chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Nausea
Clinical narrative: Shivering/Chills; Severe headache; Pain at injection site; Low grade fever (100.1); Nausea; Fatigue.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Shivering/Chills; Severe headache; Pain at injection site; Low grade fever (100.1); Nausea; Fatigue.
Age: 13.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Altered state of consciousness, Flushing, Posture abnormal, Tremor
Clinical narrative: Patient's head slumped forward to chest and appeared to almost lose consciousness. Both hands appeared to lightly shake. I estimate this occurred for 30 seconds. Patient then lifted head and was responsive but her face was flushed. She denied having trouble swallowing. She agreed to water and drank two cups. She agreed to a piece of chocolate, in case she was hypoglycemic. After sitting for about 15 minutes, she felt ok to walk and left store with mother.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Diarrhoea, Headache, Malaise, Pain
Clinical narrative: Fever, aches and joint pain, headache, diarrhea, vomiting  - for 2-3 days, general malaise - 1 week.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever, aches and joint pain, headache, diarrhea, vomiting  - for 2-3 days, general malaise - 1 week.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Feeling abnormal, Mobility decreased, Pain in extremity
Clinical narrative: A very severe arm ache. Could not move arm for 24 hours. Could finally lay on it on the 4th day. It felt like my arm had been sawed in half by a chain saw!
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Influenza like illness, Injection site pain, Insomnia
Clinical narrative: Mild headache and right arm discomfort starting 1 hr after shot which gradually increased to significant whole arm pain. At 9 hrs past injection I had strong miserable flu like symptoms which interfered with sleep which lasted a couple hours. By hour 18 I was still feeling sick and sluggish. By 24 hrs flu symptoms were gone but my deltoid still felt punched. At 48 hrs my deltoid is still sore to touch. I never had redness near the injection site. I considered taking TYLENOL but never did. I did not take my normal vitamins on 2/16 because I felt lousy.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Limb discomfort, Malaise, Pain in extremity, Sluggishness
Clinical narrative: Mild headache and right arm discomfort starting 1 hr after shot which gradually increased to significant whole arm pain. At 9 hrs past injection I had strong miserable flu like symptoms which interfered with sleep which lasted a couple hours. By hour 18 I was still feeling sick and sluggish. By 24 hrs flu symptoms were gone but my deltoid still felt punched. At 48 hrs my deltoid is still sore to touch. I never had redness near the injection site. I considered taking TYLENOL but never did. I did not take my normal vitamins on 2/16 because I felt lousy.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Malaise, Pyrexia
Clinical narrative: Patient complained of feeling sick, swelling and redness at injection site, and a mild fever.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Shoulder injury related to vaccine administration
Clinical narrative: SIRVA. Right shoulder pain since vaccine administration.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Injection site erythema, Injection site pain, Myalgia
Clinical narrative: Patient's husband called concerned patient was having chills, muscle, and joint pain starting on the morning after receiving vaccination. Also having pain and redness at injection site. Told patient to see healthcare provider.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Headache, Pyrexia
Clinical narrative: Headache, GI distress, low grade fever, fatigue
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site rash, Rash
Clinical narrative: Flu-like symptoms (resolved prior to patient being seen). Rash affecting L deltoid area, L underarm, L under breast, R under breast, and R underarm. Consulted with consulting physician Dr. who advised ZYRTEC and cool compresses and to follow up with pt's PCP if no improvement.
Age: 32.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chest discomfort, Dyspnoea, Fall, Feeling hot, Immediate post-injection reaction
Clinical narrative: Immediate: Warm sensation in Right Arm at time of injection. Began on the inside of my shoulder, expand out towards my chest, and then down arm. 5-7 minutes later: Some shakiness. Sat down. Nausea followed by a warm sensation on my face, which began to intensify. Throat started to become itchy, got up to inform front desk I may have a reaction. Chest became tight as I got up to walk, and breathing became difficult. Was unable to talk coherently to person to ask for help. Legs gave out and I fell to the ground. Tongue began to feel swollen. Personnel assisted me to room to lie down and begin watching vitals and administer oxygen. Focused on deep breaths, but still labored. Throat and tongue were no longer itchy, but chest was tight. Began to shake uncontrollably, although not hot, nor cold. Blood pressure and heart rate eventually began to drop after 5 minutes, although shaking persisted. After 10 minutes of focused breathing, oxygen, and monitoring, shaking stopped and resumed homeostasis.
Age: 32.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Incoherent, Injection site warmth, Muscular weakness, Nausea, Swollen tongue
Clinical narrative: Immediate: Warm sensation in Right Arm at time of injection. Began on the inside of my shoulder, expand out towards my chest, and then down arm. 5-7 minutes later: Some shakiness. Sat down. Nausea followed by a warm sensation on my face, which began to intensify. Throat started to become itchy, got up to inform front desk I may have a reaction. Chest became tight as I got up to walk, and breathing became difficult. Was unable to talk coherently to person to ask for help. Legs gave out and I fell to the ground. Tongue began to feel swollen. Personnel assisted me to room to lie down and begin watching vitals and administer oxygen. Focused on deep breaths, but still labored. Throat and tongue were no longer itchy, but chest was tight. Began to shake uncontrollably, although not hot, nor cold. Blood pressure and heart rate eventually began to drop after 5 minutes, although shaking persisted. After 10 minutes of focused breathing, oxygen, and monitoring, shaking stopped and resumed homeostasis.
Age: 32.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Throat irritation, Tremor
Clinical narrative: Immediate: Warm sensation in Right Arm at time of injection. Began on the inside of my shoulder, expand out towards my chest, and then down arm. 5-7 minutes later: Some shakiness. Sat down. Nausea followed by a warm sensation on my face, which began to intensify. Throat started to become itchy, got up to inform front desk I may have a reaction. Chest became tight as I got up to walk, and breathing became difficult. Was unable to talk coherently to person to ask for help. Legs gave out and I fell to the ground. Tongue began to feel swollen. Personnel assisted me to room to lie down and begin watching vitals and administer oxygen. Focused on deep breaths, but still labored. Throat and tongue were no longer itchy, but chest was tight. Began to shake uncontrollably, although not hot, nor cold. Blood pressure and heart rate eventually began to drop after 5 minutes, although shaking persisted. After 10 minutes of focused breathing, oxygen, and monitoring, shaking stopped and resumed homeostasis.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Atrial fibrillation, Atrial flutter, Constipation, Dizziness
Clinical narrative: Received the SHINGRIX vaccine on 12/10/2018. On 12/19/18, developed severe vertigo associated with nausea and vomiting. Symptoms also associated with some GI distress, constipation, and urinary frequency and urgency. At about same time developed atrial fibrillation. Have had some degree of vertigo, dizziness, and nausea since that date.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Electrocardiogram abnormal, Electrocardiogram ambulatory abnormal, Micturition urgency, Nausea, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Received the SHINGRIX vaccine on 12/10/2018. On 12/19/18, developed severe vertigo associated with nausea and vomiting. Symptoms also associated with some GI distress, constipation, and urinary frequency and urgency. At about same time developed atrial fibrillation. Have had some degree of vertigo, dizziness, and nausea since that date.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Pollakiuria, Vertigo, Vomiting
Clinical narrative: Received the SHINGRIX vaccine on 12/10/2018. On 12/19/18, developed severe vertigo associated with nausea and vomiting. Symptoms also associated with some GI distress, constipation, and urinary frequency and urgency. At about same time developed atrial fibrillation. Have had some degree of vertigo, dizziness, and nausea since that date.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Differential white blood cell count, Full blood count, Headache, Lip swelling
Clinical narrative: Felt fine until 3:00 a.m. next morning - approx. 11 hrs. after vaccine. Extremely nauseous. Took (3) doses (at ok prescribed intervals) of ZOFRAN 4 mg sublingual tablets. Did not work. Vomiting spurts last 12 hours. No fever. No rash or pain at injection site. Did have minor joint pains. Severe headache. Could have been from ZOFRAN. Brushed teeth at 10:00 p.m. on the 16th. 5 mins. later noticed severe lip swelling. No tongue or throat swelling. Nausea came back at approx. 2:00 a.m.  Did not sleep well. Woke up at 4:00 a.m. swelling still there. Headed to ER.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Metabolic function test, Nausea, Poor quality sleep, Vomiting
Clinical narrative: Felt fine until 3:00 a.m. next morning - approx. 11 hrs. after vaccine. Extremely nauseous. Took (3) doses (at ok prescribed intervals) of ZOFRAN 4 mg sublingual tablets. Did not work. Vomiting spurts last 12 hours. No fever. No rash or pain at injection site. Did have minor joint pains. Severe headache. Could have been from ZOFRAN. Brushed teeth at 10:00 p.m. on the 16th. 5 mins. later noticed severe lip swelling. No tongue or throat swelling. Nausea came back at approx. 2:00 a.m.  Did not sleep well. Woke up at 4:00 a.m. swelling still there. Headed to ER.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Patient developed a rash in the left arm. This arm was opposite of the arm the vaccination was given into.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site pain, Injection site swelling, Sensory disturbance
Clinical narrative: Raised, red, and painful at the injection site. Also reports a "strange sensation" that moved into her head. Took a week or two weeks to completely heal. Patient reports back to the pharmacy today to report that they now have shingles and is taking VALTREX to remedy this.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Patient said she had pain at the injection site shortly after the shot. She said that the pain recently stopped in her arm this past week and is now in her shoulder. Patient said she is scheduled to go to her doctor in march.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysstasia, Gait disturbance, Grip strength decreased, Hypoaesthesia, Influenza like illness
Clinical narrative: Patient had pain in left arm initially, as well as feeling flu-like symptoms. She also states that since she had the injection, she is experiencing numbness and loss of strength in both arms, hands. She has trouble opening jars with right hand (even though she had injection in left arm). She has trouble standing and walking initially when she needs to. These symptoms have started since the injection and ongoing for approximately one month.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Patient had pain in left arm initially, as well as feeling flu-like symptoms. She also states that since she had the injection, she is experiencing numbness and loss of strength in both arms, hands. She has trouble opening jars with right hand (even though she had injection in left arm). She has trouble standing and walking initially when she needs to. These symptoms have started since the injection and ongoing for approximately one month.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash, Skin warm, Urticaria
Clinical narrative: Employee called in to center to report hives/rash on left side of neck. Area is itchy and hot. No SOB or CP. BENADRYL taken at home. Advised to monitor area. If symptoms worsen or new symptoms occur seek medical attention.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Injected limb mobility decreased, Injection site reaction, Pain in extremity, X-ray limb normal
Clinical narrative: Patient reported that about 4 hours after receiving 11/26/18 vaccination had pain and decreased range of motion in left upper extremity. Within interim period, sought evaluation at non-urgent care providers for pain and had steroid taper prescribed with resolved pain only temporarily. Patient called back to clinic with continued complaints of pain unresolved with steroid treatment and was seen on 1/30/19 and diagnosed with left subdeltoid bursitis.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Rash, Rash generalised, Respiration abnormal
Clinical narrative: Bad break out all over his body and breathing started to worsen. Was instructed to increase his at home oxygen. Also started a detox bath.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Autoimmune disorder, Colonoscopy abnormal, Crohn's disease, Gastric disorder, Magnetic resonance elastography
Clinical narrative: Autoimmune diseases: Started having severe stomach problems and after lots of tests I got the diagnosis of Crohn's Disease. Mom realized it was right after the vaccination but never did anything about it and when I realized a few months ago that it was probably related, she agreed. She still had me get the third GARDASIL vaccine even though she suspected that's what triggered my autoimmune diseases.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HEP, RV1
Symptoms: Abnormal behaviour, Crying, Decreased appetite, Pyrexia
Clinical narrative: Low grade fever, radical crying, stopped eating, simply not himself.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Fatigue, Headache, Impaired work ability, Pain in extremity
Clinical narrative: Patient called the during the day on 2/17/19 to let me know that she was experiencing tiredness, a headache, arm soreness, and feeling so run down that she had to call out of work. She also sounded congested, said she had a cough and phlegm in her chest and throat.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Productive cough, Respiratory tract congestion
Clinical narrative: Patient called the during the day on 2/17/19 to let me know that she was experiencing tiredness, a headache, arm soreness, and feeling so run down that she had to call out of work. She also sounded congested, said she had a cough and phlegm in her chest and throat.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, MMR
Symptoms: Erythema, Inflammation, Peripheral swelling, Skin warm
Clinical narrative: Large area of redness, very inflamed and swollen, double the size of his other arm, very hot to the touch.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: I had slight soreness at the injection site for several days after the injection, and the soreness went away. Almost two months later, the injection site has become sore and sensitive again with no other known reason for this particular spot in my arm to have pain.
Age: 3.0
Sex: F
Vaccine: DTAPIPVHIB, HEP, MMRV
Symptoms: Condition aggravated, Discomfort, Mastocytosis, Pruritus, Pyrexia
Clinical narrative: My daughter had a fever, her body broke out in a rash that was constantly moving around her body. Lesions associated with her disease Mastocystosis, started to form. She was extremely itchy and uncomfortable. None of her medication was working to calm her symtpoms (which these medications work for all our issues related to her disesase). I took her to the emergency room and they were unsure because the reaction was so late. She was given a steroid to calm the reaction which worked. The very next day the same reaction came back with the fever and rash. I took her back to the emergency room. We were then prescribed the steroid. We followed up 10.20.16 with a dermatologist.
Age: 3.0
Sex: F
Vaccine: DTAPIPVHIB, HEP, MMRV
Symptoms: Rash generalised, Skin lesion
Clinical narrative: My daughter had a fever, her body broke out in a rash that was constantly moving around her body. Lesions associated with her disease Mastocystosis, started to form. She was extremely itchy and uncomfortable. None of her medication was working to calm her symtpoms (which these medications work for all our issues related to her disesase). I took her to the emergency room and they were unsure because the reaction was so late. She was given a steroid to calm the reaction which worked. The very next day the same reaction came back with the fever and rash. I took her back to the emergency room. We were then prescribed the steroid. We followed up 10.20.16 with a dermatologist.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Skin warm
Clinical narrative: Warm to touch. Red area lower than where shot was given.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Feeling cold, Influenza like illness, Malaise
Clinical narrative: I woke up in the middle of the night, shivering and shaking, unable to get warm. Was able to get back to sleep after putting on more clothing and wrapping up in a blanket. The next morning I woke up with flu-like symptoms: aching, weak, shaky, malaise. I rested and slept most of the day, and by next day started to feel better. As the day went on, I gradually felt better, and on the following day was feeling like myself again. No headaches, no fever. The symptoms came on suddenly, and improved gradually.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Middle insomnia, Pain, Somnolence, Tremor
Clinical narrative: I woke up in the middle of the night, shivering and shaking, unable to get warm. Was able to get back to sleep after putting on more clothing and wrapping up in a blanket. The next morning I woke up with flu-like symptoms: aching, weak, shaky, malaise. I rested and slept most of the day, and by next day started to feel better. As the day went on, I gradually felt better, and on the following day was feeling like myself again. No headaches, no fever. The symptoms came on suddenly, and improved gradually.
Age: 67.0
Sex: F
Vaccine: FLUA3
Symptoms: Atrial fibrillation, Blood test, Cardioversion, Electrocardiogram, Heart rate irregular
Clinical narrative: Approx 11 hrs. after vaccination, I woke up in middle of sleep with my heart pounding irregularly. AFIB never had it before went to clinic next morning and took ambulance to ER. Said I was in Afib. Admitted in Hospital. Sat AM, Mon AM- had cardioversion and went into sinus rhythm (regular rhythm) went home that day. Put on ELIQUIS-had to go off anti-inflammatories and suffered severe pain for approximately 2 months.
Age: 67.0
Sex: F
Vaccine: FLUA3
Symptoms: Middle insomnia, Pain, Palpitations
Clinical narrative: Approx 11 hrs. after vaccination, I woke up in middle of sleep with my heart pounding irregularly. AFIB never had it before went to clinic next morning and took ambulance to ER. Said I was in Afib. Admitted in Hospital. Sat AM, Mon AM- had cardioversion and went into sinus rhythm (regular rhythm) went home that day. Put on ELIQUIS-had to go off anti-inflammatories and suffered severe pain for approximately 2 months.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Warm to touch, swelling and redness spread over upper arm, severe itching.
Age: 27.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 27-year-old female patient. The patient's medical history included gastroesophageal reflux disease. Her concurrent conditions included "over the counter decongestant" allergy. Concomitant therapy included omeprazole. On 28-DEC-2018, the patient was vaccinated with the first dose VARIVAX subcutaneously, (lot # N014632, expiration date: 11-MAY-2019), (exact dose and injection site were not provided), for prophylaxis. The patient had no adverse event with the first dose of the vaccine. On 29-JAN-2019, the patient was vaccinated with the second dose of VARIVAX subcutaneously, (lot # R019235, expiration date: 04-JUL-2020), (exact dose and injection site were not provided), for prophylaxis. On 30-JAN-2019, the patient began experiencing redness, warmth, itching, and mild pain at the injection site. On unknown date in 2019, the patient sought medical attention by calling to the office. The patient was treated with an "unspecified around the clock" anti-histamine and unspecified anti-inflammatory medications. The outcome of the events was reported as recovered on 03-FEB-2019. The relatedness between the events and the suspect vaccine was not provided. This is one of three reports from the same reporter. Sender's Comments: US-009507513-1902USA004146: US-009507513-1902USA006029.
Age: 27.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 27-year-old female patient. The patient's medical history included gastroesophageal reflux disease. Her concurrent conditions included "over the counter decongestant" allergy. Concomitant therapy included omeprazole. On 28-DEC-2018, the patient was vaccinated with the first dose VARIVAX subcutaneously, (lot # N014632, expiration date: 11-MAY-2019), (exact dose and injection site were not provided), for prophylaxis. The patient had no adverse event with the first dose of the vaccine. On 29-JAN-2019, the patient was vaccinated with the second dose of VARIVAX subcutaneously, (lot # R019235, expiration date: 04-JUL-2020), (exact dose and injection site were not provided), for prophylaxis. On 30-JAN-2019, the patient began experiencing redness, warmth, itching, and mild pain at the injection site. On unknown date in 2019, the patient sought medical attention by calling to the office. The patient was treated with an "unspecified around the clock" anti-histamine and unspecified anti-inflammatory medications. The outcome of the events was reported as recovered on 03-FEB-2019. The relatedness between the events and the suspect vaccine was not provided. This is one of three reports from the same reporter. Sender's Comments: US-009507513-1902USA004146: US-009507513-1902USA006029.
Age: 78.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 79-year-old male patient who received SHINGRIX (batch number 9277N, expiry date 27th June 2021) for prophylaxis. On 5th February 2019, the patient received SHINGRIX (intramuscular) .5 ml. On 6th February 2019, 1 days after receiving SHINGRIX, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were not recovered/not resolved. It was unknown if the reporter considered the injection site pain and injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The pharmacist reported that the patient had pain and redness at the injection site following a dose of SHINGRIX. The symptoms had improved the day of reporting compared to the day before reporting.
Age: 63.0
Sex: F
Vaccine: DTAP, FLUX, PPV
Symptoms: Body temperature increased, Chills, Fatigue, Feeling abnormal, Headache
Clinical narrative: I got the above 3 vaccines, Pneumonia in Lt arm, Flu in Lt glut, & DTap in Rt glut. Nothing to note on Lt arm & Rt upper glut. Flu shot in Lt upper glut has been extremely painful. Next morning I woke up sore, lethargic, & temp didn't feel good. Didn't take temp that day, wasn't too severe.  Had headache, tired, took 3 hour nap. 2nd day, temp bouncing for 95.8 to 101,8 & back. Headache, chills, total lethargy, 6 hour nap. Have had similar response to flu before, but I'm going on an international trip.
Age: 63.0
Sex: F
Vaccine: DTAP, FLUX, PPV
Symptoms: Injection site pain, Lethargy, Pain, Product administered at inappropriate site, Somnolence
Clinical narrative: I got the above 3 vaccines, Pneumonia in Lt arm, Flu in Lt glut, & DTap in Rt glut. Nothing to note on Lt arm & Rt upper glut. Flu shot in Lt upper glut has been extremely painful. Next morning I woke up sore, lethargic, & temp didn't feel good. Didn't take temp that day, wasn't too severe.  Had headache, tired, took 3 hour nap. 2nd day, temp bouncing for 95.8 to 101,8 & back. Headache, chills, total lethargy, 6 hour nap. Have had similar response to flu before, but I'm going on an international trip.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Deafness, Ear tube insertion, Infection, Otitis media, Tympanic membrane perforation
Clinical narrative: Developed a middle ear infection, leading to a ruptured ear drum on two sepearate occasions with chronic infection still occurring to present day. Treated with tubes in ears to no evail. Infection persisting in spite of antibiotic treatment. Hearing loss has now occurred as of 12/17/2018.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Feeling abnormal, Headache
Clinical narrative: Starting mid-afternoon (after getting the vaccine at 8:25 am 2/14/19), developed a very strong headache, very sore, red, swollen L arm (around the injection site) muscle soreness (especially in shoulders and neck) extreme fatigue, mild nausea. Symptoms intensified at night to the point where I got little sleep owing to the pain. Felt terrible--all the same symptoms plus a little bit of wooziness and shiveryness the morning of 2/1,; wentto work that morning only because I had 2 critical meetings that morning. Left work mid-day and went home to bed, still feeling the same symptoms, but somewhat abated. Exhausted but that night was able to sleep. On Day 3, (Saturday, 2/16/19), felt better though still not fully well. By that evening felt more or less back to normal. Note that this is the 2nd shot in the 2-shot SHINGRIX for me. I got the first shot in September, 2018, (from the same provider--my regular PCP's practice) and also had similar symptoms for 2-3 days after the shot, but they were not quite as pronounced and I did not have to miss any work.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired work ability, Injection site erythema, Injection site pain, Injection site swelling, Insomnia
Clinical narrative: Starting mid-afternoon (after getting the vaccine at 8:25 am 2/14/19), developed a very strong headache, very sore, red, swollen L arm (around the injection site) muscle soreness (especially in shoulders and neck) extreme fatigue, mild nausea. Symptoms intensified at night to the point where I got little sleep owing to the pain. Felt terrible--all the same symptoms plus a little bit of wooziness and shiveryness the morning of 2/1,; wentto work that morning only because I had 2 critical meetings that morning. Left work mid-day and went home to bed, still feeling the same symptoms, but somewhat abated. Exhausted but that night was able to sleep. On Day 3, (Saturday, 2/16/19), felt better though still not fully well. By that evening felt more or less back to normal. Note that this is the 2nd shot in the 2-shot SHINGRIX for me. I got the first shot in September, 2018, (from the same provider--my regular PCP's practice) and also had similar symptoms for 2-3 days after the shot, but they were not quite as pronounced and I did not have to miss any work.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea
Clinical narrative: Starting mid-afternoon (after getting the vaccine at 8:25 am 2/14/19), developed a very strong headache, very sore, red, swollen L arm (around the injection site) muscle soreness (especially in shoulders and neck) extreme fatigue, mild nausea. Symptoms intensified at night to the point where I got little sleep owing to the pain. Felt terrible--all the same symptoms plus a little bit of wooziness and shiveryness the morning of 2/1,; wentto work that morning only because I had 2 critical meetings that morning. Left work mid-day and went home to bed, still feeling the same symptoms, but somewhat abated. Exhausted but that night was able to sleep. On Day 3, (Saturday, 2/16/19), felt better though still not fully well. By that evening felt more or less back to normal. Note that this is the 2nd shot in the 2-shot SHINGRIX for me. I got the first shot in September, 2018, (from the same provider--my regular PCP's practice) and also had similar symptoms for 2-3 days after the shot, but they were not quite as pronounced and I did not have to miss any work.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Hepatic enzyme increased, Impaired work ability, Injection site swelling, Injury
Clinical narrative: Information has been received from a pharmacist on 20-JAN-2015 referring to a 64 year old female patient. On 21-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # K009770, expiration date 09-OCT-2015), 0.65 ml, subcutaneous for vaccination. Concomitant therapies included escitalopram oxalate(LEXAPRO), alprazolam(XANAX) and acetaminophen, hydrocodone bitartrate(VICODIN). On 23-OCT-2014 the patient began to experience swelling at the injection site and was assessed by an unspecified physician. The unspecified physician prescribed unspecified antibiotics to decrease swelling. On an unspecified date after starting the antibiotics, the patient began to experience nausea and right upper quadrant abdominal pain. Unspecified labs studies were completed on an unspecified date, after starting antibiotic therapy, which had shown that the patient's liver enzymes were elevated. Other unspecified diagnostic studies have been completed on unspecified dates. The outcome of the adverse events was reported as not recovered. Follow-up information was received on 11-FEB-2019 from a lawyer regarding a female patient who had received the ZOSTAVAX)  The complaint alleges that the female patient , sustained injuries as a result of a ZOSTAVAX vaccine administered on 21-OCT-2014 at a pharmacy. In recent responses to supplemental discovery, the patient claimed that the ZOSTAVAX vaccine itself may have been defective. On or about 21-OCT-2014, the female patient visited the drugstore to get a shingles vaccination. At the drugstore, an employee administered the vaccination to the patient, but administered it negligently (not further specified), causing the patient serious injuries from which she still suffers almost 2 years later. The drugstore company's negligence injured the patient in and about her body and extremities, and suffered physical handicap and impairment, disfigurement, mental anguish, inconvenience, loss of capacity for the enjoyment of life, aggravation of a previously existing condition (not further specified), and her working ability was impaired; the injuries are either permanent or continuing in nature and the patient will suffer the losses and impairment in the future. Interrogatory: State whether the patient is contending that the shingles vaccination administrated on 21-OCT-2014 was itself unreasonably dangerous and/or defective. The patient response to Interrogatory was Presently, the patient does not know whether the actual substance that was injected was defective, but discovery is ongoing. The events of Injured in and about her body and extremities, swelling at the injection site, liver enzymes were elevated, right upper quadrant abdominal pain, and nausea were considered to be disabling. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Information has been received from a pharmacist on 20-JAN-2015 referring to a 64 year old female patient. On 21-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # K009770, expiration date 09-OCT-2015), 0.65 ml, subcutaneous for vaccination. Concomitant therapies included escitalopram oxalate(LEXAPRO), alprazolam(XANAX) and acetaminophen, hydrocodone bitartrate(VICODIN). On 23-OCT-2014 the patient began to experience swelling at the injection site and was assessed by an unspecified physician. The unspecified physician prescribed unspecified antibiotics to decrease swelling. On an unspecified date after starting the antibiotics, the patient began to experience nausea and right upper quadrant abdominal pain. Unspecified labs studies were completed on an unspecified date, after starting antibiotic therapy, which had shown that the patient's liver enzymes were elevated. Other unspecified diagnostic studies have been completed on unspecified dates. The outcome of the adverse events was reported as not recovered. Follow-up information was received on 11-FEB-2019 from a lawyer regarding a female patient who had received the ZOSTAVAX)  The complaint alleges that the female patient , sustained injuries as a result of a ZOSTAVAX vaccine administered on 21-OCT-2014 at a pharmacy. In recent responses to supplemental discovery, the patient claimed that the ZOSTAVAX vaccine itself may have been defective. On or about 21-OCT-2014, the female patient visited the drugstore to get a shingles vaccination. At the drugstore, an employee administered the vaccination to the patient, but administered it negligently (not further specified), causing the patient serious injuries from which she still suffers almost 2 years later. The drugstore company's negligence injured the patient in and about her body and extremities, and suffered physical handicap and impairment, disfigurement, mental anguish, inconvenience, loss of capacity for the enjoyment of life, aggravation of a previously existing condition (not further specified), and her working ability was impaired; the injuries are either permanent or continuing in nature and the patient will suffer the losses and impairment in the future. Interrogatory: State whether the patient is contending that the shingles vaccination administrated on 21-OCT-2014 was itself unreasonably dangerous and/or defective. The patient response to Interrogatory was Presently, the patient does not know whether the actual substance that was injected was defective, but discovery is ongoing. The events of Injured in and about her body and extremities, swelling at the injection site, liver enzymes were elevated, right upper quadrant abdominal pain, and nausea were considered to be disabling. 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 historical drugs, medical history, concomitant therapies and concurrent conditions were not reported. On 30-JAN-2019, the patient was vaccinated with an expired dose of PROQUAD lot# N020618, expiration date: 22-JAN-2019, for prophylaxis (strength, dose, route and frequency were not reported) was administered. No adverse effects reported.
Sex: F
Vaccine: VARZOS
Symptoms: Trigeminal neuralgia
Clinical narrative: This spontaneous report was received from a pharmacist via company representative and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX vial 19400 plaque forming units (PFU) (dose, route of administration, lot# and expiry date were not provided) for prophylaxis. On an unknown date the patient experienced trigeminal neuralgia-like symptoms of unclear etiology but chronologically close to the timing of ZOSTAVAX immunization. The outcome of trigeminal neuralgia-like symptoms was unknown. The relatedness between the event and ZOSTAVAX was not provided. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1902USA006444.
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a physician via a company representative, refers to a female patient of unknown age. The patient's pertinent medical history, drug reaction or allergies, and concomitant medications were unknown at the reporting time. On an unknown date (reported as couple of years ago), the patient was vaccinated with M-M-R II (dosage, route, anatomical location, lot number and expiration date were not reported), which was reconstitute with sterile diluent (dosage, lot number and expiration date were not reported), for prophylaxis. On an unknown date, the patient developed rash. No treatment was given for the event. At the reporting time, the patient recovered from rash on an unspecified date. The casual assessment between M-M-R II, sterile diluent and the aforementioned event was not provided.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from an office manager refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug allergies/reaction and concomitant medications were not reported. On an unspecified date, the patient was administered an improperly stored dose of ROTATEQ (lot # R013288 and expiry date 12-DEC-2019) for prophylaxis (dosing details not reported). The product was kept above 10.04 degree Celsius for more than 5.1 hours). Temperature and Time frame: Total Time and highest temperature above 47 degree F/9 degree C (10.04 C) for 5.1 for hours. Previous temperature excursion: Total Time and lowest temperature below36 degree F/2 degree C (0.6 C) for 8.25 hours. It was reported that digital "data logger" was not involved. Product quality complaint was not involved.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant/office manager regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # R005869 and expiry date 23-OCT-2019) orally for prophylaxis(strength, dose and frequency were not reported). No adverse effects were reported. The reporter stated that, first excursion occurred on 21-DEC-2018. The product was stored at 1.6 degrees Celsius for 26 minutes and previous excursion was reported as 1.1 degrees Celsius for 1 hour 35 minutes. This case was reported due to digital data logger. No product quality complaint was filed. This is one of the several reports form the same reporter. Sender's Comments: US-009507513-1902USA004906: US-009507513-1902USA004907: US-009507513-1902USA004942.
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Information has been received from a physician via a field employee referring to a male patient of unknown age. Information about medical history, concurrent condition and concomitant medication was unknown. On 30-JAN-2019 the patient was vaccinated with M-M-R II (dose, frequency, route and lot# unspecified) for prophylaxis, which was reconstituted by sterile diluent injection (lot# and expiration date unspecified). On an unknown date in 2019 the patient developed a rash. No treatment was given for the event. The outcome of rash and the causality were unknown.
Sex: M
Vaccine: PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: This spontaneous report was received from a healthcare professional via Pfizer refers to a male patient of unknown age. The patient's concurrent conditions included multiple sclerosis. The patient's medical history and concomitant medications were not reported. On 17-SEP-2013(also reported as 17-SEP-2017), the patient was vaccinated with first dose of PNEUMOVAX 23 for prophylaxis (strength, lot#, expiry date, dose, anatomical location, route of administration was not reported). On 12-APR-2018, the patient was vaccinated with second dose of PNEUMOVAX 23 (lot# N030987, expiry date 15-MAY-2019) when the patient was supposed to get PREVNAR 13 (wrong product administered). It was reported that the patient did not have any side effects (no adverse event).
Age: 49.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a 49 year old female patient. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported. On 11-JAN-2019, the patient was vaccinated with VAQTA 50/1.0 U/ml, first dose, intramuscular, lot number R027987 and expiration date 09-AUG-2019 (dosage schedule, anatomical location, were not reported). On 11-FEB-2019, the patient was vaccinated with VAQTA 50/1.0 U/ml,  first dose, intramuscular, lot number R031045 and expiration date 18-NOV-2019 (dosage schedule, anatomical location, were not reported). On the same day, the patient received a inappropriate schedule of vaccine administered. No adverse events were reported. The outcome of inappropriate schedule of product administration and no adverse event were unknown.
Sex: U
Vaccine: HEPA, HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant/office manager regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot # R013572 and expiry date 21-MAR-2021) (strength, dose were not reported) and VAQTA (lot # R018935 and expiry date 05-SEP-2019) (strength, dose were not reported), both for prophylaxis. No adverse effects were reported. The reporter reported first excursion occurred on 21-DEC-2018. The product was stored at 1.6 degrees Celsius for 26 minutes and previous excursion was reported as 1.1 degrees Celsius for 1 hour 35 minutes. This case was due to digital data logger. No product quality complaint was filed. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1902USA003534: US-009507513-1902USA004942.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant/office manager regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot # R013572 and expiry date 21-MAR-2021,) for prophylaxis (strength, dose, route and frequency were not reported). No adverse effects were reported. The reporter stated that first excursion occurred on 21-DEC-2018. The product was stored at 1.6 degrees Celsius for 26 minutes and previous excursion was reported as 1.1 degrees Celsius for 1 hour 35 minutes. This case was due to digital data logger. No product quality complaint was filed. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1902USA003534: US-009507513-1902USA004906.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: This spontaneous report was received from a physician via company representative regarding a 30 year old female patient. The patient's pertinent medical history, concomitant medication, drug reaction and allergies were unknown. On an unknown date, the patient was vaccinated with GARDASIL (strength, dose, route, lot# and expiry date were unknown) for prevention of human papillomavirus (HPV) (prophylaxis). The patient received a three-dose series of GARDASIL when she was 18 years old. On an unknown date, the patient was tested for HPV infection during a routine gynecological exam and the results showed that she was positive for HPV 18 (papilloma viral infection). The patient was not received any treatment for the event. Product quality complaint was not involved. No additional information was available. The outcome of papilloma viral infection was not recovered/not resolved. The causality assessment for the event was not provided.
Age: 1.0
Sex: M
Vaccine: PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: This spontaneous report as received from an administrator refers to a 12 month old male patient. The patient's pertinent medical history included anorectal malformation. No drug reactions/allergies and concomitant medications were reported. On 07-FEB-2019 the patient inadvertently received a dose of PNEUMOVAX 23 (lot # R018735, expiry date: 06-APR-2020) instead of PREVNAR 13 (dose, frequency and route were not reported) for prophylaxis. No adverse effects were reported. The patient had not received any treatment for the event. No lab diagnostics/studies were performed. No product quality complaint was involved.
Sex: M
Vaccine: ANTH, SMALL, UNK
Symptoms: Rash, Rash pruritic
Clinical narrative: Information received from a consumer medical inquiry on 16NOV2018. On 15NOV2018 an adult male of unspecified age received smallpox, anthrax vaccination and vaccine reported as "Japanese fly" while on active duty in (route, lot information not provided). He reported that upon awakening a small itchy rash had developed on his right forearm which was not the site of the shots. The consumer questioned whether the rash was a result of the smallpox vaccine. At the time of report, the outcome was unknown. Further information not provided.
Sex: U
Vaccine: MENB
Symptoms: Laboratory test, Meningococcal infection, Vaccination failure
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a adolescent patient who received BEXSERO for prophylaxis. Co-suspect products included BEXSERO for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO and the 2nd dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO and 2 years after receiving BEXSERO and BEXSERO, the patient experienced vaccination failure (serious criteria GSK medically significant) and meningococcal infection (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and meningococcal infection were unknown. It was unknown if the reporter considered the vaccination failure and meningococcal infection to be related to BEXSERO and BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient was with underlying medical conditions. The patient had disease onset 2 years after completion of primary series. Invasive isolate was not sequenced, at the time of reporting, expected polymerase chain reaction (PCR) testing to be completed soon. This case was considered as suspected vaccination failure since, laboratory confirmation for target disease and disease type were unknown. This case was one of the 4 cases reported by the same reporter. Lab Comments: The patient's invasive isolate was not sequenced, at the time of reporting, expected polymerase chain reaction (PCR).