chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pain, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a 68-year-old female patient who received SHINGRIX for prophylaxis. On 1st October 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shivering, pain, influenza-like symptoms and rash. The patient was treated with benadryl (nos) (Benadryl) and ambiguous medication nos (Cortisone (Nos)). On an unknown date, the outcome of the shivering, pain and influenza-like symptoms were unknown and the outcome of the rash was not recovered/not resolved. It was unknown if the reporter considered the shivering, pain, influenza-like symptoms and rash to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX and experienced side effects. The patient experienced shivering and stayed in bed for 24 hours. The patient also had aches, pains and flu-like symptoms. The patient also developed spots on her face that never went away. Please refer case US2019GSK023593, for tolerance of 2nd dose. This case has linked with case US2019017451, reported by same reporter.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Alopecia, Dandruff, Inappropriate schedule of product administration, Injection site pain, Lichen planopilaris
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received on 23rd May 2019, for tolerance refer case: US2019GSK021357). On 17th July 2018, the patient received the 2nd dose of SHINGRIX. On 17th July 2018, unknown after receiving SHINGRIX, the patient experienced drug dose administration interval too short. In August 2018, the patient experienced hair loss, dandruff and frontal fibrosing alopecia. On an unknown date, the patient experienced injection site pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the hair loss and dandruff were not recovered/not resolved and the outcome of the frontal fibrosing alopecia and drug dose administration interval too short were unknown. It was unknown if the reporter considered the injection site pain, hair loss, dandruff and frontal fibrosing alopecia to be related to SHINGRIX.  Additional details were received as follows: The patient had pain at injection site. The patient began to experience hair loss and dandruff in early August 2018. The patient followed up with the dermatologists who diagnosed her with fibrous alopecia. The patient reported that her hair was falling out in clumps. The reporter did not consent to follow up. The suspect vaccine lot number was unknown at the time of reporting.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received on 23rd May 2019, for tolerance refer case: US2019GSK021357). On 17th July 2018, the patient received the 2nd dose of SHINGRIX. On 17th July 2018, unknown after receiving SHINGRIX, the patient experienced drug dose administration interval too short. In August 2018, the patient experienced hair loss, dandruff and frontal fibrosing alopecia. On an unknown date, the patient experienced injection site pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the hair loss and dandruff were not recovered/not resolved and the outcome of the frontal fibrosing alopecia and drug dose administration interval too short were unknown. It was unknown if the reporter considered the injection site pain, hair loss, dandruff and frontal fibrosing alopecia to be related to SHINGRIX.  Additional details were received as follows: The patient had pain at injection site. The patient began to experience hair loss and dandruff in early August 2018. The patient followed up with the dermatologists who diagnosed her with fibrous alopecia. The patient reported that her hair was falling out in clumps. The reporter did not consent to follow up. The suspect vaccine lot number was unknown at the time of reporting.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Decreased appetite, Dizziness, Erythema, Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 67-year-old female patient who received SHINGRIX for prophylaxis. On 25th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). In January 2019, 12 hrs after receiving SHINGRIX, the patient experienced joint pain, muscle pain, sinus headache, sinus congestion and influenza like illness. On an unknown date, the patient experienced pain in arm, erythema of extremities, decreased appetite and woozy. On an unknown date, the outcome of the joint pain, muscle pain, sinus headache, sinus congestion, pain in arm, erythema of extremities, decreased appetite and woozy were recovered/resolved and the outcome of the influenza like illness was unknown. It was unknown if the reporter considered the joint pain, muscle pain, sinus headache, sinus congestion, pain in arm, erythema of extremities, influenza like illness, decreased appetite and woozy to be related to SHINGRIX. Additional details were provided as follows: The reports stated that she did not had any problems after the 1st dose of SHINGRIX. After the 2nd dose of SHINGRIX in left arm, she felt like she had the flu. About 12 hours after the dose she had severe muscle and joint pain and a bad sinus headache, like all of her sinuses were stuffed. She did not want to eat, and stayed in bed for about 24 hours because she felt woozy when she got up. The symptoms resolved after about 24 hours. Her arm was also very sore and red for about 3 days. The reporter gave consent to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity, Sinus congestion, Sinus headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 67-year-old female patient who received SHINGRIX for prophylaxis. On 25th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). In January 2019, 12 hrs after receiving SHINGRIX, the patient experienced joint pain, muscle pain, sinus headache, sinus congestion and influenza like illness. On an unknown date, the patient experienced pain in arm, erythema of extremities, decreased appetite and woozy. On an unknown date, the outcome of the joint pain, muscle pain, sinus headache, sinus congestion, pain in arm, erythema of extremities, decreased appetite and woozy were recovered/resolved and the outcome of the influenza like illness was unknown. It was unknown if the reporter considered the joint pain, muscle pain, sinus headache, sinus congestion, pain in arm, erythema of extremities, influenza like illness, decreased appetite and woozy to be related to SHINGRIX. Additional details were provided as follows: The reports stated that she did not had any problems after the 1st dose of SHINGRIX. After the 2nd dose of SHINGRIX in left arm, she felt like she had the flu. About 12 hours after the dose she had severe muscle and joint pain and a bad sinus headache, like all of her sinuses were stuffed. She did not want to eat, and stayed in bed for about 24 hours because she felt woozy when she got up. The symptoms resolved after about 24 hours. Her arm was also very sore and red for about 3 days. The reporter gave consent to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site warmth in a 70-year-old female patient who received SHINGRIX for prophylaxis. In July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site warmth, injection site pain, injection site rash and injection site itching. On an unknown date, the outcome of the injection site warmth, injection site pain, injection site rash and injection site itching were recovered/resolved. It was unknown if the reporter considered the injection site warmth, injection site pain, injection site rash and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The patient had heat, pain, bumps and itching at the injection site. The patient initially reported to her physician that these symptoms lasted for 21 days. When the pharmacist spoke with the patient she said it was might be a couple weeks. The dose of SHINGRIX was not given at the reporter's pharmacy.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site erythema, injection site pain and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site erythema and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but the patient could be 49 or 50 years old. The health care professional reported that the patient might have received a SHINGRIX subcutaneously instead of intramuscular, which led to Intramuscular formulation administered by other route. The patient also experienced a 2 to 3 inch red area with soreness at the injection site site. The reporter consented to follow up.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Feeling abnormal, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Started several hours after injection with severe pain in entire (L) arm. Had chills. Unsure if any fever. Next day reports was "out of it". Still with severe pain. No with swelling of (L) upper arm. 2 days after injection has pain, redness, swelling down his back of (L) upper arm. Feels warm to touch. Reports is not red or swollen at injection site itself. Is out of town so will go to an urgent care for eval of symptoms.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Pain in extremity
Clinical narrative: Started several hours after injection with severe pain in entire (L) arm. Had chills. Unsure if any fever. Next day reports was "out of it". Still with severe pain. No with swelling of (L) upper arm. 2 days after injection has pain, redness, swelling down his back of (L) upper arm. Feels warm to touch. Reports is not red or swollen at injection site itself. Is out of town so will go to an urgent care for eval of symptoms.
Age: 1.5
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: KINRIX given to a 1 1/2 y/o.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Skin warm
Clinical narrative: Red marks down (R) leg (rash) has pain in R Leg off/on when playing felt warm to touch but no fever. TYLENOL and warm compress for pain.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Croup infectious, Hypersensitivity
Clinical narrative: Presented with allergic reaction croup and brought to the hospital.
Age: 64.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site pain, Joint range of motion decreased, Muscular weakness, Musculoskeletal pain
Clinical narrative: Patient called today (2/8/19) and complained of shoulder pain, limited range of motion, and arm weakness. Said the shot hurt worse than it usually does.
Age: 64.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Crying, Injected limb mobility decreased, Injection site pain, Musculoskeletal disorder, Myalgia
Clinical narrative: Patient called today (2/8/19) and complained of shoulder pain, limited range of motion, and arm weakness. Said the shot hurt worse than it usually does.
Age: 64.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain, Product administered at inappropriate site, Wrong technique in product usage process
Clinical narrative: Patient called today (2/8/19) and complained of shoulder pain, limited range of motion, and arm weakness. Said the shot hurt worse than it usually does.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Gastrostomy
Clinical narrative: This spontaneous report was received from a physician via company representative regarding a 4 month old patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On an unknown date, the patient was vaccinated with his first dose of ROTATEQ via oral route (strength, dose, frequency, lot#  and expiry were not reported) for prophylaxis. On an unknown date, the patient had now undergone a G-tube insertion (gastrostomy tube insertion) for an unspecified reason. The outcome of the event was unknown. Causality assessment of the event was not provided. Upon internal review, the event of gastrostomy tube insertion was considered as medically significant.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from an radiology technician, regarding to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were unknown by the reporter. On 06-FEB-2019, the patient received an expired dose of ROTATEQ lot # N013992 with expiration date 27-JAN-2019, taken orally (dose, strength and frequency were not reported) for prophylaxis. No adverse effect was reported.
Sex: U
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: This spontaneous report has been received from a medical assistant referring to an adult patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 06-FEB-2019, the patient was vaccinated with a pediatric dose of VAQTA (dose, strength, batch/lot # and expiration date were unknown) intramuscularly for prophylaxis. The outcome of the event was unknown. No PQC presented.
Age: 0.41
Sex: U
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Flu shot given 1 day prior to patient being 6 mos old.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: The Patient received the PREVNAR vaccine on 10/31/2018 and came into the store on 02/08/2019 complaining of a local injection site pain that has been sustained since the day of administration. Patient was advised to follow up with his primary care physician while taking over-the counter Motrin for mild pain relief sparingly as needed.
Age: 2.0
Sex: M
Vaccine: MMRV, PNC13, VARCEL
Symptoms: Extra dose administered
Clinical narrative: None.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site swelling, Pyrexia
Clinical narrative: PT REPORTED LARGE HAND SIZED SWOLLEN AREA AT INJECTION SITE ABOUT 8 HOURS AFTER INJECTION. PT REPORTED FEVER AND CHILLS ALSO STARTING AT THE SAME TIME. ALL SYMPTOMS LASTED ABOUT 12 HOURS.
Age: 60.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Biopsy skin abnormal, Culture tissue specimen negative, Excessive granulation tissue, Injection site induration, Injection site inflammation
Clinical narrative: On 10/26/18, patient reported pain at injection site following administration of vaccines. She also reported a small blister at the site. Patient developed induration, blistering and scabbing on upper right arm, which later developed to ulcer with eschar. Patient was referred to Dermatology for follow-up. Biopsy on 1/8/19 revealed ulcer with granulation tissue with mixed acute and chronic inflammation (no evidence of pyoderma gangrenosum). Tissue cultures negative (skin flora on bacterial). Patient has been treated with Cephalexin po and halobetasol to affected area. Some improvement at present.
Age: 60.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site pain, Injection site reaction, Injection site scab, Injection site ulcer, Injection site vesicles
Clinical narrative: On 10/26/18, patient reported pain at injection site following administration of vaccines. She also reported a small blister at the site. Patient developed induration, blistering and scabbing on upper right arm, which later developed to ulcer with eschar. Patient was referred to Dermatology for follow-up. Biopsy on 1/8/19 revealed ulcer with granulation tissue with mixed acute and chronic inflammation (no evidence of pyoderma gangrenosum). Tissue cultures negative (skin flora on bacterial). Patient has been treated with Cephalexin po and halobetasol to affected area. Some improvement at present.
Age: 60.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Vaccination site eschar
Clinical narrative: On 10/26/18, patient reported pain at injection site following administration of vaccines. She also reported a small blister at the site. Patient developed induration, blistering and scabbing on upper right arm, which later developed to ulcer with eschar. Patient was referred to Dermatology for follow-up. Biopsy on 1/8/19 revealed ulcer with granulation tissue with mixed acute and chronic inflammation (no evidence of pyoderma gangrenosum). Tissue cultures negative (skin flora on bacterial). Patient has been treated with Cephalexin po and halobetasol to affected area. Some improvement at present.
Age: 67.0
Sex: U
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: 48 hours post administration patient complaining of arm stiffness. Soreness, difficult to move, injection site redness, swollen, and warm to the touch. Rph suggested she continue cold/ice compresses, acetaminophen (since today is friday) and to contact the md prior to the weekend.
Age: 67.0
Sex: U
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: 48 hours post administration patient complaining of arm stiffness. Soreness, difficult to move, injection site redness, swollen, and warm to the touch. Rph suggested she continue cold/ice compresses, acetaminophen (since today is friday) and to contact the md prior to the weekend.
Age: 32.0
Sex: M
Vaccine: RAB
Symptoms: Groin pain
Clinical narrative: Soreness in groin.
Age: 46.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Broke out in shingle within 24 hours of receiving vaccine.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Injection site pain, Nausea
Clinical narrative: Terrible headache, joint pain throughout body, chills, fever, nausea. Huge red mark and pain at injection site. This is the second vaccine. It's even worse than the first.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Terrible headache, joint pain throughout body, chills, fever, nausea. Huge red mark and pain at injection site. This is the second vaccine. It's even worse than the first.
Age: 61.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site discharge, Injection site pain, Injection site warmth
Clinical narrative: Patient is a 61-year-old female who presents for evaluation of right arm injection site. Patient had hepatitis A vaccination injection and proximal right upper extremity on 10/3/18. Patient reports that 3-4 weeks following injection, she noticed lying of the proximal right upper extremity near injection site. Patient also reported green drainage from the site. Patient denies any drainage since that day. Denies any fever, sweats, chills. Patient reports warmth upon palpating the area on her proximal right upper extremity. Patient also reports pain of the proximal right upper extremity, rating pain 9/10. Denies fever, sweats, chills.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Headache, Musculoskeletal pain, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Large blister, headache as soon as vaccine given, shoulder/arm stiffness/soreness, fever, itching.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia
Clinical narrative: Large blister, headache as soon as vaccine given, shoulder/arm stiffness/soreness, fever, itching.
Age: 1.5
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: The Tdap vaccine was administered instead of the correct vaccine Dtap. They have received a reduced dose. No reaction or side effect has been reported by parent or witnessed.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Chest pain, Headache, Injected limb mobility decreased, Lethargy, Nausea
Clinical narrative: Headache; Vomiting; Lethargic; Nauseated; Severe pain left arm and into left side of chest. Could not move arm for several days. Significant pain lasted for about 10 days. First 4 symptoms lasted 4 days.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Vomiting
Clinical narrative: Headache; Vomiting; Lethargic; Nauseated; Severe pain left arm and into left side of chest. Could not move arm for several days. Significant pain lasted for about 10 days. First 4 symptoms lasted 4 days.
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Balance disorder, Clumsiness, Decreased eye contact, Fall, Feeling abnormal
Clinical narrative: Around 2/1/19 child became ill, was seen on 2/5/19, had fever x 2 days and fever broke on 2/5/19, on that day rash started all over body which got worse for several days, and finally started improving, today 2/8/19 rash almost all gone. On 2/5 Dx was viral exanthem vs vaccine reaction. Father noted on 2/6/19 child becoming more clumsy, had been walking since 10 MOS old, but now loss of balance "almost like he was drunk" and fell often, he is choosing to crawl like he did 3 MOS ago. Previously he would be grabbing a ball and running with it. Dad describes a lack of eye contact. No fevers since 2/5/19, but today in daycare teachers say he won't play, just sits there. Dad describes him as "zoning out" not engaging and laughing like he used to. He was self-feeding with a spoon, now he won't really eat. He is mostly being carried, not engaged with parents the way he was. He use to point at everything and say this, now he neither points nor says anything at all. He mostly screams and "zones in and out". No treatment or tests have been done.
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Malaise, Pyrexia, Rash generalised, Regressive behaviour, Screaming
Clinical narrative: Around 2/1/19 child became ill, was seen on 2/5/19, had fever x 2 days and fever broke on 2/5/19, on that day rash started all over body which got worse for several days, and finally started improving, today 2/8/19 rash almost all gone. On 2/5 Dx was viral exanthem vs vaccine reaction. Father noted on 2/6/19 child becoming more clumsy, had been walking since 10 MOS old, but now loss of balance "almost like he was drunk" and fell often, he is choosing to crawl like he did 3 MOS ago. Previously he would be grabbing a ball and running with it. Dad describes a lack of eye contact. No fevers since 2/5/19, but today in daycare teachers say he won't play, just sits there. Dad describes him as "zoning out" not engaging and laughing like he used to. He was self-feeding with a spoon, now he won't really eat. He is mostly being carried, not engaged with parents the way he was. He use to point at everything and say this, now he neither points nor says anything at all. He mostly screams and "zones in and out". No treatment or tests have been done.
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Social avoidant behaviour, Vaccination complication, Viral rash
Clinical narrative: Around 2/1/19 child became ill, was seen on 2/5/19, had fever x 2 days and fever broke on 2/5/19, on that day rash started all over body which got worse for several days, and finally started improving, today 2/8/19 rash almost all gone. On 2/5 Dx was viral exanthem vs vaccine reaction. Father noted on 2/6/19 child becoming more clumsy, had been walking since 10 MOS old, but now loss of balance "almost like he was drunk" and fell often, he is choosing to crawl like he did 3 MOS ago. Previously he would be grabbing a ball and running with it. Dad describes a lack of eye contact. No fevers since 2/5/19, but today in daycare teachers say he won't play, just sits there. Dad describes him as "zoning out" not engaging and laughing like he used to. He was self-feeding with a spoon, now he won't really eat. He is mostly being carried, not engaged with parents the way he was. He use to point at everything and say this, now he neither points nor says anything at all. He mostly screams and "zones in and out". No treatment or tests have been done.
Age: 58.0
Sex: F
Vaccine: DTAP
Symptoms: Cough, Hypersensitivity, Influenza like illness, Nasal congestion, Pain
Clinical narrative: Several hours after the injection I experienced the onset of Flu-like symptoms. Body ache all over, lasting 3 days. Second day I also experienced sneezing, coughing and stuffed nose, but not like a regular head/chest cold but rather like a severe allergic reaction. Symptoms lasted about 6-7 days.
Age: 58.0
Sex: F
Vaccine: DTAP
Symptoms: Sneezing
Clinical narrative: Several hours after the injection I experienced the onset of Flu-like symptoms. Body ache all over, lasting 3 days. Second day I also experienced sneezing, coughing and stuffed nose, but not like a regular head/chest cold but rather like a severe allergic reaction. Symptoms lasted about 6-7 days.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Malaise.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Fever, warm red area around injection site.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Breast swelling, Joint swelling, Peripheral swelling
Clinical narrative: This spontaneous report was received from a 76 year old female patient, reporting on herself. The patient's concurrent conditions included allergy to penicillin and sulfa. The patient had no pertinent medical history and concomitant medications. On an unspecified date in October 2009, the patient was vaccinated with PNEUMOVAX 23 in an unspecified arm (strength, dose, route, lot # and expiration date were not provided) for prophylaxis. On the same date, reported as "that evening" after receiving the vaccine, the patient began to "swell at the wrist which spread to the elbow and then to the shoulder and to the breast" (breast swelling) (peripheral swelling) (joint swelling). The patient went to the physician's office on the next day, however no laboratory diagnostic studies were carried out and no treatment was given for the events. The events resolved 1 to 1 and half days later. The causality between the events breast swelling, peripheral swelling and joint swelling and therapy with PNEUMOVAX 23 was unknown.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated, Dyspnoea, Erythema, Familial tremor
Clinical narrative: Severe pain at injection site, redness about 4" to 5" in diameter, severe headache. Exacerbation of both COPD and Familial tremors symptoms. Difficulty breathing, runny nose, headache, exaggerated tremors of the hands and mouth.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Rhinorrhoea, Tremor
Clinical narrative: Severe pain at injection site, redness about 4" to 5" in diameter, severe headache. Exacerbation of both COPD and Familial tremors symptoms. Difficulty breathing, runny nose, headache, exaggerated tremors of the hands and mouth.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Anxiety, Chromatopsia, Dyspnoea, Excessive eye blinking, Fatigue
Clinical narrative: PANIC ATTACK- "After shots given, while lying down pt became very anxious, tearful, trembling, stating that he could not breathe or move his R arm, later his L arm, could not move in general, felt "vibrations" throughout his body, vision going black, vision turning all green, seeing rainbows, seeing things floating around in the air, eyelids fluttering at times, closing his eyes, saying he felt tired and wanted to sleep".
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injected limb mobility decreased, Mobility decreased, Panic attack, Somnolence, Tearfulness
Clinical narrative: PANIC ATTACK- "After shots given, while lying down pt became very anxious, tearful, trembling, stating that he could not breathe or move his R arm, later his L arm, could not move in general, felt "vibrations" throughout his body, vision going black, vision turning all green, seeing rainbows, seeing things floating around in the air, eyelids fluttering at times, closing his eyes, saying he felt tired and wanted to sleep".
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Tremor, Visual impairment, Vitreous floaters
Clinical narrative: PANIC ATTACK- "After shots given, while lying down pt became very anxious, tearful, trembling, stating that he could not breathe or move his R arm, later his L arm, could not move in general, felt "vibrations" throughout his body, vision going black, vision turning all green, seeing rainbows, seeing things floating around in the air, eyelids fluttering at times, closing his eyes, saying he felt tired and wanted to sleep".
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Feeling hot, Flushing, Nausea
Clinical narrative: Employee received second dose of the Hep B series today (02/08/2019) around 9:30 AM. Per employee, she felt nauseous, lightheaded, and felt her face hot after lunch, which was around 10:30AM. Upon assessment, employee's face was flushed. Vital signs: BP-110/71, Pulse-81, Resp-18 RA, Temp: 98.7. Vital signs taken at 11:55AM. BENADRYL 50MG by mouth given x 1. Health management services was contacted immediately and suggested to send employee to see doctor for further evaluation.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Patient reported to the clinic 2/8/19 that she was having erythema and edema to the left deltoid at the injection site. Denies having pain.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling cold, Headache, Injection site pain, Pyrexia
Clinical narrative: Rapid onset of extreme fatigue, became very cold, fever of 101.6, headache, and very sore at injection site. Lasted about 12 hours.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Erythema, Headache, Myalgia, Oropharyngeal pain
Clinical narrative: Muscle aches, sore throat, sinus drainage and injection, headache, lack of appetite, slight redness on both forearms (not in area of injection) -- lasted for 5 days.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Sinus operation
Clinical narrative: Muscle aches, sore throat, sinus drainage and injection, headache, lack of appetite, slight redness on both forearms (not in area of injection) -- lasted for 5 days.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Patient started experiencing persistent muscle pain after injection. Is now receiving medical treatment and physical therapy due to it.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Influenza like illness
Clinical narrative: Dizziness, body aches, chills, fatigue, weakness--flu like symptoms.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Dizziness, body aches, chills, fatigue, weakness--flu like symptoms.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Patient has persistent muscle pain due to vaccination.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Bursitis, Injection site pain
Clinical narrative: Patient reports onset of left shoulder pain the night of vaccine administration and presented to clinic 1 month later on 2/7/19 with continued shoulder pain. Currently being treated as with NSAID and home exercises for shoulder bursitis.
Age: 29.0
Sex: F
Vaccine: JEV1, TYP, YF
Symptoms: Dizziness, Hypoaesthesia, Injection site erythema, Nausea, Palpitations
Clinical narrative: Redness around injection site (left tricep), dizziness, lightheadedness, nausea, numbness in fingers and arm (left), heart palpatations.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain
Clinical narrative: Patient reports not being able to raise her left arm above shoulder level without pain. She also reports that she cannot extend her arm behind her back without pain.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Chest pain, Headache, Nausea, Pleuritic pain, Pyrexia
Clinical narrative: PATIENT RECIEVED SMALLPOX VACCINE ON 28 JAN 2019. PATIENT PRESENTED TO PRIMARY CARE MANAGERWITH CHEIF COMPLAINT OF CHEST PAINS, SUBJECTIVE FEVERS, HEADACHES, NAUSEA, PLEURITIC CHEST PAIN. WAS SEEN BY DR., (06 FEB 2019 08:22AM.) PATIENT WAS THEN TRANSPORTED VIA PRIVATE VEHICLE TO EMERGENCY DEPARTMENT FOR EVAC AND FURTHER TREATMENT.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Blood creatine phosphokinase MB, Blood creatine phosphokinase normal, Brain natriuretic peptide normal, C-reactive protein increased, Chest X-ray normal
Clinical narrative: PATIENT RECIEVED SMALLPOX VACCINE ON 28 JAN 2019. PATIENT PRESENTED TO PRIMARY CARE MANAGERWITH CHEIF COMPLAINT OF CHEST PAINS, SUBJECTIVE FEVERS, HEADACHES, NAUSEA, PLEURITIC CHEST PAIN. WAS SEEN BY DR., (06 FEB 2019 08:22AM.) PATIENT WAS THEN TRANSPORTED VIA PRIVATE VEHICLE TO EMERGENCY DEPARTMENT FOR EVAC AND FURTHER TREATMENT.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Chest pain, Chills, Dyspnoea, Echocardiogram abnormal, Ejection fraction decreased
Clinical narrative: PATIENT RECIEVED SMALLPOX VACCINE ON 28 JAN 2019. PATIENT PRESENTED TO PRIMARY CARE MANAGERWITH CHEIF COMPLAINT OF CHEST PAINS, SUBJECTIVE FEVERS, HEADACHES, NAUSEA, PLEURITIC CHEST PAIN. WAS SEEN BY DR., (06 FEB 2019 08:22AM.) PATIENT WAS THEN TRANSPORTED VIA PRIVATE VEHICLE TO EMERGENCY DEPARTMENT FOR EVAC AND FURTHER TREATMENT.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Electrocardiogram abnormal, Electrocardiogram ambulatory, Headache, Hyperhidrosis, Loss of personal independence in daily activities
Clinical narrative: PATIENT RECIEVED SMALLPOX VACCINE ON 28 JAN 2019. PATIENT PRESENTED TO PRIMARY CARE MANAGERWITH CHEIF COMPLAINT OF CHEST PAINS, SUBJECTIVE FEVERS, HEADACHES, NAUSEA, PLEURITIC CHEST PAIN. WAS SEEN BY DR., (06 FEB 2019 08:22AM.) PATIENT WAS THEN TRANSPORTED VIA PRIVATE VEHICLE TO EMERGENCY DEPARTMENT FOR EVAC AND FURTHER TREATMENT.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Nausea, Nuclear magnetic resonance imaging heart, Pleuritic pain, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: PATIENT RECIEVED SMALLPOX VACCINE ON 28 JAN 2019. PATIENT PRESENTED TO PRIMARY CARE MANAGERWITH CHEIF COMPLAINT OF CHEST PAINS, SUBJECTIVE FEVERS, HEADACHES, NAUSEA, PLEURITIC CHEST PAIN. WAS SEEN BY DR., (06 FEB 2019 08:22AM.) PATIENT WAS THEN TRANSPORTED VIA PRIVATE VEHICLE TO EMERGENCY DEPARTMENT FOR EVAC AND FURTHER TREATMENT.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Tricuspid valve incompetence, Troponin I increased
Clinical narrative: PATIENT RECIEVED SMALLPOX VACCINE ON 28 JAN 2019. PATIENT PRESENTED TO PRIMARY CARE MANAGERWITH CHEIF COMPLAINT OF CHEST PAINS, SUBJECTIVE FEVERS, HEADACHES, NAUSEA, PLEURITIC CHEST PAIN. WAS SEEN BY DR., (06 FEB 2019 08:22AM.) PATIENT WAS THEN TRANSPORTED VIA PRIVATE VEHICLE TO EMERGENCY DEPARTMENT FOR EVAC AND FURTHER TREATMENT.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Oral herpes
Clinical narrative: Patient experienced shingles outbreak on right side of mouth and cheek and also down her chest.
Age: 1.5
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Administered Tdap that has a reduced dose and is for age 7 and up. Should have administered Dtap. No adverse reaction was observed while in the clinic post vaccination.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Pruritus, Rash
Clinical narrative: Patient came to the pharmacy to inform us that she had small rash on her right forearm. Pt believes that it was a result of her 2nd SHINGRIX shot she received from us on 01/11/2019. Upon further discussion with the patient, she described rash as small water filled pimples, itchy, but not painful. She indicated that rash appeared about 10 days after the shot. She showed me the picture of the rash that she took on 01/25/19. She applied Hydrocortisone for approximately two weeks and the rash went away. She indicated that she did not had any adverse reaction to the 1st SHINGRIX shot.
Age: 1.0
Sex: M
Vaccine: PNC13
Symptoms: Crying, Irritability
Clinical narrative: Extreme irritability, inconsolable crying at night, 2-3 hours the last 4 nights...child previously slept through the night or was given a pacifier and comforted.
Age: 11.0
Sex: M
Vaccine: HPV9, PNC13, TDAP
Symptoms: Asthenia, Biopsy site unspecified normal, Decreased appetite, Inflammatory marker increased, Lymphadenopathy
Clinical narrative: Followed by Infectious disease for two "episodes" of fever starting Jan 2 2019. He had low energy, decreased appetite, and an 8 pound weight loss. On 10/10/2018 he had elevated inflammatory markers. On 12/19/2018 he had cervical and supra-clavicular lymphadenopathy. Biopsy did not show neoplasm. Mother is convinced that all of this was initiated post HPV vaccination, and she requested that we submit a VAERS report.
Age: 11.0
Sex: M
Vaccine: HPV9, PNC13, TDAP
Symptoms: Pyrexia, Weight decreased
Clinical narrative: Followed by Infectious disease for two "episodes" of fever starting Jan 2 2019. He had low energy, decreased appetite, and an 8 pound weight loss. On 10/10/2018 he had elevated inflammatory markers. On 12/19/2018 he had cervical and supra-clavicular lymphadenopathy. Biopsy did not show neoplasm. Mother is convinced that all of this was initiated post HPV vaccination, and she requested that we submit a VAERS report.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Influenza like illness, Pyrexia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: High fevers, possible febrile seizure, flu-like symptoms, swollen erythematous right arm at the site of both vaccines.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Chills, Injection site erythema
Clinical narrative: Patient received PREVNAR on 2/5/19. Starting that night, patient got chills and joint pain that has now since disappeared. She reports the redness at the injection site has spread and saw her doctor today 2/8/19, who advised her to apply ice and take ADVIL and to monitor the redness.
Age: 78.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Arm sore and redness around injection site.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis in left arm. Cephalexin 500mg QID x10 days.
Age: 1.17
Sex: F
Vaccine: VARCEL, FLU4, HEPA, VARCEL
Symptoms: Rash generalised, Rash vesicular
Clinical narrative: Sunday Feb 3rd: patient started with some signs of tiredness ad having less energy than usual. Monday Feb 4th: woke up with rash and blisters, on the side of her back, arm and legs. Throughout the morning, the rash progressed and more blister developed. I took her to the pediatrician and she was given the diagnosis of chicken pox that developed 7 days post-vaccination. Blisters and itchy rash appeared on her face, arms, hands, legs, feet.
Age: 1.17
Sex: F
Vaccine: VARCEL, FLU4, HEPA, VARCEL
Symptoms: Asthenia, Blister, Fatigue, Rash pruritic, Varicella post vaccine
Clinical narrative: Sunday Feb 3rd: patient started with some signs of tiredness ad having less energy than usual. Monday Feb 4th: woke up with rash and blisters, on the side of her back, arm and legs. Throughout the morning, the rash progressed and more blister developed. I took her to the pediatrician and she was given the diagnosis of chicken pox that developed 7 days post-vaccination. Blisters and itchy rash appeared on her face, arms, hands, legs, feet.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13
Symptoms: Blood glucose, Blood glucose abnormal, Body temperature increased, Febrile convulsion
Clinical narrative: Febrile seizure. Temperature of 103 F.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: The patient reported pain in the arm right after injection. She states the pain has continued. The pain is so much that she can't lift her arm. She is seeking treatment and diagnosis from a shoulder specialist for a vaccine injury.
Age: 36.0
Sex: F
Vaccine: DTAP
Symptoms: Dyspnoea
Clinical narrative: Dyspnea over several hours after vaccine administration and lasting until the next morning.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Myalgia
Clinical narrative: Muscle Ache. Medium Temperature 100.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Nasal congestion, Oropharyngeal pain
Clinical narrative: Onset of headache 02/07/19 1730, headache persisted with increased intensity throughout 02/08/19.  Sore throat onset 02/08/19 in am. Ibuprofen 200mg taken approximately 0900 02/08/19 with minimal relief. 02/08/19 approximately 1100 intensity of headache increased. 02/08/19 approximately 1300 self administered dose of Theraflu. Went to Clinic, Clinic HCP (does not remember provider name) stated that symptoms were a mild reaction to Hepatitis B vaccination and advised to treat with robitussin and zyrtec for symptom control. Afebrile during clinic visit. Zyrtec 1 tab taken yesterday. Robitussin dose x 2 yesterday. 02/09/19 0450 awaken with headache and sore throat with decreased intensity from previous day, new symptoms of nasal congestion. Robitussin 1 dose and saline nasal spray taken. Currently at 0818 02/09/19 reports mild sore throat, moderate intensity headache (decreased from yesterday) and nasal congestion.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Lethargy
Clinical narrative: Patient on interview describes headache, dizziness, lethargy. These symptoms became worse over the next 3 days leading to an emergency room visit followed by a 3 day hospital stay.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever, body ache, diarrhea, chills, sore arm.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Incomplete course of vaccination, Loss of personal independence in daily activities, Pain, Pyrexia
Clinical narrative: Fever of 100.6, chills, severe aches and pains, inability to conduct normal activities. Serious enough that I won't consider the booster, won't do this again.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Myalgia
Clinical narrative: Muscle pain or myalgia or achiness lasted for approximately 48 hours. I continued normal activity, but it was uncomfortable and more pronounced than I had expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Chills, Fatigue, Feeling cold, Injection site erythema
Clinical narrative: First series was given with a flu shot, SEQIRUS, lot yf36905. Following day had flu symptoms of achy skin and shivers. This lasted one day. The following day felt excellent. Second series, the following day I felt tired, cold (shivers). This lasted 3 days. On 2/4/2019 I noticed a red band below the shot area on my arm. It was hot and sore and itchy. I felt shooting pains in my forearm-top between the wrist and elbow.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site warmth, Pain, Pain in extremity
Clinical narrative: First series was given with a flu shot, SEQIRUS, lot yf36905. Following day had flu symptoms of achy skin and shivers. This lasted one day. The following day felt excellent. Second series, the following day I felt tired, cold (shivers). This lasted 3 days. On 2/4/2019 I noticed a red band below the shot area on my arm. It was hot and sore and itchy. I felt shooting pains in my forearm-top between the wrist and elbow.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Dizziness, Gait inability, Impaired driving ability
Clinical narrative: Severely light headed with loss of balance. Unable to walk to car or drive. Lasted about 6-8 hours.  Did not seek medical care.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pain
Clinical narrative: Severe headache, muscle aches and uncontrollable shivering (for over an hour the shivering persisted; I climbed in scalding hot shower at 0400am to get under control). Body ache and headache persist 24 hours later.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Nausea, Sluggishness
Clinical narrative: Nausea, diarrhea, fatigue, sluggish, tired.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain in extremity, Paraesthesia, Peripheral swelling, Product administered at inappropriate site
Clinical narrative: PNEUMOVAX given too high on left arm per visual inspection of site next day. Patient reports severe pain, tingling and swelling of arm during the evening after receiving immunization. Reports not being able to move arm at all on 2/8 after immunization. Swelling had subsided by when patient was seen by me on 2/9.  He reported that he could move lower arm, but could not lift upper arm still. I referred him to his regular physician as soon as he can be seen.
Age: 15.0
Sex: M
Vaccine: FLUC4
Symptoms: Dyspnoea, Rash
Clinical narrative: Rash on left side of face, breathing difficulty.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyskinesia, Fatigue, Feeling abnormal, Injection site pain, Lethargy
Clinical narrative: 1/7/2019 pt reports pain at injection site, lethargic and twitching in left index finger. Became increasingly tired and felt foggy and that her body had been invaded. 1/11/2019 She reports muscle spasms in arms and legs and jerking. 1/12/2019 jaw was twitching and continued spasms.  Saw doctor on 1/14/2019 and he ordered MRI and referred her to a neurologist. Continued to have spasms off and on from 1/15/2019-1/23/2019. MRI on 1/21/2019 was normal and B12 level was normal per doctor's office.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms, Muscle twitching, Nuclear magnetic resonance imaging normal, Vitamin B12 normal
Clinical narrative: 1/7/2019 pt reports pain at injection site, lethargic and twitching in left index finger. Became increasingly tired and felt foggy and that her body had been invaded. 1/11/2019 She reports muscle spasms in arms and legs and jerking. 1/12/2019 jaw was twitching and continued spasms.  Saw doctor on 1/14/2019 and he ordered MRI and referred her to a neurologist. Continued to have spasms off and on from 1/15/2019-1/23/2019. MRI on 1/21/2019 was normal and B12 level was normal per doctor's office.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: THE PATIENT HAD A RED, SWOLLEN, HOT, INFLAMMED AREA ABOUT 4 INCHES WIDE BELOW THE INJECTION SITE TO ABOUT THE ELBOW. HE FELT TIRED, LETHARGIC. HE DID NOT HAVE A FEVER. HE HAD NORMAL RANGE OF MOTION FOR ARM. THIS STARTED SOON AFTER THE IMMUNIZATION.  THE PATIENT WENT TO SEE HIS PRIMARY PROVIDER ON FRIDAY AND WAS TOLD THAT THE DOSE OF VACCINE HAD MOVED DOWN HIS ARM DUE TO GRAVITY. DR. TOLD HIM TO CONTINUE TYLENOL AND IBUPROFEN FOR PAIN AND TO USE ICE PACKS TOPICALLY AND IT SHOULD RESOLVE WITHIN A FEW DAYS.