chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 20-APR-2009, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and on an unknown date the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. The patient was treated for a blistering vesicular outbreak that was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 29-OCT-2014, the patient was inoculated with ZOSTAVAX at a medical group office as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unspecified date, the patient was treated by a physician from the same medical group for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was considered not resolved. Causality assessment was related. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 08-FEB-2019, the patient was vaccinated with an expired dose of PROQUAD lot # N021725 with expiration date of 06-FEB-2019, for prophylaxis (dose, route of administration, and anatomical location were not disclosed). No adverse effects events were reported.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Discomfort, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable pharmacist (patient). A 65-year-old female patient received PREVNAR 13, (lot number and expiration date unknown) via an unspecified route of administration in left upper arm on 09Jan2019 at about 9 or 10 in the morning at a single dose for immunization in the physician's office. Medical history included ongoing blood cholesterol from an unknown date. The patient had no previous vaccinations and family medical history. Concomitant medication included CENTRUM MULTIGUMMIES. On 11Jan2019, a couple days after vaccination, the patient had pain at the injection site and was not warned this could happen. She was very upset that she was not told to expect this. The patient called the doctor as she was not warned about the pain. She feels the doctors should warn patients to expect this and that the drug company should tell the doctors to tell the patients to expect pain. The patient had very severe pain and discomfort and was surprised as she had shots in the past with no problems. The patient also stated that the pain started a couple days later and is ongoing though it is better. The patient was treated with menthol cream. When the patient called the doctor, they told her that maybe she shouldn't get the pneumonia injections; that is ridiculous and she is going to call them about that to. The patient was recovering from pain at the injection site. The following information on the batch number has been requested.
Age: 46.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Asthenia, Blood test, Cardiac function test, Dizziness, Hypertension
Clinical narrative: HIGH BLOOD PRESSURE, DIZZY, PARTIAL PARALYZATION, WEAK.
Age: 46.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Paralysis, Ultrasound scan, Ultrasound skull
Clinical narrative: HIGH BLOOD PRESSURE, DIZZY, PARTIAL PARALYZATION, WEAK.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Diarrhoea, Erythema, Headache, Injection site pain
Clinical narrative: PATIENT STATE SYMPTOMS DID NOT START RIGHT AWAY. HAPPENED A DAY OR SO AFTER SHOT. REDNESS HAS BECOME WORSE OVER THE DAYS, MOVING DOWN HIS ARM, TO HALFWAY BETWEEN HIS ELBOW AND SHOULDER. PATIENT STATES SITE IS VERY SORE, LYMPH NODES UNDER LEFT ARM SORE. DOES FEEL WEAK. STATES DID HAVE DIARRHEA AND SEVERE HEADACHE ON 2/9/19. STATED SITE WAS SO HOT LAST NIGHT COULD NOT SLEEP WELL. THIS RN CONSULT WITH IMMUNIZATION NURSE. DECISION TO INSTRUCT TO SEE DOCTOR IF STARTED TO RUN A FEVER OR HEADACHES BECAME SEVERE. PATIENT HAS ALREADY BEEN DOING TYLENOL/IBUPROFEN, ICE. TEMP 97.5 F IN CLINIC. HEART RATE 100. 94% OXYGEN. 124/88 BLOOD PRESSURE.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site warmth, Lymph node pain, Poor quality sleep
Clinical narrative: PATIENT STATE SYMPTOMS DID NOT START RIGHT AWAY. HAPPENED A DAY OR SO AFTER SHOT. REDNESS HAS BECOME WORSE OVER THE DAYS, MOVING DOWN HIS ARM, TO HALFWAY BETWEEN HIS ELBOW AND SHOULDER. PATIENT STATES SITE IS VERY SORE, LYMPH NODES UNDER LEFT ARM SORE. DOES FEEL WEAK. STATES DID HAVE DIARRHEA AND SEVERE HEADACHE ON 2/9/19. STATED SITE WAS SO HOT LAST NIGHT COULD NOT SLEEP WELL. THIS RN CONSULT WITH IMMUNIZATION NURSE. DECISION TO INSTRUCT TO SEE DOCTOR IF STARTED TO RUN A FEVER OR HEADACHES BECAME SEVERE. PATIENT HAS ALREADY BEEN DOING TYLENOL/IBUPROFEN, ICE. TEMP 97.5 F IN CLINIC. HEART RATE 100. 94% OXYGEN. 124/88 BLOOD PRESSURE.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site reaction, Middle insomnia, Muscle fatigue
Clinical narrative: Following the injection there was no immediate reaction. Approximately two days later, middle of the night woke up in severe pain and immobility of right shoulder joint. Over the course of two to three weeks the severe pain subsided, but still experienced significant muscle aches, cramping, and fatigue in the right shoulder to present.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Muscle spasms, X-ray normal
Clinical narrative: Following the injection there was no immediate reaction. Approximately two days later, middle of the night woke up in severe pain and immobility of right shoulder joint. Over the course of two to three weeks the severe pain subsided, but still experienced significant muscle aches, cramping, and fatigue in the right shoulder to present.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity, Rash
Clinical narrative: Exact date when reaction started is unknown. Patient states he has a rash/pain in arm after receiving flu shot. The pain is radiating down his arm. He has had torn rotator cuff before, so he is not sure if the pain after flu shot is just coincidence or if the pain/reaction is specifically related to the flu shot.
Age: 19.0
Sex: M
Vaccine: ADEN_4_7, FLUC4, HEPAB, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Guillain-Barre syndrome
Clinical narrative: The pt is a 19 yo previously healthy male who developed GBS as a new accession with symptom onset in week 1 BCT. His immunization record states he received 7 vaccines on 15 OCT, 2018 including adenovirus, MMR, varicella, TWINRIX, IPV, Meningococcal & Tdap. However, the nursing documentation states he also received FLUCELVAX but not IPV & meningococcal in the same note.  Causality assessment is been requested for determination of potential for vaccine relationship.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Chest pain, Pain in extremity
Clinical narrative: Patient reported having chest pain and tightness along with pain in LEFT arm (opposite from vaccine site). Started "later" that night and unrelieved with standard angina medications and at home protocol.  Hospital admission to rule out heart attack (previous heart attack 7 years ago, with no other cardiac episodes since per patient).
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Dyspnoea, Eye movement disorder, Feeling cold, Injection site haemorrhage, Tremor
Clinical narrative: When vaccine given LD there was an actual spurting as if arterial of blood, lasting almost two seconds. The blood shot out an inch and a half away from pt's skin. He then became very shaky, gasping, eyes rolling. He has a fear of blood. He laid down and felt cold and shaky, while simultaneously laughing at the blood event. He did recover after about ten minutes. He has some psychiatric Dx and he almost looked like he was about to have a non epileptic seizure but he didn't lose consciousness.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Skin warm
Clinical narrative: Patient arrived at the pharmacy at 5:20pm on 02/11/2019 to report with a 4 inch diameter circle of inflammation and redness that emitted heat. Patient stated she noticed the reaction the morning of 02/09/2019. Patient stated the size of the reaction had continued to grow. Patient was advised to contact PCP for possible treatment and planned to see provider on 02/12/2019.
Age: 34.0
Sex: M
Vaccine: TYP
Symptoms: Underdose
Clinical narrative: Pt informed me that he was home took his dose like instructed. Then went to the bathroom when he notice he had passed a whole capsule. He then finished the remainder of the pills and informed the office. At which time we contacted PaxVax, that told us they would send a replacement pack to us for the pt to take again. We have advised the pt he will need to repeat the VIVOTIF pack again.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13, RV5
Symptoms: Dyskinesia, Middle insomnia
Clinical narrative: Night after received shots (PEDIARIX, Hib, PCV13, flu, Rota), developed rhythmic jerking spells for 3-5 min happened 2-3 times first night, then once during nap and next night again. Would jolt a few times then stop, then start again for 3-5 min. stopped after 5 or so episodes. Jerk awoke pt from sleep. No video made but progressively worse through episode. Whole body jerking while asleep, then maybe an arm or leg when awoke. No fever documented but higher than nml per mother. No vomiting. No FH sz disorder or developmental delays.
Age: 28.0
Sex: F
Vaccine: SMALL
Symptoms: Anxiety, Chest pain, Dyspnoea, Echocardiogram, Intensive care
Clinical narrative: Thursday night patient reports some heart palpitations and some mild chest pain (1/10). Patient reports same symptoms on Friday, but increasing frequency. On Saturday morning the patient reports chest pain and palpitations woke her up from sleep at 0530 and describes the duration and frequency increased to almost constant. The patient reports shortness of breath and some increasing anxiety due to her symptoms. The patient tried calling for a referral to visit the Emergency Room because she was afraid of receiving a bill for an ED visit without a consult. The patient could not get a referral, so her spouse drove her back home and presented to the Community Hospital ED for evaluation. The patient's spouse communicated with her office en route to hospital. ED evaluated the patient and transferred her to a facility for specialty evaluation (Cardiology). The patient was admitted to the ICU at Regional Hospital for 3 days; she had an echocardiogram and was started on 25mg daily Metoprolol and 100 mg BID Flecainide. The patient was discharged to outpatient care on  4FEB19 and followed-up with her PCM on 5FEB19. The patient has follow-up with the cardiologist, Dr. 1 week post-discharge. I was notified of the patient's symptoms and inpatient admission on 05FEB19 after follow-up with her doc, PA-C. On 06FEB19, I contacted the DHA Immunization Healthcare Support Center and spoke with MSN, ANP-BC, CRNP-Adult Nurse Practitioner, regarding the patient's case and concern for the possible relationship to the smallpox vaccination the patient received on 30JAN19. On 07FEB19, the patient returned to the Primary Care Clinic for a "take check" of her smallpox site and hand-carried her inpatient records. They are uploaded into her electronic medical record. The patient is expected to bring her echocardiogram results to hospital for uploading into her chart once they are available.
Age: 28.0
Sex: F
Vaccine: SMALL
Symptoms: Palpitations, Sleep disorder
Clinical narrative: Thursday night patient reports some heart palpitations and some mild chest pain (1/10). Patient reports same symptoms on Friday, but increasing frequency. On Saturday morning the patient reports chest pain and palpitations woke her up from sleep at 0530 and describes the duration and frequency increased to almost constant. The patient reports shortness of breath and some increasing anxiety due to her symptoms. The patient tried calling for a referral to visit the Emergency Room because she was afraid of receiving a bill for an ED visit without a consult. The patient could not get a referral, so her spouse drove her back home and presented to the Community Hospital ED for evaluation. The patient's spouse communicated with her office en route to hospital. ED evaluated the patient and transferred her to a facility for specialty evaluation (Cardiology). The patient was admitted to the ICU at Regional Hospital for 3 days; she had an echocardiogram and was started on 25mg daily Metoprolol and 100 mg BID Flecainide. The patient was discharged to outpatient care on  4FEB19 and followed-up with her PCM on 5FEB19. The patient has follow-up with the cardiologist, Dr. 1 week post-discharge. I was notified of the patient's symptoms and inpatient admission on 05FEB19 after follow-up with her doc, PA-C. On 06FEB19, I contacted the DHA Immunization Healthcare Support Center and spoke with MSN, ANP-BC, CRNP-Adult Nurse Practitioner, regarding the patient's case and concern for the possible relationship to the smallpox vaccination the patient received on 30JAN19. On 07FEB19, the patient returned to the Primary Care Clinic for a "take check" of her smallpox site and hand-carried her inpatient records. They are uploaded into her electronic medical record. The patient is expected to bring her echocardiogram results to hospital for uploading into her chart once they are available.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Erythema, Headache, Immediate post-injection reaction
Clinical narrative: Soreness and redness L. arm - immediately. Headache, Painful joints, Uncontrollable shivering, Chills, Fever.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Soreness and redness L. arm - immediately. Headache, Painful joints, Uncontrollable shivering, Chills, Fever.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: The patient spoke to us on the phone today and stated that she still has slight soreness in the arm that the vaccine was administered to. She states that it is not painful but that when she moves it a certain way she does feel some soreness.
Age: 16.0
Sex: F
Vaccine: JEV1
Symptoms: Acupuncture, Allergy test negative, Bipolar II disorder, Blood test normal, Borrelia test negative
Clinical narrative: Within one month of receiving the vaccine, I began to have chronic headaches accompanied by dizziness (vertigo), as well as depression. These symptoms have remained chronic until the present, nearly seven years. I have tried many different treatments, including migraine medications (rizatriptan, topamax, beta blockers), supplements, psychiatric medications, Botox, acupuncture, chiropractic, massage, craniosacral, amino neurofrequency, and NSAIDs with limited success. My diagnoses are chronic migraine, new daily persistent headache or chronic daily headache, bipolar II and fibromyalgia. These conditions have caused significant and permanent disability.
Age: 16.0
Sex: F
Vaccine: JEV1
Symptoms: Chiropractic, Depression, Dizziness, Fibromyalgia, Headache
Clinical narrative: Within one month of receiving the vaccine, I began to have chronic headaches accompanied by dizziness (vertigo), as well as depression. These symptoms have remained chronic until the present, nearly seven years. I have tried many different treatments, including migraine medications (rizatriptan, topamax, beta blockers), supplements, psychiatric medications, Botox, acupuncture, chiropractic, massage, craniosacral, amino neurofrequency, and NSAIDs with limited success. My diagnoses are chronic migraine, new daily persistent headache or chronic daily headache, bipolar II and fibromyalgia. These conditions have caused significant and permanent disability.
Age: 16.0
Sex: F
Vaccine: JEV1
Symptoms: Migraine, New daily persistent headache, Nuclear magnetic resonance imaging normal, Sleep study normal, Vertigo
Clinical narrative: Within one month of receiving the vaccine, I began to have chronic headaches accompanied by dizziness (vertigo), as well as depression. These symptoms have remained chronic until the present, nearly seven years. I have tried many different treatments, including migraine medications (rizatriptan, topamax, beta blockers), supplements, psychiatric medications, Botox, acupuncture, chiropractic, massage, craniosacral, amino neurofrequency, and NSAIDs with limited success. My diagnoses are chronic migraine, new daily persistent headache or chronic daily headache, bipolar II and fibromyalgia. These conditions have caused significant and permanent disability.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: After a week after his vaccine was administered, the patient came into the pharmacy and said his shoulder hurt really bad. I asked patient to see his physician as I wasn't sure if the vaccine caused his pain or whether it might have been caused by something else. He thinks his vaccine was given high on the arm compared to other shots he had in the past. Patient still has pain in his shoulder.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Influenza like illness, Pain, Pyrexia
Clinical narrative: Aching all over, mild fever. Stayed home all day long. Flu like symptoms. Pt never had flu. Felt awful.
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, X-ray
Clinical narrative: Pain/Sharp pain AC area in left arm.
Age: 47.0
Sex: M
Vaccine: TDAP
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient complains of soreness in the upper arm. Deep ache. Constant dull pain.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Lymphadenitis, Musculoskeletal pain, Neck pain
Clinical narrative: Patient came to the pharmacy on 2/11 at around 5 pm and said that yesterday at around 9 pm she started to get bad pain around the shoulder and neck. She also reported chills and said that her lymph nodes were significantly inflamed. She was visibly in pain at the pharmacy on 2/11 when she reported the pain. Her doctor told her to put ice on it and take ibuprofen and if there is no improvement to come in for an appointment in a couple of days. Muscle pain after a vaccine is a common side effect but this was significantly worse. I am not sure if she had an allergic reaction of some sort to the vaccine.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth, Rash
Clinical narrative: Patient came into pharmacy on 2/11/2019 around noon. Her left arm 2 inches above her elbow was red and warm to the touch. The patient did not complain of pain or discomfort. She said the rash appeared the next day after the immunization and appeared to expand the following day.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13
Symptoms: Blood test, Electroencephalogram, Generalised tonic-clonic seizure, Influenza, Nuclear magnetic resonance imaging
Clinical narrative: Within 24-hours of receiving these vaccinations, my daughter had her first grand-mal seizure and absence seizure. Her medical staff tried to say it was a febrile seizure; however, she has had the flu, with a fever, documented prior to this, and she never had any seizures then. Over the last 2+ years, we have tried every seizure medication with no seizure control what-so-ever. My daughter has over 1,230 reported seizures a day, according to her most recent EEG three weeks ago. It wasn't until recently, a Dr. suggested a water pill to help relieve possibly water off her brain, which can be caused by the MMR vaccination.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13
Symptoms: Petit mal epilepsy, Pyrexia
Clinical narrative: Within 24-hours of receiving these vaccinations, my daughter had her first grand-mal seizure and absence seizure. Her medical staff tried to say it was a febrile seizure; however, she has had the flu, with a fever, documented prior to this, and she never had any seizures then. Over the last 2+ years, we have tried every seizure medication with no seizure control what-so-ever. My daughter has over 1,230 reported seizures a day, according to her most recent EEG three weeks ago. It wasn't until recently, a Dr. suggested a water pill to help relieve possibly water off her brain, which can be caused by the MMR vaccination.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient's arm became swollen and red at injection site. Monitored in the office for 15 minutes at which time swelling lessened. FNP checked arm and advised patient's father to go home and give BENADRYL. He was also advised to call our office tomorrow if any sign of redness or swelling returns.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Blindness transient, Crying, Dizziness
Clinical narrative: Patient received Tdap vaccine on 1/18/19 at about 2:20 pm. That same evening at 6:50 she was taking a shower and was feeling a bit lightheaded so I stayed in the room with her. She started crying b/c "everything went black" so I grabbed her and helped lower her to the floor. She was extremely dizzy for about 15 minutes but only temporarily was unable to see. There was no injury since I was with her in the room when this occurred.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Dizziness, Injected limb mobility decreased, Injection site pain, Injection site warmth
Clinical narrative: Per pt: sore and achy from elbow up, unable to move arm, hot at injection site, has had chills and been dizzy today. Has taken 2 doses of naproxen without relief.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Autoimmune disorder, Biopsy skin, Erythema, Peripheral swelling, Rash
Clinical narrative: Patient began getting swollen cuticles on fingers. Became red and irritated - looked like a fungal infection. She then got a slightly raised, red rash on her upper arms that began to extend across her breasts. The rash is not itchy and is still there - it has spread to her upper thighs then down her legs. Today, 2/11/19.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Skin irritation
Clinical narrative: Patient began getting swollen cuticles on fingers. Became red and irritated - looked like a fungal infection. She then got a slightly raised, red rash on her upper arms that began to extend across her breasts. The rash is not itchy and is still there - it has spread to her upper thighs then down her legs. Today, 2/11/19.
Age: 1.08
Sex: M
Vaccine: DTAP, FLU4, HEPA, HIBV, MMRV, PNC13
Symptoms: Electroencephalogram, Staring, Tremor, Unresponsive to stimuli
Clinical narrative: 13 mo M with possible seizure (staring, unresponsiveness, and head and L hand shaking every 30 seconds, currently undergoing  further evaluation) 2 days after receiving vaccines, had fever and URI sx concurrently but no known fever at the time of the possible seizure. Episode lasted approximately 15 minutes and resolved spontaneously. Patient taken to ED after episode.
Age: 1.0
Sex: M
Vaccine: HEPA, IPV, MMR, PNC13
Symptoms: Cough, Croup infectious, Decreased appetite, Irritability, Otitis media
Clinical narrative: High fever lasting 3 days. Extreme irritability, loss of appetite, otitis media, croup like cough.
Age: 1.0
Sex: M
Vaccine: HEPA, IPV, MMR, PNC13
Symptoms: Pyrexia
Clinical narrative: High fever lasting 3 days. Extreme irritability, loss of appetite, otitis media, croup like cough.
Age: 31.0
Sex: M
Vaccine: MNQ
Symptoms: Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: PATIENT FAINTED IMMEDIATELY AFTER BEING ADMINISTERED THE VACCINE. HE WAS UNCONSCIOUS FOR ABOUT 10-15 SECONDS AND THEN REGAINED CONSCIOUSNESS. HE FELT FINE WITHIN A FEW MINUTES AFTER AND PARAMEDICS DETERMINED HIM TO BE IN GOOD HEALTH THEREAFTER. HE DENIED FURTHER TREATMENT AND CHOSE TO GO HOME.
Age: 1.25
Sex: M
Vaccine: PNC13
Symptoms: Aphasia
Clinical narrative: Son stopped talking. He has been getting speech therapy 2x a week since 8/2017. He still cannot speak correctly and is starting special education pre k.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient presented with large egg sized hives on upper arms that then migrated to across her chest and down her thighs. The hives then began on her face. They were extremely itchy in nature. She failed on BENADRYL and went to urgent care where she received a prednisone taper.
Age: 64.0
Sex: M
Vaccine: HEPAB, TYP
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood bilirubin increased, Chills, Chromaturia
Clinical narrative: Fever, chills, dark urine, jaundice, headache, body aches, severe fatigue. Took Tylenol and 3 days of prednisone from Urgent Care on 1/29/2019. Was swabbed for flu , negative. Still felt sick, went to Dr.'s office on 2/1/2019. She indicated the gall bladder had to be removed. Was admitted to Hospital. On 2/2/2019 - GI doctor indicated Gall Bladder did not have to be removed as patient not in pain.
Age: 64.0
Sex: M
Vaccine: HEPAB, TYP
Symptoms: Fatigue, Gallbladder disorder, Headache, Hepatic enzyme increased, Influenza virus test negative
Clinical narrative: Fever, chills, dark urine, jaundice, headache, body aches, severe fatigue. Took Tylenol and 3 days of prednisone from Urgent Care on 1/29/2019. Was swabbed for flu , negative. Still felt sick, went to Dr.'s office on 2/1/2019. She indicated the gall bladder had to be removed. Was admitted to Hospital. On 2/2/2019 - GI doctor indicated Gall Bladder did not have to be removed as patient not in pain.
Age: 64.0
Sex: M
Vaccine: HEPAB, TYP
Symptoms: Jaundice, Malaise, Pain, Pyrexia
Clinical narrative: Fever, chills, dark urine, jaundice, headache, body aches, severe fatigue. Took Tylenol and 3 days of prednisone from Urgent Care on 1/29/2019. Was swabbed for flu , negative. Still felt sick, went to Dr.'s office on 2/1/2019. She indicated the gall bladder had to be removed. Was admitted to Hospital. On 2/2/2019 - GI doctor indicated Gall Bladder did not have to be removed as patient not in pain.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, tenderness and erythema of the injection site extending throughout the entire thigh up to the groin and extending down toward and including the level of the calf. This lasted for 7 days.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site haemorrhage, Injection site urticaria
Clinical narrative: Patient experienced excessive bleeding at the site of injection. Blood began to pool under the inject safe barrier bandage, went get another bandage, and blood was coming from around the bandage. Pulled off the bandage and began cleaning around injection site and seen a small whelp. Bleeding  stopped. Applied small amount of pressure at the site, whelp went down.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Peripheral swelling
Clinical narrative: Erythema, swelling, tenderness of the injection site and then entire arm from shoulder down to the fingers. Swelling to size of double the arm size in diameter.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Tenderness
Clinical narrative: Erythema, swelling, tenderness of the injection site and then entire arm from shoulder down to the fingers. Swelling to size of double the arm size in diameter.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient said they had pain in their arm, and they couldn't lift it for two days. Today when the patient was contacted later in the day for the follow up. They said their arm is little bit better.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Full blood count normal, Injection site erythema, Injection site warmth, Metabolic function test normal, Rash erythematous
Clinical narrative: Erythematous rash on trunk and arms, groin, buttocks, upper legs. No pruritic. At injection site. 6x4cm raised, warm, erythematous patch, Onset 3 days after vaccination. Given steroids PRN as antihistamines ineffective.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Hypoaesthesia, Muscle spasms, Muscular weakness
Clinical narrative: (L) arm numbness down to fingers, difficulty walking, bilateral leg numbness, cramping urinary incontinence. (L) shoulder, arms very weak, weakness, tired. Symptoms lasting 2-3 days.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Urinary incontinence
Clinical narrative: (L) arm numbness down to fingers, difficulty walking, bilateral leg numbness, cramping urinary incontinence. (L) shoulder, arms very weak, weakness, tired. Symptoms lasting 2-3 days.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling and erythema/warmth to injection site. Patient is retired RN and described this as "severe" - she had to ice her arm.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Cough, Pyrexia, Serum sickness, Syncope, Wheezing
Clinical narrative: Fever, cough, wheeze, syncope and serum sickness. Prednisone 60 mg every day and taper as directed.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: Fever and skin rash.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Myalgia
Clinical narrative: Myalgia and redness and tenderness in left deltoid.
Age: 71.0
Sex: M
Vaccine: FLUA3
Symptoms: Erythema, Injection site rash, Pruritus
Clinical narrative: Patient presented to the clinic 7 days after vaccination. Nursing notes, arm red, itchy started 2 days after receiving vaccination. Rash localized to the arm where he receiving the injection.
Age: 46.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Patient reports redness, swelling, and pain at injection site approximately 5 hours after receiving pneumococcal injection. Fever, chills - uncontrollable, night sweats. Myalgias still on day 3. Redness, swelling, severe pain at injection site still on day 3.
Age: 46.0
Sex: M
Vaccine: PPV
Symptoms: Night sweats, Pyrexia
Clinical narrative: Patient reports redness, swelling, and pain at injection site approximately 5 hours after receiving pneumococcal injection. Fever, chills - uncontrollable, night sweats. Myalgias still on day 3. Redness, swelling, severe pain at injection site still on day 3.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Full blood count, Headache, Metabolic function test
Clinical narrative: Patient's mother updated PPA by phone on 2/1/19 that patient had had a headache since about an hour after receiving the Men B #2 vaccine. She had also gone to the ER for this, who had sent her home with supportive care. We directed her to follow up with her neurologist, who apparently felt the headache is related to the MenB. She is apparently not taking the ibuprofen/acetaminophen as per neuro because she is concerned for stomach upset.
Age: 67.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Lip swelling
Clinical narrative: Lips swollen profusely.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Rash
Clinical narrative: Around the end of September or first of October had a itch (bad-breakout) on left back just above waistband. Finally cleared up then around first of December broke out in rash (itching) and (hurting) on left side in front. Still itching and hurting.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Eye irritation, Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: 12-15-2018 woke up with both shoulders painful, both elbows painful,. Both wrists and fingers very painful. Hard to move fingers. Both eyes felt they were on fire. This situation lasted for about a 24 Hr. period.
Age: 1.33
Sex: F
Vaccine: FLU4, MMR, VARCEL
Symptoms: Blood culture negative, Culture throat negative, Culture urine negative, Febrile convulsion, Full blood count normal
Clinical narrative: 17 mo who developed fever, LAOM and acute tinnitus. Febrile seizure with onset of fever.
Age: 1.33
Sex: F
Vaccine: FLU4, MMR, VARCEL
Symptoms: Otitis media acute, Pyrexia, Tinnitus
Clinical narrative: 17 mo who developed fever, LAOM and acute tinnitus. Febrile seizure with onset of fever.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash erythematous
Clinical narrative: Patient said he started to have small red dots from mouth and neck down to back and went to see a dermatologist who diagnosed it as being shingles.
Age: 81.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt received both FLUZONE QUAD and PREVNAR 13 in left deltoid 2-7-19. Patient says never reacted to flu shot in past so thinks might be PREVNAR 13. Area below injection site became pink, swollen, and warm 2 days after receiving shot (was not yet swollen when received SHINGRIX the day after, in apposite arm) was able to golf and was not concerned enough to call/see MD. It is "going down" and improving. No injection site pain or swelling.
Sex: M
Vaccine: VARZOS
Symptoms: Intensive care, Lyme disease
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of lyme disease in a 81-year-old male patient who received SHINGRIX for prophylaxis.  On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced lyme disease (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the lyme disease was unknown. It was unknown if the reporter considered the lyme disease to be related to SHINGRIX. Additional details were received as follows: This case was received from Veterinarian. The age at vaccination was not reported, but it could be 80 or 81 year. Veterinarian reported that the father of a friend was in the hospital and ICU for a week after getting SHINGRIX vaccine. The reporter thought that around September 2018. The patient was diagnosed with Lyme disease shortly afterwards.
Sex: U
Vaccine: RV5, RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding patient's pertinent medical history, drug reactions, allergies and concomitant medications was provided. On 05-FEB-2019, the patient was inadvertently vaccinated with expired dose of ROTATEQ, orally, (lot # N011648, expiration date: 01-DEC-2018), (dose was not reported), for prophylaxis. There was no adverse event reported.
Age: 74.0
Sex: F
Vaccine: UNK
Symptoms: Herpes zoster
Clinical narrative: Patient has experienced a shingles outbreak. This is the 3rd day.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid spontaneous report was received from a nurse prescriber concerning an unspecified number of patients of unknown age and gender. The patients' historical conditions, concurrent conditions, concomitant therapies, historical drugs or allergies, and concomitant therapies were not reported. On an unspecified date, the patients were vaccinated with an unknown number of improperly stored doses of RECOMBIVAX HB (Thimerosal free) reported lot number R006746, expiration date: 09-NOV-2020 (strength, dose, frequency and route of administration were not reported) for prophylaxis. The administered doses of the vaccine, experienced a temperature excursion below 32 Fahrenheit (F) degrees (29. 5 F) for 11 hours, and 32 Fahrenheit degrees up to 35 Fahrenheit degrees (33.4 F) for 8 hours as recorded by a data logger. The vaccine had not had any previous temperature excursions. There was no adverse effect reported. No product quality complaint was filed.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Extra dose administered, Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 66 years old female patient. The patient's concurrent condition included high blood pressure. The patient's concomitant therapy included unspecified high blood pressure medication. The patient had no drug allergies. In December 2017, the patient was vaccinated with the first dose of PNEUMOVAX 23 (strength, dose, lot # and expiration date were not reported) intramuscularly for prophylaxis. On 22-JAN-2019 (reported as "about a week ago") the patient was vaccinated with the second dose of PNEUMOVAX 23 lot # R000692, expiration date 09-SEP-2019, intramuscularly for prophylaxis. On 28-JAN-2019, the patient returned to the pharmacy and reported that since receiving the second dose of PNEUMOVAX 23 she experienced soreness in the vaccinated arm. No treatment was given to the event. No lab diagnostics and studies were performed. The outcome of the event was unknown. The causality between the event and the suspect vaccine was not reported.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent condutions, drug reactions, allergies and concomitant medications were not reported. On 29-JAN-2018, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported). On 30-JAN-2019, the patient was vaccinated with the second dose of GARDASIL 9, longer than the recommended scheduling (inappropriate schedule of product administration). No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Rash generalised, Visual impairment
Clinical narrative: This initial spontaneous report was received from a female patient of unspecified age referring to herself. The patient did not wish to provide information regarding her medical history, concurrent conditions, drug allergies/reactions, or concomitant medications. On 14-SEP-2018, the patient was given ZOSTAVAX 0.65 ml once (route and lot # not provided). On an unspecified date since receiving the vaccine (reported as "since then"), she developed vision problems, dizziness and she is "all broke out on [her] face and body and [her] face looks a mess. The patient saw a physician for the events. Causality assessment was not provided. The patient asked if there were treatment recommendations for the events (based on this, the outcome of the events were considered not resolved). When she was directed to her doctor, she mentioned that she may contact a lawyer. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Diarrhoea, Dyspnoea, Nausea
Clinical narrative: This spontaneous report was received from a physician referring to a male patient (currently 59-year-old). The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, lot # and expiry date were not reported) for prophylaxis. On an unknown date, the patient experienced shortness of breath, nausea and diarrhea. The outcome of dyspnoea, nausea and diarrhoea was unknown. The reporter considered dyspnea, nausea and diarrhea to be related to PNEUMOVAX 23. This case was linked to the case#1902USA004040 (same patient and reporter). Sender's Comments: US-009507513-1902USA004040.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypersensitivity, Injection site pain, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report was received from a consumer via Pfizer regarding a female patient of unknown age. Information on pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23, 25 mcg/0.5 ml, for prophylaxis. On an unknown date, the patient had an allergic reaction to PNEUMOVAX 23. Ended up in ER. Her face turned bright red and puffy (It was also reported that she did not believe her face was puffy). The patient experienced puffiness in vaccinated arm, which went down to her elbow. She clarified the puffiness was only in her arm, explained her arm blew up, it was so fat and hurting. She had a topical cream from what her urgent care doctor gave her. The injection site was very tender. Her arm was tomato red and was crawling down her arm. The reporter wanted to know the difference between PNEUMOVAX 23 and PREVNAR 13. Outcome of the events were not reported. Causality of the events was related to PNEUMOVAX 23.
Sex: F
Vaccine: PPV
Symptoms: Swelling face
Clinical narrative: This spontaneous report was received from a consumer via Pfizer regarding a female patient of unknown age. Information on pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23, 25 mcg/0.5 ml, for prophylaxis. On an unknown date, the patient had an allergic reaction to PNEUMOVAX 23. Ended up in ER. Her face turned bright red and puffy (It was also reported that she did not believe her face was puffy). The patient experienced puffiness in vaccinated arm, which went down to her elbow. She clarified the puffiness was only in her arm, explained her arm blew up, it was so fat and hurting. She had a topical cream from what her urgent care doctor gave her. The injection site was very tender. Her arm was tomato red and was crawling down her arm. The reporter wanted to know the difference between PNEUMOVAX 23 and PREVNAR 13. Outcome of the events were not reported. Causality of the events was related to PNEUMOVAX 23.
Sex: F
Vaccine: HPV9
Symptoms: Cervical dysplasia, Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: This spontaneous report was received from a pharmacist referring to her daughter of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date, the patient was vaccinated with GARDASIL 9 (dosage, frequency, strength, lot number and expiration were not reported) for prophylaxis additionally, was reported that she completed the treatment. On an unknown date, the patient had a pap test performed on an unspecified date which resulted in the following> hpv high risk DNS non 16/18 alpha abnormal low grade intraepithelial lesion (Human papilloma virus infection).  The patient was scheduled to have a colposcopy on 08-FEB-2019.  The outcome of human papilloma virus infection was unknown. The causality between the event and the therapy with GARDASIL 9 was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular, Varicella zoster pneumonia
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 30-MAY-2017, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), by a physician at a medical center, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and on an unknown date the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. The patient was treated for a blistering vesicular outbreak that was diagnosed as severe varicella pneumonia. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered  painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was considered to be not recovered. Upon internal review, severe varicella pneumonia was determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concomitant medication included sterile diluent. The patient's pertinent medical history, drug reactions and allergies were not reported. On 07-FEB-2019, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX lot # N025701, expiry date 16-DEC-2018 (strength, dose, route and site of administration were not provided) for prophylaxis. No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Blindness unilateral, Ophthalmic herpes zoster
Clinical narrative: This initial spontaneous report was received from an approximately 79 year old male patient referring to himself. Medical history, concurrent conditions, and concomitant medications were unknown. The patient had no drug reactions/allergies. In 2017, the patient received an unspecified shingles vaccine and sterile diluent (manufacturer not specified; dose, route, and lot #'s not reported). On an unspecified date, he developed shingles in his right eye resulting in a loss of vision in the eye. The patient saw an Optometrist for the event and received unspecified treatment. The patient was not hospitalized. No labs or diagnostic studies were performed. The event was not resolved. Causality assessment was not provided. The patient requested compensation for his inconvenience. Upon internal review, shingles in his right eye resulting in a loss of vision in the eye was considered to be medically significant. Additional information has been requested.