurt way more than mine. Note that our first SHINGRIX shots did not produce this severe reaction, just some mild soreness in the injection arm.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity
Clinical narrative: 36 plus hours of arm pain, bad headache, joint pain, muscle pain, lethargy, unable to sleep, just felt awful! My husband got his shot at the same time and he had the same symptoms except his arm hurt way more than mine. Note that our first SHINGRIX shots did not produce this severe reaction, just some mild soreness in the injection arm.
Age: 31.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Pt reported pain/limited range of motion in left arm after vaccine administration lasting for 3 months.
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: Electroencephalogram normal, Erythema, Feeding disorder, Gastrooesophageal reflux disease, Infantile back arching
Clinical narrative: Baby had perfect Apgar scores and was resting peacefully from birth to time of immunization. She was given her Hep B vaccine and we decided to try to rest. Approximately 1 hour later, patient woke up, was beat red screaming arching her back and vomiting. She has dealt with so much pain from reflux that we thought she was having seizures (EEG came back clear). At 17 mos old now, we finally have a diagnosis of long-term, incurable Mast Cell Activation Syndrome. She cannot eat any foods whatsoever and doesn't tolerate formula well. She vomits into her mouth hundreds of times a day and swallows back down.