chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Nausea, Pain, Pyrexia
Clinical narrative: Fever 102.2, chills, body aches, dizziness, nausea. Lasted for 15 hours. Went away on it?s own.
Age: 89.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Burning sensation, Injection site pain, Injection site warmth, Sleep disorder
Clinical narrative: Patient received the vaccine in the left deltoid on 10/07. Patient noticed soreness in his deltoid muscle the day after the vaccine was given, on 10/8, but his pain increased dramatically in intensity on 10/15, roughly 1 week after the vaccine was administered. Patient described a burning sensation which began in his deltoid and radiated down his fingertips, and also radiated to his left scapular region. Patient applied a lidocaine patch to his left scapular region the evening of 10/15, and experienced temporary relief of the pain. However, the pain resumed on 10/17 and interrupted his sleep that night, and patient visited the pharmacy on 10/18. Examination of the patient revealed pinpoint tenderness in the central area of his deltoid muscle and mild warmth to the deltoid region. No redness, induration, or area of flocculance was observed.  Patient was able to abduct his arm 90 degrees easily. Patient was encouraged to continue the lidocaine patches, and also supplement with ibuprofen for 1 week for the pain. Patient was told to contact his primary care physician if his symptoms did not mostly resolve in 1 week's time.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site haemorrhage, Pallor, Syncope
Clinical narrative: patient fainted.  pale. After seeing her arm bleed after the immunization.  Bleeding was stopped with cotton ball and bandaid. Had patient drink water, had parents fan the patient to keep her cool, had her stay seated,  breathing exercise.  Called family about an hour later and father said she is feeling fine.
Age: 66.0
Sex: F
Vaccine: FLUC4
Symptoms: Contusion, Erythema, Skin warm
Clinical narrative: Redness, warm to the touch the size of tennis ball, then couple Days turning into light bruising .
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Chills, Diarrhoea, Eye pruritus, Fatigue
Clinical narrative: About 4 hours after receiving the vaccine (day 1) I developed itchy, watery eyes, swelling at the back of my throat and diarrhea. An hour later I developed uncontrollable shaking chills. I took Benedryl and Tylenol and laid down under the covers. After an hour I fell asleep but awoke a couple of hours later with nausea. Day 2: I was very weak and tired all day. The diarrhea continued until the afternoon. By evening I was able to tolerate some soup.
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Lacrimation increased, Nausea, Pharyngeal swelling, Tremor
Clinical narrative: About 4 hours after receiving the vaccine (day 1) I developed itchy, watery eyes, swelling at the back of my throat and diarrhea. An hour later I developed uncontrollable shaking chills. I took Benedryl and Tylenol and laid down under the covers. After an hour I fell asleep but awoke a couple of hours later with nausea. Day 2: I was very weak and tired all day. The diarrhea continued until the afternoon. By evening I was able to tolerate some soup.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: Next day experienced Fever, nausea, headache, achy body, fatigue, Sore throat, cough and diarrhea
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Oropharyngeal pain, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Next day experienced Fever, nausea, headache, achy body, fatigue, Sore throat, cough and diarrhea
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PPV, RV5
Symptoms: Abnormal faeces, Blood test abnormal, Hepatic enzyme abnormal, Immediate post-injection reaction, Immunoglobulins decreased
Clinical narrative: Patient was solely breastfed. Patient became increasingly fussy and irritable immediately after his vaccines on 10/16/2017. His poops started looking and smelling very abnormal (and did not return to normal until months later after initiation of probiotics). on 11/25/2017 I checked his temperature for the first time ever rectally, he was 102. We went to the ER but they sent us home without doing any bloodwork.  Then 12/5/2017 we went to the ER again for fever (as the fevers never went away, they kept occurring daily) and his bloodwork showed he was Neutropenic. His fevers never went away, he had recurrent fevers which led to him being admitted to Hospital on 12/13/2017 for 2 days. It was there that it was discovered he was severely Neutropenic and he was put on Neutropenic precautions. His liver values were also out of range. He was discharged after 2 days later because he was otherwise thriving and there were no explanations for his fevers.  The fevers would frequently occur, almost daily, for months. There were several other trips to the ER per MD advice since that December admission. Further work-up showed his Immunoglobulins were low, his liver enzymes were consistently out of range, his Neutrophils were low several times.  He saw many specialists. We declined further vaccinations due to his recurrent fevers and abnormal bloodwork. An Immunologist, Dr., at Hospital eventually diagnosed Patient with Transient Hypogammaglobulinemia at 9 months of age.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PPV, RV5
Symptoms: Irritability, Liver function test abnormal, Neutropenia, Neutrophil count decreased, Pyrexia
Clinical narrative: Patient was solely breastfed. Patient became increasingly fussy and irritable immediately after his vaccines on 10/16/2017. His poops started looking and smelling very abnormal (and did not return to normal until months later after initiation of probiotics). on 11/25/2017 I checked his temperature for the first time ever rectally, he was 102. We went to the ER but they sent us home without doing any bloodwork.  Then 12/5/2017 we went to the ER again for fever (as the fevers never went away, they kept occurring daily) and his bloodwork showed he was Neutropenic. His fevers never went away, he had recurrent fevers which led to him being admitted to Hospital on 12/13/2017 for 2 days. It was there that it was discovered he was severely Neutropenic and he was put on Neutropenic precautions. His liver values were also out of range. He was discharged after 2 days later because he was otherwise thriving and there were no explanations for his fevers.  The fevers would frequently occur, almost daily, for months. There were several other trips to the ER per MD advice since that December admission. Further work-up showed his Immunoglobulins were low, his liver enzymes were consistently out of range, his Neutrophils were low several times.  He saw many specialists. We declined further vaccinations due to his recurrent fevers and abnormal bloodwork. An Immunologist, Dr., at Hospital eventually diagnosed Patient with Transient Hypogammaglobulinemia at 9 months of age.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PPV, RV5
Symptoms: Transient hypogammaglobulinaemia of infancy
Clinical narrative: Patient was solely breastfed. Patient became increasingly fussy and irritable immediately after his vaccines on 10/16/2017. His poops started looking and smelling very abnormal (and did not return to normal until months later after initiation of probiotics). on 11/25/2017 I checked his temperature for the first time ever rectally, he was 102. We went to the ER but they sent us home without doing any bloodwork.  Then 12/5/2017 we went to the ER again for fever (as the fevers never went away, they kept occurring daily) and his bloodwork showed he was Neutropenic. His fevers never went away, he had recurrent fevers which led to him being admitted to Hospital on 12/13/2017 for 2 days. It was there that it was discovered he was severely Neutropenic and he was put on Neutropenic precautions. His liver values were also out of range. He was discharged after 2 days later because he was otherwise thriving and there were no explanations for his fevers.  The fevers would frequently occur, almost daily, for months. There were several other trips to the ER per MD advice since that December admission. Further work-up showed his Immunoglobulins were low, his liver enzymes were consistently out of range, his Neutrophils were low several times.  He saw many specialists. We declined further vaccinations due to his recurrent fevers and abnormal bloodwork. An Immunologist, Dr., at Hospital eventually diagnosed Patient with Transient Hypogammaglobulinemia at 9 months of age.
Age: 82.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: patient complains of arm pain and stiffness that has not improved with time
Age: 35.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Patient complains of shoulder pain that has not subsided since injection
Age: 34.0
Sex: F
Vaccine: FLUR4
Symptoms: Hypersensitivity, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: About 4-5 hours after receiving flu shot, substantial swelling  had formed around injection site (circle with diameter of about 5 inches). Swollen skin was warm and tender to the touch. Center of swollen area was reddish, surrounded by tight white skin, with a reddish border. Itching was minimal. Doctor recommended treatment with Benadryl (standard dosage, per directions on bottle)
Age: 34.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site warmth
Clinical narrative: About 4-5 hours after receiving flu shot, substantial swelling  had formed around injection site (circle with diameter of about 5 inches). Swollen skin was warm and tender to the touch. Center of swollen area was reddish, surrounded by tight white skin, with a reddish border. Itching was minimal. Doctor recommended treatment with Benadryl (standard dosage, per directions on bottle)
Age: 18.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Dizziness, Dyspnoea, Fatigue, Headache
Clinical narrative: Started about 45-60 minutes after injection.  Fever between 99-100. Nausea. Weakness. Muscle ache. Dizzy. Blurry vision. Headache. Shortness of breath- only for a short time. Feeling faint. Very tired.
Age: 18.0
Sex: F
Vaccine: UNK
Symptoms: Myalgia, Nausea, Pyrexia, Vision blurred
Clinical narrative: Started about 45-60 minutes after injection.  Fever between 99-100. Nausea. Weakness. Muscle ache. Dizzy. Blurry vision. Headache. Shortness of breath- only for a short time. Feeling faint. Very tired.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: Pins and needles back, underside of tongue; Slight fever (99.5 F) . Symptoms lasted 5-6 hours.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Skin warm, Swelling, Vomiting
Clinical narrative: Swelling, redness, warmth, vomiting, redness from shoulder to about an inch above elbow as of right now
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Blood culture negative, Erythema, Haemoglobin normal, Neutrophil count decreased, Neutrophil percentage decreased
Clinical narrative: One week after vaccines he started with a temp of 101.4.  Fever lasted from that Thursday until Sunday.  Went to ER 9/27/2020. 9/28/2020 developed rash from neck down on back/trunk.  9/29/2020 seen in office, 1-2 mm blanching papules on back, trunk, arms, legs.  Slight pink cheeks.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Pallor, Papule, Platelet count normal, Pyrexia, Rash
Clinical narrative: One week after vaccines he started with a temp of 101.4.  Fever lasted from that Thursday until Sunday.  Went to ER 9/27/2020. 9/28/2020 developed rash from neck down on back/trunk.  9/29/2020 seen in office, 1-2 mm blanching papules on back, trunk, arms, legs.  Slight pink cheeks.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: White blood cell count decreased
Clinical narrative: One week after vaccines he started with a temp of 101.4.  Fever lasted from that Thursday until Sunday.  Went to ER 9/27/2020. 9/28/2020 developed rash from neck down on back/trunk.  9/29/2020 seen in office, 1-2 mm blanching papules on back, trunk, arms, legs.  Slight pink cheeks.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: high fever (103) and axillary lymph node swelling
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Body temperature increased, Cerebrovascular accident, Muscle spasms, Musculoskeletal stiffness
Clinical narrative: Immediately felt a stiff neck (left side) that slowly over the course of hours spread to my Left shoulder and became extremely painful muscle spasms. Even my lips throbbed. At 6 am on 10/1702020 I was so debilitated, I could hardly move a muscle. I felt like I was having a stroke or blood clot. We waited for the walk in clinic to open at 9am, but since I?d been up all night in extreme pain I laid down and slept a while. I felt like the symptoms had let up a bit so decided to convalesce at home unless it got worse. At the peak of the pain I was running a temperature of 99.4. I?m usually 97,6. My bloodpressure and heartbeat were normal.  Then ever so slowly the pain has pulled back and reduced in area affected so that by 6 PM Sunday, 10/18/2020 I could only detect some residue pain in my neck ( left side) where it all started.  I did not expect a reaction since I took this vaccine last year. But there must be a difference that blew me out of the water this time. It was so painful and horrible. A 10 on the pain scale.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Thrombosis
Clinical narrative: Immediately felt a stiff neck (left side) that slowly over the course of hours spread to my Left shoulder and became extremely painful muscle spasms. Even my lips throbbed. At 6 am on 10/1702020 I was so debilitated, I could hardly move a muscle. I felt like I was having a stroke or blood clot. We waited for the walk in clinic to open at 9am, but since I?d been up all night in extreme pain I laid down and slept a while. I felt like the symptoms had let up a bit so decided to convalesce at home unless it got worse. At the peak of the pain I was running a temperature of 99.4. I?m usually 97,6. My bloodpressure and heartbeat were normal.  Then ever so slowly the pain has pulled back and reduced in area affected so that by 6 PM Sunday, 10/18/2020 I could only detect some residue pain in my neck ( left side) where it all started.  I did not expect a reaction since I took this vaccine last year. But there must be a difference that blew me out of the water this time. It was so painful and horrible. A 10 on the pain scale.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: SHIVERS, FEVER, at 10 pm on 10/17/20. took Advil which didn't seem to help. Took  Tylenol that helped. Shivers, fever again at 7:45 pm on 10/18/20. Took tylenol.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site of injection is red, swollen & painful for up to 3 days after vaccine
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Area of injection raised / red inflamed.
Age: 81.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Incoherent, Posture abnormal, Somnolence
Clinical narrative: 24 hours after vaccination patient was unable to awaken, slowly throughout the following 24 h the patients husband said she was starting to respond but not make sense and couldn't hold her head up. no fever reported, symptoms all resolved by 72 hours.
Age: 80.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Injection site erythema, Injection site warmth, Mobility decreased
Clinical narrative: Patient Presented with Red - warm Injection site reaction, complained of Discomfort and Limited Mobility, possible bursitis
Sex: U
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: Bell's Palsy; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. At the time of the patient's vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through patient's healthcare provider(s) that zoster vaccine live (ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced the patient to be vaccinated. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider for Bell's palsy. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event Bell's palsy was not reported and the lawyer considered the event to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review the event Bell's palsy was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer referring to a female patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 11-SEP-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered an outbreak of shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event shingles was considered to be not recovered and causal relationship was assessed as related.    The lawyer considered the event shingles to be disability.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: chills; headache; Fever; This spontaneous report was received from a 66-year-old female patient who was nurse practitioner, referring to herself. The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported.      In October 2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis and influenza virus vaccine (unspecified)(reported as flu); for both vaccines (strengths, dose, route of administration, anatomical location, lot number and expiration date were not reported).      On an unknown date, the patient experienced pyrexia, headache and chills.      The outcome of chills, pyrexia and headache of aforementioned event was not reported. The causality between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and influenza virus vaccine (unspecified)(reported as flu) was reported as related.   This is one of two reports received from the same patient.; Sender's Comments:  US-009507513-2006USA008232:
Age: 80.0
Sex: F
Vaccine: VARZOS, FLU4, FLUA4, MMR, VARZOS
Symptoms: Back pain, Chest pain, Herpes zoster, Lip swelling
Clinical narrative: Full blown shingles:  9/22 2020 vacine: Shingrix (10-pk) kit 9/24 " all symtoms pain, shigles left under chest and back, lips, inside of mouth. Tongue.  10/4 2020 Drs office have shingles. in the area 1 1/2 days later. To date having pain, aching and a sore left arm where the MMR vaccine was given. It has been over a month with pain. I have been using a heat pad, Ben gay ice, Ibuprofen and has not helped much. Amount of aching pain varies throughout the day, sometimes severe. Sometimes it actually wakes me from sleep or keeps me from having a good nights sleep.  P.S. Shingle; almost 16 days. Still I have blisters under the chest (left side) and back. Lips and inside mouth (gums x tongue). I thought taking vaccine preventing from illness. Flu vaccine: I got flu. Shingles vaccine: I got shingles And I am suffering all these, those, symptoms.
Age: 80.0
Sex: F
Vaccine: VARZOS, FLU4, FLUA4, MMR, VARZOS
Symptoms: Allergy to vaccine, Cough, Diarrhoea, Nausea, Pain
Clinical narrative: Full blown shingles:  9/22 2020 vacine: Shingrix (10-pk) kit 9/24 " all symtoms pain, shigles left under chest and back, lips, inside of mouth. Tongue.  10/4 2020 Drs office have shingles. in the area 1 1/2 days later. To date having pain, aching and a sore left arm where the MMR vaccine was given. It has been over a month with pain. I have been using a heat pad, Ben gay ice, Ibuprofen and has not helped much. Amount of aching pain varies throughout the day, sometimes severe. Sometimes it actually wakes me from sleep or keeps me from having a good nights sleep.  P.S. Shingle; almost 16 days. Still I have blisters under the chest (left side) and back. Lips and inside mouth (gums x tongue). I thought taking vaccine preventing from illness. Flu vaccine: I got flu. Shingles vaccine: I got shingles And I am suffering all these, those, symptoms.
Age: 80.0
Sex: F
Vaccine: VARZOS, FLU4, FLUA4, MMR, VARZOS
Symptoms: Pain in extremity, Vomiting
Clinical narrative: Full blown shingles:  9/22 2020 vacine: Shingrix (10-pk) kit 9/24 " all symtoms pain, shigles left under chest and back, lips, inside of mouth. Tongue.  10/4 2020 Drs office have shingles. in the area 1 1/2 days later. To date having pain, aching and a sore left arm where the MMR vaccine was given. It has been over a month with pain. I have been using a heat pad, Ben gay ice, Ibuprofen and has not helped much. Amount of aching pain varies throughout the day, sometimes severe. Sometimes it actually wakes me from sleep or keeps me from having a good nights sleep.  P.S. Shingle; almost 16 days. Still I have blisters under the chest (left side) and back. Lips and inside mouth (gums x tongue). I thought taking vaccine preventing from illness. Flu vaccine: I got flu. Shingles vaccine: I got shingles And I am suffering all these, those, symptoms.
Age: 80.0
Sex: F
Vaccine: VARZOS, FLU4, FLUA4, MMR, VARZOS
Symptoms: Blister, Gingival blister, Herpes zoster, Influenza, Lip blister
Clinical narrative: Full blown shingles:  9/22 2020 vacine: Shingrix (10-pk) kit 9/24 " all symtoms pain, shigles left under chest and back, lips, inside of mouth. Tongue.  10/4 2020 Drs office have shingles. in the area 1 1/2 days later. To date having pain, aching and a sore left arm where the MMR vaccine was given. It has been over a month with pain. I have been using a heat pad, Ben gay ice, Ibuprofen and has not helped much. Amount of aching pain varies throughout the day, sometimes severe. Sometimes it actually wakes me from sleep or keeps me from having a good nights sleep.  P.S. Shingle; almost 16 days. Still I have blisters under the chest (left side) and back. Lips and inside mouth (gums x tongue). I thought taking vaccine preventing from illness. Flu vaccine: I got flu. Shingles vaccine: I got shingles And I am suffering all these, those, symptoms.
Age: 80.0
Sex: F
Vaccine: VARZOS, FLU4, FLUA4, MMR, VARZOS
Symptoms: Oral mucosal blistering, Pain, Pain in extremity, Sleep disorder, Tongue blistering
Clinical narrative: Full blown shingles:  9/22 2020 vacine: Shingrix (10-pk) kit 9/24 " all symtoms pain, shigles left under chest and back, lips, inside of mouth. Tongue.  10/4 2020 Drs office have shingles. in the area 1 1/2 days later. To date having pain, aching and a sore left arm where the MMR vaccine was given. It has been over a month with pain. I have been using a heat pad, Ben gay ice, Ibuprofen and has not helped much. Amount of aching pain varies throughout the day, sometimes severe. Sometimes it actually wakes me from sleep or keeps me from having a good nights sleep.  P.S. Shingle; almost 16 days. Still I have blisters under the chest (left side) and back. Lips and inside mouth (gums x tongue). I thought taking vaccine preventing from illness. Flu vaccine: I got flu. Shingles vaccine: I got shingles And I am suffering all these, those, symptoms.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9
Symptoms: Anxiety, Dizziness, Tachycardia
Clinical narrative: On July 29th 2020, my son was given 3 vaccines at pediatrics, 2 of which he has had before. One was the Gardasil vaccine. It was shortly after he started having flu like symtoms. We have been in and out of the ER since that day. Side effects are chest pain, memory loss, sensations in his legs and chest, loss of feeling in his legs to where he is urinating on himself, trimmers that are not seizures which an eeg ruled that out this past week. fainting, blurred vision, pins and needles in his face he says it feels like. These symtoms have gone on since July and each week it gets worse. He cannot attend school anymore, or any sports that he was playing at the time. We have been admitted to hospital twice and now we are in waiting for a referal so we can be seen by another facility. We have had an eeg, ekg, and two spinal taps. His ekg read normal. We are waiting on the other results as it will be 2 weeks before facility gets them.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9
Symptoms: Amnesia, Chest pain, Electrocardiogram normal, Electroencephalogram normal, Impaired work ability
Clinical narrative: On July 29th 2020, my son was given 3 vaccines at pediatrics, 2 of which he has had before. One was the Gardasil vaccine. It was shortly after he started having flu like symtoms. We have been in and out of the ER since that day. Side effects are chest pain, memory loss, sensations in his legs and chest, loss of feeling in his legs to where he is urinating on himself, trimmers that are not seizures which an eeg ruled that out this past week. fainting, blurred vision, pins and needles in his face he says it feels like. These symtoms have gone on since July and each week it gets worse. He cannot attend school anymore, or any sports that he was playing at the time. We have been admitted to hospital twice and now we are in waiting for a referal so we can be seen by another facility. We have had an eeg, ekg, and two spinal taps. His ekg read normal. We are waiting on the other results as it will be 2 weeks before facility gets them.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9
Symptoms: Influenza like illness, Loss of bladder sensation, Loss of personal independence in daily activities, Lumbar puncture, Paraesthesia
Clinical narrative: On July 29th 2020, my son was given 3 vaccines at pediatrics, 2 of which he has had before. One was the Gardasil vaccine. It was shortly after he started having flu like symtoms. We have been in and out of the ER since that day. Side effects are chest pain, memory loss, sensations in his legs and chest, loss of feeling in his legs to where he is urinating on himself, trimmers that are not seizures which an eeg ruled that out this past week. fainting, blurred vision, pins and needles in his face he says it feels like. These symtoms have gone on since July and each week it gets worse. He cannot attend school anymore, or any sports that he was playing at the time. We have been admitted to hospital twice and now we are in waiting for a referal so we can be seen by another facility. We have had an eeg, ekg, and two spinal taps. His ekg read normal. We are waiting on the other results as it will be 2 weeks before facility gets them.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9
Symptoms: Sensory loss, Syncope, Tremor, Vision blurred
Clinical narrative: On July 29th 2020, my son was given 3 vaccines at pediatrics, 2 of which he has had before. One was the Gardasil vaccine. It was shortly after he started having flu like symtoms. We have been in and out of the ER since that day. Side effects are chest pain, memory loss, sensations in his legs and chest, loss of feeling in his legs to where he is urinating on himself, trimmers that are not seizures which an eeg ruled that out this past week. fainting, blurred vision, pins and needles in his face he says it feels like. These symtoms have gone on since July and each week it gets worse. He cannot attend school anymore, or any sports that he was playing at the time. We have been admitted to hospital twice and now we are in waiting for a referal so we can be seen by another facility. We have had an eeg, ekg, and two spinal taps. His ekg read normal. We are waiting on the other results as it will be 2 weeks before facility gets them.
Age: 25.0
Sex: F
Vaccine: FLU4, FLU4, FLU4
Symptoms: Pharyngeal swelling, Pruritus
Clinical narrative: she was fine after getting the vaccine, when she reached her car, she started feeling that her throat is closing , having difficulty breathing,   didn't call 911, nor went back to pharmacy to ask for help, but instead drove herself to the hospital, Patient said, she wasn't given any injection to reverse any allergic reaction, or to aid for her difficulty in breathing, but instead, she was given oral steroid, & hydroxyzine,  was given prescription for prednisone, hydroxyzine & famotidine
Age: 25.0
Sex: F
Vaccine: FLU4, FLU4, FLU4
Symptoms: Anaphylactic reaction, Immediate post-injection reaction, Pharyngeal swelling
Clinical narrative: she was fine after getting the vaccine, when she reached her car, she started feeling that her throat is closing , having difficulty breathing,   didn't call 911, nor went back to pharmacy to ask for help, but instead drove herself to the hospital, Patient said, she wasn't given any injection to reverse any allergic reaction, or to aid for her difficulty in breathing, but instead, she was given oral steroid, & hydroxyzine,  was given prescription for prednisone, hydroxyzine & famotidine
Age: 25.0
Sex: F
Vaccine: FLU4, FLU4, FLU4
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: she was fine after getting the vaccine, when she reached her car, she started feeling that her throat is closing , having difficulty breathing,   didn't call 911, nor went back to pharmacy to ask for help, but instead drove herself to the hospital, Patient said, she wasn't given any injection to reverse any allergic reaction, or to aid for her difficulty in breathing, but instead, she was given oral steroid, & hydroxyzine,  was given prescription for prednisone, hydroxyzine & famotidine
Age: 21.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect route of product administration
Clinical narrative: Patient administrated VARIVAX as an intramuscular dose, rather than subcutaneous dose; This spontaneous report has been received from a pharmacy intern referring to a 21 years old male patient. The patient's pertinent medical history, concomitant therapies and drug allergy or reactions were unknown.  On 22-SEP-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (lot# S019462 has been verified to be a valid lot number, expiration date: 24-JUN-2021, strength was unknown) 1 dose intramuscularly, rather than subcutaneously for prophylaxis (incorrect route of product administration). The pharmacy intern would like to know if she needed to administer another dose.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: an expired (exp date 8/12/2020) dose of PNEUMOVAX 23 was administered to the patient on 9/30/2020; This spontaneous report has been received from a medical assistance, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 30-SEP-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # S004547 with expiration date 12-AUG-2020, 0.5 milliliter(frequency, route and anatomical location were not provided) for prophylaxis. The reporter inquired about revaccination.   combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 37.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: A patient received Gardasil 9 about 2 years ago; The patient is wanting to finish the series; This spontaneous report has been received from a pharmacist referring to a 37 year old male patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.    On an unspecified date in 2018 (reported as "about 2 years ago"), the patient was vaccinated with the first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) dose 1 (strength, dose, route, frequency, anatomical location, lot # and expiration date were not provided) for prophylaxis. It was reported that the patient want to administer the third dose (inappropriate schedule of product administration and circumstance or information capable of leading to medication error).
Age: 39.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: they administered a PNEUMOVAX 23 vaccine to a patient and then realized the vaccine had expired.; This spontaneous report was received from an office manager referring to a 39 years old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 09-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S002582, expiration date 10-AUG-2020; dose and route were not reported) for prophylaxis, then realized the vaccine had expired (expired product administered). They were wanting to know if the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vaccine was still viable. No prior excursions. Device was not available for evaluation (obtain was false). combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S002582; expirationdate: 10-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: MMR
Symptoms: Product preparation error
Clinical narrative: Caller states a different diluent was used to reconstitute a dose of MMR II and it was given to a patient.; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.  On 05-OCT-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) 1 dosage form (Route of administration, lot number and expiration date were not provided) for immunization, that was reconstituted with a different diluent, rather  than sterile water.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Lymphadenitis, Pyrexia
Clinical narrative: Fever; unilateral lymphadenitis; inflammatory parotitis on the left side; This spontaneous report was received from a physician referring to a 4-year-old male patient. The patient had no concomitant medications, no pertinent medical history and no drug reactions/allergies.   On 09-OCT-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 0.5 milliliter, subcutaneous for immunisation (strength, lot number and expiration date were not reported) and within 12 hours after receiving the vaccine, the patient developed a fever (pyrexia), unilateral lymphadenitis and possibly inflammatory parotitis on the left side.      The patient recceived trreatment with antipyretic and at the time of reporting, he was recovering from pyrexia, lymphadenitis and parotitis.  The causal relationship between measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and all the reported events was unknonwn.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: HCP calling to report improperly stored vaccine was administer prior to temperature excursion evaluation.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 14-OCT-2020, the patient was administered an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, lot number S028919, expiration date 16-SEP-2021 (route of administration was not provided) for prophylaxis.         The vaccine had a temperature excursion ranging from 6 Fahrenheit degrees (°F) to 14 °F with an average of 13.1 °F for 5 hours and 32 minutes. The vaccine had been exposed to previous temperature excursions. The call was due to digital data logger.
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Hodgkin's disease, Product administered at inappropriate site
Clinical narrative: he now has a diagnosis of Hodgkin's lymphoma; her son received GARDASIL 9 in the buttocks; This spontaneous report was received from a office manager who is the patient's mother via company representative and was referring to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) also reported as quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), (conflicting information), in the patient's buttocks (product administered at inappropriate site), (strength, dose, dose number, frequency, lot number and expiration date were not reported), as prophylaxis.  On an unknown date (also reported as "now"), the patient had a diagnosis of Hodgkin's Lymphoma (hodgkin's disease).  At the time of reporting, the outcome of hodgkin's disease was unknown, and the reporter did not assess the causal relationship between the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) or Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine(GARDASIL) with Hodgkin's Lymphoma (hodgkin's disease).     Upon internal review Hodgkin's Lymphoma (hodgkin's disease) was determined to be a medically significant event.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: 17 year old male fainted on the 2rd dose of GARDASIL 9; Information has been received from a physician, referring to a 17 year old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported On an unknown date, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot number, expiration date, anatomical location and administration route were not reported) for prophylaxis.        On 26-NOV-2019, the patient fainted (syncope) on the second dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). The outcome of syncope was unknown.       The casuality assessment between the syncope and the vaccination with the third dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported. Upon internal review, the fainted was considered as a medically significant event.  This is one of three reports received from the same source.; Sender's Comments:  US-009507513-2010USA004817: US-009507513-2010USA006059:
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: 15 year old male fainted on the 3rd dose of GARDASIL 9; Information has been received from a physician, referring to a 15 year old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported On an unknown date, the patient was vaccinated with the third dose of GARDASIL 9 (lot number, expiration date, anatomical location and administration route were not reported) for prophylaxis.        On 22-FEB-2014, the patient fainted (syncope) on the third dose of GARDASIL 9. The outcome of syncope was unknown.       The causality assessment between the syncope and the vaccination with the third dose of GARDASIL 9 was not reported. Upon internal review, the fainted was considered as a medically significant event. This is one of three reports received from the same source; Sender's Comments:  US-009507513-2010USA004817: US-009507513-2010USA006056:
Sex: U
Vaccine: MENB
Symptoms: Swelling
Clinical narrative: Commonly sees swelling after injections; This case was reported by a nurse via call center representative and described the occurrence of swelling in a patient who received Men B NVS BEXSERO for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, unknown after receiving BEXSERO, the patient experienced swelling. On an unknown date, the outcome of the swelling was unknown.   The reporter considered the swelling to be unlikely related to Bexsero.  Additional details were provided as follows:  The age at vaccination was not reported. The patient's experienced swelling after injections. The nurse did not have any patient details available at the time of reporting. The reporter did not take the patient's follow up phone call to the office. However, the nurse states if safety wanted to follow up, she would likely be able to gather the patient details if needed. The reporter consented to follow up. This case had been linked to the case US2020202283 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020202283:same reporter,specific patient
Sex: F
Vaccine: FLUX
Symptoms: Paraesthesia, Throat tightness
Clinical narrative: tightening of her throat; tingling in her extremities; This case was reported by a nurse via sales rep and described the occurrence of throat tightness in a 75-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2019-2020 season. On an unknown date, several hours after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced throat tightness and tingling of extremity. The patient was treated with corticosteroid nos (Corticosteroids Nos). On an unknown date, the outcome of the throat tightness and tingling of extremity were unknown.   The reporter considered the throat tightness and tingling of extremity to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported but could be 74 or 75 years. The patient received a flu vaccine in fall 2019 (specific product unknown). Several hours later she experienced tightening of her throat and tingling in her extremities. The patient went to the emergency room and was administered corticosteroids. The patient told the health care provider that the emergency room physician told her the symptoms were likely caused by the flu vaccine. No further information is available.
Sex: F
Vaccine: MEN
Symptoms: Cerebrovascular accident
Clinical narrative: altering mid brain stroke; This case was reported by a consumer via interactive digital media and described the occurrence of stroke in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, 24 hrs after receiving Meningococcal B vaccine, the patient experienced stroke (serious criteria GSK medically significant). On an unknown date, the outcome of the stroke was unknown.   It was unknown if the reporter considered the stroke to be related to Meningococcal B vaccine.  Additional details were provided as follows: The case was reported by patient's parent. The age at vaccination was not reported. The patient was experienced about her life altering mid brain stroke 24 hours after receiving this vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: I got hives for about 1 week after shot #1/ intermittent hives; This case was reported by a consumer via call center representative and described the occurrence of hives in a 59-year-old patient who received Herpes zoster (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 hives. On an unknown date, the outcome of the hives was recovered/resolved.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient experienced intermittent hives for a week after first shot. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles/ came down with shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included adalimumab (Humira) for rheumatoid arthritis.   Concurrent medical conditions included rheumatoid arthritis.   On an unknown date, the patient received Shingrix and Humira (subcutaneous) at an unknown dose and frequency. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The action taken with Humira was unknown. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received shingrix vaccine and humira and experienced shingles. The reporter did not have the lot number information for humira because the packaging was discarded. The reporter's causality for the event shingle with humira was no reasonable possibility. No concomitant drugs taken by patient. No relevant medical history was reported. No known allergies were reported. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.