chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Musculoskeletal disorder
Clinical narrative: This is a spontaneous report from a contactable Physician Assistant. A male patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration in arm (deltoid) on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced joint pain and typical musculoskeletal side effects of the medication on unspecified date. The events were non-serious with outcome of unknown. The information on the batch number has been requested.
Age: 0.58
Sex: F
Vaccine: DTAP, PNC13, RV1
Symptoms: Aggression, Emotional disorder, Lethargy, Pyrexia, Quality of life decreased
Clinical narrative: Patient had a fever and was lethargic after receiving 3 vaccines. We administered Tylenol per her doctor. She seemed to recover, but then began having extreme emotional problems. Within a few months she was having as many as 20 tantrums per day. We had her evaluated by a developmental pediatrician who said she was extremely sensory sensitive and high strung. We did not immediately associate this development with the vaccinations, but later realized that they were implicated. She has since been diagnosed with sensory processing disorder and is undergoing occupational therapy. Her sensory issues make her life very difficult but she is slowly improving.
Age: 0.58
Sex: F
Vaccine: DTAP, PNC13, RV1
Symptoms: Sensory disturbance, Sensory processing disorder
Clinical narrative: Patient had a fever and was lethargic after receiving 3 vaccines. We administered Tylenol per her doctor. She seemed to recover, but then began having extreme emotional problems. Within a few months she was having as many as 20 tantrums per day. We had her evaluated by a developmental pediatrician who said she was extremely sensory sensitive and high strung. We did not immediately associate this development with the vaccinations, but later realized that they were implicated. She has since been diagnosed with sensory processing disorder and is undergoing occupational therapy. Her sensory issues make her life very difficult but she is slowly improving.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia, Pyrexia
Clinical narrative: Complained of severe deltoid pain where the vaccine was given, also low grade fever, and full body muscle aches. Lasted for about 24 hours after onset. Patient feels much better today 2 days post vaccination.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Abdominal pain, Asthenia, Chills, Dizziness, Electrocardiogram
Clinical narrative: 2/15/2018: presented at ED with hives, dizziness, nausea, and facial swelling. Symptoms treated and discharged. 2/17/2018: brought to ED by EMS for evaluation of syncopal event, fever, chills, fatigue.  Labs and ECG done, symptoms treated, and discharged. 2/18/2018: presented at ED with continued dizziness and weakness, hives. Labs done, symptoms treated, and discharged. 2/21/2018:  presented at ED with lower abdominal pain, vomiting, fatigue, headache. Labs and x-ray done, symptoms treated, and discharged. 2/28/2018:  appointment with PCP for ED follow up:  since BEXSERO #2 on 2/14/2018 continues with racing heart, fatigue, muscle aches, lightheadedness. Further testing pending.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Headache, Laboratory test, Myalgia, Nausea
Clinical narrative: 2/15/2018: presented at ED with hives, dizziness, nausea, and facial swelling. Symptoms treated and discharged. 2/17/2018: brought to ED by EMS for evaluation of syncopal event, fever, chills, fatigue.  Labs and ECG done, symptoms treated, and discharged. 2/18/2018: presented at ED with continued dizziness and weakness, hives. Labs done, symptoms treated, and discharged. 2/21/2018:  presented at ED with lower abdominal pain, vomiting, fatigue, headache. Labs and x-ray done, symptoms treated, and discharged. 2/28/2018:  appointment with PCP for ED follow up:  since BEXSERO #2 on 2/14/2018 continues with racing heart, fatigue, muscle aches, lightheadedness. Further testing pending.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Palpitations, Pyrexia, Swelling face, Syncope, Urticaria
Clinical narrative: 2/15/2018: presented at ED with hives, dizziness, nausea, and facial swelling. Symptoms treated and discharged. 2/17/2018: brought to ED by EMS for evaluation of syncopal event, fever, chills, fatigue.  Labs and ECG done, symptoms treated, and discharged. 2/18/2018: presented at ED with continued dizziness and weakness, hives. Labs done, symptoms treated, and discharged. 2/21/2018:  presented at ED with lower abdominal pain, vomiting, fatigue, headache. Labs and x-ray done, symptoms treated, and discharged. 2/28/2018:  appointment with PCP for ED follow up:  since BEXSERO #2 on 2/14/2018 continues with racing heart, fatigue, muscle aches, lightheadedness. Further testing pending.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Vomiting, X-ray
Clinical narrative: 2/15/2018: presented at ED with hives, dizziness, nausea, and facial swelling. Symptoms treated and discharged. 2/17/2018: brought to ED by EMS for evaluation of syncopal event, fever, chills, fatigue.  Labs and ECG done, symptoms treated, and discharged. 2/18/2018: presented at ED with continued dizziness and weakness, hives. Labs done, symptoms treated, and discharged. 2/21/2018:  presented at ED with lower abdominal pain, vomiting, fatigue, headache. Labs and x-ray done, symptoms treated, and discharged. 2/28/2018:  appointment with PCP for ED follow up:  since BEXSERO #2 on 2/14/2018 continues with racing heart, fatigue, muscle aches, lightheadedness. Further testing pending.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Astrovirus test positive, Intussusception, Large intestinal obstruction reduction, Norovirus test positive, Small intestinal intussusception reduction
Clinical narrative: Ileocolic intussusception -- 2/20/2018 -- successful pneumatic reduction (ER visit, hospitalized 2/19 - 2/20). Recurrent ileocolic intussusception, hospitalized 2/26/2018 - 2/28/2018, successful pneumatic reduction.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Ultrasound abdomen abnormal
Clinical narrative: Ileocolic intussusception -- 2/20/2018 -- successful pneumatic reduction (ER visit, hospitalized 2/19 - 2/20). Recurrent ileocolic intussusception, hospitalized 2/26/2018 - 2/28/2018, successful pneumatic reduction.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Abnormal behaviour, Abscess oral, Anaphylactic reaction, Anger, Aphasia
Clinical narrative: 3/22-5/2 reactions included: abscesses tooth, congestion, irritation, anger, chicken pox and shingles external and internal  mild to moderate anaphylaxis, hives, fever, eating issues, pain, excessive crying, cough, behaviors such as spitting and OCD behaviors, bowl issues, and loss of all remaining verbal speech.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Cough, Crying, Eating disorder, Functional gastrointestinal disorder, Herpes zoster
Clinical narrative: 3/22-5/2 reactions included: abscesses tooth, congestion, irritation, anger, chicken pox and shingles external and internal  mild to moderate anaphylaxis, hives, fever, eating issues, pain, excessive crying, cough, behaviors such as spitting and OCD behaviors, bowl issues, and loss of all remaining verbal speech.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Irritability, Nasal congestion, Obsessive-compulsive disorder, Pain, Pyrexia
Clinical narrative: 3/22-5/2 reactions included: abscesses tooth, congestion, irritation, anger, chicken pox and shingles external and internal  mild to moderate anaphylaxis, hives, fever, eating issues, pain, excessive crying, cough, behaviors such as spitting and OCD behaviors, bowl issues, and loss of all remaining verbal speech.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Urticaria, Varicella
Clinical narrative: 3/22-5/2 reactions included: abscesses tooth, congestion, irritation, anger, chicken pox and shingles external and internal  mild to moderate anaphylaxis, hives, fever, eating issues, pain, excessive crying, cough, behaviors such as spitting and OCD behaviors, bowl issues, and loss of all remaining verbal speech.
Age: 23.0
Sex: M
Vaccine: MENB
Symptoms: Impaired driving ability, Injection site pain, Joint stiffness, Loss of personal independence in daily activities, Periarthritis
Clinical narrative: 2 days after receiving Bexsero #2, developed right shoulder pain and stiffness in the shoulder joint.  Not improved with ice, heat, and ibuprofen. In fact symptoms increased including at rest, sleeping, and with any movement or motion. 02/19/2018: first visit to PCP. Home care advised. 02/23/2018: second visit to PCP. Symptoms worsening; right shoulder stiffening and freezing up. Treatment with oral prednisone started. 02/28/2018: third visit to PCP. Gradual improvement but impossible to drive a car and difficult to change clothes. Continue prednisone taper; start naproxen twice daily; physical therapy evaluation and treatment.
Age: 14.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Lip swelling
Clinical narrative: The patient awoke the next day after the vaccines were given and had developed a swollen upper lip. She did not have any pruritis, airway compromise, difficulty with speech or swallowing, rash, hives, fever, or other symptoms. The swelling resolved within 48 hours.
Age: 23.0
Sex: U
Vaccine: MENB, MENB
Symptoms: Headache, Nausea, Urticaria
Clinical narrative: Headache a short time after receiving the vaccine. 'Hives" and nausea at 5 AM. Pt took BENADRYL 25 mg at 5 A. Hives resolved. Came to Health Services at 940 AM. No hives present. Still slight nausea and headache. Vital signs stable. Given ZYRTEC on tab PO and Acetaminophen 2 tabs PO.
Age: 23.0
Sex: U
Vaccine: MENB, MENB
Symptoms: Dizziness, Headache, Heart rate increased, Nausea, Pruritus
Clinical narrative: Headache a short time after receiving the vaccine. 'Hives" and nausea at 5 AM. Pt took BENADRYL 25 mg at 5 A. Hives resolved. Came to Health Services at 940 AM. No hives present. Still slight nausea and headache. Vital signs stable. Given ZYRTEC on tab PO and Acetaminophen 2 tabs PO.
Age: 23.0
Sex: U
Vaccine: MENB, MENB
Symptoms: Urticaria
Clinical narrative: Headache a short time after receiving the vaccine. 'Hives" and nausea at 5 AM. Pt took BENADRYL 25 mg at 5 A. Hives resolved. Came to Health Services at 940 AM. No hives present. Still slight nausea and headache. Vital signs stable. Given ZYRTEC on tab PO and Acetaminophen 2 tabs PO.
Age: 23.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Headache, Nausea, Urticaria
Clinical narrative: Headache approximately an hour after injection. Hives, nausea, lightheadedness and racing pulse started approximately 16 hours after injection. Took BENADRYL, slept. Went into health center at 9:30am on 03/07/2018. They monitored me for 2 hours, gave me Acetaminophen (for headache) and ZYRTEC for hives and itchiness.
Age: 23.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Dizziness, Headache, Heart rate increased, Nausea, Pruritus
Clinical narrative: Headache approximately an hour after injection. Hives, nausea, lightheadedness and racing pulse started approximately 16 hours after injection. Took BENADRYL, slept. Went into health center at 9:30am on 03/07/2018. They monitored me for 2 hours, gave me Acetaminophen (for headache) and ZYRTEC for hives and itchiness.
Age: 23.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Urticaria
Clinical narrative: Headache approximately an hour after injection. Hives, nausea, lightheadedness and racing pulse started approximately 16 hours after injection. Took BENADRYL, slept. Went into health center at 9:30am on 03/07/2018. They monitored me for 2 hours, gave me Acetaminophen (for headache) and ZYRTEC for hives and itchiness.
Age: 1.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMRV, PNC13
Symptoms: Haematoma, Injection site induration, Injection site pain, Swelling, Ultrasound scan abnormal
Clinical narrative: Received routine immunizations (R) thigh on 2/5/18, Mother noticed swelling next day. Came to ED for viral URI on 2/19 and thigh noted to be tender and hard. Xray-> no FB or osteo, US showed hematoma, less likely abscess, worse on 3/6/18 -> ED.
Age: 1.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMRV, PNC13
Symptoms: Viral upper respiratory tract infection, X-ray normal
Clinical narrative: Received routine immunizations (R) thigh on 2/5/18, Mother noticed swelling next day. Came to ED for viral URI on 2/19 and thigh noted to be tender and hard. Xray-> no FB or osteo, US showed hematoma, less likely abscess, worse on 3/6/18 -> ED.
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Fatigue, Pain, Pain in extremity
Clinical narrative: Body aches, fatigue, arm pain.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 74-year-old female patient who received SHINGRIX. Concurrent medical conditions included blood cholesterol increased (high cholesterol for years) and hematoma (for years and it had not changed). On 22nd February 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 22nd February 2018, less than a day after receiving SHINGRIX, the patient experienced injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site swelling and injection site erythema were not recovered/not resolved. The reporter considered the injection site swelling and injection site erythema to be related to SHINGRIX. Additional information was received as follows: Concomitant medication included TRICOR. The patient received SHINGRIX at 03:00, on left deltoid near the hematoma. The patient stated that she did not notice an injection site reaction until later at night after receiving SHINGRIX it was when she felt swelling. The patient said that the injection site was a big red circle, about 2 inches long and 1 and half inches wide. The injection site reaction was raised and swollen above the hematoma. The patient said that the injection site reaction had gotten more red in color in the last 24 hours before the time of reporting. The patient felt fine and she had not experienced other problems.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Eye pain, Headache, Herpes zoster, Lacrimation increased, Visual impairment
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 72-year-old male patient who received SHINGRIX (batch number NX952, expiry date 6th March 2020). Concomitant products included citalopram, Diltiazem ER, Simvastatin, zolpidem and ELIQUIS. On 8th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In February 2018, 4 days after receiving SHINGRIX, the patient experienced shingles, headache and eye pain. In February 2018, the patient also experienced watering eyes, vision decreased. The patient was treated with acyclovir and Valacyclovir. On an unknown date, the outcome of the shingles, watering eyes and vision decreased were not recovered/not resolved and the outcome of the headache and eye pain were unknown. It was unknown if the reporter considered the shingles, watering eyes, vision decreased, headache and eye pain to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX in the left deltoid and the patient experienced headache and eye pain following vaccination. The patient went to emergency room for these symptoms and he diagnosed with shingles. Acyclovir 800mg prescribed on 19th February 2018. Acyclovir did not work to treat symptoms; thus, the patient switched to valacyclovir 1 gram TID on 21st February 2018. The patient visited eye specialist who prescribed prednisolone eye drops on 28th February 2018. Less than a month after vaccination, additional symptoms of decreased vision and watery eye reported for the left eye, regarding decreased vision, it was reported as 20/40 left eye.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 72-year-old male patient who received SHINGRIX (batch number NX952, expiry date 6th March 2020). Concomitant products included citalopram, Diltiazem ER, Simvastatin, zolpidem and ELIQUIS. On 8th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In February 2018, 4 days after receiving SHINGRIX, the patient experienced shingles, headache and eye pain. In February 2018, the patient also experienced watering eyes, vision decreased. The patient was treated with acyclovir and Valacyclovir. On an unknown date, the outcome of the shingles, watering eyes and vision decreased were not recovered/not resolved and the outcome of the headache and eye pain were unknown. It was unknown if the reporter considered the shingles, watering eyes, vision decreased, headache and eye pain to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX in the left deltoid and the patient experienced headache and eye pain following vaccination. The patient went to emergency room for these symptoms and he diagnosed with shingles. Acyclovir 800mg prescribed on 19th February 2018. Acyclovir did not work to treat symptoms; thus, the patient switched to valacyclovir 1 gram TID on 21st February 2018. The patient visited eye specialist who prescribed prednisolone eye drops on 28th February 2018. Less than a month after vaccination, additional symptoms of decreased vision and watery eye reported for the left eye, regarding decreased vision, it was reported as 20/40 left eye.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blepharospasm, Blood pressure increased, Corneal irritation, Eye disorder, Eye pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 72-year-old male patient who received SHINGRIX (batch number NX952, expiry date 6th March 2020). Concomitant products included citalopram, Diltiazem ER, Simvastatin, zolpidem and ELIQUIS. On 8th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In February 2018, 4 days after receiving SHINGRIX, the patient experienced shingles, headache and eye pain. In February 2018, the patient also experienced watering eyes, vision decreased. The patient was treated with acyclovir and Valacyclovir. On an unknown date, the outcome of the shingles, watering eyes and vision decreased were not recovered/not resolved and the outcome of the headache and eye pain were unknown. It was unknown if the reporter considered the shingles, watering eyes, vision decreased, headache and eye pain to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX in the left deltoid and the patient experienced headache and eye pain following vaccination. The patient went to emergency room for these symptoms and he diagnosed with shingles. Acyclovir 800mg prescribed on 19th February 2018. Acyclovir did not work to treat symptoms; thus, the patient switched to valacyclovir 1 gram TID on 21st February 2018. The patient visited eye specialist who prescribed prednisolone eye drops on 28th February 2018. Less than a month after vaccination, additional symptoms of decreased vision and watery eye reported for the left eye, regarding decreased vision, it was reported as 20/40 left eye.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Fatigue, Headache, Herpes zoster, Lacrimation increased, Nasal discomfort
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 72-year-old male patient who received SHINGRIX (batch number NX952, expiry date 6th March 2020). Concomitant products included citalopram, Diltiazem ER, Simvastatin, zolpidem and ELIQUIS. On 8th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In February 2018, 4 days after receiving SHINGRIX, the patient experienced shingles, headache and eye pain. In February 2018, the patient also experienced watering eyes, vision decreased. The patient was treated with acyclovir and Valacyclovir. On an unknown date, the outcome of the shingles, watering eyes and vision decreased were not recovered/not resolved and the outcome of the headache and eye pain were unknown. It was unknown if the reporter considered the shingles, watering eyes, vision decreased, headache and eye pain to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX in the left deltoid and the patient experienced headache and eye pain following vaccination. The patient went to emergency room for these symptoms and he diagnosed with shingles. Acyclovir 800mg prescribed on 19th February 2018. Acyclovir did not work to treat symptoms; thus, the patient switched to valacyclovir 1 gram TID on 21st February 2018. The patient visited eye specialist who prescribed prednisolone eye drops on 28th February 2018. Less than a month after vaccination, additional symptoms of decreased vision and watery eye reported for the left eye, regarding decreased vision, it was reported as 20/40 left eye.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Neuralgia, Ocular hyperaemia, Skin lesion, Stomatitis, Tongue ulceration
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 72-year-old male patient who received SHINGRIX (batch number NX952, expiry date 6th March 2020). Concomitant products included citalopram, Diltiazem ER, Simvastatin, zolpidem and ELIQUIS. On 8th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In February 2018, 4 days after receiving SHINGRIX, the patient experienced shingles, headache and eye pain. In February 2018, the patient also experienced watering eyes, vision decreased. The patient was treated with acyclovir and Valacyclovir. On an unknown date, the outcome of the shingles, watering eyes and vision decreased were not recovered/not resolved and the outcome of the headache and eye pain were unknown. It was unknown if the reporter considered the shingles, watering eyes, vision decreased, headache and eye pain to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX in the left deltoid and the patient experienced headache and eye pain following vaccination. The patient went to emergency room for these symptoms and he diagnosed with shingles. Acyclovir 800mg prescribed on 19th February 2018. Acyclovir did not work to treat symptoms; thus, the patient switched to valacyclovir 1 gram TID on 21st February 2018. The patient visited eye specialist who prescribed prednisolone eye drops on 28th February 2018. Less than a month after vaccination, additional symptoms of decreased vision and watery eye reported for the left eye, regarding decreased vision, it was reported as 20/40 left eye.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Visual acuity reduced
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 72-year-old male patient who received SHINGRIX (batch number NX952, expiry date 6th March 2020). Concomitant products included citalopram, Diltiazem ER, Simvastatin, zolpidem and ELIQUIS. On 8th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In February 2018, 4 days after receiving SHINGRIX, the patient experienced shingles, headache and eye pain. In February 2018, the patient also experienced watering eyes, vision decreased. The patient was treated with acyclovir and Valacyclovir. On an unknown date, the outcome of the shingles, watering eyes and vision decreased were not recovered/not resolved and the outcome of the headache and eye pain were unknown. It was unknown if the reporter considered the shingles, watering eyes, vision decreased, headache and eye pain to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX in the left deltoid and the patient experienced headache and eye pain following vaccination. The patient went to emergency room for these symptoms and he diagnosed with shingles. Acyclovir 800mg prescribed on 19th February 2018. Acyclovir did not work to treat symptoms; thus, the patient switched to valacyclovir 1 gram TID on 21st February 2018. The patient visited eye specialist who prescribed prednisolone eye drops on 28th February 2018. Less than a month after vaccination, additional symptoms of decreased vision and watery eye reported for the left eye, regarding decreased vision, it was reported as 20/40 left eye.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Erythema multiforme, Injection site rash, Rash erythematous
Clinical narrative: 03/05/2018: presented at PCP appointment with rash at site of Bexsero injection (administered 02/23/2018). Exam showed patch of 12-15 roundish red spots, size from 5-15mm. Ring-like appearance, center pale pink with no bullseye. Non-tender, non-blanching. Appearance suggestive of erythema multiforme except for no central bullseye. No treatment other than OTC hydrocortisone cream prn, with recheck in 2-3 days.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Febrile convulsion, Generalised tonic-clonic seizure, Postictal state
Clinical narrative: Febrile seizure 3 days after vaccine, tonic clonic lasting about 1-2 minutes with post ictal state lasting 5-10 minutes.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash erythematous, Rash vesicular
Clinical narrative: Patient is a 59 y.o. male how is here with rash since yesterday. The rash is described as painful and located on the left area of the patient's torso. The rash is bright red in nature and slowly got worse over time since yesterday.  Patient denies any fevers or chills. Patient has had shingles possible for his life. Patient got the shingles vaccine last week. The rash is getting more and more red. There is no nausea, vomiting, shortness of breath, or diarrhea, or other skin rash. Nothing makes the pain better or worse. The pain does not radiate. There are no other associated symptoms. Vitals: BP 119/75 | Pulse 66 | Temp 37 °C (98.6 °F) (Oral) | Resp 16 | Ht 1.727 m (5' 8") | Wt 99.8 kg (220 lb) | SpO2 93% | BMI 33.45 kg/m². General: alert, appears stated age and cooperative. Skin: Patient has an erythematous painful vesicular rash on the left torso corresponding to about the L5 dermatome. Throat: lips, mucosa, and tongue normal; teeth and gums normal. Mouth: No perioral or gingival cyanosis or lesions. Tongue is normal in appearance. Neck: Back: no scoliosis present, symmetric, no curvature. ROM normal. No CVA tenderness. Lungs: clear to auscultation bilaterally. Heart: regular rate and rhythm, S1, S2 normal, no murmur, click, rub or gallop. Abdomen: soft, non-tender; bowel sounds normal; no masses, no organomegaly. GU: defer exam. Musculoskeletal: negative. Extremities: extremities normal, atraumatic, no cyanosis or edema. Pulses: 2+ and symmetric. 1. Herpes zoster without complication -valacyclovir for 10 days -return to clinic for worsening symptoms -continue lidocaine patches as needed for pain.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Myalgia
Clinical narrative: This spontaneous report was received from a nurse referring to a 66 year old male patient. The patient's pertinent medical history was not reported. The patient had no known allergies. The patient's concurrent conditions included vitamin B12 deficiency, chronic obstructive pulmonary disease (COPD), dementia, gastrooesophageal reflux disease (GERD), high cholesterol, osteoarthritis, osteoporosis and vitamin D deficiency. On 16-FEB-2018, the patient was vaccinated with PNEUMOVAX23 in the left upper arm, lot # N023650 with expiration date 20-MAY-2019, for prophylaxis (dose and route of administration were not reported). Concomitant therapies included ARICEPT, biotin, calcium, CLARITIN, ubidecarenone, fish oil, FOSAMAX, MOBIC, multiple vitamins, omeprazole, ranitidine, red yeast rice extract, vitamin A, TYLENOL, cholecalciferol and zinc. On 16-FEB-2018, the patient was experiencing myalgia all over his upper body. An unspecified treatment was given for the event. No laboratory/diagnostic tests were performed. On 06-MAR-2018, the patient was seen by the physician. At the time of reporting, the outcome of the event was reported as not recovered. The causality assessment between myalgia and PNEUMOVAX23 was not provided.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 01-FEB-2018, previously reported as 22-FEB-2018, the patient was vaccinated with an improperly stored dose of PROQUAD injection U, lot number N004631 with expiration date on 07-AUG-2018, for prophylaxis (dose, route of administration and anatomical location were not reported). The administered dose of the vaccine experienced multiple temperature excursions in the range approximately between -13.86°C to 0 °C, for a maximum cumulative time of 449 hours, as recorded by a data logger. The vaccine had not had a previous temperature excursion. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1803USA002880.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 01-FEB-2018, previously reported as 22-FEB-2018, the patient was vaccinated with an improperly stored dose of PROQUAD injection U, lot number N004631 with expiration date on 07-AUG-2018, for prophylaxis (dose, route of administration and anatomical location were not reported). The administered dose of the vaccine experienced multiple temperature excursions in the range approximately between -13.86°C to 0 °C, for a maximum cumulative time of 449 hours, as recorded by a data logger. The vaccine had not had a previous temperature excursion. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1803USA002737.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Limb injury, Loss of personal independence in daily activities, Mobility decreased, Monoplegia, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself and enrolled in a Pfizer-sponsored program (XELSOURCE); this report regards an event part of the medical history of the patient. A 77 years old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (trade name not reported) on 13Oct2015, in left shoulder, at single dose, for immunization. Medical history and concomitant medications were not reported. Since an unspecified date the vaccine paralyzed her left arm for about 8 months. Her left shoulder was 90% destroyed. She believed that it was what caused the rheumatoid to begin with. She had an X-ray of the shot going into the bursis on an unspecified date. She even asked about draining of the bursis for testing. They said that pneumoccal was not a live virus, but she thought it was a diminished form of a live virus. She knew it was a foreign substance going into a sealed sack. For 4-5 months she did physical therapy 3 times a day. She had diminished movement in the arm, but it was not causing horrible pain like her feet; she still cannot put on a bra. The final outcome of the events was unknown at the time of report. Information on the batch number has been requested. Pfizer is Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Rheumatic disorder, X-ray limb
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself and enrolled in a Pfizer-sponsored program (XELSOURCE); this report regards an event part of the medical history of the patient. A 77 years old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (trade name not reported) on 13Oct2015, in left shoulder, at single dose, for immunization. Medical history and concomitant medications were not reported. Since an unspecified date the vaccine paralyzed her left arm for about 8 months. Her left shoulder was 90% destroyed. She believed that it was what caused the rheumatoid to begin with. She had an X-ray of the shot going into the bursis on an unspecified date. She even asked about draining of the bursis for testing. They said that pneumoccal was not a live virus, but she thought it was a diminished form of a live virus. She knew it was a foreign substance going into a sealed sack. For 4-5 months she did physical therapy 3 times a day. She had diminished movement in the arm, but it was not causing horrible pain like her feet; she still cannot put on a bra. The final outcome of the events was unknown at the time of report. Information on the batch number has been requested. Pfizer is Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received SHINGRIX. On 21st December 2017, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 19th January 2018, 29 days after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. The reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. At 16:52 hours, the patient received SHINGRIX in left arm. When asked if the vaccine was given subcutaneous or intramuscular, the patient said she assumed it was intramuscular because her arm was sore. No information was gathered for the sore arm other than they assumed the shot was given intramuscularly as both he and his wife had sore arms. The case was linked with the case US2018032691, reported for her husband.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left upper arm (deltoid area) red, swollen, warm to touch.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling and inc warmth at injection site measuring 6 cms circular.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Oedema
Clinical narrative: Left upper arm: redness and swelling at injection site with redness spreading on upper arm, area warm to touch and tender. Instructed to apply cool compresses and give oral Benadryl for edema. should resolve in few days. Parents to monitor area and if no improvement in few days, return.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Bacterial test, Body fluid analysis, Culture, Diagnostic aspiration, Differential white blood cell count
Clinical narrative: Left arm became warm, red and swollen. She continued to have swelling and pain 5 days after injection. Returned to clinic. Ultrasound of area was done and found an abscess. Fluid was aspirated from the area using guided ultrasound and sent to lab for testing. Patient was directly admitted that same day to the hospital for IV antibiotic treatment.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site abscess, Pain, Peripheral swelling, Skin warm
Clinical narrative: Left arm became warm, red and swollen. She continued to have swelling and pain 5 days after injection. Returned to clinic. Ultrasound of area was done and found an abscess. Fluid was aspirated from the area using guided ultrasound and sent to lab for testing. Patient was directly admitted that same day to the hospital for IV antibiotic treatment.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Ultrasound scan abnormal
Clinical narrative: Left arm became warm, red and swollen. She continued to have swelling and pain 5 days after injection. Returned to clinic. Ultrasound of area was done and found an abscess. Fluid was aspirated from the area using guided ultrasound and sent to lab for testing. Patient was directly admitted that same day to the hospital for IV antibiotic treatment.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # N017698; expiration date: 09-JUN-2019) or (lot # N017701; expiration date: 09-JUN-2019) for prophylaxis, which had a temperature excursion of 6F to 14F for 2 hours 12 minutes on an unknown date. Previous temperature excursions included the same previous temperature for 2 hours 48 minutes and 15F to 46F for 1 hour 59 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of Merck sterile diluent.   No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1801USA005992.
Sex: F
Vaccine: PNC13
Symptoms: Electrocardiogram ambulatory abnormal, Electrocardiogram normal, Hypoaesthesia, Middle insomnia, Palpitations
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for herself. A 74-year-old  female patient received PREVNAR 13, via an unspecified route of administration maybe in the right arm, on 06Dec2017 around 10:00 AM, at single dose, for immunisation. Patient was vaccinated in the physician's office. Relevant medical history included blood pressure high. Patient presented no illness at time of vaccination. Concomitant medications included Lisinopril/HCTZ from an unspecified date and ongoing for blood pressure high and Aspirin from an unspecified date and ongoing. The patient previously received an unspecified pneumococcal vaccine (but not PREVNAR 13, several years before, for immunisation, with no adverse effect. The patient experienced heart racing in Dec2017 with outcome of not recovered, hands and feet would be numb like they were asleep in Dec2017 with outcome of recovering, some premature ventricular contractions (PVC's) on an unspecified date with outcome of unknown, started waking up at night on an unspecified date with outcome of unknown. Very shortly after receiving the vaccine the patient started waking up at night with her heart racing. Heart racing was persisting, but this was concerning to her because it was getting a little more frequent. She feels it mainly at night, and it generally wakes her up. She has seen her physician and had a 24 hour heart monitor in the beginning of Jan2018. She didn't think that she had an episode of heart racing during the heart monitor, so all it showed was some PVC's. On 28Feb2018, she called the nurse line available through her insurance company because of the heart racing, and was told that she should go to the emergency room. She went to the emergency room that night and had an EKG and an X-ray that both came back okay. The patient also stated that since getting the vaccine, she would wake up and her hands and feet would be numb like they were asleep. She wasn't sure if this was from the vaccine, or from the new job that she started a few months before. This improved.
Sex: F
Vaccine: PNC13
Symptoms: Ventricular extrasystoles, X-ray normal
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for herself. A 74-year-old  female patient received PREVNAR 13, via an unspecified route of administration maybe in the right arm, on 06Dec2017 around 10:00 AM, at single dose, for immunisation. Patient was vaccinated in the physician's office. Relevant medical history included blood pressure high. Patient presented no illness at time of vaccination. Concomitant medications included Lisinopril/HCTZ from an unspecified date and ongoing for blood pressure high and Aspirin from an unspecified date and ongoing. The patient previously received an unspecified pneumococcal vaccine (but not PREVNAR 13, several years before, for immunisation, with no adverse effect. The patient experienced heart racing in Dec2017 with outcome of not recovered, hands and feet would be numb like they were asleep in Dec2017 with outcome of recovering, some premature ventricular contractions (PVC's) on an unspecified date with outcome of unknown, started waking up at night on an unspecified date with outcome of unknown. Very shortly after receiving the vaccine the patient started waking up at night with her heart racing. Heart racing was persisting, but this was concerning to her because it was getting a little more frequent. She feels it mainly at night, and it generally wakes her up. She has seen her physician and had a 24 hour heart monitor in the beginning of Jan2018. She didn't think that she had an episode of heart racing during the heart monitor, so all it showed was some PVC's. On 28Feb2018, she called the nurse line available through her insurance company because of the heart racing, and was told that she should go to the emergency room. She went to the emergency room that night and had an EKG and an X-ray that both came back okay. The patient also stated that since getting the vaccine, she would wake up and her hands and feet would be numb like they were asleep. She wasn't sure if this was from the vaccine, or from the new job that she started a few months before. This improved.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Patient stated that arm was stiff and painful. Patient could not move arm well due to the stiffness and pain. No swelling or inject site redness.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Arthralgia
Clinical narrative: She got a shot in the morning yesterday and she said she went to work out. All evening, her hips and waist area hurt. I asked her if it was more of muscle or bone. She said she couldn't tell. Today, she feels 100% BETTER.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Muscular weakness
Clinical narrative: Patient reports pain at injection site months after receiving the injection. Temporarily relief with creams given by her dermatologist, but it still lingers. Weakness in her right arm as well.
Age: 23.0
Sex: F
Vaccine: SMALL
Symptoms: Blood pressure increased, Dizziness, Feeling hot, Headache, Oropharyngeal pain
Clinical narrative: About 30 minutes following vaccination pt started hot, dizzy, and followed with throat pain with a headache about 2 after vaccination. Pt reported to medical about 4 hours after vaccination to be evaluated. She was treated with one 0.3mg  Epinephrine auto-injector.
Age: 23.0
Sex: F
Vaccine: SMALL
Symptoms: Tachycardia
Clinical narrative: About 30 minutes following vaccination pt started hot, dizzy, and followed with throat pain with a headache about 2 after vaccination. Pt reported to medical about 4 hours after vaccination to be evaluated. She was treated with one 0.3mg  Epinephrine auto-injector.
Age: 81.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction, Mobility decreased, Muscle swelling, Musculoskeletal pain, Pain
Clinical narrative: Pt claims inability to raise arm sometimes but excruciating pain that is now radiating to the shoulder. The injection site appears normal but the muscle can be swollen at times. The pain is worse in the middle of the night and is slightly relieved by aspirin/ibuprofen/ice/heat/ or muscle rubs. All symptoms appeared 1 week or more after injection.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Asthenia, Flatulence, Headache, Nausea
Clinical narrative: Headache, nausea, vomiting, severe body aches, gas pains in abdomen, general weakness.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Vomiting
Clinical narrative: Headache, nausea, vomiting, severe body aches, gas pains in abdomen, general weakness.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Patient developed cellulitis around the injection site a few days after injection, primary care MD gave her KEFLEX 500mg every 8 hours for 7 days and patient will report to MD if area enlarges further.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: On 2/21/18, patient was given SHINGRIX vaccine that was mixed with the sterile diluent (instead of the adjuvant diluent that comes from the manufacturer). We called the manufacturer to report this discrepancy and they told us if SHINGRIX is reconstituted with anything other than adjuvant suspension diluent, the dose will not be effective. We need to repeat the first dose immediately and may give the second dose between (2-6 months as per regular interval), so patient gets an effective dose.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Right arm redden, swollen and warm to touch, denies pain to area, complains of itching. She will take some benadryl when she gets home and apply an ice pack to the area, ibuprofen as needed for discomfort, the patient will come back in 24 hours for us to check the progress of area.
Age: 1.08
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Dehydration, Flatulence, Irritability, Pyrexia, Skin warm
Clinical narrative: HPI: Seen here yesterday, received 12mo vaccines (MMR, Varicella, PCV, HIB), Here b/c of constant vomiting since 3am: not holding anything down since. Emesis is green/yellow, also milkstuff. Patient is wanting to drink liquid but vomiting immediately after- breastmilk, water & juice. Last emesis was on drive here. Total 10-11 times today. Reportedly projectile "turning on hose of water." Gassy and smelly farts, no diarrhea. Last dose of medication was at 10am motrin given threw up 5 minutes after. 1 wet diaper today at 8am & then again now. Fussy and fevers on and off. No temp taken, feels warm.    Vomiting (ICD-787.03) (ICD10-R11.10) Assessment: 13mo old F who received her 12mo vaccines yesterday, presented w/ 10-11 episodes of nonbilious emesis in 12 hours, associated w/ extreme fussines. She nursed in office but then had large emesis after we tried to give Zofran dose (yellow, milk stuff). Sent to ER for further eval & management (I had ordered the US & KUB while zofran was attempted, will cancel). Dehydration (ICD-276.51) (ICD10-E86.0) Assessment: lost about 200g since yesterday, mildly dehydrated- sent to ER for fluids & evaluation. Fussy infant (ICD-780.91) (ICD10-R68.12) Assessment: initially ordered rectal supp of tylenol to help with fussiness but canceled it since she vomited in office & was sent to the ER. Attempted to administer 2mg of orally disintegrating ondansetron - vomited up immediately. Patient was sent to ER for above diagnosis.