chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Lethargy, Pyrexia, Vaccine positive rechallenge
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 66-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (received 1st dose on 21st February 2018, experienced chills and lethargy, for tolerance see case US2018GSK111503). On 30th May 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced chills, lethargy and fever. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the chills, lethargy and fever were unknown. It was unknown if the reporter considered the chills, lethargy and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX vaccine after lunch. The patient experienced low fever. The patient's symptoms were less severe as compared to the same events which occurred after the first dose of SHINGRIX. The suspect vaccine lot number and expiry date was not available. This case is one of the 5 cases, reported by the same reporter.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dyspnoea, Ear discomfort, Eye swelling, Fatigue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 58-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site reaction (For tolerance to the 1st dose received in March 2018, refer case US2018106401). On 12th June 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 13th June 2018, 1 days after receiving SHINGRIX, the patient experienced headache, eye swelling, leg pain, labored breathing, fatigue, ear feels clogged, shivering, temperature regulation disorder, walking difficulty and feeling abnormal. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the headache, eye swelling, leg pain, labored breathing, ear feels clogged, shivering, temperature regulation disorder, walking difficulty and feeling abnormal were not recovered/not resolved and the outcome of the fatigue was unknown. The reporter considered the headache, eye swelling, leg pain, labored breathing, fatigue, ear feels clogged, shivering, temperature regulation disorder, walking difficulty and feeling abnormal to be probably related to SHINGRIX. Additional details were provided as follows: The patient received her 2nd dose of SHINGRIX in left arm. The patient felt walking was an effort for her. The patient experienced overheated, shivering, ears plugged, body shutting down, labored breathing, arms aching, legs aching, eyes swollen and headache.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Gait disturbance, Headache, Pain in extremity, Temperature regulation disorder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 58-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site reaction (For tolerance to the 1st dose received in March 2018, refer case US2018106401). On 12th June 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 13th June 2018, 1 days after receiving SHINGRIX, the patient experienced headache, eye swelling, leg pain, labored breathing, fatigue, ear feels clogged, shivering, temperature regulation disorder, walking difficulty and feeling abnormal. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the headache, eye swelling, leg pain, labored breathing, ear feels clogged, shivering, temperature regulation disorder, walking difficulty and feeling abnormal were not recovered/not resolved and the outcome of the fatigue was unknown. The reporter considered the headache, eye swelling, leg pain, labored breathing, fatigue, ear feels clogged, shivering, temperature regulation disorder, walking difficulty and feeling abnormal to be probably related to SHINGRIX. Additional details were provided as follows: The patient received her 2nd dose of SHINGRIX in left arm. The patient felt walking was an effort for her. The patient experienced overheated, shivering, ears plugged, body shutting down, labored breathing, arms aching, legs aching, eyes swollen and headache.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 51-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. Concomitant products included gabapentin and trazodone. 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 in arm, fatigue, headache and fever. On an unknown date, the outcome of the pain in arm, fatigue, headache and fever were recovered/resolved. The reporter considered the pain in arm, fatigue, headache and fever to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the right arm and she experienced sore arm, fatigue, headache, and fever which lasted for total of 4 days. No further details were provided. For tolerance to the 2nd dose of Shingrix vaccine, refer case US2018106404 for same patient.
Sex: F
Vaccine: FLU4
Symptoms: Chills, Injection site pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a adult female patient who received Influenza vaccine Quadrivalent unspecified season for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced chills, fever and injection site pain. On an unknown date, the outcome of the chills and fever were recovered/resolved and the outcome of the injection site pain was recovering/resolving. It was unknown if the reporter considered the chills, fever and injection site pain to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. She also noted a history of fever, chills and soreness at the injection site with flu vaccine from unknown manufacturer. She noted her last flu vaccine was a couple of years ago when they combined with the swine flu. That was the worst of her reactions and she had not gotten one since. This case has been linked with US2018107202, reported for the same patient.
Sex: U
Vaccine: HPV4
Symptoms: Burning sensation, Hypersensitivity, Pruritus, Rash, Urticaria
Clinical narrative: Allergic reaction, skin rash, itching and hives. A cause has been identified. This started 1 1/2 hours ago; Patient was at pediatrician's office yesterday, received some vaccinations, started with hives about 1.5 hours ago, only new vaccine that he hasn't had was HPV. Now hives with itching and burning covering full abdomen and back, bilateral arms, neck, and face. Denies any difficulty breathing or swallowing. Took BENADRYL 25mg at home about 20 minutes ago and feeling slightly better. No previous Hx of allergic reactions in past, and is still present. The patient has had a skin rash and itching but not had swelling or trouble swallowing. No difficulty breathing, dizziness or fainting episodes. Instructions (Continue taking the BENADRYL as needed for rash and itching).  Warnings: General Warnings: Return or contact your physician immediately if your condition worsens or changes unexpectedly, if not improving as expected, or if other problems arise. Prescription Medications: Prednisone 20 mg: take 2 orally every day for 4 days. Dispense sufficient quantity. No refills. (Start Prednisone tomorrow morning). Ranitidine 150 mg: take 1 orally every 12 hours. Dispense thirty (30). No refills. (PRN rash).
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Headache, Pain
Clinical narrative: Local redness, swelling, pain x 2.5 days - itch on day 2 - body aches, fatigue started about 22 hours after injection, chills and headache.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Swelling
Clinical narrative: Local redness, swelling, pain x 2.5 days - itch on day 2 - body aches, fatigue started about 22 hours after injection, chills and headache.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Insomnia, Middle insomnia, Pain, X-ray normal
Clinical narrative: Pain in her left shoulder since getting her PREVNAR 13 injection on 5/22/18. Pain began the evening after the injection was severe. It persisted and she went to the doctor after hours 2 weeks later. She was given a steroid pack. She states her pain is more tolerable now, but it persists. She is unable to sleep on her left side at night. It is painful she raises her left arm to her side. It does wake her at night. On a regular basis.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient was given SHINGRIX vaccine via subcutaneous route (incorrect) instead of IM route.  Patient has since suffered worsening redness, swelling, and pain at site of injection. Two days after vaccination, patient went to urgent care and was prescribed AUGMENTIN 875/125mg twice daily for 10 days. Patient also went to see PCP and size of reaction was measured and was told to use warm compress to affected area.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Cellulitis, Incorrect route of drug administration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient was given SHINGRIX vaccine via subcutaneous route (incorrect) instead of IM route.  Patient has since suffered worsening redness, swelling, and pain at site of injection. Two days after vaccination, patient went to urgent care and was prescribed AUGMENTIN 875/125mg twice daily for 10 days. Patient also went to see PCP and size of reaction was measured and was told to use warm compress to affected area.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Incorrect route of drug administration, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Patient was given SHINGRIX vaccine via subcutaneous route (incorrect) instead of IM route.  Patient has since suffered worsening redness, swelling, and pain at site of injection. Two days after vaccination, patient went to urgent care and was prescribed AUGMENTIN 875/125mg twice daily for 10 days. Patient also went to see PCP and size of reaction was measured and was told to use warm compress to affected area.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site swelling, Injection site warmth, Overdose
Clinical narrative: Patient was given SHINGRIX vaccine via subcutaneous route (incorrect) instead of IM route.  Patient has since suffered worsening redness, swelling, and pain at site of injection. Two days after vaccination, patient went to urgent care and was prescribed AUGMENTIN 875/125mg twice daily for 10 days. Patient also went to see PCP and size of reaction was measured and was told to use warm compress to affected area.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood creatine phosphokinase, Blood thyroid stimulating hormone, C-reactive protein, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: Patient reports having myalgia and Pain B/L Shoulder from the date of SHINGRIX administration which was in April. She was seen in Clinic on 06/25/18 and she has pain as mentioned above which is affecting her quality of life and ADL.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Myalgia, Quality of life decreased, Red blood cell sedimentation rate, X-ray limb
Clinical narrative: Patient reports having myalgia and Pain B/L Shoulder from the date of SHINGRIX administration which was in April. She was seen in Clinic on 06/25/18 and she has pain as mentioned above which is affecting her quality of life and ADL.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: X-ray of pelvis and hip
Clinical narrative: Patient reports having myalgia and Pain B/L Shoulder from the date of SHINGRIX administration which was in April. She was seen in Clinic on 06/25/18 and she has pain as mentioned above which is affecting her quality of life and ADL.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Loss of personal independence in daily activities, Musculoskeletal stiffness, Pain
Clinical narrative: Low fever, chills within 8 hours of shot lasting 10 hours, swelling, upper arm turned red, pain tenderness, could not lift arm above 2 inches without extreme pain, could not put on sweater or blouse without pain or help for 5 days (stiffness in arm).
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia, Tenderness
Clinical narrative: Low fever, chills within 8 hours of shot lasting 10 hours, swelling, upper arm turned red, pain tenderness, could not lift arm above 2 inches without extreme pain, could not put on sweater or blouse without pain or help for 5 days (stiffness in arm).
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Diarrhoea, Erythema, Injection site pruritus, Injection site rash, Pruritus
Clinical narrative: Swelling, redness warm to touch and itchy. Rash and itchiness on right upper thigh and back of neck. Patient seen at Hospital and Given ABX: cephalexin (KEFLEX) 250 MG/5ML suspension--Dose: 50 mg/kg/day × 19 kg Route: Oral Frequency: 2 times daily Sig: Take 9.5 mL by mouth 2 times daily for 10 days for antibiotic. Patient re-evaluated in the PCP office on 6/25/2018: Will continue oral antibiotics for 10 days. Discussed natural history of problem. Warm compresses four times daily as needed. Discussed pain management and contagion prevention. Reviewed use of good skin hygiene and protection, including topical hypoallergenic emollient once daily as needed. Continued use of non-scented, hypoallergenic soaps, lotions, detergents, etc. Probiotics given for diarrhea; recommend take it easy on the dairy and BRAT diet. Use probiotics to help while on abx. Push fluids to stay hydrated. Let us know if recurrent off abx. Family informed to call or return to the office as needed if patient's symptoms worsen or fail to improve as anticipated. Risks and possible side effects of the prescribed medication[s] as well as appropriate use were discussed. Family indicated understanding of the information.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Rash, Skin warm, Swelling
Clinical narrative: Swelling, redness warm to touch and itchy. Rash and itchiness on right upper thigh and back of neck. Patient seen at Hospital and Given ABX: cephalexin (KEFLEX) 250 MG/5ML suspension--Dose: 50 mg/kg/day × 19 kg Route: Oral Frequency: 2 times daily Sig: Take 9.5 mL by mouth 2 times daily for 10 days for antibiotic. Patient re-evaluated in the PCP office on 6/25/2018: Will continue oral antibiotics for 10 days. Discussed natural history of problem. Warm compresses four times daily as needed. Discussed pain management and contagion prevention. Reviewed use of good skin hygiene and protection, including topical hypoallergenic emollient once daily as needed. Continued use of non-scented, hypoallergenic soaps, lotions, detergents, etc. Probiotics given for diarrhea; recommend take it easy on the dairy and BRAT diet. Use probiotics to help while on abx. Push fluids to stay hydrated. Let us know if recurrent off abx. Family informed to call or return to the office as needed if patient's symptoms worsen or fail to improve as anticipated. Risks and possible side effects of the prescribed medication[s] as well as appropriate use were discussed. Family indicated understanding of the information.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Flushing, Pruritus, Urticaria
Clinical narrative: Gradual flushing of face and neck. Each following day increased redness, itch and by 4th day hives apparent. These extended onto upper chest. I did not connect this to the vaccine. I applied topical cortisone which brought down the redness but not the hives. Very little change in hives which seemed to increase. Finally saw MD on Sunday the 24th of June. He ordered a cortisone injection IM and I started a methylprednisolone/MEDROL 4mg DOSEPAK. By this time the itching and hives had extended to behind my ears. One day into meds, the angry redness is reduced, the itching remains but is diminishing, the epicenter remains my chin and throat.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HEP, PNC13
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: PT WAS GIVEN PEDIARIX IN THE RIGHT THIGH BUT WAS THEN GIVEN HEP B VACCINE IN RIGHT THIGH INSTEAD OF HIB. NO ADVERSE REACTIONS OBSERVED WHILE PATIENT WAS IN OFFICE. MOM NOTIFIED OF EXTRA DOSE OF HEP B AND TO CALL BACK IF SYMPTOMS OR SIDE EFFECTS APPEAR.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash macular, Rash pruritic, Rash vesicular
Clinical narrative: Rash in abdomen, macular vesicular, red, pruritic and grouped.
Age: 50.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Skin warm, Tenderness
Clinical narrative: LA, WARM TO TOUCH, MILDLY TENDER TO TOUCH.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anxiety, Blood test normal, Chest X-ray normal, Chest discomfort, Computerised tomogram normal
Clinical narrative: Woke up at 5am not feeling well at all, started having a massive anxiety attack, sore throat, shortness of breath, followed by headaches, nausea and a heavy pressure on my chest. After the 1st 24 hours the anxiety subsided, after 4-7 days the nausea and then the headaches went away. I still have the shortness of breath and the heavy pressure on my chest, along with the sore throat. I can't walk a flight of stairs without being "winded". I've been to the ER twice. I still have the shortness of breath and the heaviness on the chest today.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Electrocardiogram normal, Headache, Malaise, Nausea
Clinical narrative: Woke up at 5am not feeling well at all, started having a massive anxiety attack, sore throat, shortness of breath, followed by headaches, nausea and a heavy pressure on my chest. After the 1st 24 hours the anxiety subsided, after 4-7 days the nausea and then the headaches went away. I still have the shortness of breath and the heavy pressure on my chest, along with the sore throat. I can't walk a flight of stairs without being "winded". I've been to the ER twice. I still have the shortness of breath and the heaviness on the chest today.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Oropharyngeal pain, Scan with contrast normal
Clinical narrative: Woke up at 5am not feeling well at all, started having a massive anxiety attack, sore throat, shortness of breath, followed by headaches, nausea and a heavy pressure on my chest. After the 1st 24 hours the anxiety subsided, after 4-7 days the nausea and then the headaches went away. I still have the shortness of breath and the heavy pressure on my chest, along with the sore throat. I can't walk a flight of stairs without being "winded". I've been to the ER twice. I still have the shortness of breath and the heaviness on the chest today.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cardiac stress test normal, Chest X-ray normal, Chest discomfort, Dizziness, Dyspnoea
Clinical narrative: Woke up at 5am not feeling well at all, started having a massive anxiety attack, sore throat, shortness of breath, followed by headaches, nausea and a heavy pressure on my chest. After the 1st 24 hours the anxiety subsided, after 4-7 days the nausea and then the headaches went away. I still have the shortness of breath and the heavy pressure on my chest, along with the sore throat. I can't walk a flight of stairs without being "winded". I've been to the ER twice. I still have the shortness of breath and the heaviness on the chest today.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Headache, Nausea, Palpitations, Ultrasound scan normal
Clinical narrative: Woke up at 5am not feeling well at all, started having a massive anxiety attack, sore throat, shortness of breath, followed by headaches, nausea and a heavy pressure on my chest. After the 1st 24 hours the anxiety subsided, after 4-7 days the nausea and then the headaches went away. I still have the shortness of breath and the heavy pressure on my chest, along with the sore throat. I can't walk a flight of stairs without being "winded". I've been to the ER twice. I still have the shortness of breath and the heaviness on the chest today.
Age: 23.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Redness and induration at the site of the vaccines.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pt had redness at injection site about size of index card and complained of pain. Issues did not last longer than approximately 3 days.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site rash, Pallor, Rash, Rash pruritic, Scratch
Clinical narrative: Per the mother, patient started vomiting and broke out in a rash on his face when they were pulling out of the doctor's office parking lot. Mom states that the patient is also very sleepy. Patient is scratching rash in the office, and the rash has spread to back and legs. He was pale when he came back to the office. Patient was examined by doctor. No difficuly breathing noted. He was given 1 tsp po of BENADRYL. He was watched for 45 minutes. Patient was alert, color was good, no difficulty when he left the office.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Somnolence, Vomiting
Clinical narrative: Per the mother, patient started vomiting and broke out in a rash on his face when they were pulling out of the doctor's office parking lot. Mom states that the patient is also very sleepy. Patient is scratching rash in the office, and the rash has spread to back and legs. He was pale when he came back to the office. Patient was examined by doctor. No difficuly breathing noted. He was given 1 tsp po of BENADRYL. He was watched for 45 minutes. Patient was alert, color was good, no difficulty when he left the office.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 31-MAY-2018, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # N022167, expiration date: 08-FEB-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA001505: US-009507513-1806USA009026: US-009507513-1806USA009027: US-009507513-1806USA009028: US-009507513-1806USA009029: US-009507513-1806USA009030: US-009507513-1806USA009031: US-009507513-1806USA009032: US-009507513-1806USA009033: US-009507513-1806USA009034: US-009507513-1806USA009035: US-009507513-1806USA009036: US-009507513-1806USA009037: US-009507513-1806USA009038: US-009507513-1806USA009039: US-009507513-1806USA009040: US-009507513-1806USA009041: US-009507513-1806USA009042: US-009507513-1806USA009043: US-009507513-1806USA009044: US-009507513-1806USA009045: US-009507513-1806USA009046: US-009507513-1806USA009047: US-009507513-1806USA009048: US-009507513-1806USA009049: US-009507513-1806USA009050: US-009507513-1806USA009051: US-009507513-1806USA009053: US-009507513-1806USA009054: US-009507513 1806USA009055: US-009507513-1806USA009056.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 29-MAY-2018, the patient was vaccinated with an improperly stored dose of PEDVAXHIB lot # N022167, expiration date: 08-FEB-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA001505: US-009507513-1806USA009026: US-009507513-1806USA009027: US-009507513-1806USA009028: US-009507513-1806USA009029: US-009507513-1806USA009030: US-009507513-1806USA009031: US-009507513-1806USA009032: US-009507513-1806USA009033: US-009507513-1806USA009034: US-009507513-1806USA009035: US-009507513-1806USA009036: US-009507513-1806USA009037: US-009507513-1806USA009038: US-009507513-1806USA009039: US-009507513-1806USA009040: US-009507513-1806USA009041: US-009507513-1806USA009042: US-009507513-1806USA009043: US-009507513-1806USA009044: US-009507513-1806USA009045: US-009507513-1806USA009046: US-009507513-1806USA009047: US-009507513-1806USA009048: US-009507513-1806USA009049: US-009507513-1806USA009050: US-009507513-1806USA009051: US-009507513-1806USA009052: US-009507513-1806USA009054: US-009507513-1806USA009055: US-009507513-1806USA009056.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Ophthalmic herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 08-MAR-2016, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 22-MAY-2016, she was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster keratitis. The patient was prescribed instill brinzolamide (AZOPT), acyclovir, and hypromellose (GENTEAL) gel for management of her painful symptoms. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Upon internal review, herpes zoster keratitis was determined to be medically significant. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report was received from a physician referring to a 19 year old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patient was vaccinated with a complete series of RECOMBIVAX HB (strength, dose, route, anatomical location, lot # and expiration date were not provided), for prophylaxis. On an unspecified date, a post-vaccination testing was performed and the patient did not show "a protective level of anti-HBs". At the reporting time, the outcome of hepatitis b surface antibody negative was unknown. The causal relationship between the event and the RECOMBIVAX HB was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of pain localized in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain localized, localized itching and localized erythema. On an unknown date, the outcome of the pain localized, localized itching and localized erythema were unknown. It was unknown if the reporter considered the pain localized, localized itching and localized erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional (HCP) reported that, the patient had a localized reaction which included pain, redness and pruritus. The HCP did not report any patient or vaccine information. No other details about the adverse events were reported. The HCP did not specify what type of HCP they were nor gave an address of their location.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse event in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was recovered/resolved. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were reported as follows: The patient was a friend of the reporter. The age at vaccination was not reported. The patient had bad side effects. The caller reported 3 friends all had bad side effects. This was 1 of 4 cases, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Emotional distress, Frustration tolerance decreased, Influenza, Mobility decreased
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of flu symptoms in a adult female patient who received SHINGRIX for prophylaxis. On 13th June 2018, the patient received SHINGRIX. On 13th June 2018, 4 hrs after receiving SHINGRIX the patient experienced flu symptoms, general body pain, joint pain and mobility decreased. In June 2018, the patient experienced frustration and emotional distress. On an unknown date, the outcome of the flu symptoms, general body pain and joint pain were unchanged and the outcome of the mobility decreased, frustration and emotional distress were not recovered/not resolved. The reporter considered the flu symptoms, general body pain and joint pain to be related to SHINGRIX. It was unknown if the reporter considered the mobility decreased, frustration and emotional distress to be related to SHINGRIX. Additional details were provided as follows: This case was reported by nurse for herself. The age at vaccination was not reported. Four hours after receiving SHINGRIX, the patient horrible flu symptoms (without fever) including body aches and joint pain. The patient could not lift her arm. The symptoms worsened over the past 24 hours. Less than a week, after receiving SHINGRIX, the patient experienced distress and frustration. The reporter had some difficulty obtaining information due to distress and frustration and did not have lot or expiry for vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of flu symptoms in a adult female patient who received SHINGRIX for prophylaxis. On 13th June 2018, the patient received SHINGRIX. On 13th June 2018, 4 hrs after receiving SHINGRIX the patient experienced flu symptoms, general body pain, joint pain and mobility decreased. In June 2018, the patient experienced frustration and emotional distress. On an unknown date, the outcome of the flu symptoms, general body pain and joint pain were unchanged and the outcome of the mobility decreased, frustration and emotional distress were not recovered/not resolved. The reporter considered the flu symptoms, general body pain and joint pain to be related to SHINGRIX. It was unknown if the reporter considered the mobility decreased, frustration and emotional distress to be related to SHINGRIX. Additional details were provided as follows: This case was reported by nurse for herself. The age at vaccination was not reported. Four hours after receiving SHINGRIX, the patient horrible flu symptoms (without fever) including body aches and joint pain. The patient could not lift her arm. The symptoms worsened over the past 24 hours. Less than a week, after receiving SHINGRIX, the patient experienced distress and frustration. The reporter had some difficulty obtaining information due to distress and frustration and did not have lot or expiry for vaccine administered.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Herpes virus infection, Injection site pain, Myalgia, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 64-year-old female patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2020) for prophylaxis. The patient's past medical history included shingles. On 12th June 2018 15:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In June 2018, less than a week after receiving SHINGRIX, the patient experienced fever, herpes virus infection, fatigue, injection site pain and myalgia. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the herpes virus infection was not recovered/not resolved and the outcome of the fatigue, injection site pain and myalgia were recovering/resolving. It was unknown if the reporter considered the fever, herpes virus infection, fatigue, injection site pain and myalgia to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine in the left deltoid. The patient experienced fever, injection site pain, fatigue and myalgia. The patient stated that, they had what looked like an outbreak on their tailbone. A follow up request was made for the event outbreak on tailbone and it was not diagnosed at the time of the report. The pharmacist did not see the outbreak.
Sex: F
Vaccine: VARZOS
Symptoms: Circumstance or information capable of leading to medication error, Immediate post-injection reaction, Injection site pain, Underdose
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult female patient who received SHINGRIX (batch number Z9RR4, expiry date 15th November 2020) for prophylaxis. On an unknown date, the patient received SHINGRIX (subcutaneous). On an unknown date, immediately after receiving SHINGRIX, the patient experienced injection site pain, wrong route of administration and accidental underdose. On an unknown date, the outcome of the injection site pain, wrong route of administration and accidental underdose were unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided s follows: The age at administration was not reported. The healthcare professional (HCP) reported that reports that while administering a dose of SHINGRIX a patient pulled away and some of the dose might have been given subcutaneously and also stated that full dose was not administered due to the patient pulled away which led to wrong route of administration and accidental underdose. The HCP further stated the patient then complained of injection site pain.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Bronchitis, Injection site rash, Injection site swelling, Oropharyngeal pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 70-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included vitamin d and hydrochlorothiazide. On 11th March 2018, the patient received the 1st dose of SHINGRIX. On 11th March 2018, less than a day after receiving SHINGRIX, the patient experienced injection site rash and injection site swelling. On 12th March 2018, the patient experienced bronchitis and sore throat. On an unknown date, the outcome of the injection site rash, injection site swelling, bronchitis and sore throat were recovered/resolved. The reporter considered the injection site rash, injection site swelling, bronchitis and sore throat to be related to SHINGRIX. Additional details were provided as follows: The patient did not think the injection itself was done very well, she thought the person doing it did not know what he was doing. The patient had an exceptional rash and swelling on her arm where she received the injection and the next day she developed bronchitis and a sore throat that lasted for weeks. She did not want to get the 2nd dose, but upon instructions by her health care professional she received the 2nd dose. This case has been linked to case US2018GSK112543 reported by the same reporter for same patient.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Skin lesion
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of herpes zoster in a 60-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox. In May 2018, the patient received the 1st dose of SHINGRIX. On 14th June 2018, 30 days after receiving SHINGRIX, the patient experienced herpes zoster. The patient was treated with Antivirals for systemic use. On an unknown date, the outcome of the herpes zoster was not recovered/not resolved. It was unknown if the reporter considered the herpes zoster to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient experienced lesions on his upper left shoulder those were consistent with herpes zoster, about 1 month after vaccination. At the time of reporting, the lesions were 1 day old and the physician intended on treating with an antiviral. The healthcare professional who was a dermatologist called and said that, he was seeing the patient for an unrelated issue. The patient thought he got bit by something on his shoulder, but the healthcare professional felt it was a shingles rash.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site inflammation, Injection site pain, Swelling face
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site inflammation in a 79-year-old female patient who received SHINGRIX (batch number 27K24, expiry date 2nd February 2021) for prophylaxis. On 11th June 2018 11:38, the patient received SHINGRIX (intramuscular). In June 2018, several hours after receiving SHINGRIX, the patient experienced injection site inflammation, facial puffiness and injection site pain. On an unknown date, the outcome of the injection site inflammation, facial puffiness and injection site pain were recovering/resolving. The reporter considered the injection site inflammation and injection site pain to be related to SHINGRIX. It was unknown if the reporter considered the facial puffiness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the SHINGRIX vaccine in left deltoid. The health care professional reported that the patient experienced inflammation and soreness in the arm where the injection was given. The patient also experienced puffy feeling in the face. The reporter did not provide patient information.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Peripheral swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site inflammation in a 79-year-old female patient who received SHINGRIX (batch number 27K24, expiry date 2nd February 2021) for prophylaxis. On 11th June 2018 11:38, the patient received SHINGRIX (intramuscular). In June 2018, several hours after receiving SHINGRIX, the patient experienced injection site inflammation, facial puffiness and injection site pain. On an unknown date, the outcome of the injection site inflammation, facial puffiness and injection site pain were recovering/resolving. The reporter considered the injection site inflammation and injection site pain to be related to SHINGRIX. It was unknown if the reporter considered the facial puffiness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the SHINGRIX vaccine in left deltoid. The health care professional reported that the patient experienced inflammation and soreness in the arm where the injection was given. The patient also experienced puffy feeling in the face. The reporter did not provide patient information.
Sex: F
Vaccine: TDAP
Symptoms: Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a adult female patient who received DTaP vaccine for prophylaxis. On an unknown date, the patient received DTaP vaccine. On an unknown date, 1 day after receiving DTaP vaccine, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved. It was unknown if the reporter considered the headache to be related to DTaP vaccine. Additional details were provided as follows: The age at vaccination was not reported. The caller declined identifiers and stated she didn't know specifics. The caller stated that she will report to VAERS, because she was not sure what product she received. The caller stated that she did report to her physician but he refused to report. The caller wanted to know length of time adverse event would be expected to last.  No information in the PI related to time of resolve. Referred to health care professional, then questions related to legally required to provide if the information is known by medical information. So the caller asked question if these questions were related to her or someone else and that was when she reported the adverse event.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Rash macular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received SHINGRIX (batch number B334Y, expiry date 7th October 2020) for prophylaxis. On 6th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 7th June 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema. In June 2018, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site erythema and injection site reaction were unknown. The reporter considered the injection site erythema and injection site reaction to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on the left deltoid. The reporter was a pharmacist at the pharmacy where the vaccination took place. The patient experienced red blotch at the injection site. On 12th June 2018, the patient returned to the pharmacy and showed her arm to the reporter. The patient thought the reaction looks like shingles. As described by the reporter, there were what looked like insect bites but were not actual insect bites also at the injection site. The reporter said that the patient thought that, the reaction was shingles but that she did not think the reaction looks like shingles. At first the patient said that she could not say if the symptoms are related to SHINGRIX but later said she did think SHINGRIX caused the symptoms. The patient told to the reporter that the symptom described as what looks like insect bites started a couple days after when the symptom of the red blotch started. The status of the symptoms as of reporting date was unknown. The batch number reported for SHINGRIX (B334Y), did not exist and was updated to B3344, as per sales database.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry mouth, Injection site erythema, Lip swelling, Somnolence, Swollen tongue
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of swollen tongue in a 78-year-old female patient who received SHINGRIX (batch number B9739, expiry date 22nd November 2020) for prophylaxis. On 12th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 13th June 2018, 1 days after receiving SHINGRIX, the patient experienced swollen tongue, sleepiness, injection site erythema, lip swelling and dry mouth. On an unknown date, the outcome of the swollen tongue, lip swelling and dry mouth were recovering/resolving and the outcome of the sleepiness was unknown and the outcome of the injection site erythema was not recovered/not resolved. It was unknown if the reporter considered the swollen tongue, sleepiness, injection site erythema, lip swelling and dry mouth to be related to SHINGRIX. Additional details were provided as follows: At 18:30 hours, the patient received SHINGRIX in left arm. The patient had not reported the events to her physician but questioned if she should receive the 2nd dose. The pharmacist was encouraged to have the consumer report the events to her physician and discuss.
Age: 76.0
Sex: M
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 76-year-old male patient who received SHINGRIX for prophylaxis. On 26th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, 7 days after receiving SHINGRIX, the patient experienced injection site pain. The patient was treated with Pain Reliever (Nos). On an unknown date, the outcome of the injection site pain was unchanged. The reporter considered the injection site pain to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on the left arm. The patient reported that the pain became progressively worse and had leveled off at the time of reporting. The patient said that all he had to do was press a little bit on the site and it was very painful and the painful area included the injection site, 2 to 3 inches in circumference around it. The patient went to the physician 2 to 3 weeks after receiving the injection and was told to take pain relievers twice daily for 7 days.
Sex: F
Vaccine: VARZOS
Symptoms: Rash macular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of red blotches in a 70-year-old female patient who received SHINGRIX (batch number 32GR4, expiry date unknown) for prophylaxis. Concomitant products included RESTASIS, Losartan, TRAVATAN and hydrochlorothiazide. On 13th June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a week after receiving SHINGRIX, the patient experienced red blotches. On an unknown date, the outcome of the red blotches was unchanged. It was unknown if the reporter considered the red blotches to be related to SHINGRIX. Additional details were provided as follows: The age at the time of vaccination could be 70 years or 69 years. The age at vaccination was not reported. The patient received SHINGRIX vaccine on left arm. The patient reported blotchy redness with uneven borders after receiving SHINGRIX. The exact time of onset was unknown. The pharmacist did not have other patient information or expiration date at time of call.