chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Peripheral swelling, Pruritus, Pyrexia, Rash generalised, Skin warm
Clinical narrative: On 06/19/17, approximately 2-3 hours after having the HPV vaccination, patient began complaining of being itchy on his head and neck area. He woke up the next morning, 6/20/17 with hives and rash all over his body. They were red, hot to the touch and itchy and covered most of his upper body. I took him to urgent care in the evening and he was treated with ZYRTEC. The hives/rash continued in 06/21/17 and we took him to the Emergency Room in the early hours of 06/21/17 because the hives/rash had spread across his entire body. He was treated with Prednisone, ZYRTEC, and additional medications. The hives and rash continued into 6/22/17 and in the early morning of 06/23/17 we again took him back to the Emergency Room due to continued hives/rash but he also began a fever and vomiting. He also had a swollen face, his airway was itchy, and his lips were swollen. He was treated with an EPIPEN and he was continued on the Prednisone and ZYRTEC. He was kept at the hospital under observation until approximately 6:00pm. He was released. Prior to his leaving the hospital it complained of a stomach ache. He was given nausea medication. His stomach ache continued and the rash/hives began to inflame and were extremely itchy into the early morning hours of 06/24/17. His lips were swollen and his hands and feet began to swell.  He continues to have the rash and hives all over his body.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Swelling face, Throat irritation, Urticaria, Vomiting
Clinical narrative: On 06/19/17, approximately 2-3 hours after having the HPV vaccination, patient began complaining of being itchy on his head and neck area. He woke up the next morning, 6/20/17 with hives and rash all over his body. They were red, hot to the touch and itchy and covered most of his upper body. I took him to urgent care in the evening and he was treated with ZYRTEC. The hives/rash continued in 06/21/17 and we took him to the Emergency Room in the early hours of 06/21/17 because the hives/rash had spread across his entire body. He was treated with Prednisone, ZYRTEC, and additional medications. The hives and rash continued into 6/22/17 and in the early morning of 06/23/17 we again took him back to the Emergency Room due to continued hives/rash but he also began a fever and vomiting. He also had a swollen face, his airway was itchy, and his lips were swollen. He was treated with an EPIPEN and he was continued on the Prednisone and ZYRTEC. He was kept at the hospital under observation until approximately 6:00pm. He was released. Prior to his leaving the hospital it complained of a stomach ache. He was given nausea medication. His stomach ache continued and the rash/hives began to inflame and were extremely itchy into the early morning hours of 06/24/17. His lips were swollen and his hands and feet began to swell.  He continues to have the rash and hives all over his body.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Blood culture negative, Polymerase chain reaction, Pyrexia, Respiratory viral panel, Urine analysis normal
Clinical narrative: 7 days of fever following vaccine administration. Hospitalized for prolonged fevers. Respiratory panels were negative and nonfocal exam.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Viral test negative
Clinical narrative: 7 days of fever following vaccine administration. Hospitalized for prolonged fevers. Respiratory panels were negative and nonfocal exam.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Fatigue, Vomiting
Clinical narrative: Fatigue, vomiting.
Age: 42.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Blood test, Dysstasia, Hyperhidrosis, Hypopnoea, Laboratory test
Clinical narrative: Paralysis, shallow breathing, shaking, sweating profusely.
Age: 42.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Mobility decreased, Paralysis, Tremor
Clinical narrative: Paralysis, shallow breathing, shaking, sweating profusely.
Age: 42.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Abasia, Dyspnoea, Monoplegia, Tremor
Clinical narrative: Paralysis, shallow breathing, shaking, sweating profusely.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Redness, swelling and pain.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Headache, Injection site pain, Pain, Pain in extremity
Clinical narrative: Injection site was sore all day. Around 3PM onset of entire body aches. Chills started along with a headache and fever 101.3. The fever started to come down after several hours and noticed red splotches on the same arm. Slept for 10 hours. Fever was normal next morning but still had some body aches and the red splotches got a bigger and the entire top part of the arm is sore.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Rash macular
Clinical narrative: Injection site was sore all day. Around 3PM onset of entire body aches. Chills started along with a headache and fever 101.3. The fever started to come down after several hours and noticed red splotches on the same arm. Slept for 10 hours. Fever was normal next morning but still had some body aches and the red splotches got a bigger and the entire top part of the arm is sore.
Age: 63.0
Sex: M
Vaccine: TDAP
Symptoms: Cold sweat, Decreased appetite, Diarrhoea, Dizziness, Fatigue
Clinical narrative: Patient felt faint on the way home. Passed out briefly about 1/2 hour after vaccination. Over the next 24 hours: nausea, vomiting, loss of appetite, diarrhea, clammy skin, cold sweats. Subsided after 1 and 1/2 days, with remaining malaise and tiredness.
Age: 63.0
Sex: M
Vaccine: TDAP
Symptoms: Loss of consciousness, Malaise, Nausea, Vomiting
Clinical narrative: Patient felt faint on the way home. Passed out briefly about 1/2 hour after vaccination. Over the next 24 hours: nausea, vomiting, loss of appetite, diarrhea, clammy skin, cold sweats. Subsided after 1 and 1/2 days, with remaining malaise and tiredness.
Age: 17.0
Sex: M
Vaccine: MEN
Symptoms: Abdominal pain upper, Fatigue, Headache
Clinical narrative: Headache, stomach ache, fatigue.
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site swelling, Pain
Clinical narrative: Patient presented with extremely swollen upper left (immunized) arm. The swelling is more so at the bicep area compared to deltoid when the immunization would normally be given at. The whole area is red and hard to touch. Pt was unable to stretch his arm into a normal position as it cause him a lot of pain if he tried.
Age: 0.17
Sex: M
Vaccine: HEPA, RV5
Symptoms: No adverse event, Respiratory tract congestion, Wrong drug administered
Clinical narrative: On 5/15/17, child seen for nurse to give Hep B vaccine (vaccine ordered 5/1/17 by MD). Nurse accidentally gave Hep A vaccine. Mild congestion reported by mom 6/5/17 - but no fever, no rash, no irritability/crying, local RXN at injection site. Child's hx and exam all benign on 6/24/17. Mistake by LPN discovered when lot # checked. No adverse RXN noted from vaccine administration error.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Local swelling, Peripheral swelling
Clinical narrative: Severe swelling in arm developed within 24 hours of administration 06/21/17. Seen in ER 06/22 treated with Prednisone and BENADRYL. Swelling 7cm x 5cm with circumferential swell on follow up 6/24 decreased to 4.5cmx3.5cm.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Lymphadenopathy, Pruritus
Clinical narrative: Redness around injection site. Redness under armpit. Swollen lymph node. Pain as area of injection. Slight itching.
Age: 62.0
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Cellulitis, Discomfort, Injection site erythema, Injection site induration
Clinical narrative: Blister/cellulitis.
Age: 62.0
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site mass, Rash, Skin warm, Vaccination complication
Clinical narrative: Blister/cellulitis.
Age: 62.0
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Blister/cellulitis.
Age: 62.0
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site vesicles, Injection site warmth, Pain
Clinical narrative: Blister/cellulitis.
Age: 62.0
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Cellulitis
Clinical narrative: Blister/cellulitis.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Peripheral swelling
Clinical narrative: PATIENT STATED THAT HE WOKE UP THIS MORNING AND THAT HIS ARM WAS SWOLLEN HARD TO LIFT. IT WAS THE ARM THAT PNEUMOVAX 23 WAS ADMINISTERED INTRAMUSCULARLY. NO FEVER OR PAIN WAS REPORTED BY PATIENT.
Age: 42.0
Sex: M
Vaccine: TYP
Symptoms: Pruritus, Rash, Rash macular
Clinical narrative: Rash developed on forehead, later red splotches developed on arms and legs, itching. Patient took ZYRTEC until all typhoid capsules taken and itching and rash and itching subsided.
Age: 32.0
Sex: F
Vaccine: ANTH, JEV1, SMALL, TYP
Symptoms: Pain, Papule, Pruritus
Clinical narrative: Onset of painful/itching papules on dorsum of hands and elbows bilaterally 3-4 days after receiving small pox vaccination, Concern for Eczema Vaccinatum. Denies prior hx of eczema.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis contact, Injection site reaction, Rash erythematous, Vaccination site reaction
Clinical narrative: Patient developed a flat red rash near injection site, which is suspected to be related to bandage adhesive vs vaccine reaction.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Severe pain when injecting, pain has continued for 3 weeks and transverse to hand.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphagia, Local reaction, Palpitations, Swelling, Swollen tongue
Clinical narrative: Local reaction, swelling throughout the day, then 6/25/2017 pt complained of difficulty swallowing, swollen tongue, racing heart rate.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Haematochezia
Clinical narrative: Bloody stool.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site reaction, Pruritus, Rash pruritic
Clinical narrative: Pt. thought felt itchy after giving but also said that sometimes has reaction to adhesive so removed BANDAID. Before pt. left after waiting a while to leave pts. redness seemed gone. Pt. came back in on 6/25/17 after going to Urgent Care because had circular itchy rash around injection site.
Age: 54.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Burning sensation, Computerised tomogram normal, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: The patient is a 54 yo female with a history of arm pain after receipt of IIV (lot and brand unknown) on 07 OCT 2016 at pharmacy. She experienced no immediate pain. She states about two hours later it started to hurt became progressively painful and by the next day felt like being stung by a bee. She denies local site reaction of erythema, but felt like it was hot and edematous, (but reports providers did not feel was edematous.). Pain improved somewhat but spread to include her upper arm and shoulder then worsened. It disrupted sleep and had difficulty with ADLs such as dressing or reaching, especially above her head. She was seen in urgent care and treated with topical KENALOG which was not helpful. She was seen in ER the day before holiday but does not think they took her seriously and feels they thought she was drug seeking. She was prescribed SOMA and hydrocodone, which helped but limited and then stopped use due to severe nausea and emesis. She also started experiencing pain in her thumb, followed by an electric sensation to her index, middle and ring finger. She reports a history of C5-C7 stenosis, had been told it was bilateral and had experienced similar pain in her other arm, but not on that side before. She has noted increased difficulty with ROM due to pain, particularly moving her arm above her head. She reports weakness to the arm, but denies difficulty with grasp, is not dropping things nor described numbness, but is unsure if the weakness is nerves vs. muscles. She states she was seen on 09 DEC and they ordered CT scan which was negative except for minimal osteophyte formation. She has been receiving PT and has completed 10 sessions. At this point the pain has significantly improved decreased to maximum of 4/10 but remains disruptive. She has self-treated with ice, heat, TYLENOL, Ibuprofen 800 2-3x per day. She reports the injection site was 'high in the deltoid' and she is sure of that because there was residual depression at the site for several months. She states providers told her the site placement was still correct. She states she is of thin body habitus. She denies previous injury. Ortho and neuro referrals. MRI and NCS completed but significant delay after event onset. Declined steroid injection at last ortho visit June 06-2017.
Age: 54.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Musculoskeletal pain, Pain in extremity, X-ray limb normal
Clinical narrative: The patient is a 54 yo female with a history of arm pain after receipt of IIV (lot and brand unknown) on 07 OCT 2016 at pharmacy. She experienced no immediate pain. She states about two hours later it started to hurt became progressively painful and by the next day felt like being stung by a bee. She denies local site reaction of erythema, but felt like it was hot and edematous, (but reports providers did not feel was edematous.). Pain improved somewhat but spread to include her upper arm and shoulder then worsened. It disrupted sleep and had difficulty with ADLs such as dressing or reaching, especially above her head. She was seen in urgent care and treated with topical KENALOG which was not helpful. She was seen in ER the day before holiday but does not think they took her seriously and feels they thought she was drug seeking. She was prescribed SOMA and hydrocodone, which helped but limited and then stopped use due to severe nausea and emesis. She also started experiencing pain in her thumb, followed by an electric sensation to her index, middle and ring finger. She reports a history of C5-C7 stenosis, had been told it was bilateral and had experienced similar pain in her other arm, but not on that side before. She has noted increased difficulty with ROM due to pain, particularly moving her arm above her head. She reports weakness to the arm, but denies difficulty with grasp, is not dropping things nor described numbness, but is unsure if the weakness is nerves vs. muscles. She states she was seen on 09 DEC and they ordered CT scan which was negative except for minimal osteophyte formation. She has been receiving PT and has completed 10 sessions. At this point the pain has significantly improved decreased to maximum of 4/10 but remains disruptive. She has self-treated with ice, heat, TYLENOL, Ibuprofen 800 2-3x per day. She reports the injection site was 'high in the deltoid' and she is sure of that because there was residual depression at the site for several months. She states providers told her the site placement was still correct. She states she is of thin body habitus. She denies previous injury. Ortho and neuro referrals. MRI and NCS completed but significant delay after event onset. Declined steroid injection at last ortho visit June 06-2017.
Age: 54.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Computerised tomogram normal, Injection site atrophy, Injection site oedema, Injection site warmth, Joint range of motion decreased
Clinical narrative: The patient is a 54 yo female with a history of arm pain after receipt of IIV (lot and brand unknown) on 07 OCT 2016 at pharmacy. She experienced no immediate pain. She states about two hours later it started to hurt became progressively painful and by the next day felt like being stung by a bee. She denies local site reaction of erythema, but felt like it was hot and edematous, (but reports providers did not feel was edematous.). Pain improved somewhat but spread to include her upper arm and shoulder then worsened. It disrupted sleep and had difficulty with ADLs such as dressing or reaching, especially above her head. She was seen in urgent care and treated with topical KENALOG which was not helpful. She was seen in ER the day before holiday but does not think they took her seriously and feels they thought she was drug seeking. She was prescribed SOMA and hydrocodone, which helped but limited and then stopped use due to severe nausea and emesis. She also started experiencing pain in her thumb, followed by an electric sensation to her index, middle and ring finger. She reports a history of C5-C7 stenosis, had been told it was bilateral and had experienced similar pain in her other arm, but not on that side before. She has noted increased difficulty with ROM due to pain, particularly moving her arm above her head. She reports weakness to the arm, but denies difficulty with grasp, is not dropping things nor described numbness, but is unsure if the weakness is nerves vs. muscles. She states she was seen on 09 DEC and they ordered CT scan which was negative except for minimal osteophyte formation. She has been receiving PT and has completed 10 sessions. At this point the pain has significantly improved decreased to maximum of 4/10 but remains disruptive. She has self-treated with ice, heat, TYLENOL, Ibuprofen 800 2-3x per day. She reports the injection site was 'high in the deltoid' and she is sure of that because there was residual depression at the site for several months. She states providers told her the site placement was still correct. She states she is of thin body habitus. She denies previous injury. Ortho and neuro referrals. MRI and NCS completed but significant delay after event onset. Declined steroid injection at last ortho visit June 06-2017.
Age: 54.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Loss of personal independence in daily activities, Muscular weakness, Musculoskeletal pain, Nerve conduction studies abnormal, Nuclear magnetic resonance imaging abnormal
Clinical narrative: The patient is a 54 yo female with a history of arm pain after receipt of IIV (lot and brand unknown) on 07 OCT 2016 at pharmacy. She experienced no immediate pain. She states about two hours later it started to hurt became progressively painful and by the next day felt like being stung by a bee. She denies local site reaction of erythema, but felt like it was hot and edematous, (but reports providers did not feel was edematous.). Pain improved somewhat but spread to include her upper arm and shoulder then worsened. It disrupted sleep and had difficulty with ADLs such as dressing or reaching, especially above her head. She was seen in urgent care and treated with topical KENALOG which was not helpful. She was seen in ER the day before holiday but does not think they took her seriously and feels they thought she was drug seeking. She was prescribed SOMA and hydrocodone, which helped but limited and then stopped use due to severe nausea and emesis. She also started experiencing pain in her thumb, followed by an electric sensation to her index, middle and ring finger. She reports a history of C5-C7 stenosis, had been told it was bilateral and had experienced similar pain in her other arm, but not on that side before. She has noted increased difficulty with ROM due to pain, particularly moving her arm above her head. She reports weakness to the arm, but denies difficulty with grasp, is not dropping things nor described numbness, but is unsure if the weakness is nerves vs. muscles. She states she was seen on 09 DEC and they ordered CT scan which was negative except for minimal osteophyte formation. She has been receiving PT and has completed 10 sessions. At this point the pain has significantly improved decreased to maximum of 4/10 but remains disruptive. She has self-treated with ice, heat, TYLENOL, Ibuprofen 800 2-3x per day. She reports the injection site was 'high in the deltoid' and she is sure of that because there was residual depression at the site for several months. She states providers told her the site placement was still correct. She states she is of thin body habitus. She denies previous injury. Ortho and neuro referrals. MRI and NCS completed but significant delay after event onset. Declined steroid injection at last ortho visit June 06-2017.
Age: 54.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Pain, Pain in extremity, Paraesthesia, Sleep disorder, Tendon disorder
Clinical narrative: The patient is a 54 yo female with a history of arm pain after receipt of IIV (lot and brand unknown) on 07 OCT 2016 at pharmacy. She experienced no immediate pain. She states about two hours later it started to hurt became progressively painful and by the next day felt like being stung by a bee. She denies local site reaction of erythema, but felt like it was hot and edematous, (but reports providers did not feel was edematous.). Pain improved somewhat but spread to include her upper arm and shoulder then worsened. It disrupted sleep and had difficulty with ADLs such as dressing or reaching, especially above her head. She was seen in urgent care and treated with topical KENALOG which was not helpful. She was seen in ER the day before holiday but does not think they took her seriously and feels they thought she was drug seeking. She was prescribed SOMA and hydrocodone, which helped but limited and then stopped use due to severe nausea and emesis. She also started experiencing pain in her thumb, followed by an electric sensation to her index, middle and ring finger. She reports a history of C5-C7 stenosis, had been told it was bilateral and had experienced similar pain in her other arm, but not on that side before. She has noted increased difficulty with ROM due to pain, particularly moving her arm above her head. She reports weakness to the arm, but denies difficulty with grasp, is not dropping things nor described numbness, but is unsure if the weakness is nerves vs. muscles. She states she was seen on 09 DEC and they ordered CT scan which was negative except for minimal osteophyte formation. She has been receiving PT and has completed 10 sessions. At this point the pain has significantly improved decreased to maximum of 4/10 but remains disruptive. She has self-treated with ice, heat, TYLENOL, Ibuprofen 800 2-3x per day. She reports the injection site was 'high in the deltoid' and she is sure of that because there was residual depression at the site for several months. She states providers told her the site placement was still correct. She states she is of thin body habitus. She denies previous injury. Ortho and neuro referrals. MRI and NCS completed but significant delay after event onset. Declined steroid injection at last ortho visit June 06-2017.
Age: 27.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of gastrointestinal pain in a adult female patient who received Hepatitis B vaccine. Co-suspect products included ENGERIX B (batch number XM59T, expiry date 29th May 2019). On an unknown date, patient received Hepatitis B vaccine at an unknown dose. On 13th May 2017 15:00, the patient received the 1st dose ENGERIX B (intramuscular) 1 ml. On 13th May 2017 20:00, not applicable after receiving Hepatitis B vaccine and 5 hrs after receiving ENGERIX B, the patient experienced gastrointestinal pain and diarrhea. On an unknown date, the patient experienced gastrointestinal pain and diarrhea. On 14th May 2017, the outcome of the gastrointestinal pain and diarrhea were recovered/resolved. On an unknown date, the outcome of the gastrointestinal pain and diarrhea were recovered/resolved. It was unknown if the reporter considered the gastrointestinal pain and diarrhea to be related to Hepatitis B vaccine. The reporter considered the gastrointestinal pain and diarrhea to be almost certainly related to Hepatitis B vaccine. The reporter considered the gastrointestinal pain and diarrhea to be almost certainly related to ENGERIX B. It was unknown if the reporter considered the gastrointestinal pain and diarrhea to be related to ENGERIX B. Additional details were reports as follows: The reporter reported that the patient developed severe diarrhoea and gastrointestinal pain. It was reported that the patient received hepatitis B serious 2 years ago and had the same reaction. At the time of vaccination with ENGERIX B, the patient age was 27 years. It was reported that the ENGERIX B was not going to be continued. The reporter asked healthcare professional about patient revaccination if she received a complete hepatitis B series two years ago but the healthcare professional did not know. It was reported that the patient was not on dialysis. The healthcare professional did not know brand of hepatitis B vaccine given. The patient was working in a plasma collection center.
Age: 27.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Diarrhoea, Gastrointestinal pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of gastrointestinal pain in a adult female patient who received Hepatitis B vaccine. Co-suspect products included ENGERIX B (batch number XM59T, expiry date 29th May 2019). On an unknown date, patient received Hepatitis B vaccine at an unknown dose. On 13th May 2017 15:00, the patient received the 1st dose ENGERIX B (intramuscular) 1 ml. On 13th May 2017 20:00, not applicable after receiving Hepatitis B vaccine and 5 hrs after receiving ENGERIX B, the patient experienced gastrointestinal pain and diarrhea. On an unknown date, the patient experienced gastrointestinal pain and diarrhea. On 14th May 2017, the outcome of the gastrointestinal pain and diarrhea were recovered/resolved. On an unknown date, the outcome of the gastrointestinal pain and diarrhea were recovered/resolved. It was unknown if the reporter considered the gastrointestinal pain and diarrhea to be related to Hepatitis B vaccine. The reporter considered the gastrointestinal pain and diarrhea to be almost certainly related to Hepatitis B vaccine. The reporter considered the gastrointestinal pain and diarrhea to be almost certainly related to ENGERIX B. It was unknown if the reporter considered the gastrointestinal pain and diarrhea to be related to ENGERIX B. Additional details were reports as follows: The reporter reported that the patient developed severe diarrhoea and gastrointestinal pain. It was reported that the patient received hepatitis B serious 2 years ago and had the same reaction. At the time of vaccination with ENGERIX B, the patient age was 27 years. It was reported that the ENGERIX B was not going to be continued. The reporter asked healthcare professional about patient revaccination if she received a complete hepatitis B series two years ago but the healthcare professional did not know. It was reported that the patient was not on dialysis. The healthcare professional did not know brand of hepatitis B vaccine given. The patient was working in a plasma collection center.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Asthenia, Fatigue, Headache, Immediate post-injection reaction, Influenza like illness
Clinical narrative: This is a spontaneous report from a contactable 66-year-old female consumer reporting for herself. A 66-year-old female patient received PREVNAR 13, via an unspecified route of administration on 05Apr2017 at 0.5 ml, single for immunisation. Medical history included blood glucose increased at  6.1  pain from an unknown date, pancreatectomy partial pancreatectomy and splenectomy because of the birth control pill in 1989, urticaria due to Sulphides. Ended up in the emergency ward (not clarified if she was hospitalized) with hives from head to toe. That's happened several times. Also had hallucinations, night sweats, muscle twitches and nightmares with PERCOCET and PERGONAL, and Migraine headache with Fluticasone. There were no concomitant medications. The patient previously took cephalexin and experienced hepatitis, and pyrexia, ciprofloxacin and experienced swelling face and lymphadenopathy. About 28 years before the patient received an unspecified pneumococcal vaccination. The day after vaccination the patient experienced acute nausea, relenting headache which is horrible, tremendous amount of indigestion, gas, on an unspecified date with outcome of not recovered, and arm was sore on an unspecified date with outcome of unknown. The patient had Chinese medicine, acupuncture and done 5 treatments so far. The patient underwent lab tests and procedures which included blood test: nothing at that point or since then, blood glucose: 6.1 on an unknown date.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site pain, Nausea
Clinical narrative: This is a spontaneous report from a contactable 66-year-old female consumer reporting for herself. A 66-year-old female patient received PREVNAR 13, via an unspecified route of administration on 05Apr2017 at 0.5 ml, single for immunisation. Medical history included blood glucose increased at  6.1  pain from an unknown date, pancreatectomy partial pancreatectomy and splenectomy because of the birth control pill in 1989, urticaria due to Sulphides. Ended up in the emergency ward (not clarified if she was hospitalized) with hives from head to toe. That's happened several times. Also had hallucinations, night sweats, muscle twitches and nightmares with PERCOCET and PERGONAL, and Migraine headache with Fluticasone. There were no concomitant medications. The patient previously took cephalexin and experienced hepatitis, and pyrexia, ciprofloxacin and experienced swelling face and lymphadenopathy. About 28 years before the patient received an unspecified pneumococcal vaccination. The day after vaccination the patient experienced acute nausea, relenting headache which is horrible, tremendous amount of indigestion, gas, on an unspecified date with outcome of not recovered, and arm was sore on an unspecified date with outcome of unknown. The patient had Chinese medicine, acupuncture and done 5 treatments so far. The patient underwent lab tests and procedures which included blood test: nothing at that point or since then, blood glucose: 6.1 on an unknown date.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Acupuncture, Blood glucose normal, Blood test, Dyspepsia, Flatulence
Clinical narrative: This is a spontaneous report from a contactable 66-year-old female consumer reporting for herself. A 66-year-old female patient received PREVNAR 13, via an unspecified route of administration on 05Apr2017 at 0.5 ml, single for immunisation. Medical history included blood glucose increased at  6.1  pain from an unknown date, pancreatectomy partial pancreatectomy and splenectomy because of the birth control pill in 1989, urticaria due to Sulphides. Ended up in the emergency ward (not clarified if she was hospitalized) with hives from head to toe. That's happened several times. Also had hallucinations, night sweats, muscle twitches and nightmares with PERCOCET and PERGONAL, and Migraine headache with Fluticasone. There were no concomitant medications. The patient previously took cephalexin and experienced hepatitis, and pyrexia, ciprofloxacin and experienced swelling face and lymphadenopathy. About 28 years before the patient received an unspecified pneumococcal vaccination. The day after vaccination the patient experienced acute nausea, relenting headache which is horrible, tremendous amount of indigestion, gas, on an unspecified date with outcome of not recovered, and arm was sore on an unspecified date with outcome of unknown. The patient had Chinese medicine, acupuncture and done 5 treatments so far. The patient underwent lab tests and procedures which included blood test: nothing at that point or since then, blood glucose: 6.1 on an unknown date.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Headache, Laboratory test, Nausea, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable 66-year-old female consumer reporting for herself. A 66-year-old female patient received PREVNAR 13, via an unspecified route of administration on 05Apr2017 at 0.5 ml, single for immunisation. Medical history included blood glucose increased at  6.1  pain from an unknown date, pancreatectomy partial pancreatectomy and splenectomy because of the birth control pill in 1989, urticaria due to Sulphides. Ended up in the emergency ward (not clarified if she was hospitalized) with hives from head to toe. That's happened several times. Also had hallucinations, night sweats, muscle twitches and nightmares with PERCOCET and PERGONAL, and Migraine headache with Fluticasone. There were no concomitant medications. The patient previously took cephalexin and experienced hepatitis, and pyrexia, ciprofloxacin and experienced swelling face and lymphadenopathy. About 28 years before the patient received an unspecified pneumococcal vaccination. The day after vaccination the patient experienced acute nausea, relenting headache which is horrible, tremendous amount of indigestion, gas, on an unspecified date with outcome of not recovered, and arm was sore on an unspecified date with outcome of unknown. The patient had Chinese medicine, acupuncture and done 5 treatments so far. The patient underwent lab tests and procedures which included blood test: nothing at that point or since then, blood glucose: 6.1 on an unknown date.
Age: 50.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS, TDAP, VARZOS
Symptoms: Blister, Cold sweat, Hot flush, Hyperhidrosis, Injection site erythema
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 50 year old female patient. The patient's medical history, concurrent conditions, drug and allergy history were not reported. On 13-JUN-2017, the patient was vaccinated with ZOSTAVAX injection, lot # M039453 expiration date 19-DEC-2017 (strength and route of administration were not provided) for prophylaxis. The vaccine was reconstitued with an sterile water diluent(MERCK STERILE DILUENT), lot # reported as "M034443" and expiration date 20-APR-2019. The patient's concomitant medication was not reported. On an uspecified date in June 2017, following administration of the vaccine, the patient developed hives all over her uvula and what appeared to be scratches down the back of her throat, the patient was tested for streptococcus (strep) but the results were negative. The pharmacist reported that it was determined that the patient experienced an anaphylactic reaction and, what appeared to be scratches, were also hives down the back of the patient's throat. The patient was administered an unspecified steroid injection and was released from the emergency room, without being admitted to the hospital, in addition, the patient was prescribed prednisone (manufacturer unknown) and amoxicillin for treatment. At the time of report, the outcome of anaphylactic reaction was unknown. The causality assessment between anaphylactic reaction and vaccination with ZOSTAVAX diluted with sterile water diluent(MERCK STERILE DILUENT) was unknown. Upon internal review, the event of anaphylactic reaction was determined to be medically significant. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS, TDAP, VARZOS
Symptoms: Injection site swelling, Nausea, Pharyngeal erythema, Pharyngeal oedema, Rash erythematous
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 50 year old female patient. The patient's medical history, concurrent conditions, drug and allergy history were not reported. On 13-JUN-2017, the patient was vaccinated with ZOSTAVAX injection, lot # M039453 expiration date 19-DEC-2017 (strength and route of administration were not provided) for prophylaxis. The vaccine was reconstitued with an sterile water diluent(MERCK STERILE DILUENT), lot # reported as "M034443" and expiration date 20-APR-2019. The patient's concomitant medication was not reported. On an uspecified date in June 2017, following administration of the vaccine, the patient developed hives all over her uvula and what appeared to be scratches down the back of her throat, the patient was tested for streptococcus (strep) but the results were negative. The pharmacist reported that it was determined that the patient experienced an anaphylactic reaction and, what appeared to be scratches, were also hives down the back of the patient's throat. The patient was administered an unspecified steroid injection and was released from the emergency room, without being admitted to the hospital, in addition, the patient was prescribed prednisone (manufacturer unknown) and amoxicillin for treatment. At the time of report, the outcome of anaphylactic reaction was unknown. The causality assessment between anaphylactic reaction and vaccination with ZOSTAVAX diluted with sterile water diluent(MERCK STERILE DILUENT) was unknown. Upon internal review, the event of anaphylactic reaction was determined to be medically significant. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS, TDAP, VARZOS
Symptoms: Rash generalised, Rash pruritic, Streptococcus test negative, Urticaria, Vomiting
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 50 year old female patient. The patient's medical history, concurrent conditions, drug and allergy history were not reported. On 13-JUN-2017, the patient was vaccinated with ZOSTAVAX injection, lot # M039453 expiration date 19-DEC-2017 (strength and route of administration were not provided) for prophylaxis. The vaccine was reconstitued with an sterile water diluent(MERCK STERILE DILUENT), lot # reported as "M034443" and expiration date 20-APR-2019. The patient's concomitant medication was not reported. On an uspecified date in June 2017, following administration of the vaccine, the patient developed hives all over her uvula and what appeared to be scratches down the back of her throat, the patient was tested for streptococcus (strep) but the results were negative. The pharmacist reported that it was determined that the patient experienced an anaphylactic reaction and, what appeared to be scratches, were also hives down the back of the patient's throat. The patient was administered an unspecified steroid injection and was released from the emergency room, without being admitted to the hospital, in addition, the patient was prescribed prednisone (manufacturer unknown) and amoxicillin for treatment. At the time of report, the outcome of anaphylactic reaction was unknown. The causality assessment between anaphylactic reaction and vaccination with ZOSTAVAX diluted with sterile water diluent(MERCK STERILE DILUENT) was unknown. Upon internal review, the event of anaphylactic reaction was determined to be medically significant. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS, TDAP, VARZOS
Symptoms: Chills, Enlarged uvula, Erythema, Hyperhidrosis, Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 50 year old female patient. The patient's medical history, concurrent conditions, drug and allergy history were not reported. On 13-JUN-2017, the patient was vaccinated with ZOSTAVAX injection, lot # M039453 expiration date 19-DEC-2017 (strength and route of administration were not provided) for prophylaxis. The vaccine was reconstitued with an sterile water diluent(MERCK STERILE DILUENT), lot # reported as "M034443" and expiration date 20-APR-2019. The patient's concomitant medication was not reported. On an uspecified date in June 2017, following administration of the vaccine, the patient developed hives all over her uvula and what appeared to be scratches down the back of her throat, the patient was tested for streptococcus (strep) but the results were negative. The pharmacist reported that it was determined that the patient experienced an anaphylactic reaction and, what appeared to be scratches, were also hives down the back of the patient's throat. The patient was administered an unspecified steroid injection and was released from the emergency room, without being admitted to the hospital, in addition, the patient was prescribed prednisone (manufacturer unknown) and amoxicillin for treatment. At the time of report, the outcome of anaphylactic reaction was unknown. The causality assessment between anaphylactic reaction and vaccination with ZOSTAVAX diluted with sterile water diluent(MERCK STERILE DILUENT) was unknown. Upon internal review, the event of anaphylactic reaction was determined to be medically significant. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS, TDAP, VARZOS
Symptoms: Pharyngeal oedema, Pruritus, Rash, Urticaria, Vomiting
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 50 year old female patient. The patient's medical history, concurrent conditions, drug and allergy history were not reported. On 13-JUN-2017, the patient was vaccinated with ZOSTAVAX injection, lot # M039453 expiration date 19-DEC-2017 (strength and route of administration were not provided) for prophylaxis. The vaccine was reconstitued with an sterile water diluent(MERCK STERILE DILUENT), lot # reported as "M034443" and expiration date 20-APR-2019. The patient's concomitant medication was not reported. On an uspecified date in June 2017, following administration of the vaccine, the patient developed hives all over her uvula and what appeared to be scratches down the back of her throat, the patient was tested for streptococcus (strep) but the results were negative. The pharmacist reported that it was determined that the patient experienced an anaphylactic reaction and, what appeared to be scratches, were also hives down the back of the patient's throat. The patient was administered an unspecified steroid injection and was released from the emergency room, without being admitted to the hospital, in addition, the patient was prescribed prednisone (manufacturer unknown) and amoxicillin for treatment. At the time of report, the outcome of anaphylactic reaction was unknown. The causality assessment between anaphylactic reaction and vaccination with ZOSTAVAX diluted with sterile water diluent(MERCK STERILE DILUENT) was unknown. Upon internal review, the event of anaphylactic reaction was determined to be medically significant. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: TDAP, VARZOS, TDAP, VARZOS, TDAP, VARZOS
Symptoms: Anaphylactic reaction, Streptococcus test negative, Throat irritation, Urticaria
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 50 year old female patient. The patient's medical history, concurrent conditions, drug and allergy history were not reported. On 13-JUN-2017, the patient was vaccinated with ZOSTAVAX injection, lot # M039453 expiration date 19-DEC-2017 (strength and route of administration were not provided) for prophylaxis. The vaccine was reconstitued with an sterile water diluent(MERCK STERILE DILUENT), lot # reported as "M034443" and expiration date 20-APR-2019. The patient's concomitant medication was not reported. On an uspecified date in June 2017, following administration of the vaccine, the patient developed hives all over her uvula and what appeared to be scratches down the back of her throat, the patient was tested for streptococcus (strep) but the results were negative. The pharmacist reported that it was determined that the patient experienced an anaphylactic reaction and, what appeared to be scratches, were also hives down the back of the patient's throat. The patient was administered an unspecified steroid injection and was released from the emergency room, without being admitted to the hospital, in addition, the patient was prescribed prednisone (manufacturer unknown) and amoxicillin for treatment. At the time of report, the outcome of anaphylactic reaction was unknown. The causality assessment between anaphylactic reaction and vaccination with ZOSTAVAX diluted with sterile water diluent(MERCK STERILE DILUENT) was unknown. Upon internal review, the event of anaphylactic reaction was determined to be medically significant. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Very sore arm. Movement limited. Four physical therapy sessions. Still bothersome five months later.
Age: 47.0
Sex: M
Vaccine: HEP, TTOX
Symptoms: Injection site nodule, Injection site pain, Musculoskeletal pain, Musculoskeletal stiffness, Neck pain
Clinical narrative: Initially pain and knot at injection site. On Sunday 06/25/2017 began having pain and stiffness to neck and upper shoulder area.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 09-JUN-2017, the patient was inadvertently vaccinated with an expired dose of VAQTA injection, lot # L002717, expiration date: 02-JUN-2017 (strength, dose and route of administration were not provided). There were no adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and an office manager referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. From 26-MAY-2017 to 09-JUN-2017, the patients were vaccinated with improperly stored doses of VAQTA (lot number N003194 with expiration date of 28-OCT-2017, lot number reported as N005796 with expiration date of 26-MAY-2018, lot number N005274 with expiration date of 03-APR-2018, lot number M047658 with expiration date of 28-OCT-2017 and lot number M027879 with expiration date of 24-JAN-2018; strength, dose, route and anatomical location were not provided), for prophylaxis. It was also reported that the administered doses experienced a temperature excursion during 1 hour at a temperature of 51.4 degrees Fahrenheit on unspecified dates. No previous temperature excursion and no adverse effects were reported. A data logger issue was involved. Additional information has been requested.; Sender's Comments: US-009507513-1706USA010930: US-009507513-1706USA010931:
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a male physician of an unknown age, referring to himself as patient. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On an unspecified date in 1986, the patient received the first intramuscular dose of PNEUMOVAX 23 (dose, frequency, route, lot # and expiration date were not reported), for prophylaxis. On an unspecified date in 2012, he received the last intramuscular dose of PNEUMOVAX 23 (dose, frequency and route were not reported) lot # reported as 1158AA with expiration date of 10-APR-2013 for prophylaxis. The patient reported that he had received "two to four" doses of PNEUMOVAX 23 over his life time; however, the information regarding other doses was unknown. No adverse effects were reported. Additional information has been requested.