chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Skin warm, Swelling
Clinical narrative: Patient developed warm red induration adjacent to injection site, starting the days she received the injection. When the patient came in 2 days later on Saturday, it was warm to the touch and was still warm, red and swollen. The pharmacist referred patient to seek medical care. The patient was assessed at an urgent care and given an antibiotic.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Arthralgia, Crying, Decreased appetite, Heart rate increased, Laboratory test
Clinical narrative: High fever and head to toe rash. Racing pulse and occasional fast breathing. Joint pain and inconsolable crying with no appetite for 6 weeks...
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia, Rash, Respiratory rate increased
Clinical narrative: High fever and head to toe rash. Racing pulse and occasional fast breathing. Joint pain and inconsolable crying with no appetite for 6 weeks...
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pruritus, Rash pruritic
Clinical narrative: Patient brought this to our attention today 9/30/2019.  But complained of itchiness on her left arm the next day after getting the arm.  She then said it got swollen and bumpy spots appeared on her shoulder area.  She then said she developed a rash between both her legs, shoulder, thight and that it would itch a lot.  She said it has gotten a little better but rash is still there.  I recommended that she see her MD, Dr. since this has been going on since 9/11/19 to get proper treatment.  She has a visit with her MD last week but forgot to mention it to her.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Disorientation, Dizziness, Hypoaesthesia, Musculoskeletal stiffness, Pallor
Clinical narrative: Panic attack: dizziness, disorientation, tingling and numbness in both arms and hands, muscle stiffness in both hands, near fainting, white lips. Episode lasted 5-10 minutes.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Panic attack, Paraesthesia, Presyncope
Clinical narrative: Panic attack: dizziness, disorientation, tingling and numbness in both arms and hands, muscle stiffness in both hands, near fainting, white lips. Episode lasted 5-10 minutes.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Pain in extremity, Rash
Clinical narrative: Arm pain, rash (2 inch), fatigue, joint pain (shoulder on that arm)
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain
Clinical narrative: Pain started the evening of injection, Redness started 48 hours after injection with more pain, Symptoms resolved 5 days after injection
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Swollen , redness at injection site. Cellulitis -looking skin.  No systemic symptoms reported .
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Pt had fever, nausea/vomiting, body ache and pain. "FEEL LIKE HAVING A PNEUMONIA"
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Eye movement disorder, Posture abnormal, Syncope, Vomiting
Clinical narrative: Patient got the shot & got up from her chair & sat on another chair. I was giving vaccine to her sister, & when done we turned around she started to role up her eyes & head started falling then she threw up (vomited) Called 911 & hollered Per MD SYNCOPE
Sex: U
Vaccine: FLU3
Symptoms: Brain scan normal, Computerised tomogram, Electrocardiogram, Hypoaesthesia, Increased upper airway secretion
Clinical narrative: SHOT GIVEN ON /  /19 - 2 hrs. later - congestion in throat, + bronchial area, sneezing. Approx 10.30 AM on /  /19 left arm + jaw numbness - Rushed to ER. Neurologist reviews MRI. Admitted to hospital. Brain scan. No STROke - Flu shot reaction
Sex: U
Vaccine: FLU3
Symptoms: Lower respiratory tract congestion, Magnetic resonance imaging brain normal, Sneezing, Vaccination complication
Clinical narrative: SHOT GIVEN ON /  /19 - 2 hrs. later - congestion in throat, + bronchial area, sneezing. Approx 10.30 AM on /  /19 left arm + jaw numbness - Rushed to ER. Neurologist reviews MRI. Admitted to hospital. Brain scan. No STROke - Flu shot reaction
Age: 72.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site discharge, Injection site erythema, Injection site oedema, Injection site vesicles, Injection site warmth
Clinical narrative: erythema, edema, heat, formation of blisters weeping clear fluid, covering entire upper arm of affected side
Age: 67.0
Sex: F
Vaccine: FLUA3
Symptoms: Asthenia, Hallucination, auditory, Insomnia, Loss of consciousness, Mental impairment
Clinical narrative: Patient stated couldn't think straight. Felt weak and was hearing voices. She said it was keeping her up all night and she was blacking out.
Age: 72.0
Sex: M
Vaccine: HEPAB
Symptoms: Dizziness, Hypertension, Nausea
Clinical narrative: high blood pressure, lightheadness, nauseated
Age: 72.0
Sex: M
Vaccine: HEPAB
Symptoms: C-reactive protein increased, Muscular weakness, Myalgia, Pain in extremity, Red blood cell sedimentation rate increased
Clinical narrative: BUE achyness & weakness BUE. Very high ESR/CRP - pt being Txd with prednisone  - a polymyalgia like illness
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Antinuclear antibody, Arthralgia, C-reactive protein, Full blood count, Injection site rash
Clinical narrative: 9-26-19 Jaw swelling, left ear felt hot. Joint pain, knee swelled Lt. Rash all over her body.  9-30-19 Rash on lower extremities, worse on anterior right tigh, dark red in color.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Joint swelling, Metabolic function test, Protein urine present, Rash, Rash erythematous
Clinical narrative: 9-26-19 Jaw swelling, left ear felt hot. Joint pain, knee swelled Lt. Rash all over her body.  9-30-19 Rash on lower extremities, worse on anterior right tigh, dark red in color.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Red blood cell sedimentation rate, Rheumatoid factor, Skin warm, Swelling face, Tryptase
Clinical narrative: 9-26-19 Jaw swelling, left ear felt hot. Joint pain, knee swelled Lt. Rash all over her body.  9-30-19 Rash on lower extremities, worse on anterior right tigh, dark red in color.
Age: 64.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Feeling abnormal, Musculoskeletal stiffness
Clinical narrative: Joint pain, stiff neck, feels poorly -
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: body aches           fatigue chills severe HA (L) arm pain
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash, Peripheral swelling
Clinical narrative: Patient came today 9/30/19 to report that on the day of the vaccine after she got home her arm swelled up and she noticed a rash on the inection site. The next day her arm swelled up completely from shoulder to elbow She did cold compresses and Ibuprofen, she was fine after
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Corneal dystrophy, Injected limb mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: Approximately 18 to 24 hours post-injection, patient experienced a fever of 102 degrees, a corneal guttata of the left eye, and pain and impaired movement in the left arm. The fever and eye symptoms resolved within 24 hours, and the symptoms in the arm resolved within 48 hours. All symptoms have completely resolved.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: -Fever and chills; sore swollen arm -suggested taking ibuprofen and/or Tylenol -if symptoms don't resolve or get better by tomorrow, patient is going to call back
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB
Symptoms: Injection site induration, Irritability, Lethargy, Poor feeding infant, Pyrexia
Clinical narrative: Fever, lethargy and grunting for 24 hours  Inability to breastfeeding/ maintain suck and hypotonia for 4 days (no fever during this time)  Red lump at injection site
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB
Symptoms: Somnolence
Clinical narrative: Fever, lethargy and grunting for 24 hours  Inability to breastfeeding/ maintain suck and hypotonia for 4 days (no fever during this time)  Red lump at injection site
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB
Symptoms: Grunting, Hypotonia, Injection site erythema, Injection site mass, Lethargy
Clinical narrative: Fever, lethargy and grunting for 24 hours  Inability to breastfeeding/ maintain suck and hypotonia for 4 days (no fever during this time)  Red lump at injection site
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB
Symptoms: Poor feeding infant, Poor sucking reflex, Pyrexia
Clinical narrative: Fever, lethargy and grunting for 24 hours  Inability to breastfeeding/ maintain suck and hypotonia for 4 days (no fever during this time)  Red lump at injection site
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Erythema, Feeling abnormal, Pain in extremity, Peripheral swelling
Clinical narrative: really being so sick / I couldn't function; wiped out; Flu like symptoms; This case was reported by a nurse and described the occurrence of sickness in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (For tolerance of 1st dose refer case ID US2019AMR131664.). Concurrent medical conditions included knee osteoarthritis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced sickness, exhaustion and influenza-like symptoms. On an unknown date, the outcome of the sickness, exhaustion and influenza-like symptoms were unknown.   It was unknown if the reporter considered the sickness, exhaustion and influenza-like symptoms to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient contacted regarding a severe side effect caused by the Shingles 2 shot series. The patient had in general good health except for osteoarthritis in her knees. The patient spoke with the pharmacist and he said patient was on the extreme end of the expected response. The second shot was given even though she was hesitant but the pharmacist encouraged her to get it anyway saying since she had a good immune response the first time this second shot hopefully would not be as severe. It was worsed. The patient was completely wiped out with flu like symptoms and almost went to the emergency room, but being a nurse, she knew there was not much they could do for her. For 300 Dollar and many days of really being so sick patient couldn't function, this seems to not be uncommon. The patient put out a pole of feedback to ask who else had this severe reaction and it was surprising to hear so many say they would not recommend getting it. The patient knew getting shingles could be life altering, but there has got to be something you could do to attenuate these severe reactions. Do no harm. The reporter gave permission to follow up.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Chills, Diarrhoea, Erythema, Fatigue
Clinical narrative: really being so sick / I couldn't function; wiped out; Flu like symptoms; This case was reported by a nurse and described the occurrence of sickness in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (For tolerance of 1st dose refer case ID US2019AMR131664.). Concurrent medical conditions included knee osteoarthritis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced sickness, exhaustion and influenza-like symptoms. On an unknown date, the outcome of the sickness, exhaustion and influenza-like symptoms were unknown.   It was unknown if the reporter considered the sickness, exhaustion and influenza-like symptoms to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient contacted regarding a severe side effect caused by the Shingles 2 shot series. The patient had in general good health except for osteoarthritis in her knees. The patient spoke with the pharmacist and he said patient was on the extreme end of the expected response. The second shot was given even though she was hesitant but the pharmacist encouraged her to get it anyway saying since she had a good immune response the first time this second shot hopefully would not be as severe. It was worsed. The patient was completely wiped out with flu like symptoms and almost went to the emergency room, but being a nurse, she knew there was not much they could do for her. For 300 Dollar and many days of really being so sick patient couldn't function, this seems to not be uncommon. The patient put out a pole of feedback to ask who else had this severe reaction and it was surprising to hear so many say they would not recommend getting it. The patient knew getting shingles could be life altering, but there has got to be something you could do to attenuate these severe reactions. Do no harm. The reporter gave permission to follow up.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Feeling abnormal, Headache, Influenza like illness, Loss of personal independence in daily activities, Nausea
Clinical narrative: really being so sick / I couldn't function; wiped out; Flu like symptoms; This case was reported by a nurse and described the occurrence of sickness in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (For tolerance of 1st dose refer case ID US2019AMR131664.). Concurrent medical conditions included knee osteoarthritis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced sickness, exhaustion and influenza-like symptoms. On an unknown date, the outcome of the sickness, exhaustion and influenza-like symptoms were unknown.   It was unknown if the reporter considered the sickness, exhaustion and influenza-like symptoms to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient contacted regarding a severe side effect caused by the Shingles 2 shot series. The patient had in general good health except for osteoarthritis in her knees. The patient spoke with the pharmacist and he said patient was on the extreme end of the expected response. The second shot was given even though she was hesitant but the pharmacist encouraged her to get it anyway saying since she had a good immune response the first time this second shot hopefully would not be as severe. It was worsed. The patient was completely wiped out with flu like symptoms and almost went to the emergency room, but being a nurse, she knew there was not much they could do for her. For 300 Dollar and many days of really being so sick patient couldn't function, this seems to not be uncommon. The patient put out a pole of feedback to ask who else had this severe reaction and it was surprising to hear so many say they would not recommend getting it. The patient knew getting shingles could be life altering, but there has got to be something you could do to attenuate these severe reactions. Do no harm. The reporter gave permission to follow up.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Pain, Pain in extremity, Peripheral swelling, Pyrexia, Skin discolouration
Clinical narrative: really being so sick / I couldn't function; wiped out; Flu like symptoms; This case was reported by a nurse and described the occurrence of sickness in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (For tolerance of 1st dose refer case ID US2019AMR131664.). Concurrent medical conditions included knee osteoarthritis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced sickness, exhaustion and influenza-like symptoms. On an unknown date, the outcome of the sickness, exhaustion and influenza-like symptoms were unknown.   It was unknown if the reporter considered the sickness, exhaustion and influenza-like symptoms to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient contacted regarding a severe side effect caused by the Shingles 2 shot series. The patient had in general good health except for osteoarthritis in her knees. The patient spoke with the pharmacist and he said patient was on the extreme end of the expected response. The second shot was given even though she was hesitant but the pharmacist encouraged her to get it anyway saying since she had a good immune response the first time this second shot hopefully would not be as severe. It was worsed. The patient was completely wiped out with flu like symptoms and almost went to the emergency room, but being a nurse, she knew there was not much they could do for her. For 300 Dollar and many days of really being so sick patient couldn't function, this seems to not be uncommon. The patient put out a pole of feedback to ask who else had this severe reaction and it was surprising to hear so many say they would not recommend getting it. The patient knew getting shingles could be life altering, but there has got to be something you could do to attenuate these severe reactions. Do no harm. The reporter gave permission to follow up.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Sleep disorder
Clinical narrative: really being so sick / I couldn't function; wiped out; Flu like symptoms; This case was reported by a nurse and described the occurrence of sickness in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (For tolerance of 1st dose refer case ID US2019AMR131664.). Concurrent medical conditions included knee osteoarthritis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced sickness, exhaustion and influenza-like symptoms. On an unknown date, the outcome of the sickness, exhaustion and influenza-like symptoms were unknown.   It was unknown if the reporter considered the sickness, exhaustion and influenza-like symptoms to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient contacted regarding a severe side effect caused by the Shingles 2 shot series. The patient had in general good health except for osteoarthritis in her knees. The patient spoke with the pharmacist and he said patient was on the extreme end of the expected response. The second shot was given even though she was hesitant but the pharmacist encouraged her to get it anyway saying since she had a good immune response the first time this second shot hopefully would not be as severe. It was worsed. The patient was completely wiped out with flu like symptoms and almost went to the emergency room, but being a nurse, she knew there was not much they could do for her. For 300 Dollar and many days of really being so sick patient couldn't function, this seems to not be uncommon. The patient put out a pole of feedback to ask who else had this severe reaction and it was surprising to hear so many say they would not recommend getting it. The patient knew getting shingles could be life altering, but there has got to be something you could do to attenuate these severe reactions. Do no harm. The reporter gave permission to follow up.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Fatigue, Influenza like illness, Malaise
Clinical narrative: really being so sick / I couldn't function; wiped out; Flu like symptoms; This case was reported by a nurse and described the occurrence of sickness in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (For tolerance of 1st dose refer case ID US2019AMR131664.). Concurrent medical conditions included knee osteoarthritis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced sickness, exhaustion and influenza-like symptoms. On an unknown date, the outcome of the sickness, exhaustion and influenza-like symptoms were unknown.   It was unknown if the reporter considered the sickness, exhaustion and influenza-like symptoms to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient contacted regarding a severe side effect caused by the Shingles 2 shot series. The patient had in general good health except for osteoarthritis in her knees. The patient spoke with the pharmacist and he said patient was on the extreme end of the expected response. The second shot was given even though she was hesitant but the pharmacist encouraged her to get it anyway saying since she had a good immune response the first time this second shot hopefully would not be as severe. It was worsed. The patient was completely wiped out with flu like symptoms and almost went to the emergency room, but being a nurse, she knew there was not much they could do for her. For 300 Dollar and many days of really being so sick patient couldn't function, this seems to not be uncommon. The patient put out a pole of feedback to ask who else had this severe reaction and it was surprising to hear so many say they would not recommend getting it. The patient knew getting shingles could be life altering, but there has got to be something you could do to attenuate these severe reactions. Do no harm. The reporter gave permission to follow up.
Age: 17.0
Sex: F
Vaccine: FLU4, FLUR4
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal pain
Clinical narrative: Shoulder soreness, down to elbow, and then towards center of shoulder blade
Age: 17.0
Sex: F
Vaccine: FLU4, FLUR4
Symptoms: Musculoskeletal pain, Pain in extremity, Tendonitis
Clinical narrative: Shoulder soreness, down to elbow, and then towards center of shoulder blade
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Blood glucose, Cough, Cyanosis, Dyspnoea
Clinical narrative: Right after injection of all 3 vaccines patient started coughing, having trouble breathing with lips turning blue. Patient was given 0.3mg EpiPen. Symptoms resolved after one minute. 911 was also called. EMT arrived about 10 minutes after vaccination. Patient was examined but no further treatment was needed. Patient went home with daughter.
Age: 65.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Chills, Feeling cold, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Around 7:45 pm on Saturday, I began to feel unwell.  Around 8:30 pm, my heart rate was racing,  I had a terrible headache, I was shivering and unable to get warm, my hands and feet were like ice, my upper left arm (site of injection) was hot, swollen, and painful.  I felt feverish. My heart raced the entire night and did not return to a normal beat until early in the morning.    Today, on Tuesday, the injection site has an angry rash that extends down to my elbow.  It is hot and swollen and painful.  My history:  I got shingles while undergoing chemotherapy in 2014.  I received the shingles vaccine in 11/2015.  I also received the flu shot at the same time as the shingles vaccine on Saturday, 9/28/2019.
Age: 65.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Injection site warmth, Malaise, Palpitations, Peripheral coldness, Pyrexia
Clinical narrative: Around 7:45 pm on Saturday, I began to feel unwell.  Around 8:30 pm, my heart rate was racing,  I had a terrible headache, I was shivering and unable to get warm, my hands and feet were like ice, my upper left arm (site of injection) was hot, swollen, and painful.  I felt feverish. My heart raced the entire night and did not return to a normal beat until early in the morning.    Today, on Tuesday, the injection site has an angry rash that extends down to my elbow.  It is hot and swollen and painful.  My history:  I got shingles while undergoing chemotherapy in 2014.  I received the shingles vaccine in 11/2015.  I also received the flu shot at the same time as the shingles vaccine on Saturday, 9/28/2019.
Age: 65.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Chills, Feeling cold, Headache, Injection site erythema, Injection site rash
Clinical narrative: Around 7:45 pm on Saturday, I began to feel unwell.  Around 8:30 pm, my heart rate was racing,  I had a terrible headache, I was shivering and unable to get warm, my hands and feet were like ice, my upper left arm (site of injection) was hot, swollen, and painful.  I felt feverish. My heart raced the entire night and did not return to a normal beat until early in the morning.    Today, on Tuesday, the injection site has an angry rash that extends down to my elbow.  It is hot and swollen and painful.  My history:  I got shingles while undergoing chemotherapy in 2014.  I received the shingles vaccine in 11/2015.  I also received the flu shot at the same time as the shingles vaccine on Saturday, 9/28/2019.
Age: 65.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Nervousness, Peripheral coldness
Clinical narrative: Around 7:45 pm on Saturday, I began to feel unwell.  Around 8:30 pm, my heart rate was racing,  I had a terrible headache, I was shivering and unable to get warm, my hands and feet were like ice, my upper left arm (site of injection) was hot, swollen, and painful.  I felt feverish. My heart raced the entire night and did not return to a normal beat until early in the morning.    Today, on Tuesday, the injection site has an angry rash that extends down to my elbow.  It is hot and swollen and painful.  My history:  I got shingles while undergoing chemotherapy in 2014.  I received the shingles vaccine in 11/2015.  I also received the flu shot at the same time as the shingles vaccine on Saturday, 9/28/2019.
Age: 65.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Chills, Feeling cold, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: The evening the patient received shingrix and fluarix (lot 3bf77, exp 06-30-2020, manufacturer GSK) patient began to feel shaky and cold (covered up in comforters and had cold hands and feet and teeth chattering),  headache lasting all weekend. She states that she was feeling better as of this evening (9/30/19). Patient reported a rash/redness from injection site to elbow that is still present and has not improved. Patient advised to continue to monitor rash for signs of improvement
Age: 65.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Injection site warmth, Malaise, Palpitations, Peripheral coldness, Pyrexia
Clinical narrative: The evening the patient received shingrix and fluarix (lot 3bf77, exp 06-30-2020, manufacturer GSK) patient began to feel shaky and cold (covered up in comforters and had cold hands and feet and teeth chattering),  headache lasting all weekend. She states that she was feeling better as of this evening (9/30/19). Patient reported a rash/redness from injection site to elbow that is still present and has not improved. Patient advised to continue to monitor rash for signs of improvement
Age: 65.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Chills, Feeling cold, Headache, Injection site erythema, Injection site rash
Clinical narrative: The evening the patient received shingrix and fluarix (lot 3bf77, exp 06-30-2020, manufacturer GSK) patient began to feel shaky and cold (covered up in comforters and had cold hands and feet and teeth chattering),  headache lasting all weekend. She states that she was feeling better as of this evening (9/30/19). Patient reported a rash/redness from injection site to elbow that is still present and has not improved. Patient advised to continue to monitor rash for signs of improvement
Age: 65.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Nervousness, Peripheral coldness
Clinical narrative: The evening the patient received shingrix and fluarix (lot 3bf77, exp 06-30-2020, manufacturer GSK) patient began to feel shaky and cold (covered up in comforters and had cold hands and feet and teeth chattering),  headache lasting all weekend. She states that she was feeling better as of this evening (9/30/19). Patient reported a rash/redness from injection site to elbow that is still present and has not improved. Patient advised to continue to monitor rash for signs of improvement
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash, Rash
Clinical narrative: PATIENT HAS RASH ON HER ARM THAT SHE STATES BEGAN NEAR THE INJECTION SITE AND THEN MOVED DOWN THE ARM AND TO THE OTHER ARM.  SHE STATES THAT SHE DID VISIT HER PRIMARY CARE PHYSICIAN ON 9/30/2019 FOR A STEROID CREAM AND ORAL STEROID BECAUSE SHE FELT THAT SHE MAY BE ALLERGIC.  SHE DID RECEIVE THE SAME BRAND OF SHOT LAST YEAR.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain
Clinical narrative: soreness, redness that developed and persists , 4x4 inches
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Myalgia, Syncope
Clinical narrative: chills, muscle ache, and syncope requiring EMS
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash, Rash erythematous, Urticaria
Clinical narrative: Flat red rash developed next morning on neck, chest, both arms; Hive developing on right hand; No increased SOB; only itching on right hand at time of exam
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; patient received improperly stored PROQUAD; This spontaneous report was received from a medial assistant and refers to a 4 year old patient of unknown gender. Information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies was not provided.      On 12-SEP-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S002494 with an expiration date in 23-JUL-2020), for prophylaxis (strength, dose, route and frequency were not provided), that underwent a temperature excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit ,during a time frame of 50 minutes, and was reconstituted with properly stored    sterile diluent. No previous temperature excursion was reported, Digital data logger was involved. No adverse effects were reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1909USA005231:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; One dose of an improperly stored vaccine; Route of administration: Intramuscular; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant therapy included sterile diluent (possible lot# S000130 and possible expiration date 23-AUG-2021) which was reported to be stored in the correct storage temperature range. On 10-SEP-2019, the patient was vaccinated with one dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength and anatomical locations were unknown) of lot # S002877 with an expiration date of 29-JAN-2021, at a dose of 0.5 milliliter, once via intramuscular route (Incorrect route of product administration) for prophylaxis (Product storage error). The temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was at 8.1 Fahrenheit (F) for 20 minutes. The previous temperature excursion reported as 8.1 F for 17 minutes and (9.5 F) for 21 minutes. No adverse effects were reported. The data logger was involved. No Product quality complaint (PQC) was present.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverese effects; A dose of PROQUAD was given to an unspecified "53 year old patient"; This spontaneous report has been received from a medical assistant referring to a 53 year old patient of unknown gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided      On 03-SEP-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), subcutaneously (strength, frequency, dose, lot # and expiration date were not provided) for prophylaxis. No adverse effects were reported.
Age: 1.0
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Ear infection, Pyrexia, Respiratory viral panel, Vomiting
Clinical narrative: The patient was inadvertently given a fourth dose of ROTATEQ; fever; vomiting; Diarrhea; This spontaneous report has been received from a nurse regarding to a 12-month-old male patient. The patient's concurrent conditions included asthma, ear infection and gastroesophageal reflux disease. The patient's medical history included gastroesophageal reflux disease. Concomitant therapies included albuterol, omeprazole and cefdinir. The patient had not drug reaction or allergies.   On 25-OCT-2018, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # N034400, expiration date 10-MAY-2019; on 22-JAN-2019, he received the second dose of the vaccine, lot # N030150, expiration date 29-AUG-2019, and on 07-MAR-2019, the patient received the third dose of the vaccine, lot # N030150, expiration date 29-AUG-2019; all doses were administered orally for prophylaxis.  On 22-AUG-2019, the patient was prescribed with antibiotic such as cefdinir as treatment for an ear infection. On 16-SEP-201,9 the patient at his 1 year well check exam, he was inadvertently given a fourth dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot # R030924, expiration date 10-JUL-2020, Orally for immunizations. On 17-SEP-2019, the patient's mother called to the office to report that he presented fever, vomiting and diarrhea but, it was stated that he had been ill prior to receiving the fourth dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ). However, respiratory film panel were done but not results were reported; additionally, treatment as comfort measures and monitor were provided. At the reporting time, the outcome for fever, diarrhea and vomiting was reported as not recovered.   The causality assessment between fever, diarrhea, vomiting and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was unknown.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash papular
Clinical narrative: suffered a persistent, papulovesicular rash on Plaintiff's dermatomes and was diagnosed with herpes zoster.; Information has been received from a lawyer and the patient (pt) regarding a case in litigation involving a male patient (pt) of unknown age. No information about the pt's pertinent medical history, concomitant medications and drug reactions or allergies was provided.     In or around 25-sep-2017, the pt was inoculated with a dose of zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, route, frequency, lot/batch # and expiration date were not reported).     On an unknown date, reported as "shortly after receiving zoster vaccine live (ZOSTAVAX)", the pt suffered a persistent, papulovesicular rash on pt dermatomes and was diagnosed with herpes zoster.  As a direct and proximate result of zoster vaccine live (ZOSTAVAX), pt symptoms had resulted in physical limitations not present prior to using it. Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition.  As a result of the manufacture, marketing, advertising, promotion, distribution, and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained serious, progressive, incurable and permanent personal injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.    The reporter considered the event to be related to zoster Vaccine Live (ZOSTAVAX).  Herpes zoster was considered as disabling event, due to the pt's permanent and incurable injuries.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored dose of GARDASIL 9; no adverse effects; This spontaneous report was received from a medical assistant concerning to an patient of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications.  On an unknown date, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot number N022952 with expiration date on 14-JUN-2020 (dosage schedule, route and anatomical location were not reported) for prophylaxis.  Administered doses of vaccine experienced temperature excursion below 36 degrees Fahrenheit (F) (32.1 F)  for 8 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient was vaccinated with improperly stored LIQUID PEDVAXHIB vaccine; No adverse effects were reported.; This spontaneous report was received form a medical assistance, referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications.  On an unknown date, the patient was vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) for prophylaxis, lot# N024570 expiration date on 01-MAY-2020 (dose, dose number, route of administration and anatomical location were not provided). It was reported that the dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) that the patient received, was improperly stored.    It was reported that on an unspecified date, the vaccine was exposed to a temperature below of 36 Fahrenheit degrees and 32.1 Fahrenheit degrees for 8 hours. There was no previous temperature excursion. The call was placed because of a Digital Data logger report. No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: A 13-year-old patient received properly stored PROQUAD; No adverse effects reported; This spontaneous report was received from a registered nurse, referring to a 13-year-old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications.  On an unknown date, the patient was vaccinated with properly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (product administered to patient of inappropriate age)for prophylaxis, lot number S002490  expiration date on 23-JUL-2020 (dose, dose number, route of administration and anatomical location were not provided) and properly stored sterile diluent (MERCK STERILE DILUENT) lot # R019504 (expiration date unknown by reporter). No adverse effects were reported.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: The patient may have experienced a mild fever after the second vaccination; Route of administration: intramuscular (IM); This spontaneous report was received from the patient's mother concerning an approximately 5 year old female patient. The patient had no medical history, concomitant medications, drug reactions or allergies.  On an unspecified date in 2011, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot #, expiration date, anatomical location were not provided), administered intramuscularly (IM) (incorrect route of product administration) as prophylaxis (reported as states mandated). After the second vaccination, the patient might have experienced mild fever (pyrexia). In consequence, she sought for medical attention and the patient was treated with ibuprofen. It was reported that the patient received separately the first 3 doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II) and then she received the "follow up titers because it was a state mandated". No laboratory diagnostics or studies were performed. At the reporting time, the outcome of fever (mild) was unknown.   The causality between the event of fever (mild) and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II) was not reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored dose os PEDVAX; no adverse effects; This spontaneous report was received from a medical assistant concerning to an patient of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications.  On an unknown date, the patient was vaccinated with an improperly stored dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) lot number N024570 with expiration date on 01-MAY-2020 (dosage schedule, route and anatomical location were not reported) for prophylaxis.  Administered doses of vaccine experienced temperature excursion below 36 degrees Fahrenheit (F) (32.1 F)  for 8 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Death, Herpes zoster
Clinical narrative: death; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 61-year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 23-SEP-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, exact dose, dose# and route not specified) at a pharmacy. On an unknown date in 2017, reported as within one month after receiving zoster vaccine live (ZOSTAVAX), and as a result of his receipt of zoster vaccine live (ZOSTAVAX), the patient was caused to suffer shingles, including any and all of its sequelae. As a result of his receipt of zoster vaccine live (ZOSTAVAX), the patient had been caused to suffer severe personal injuries, pain, suffering and emotional distress, as well as to incur substantial economic damages. On an unknown date, the patient died. The cause of death and if autopsy was done was unknown. The outcome of the event of shingles was not reported. The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX). The relatedness between the event of death and zoster vaccine live (ZOSTAVAX) was not reported.
Sex: M
Vaccine: VARZOS
Symptoms: Meniere's disease
Clinical narrative: Meniere's disease; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around September 2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, exact dose, dose# and route not specified) for routine health maintenance and for its intended purpose: prevention of shingles (herpes zoster). On an unknown date, reported as shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered Meniere's disease. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine use, the patient's symptoms had resulted in physical limitation not presented prior to zoster vaccine live (ZOSTAVAX) vaccination. The patient also experienced mental and emotional distress due to resulting physical limitation and seriousness of the patient's condition. As a result of zoster vaccine live (ZOSTAVAX) vaccination, the patient sustained severe and permanent personal injuries; suffered serious progressive permanent and incurable injuries as well as significant conscious pan and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury; suffered and incurred damages, included medical expanses; the loss of accumulations and other. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The event of Meniere's disease was considered to be disabling. Upon internal review, the event of Meniere's disease was considered to be medically significant.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse events.; Patient was administered an improperly stored VAQTA.; This spontaneous report was received from a Nurse Practitioner referring to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, historical drugs, drug reaction and allergies were not reported.  On 23-SEP-2019, the patient was vaccinated with an improperly stored dose Hepatitis A Vaccine, Inactivated(VAQTA) with lot # S007769, expiration date on 24-JUL-2020 (strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis.  The administered dose of vaccine experienced above temperature of 47°F/9°C(11.3°C) °C degrees Celsius, for 9 hours and 55 minutes. There was no digital data logger invloved, and no previous temperature excursion. No adverse effects reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; Reporter states patient was administered VAQTA post expiration; This spontaneous report was received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent conditions, drug reactions, allergies, concomitant therapies and pertinent medical history was not provided.   On 24-SEP-2019, the patient was vaccinated with post expiration (expire vaccine used) Hepatitis A Vaccine, Inactivated (VAQTA) 0.5 ml, one dose, lot number R027431, expiration date 08-SEP-2019  for prophylaxis. No adverse effects were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1909USA011985:
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Rash, Respiratory tract infection
Clinical narrative: respiratory infection; rash; This spontaneous report was received from a registered nurse and refers to a 13 year old male patient. No information was given regarding the patient's concurrent conditions, concomitant medications or medical history.      On 20-FEB-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # N025429, with expiration date on 21-JUL-2020 for Human Papilloma Virus (HPV) prevention (strength, dose and route were unknown). On 23-SEP-2019, the patient developed a respiratory tract infection and a rash. The patient sought medical attention and was treated with unspecified corticosteroids. The events were no cancer events and did not produce a significant disability or incapacity, hospitalization or was life threatening.     The outcome of the events and the causal relationship between vaccination with of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the events were not reported.        Upon internal review, the event respiratory tract infection was considered to be a medically significant event.