chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: M
Vaccine: HEPA
Symptoms: Hyperhidrosis, Loss of consciousness, Malaise, Mydriasis, Pallor
Clinical narrative: After about 3 minutes of the vaccine administration, the patient stated he didn't feel well and then began to faint. His head dropped forward first as he was losing consciousness and he began to turn red in color and start to sweat. We called code white in the pharmacy. When we lifted him upward his head tilted back and his pupils were both completely dilated. He then began to lose the color in face and became very pale including white lips. His body then started to tighten/seize with his arms in a straight forward position. While his upper body was seizing, his lower body was still slumping and sliding down the chair as we attempted to keep him sitting upright. His mouth/jaw appeared to be clenching and the pharmacist thought for a second he almost started foaming at the mouth. Within only about 20 seconds, the patient regained consciousness and stated he just went out of it for a minute. It was confirmed that he did not remember actually having the reaction, so he blacked out for the entirety of the incident. After regaining consciousness and body control, we kept the patient upright and brought him water and ice packs. His skin was still pale and hands were cold and clammy. We monitored the patient for the next 45 minutes. He regained normal skin color and the general feelings of weakness subsided. We took the patient's BP and it was 117/77 with pulse 66. We took it again later and it remained normal. The patient was offered additional medical assistance (911 or EMS) and declined. We continued to monitor and discuss the patient's history in further detail. It was exposed that the patient had history of general anxiety, albeit no history of any seizure or otherwise CNS issues. He had been weaned off anxiety medication and was not currently on any. The patient works night shift and expressed that they had just woken up and he had not eaten any food in the last 12-16 hours. He also confirmed that his current schedule and sleep quality is low. Per his request, the patient got up after 30 minutes and was escorted to and from the bathroom by our AP associate (large enough build to support the patient in height and weight). He finished his water and then confirmed he would go to the grocery side of the store to get food. All symptoms had subsided and vitals were normal after 45 minutes, but the patient did mention having a general "heaviness" in the mouth and felt it was kind of hard to speak or "slow." Given this later symptom, we referred the patient to go to the ER for extended monitoring to rule out any stroke or general CNS issues that could not be seen by the naked eye. The patient's wife was in accompaniment throughout the entirety of the incidence and was fully capable of taking the patient out of the pharmacy with proper follow-up plans.
Age: 25.0
Sex: M
Vaccine: HEPA
Symptoms: Posture abnormal, Seizure, Slow speech, Syncope
Clinical narrative: After about 3 minutes of the vaccine administration, the patient stated he didn't feel well and then began to faint. His head dropped forward first as he was losing consciousness and he began to turn red in color and start to sweat. We called code white in the pharmacy. When we lifted him upward his head tilted back and his pupils were both completely dilated. He then began to lose the color in face and became very pale including white lips. His body then started to tighten/seize with his arms in a straight forward position. While his upper body was seizing, his lower body was still slumping and sliding down the chair as we attempted to keep him sitting upright. His mouth/jaw appeared to be clenching and the pharmacist thought for a second he almost started foaming at the mouth. Within only about 20 seconds, the patient regained consciousness and stated he just went out of it for a minute. It was confirmed that he did not remember actually having the reaction, so he blacked out for the entirety of the incident. After regaining consciousness and body control, we kept the patient upright and brought him water and ice packs. His skin was still pale and hands were cold and clammy. We monitored the patient for the next 45 minutes. He regained normal skin color and the general feelings of weakness subsided. We took the patient's BP and it was 117/77 with pulse 66. We took it again later and it remained normal. The patient was offered additional medical assistance (911 or EMS) and declined. We continued to monitor and discuss the patient's history in further detail. It was exposed that the patient had history of general anxiety, albeit no history of any seizure or otherwise CNS issues. He had been weaned off anxiety medication and was not currently on any. The patient works night shift and expressed that they had just woken up and he had not eaten any food in the last 12-16 hours. He also confirmed that his current schedule and sleep quality is low. Per his request, the patient got up after 30 minutes and was escorted to and from the bathroom by our AP associate (large enough build to support the patient in height and weight). He finished his water and then confirmed he would go to the grocery side of the store to get food. All symptoms had subsided and vitals were normal after 45 minutes, but the patient did mention having a general "heaviness" in the mouth and felt it was kind of hard to speak or "slow." Given this later symptom, we referred the patient to go to the ER for extended monitoring to rule out any stroke or general CNS issues that could not be seen by the naked eye. The patient's wife was in accompaniment throughout the entirety of the incidence and was fully capable of taking the patient out of the pharmacy with proper follow-up plans.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Pain and swelling at the site of injection and fever. She went to the doctor and was prescribed antibiotic.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Within 12 hours patient had Redness, swelling and pain at injection site. Her arm became immobile. Within 72 hours, she developed a fever of 100 that lasted over 2 days. Other symptoms include, nausea, cramping, muscle pain, fatigue. Patient described symptoms as flu like symptoms. Patient presented to MD with symptoms. MD was concerned patient may develop cellulitis. After physical exam of injection site as well as surrounding area, MD found no cellulitis. Patient came into the pharmacy today, 5/19/2018 to tell me about symptoms and said she is just now getting back to normal.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Muscle spasms, Myalgia, Nausea, Pyrexia
Clinical narrative: Within 12 hours patient had Redness, swelling and pain at injection site. Her arm became immobile. Within 72 hours, she developed a fever of 100 that lasted over 2 days. Other symptoms include, nausea, cramping, muscle pain, fatigue. Patient described symptoms as flu like symptoms. Patient presented to MD with symptoms. MD was concerned patient may develop cellulitis. After physical exam of injection site as well as surrounding area, MD found no cellulitis. Patient came into the pharmacy today, 5/19/2018 to tell me about symptoms and said she is just now getting back to normal.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Cold sweat, Dizziness, Fatigue, Injection site erythema
Clinical narrative: 3 inch swelling and pain at injection site, severe diarrhea, light-headedness/dizziness, nausea, fever, cold sweats, painful rash from top of neck down front of body to navel & under arms. Next morning, felt very weak and tired. Rash started to itch by that evening. 48 hours later rash is starting to subside with tenderness/redness at injection site. All other symptoms disappeared.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Nausea, Pruritus, Pyrexia
Clinical narrative: 3 inch swelling and pain at injection site, severe diarrhea, light-headedness/dizziness, nausea, fever, cold sweats, painful rash from top of neck down front of body to navel & under arms. Next morning, felt very weak and tired. Rash started to itch by that evening. 48 hours later rash is starting to subside with tenderness/redness at injection site. All other symptoms disappeared.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: 3 inch swelling and pain at injection site, severe diarrhea, light-headedness/dizziness, nausea, fever, cold sweats, painful rash from top of neck down front of body to navel & under arms. Next morning, felt very weak and tired. Rash started to itch by that evening. 48 hours later rash is starting to subside with tenderness/redness at injection site. All other symptoms disappeared.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Headache; Fever 100.5; Stomach; Flu like muscle ache; Tired.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Insomnia, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Patient described stiffness in his head, very painful, weren't able to move head. Began in the evening of the day he received vaccine. Weren't able to sleep for two nights due to pain in head and started getting better slowly from third day.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Feeling abnormal
Clinical narrative: Pt received shot in the morning. Then during the night had feeling of being in a daze. She went to bed and next morning had similar feeling but more intense than before. Also she felt as if she couldn't catch her breath. She took a BENADRYL, then next day she felt better.
Age: 34.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Loss of consciousness, Presyncope
Clinical narrative: Patient passed after HAVRIX (second vaccination was given), 911 and the Clinic Nurse was notified, pt was sitting down and we propped legs up in a chair, patient started to seize and came back. Patient came back before ammonia inhalent could be used. The Clinic nurse came straight over to assess the patient, upon assessment she said it was a vasovagal response (patient indicated he has a fear and anxiety of needles, also stated he passes out after giving blood).
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Feeling hot, Flushing, Immediate post-injection reaction, Paraesthesia
Clinical narrative: Immediate flushing, dizziness, feeling hot, followed by tingling in the fingers a few minutes later.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthritis, Headache, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: Within 12 hours the injection site was sore. As of 3:00 PM, 5-19-18 the site is still sore, red and warm. Within 12 hours I started having flu like symptoms (headache, muscle aches, malaise, joint inflammation) that lasted for 36 hours. Within 24 hours I had a fever of 99.9 degrees that lasted for 12 hours.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site warmth, Malaise, Myalgia, Pyrexia
Clinical narrative: Within 12 hours the injection site was sore. As of 3:00 PM, 5-19-18 the site is still sore, red and warm. Within 12 hours I started having flu like symptoms (headache, muscle aches, malaise, joint inflammation) that lasted for 36 hours. Within 24 hours I had a fever of 99.9 degrees that lasted for 12 hours.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Laboratory test abnormal, Mast cell activation syndrome, Postural orthostatic tachycardia syndrome, Sjogren's syndrome
Clinical narrative: Syncope immediately following 3rd vaccination in series, and later developed Postural Orthostatic Tachycardia (POTS), Mast Cell Activation Syndrome (MCAS), and Sjogren's Syndrome.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope, Tilt table test positive
Clinical narrative: Syncope immediately following 3rd vaccination in series, and later developed Postural Orthostatic Tachycardia (POTS), Mast Cell Activation Syndrome (MCAS), and Sjogren's Syndrome.
Age: 79.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Blood pressure increased, Blood test, Induration, Mass, Peripheral swelling
Clinical narrative: Arm swelled, hot to touch, hard lump, increased blood pressure, febrile, increased white blood cell count went to emergency room, and started on cephalexin.
Age: 79.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Pyrexia, Skin warm, White blood cell count increased
Clinical narrative: Arm swelled, hot to touch, hard lump, increased blood pressure, febrile, increased white blood cell count went to emergency room, and started on cephalexin.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Feeling hot, Feeling of body temperature change, Injection site erythema
Clinical narrative: Vaccine was administered on Friday, May 4 in the evening. Patient stated that on Saturday and Sunday, she had chills and was hot and cold on and off. She also had swelling and redness in the injection area. It felt burning hot and was itchy as well. On Wednesday, May 9 she went to the doctor and was prescribed a 6 day course of prednisone or methylprednisolone (she could not remember which steroid) and a 10 day course of cephalexin. She stated that she did not like the insomnia from the steroid, so she stopped it after 3 days and is currently finishing up the cephalexin course. Per the patient, the area is still red but is gradually getting better. She is planning on talking to her doctor about getting over the counter hydrocortisone since she stopped the systemic steroid early.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Insomnia, Pruritus
Clinical narrative: Vaccine was administered on Friday, May 4 in the evening. Patient stated that on Saturday and Sunday, she had chills and was hot and cold on and off. She also had swelling and redness in the injection area. It felt burning hot and was itchy as well. On Wednesday, May 9 she went to the doctor and was prescribed a 6 day course of prednisone or methylprednisolone (she could not remember which steroid) and a 10 day course of cephalexin. She stated that she did not like the insomnia from the steroid, so she stopped it after 3 days and is currently finishing up the cephalexin course. Per the patient, the area is still red but is gradually getting better. She is planning on talking to her doctor about getting over the counter hydrocortisone since she stopped the systemic steroid early.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: PATIENT WOKE UP NEXT DAY (5/15/18) WITH ABOUT A 2-3 INCH RAISED RED MARK AROUND INJECTION SITE, WARM TO THE TOUCH, ITCHING, AND SORE. WAS ALSO EXPERIENCING FATIGUE.  FOLLOWED-UP WITH PATIENT AGAIN ON 5/19/18, SHE SAID MOST OF THE REDNESS IS GONE, STILL ITCHING SOME, AND PAIN IS BETTER BUT NOT COMPLETELY GONE.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: PATIENT WOKE UP NEXT DAY (5/15/18) WITH ABOUT A 2-3 INCH RAISED RED MARK AROUND INJECTION SITE, WARM TO THE TOUCH, ITCHING, AND SORE. WAS ALSO EXPERIENCING FATIGUE.  FOLLOWED-UP WITH PATIENT AGAIN ON 5/19/18, SHE SAID MOST OF THE REDNESS IS GONE, STILL ITCHING SOME, AND PAIN IS BETTER BUT NOT COMPLETELY GONE.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Feeling hot, Headache, Neuralgia
Clinical narrative: About 5 hours after receiving SHINGRIX, patient experienced severe headache and heat sensation on her face. The area affected starts below the right eye and radiated up the right side for her face to the back right side of her head. She said it was throbbing with a hot nerve pain limited to the specified area. She also experienced increased blood pressure of 167/77. She went to bed and felt better the next day, but was having intermittent pain and heat on the right side of her face/head for the next few days.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Fatigue, Headache, Influenza like illness, Injection site pain, Malaise
Clinical narrative: I don't know what the type of pneumonia shot was. Experienced flu-like symptoms including extreme fatigue, fever, aches and head-ache. Its now day three and I still feel somewhat sick. Extreme pain at shot site: a number 6 on a scale 1-10.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Pyrexia
Clinical narrative: I don't know what the type of pneumonia shot was. Experienced flu-like symptoms including extreme fatigue, fever, aches and head-ache. Its now day three and I still feel somewhat sick. Extreme pain at shot site: a number 6 on a scale 1-10.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Pt received SHINGRIX in left deltoid muscle on 5-17-18. On 5-19-18, came in presenting with large red area where vaccine was administered or possible cellulitis.
Age: 1.08
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HEPA, PNC13, DTAPHEPBIP, FLU4, HEPA, PNC13
Symptoms: Acute respiratory failure, Ataxia, Endotracheal intubation, Paralysis
Clinical narrative: Patient with an unclear sensorimotor neuropathy now requiring tracheostomy with full ventilator support and G-tube feedings. Previously completely immobile, unresponsive to IVIG, now with minimal movement throughout (upper extremities and trunk greater than lower extremities). Neurological work up continues to be in progress with no definitive etiology.
Age: 1.08
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HEPA, PNC13, DTAPHEPBIP, FLU4, HEPA, PNC13
Symptoms: Feeding tube user, Gastrostomy, Immobile, Immunoglobulin therapy, Mechanical ventilation
Clinical narrative: Patient with an unclear sensorimotor neuropathy now requiring tracheostomy with full ventilator support and G-tube feedings. Previously completely immobile, unresponsive to IVIG, now with minimal movement throughout (upper extremities and trunk greater than lower extremities). Neurological work up continues to be in progress with no definitive etiology.
Age: 1.08
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HEPA, PNC13, DTAPHEPBIP, FLU4, HEPA, PNC13
Symptoms: Mobility decreased, Neurological examination, Peripheral sensorimotor neuropathy, Tracheostomy
Clinical narrative: Patient with an unclear sensorimotor neuropathy now requiring tracheostomy with full ventilator support and G-tube feedings. Previously completely immobile, unresponsive to IVIG, now with minimal movement throughout (upper extremities and trunk greater than lower extremities). Neurological work up continues to be in progress with no definitive etiology.
Age: 0.25
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Chills, Pain, Pyrexia, Screaming
Clinical narrative: High fever. Chills. SCREAMING IN AGONY FOR DAYS.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Dyspnoea, Dysstasia, Feeling abnormal, Influenza virus test negative, Intensive care
Clinical narrative: Within 20 hours I could not stand without help, trouble breathing, felt like body shutting down. From onset to admitting in ER time was probably 5 hours from onset. Told I had sepsis pneumonia, white count over 40000. Remained in hospital ICU for 5 days with treatment.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Laboratory test, Pneumococcal sepsis, White blood cell count increased
Clinical narrative: Within 20 hours I could not stand without help, trouble breathing, felt like body shutting down. From onset to admitting in ER time was probably 5 hours from onset. Told I had sepsis pneumonia, white count over 40000. Remained in hospital ICU for 5 days with treatment.
Age: 54.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Chills, Pain, Vaccination site rash
Clinical narrative: Patient developed a rash in the area of the vaccine and complained of moderately severe pain. Patient also stated he may have had a fever because he was experiencing chills.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Lethargy, Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Arm/shoulder pain and difficulty with arm movements that has not diminished. Flu like symptoms that subsided after a week, however extreme lethargy daily.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Hypoaesthesia, Influenza like illness, Injection site pain
Clinical narrative: When the injection was made, it felt like metal was being injected in me, it hurt so bad. By 3:00 it hurt to move my arm. Even the slightest movement would cause a higher amount of pain. My fingers, on my right arm, felt a slight numbness and tingling. As the day progressed into evening I felt exhausted and my head ached. During the night my sleep was restless due to the constant pain in my right arm. The next day I was on the couch as it felt like I had the flu. About 48 hours after getting the shot I started feeling better. It wasn't until Wednesday that I felt myself. Also, on a side note I started my day out, on the day of the shot, feeling very very good.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Paraesthesia, Poor quality sleep
Clinical narrative: When the injection was made, it felt like metal was being injected in me, it hurt so bad. By 3:00 it hurt to move my arm. Even the slightest movement would cause a higher amount of pain. My fingers, on my right arm, felt a slight numbness and tingling. As the day progressed into evening I felt exhausted and my head ached. During the night my sleep was restless due to the constant pain in my right arm. The next day I was on the couch as it felt like I had the flu. About 48 hours after getting the shot I started feeling better. It wasn't until Wednesday that I felt myself. Also, on a side note I started my day out, on the day of the shot, feeling very very good.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Patient reported via phone call that on the 2nd day after receiving SHINGRIX immunization that there was a rash below the injection site. The rash is closer to the injection site but between the site and elbow.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: Patient developed a vesicular rash and associated pain on left upper chest, under arm, and onto patient's back. Symptoms started on 5/19/18 in the evening.
Age: 1.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Pyrexia, Rash vesicular
Clinical narrative: Noticed bug bite type rash on 5/18/18 on wrist, feet, ear, low grade fever that night, woke up on 5/19/18 and they were all blistered. Counted about 10 spots.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT HAD SWELLING AT INJECTION SITE AND INFLAMMATION/REDNESS/WARMTH IN THE SURROUNDING AREA - SHE TOOK BENADRYL, APAP, AND APPLIED AN ICE PACK. I COUNSELED HER TO CONTACT PCP IF ANYTHING WORSENS.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Musculoskeletal stiffness
Clinical narrative: Patient stated she was having a stiff arm but since then has reported it has gotten better. Thinks it could be arthritis.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient complained of swelling and redness at injection site.
Age: 68.0
Sex: F
Vaccine: HEPAB, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient experienced pain, redness and swelling at the injection site and these symptoms extended down to her elbow on her right arm. She stated that the symptoms started shortly after she received the vaccines and she called the pharmacy one day later and was still having symptoms. She tried ibuprofen and ice but was getting little relief.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache, Nausea
Clinical narrative: Headache, shivers, joint pain, fatigue, nausea.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hyperhidrosis, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Patient reported headache, sweating, slight fever (99-100), muscle aches. She said it was "flu like" symptoms.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain, Swelling
Clinical narrative: Extreme soreness, swelling. Headache. Tired.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Injection site pain, Musculoskeletal pain, Nausea
Clinical narrative: Shoulder pain, extreme pain at site, body aches, exhaustion, fever (99.2) weakness, nausea.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Shoulder pain, extreme pain at site, body aches, exhaustion, fever (99.2) weakness, nausea.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Hypotension, Pain
Clinical narrative: Body aches and generalized weakness started about 6 hours after injection and became progressively more severe. I was shivering, and became hypotensive, with near-syncope walking back from the bathroom. My vision went black and I walked into the bedpost. At about 2 AM, the shivering stopped, and I felt much better by morning, though I continue to feel weak and fatigued. I know this is within the range of possible side effects, though on the severe end of the spectrum.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Presyncope, Visual impairment
Clinical narrative: Body aches and generalized weakness started about 6 hours after injection and became progressively more severe. I was shivering, and became hypotensive, with near-syncope walking back from the bathroom. My vision went black and I walked into the bedpost. At about 2 AM, the shivering stopped, and I felt much better by morning, though I continue to feel weak and fatigued. I know this is within the range of possible side effects, though on the severe end of the spectrum.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Gait inability, Myalgia, Pain
Clinical narrative: Patient reports feeling normal the day receiving vaccine. However, woke up the next morning and was sore all over -- said muscles and joints felt sore. She reported symptoms progressing throughout day 2 and by the end of the day, husband had to pick her up out of bed and bring her to the restroom and back. Patient reports not being able to walk at all. Patient reports feeling really sore Thursday upon awakening, but was able to move at this time. Symptoms improved through the day and patient reports full recovery at this time.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site erythema, Injection site induration, Injection site rash, Peripheral swelling
Clinical narrative: Patient experience dizziness later in the day after vaccinated. Stopped. Rash around site later in day after vaccination, then disappeared. Patient reported arm swelled from elbow on up. Red around site. Site hard. Applied ice and took TYLENOL and Ibuprofen. Improving.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Injection site pain
Clinical narrative: Fatigue, pain in left arm from top to wrist, nausea, chills, diarrhea, exhaustion - all of these started around 6:30am the morning after the shot. Had to take a vacation day from work. They continued the 2nd day after the shot, though they were slightly improved. Managed to work that day, but had to rest all evening. Worked the 3rd day. Was starting to finally feel better. Was a bit tired the 4th day, but that was likely because I hadn't eaten much for 3 days (too nauseous). Completely well on 5th day after shot.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity
Clinical narrative: Fatigue, pain in left arm from top to wrist, nausea, chills, diarrhea, exhaustion - all of these started around 6:30am the morning after the shot. Had to take a vacation day from work. They continued the 2nd day after the shot, though they were slightly improved. Managed to work that day, but had to rest all evening. Worked the 3rd day. Was starting to finally feel better. Was a bit tired the 4th day, but that was likely because I hadn't eaten much for 3 days (too nauseous). Completely well on 5th day after shot.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Rash
Clinical narrative: Red arm, rash.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Chills, Haematoma, Headache, Influenza like illness
Clinical narrative: Flu like symptoms (nausea, vomiting, fever, headache, chills, lethargic) swelling, large red blotch, hematoma, itching. On 4/20/2018 Pharmacist suggested extra strength TYLENOL for headache and then on 4/21/2018 suggested hydrocortisone for itching. Helped some but not much. On 4/23/2018, saw primary who prescribed a 7 day course of 500 mg Cefuroxime for Cellulitis.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Nausea, Pruritus, Pyrexia, Rash macular
Clinical narrative: Flu like symptoms (nausea, vomiting, fever, headache, chills, lethargic) swelling, large red blotch, hematoma, itching. On 4/20/2018 Pharmacist suggested extra strength TYLENOL for headache and then on 4/21/2018 suggested hydrocortisone for itching. Helped some but not much. On 4/23/2018, saw primary who prescribed a 7 day course of 500 mg Cefuroxime for Cellulitis.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling, Vomiting
Clinical narrative: Flu like symptoms (nausea, vomiting, fever, headache, chills, lethargic) swelling, large red blotch, hematoma, itching. On 4/20/2018 Pharmacist suggested extra strength TYLENOL for headache and then on 4/21/2018 suggested hydrocortisone for itching. Helped some but not much. On 4/23/2018, saw primary who prescribed a 7 day course of 500 mg Cefuroxime for Cellulitis.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Pyrexia
Clinical narrative: Very sore arm at site of injection, pain radiating down arm and into shoulder. Next day, in the afternoon, I got the shivers. Overnight, I woke at 2 am with 101.3 fever, which lasted 3 hours.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Vaccination complication
Clinical narrative: Patient's arm become red, swollen and painful. She was diagnosed with a reaction to the vaccination and prescribed prednisone.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: SHINGRIX was administered intramuscularly to the right deltoid on 5/20/18 around 1100. No acute anaphylactic reaction was observed during the 15 minutes the patient was asked to wait after receiving the vaccine. The patient had no complaints of pain, itching, or shortness of breath upon leaving the pharmacy. The patient returned to the pharmacy about 5 hours after receiving the vaccine, complaining of severe pain on her right upper arm. Patient rated the pain 9/10. Due to the severity of the pain the patient was initially recommended to be seen at an urgent care center. The patient opted to be seen at her primary care for the following day instead. Patient was advised to take acetaminophen for the pain, diphenhydramine for any itching, and cold compress to the site.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Tremor
Clinical narrative: Sore arm, shakes, low grade fever (not measured) - no treatment, started approx. 24 hours after vaccine given. Shakes and fever resolved but arm is still sore 48 hours after vaccine given.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site reaction, Injection site swelling, Skin reaction
Clinical narrative: Patient reported a superficial skin reaction at the site of injection, reporting some redness and swelling. Vaccine was inadvertently administered subcutaneously. It was supposed to be given intramuscular, however according to CDC the dose is still considered valid. Skin reaction subsided during the course of a few days.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Adrenal disorder, Chest discomfort, Condition aggravated, Dyspnoea
Clinical narrative: Several days after vaccine patient came in and said he had trouble breathing, his chest was tight, maybe had a fever, and his blood disease (adrenal gland disease) was acting up within 24 hours of having vaccine. He was not sure if he wanted to get the 2nd shot.
Age: 1.0
Sex: F
Vaccine: DTAP, PNC13, VARCEL
Symptoms: Injection site erythema, Local reaction, Upper respiratory tract infection, Vaccination site haematoma, Vaccination site swelling
Clinical narrative: Local reaction on right thigh around vaccination puncture site. Redness and swelling, noticed on Tuesday evening the size of a dime, grew continuously until Thursday morning when it was size of quarter or bigger. Small hematoma formed and still present at this time. Simultaneously, patient developed an URI requiring nebulizer albuterol treatments for 3 days.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain in extremity
Clinical narrative: Severe arm pain, requiring ice and TYLENOL. I was also shivering uncontrollably.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient states arm is red, warm, swollen, and itchy at injection site for the last 2 days. He also says he doesn't quite feel right (feels like he is getting "sick"). No treatment has been done.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Dysgeusia, Fatigue, Headache
Clinical narrative: Massive headache, fever: 101 degrees, fatigue: napped the entire day: got up at 7:30, slept from 8:30-11:30, slept again from 1-2:30, slept again from 3-5pm, no appetite, metallic taste in mouth flu-like symptoms: achy muscles, chills.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Massive headache, fever: 101 degrees, fatigue: napped the entire day: got up at 7:30, slept from 8:30-11:30, slept again from 1-2:30, slept again from 3-5pm, no appetite, metallic taste in mouth flu-like symptoms: achy muscles, chills.
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: Anuria, Cardiac failure, Cardiomegaly, Constipation, Diet refusal
Clinical narrative: Patient presented with refusal to eat and no stool or urine output for more than 6 hours. She was referred to ER, where she was found to be hypertensive and lethargic. Transferred to another hospital where she was diagnosed with myocarditis and heart failure. She was started on Milrinone and LASIX. Within 3 days she recovered. Viral respiratory panel was negative. Cause of myocarditis was not discovered.
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: Hypertension, Lethargy, Mitral valve incompetence, Myocarditis, Pulmonary arterial pressure increased
Clinical narrative: Patient presented with refusal to eat and no stool or urine output for more than 6 hours. She was referred to ER, where she was found to be hypertensive and lethargic. Transferred to another hospital where she was diagnosed with myocarditis and heart failure. She was started on Milrinone and LASIX. Within 3 days she recovered. Viral respiratory panel was negative. Cause of myocarditis was not discovered.
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: Respiratory viral panel, Viral test negative
Clinical narrative: Patient presented with refusal to eat and no stool or urine output for more than 6 hours. She was referred to ER, where she was found to be hypertensive and lethargic. Transferred to another hospital where she was diagnosed with myocarditis and heart failure. She was started on Milrinone and LASIX. Within 3 days she recovered. Viral respiratory panel was negative. Cause of myocarditis was not discovered.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Headache, fever, body muscle pain, flu-like symptoms.
Age: 36.0
Sex: M
Vaccine: MMR, TDAP, VARCEL
Symptoms: Eye swelling, Pyrexia, Respiratory symptom
Clinical narrative: Patient developed a fever that lasted 3 days post vaccination. Is also experiencing swelling around his eyes, as well as upper respiratory symptoms not resolved if treated as seasonal allergies (has persisted since vaccination until present).
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Laboratory test, Pruritus, Rash
Clinical narrative: Patient came on May 8 to pickup a prescription to help for the rash on his arm, legs and torso. He had the rash 1 week after the SHINGRIX shot. The rash gets better and he's on CLARITIN daily for itchy 5/20/18.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Varicella
Clinical narrative: Patient came on May 8 to pickup a prescription to help for the rash on his arm, legs and torso. He had the rash 1 week after the SHINGRIX shot. The rash gets better and he's on CLARITIN daily for itchy 5/20/18.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Pruritus
Clinical narrative: Pt reports itchy, tingling on hands, elbows going up the arms without any physical rash. Pt has been using BENADRYL. Pt states no new perfume, detergents not any new OTC or Rx meds.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site rash, Rash, Rash erythematous
Clinical narrative: Patient developed Nonpruritic rash on left upper arm at injection site, under breasts and then spread to back and neck on left area.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: Patient developed Nonpruritic rash on left upper arm at injection site, under breasts and then spread to back and neck on left area.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Patient developed Nonpruritic rash on left upper arm at injection site, under breasts and then spread to back and neck on left area.
Age: 83.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 83-year-old female who received SHINGRIX. Concurrent medical conditions included hypertension and drug allergy (allergy to buspirone, corticosteroids, ACE inhibitors and nizatidine). Concomitant products included valsartan and clonidine. On 12th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site erythema and injection site warmth. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema and injection site warmth were recovered/resolved. The reporter considered the extensive swelling of vaccinated limb, injection site erythema and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine in unknown deltoid. In 2018, the patient developed significant swelling with size of a baseball around the injection site (extensive swelling of vaccinated limb). The reporting pharmacist stated that, she was not sure when the patient's symptoms began, but the symptoms lasted for 2.5 weeks. The pharmacist was not aware of any medical intervention taken. The pharmacist did not have lot number or expiration date.
Age: 83.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 83-year-old female who received SHINGRIX. Concurrent medical conditions included hypertension and drug allergy (allergy to buspirone, corticosteroids, ACE inhibitors and nizatidine). Concomitant products included valsartan and clonidine. On 12th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site erythema and injection site warmth. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema and injection site warmth were recovered/resolved. The reporter considered the extensive swelling of vaccinated limb, injection site erythema and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine in unknown deltoid. In 2018, the patient developed significant swelling with size of a baseball around the injection site (extensive swelling of vaccinated limb). The reporting pharmacist stated that, she was not sure when the patient's symptoms began, but the symptoms lasted for 2.5 weeks. The pharmacist was not aware of any medical intervention taken. The pharmacist did not have lot number or expiration date.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Chills, Decreased appetite, Diarrhoea, Fatigue, Injection site cellulitis
Clinical narrative: Rash, redness, swelling and pain at injection site since 5/12/18, rash continuing to spread.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Rash, redness, swelling and pain at injection site since 5/12/18, rash continuing to spread.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Pruritus generalised, Pyrexia, Urge incontinence
Clinical narrative: Rash, redness, swelling and pain at injection site since 5/12/18, rash continuing to spread.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Rash, redness, swelling and pain at injection site since 5/12/18, rash continuing to spread.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Allodynia, Blister, Headache, Pain, Pruritus
Clinical narrative: Headache, itching, allodynia, rash, blisters, pain.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Headache, itching, allodynia, rash, blisters, pain.
Age: 69.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Chills, Injection site erythema, Injection site swelling, Lymphadenopathy, Pyrexia
Clinical narrative: Redness and swelling at the injection site. Pt also endorsed fever and chills for the past several days. And swelling of the lymph nodes.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia, Tremor
Clinical narrative: Fever with shaking chills at night. Headache. Fever was gone by 10:00a the next day.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Mobility decreased, Myalgia, Pain
Clinical narrative: Couple hours after vaccination reported extreme fatigue, muscle aches and pains throughout entire body. Reported having for 2 days and unable to get out of bed.
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous non-valid report as received from a pharmacist refers to a patient of unknown age and gender. Patients' concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, units and frequency not reported) (lot# and expiration date not reported) intramuscularly. On an unknown date, patients experienced soreness at injection site. The outcome of the event injection site pain was not reported. The reporter did not provide the causal relationship for the event with suspect therapy PNEUMOVAX 23. This is a non-valid spontaneous report due to lack of patient identifiers. Upon receipt of follow-up information it was determined that this case is now valid because of patient identifier. Information has been received from a pharmacist on 16-MAY-2018. Reporter clarified that, this report refers to male patient of an unknown age. This is one of the multiple reports received from the same reporter. Sender's Comments: US-009507513-1805USA007662: US-009507513-1805USA007660: US-009507513-1805USA007661.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions or concomitant medication were not informed. On 09-APR-2018, the patient received an expired dose of M-M-R II lot # M016233, expiration date 31-MAR-2018, subcutaneously, for prophylaxis (dosage information was not informed). No known adverse effects.
Age: 4.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report as received from a medical assistant via Center, refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 09-MAY-2018, the patient was vaccinated with PROQUAD injection (Strength, anatomical location, route, lot # and expiry date were not reported) for prophylaxis. Other suspect therapies included VARIVAX and diluents for reconstitution of PROQUAD and VARIVAX. On the same day, during the same office visit, the patient was vaccinated with PROQUAD and VARIVAX. It was unknown if the patient experienced a reaction after being provided PROQUAD and VARIVAX during the same office visit on the same day. As of 09-MAY-2018, it was unknown if the patient would receive future doses of PROQUAD or VARIVAX.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 35 year old female patient. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On an unspecified date "5 or 10 years ago", the patient was vaccinated with PNEUMOVAX 23 (dose, route, lot number and expiration date were not reported) for prophylaxis. Since an unknown date, the patient had been experiencing "pneumonia a lot", and for that reason, she had been requesting a revaccination of PNEUMOVAX 23. The outcome of pneumonia and the causal relationship between the event and PNEUMOVAX 23 was not reported. Upon internal review, the event of pneumonia was considered to be as medically significant.