chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a adult male patient who received SHINGRIX for prophylaxis. The patient's past medical history included spinal operation, hepatitis C, arthritis (back arthritic issues) and spinal disorder. Previously administered products included ZEPATIER and ZOSTAVAX. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was not recovered/not resolved. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient reported that he suffered from Hepatitis C for the past 48 years that damaged his liver and for a three month period of 84 days he was taking an anti-viral medication by Merck called ZEPATIER. He also had suffered with spinal issues for many years including having back surgery and back arthritic issues. The patient also reported that he has had multiple flu shots over the years (manufacture and product name unknown) and he had experienced a little muscle soreness and redness at the injection site occasionally with the flu shot. The patient described this occurrence as happening once every several years but it was rare. The patient claims that he would be slightly sore for the next day and then it would resolve. He completed his treatment by 4th March 2018. The reporter gave consent to follow up. The patient refused to provide physician permission. This case has been linked with US2018198761, reported by same reporter for the same patient.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 79-year-old male patient who received SHINGRIX for prophylaxis. In July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 5th October 2018, less than a year after receiving SHINGRIX, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles and pain were recovered/resolved. It was unknown if the reporter considered the shingles and pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for himself. The patient SHINGRIX injection the end of July 2018. After vaccination, the patient experienced outbreak of shingles. It was not as severe as it could have been. The pain was resolved about one week before the date of reporting. Consent to follow up was given. The patient has no relation with this physician - just shares same last name.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old male 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 pain in arm and erythema of extremities. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the erythema of extremities was unknown. It was unknown if the reporter considered the pain in arm and erythema of extremities to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient called to the GlaxoSmithKline Response Center (GRC) about the availability of a SHINGRIX vaccine and reported that first shot of SHINGRIX was resulted in his arm aching so badly. The arm that received the shot had redness. The pain lasted for over 48 hours. The patient gave consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Impaired work ability, Influenza like illness, Pain
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain, headache and influenza-like symptoms. On an unknown date, the outcome of the pain, headache and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the pain, headache and influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: GlaxoSmithKline representative called to report two adverse events on SHINGRIX. The pharmacist told GlaxoSmithKline representative that he had two patients with severe flu like reactions after having the first dose of SHINGRIX. The patient stayed in bed for 2 to 3 days, missed 3 days of work and would not be receiving the second dose of SHINGRIX. The symptoms were pain, headache, general flu like symptoms. One case happened during the summer and the other one two months before the date of reporting. It was unknown which of the two reports happened during the summer or two months before the date of reporting. There were no additional addresses listed for initial reporter. The reporter did not have a phone number for pharmacist. This case has been linked with the case US2018203979, reported by same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Impaired work ability, Influenza like illness, Pain
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of pain in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain, headache and influenza-like symptoms. On an unknown date, the outcome of the pain, headache and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the pain, headache and influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: GlaxoSmithKline representative called to report two adverse events on SHINGRIX.  The pharmacist told GlaxoSmithKline representative that he had two patients with severe flu like reactions after having the first dose of SHINGRIX. The patient stayed in bed for 2 to 3 days, missed 3 days of work and would not be receiving the second dose of SHINGRIX. The symptoms were pain, headache, general flu like symptoms. One case happened during the summer and the other one two months before the date of reporting. It was unknown which of the two reports happened during the summer or two months before the date of reporting. There were no additional addresses listed for initial reporter. The reporter did not have a phone number for pharmacist. This case has been linked with the case US2018203979, reported by same reporter.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry skin, Eye irritation, Eye pruritus, Eye swelling, Skin exfoliation
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of periocular swelling in a 71-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received 10 years ago). On 5th October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, 10 days after receiving SHINGRIX, the patient experienced periocular swelling, dry skin, eye pruritus, burning in eyes, flaking skin and swelling of eyelid. The patient was treated with ophthalmologicals (Eye Drops) and erythromycin cream. On an unknown date, the outcome of the periocular swelling, dry skin, eye pruritus, burning in eyes, flaking skin and swelling of eyelid were not recovered/not resolved. It was unknown if the reporter considered the periocular swelling, dry skin, eye pruritus, burning in eyes, flaking skin and swelling of eyelid to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the right arm. The patient experienced itching and burning around and in her eyes. The patient also experienced swelling of the eyelids and the skin around her eyes. The patient also reported that the skin around her eyelids had become dry and was flaking off. The patient went to see her doctor and was prescribed eye drops and erythromycin 5% antibiotic cream. The patient stated that neither of these medications have helped. The patient consented to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling of eyelid
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of periocular swelling in a 71-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received 10 years ago). On 5th October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, 10 days after receiving SHINGRIX, the patient experienced periocular swelling, dry skin, eye pruritus, burning in eyes, flaking skin and swelling of eyelid. The patient was treated with ophthalmologicals (Eye Drops) and erythromycin cream. On an unknown date, the outcome of the periocular swelling, dry skin, eye pruritus, burning in eyes, flaking skin and swelling of eyelid were not recovered/not resolved. It was unknown if the reporter considered the periocular swelling, dry skin, eye pruritus, burning in eyes, flaking skin and swelling of eyelid to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the right arm. The patient experienced itching and burning around and in her eyes. The patient also experienced swelling of the eyelids and the skin around her eyes. The patient also reported that the skin around her eyelids had become dry and was flaking off. The patient went to see her doctor and was prescribed eye drops and erythromycin 5% antibiotic cream. The patient stated that neither of these medications have helped. The patient consented to follow up.
Age: 49.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a 50-year-old male patient who received SHINGRIX for prophylaxis. On 11th May 2018, the patient received SHINGRIX. On 12th May 2018, 1 days after receiving SHINGRIX, the patient experienced pain and influenza-like symptoms. On an unknown date, the outcome of the pain and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the pain and influenza-like symptoms to be related to SHINGRIX. Additional information received as follows: At afternoon the patient received SHINGRIX and the symptoms presented the next day of vaccination. The patient experienced feeling achy all over like he had the flu and lasted for 2 days. The reporter did not give consent to follow-up. The patient declined to provide address and phone number.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site vesicles, Injection site warmth
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site blisters in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced injection site blisters, injection site warmth, injection site erythema and injection site itching. On an unknown date, the outcome of the injection site blisters, injection site warmth, injection site erythema and injection site itching were unknown. It was unknown if the reporter considered the injection site blisters, injection site warmth, injection site erythema and injection site itching to be related to SHINGRIX. Additional information received as follows: The case was reported by the pharmacy intern. The age at vaccination was not reported. The patient received SHINGRIX on the upper arm. The reporter said that the patient wanted to receive the 2nd dose of SHINGRIX at their pharmacy; however, after the first dose the patient he had pin head blisters on the upper arm where the SHINGRIX was given; the blisters formed about 2-3 days after receiving SHINGRIX. The healthcare professional said that the patient also said it was red, hot and itchy. The first dose of SHINGRIX was not given at their pharmacy and was given at the patient's physician's office; the healthcare professional refused to provide any additional information since the healthcare professional said that the patient's physician already filled out a VAERS report for this reaction. The reporter did not give consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX (subcutaneous). On an unknown date, unknown after receiving SHINGRIX, the patient experienced rash and intramuscular formulation administered by other route. On an unknown date, the outcome of the rash and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The healthcare professional (HCP) reported that his patient received SHINGRIX at another pharmacy and it was given subcutaneously, which led to incorrect route of product administration. Following administration, the patient experienced rash 4 to 6 diameters in size. The HCP did not give consent to follow up. The HCP was unable to provide lot number, expiry date or patient demographics.
Sex: M
Vaccine: VARZOS
Symptoms: Hypopnoea, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of generalized muscle aches in a adult male 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 generalized muscle aches and shallow breathing. On an unknown date, the outcome of the generalized muscle aches and shallow breathing were unknown. It was unknown if the reporter considered the generalized muscle aches and shallow breathing to be related to SHINGRIX. Additional details were provided as follows: The patient was transferred from GSK customer relations. The age at vaccination was not reported. The patient reported that he experienced severe muscle aches all over his body and shallow breathing (due to the severe muscle aches) after he received his 1st injection of the SHINGRIX. The reporter gave consent to follow up. Limited information was provided. The patient disconnected early in the conversation.
Sex: M
Vaccine: MENB
Symptoms: Induration
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of induration in a male patient who received BEXSERO (batch number 16B701A, expiry date 28th February 2019) for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, less than a day after receiving BEXSERO, the patient experienced induration. On an unknown date, the outcome of the induration was recovered/resolved. It was unknown if the reporter considered the induration to be related to BEXSERO. Additional information received as follows: The age at vaccination was not reported. The patient experienced an induration of about 2 inches in diameter for approximately 2 weeks after vaccination with BEXSERO. The reporter did not give consent to follow-up. The healthcare professional not willing to provide the patient's details beyond gender.
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis
Clinical narrative: Initial information received on 15-Nov-2018 regarding an unsolicited valid serious case received from a nurse. This case involves an unknown age female patient who experienced cellulitis, while she received vaccine FLUZONE HIGH DOSE. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date the patient experienced a serious looked like cellulitis (cellulitis) Unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as medically significant. Nurse was not sure if it was from FLUZONE HD, as patient had also get other immunizations. Other relevant tests included no lab data. Final diagnosis was looked like cellulitis. It was not reported if the patient received a corrective treatment. The patient outcome was not reported. List of documents held by sender: none. Sender's Comments: This case involves an unknown age female patient who experienced cellulitis post vaccination with FLUZONE HIGH DOSE. Time to onset is unknown. There is, however, no information regarding patient's medical condition at time of vaccination, site of cellulitis, identification of the causative organism, safety of the vaccination procedure and lab tests ruling out alternate etiologies. There is a possibility that the cellulitis is due to a pre-existing nidus of infection or introduction of skin commensals during inoculation. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: M
Vaccine: MENB, MNQ
Symptoms: Injection site cellulitis
Clinical narrative: Initial information received on 21-Nov-2018 regarding an unsolicited valid serious case received from a nurse. This case involves male patient of an unknown age who experienced left arm cellulitis, 8x9 cm on left deltoid, while he received vaccines TRUMENBA and MENACTRA. The patient's past medical history included Depression in 2016 and Anxiety in 2016. The patient's past medical treatment(s), vaccination(s) and family history were not provided. On 24-SEP-2018, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6151AB, expiry date: 16-MAR-2020 via intramuscular route in the right deltoid. On 24-Sep-2018, the patient received a 0.5 mL dose of suspect TRUMENBA not produced by Sanofi Pasteur lot W09937, expiry date: JAN-2020 via intramuscular route in the left deltoid. On 24-Sep-2018, the patient developed a serious left arm cellulitis, 8x9 cm on left deltoid same day following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and TRUMENBA. Patient had physician office visit. This event was assessed as medically significant. Other relevant tests included no lab data. Final diagnosis was arm left arm cellulitis, 8x9 cm on left deltoid. The patient was treated with PREDNISONE for Product used for unknown indication and KEFLEX for Product used for unknown indication. On 27-Sep-2018, the patient was recovered from left arm cellulitis, 8x9 cm on left deltoid. The reporter assessed the event to be related to TRUMENBA. List of documents held by sender- none. Sender's Comments: This case involves a patient of an unknown age who experienced cellulitis of 8x9 cm same day post vaccination with TRUMENBA and MENACTRA. Time to onset is compatible. To be noted that MENACTRA was administered in right deltoid and cellulitis was observed on left deltoid (TRUMENBA site) and reporter also the event to be related to TRUMENBA. Based upon reported information, role of MENACTRA is considered unlikely.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Cough, Measles antibody, Pain, Pallor, Pyrexia
Clinical narrative: URI SYMPTOMS WITH 24 HOURS, CONGESTION/COUGH/FEVER OF 100.6F/BODY ACHES DAY 3, RASH OVER FACE/ABDOMEN AND TRUNK, MACULOPAPULAR RASH BLANCHING.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Rash, Rash maculo-papular, Respiratory tract congestion, Rubella antibody test, Upper respiratory tract infection
Clinical narrative: URI SYMPTOMS WITH 24 HOURS, CONGESTION/COUGH/FEVER OF 100.6F/BODY ACHES DAY 3, RASH OVER FACE/ABDOMEN AND TRUNK, MACULOPAPULAR RASH BLANCHING.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event reported. ENGERIX-B 20mcg/ml was given to the 18 year old instead of ENGERIX-B 10mcg/ml. Contacted patient 11/27/18. Reported to patient's PCP's office 11/27/18. Spoke with GSK Med Info 11/27/18; no need to revaccinate this dose; continue with age-appropriate dosing schedule when doses 2 and 3 are due.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: Per patient the nurse was talking when she gave vaccine and patient felt like she hit the bone, felt like she gave it higher up than usual. Denies any redness or fevers. Feels like a bruise, hurts to move shoulder. She has limited range of motion of left shoulder.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Headache, Pyrexia, Vomiting
Clinical narrative: PT WOKE UP AT 3 AM WITH HEADACHE SEVERE, VOMITING AND FEVER 101.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Vomiting
Clinical narrative: She said that she began vomiting and had diarrhea later that day, was better the next day, Dr wanted us to report.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Hyperhidrosis, Loss of personal independence in daily activities, Pyrexia
Clinical narrative: Sweats, severe and uncontrollable shivering - actually more like shakes lasting for about 30 minutes, fever, tired to point of not wanting to engage in normal light duties - lots of sleeping.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Somnolence, Tremor
Clinical narrative: Sweats, severe and uncontrollable shivering - actually more like shakes lasting for about 30 minutes, fever, tired to point of not wanting to engage in normal light duties - lots of sleeping.
Age: 81.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site reaction, Rash vesicular
Clinical narrative: Vesicular rash left deltoid starting 2-3 days after immunization. Itched and red initially. Improving now.
Age: 81.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Rash vesicular
Clinical narrative: Vesicular rash left deltoid starting 2-3 days after immunization. Itched and red initially. Improving now.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Headache, Injection site pain
Clinical narrative: Symptoms: headache, feeling of extreme cold, slight soreness on arm at injection site. Treatment: extra strength Acetaminophen.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Computerised tomogram, Dizziness, Headache, Neck pain
Clinical narrative: Patient a lot of pain in neck to head, dizziness couldn't move neck either way for 2 days Had a catsc& MRI of head & neck+ X-rays of the neck & blood work.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: Patient a lot of pain in neck to head, dizziness couldn't move neck either way for 2 days Had a catsc& MRI of head & neck+ X-rays of the neck & blood work.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Sensitivity of teeth, Toothache
Clinical narrative: Onset on dental hypersensitivity within 24 hrs injection. Dental pain lasted 3 months. No known changes in oral hygiene or identified dental issues confounding pain. Patient describes pain as, "cold air on teeth pain."
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Sensitivity of teeth, Toothache
Clinical narrative: Onset on dental hypersensitivity within 24 hrs injection. Dental pain lasted 3 months. No known changes in oral hygiene or identified dental issues confounding pain. Patient describes pain as, "cold air on teeth pain."
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash, Varicella post vaccine
Clinical narrative: Developed mild chicken pox that started with fever of 101.5 11/24/2018 and then rash developed 11/25/2018.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Injection site pain, Pain, Pyrexia
Clinical narrative: SHINGRIX. History: I had chicken pox as a chid, shingles in my thirties, shingles in 2017. The reaction to the shot was a couple of hours after the shot. Pain in the shot area and flu like symptoms, aches, fever, shivers. These went away the following morning.
Age: 0.25
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Crying, Loss of consciousness, Screaming
Clinical narrative: Patient screamed high pitched screams for almost 48 hours. There were small breaks where she would pass out from crying but she'd wake back up screaming and crying uncontrollably.
Age: 73.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site atrophy, Injection site erythema
Clinical narrative: Patient received vaccine on 08/29/2018 IM left arm at Pharmacy. After about one week patient reported a red circular form on her left arm where the vaccine was administered. Patient then arrives at pharmacy 11/27/2018 and area of vaccination shows an indent in the deltoid area about one inch in diameter and about a little less than half an inch in depth. Patient did not report any pain or warmth in the area. Patient has a doctors appointment today at 2PM and will get it examined by a medical doctor
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Left arm pain numbness, stiffness. Nighttime increase in pain. L deltoid pain.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Acute lymphocytic leukaemia, Biopsy bone marrow abnormal, Blast cell count increased, Chemotherapy, Flow cytometry
Clinical narrative: Presented to clinic on 11/6/18 with paleness of 1-2 months duration. He had been having cold symptoms for about 4-5 days with low grade fevers. The paleness was not noticed or believed to have started before his visit with me on 9/18/18. He was found to have hepatosplenomegaly on exam that day and initial CBC showed very low counts. He was immediately sent to our Hospital and diagnosed with acute lymphoblastic leukemia. He is currently being treated with chemotherapy through one of our tertiary care centers - Hospitals and Clinics.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Full blood count abnormal, Haemoglobin decreased, Hepatosplenomegaly, Human rhinovirus test positive, Nasopharyngitis
Clinical narrative: Presented to clinic on 11/6/18 with paleness of 1-2 months duration. He had been having cold symptoms for about 4-5 days with low grade fevers. The paleness was not noticed or believed to have started before his visit with me on 9/18/18. He was found to have hepatosplenomegaly on exam that day and initial CBC showed very low counts. He was immediately sent to our Hospital and diagnosed with acute lymphoblastic leukemia. He is currently being treated with chemotherapy through one of our tertiary care centers - Hospitals and Clinics.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Pallor, Platelet count decreased, Pyrexia, White blood cell count normal
Clinical narrative: Presented to clinic on 11/6/18 with paleness of 1-2 months duration. He had been having cold symptoms for about 4-5 days with low grade fevers. The paleness was not noticed or believed to have started before his visit with me on 9/18/18. He was found to have hepatosplenomegaly on exam that day and initial CBC showed very low counts. He was immediately sent to our Hospital and diagnosed with acute lymphoblastic leukemia. He is currently being treated with chemotherapy through one of our tertiary care centers - Hospitals and Clinics.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: After her first dose of SHINGRIX she did not have a reacion. She received her second dose of SHINGRIX on 11-23 and that evening she developed a red rash that was a little raised and had heat and was itchy at the injection site that did spread down her arm to roughly her elbow. Today (11-27) was the first she had time to get in to explain what had happened. The rash had mostly cleared, only a small bit remains by her elbow.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Pt describes sore arm and limited range of motion with pain not subsiding. Patient has not yet seen ortho or a primary care doc but she will follow up with primary care.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Injection site haematoma, Injection site induration, Injection site nodule, Injection site warmth
Clinical narrative: Patient said she experienced burning later that night, then swelling. We I saw patient next day she had a 5cm firm round raised knot on her right shoulder, slightly warm to touch.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Patient said she experienced burning later that night, then swelling. We I saw patient next day she had a 5cm firm round raised knot on her right shoulder, slightly warm to touch.
Age: 58.0
Sex: F
Vaccine: HEPAB
Symptoms: Abdominal pain upper, Decreased appetite, Headache, Influenza like illness, Pain in extremity
Clinical narrative: Arm was sore afterward, woke up at 2:00 AM shaking with a low grade fever, headache, no appetite, stomach ache. I was flat on my back like I was suffering from the flu. It took me 60 hours of rest to recover and feel like myself again.
Age: 58.0
Sex: F
Vaccine: HEPAB
Symptoms: Pyrexia, Tremor
Clinical narrative: Arm was sore afterward, woke up at 2:00 AM shaking with a low grade fever, headache, no appetite, stomach ache. I was flat on my back like I was suffering from the flu. It took me 60 hours of rest to recover and feel like myself again.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Nausea
Clinical narrative: Mild headache initially within about 4 hours after injection. 12 hours later, experiencing severe headache, general fatigue, nausea and occasional chills. Took acetaminophen to help lessen symptoms. Symptoms continuing at approximately 17 hours after injection and at the time of this report.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Headache, Pyrexia
Clinical narrative: Day after shot Headache Fever/Chills Back Ache.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Cerebral infarction, Facial paralysis, Gaze palsy
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication use were not provided. In or around 03-JAN-2017, the patient was inoculated with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the ZOSTAVAX vaccine, the patient suffered from focal weakness with a left sided facial droop and right sided gaze. The patient was diagnosed with an acute right middle cerebral artery infarction. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of ZOSTAVAX vaccine, the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the use of the ZOSTAVAX vaccine, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. Upon internal review, Acute right middle cerebral artery infarction was determined to be a medically significant event. Acute right middle cerebral artery infarction was considered to be disabling. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Incomplete course of vaccination, Visual impairment
Clinical narrative: This spontaneous report was received from a physician via company representative and refers to a 12-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with first dose of GARDASIL (dose, route and site of administration, lot # and expiration date were not reported) for prophylaxis. The patient did not come for her second dose of GARDASIL because a couple months after first vaccination reported as ''3 or 4 years ago'', the patient felt that her vision was tricking her. It was also reported as ''when you look at your iPad and you need to move the screen from upside down to rightside up she would had to screen rightside up and she would feel it was upside down''. At that time the physician referred her to a neurologist but the neurologist could not find anything wrong with the girl. The event resolved on its own on unknown date reported as ''couple months later''. It was unknown if the patient was seeking medical attention. The causality assessment between the event and GARDASIL was not provided.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse prescriber and refers to a pediatric patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 13-AUG-2018, the patient was vaccinated with a first dose of VAQTA (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. On 14-NOV-2018, the patient received a second dose of VAQTA lot # R013857, expiration date 22-APR-2019 (dose and route of administration were not reported) for prophylaxis (Inappropriate schedule of vaccine administered). No adverse effects were reported. This is one of the two reports received from the same reporter. Sender's Comments: US-009507513-1811USA010882.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Fall, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: This spontaneous report as received from a physician refers to a 12-year-old male patient (weight 52.61Kg, height 171 cm). The patient had no pertinent medical history. The patient reported no concomitant medication. The patient had no drug reactions and no allergies. On 08-AUG-2018, the patient was vaccinated with the first dose of HPV GARDASIL 9 (Lot # R002344 and Expiration date 16-NOV-2010), intramuscular (Site of vaccination was not reported) by the nurse in the physician's office for human papillomavirus prophylaxis (HPV) prevention. The physician reported that immediately after administration of the GARDASIL 9, "the patient fell in the office and briefly lost consciousness." It was reported that he received treatment. The physician called the emergency medical services (EMS) and the patient was taken to a medical center hospital emergency room (ER) on 08-AUG-2018. The patient was observed for a few hours and sent home on 08-AUG-2018. No lab diagnostics or studies performed. The physician reported that she followed up with the patient's mother on the phone. The physician reported that "the patient has recovered, but was not seen again in the office". The physician reported that on an unspecified date the patient's mother called her to report they have medical insurance, but have a co-pay, and are requesting reimbursement for the co-pay. No further information provided. Upon internal review, Loss of consciousness was determined to be a medically significant event. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood calcium decreased, Blood pressure decreased, Hypoaesthesia, Mobility decreased, Vision blurred
Clinical narrative: Thirty minutes after getting shot, my arm was numb and I could not move it or my fingers. My blood pressure dropped to 60/30 and my vision was blurred severely. Paramedics took me to the hospital where I was admitted. It took 1 week to regain arm use.
Age: 87.0
Sex: F
Vaccine: FLUX
Symptoms: Body temperature increased, Musculoskeletal discomfort
Clinical narrative: Severe muscular discomfort, 101 temperature for 24 hrs.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Fall, Loss of consciousness, Syncope
Clinical narrative: Syncope resulting in pt fell to ground. Within 5 minutes of receiving vaccine. Unconscious for seconds then responsive to verbal stimuli.
Age: 28.0
Sex: F
Vaccine: HPV9, MMR
Symptoms: Arthralgia, Cough, Dyspnoea, Eye pain, Lymph node pain
Clinical narrative: Sore arm the next day. A slight cough developed 1 week in. 8 days in I developed a fever of 100-101, throbbing lymph nodes, very sore eyes, aching joints and body, very short of breath and more persistent cough. 9 days in I developed a full body rash which is currently worsening.
Age: 28.0
Sex: F
Vaccine: HPV9, MMR
Symptoms: Pain, Pain in extremity, Pyrexia, Rash generalised
Clinical narrative: Sore arm the next day. A slight cough developed 1 week in. 8 days in I developed a fever of 100-101, throbbing lymph nodes, very sore eyes, aching joints and body, very short of breath and more persistent cough. 9 days in I developed a full body rash which is currently worsening.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Injection site paraesthesia, Paraesthesia
Clinical narrative: Complains of numbness and tingling down Right arm from shoulder to fingers along ulnar distribution since vaccination. Exam completed by Occupational Health physician. Employee with continues symptoms referred to her own provider.
Age: 37.0
Sex: F
Vaccine: HEPA
Symptoms: Chest discomfort, Dizziness, Feeling hot, Hyperhidrosis, Pallor
Clinical narrative: PATIENT WAS FINE IMMEDIATELY FOLLOWING INJECTION. BEGAN FEELING HOT AND DIZZY ONCE SHE WALKED DOWN THE HALL TO HER CLASSROOM. REPORTED TIGHTNESS IN CHEST. PATIENT WAS PALE AND SWEATING. DOES NOT THINK SHE ACTUALLY FAINTED. PHARMACIST, SCHOOL NURSE, AND PRINCIPAL ADMINISTERED FIRST AID WITH AN ICE PACK, FOOD, AND DRINK. BLOOD PRESSURE WAS 126/78. PATIENT RETURNED TO HER CLASSROOM APPROXIMATELY HALF AN HOUR LATER REPORTING THAT SHE FELT MUCH BETTER.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash, Rash pruritic
Clinical narrative: Developed rashes on wrist/lower arm (right arm), right buttocks, minor rashes on left arm, forehead, thighs. Rash on right wrist developed into blisters. Only minor itching associated with rashes. Have not contacted Dr., but will call shortly to let her know. I don't believe it requires treatment. Concerned that this side affect wasn't indicated and little information available online about it. I consider myself healthy and with a strong immune system. Also concerned that I will get this reaction with 2nd vaccine, though not enough not to receive it.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Headache, Impaired work ability, Injection site pain
Clinical narrative: About 2.5 hrs after the vaccine I developed a headache (and still have it the following day, about 17.5 hours later). Painwise it kind of feels like a moderately-bad red wine hangover. Not a migraine, but unpleasant and getting in the way of working today. I took ibuprofen and it did not seem to reduce the pain. About 4 hours after the vaccine I developed very bad chills -- could not get warm with heavy blankets, robe, hat, scarf, heating pad. I am still experiencing them now (about 17.5 hours after the injection), but they are intermittent. Along with the chills came pretty bad pain (5? 6?) at injection site, which was the RT shoulder (I had rotator cuff surgery on this shoulder two months ago). It is now the day following the injection and I've just started presenting with diarrhea.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: Swelling greater than 2mm. Pain, fever. Swelling lasted longer than 5 months and may have been administered further posterior. Still at the deltoid muscle.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Feeling hot
Clinical narrative: ADVERSE EVENT: LIGHTHEADED, DIZZY & HOT. TREATMENT: GAVE WATER, HAD PATIENT SIT DOWN, TOOK VITAL SIGNS. PATIENT REFUSED ICE PACK. OUTCOME: PATIENT REFUSED TO HAVE MEDICAL TREATMENT DUE TO NO INSURANCE. PATIENT IS AWAITING TRANSPORTATION HOME FROM FAMILY.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine, Injected limb mobility decreased, Peripheral swelling, Skin warm
Clinical narrative: Patient came back to pharmacy today 11/27 to let us know that she did have significant arm swelling and heat as well as immobility of her left arm for 3 days. She did go to her doctor who told her to let us know that she was allergic to the vaccine.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Vaccine positive rechallenge
Clinical narrative: Patient's shoulder has been sore ever since receiving the vaccination 2 months ago. The soreness is the same as when she 1st got it and has not abated.
Age: 43.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Asthenia, Dizziness, Migraine, Myalgia
Clinical narrative: Severe acute migraine lasting 24 hours. Sudden severe joint and muscle burning/pain dizziness and weakness.
Age: 68.0
Sex: F
Vaccine: HEP
Symptoms: Injection site scab, Peripheral swelling, Swelling face
Clinical narrative: Scab at injection site, swollen arm, facial swelling.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Evening of the 19th pain both shoulders at the injection location. Continued pain along with a rash on the 11/21/18 on both shoulders. In order to treat this the patient took TYLENOL 2-500mg that night(11/19 and 11/20) and 2-500 mg the next morning (11/21). Patient took BENADRYL (11/20, 11/21 ,and 11/22, 11/23, 11/24, 11/25 and 11/26). Rash resolved on the morning of 11/25. Pain has resolved on 11/26.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Flu shot - hot, red, swollen, tender.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse prescriber and refers to a pediatric patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 13-AUG-2018, the patient was vaccinated with a first dose of VAQTA (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. On 14-NOV-2018 , the patient received a second dose of hepatitis a vaccine, inactivated (VAQTA) lot # R013857, expiration date 22-APR-2019 (dose and route of administration were not reported) for prophylaxis (Inappropriate schedule of vaccine administered). No adverse effects were reported. This is one of the two reports received from the same reporter. Sender's Comments: US-009507513-1811USA009086.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Bone pain, Impaired work ability, Malaise, Mobility decreased
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of bone pain in a female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, several hours after receiving SHINGRIX, the patient experienced bone pain, sickness, mobility decreased, pain in hip, muscle pain, nausea and fever. On an unknown date, the outcome of the bone pain, sickness, mobility decreased, pain in hip, muscle pain, nausea and fever were unknown. It was unknown if the reporter considered the bone pain, sickness, mobility decreased, pain in hip, muscle pain, nausea and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient worked in the clinic. The reporter stated that the patient's 1st dose experienced was not as bad as 2nd one. The patient received the shot mid afternoon and became very sick 8 hours later that and through the night. The patient could barely move because of pain. Her bones hurt (femur, hip, big bones) experienced muscle pain, nausea, and fever. Had a very difficult time working next day. The reporter agreed to be followed up.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of bone pain in a female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, several hours after receiving SHINGRIX, the patient experienced bone pain, sickness, mobility decreased, pain in hip, muscle pain, nausea and fever. On an unknown date, the outcome of the bone pain, sickness, mobility decreased, pain in hip, muscle pain, nausea and fever were unknown. It was unknown if the reporter considered the bone pain, sickness, mobility decreased, pain in hip, muscle pain, nausea and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient worked in the clinic. The reporter stated that the patient's 1st dose experienced was not as bad as 2nd one. The patient received the shot mid afternoon and became very sick 8 hours later that and through the night. The patient could barely move because of pain. Her bones hurt (femur, hip, big bones) experienced muscle pain, nausea, and fever. Had a very difficult time working next day. The reporter agreed to be followed up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Pain, Pyrexia, Vaccine positive rechallenge
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of fever in a 59-year-old female patient who received SHINGRIX (batch number M77B4, expiry date 8th February 2021) for prophylaxis. Concomitant products included SHINGRIX. On 9th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 9th August 2018, unknown after receiving SHINGRIX, the patient experienced drug dose administration interval too short. On an unknown date,less than a year after receiving SHINGRIX, the patient experienced fever and general body pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fever and general body pain were recovered/resolved and the outcome of the drug dose administration interval too short was unknown.  It was unknown if the reporter considered the fever and general body pain to be related to SHINGRIX. Additional details were provided as follows: The patient experienced fever and body ache. This case has been linked with case US2018GSK173231, reported by same reporter for same patient.
Sex: F
Vaccine: MEN
Symptoms: Gait inability
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of gait inability in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis. On an unknown date, the patient received Meningococcal B vaccine at an unknown dose. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced gait inability. On an unknown date, the outcome of the gait inability was unknown. It was unknown if the reporter considered the gait inability to be related to Meningococcal B vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient received Meningococcal B vaccine and crippled at the time of reporting, cannot walk out to go to school.