chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: U
Vaccine: HIBV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 3-year-old patient of unknown gender. On 06-MAR-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and a dose of VARIVAX lot number N021720 (expiration date: 10-AUG-2019) (doses, routes and anatomical locations of administration were not provided for both vaccines) for prophylaxis. This is one of multiple reports received from the same reporter.; Sender's Comments: US-009507513-1807USA011661:
Age: 5.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Wrong product administered
Clinical narrative: This spontaneous report was received from a medical assistant concerning to a 5-year-old patient, of unknown gender. Additional patient's information was not provided. On an unknown date, the patient was vaccinated with M-M-R II (strength, dose, route of administration, lot # and expiration date were not provided) rather than PROQUAD lot # N031294, expiration date 21-AUG-2019, for prophylaxis (strength and dose were not provided). Other suspect therapies included sterile diluent for prophylaxis (strength, dose, route of administration, lot # and expiration date were not provided). No adverse effects were reported.
Sex: F
Vaccine: HPVX
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: This spontaneous report was received from a consumer who is also a patient mother and refers to a female patient in her early twenties. No information regarding the patient's concurrent condition, medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date, the patient had unidentified Merck hpv vaccine administered (name, lot number and expiration date not provided) 1 injection in upper arm to avoid HPV. On an unknown date (reported as a month after the vaccination), the patient developed injection site swelling and hardening under the skin. The outcome of the injection site swelling and hardening under the skin was reported as recovered about a week after it appeared. The relatedness between the event and unidentified Merck hpv vaccine was not reported.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Apathy, Asthenia, Chills, Decreased appetite, Depression
Clinical narrative: Day 1 - increasingly tired - couldn't drive home after work, slight nausea, aching muscles entire body. Day 2 - all above plus fever-like symptoms (chills, sweating, nightmares), loss of appetite but no fever. Day 3 - all above plus frequent urination, feeling really ill - more sick than I have ever felt in my adult life (not since I had mono as a child). Day 4 to Day 21 - feeling weak, unmotivated, lethargic, depressed, muscle pain (especially in legs) off and on. Day 22 - 25 unusually tired, increasing pain in muscles of legs to the point of being almost unable to walk. Day 26 (Christmas) - still unusually tired, muscle pains plus feeling nauseous, loss of appetite, feverish achiness, chills, sweats, restlessness, unable to sleep but no fever at all once again, and nightmares--feeling more sick than I ever have in my adult life (not since mono as a child). Day 27 - same as Day 26 - feeling better in mornings - fitful feverish sleep in the afternoon with difficulty waking no fever. Day 28 - Day 30 (today) - same as above, with mucus and sneezing starting and on Day 30 some head and lung congestion.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Gait disturbance, Hyperhidrosis, Impaired driving ability, Insomnia
Clinical narrative: Day 1 - increasingly tired - couldn't drive home after work, slight nausea, aching muscles entire body. Day 2 - all above plus fever-like symptoms (chills, sweating, nightmares), loss of appetite but no fever. Day 3 - all above plus frequent urination, feeling really ill - more sick than I have ever felt in my adult life (not since I had mono as a child). Day 4 to Day 21 - feeling weak, unmotivated, lethargic, depressed, muscle pain (especially in legs) off and on. Day 22 - 25 unusually tired, increasing pain in muscles of legs to the point of being almost unable to walk. Day 26 (Christmas) - still unusually tired, muscle pains plus feeling nauseous, loss of appetite, feverish achiness, chills, sweats, restlessness, unable to sleep but no fever at all once again, and nightmares--feeling more sick than I ever have in my adult life (not since mono as a child). Day 27 - same as Day 26 - feeling better in mornings - fitful feverish sleep in the afternoon with difficulty waking no fever. Day 28 - Day 30 (today) - same as above, with mucus and sneezing starting and on Day 30 some head and lung congestion.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Malaise, Myalgia, Nausea, Nightmare
Clinical narrative: Day 1 - increasingly tired - couldn't drive home after work, slight nausea, aching muscles entire body. Day 2 - all above plus fever-like symptoms (chills, sweating, nightmares), loss of appetite but no fever. Day 3 - all above plus frequent urination, feeling really ill - more sick than I have ever felt in my adult life (not since I had mono as a child). Day 4 to Day 21 - feeling weak, unmotivated, lethargic, depressed, muscle pain (especially in legs) off and on. Day 22 - 25 unusually tired, increasing pain in muscles of legs to the point of being almost unable to walk. Day 26 (Christmas) - still unusually tired, muscle pains plus feeling nauseous, loss of appetite, feverish achiness, chills, sweats, restlessness, unable to sleep but no fever at all once again, and nightmares--feeling more sick than I ever have in my adult life (not since mono as a child). Day 27 - same as Day 26 - feeling better in mornings - fitful feverish sleep in the afternoon with difficulty waking no fever. Day 28 - Day 30 (today) - same as above, with mucus and sneezing starting and on Day 30 some head and lung congestion.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pollakiuria, Poor quality sleep, Pulmonary congestion, Pyrexia, Respiratory tract congestion
Clinical narrative: Day 1 - increasingly tired - couldn't drive home after work, slight nausea, aching muscles entire body. Day 2 - all above plus fever-like symptoms (chills, sweating, nightmares), loss of appetite but no fever. Day 3 - all above plus frequent urination, feeling really ill - more sick than I have ever felt in my adult life (not since I had mono as a child). Day 4 to Day 21 - feeling weak, unmotivated, lethargic, depressed, muscle pain (especially in legs) off and on. Day 22 - 25 unusually tired, increasing pain in muscles of legs to the point of being almost unable to walk. Day 26 (Christmas) - still unusually tired, muscle pains plus feeling nauseous, loss of appetite, feverish achiness, chills, sweats, restlessness, unable to sleep but no fever at all once again, and nightmares--feeling more sick than I ever have in my adult life (not since mono as a child). Day 27 - same as Day 26 - feeling better in mornings - fitful feverish sleep in the afternoon with difficulty waking no fever. Day 28 - Day 30 (today) - same as above, with mucus and sneezing starting and on Day 30 some head and lung congestion.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Restlessness, Rhinorrhoea, Sneezing
Clinical narrative: Day 1 - increasingly tired - couldn't drive home after work, slight nausea, aching muscles entire body. Day 2 - all above plus fever-like symptoms (chills, sweating, nightmares), loss of appetite but no fever. Day 3 - all above plus frequent urination, feeling really ill - more sick than I have ever felt in my adult life (not since I had mono as a child). Day 4 to Day 21 - feeling weak, unmotivated, lethargic, depressed, muscle pain (especially in legs) off and on. Day 22 - 25 unusually tired, increasing pain in muscles of legs to the point of being almost unable to walk. Day 26 (Christmas) - still unusually tired, muscle pains plus feeling nauseous, loss of appetite, feverish achiness, chills, sweats, restlessness, unable to sleep but no fever at all once again, and nightmares--feeling more sick than I ever have in my adult life (not since mono as a child). Day 27 - same as Day 26 - feeling better in mornings - fitful feverish sleep in the afternoon with difficulty waking no fever. Day 28 - Day 30 (today) - same as above, with mucus and sneezing starting and on Day 30 some head and lung congestion.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Anxiety, Blood test, Cardiac stress test, Computerised tomogram, Dizziness
Clinical narrative: Approximately 20 minutes later started feeling tightness numbness on right side of face. About 2 hours later started feeling extremely faint, shaking, pounding heart, sweating and numbness. Called the doctors office to report. Went to ER same day. Started having pounding heart at night, panic attacks, anxiety attacks, unable to sleep. At times feel jittery, racing pulse like nerves is off. Right side of face at times is still tight tingly.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling jittery, Hyperhidrosis, Hypoaesthesia, Insomnia, Palpitations
Clinical narrative: Approximately 20 minutes later started feeling tightness numbness on right side of face. About 2 hours later started feeling extremely faint, shaking, pounding heart, sweating and numbness. Called the doctors office to report. Went to ER same day. Started having pounding heart at night, panic attacks, anxiety attacks, unable to sleep. At times feel jittery, racing pulse like nerves is off. Right side of face at times is still tight tingly.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Panic attack, Paraesthesia, Sensory disturbance, Skin tightness, Tremor
Clinical narrative: Approximately 20 minutes later started feeling tightness numbness on right side of face. About 2 hours later started feeling extremely faint, shaking, pounding heart, sweating and numbness. Called the doctors office to report. Went to ER same day. Started having pounding heart at night, panic attacks, anxiety attacks, unable to sleep. At times feel jittery, racing pulse like nerves is off. Right side of face at times is still tight tingly.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Ultrasound scan, X-ray
Clinical narrative: Approximately 20 minutes later started feeling tightness numbness on right side of face. About 2 hours later started feeling extremely faint, shaking, pounding heart, sweating and numbness. Called the doctors office to report. Went to ER same day. Started having pounding heart at night, panic attacks, anxiety attacks, unable to sleep. At times feel jittery, racing pulse like nerves is off. Right side of face at times is still tight tingly.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Influenza like illness, Myalgia, Nausea
Clinical narrative: Per patient, she is experiencing muscle aches, nausea, nightmares, lost appetite, and tiredness. It is almost like flu-like symptoms.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Nightmare
Clinical narrative: Per patient, she is experiencing muscle aches, nausea, nightmares, lost appetite, and tiredness. It is almost like flu-like symptoms.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Impaired work ability, Pyrexia, Rash, Rash erythematous
Clinical narrative: Large red shingles appearing rash measuring approximately 8" down arm, very painful but not blistering. "Road rash" appearance at four days post injection. Fever accompanied symptoms for 3 days. Unable to work due to rash and fever presence and possibility of transmission.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmological examination normal
Clinical narrative: SHINGRIX dose #2 administered by local Pharmacy not by reporting provider. Only partial product info available. Event: Patient seen in our clinic a few days after receiving his 2nd SHINGRIX vaccine. He was diagnosed with shingles rash to the right forehead. Symptoms onset the day after he received the vaccine (12/6/18), patient sent to Ophthalmology for urgent eval to rule out optic nerve involvement and was cleared for this. His primary provider would like this reported in case it is related to the vaccine in any way.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Guillain-Barre syndrome, Paraesthesia
Clinical narrative: Paresthesia, increased full body weakness. Diagnosed with Guillain-Barre 2 days after his second SHINGRIX vaccine.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Burning sensation, Injection site haemorrhage, Injection site pain, Injection site reaction
Clinical narrative: When bandage taken off in the evening there was black material on the arm (did not look like dried blood). The arm has been painful for > 2 months. There is weakness at the site, aching and burning sensation like pins and needles sticking in arm (still happening as of 12/28/2018). The site oozes at times and was last noticed bleeding 12/7/2018 (shot was given 10/12/18).
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: When bandage taken off in the evening there was black material on the arm (did not look like dried blood). The arm has been painful for > 2 months. There is weakness at the site, aching and burning sensation like pins and needles sticking in arm (still happening as of 12/28/2018). The site oozes at times and was last noticed bleeding 12/7/2018 (shot was given 10/12/18).
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Induration, Skin warm, Swelling, Tenderness
Clinical narrative: Tender for 4-5 days after, Hives that then turned into hard spots, light bruising and raised, warm skin.
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Tender for 4-5 days after, Hives that then turned into hard spots, light bruising and raised, warm skin.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Affective disorder, Chills, Headache, Lethargy, Pyrexia
Clinical narrative: High fever; extreme shivering; headache; lethargy; moody.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: Sore arm, fever, chills.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Dizziness, Hypoaesthesia, Pain in jaw
Clinical narrative: Blood pressure went up and remained higher than normal for several hours even though I was resting. Felt faint/dizzy. Had a twinge of pain in my jaw and my face felt slightly numb on that side (left).
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Pain
Clinical narrative: Pain at shot location for several days, tender to the touch. Extreme fatigue for two days. Shivering, chills two nights. Possible fever, two days. Achy for two days. I am not sure if it is Zoster SHINGRIX or ZOSTAVAX - the paper I was given did not specify.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions, past drugs and concomitant medications were unknown. On 21-DEC-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (dose, frequency and route were unknown) (lot# R015607; expiration date: 21-APR-2020) for prophylaxis. There was no adverse effect reported. The temperature and timeframe were below 32 Fahrenheit (29 Fahrenheit) for 1 hour 15 minutes. There were no previous temperature excursions. A digital data logger was involved. The outcome of product storage error and no adverse event was unknown. This is one of the three reports from the same reporter.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Erythema, Myalgia
Clinical narrative: Patient received SHINGRIX in the right deltoid and AFLURIA in the left deltoid on 10/1/2018. Per 10/2/2018 Primary Care note, patient reported generalized myalgias and dizziness 6 hours after receiving vaccines. Also has bilateral erythema and possible early cellulitis at both upper arms R greater that L. Given push fluids, Tylenol PRN fever, and Z-Pak.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy skin, Mycosis fungoides, Positron emission tomogram
Clinical narrative: CUTANEOUS T CELL LYMPHIOMA APPEARED THREE WEEKS AFTER VACCINATION.
Age: 13.0
Sex: M
Vaccine: FLUX
Symptoms: Blood test, Contusion, Haemorrhage subcutaneous, Immune thrombocytopenic purpura, Platelet count decreased
Clinical narrative: He only had the flu shot. He started bruising and having blood spots under the skin. Went to pediatrician and sent for labs. Bloodwork showed platelet count of 5. Sent to ER. Bloodwork confirmed low count. Sent to hematologist and diagnosed with ITP on 12/11/2018. Went to clinic for second opinion on 12/13/18 and diagnosis was agreed.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Injection site pain, Injection site reaction
Clinical narrative: Achiness, tenderness, and burning sensation in arm where shot was given starting on 12/3/18 through entire month. Shot was given approx. 4 inches below shoulder. No redness. No fever. Last few days, symptoms have lessened and improved.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Fatigue, Foreign travel, Headache, Influenza
Clinical narrative: Pt states coughing starts, fatigue, headache, and flu-symptoms. She for oversea trip a few days after the vaccination so unable to contact primary physician. She states she still cough and taking promethazine/dm to help with coughing.
Age: 57.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Dizziness, Injection site erythema, Myalgia, Pyrexia
Clinical narrative: Patient received SHINGRIX in the right deltoid and AFLURIA in the left deltoid on 10/1/2018. Per 10/2/2018 Primary Care note, patient reported generalized myalgias and dizziness 6 hours after receiving vaccines. Also has bilateral erythema and possible early cellulitis at both upper arms R greater than L. Given push fluids, TYLENOL prn fever, and Z-PAK.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: High fever, Influenza-like symptoms.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: High fever, influenza-like symptoms.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Nausea, Pain, Pyrexia
Clinical narrative: Feverish, nausea, soreness at injection site, fatigue, achy all over.
Age: 67.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Insomnia, Musculoskeletal pain, Myalgia, Sleep disorder
Clinical narrative: Shoulder pain that was much more severe and longer lasting than usual injection soreness. After one week, symptoms have improved somewhat, but still cannot lie down to sleep because of pain. I have been sleeping sitting up all week, a position which reduces or eliminates the ache. Pain can affect muscles down arm, including hand. I take CELEBREX routinely, tried ice the first night; now using heat and passive range of motion. Taking TYLENOL and BENADRYL at bedtime to sleep, but still wake up in pain several times.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: After leaving the immunization room the patient got lightheaded and sat down for a moment until he regained his composure. He is doing fine now.
Age: 66.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Mobility decreased
Clinical narrative: Patient said he can not move his arm for about 6 months for the vaccine that he received on 09/05/2018.
Age: 4.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Vomiting
Clinical narrative: Vomiting multiple times.
Age: 30.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Dizziness, Dysstasia, Fatigue, Feeling abnormal
Clinical narrative: Woke up the following morning with my entire body aching, chills, hot/cold and sweating. Mind was very very foggy and felt dizzy. Very hard to describe but it almost felt as if I was hallucinating and separated from my body. Seemed to feel a little better that night. Symptoms were still there and 22nd and 23rd and started to worsen around noon on the 24th. Legs ached very bad and felt as if I was hallucinating again. Tried to finish some last minute Christmas shopping but had a hard time driving, was also very hard to focus or think about anything. I went into a store for about 5 minutes and felt as if I was going to pass out while I was checking out, along with intense sweating and what I would describe as hot flashes. Tried to rest for the next few hours into the evening, but even though I was exhausted I could not sleep. As the night went on the symptoms peaked. Around 1AM on the 25th I found myself shaking, sweating, and my legs gave out two times as I tried to stand up. My face was pale and my head was so cloudy and could not think straight. I tried splashing some water on my face and to focus, and almost decided to go to the ER. At this point it felt as if I was drugged, but the feeling that was in my head is so difficult to describe. I finally fell asleep around 3am and when I awoke around 10AM the symptoms were weak and by the end of the night I felt OK again. Still don't feel 100% right though as of today 12/28.
Age: 30.0
Sex: M
Vaccine: FLU4
Symptoms: Feeling of body temperature change, Hot flush, Hyperhidrosis, Impaired driving ability, Insomnia
Clinical narrative: Woke up the following morning with my entire body aching, chills, hot/cold and sweating. Mind was very very foggy and felt dizzy. Very hard to describe but it almost felt as if I was hallucinating and separated from my body. Seemed to feel a little better that night. Symptoms were still there and 22nd and 23rd and started to worsen around noon on the 24th. Legs ached very bad and felt as if I was hallucinating again. Tried to finish some last minute Christmas shopping but had a hard time driving, was also very hard to focus or think about anything. I went into a store for about 5 minutes and felt as if I was going to pass out while I was checking out, along with intense sweating and what I would describe as hot flashes. Tried to rest for the next few hours into the evening, but even though I was exhausted I could not sleep. As the night went on the symptoms peaked. Around 1AM on the 25th I found myself shaking, sweating, and my legs gave out two times as I tried to stand up. My face was pale and my head was so cloudy and could not think straight. I tried splashing some water on my face and to focus, and almost decided to go to the ER. At this point it felt as if I was drugged, but the feeling that was in my head is so difficult to describe. I finally fell asleep around 3am and when I awoke around 10AM the symptoms were weak and by the end of the night I felt OK again. Still don't feel 100% right though as of today 12/28.
Age: 30.0
Sex: M
Vaccine: FLU4
Symptoms: Mental impairment, Muscular weakness, Pain, Pain in extremity, Pallor
Clinical narrative: Woke up the following morning with my entire body aching, chills, hot/cold and sweating. Mind was very very foggy and felt dizzy. Very hard to describe but it almost felt as if I was hallucinating and separated from my body. Seemed to feel a little better that night. Symptoms were still there and 22nd and 23rd and started to worsen around noon on the 24th. Legs ached very bad and felt as if I was hallucinating again. Tried to finish some last minute Christmas shopping but had a hard time driving, was also very hard to focus or think about anything. I went into a store for about 5 minutes and felt as if I was going to pass out while I was checking out, along with intense sweating and what I would describe as hot flashes. Tried to rest for the next few hours into the evening, but even though I was exhausted I could not sleep. As the night went on the symptoms peaked. Around 1AM on the 25th I found myself shaking, sweating, and my legs gave out two times as I tried to stand up. My face was pale and my head was so cloudy and could not think straight. I tried splashing some water on my face and to focus, and almost decided to go to the ER. At this point it felt as if I was drugged, but the feeling that was in my head is so difficult to describe. I finally fell asleep around 3am and when I awoke around 10AM the symptoms were weak and by the end of the night I felt OK again. Still don't feel 100% right though as of today 12/28.
Age: 30.0
Sex: M
Vaccine: FLU4
Symptoms: Tremor
Clinical narrative: Woke up the following morning with my entire body aching, chills, hot/cold and sweating. Mind was very very foggy and felt dizzy. Very hard to describe but it almost felt as if I was hallucinating and separated from my body. Seemed to feel a little better that night. Symptoms were still there and 22nd and 23rd and started to worsen around noon on the 24th. Legs ached very bad and felt as if I was hallucinating again. Tried to finish some last minute Christmas shopping but had a hard time driving, was also very hard to focus or think about anything. I went into a store for about 5 minutes and felt as if I was going to pass out while I was checking out, along with intense sweating and what I would describe as hot flashes. Tried to rest for the next few hours into the evening, but even though I was exhausted I could not sleep. As the night went on the symptoms peaked. Around 1AM on the 25th I found myself shaking, sweating, and my legs gave out two times as I tried to stand up. My face was pale and my head was so cloudy and could not think straight. I tried splashing some water on my face and to focus, and almost decided to go to the ER. At this point it felt as if I was drugged, but the feeling that was in my head is so difficult to describe. I finally fell asleep around 3am and when I awoke around 10AM the symptoms were weak and by the end of the night I felt OK again. Still don't feel 100% right though as of today 12/28.
Age: 18.0
Sex: F
Vaccine: FLUC4
Symptoms: Fall, Head injury, Skin laceration, Syncope
Clinical narrative: Patient fainted a few minutes after vaccination, fell and hit back of head on counter. Patient left vaccine site for urgent care to see if stiches required for laceration at back of head.
Age: 27.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site paraesthesia
Clinical narrative: Severe shoulder pain in left arm and liminted mobility. Tingling burning sensation where vaccine was administered.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Pt had redness, swelling and warm to the touch, 13 cm long.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Extreme swelling around injection site of SHINGRIX.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: High fever, influenza-like symptoms.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Hyperhidrosis, Lymphadenopathy, Pyrexia
Clinical narrative: After 2nd dose patient reported fever, sweats chills. Lymphadenopathy of (L) armpit. Low energy.
Sex: U
Vaccine: VARZOS
Symptoms: Antibody test positive, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sickness in a patient who received SHINGRIX for prophylaxis. Previously administered products included shingles vaccine. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. After receiving a dose of SHINGRIX, the patient was very sick. The physician thought that it might be reaction to shot because at the time of reporting, the patient had antibodies from the original live vaccine from several years before the reporting date. The physician recommended not to take 2nd dose of SHINGRIX. The patient was asking, what would happen if the patient would not receive the shot. Lab Comments: On an unknown date, the patient did lab test.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Product supply issue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced pain in arm and product supply issue. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the product supply issue was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: After receiving the first dose of SHINGRIX, the patient's arm was sore for a week which was part of the reason she waited until closer to six months. The patient was told to come back within 2 to 6 months to receive the second dose of SHINGRIX. Two weeks ago, from the date of reporting, the patient went back to pharmacy where she received the first dose and they told her that it was on backorder and hundreds of people were ahead of her. The patient asked if those that had the first vaccine received a priority and she was told no. The patient asked the pharmacist when she could receive her SHINGRIX shot and he said she might need to get two more shots. The patient doesn't want to start the series over again. The patient called another pharmacy and they told her they did give anyone who had the first shot a priority. The patient asked is the 6 months critical to the effectiveness of the vaccine or could it be a longer time and could you influence pharmacies to give priority to those that had already had first shot. The patient reported that it sounds like they don't even have any vaccine to distribute. This case has been linked with case US2018GSK232257, reported by same reporter.
Age: 56.0
Sex: U
Vaccine: VARZOS
Symptoms: Aphthous ulcer
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of aphthous stomatitis in a 56-year-old patient who received SHINGRIX for prophylaxis. On 27th November 2018, the patient received the 1st dose of SHINGRIX. On 28th November 2018, 1 days after receiving SHINGRIX, the patient experienced aphthous stomatitis. On an unknown date, the outcome of the aphthous stomatitis was unknown. It was unknown if the reporter considered the aphthous stomatitis to be related to SHINGRIX. Additional details were reported as follows: On Tuesday, the patient received SHINGRIX. The night before the date of reporting and on the day of reporting, the patient's mouth was filled with canker sores about 20. The patient asked if this was a side effect. When asked for physician details for follow up, the patient stated that, vaccine was administered at a pharmacy.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 77-year-old female patient who received SHINGRIX for prophylaxis. On 27th November 2018, the patient received the 2nd dose of SHINGRIX. In November 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm, erythema of extremities and fever. On an unknown date, the outcome of the pain in arm and erythema of extremities were unknown and the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the pain in arm, erythema of extremities and fever to be related to SHINGRIX. Additional details were reported as follows: On Tuesday, the patient received SHINGRIX. At the time of reporting, the patient had a large red painful area down his arm below the injection site. The patient also experienced fever for 36 hours. The reporter wanted to know, if the patient should use heat or cold for pain relief, but did not realize this constituted an adverse reaction. The reporter asked to call center representative, any thoughts on how to relieve the pain. The contact details of the physician was provided.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 54-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (reoccurred 2 times). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: After receiving SHINGRIX, the patient just broke out with one tiny spot in the same area where shingles recurred two times previously. The patient was due for her second SHINGRIX vaccine. The patient was asking if it was okay to get the vaccine today. Batch number was not provided. Clarification raised for follow up source document.
Age: 54.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult patient who received SHINGRIX for prophylaxis. In July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional information was provided as follows: The age at vaccination was not reported. The patient experienced injection site pain.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Local reaction, Swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of erythema in a 63-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema, local reaction, induration and swelling. On an unknown date, the outcome of the erythema, local reaction, induration and swelling were unknown. It was unknown if the reporter considered the erythema, local reaction, induration and swelling to be related to SHINGRIX. Additional details were provided as follows: Patient reported that, the reaction occurred 3 months before and she just notified to physician. In 2018, the patient experienced huge local reaction, redness, hardness and swelling of about 10 cm. It was lasted for almost 2 weeks.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site pain, Injection site swelling, Musculoskeletal pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site swelling, injection site pain, injection site bruising and shoulder pain. On an unknown date, the outcome of the injection site swelling, injection site pain, injection site bruising and shoulder pain were unknown. It was unknown if the reporter considered the injection site swelling, injection site pain, injection site bruising and shoulder pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine on left arm, which swelled and was very painful and bruised. The patient also experienced shoulder pain and there is a ball like knot which was formed clavicle.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in joint involving hand in a 62-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On 18th December 2018, unknown after receiving SHINGRIX, the patient experienced pain in joint involving hand, chills, headache and nausea. On an unknown date, the outcome of the pain in joint involving hand, chills, headache and nausea were not recovered/not resolved. It was unknown if the reporter considered the pain in joint involving hand, chills, headache and nausea to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. After receiving SHINGRIX injection, the patient experienced joint pain in both arms and hand, chills, headache and nausea. The reporter wanted to know how long does the side effects lasts.
Sex: U
Vaccine: VARZOS
Symptoms: Eosinophil count increased, Eosinophilia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of eosinophilia in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, several days after receiving SHINGRIX, the patient experienced eosinophilia. On an unknown date, the outcome of the eosinophilia was unknown. It was unknown if the reporter considered the eosinophilia to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. Few days after receiving SHINGRIX, the patient had lab test which was resulted mild eosinophilia. The reporter asked if any data on this with SHINGRIX. Lab Comments: On an unknown date, lab test was performed.
Sex: M
Vaccine: TDAP
Symptoms: Body temperature increased, Hypersensitivity, Learning disability
Clinical narrative: This case was reported by a consumer via media and described the occurrence of allergic reaction in a male patient who received DTPa vaccine for prophylaxis. On an unknown date, the patient received the 1st dose of DTPa vaccine. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced allergic reaction, learning disability and body temperature increased. On an unknown date, the outcome of the allergic reaction, learning disability and body temperature increased were unknown. It was unknown if the reporter considered the allergic reaction, learning disability and body temperature increased to be related to DTPa vaccine. Additional details were provided as follows: The patient was son of the reporter. Age at vaccination was not reported. The patient got his 1st DTP shot and had an allergic reaction to the Pertussis, body temperature of 106 degree F, severe academic learning disability. The reporter blamed himself/herself for this. Lab Comments: The body temperature was measured on an unknown date.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. On 8th December 2018, the patient received the 1st dose of SHINGRIX. On 19th December 2018, 11 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient had a Shingles eruption on the day before reporting on 19th December 2018. The patient was asking was this a common occurrence, could they expect more outbreaks before or after they get there 2nd shot in two months.
Sex: F
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a adolescent female patient who received BEXSERO for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to BEXSERO. Additional details were provided as follows: The age of vaccination was not reported. The patient experienced injection site pain which persisted for approximately one week. This case has been linked to the cases US2018GSK164861, US2018GSK164860 and US2018GSK091195. For tolerance of 2nd dose refer case US2018GSK233061.
Sex: F
Vaccine: MENB
Symptoms: Erythema, Pain, Swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pain in a female patient who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced pain, erythema and swelling. On an unknown date, the outcome of the pain, erythema and swelling were unknown. It was unknown if the reporter considered the pain, erythema and swelling to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient made a general statement regarding adverse event and BEXSERO that she stated that she had experienced pain, redness, and swelling.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Influenza like illness, Pain, Peripheral swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of swelling arm in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced swelling arm, erythema of extremities, influenza-like symptoms, fever, chills and pain. On an unknown date, the outcome of the swelling arm and erythema of extremities were recovered/resolved and the outcome of the influenza-like symptoms, fever, chills and pain were unknown. It was unknown if the reporter considered the swelling arm, erythema of extremities, influenza-like symptoms, fever, chills and pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient's arm swelled, was red and lasted for about 48 hours. The patient experienced flu like symptoms which were fever, chills and was achy. The reporter did not agree for follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of swelling arm in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced swelling arm, erythema of extremities, influenza-like symptoms, fever, chills and pain. On an unknown date, the outcome of the swelling arm and erythema of extremities were recovered/resolved and the outcome of the influenza-like symptoms, fever, chills and pain were unknown. It was unknown if the reporter considered the swelling arm, erythema of extremities, influenza-like symptoms, fever, chills and pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient's arm swelled, was red and lasted for about 48 hours. The patient experienced flu like symptoms which were fever, chills and was achy. The reporter did not agree for follow up.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Blood pressure decreased, Dizziness, Immediate post-injection reaction, Pallor, Pulse abnormal
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of syncope in a 18-year-old male patient who received BEXSERO (batch number ABX766AA, expiry date July 2020) for prophylaxis. Co-suspect products included MENVEO for prophylaxis. The patient's past medical history included syncope (similar episode occurred on 7th April 2014) and sickness. On 19th November 2018, the patient received the 1st dose of BEXSERO .5 ml and MENVEO. On 19th November 2018, immediately after receiving BEXSERO and MENVEO, the patient experienced syncope (serious criteria GSK medically significant), dizziness, pallor, blood pressure decreased and pulse weak. The patient was treated with nutritional supplement nos (Pediasure) and citric acid + glucose + potassium phosphate monobasic + sodium chloride + sodium citrate + sucrose (Gatorade). On an unknown date, the outcome of the syncope was recovered/resolved and the outcome of the dizziness, pallor, blood pressure decreased and pulse weak were unknown. It was unknown if the reporter considered the syncope, dizziness, pallor, blood pressure decreased and pulse weak to be related to BEXSERO and MENVEO. Additional details were reported as follows: According to the physician, the patient visited to a physician because the patient was sick but no vaccine was administered at this visit. The patient received BEXSERO on the left arm. On 19th November 2018, the patient received MENVEO on the right arm. Almost immediately (like within 2 minutes) after vaccination, the patient experienced dizzy, face and lips were pale. The patient was lie down and this was all had in the office. The physician took pulses and noted they were weak but blood pressure was 110/70. So, the patient was observed and syncope resolved without further issue or medical intervention. On 19th November 2018 around 3:40 PM, the patient visited to a physician. The physician informed that, the patient had not anything to eat all day but drunk only Gatorade. The patient was left office at 4:40 pm with instructions from physician to eat something. On 20th December 2018, the patient received 2nd dose of BEXSERO without any incident. The reporter agreed upon follow up from GlaxoSmithKline.