chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis to L arm, treated with KEFLEX on 9/6/18.
Age: 80.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported upper part of left arm (where she got PNEUMOVAX) is red, swollen, and warm to the touch from the vaccine injection site down to the bend in her arm. Patient is contacting her physician. That is all information available at this time.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Amnesia
Clinical narrative: MEMORY LOSS.
Age: 2.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Erythema, Oedema, Pain, Rash
Clinical narrative: Edema, Redness, Pain, rash all over the left leg. Treatment: Clindamycin (5 CC every 6 hours X 7 days), PRELONE (5 CC every 12 hours x 5 days), ZANTAC (5 CC twice a day).
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient received 2nd series greater than 6 months from the 1 dose.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Myalgias, fevers, headache, shivering, abdominal pain, hives.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Myalgias, fevers, headache, shivering, abdominal pain, hives.
Age: 3.0
Sex: M
Vaccine: HEP
Symptoms: Borrelia test negative, Facial asymmetry, Facial paralysis, Full blood count normal, Metabolic function test normal
Clinical narrative: Seen at Hospital ER on 9/1/18 for c/o asymmetric smile, dx with (L) idiopathic facial nerve palsy. 1 week post Hepatitis B vaccine (number 2 dose) no other symptoms noted. Empirically treated with CEFTIN for Lyme (x 14 days), referred.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Dyspnoea, Throat tightness
Clinical narrative: 10 minutes after flu vaccination, experienced throat tightness, coughing, and difficulty breathing. Treated in the ER at facility where she was working.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Nodule
Clinical narrative: Received pneumonia shot as usual - 1st time it really stung for days and big golf ball size knot on arm.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site swelling, Peripheral swelling, Pruritus, Swelling
Clinical narrative: Swelling in (L) arm up into neck, back of neck, redness and itching.
Age: 16.0
Sex: M
Vaccine: FLU4, HPV9, MNQ
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Fainted; Complete loss of consciousness.
Age: 1.75
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Patient received varicella and MMRV on the same visit. Intended immunizations were MMR and Varicella. Provider and parent notified. No adverse effects were noted. This is an immunization error, not an adverse event, however ND State Dept of Health felt it should be reported.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient has a bruise at the injection site and a warm, red, swollen patch on her left arm slightly below the injection site. No fever or pain. The patient was instructed to ice the area and contact her physician if the swollen area increases or her symptoms worsen.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Joint noise, Musculoskeletal discomfort, Pain
Clinical narrative: Certain arm movements cause popping and discomfort in the shoulder.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Joint noise
Clinical narrative: Certain arm movements cause popping and discomfort in the shoulder.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Injection site haemorrhage, Injection site pain
Clinical narrative: Headache, fatigue, body aches, L deltoid area hot, swollen, tender and redness was 7x8 cm; this was about 2 cm below the injection site. After 3 days, ecchymoses noted at injection site. Redness continues but headache lasted only several hours.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Pain
Clinical narrative: Headache, fatigue, body aches, L deltoid area hot, swollen, tender and redness was 7x8 cm; this was about 2 cm below the injection site. After 3 days, ecchymoses noted at injection site. Redness continues but headache lasted only several hours.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Sluggishness
Clinical narrative: Full arm pain after about 3 hours after injection; I took an ADVIL at 6:00p.m; pain subsided some, but started returning next morning, along with sluggishness, and body aches; another ADVIL at noon the next day, and arm pain and body aches ended about 7:00p.m.
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist via company representative concerning a 21 year old female patient. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 21-AUG-2018, the patient inadvertently received first dose of HPV series of GARDASIL 9, which was expired lot number M018810 (EXP 18-MAY-2018) for prophylaxis (strength, route of administration, lot number were not reported). No adverse events reported. No further information provided.
Sex: F
Vaccine: VARZOS
Symptoms: Occupational exposure to product, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 57 year old female patient with drug hypersensitivity. The patient's medical history included herpes zoster. On an unknown date the patient was vaccinated with ZOSTAVAX for prophylaxis. Concomitant therapies included duloxetine hydrochloride(CYMBALTA), fluoxetine hydrochloride(PROZAC), metoprolol succinate(TOPROL XL TABLETS), losartan(LOSARTAN), aspirin(ASPIRIN), prasugrel hydrochloride(EFFIENT), trazodone hydrochloride(TRAZODONE HYDROCHLORIDE), atorvastatin calcium(LIPITOR) and lansoprazole(PREVACID). On JUN-2018 the patient experienced rash. On an unknown date the patient experienced occupational exposure to product. The outcome of rash was reported as not recovered/not resolved. The outcome of occupational exposure to product was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Eye swelling, Eyelid rash, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a 65-year-old 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 rash and eye swelling. The patient was treated with ophthalmologicals (Eye Drops). On an unknown date, the outcome of the rash and eye swelling were recovered/resolved. It was unknown if the reporter considered the rash and eye swelling to be related to SHINGRIX. Additional information was received as follows: The patient was basically healthy. The case was reported by the patient's friend. The age at vaccination was not reported. The patient experienced the rash on her face, eyes, chest, back and hands. The patient's physician got the condition under control, but it flared up again. She took eye drops to treat her eyes.
Sex: M
Vaccine: MENB
Symptoms: Pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in a male patient who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved. It was unknown if the reporter considered the pain to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced pain for three days post vaccination. The reporter did not agree to follow up from GlaxoSmithKline. This case has linked to case US2018GSK155665, reported by the same reporter.
Sex: U
Vaccine: PNC13
Symptoms: Injection site urticaria
Clinical narrative: This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received first dose of PREVNAR 13, via an unspecified route of administration in the arm on 29Aug2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On 04Sep2018, the patient reported that she noticed hives in her arm in the area of the vaccine. The outcome of the event was unknown. Information on the batch number has been requested.
Age: 18.0
Sex: M
Vaccine: HEPA, MENB, MNQ
Symptoms: Dyspnoea
Clinical narrative: This is a spontaneous report from a contactable consumer (medical assistant) via a Pfizer-sales representative. A 18-year-old male patient received TRUMENBA (lot number: 560256 and expiration date: 01Aug 2019), at a single dose; MENACTRA (lot number: U58338A and expiration date: 25Feb 2019) at an unknown dose; and hepatitis a vaccine at an unknown dose; all via an unspecified route of administration, on 27Aug2018 for immunization. The patient's medical history and patient's concomitant medications were not reported. The patient experienced shortness of breath on 28Aug2018. The patient recovered from the event at an unknown date.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Pain, Pyrexia, Tremor
Clinical narrative: Severe shaking, chills, sweating and fever. Severe all over body aches.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: Patient came to pharmacy two days after injection. Area around shot was red, inflamed and warm to touch. Red area was about size of a baseball. Injection site could be seen and was in correct area.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient reports inability to move left arm for 20 hours post vaccine. Did have pain and sensation of feeling in left arm. Reports having to use right arm to move left arm for use.
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: Fall, Loss of consciousness, Seizure
Clinical narrative: The patient presented to the clinic for his 2nd Hepatitis A vaccine for school entry. After I administered the vaccine the mother, patient and other child proceeded to the check out window to receive updated shot record. As they were waiting, the mother yelled that something was wrong and it was paged overhead for the nurses to come to the waiting room. The mother reported that the child loss consciousness, had seizure activity and fell to the floor. Nurses and myself, as well as, ANP went to the front, one of the nurse was the first to the front. We brought the child back into a patient room where ANP assessed him. The child was also given water, juice and a small snack as the mother reported the he had not eaten since breakfast. The patient stayed in the clinic an additional 20 minutes and after having ANP assess him a 2nd time the mother and patient left the clinic.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Acoustic stimulation tests, Balance disorder, Deafness unilateral, Dizziness, Ear discomfort
Clinical narrative: 7-10-18  Tdap immunization; 7-12-18  Both ears plugged; 7-13-18  Pressure on head from one ear to other ear; 7-14-18  Woke up dizzy, hard to walk; 7-15-18  Still dizzy, ringing of ears; 7-16-18  Dizzy, ringing of ears, minor headache; 7-17-18  Dizziness gone, equilibrium challenged; 7-20-18  Ringing of right ear changed to constant static, left ear unplugged & no static on left side; 7-21-18  Hearing loss in right ear more & more evident; 8-23-18  Clicking in right ear began along with constant static; 9-06-18  More clicking occurring with constant static & substantial hearing loss in right ear.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Gait disturbance, Head discomfort, Headache, Nuclear magnetic resonance imaging brain, Tinnitus
Clinical narrative: 7-10-18  Tdap immunization; 7-12-18  Both ears plugged; 7-13-18  Pressure on head from one ear to other ear; 7-14-18  Woke up dizzy, hard to walk; 7-15-18  Still dizzy, ringing of ears; 7-16-18  Dizzy, ringing of ears, minor headache; 7-17-18  Dizziness gone, equilibrium challenged; 7-20-18  Ringing of right ear changed to constant static, left ear unplugged & no static on left side; 7-21-18  Hearing loss in right ear more & more evident; 8-23-18  Clicking in right ear began along with constant static; 9-06-18  More clicking occurring with constant static & substantial hearing loss in right ear.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site induration, Injection site mass
Clinical narrative: Extreme fatigue, chills, headache that would not be helped with 2 Tylenol every four hours. Was unable to leave bed for two days, then had lesser degrees of symptoms for the remainder of a week. Still very fatigued for another week. Also hard lump and rash at injection site for 12 days. Injection site very itchy for two days starting the night of 8/16. No relief except ice pack. Needed ice pack to sleep.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Extreme fatigue, chills, headache that would not be helped with 2 Tylenol every four hours. Was unable to leave bed for two days, then had lesser degrees of symptoms for the remainder of a week. Still very fatigued for another week. Also hard lump and rash at injection site for 12 days. Injection site very itchy for two days starting the night of 8/16. No relief except ice pack. Needed ice pack to sleep.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Rash, Rash erythematous
Clinical narrative: Red circular rash on left arm, body aches and fever.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site inflammation, Joint range of motion decreased, Musculoskeletal stiffness
Clinical narrative: Information has been received from an office manager via a field representative referring to 75 year old female patient. The patient's pre-existing physician-diagnosed allergies, birth defects, medical conditions were reported as none. On 08-AUG-2018 the patient received her first dose of PNEUMOVAX 23 (lot # R002084, expiration date 26-OCT-2019, route, strength and dose not reported) at left deltoid for prophylaxis. On 09-AUG-2018 the patient experienced fever, chills and body aches. There was redness and inflammation around the injection site, which had moved down her arm slightly. Arm had also stiff and her range of motion was limited due to pain. The outcome of events was reported as recovered. The causality between the events and PNEUMOVAX 23 was not reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1808USA010654.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Information has been received from an office manager via a field representative referring to 75 year old female patient. The patient's pre-existing physician-diagnosed allergies, birth defects, medical conditions were reported as none. On 08-AUG-2018 the patient received her first dose of PNEUMOVAX 23 (lot # R002084, expiration date 26-OCT-2019, route, strength and dose not reported) at left deltoid for prophylaxis. On 09-AUG-2018 the patient experienced fever, chills and body aches. There was redness and inflammation around the injection site, which had moved down her arm slightly. Arm had also stiff and her range of motion was limited due to pain. The outcome of events was reported as recovered. The causality between the events and PNEUMOVAX 23 was not reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1808USA010654.
Sex: F
Vaccine: HPV9
Symptoms: Death, Vaccination complication
Clinical narrative: This spontaneous report was received from a consumer who saw a video on the internet referring to a female patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with GARDASIL 9 for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). On an unknown date, the patient experienced reactions after the vaccination and subsequently died due to an unspecified reason; it was unknown whether an autopsy was performed. The reporter did not provided causality assessment between the adverse reaction and vaccination with GARDASIL 9. Upon internal review the patient's death was determined to be medically significant. This is one of several cases received from the same reporter. Sender's Comments: US-009507513-1809USA001815: Reported Cause(s) of Death: Unknown cause of death.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of VAQTA lot # R002086, expiration date: 22-APR-2019 (exact dose, route and site of administration were not reported) for prophylaxis. The vaccine was exposed to temperature in the range of 47 degrees Fahrenheit to 77 degrees Fahrenheit (47.9 degrees Fahrenheit) for 10 minutes. Temperature excursion was detected by a data logger. There was no previous temperature excursion. No adverse events were reported. This is one of three reports from the same reporter. Sender's Comments: US-009507513-1808USA009171: US-009507513-1809USA001769.
Sex: F
Vaccine: HPV9
Symptoms: Death
Clinical narrative: This spontaneous report was received from a consumer who saw a video on the internet referring to several female kids of unknown age. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patients were vaccinated with GARDASIL 9 for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). On unknown dates, the patients died after the vaccination due to an unspecified reason; it was unknown whether an autopsy was performed. The reporter did not provided causality assessment between the patients' deaths and vaccination with GARDASIL 9. Upon internal review the patient's death was determined to be medically significant. This is one of several cases received from the same reporter. Sender's Comments: US-009507513-1809USA000416: Reported Cause(s) of Death: Unknown cause of death.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided. On 27-AUG-2018, the patient was vaccinated with an improperly stored dose of PROQUAD lot # R002939, expiration date: 29-JUL-2019 (strength, dose, route of administration and anatomical location were not reported) indicated for prophylaxis which was reconstituted with sterile diluent (MERCK) (lot# and expiration date not reported) properly stored. The administered dose of the vaccine PROQUAD experienced multiple temperature excursions of 6 degrees Fahrenheit (degree F) to 14 degrees Fahrenheit (degree F) for 303 minutes, as recorded by a data logger. There were no previous excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA002034: US-009507513-1809USA002036: US-009507513-1809USA002033: US-009507513-1809USA002037: US-009507513-1809USA001866: US-009507513-1809USA002032: US-009507513-1809USA002031.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Injection site erythema, Injection site paraesthesia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site tingling in a 65-year-old male patient who received Shingrix (batch number L349E, expiry date 22nd February 2020) for prophylaxis. On 27th August 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In August 2018, 12 hrs after receiving Shingrix, the patient experienced injection site tingling and injection site erythema. On 27th August 2018, the patient experienced blister and shingles. On an unknown date, the outcome of the injection site tingling, blister, injection site erythema and shingles were not recovered/not resolved. It was unknown if the reporter considered the injection site tingling, blister, injection site erythema and shingles to be related to Shingrix. Additional details were provided as follows: At 14:40 hours, the patient received his Shingrix on left deltoid. The patient developed tingling and redness at the injection site 12 hours later. Three hours later, he developed what appear to be shingles blisters that were big, round and filled with fluid.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm 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 in arm and chills. On an unknown date, the outcome of the pain in arm and chills were unknown. It was unknown if the reporter considered the pain in arm and chills to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The health care professional reported that, the patient experienced sore arm after both doses of Shingrix vaccine. Soreness seemed to be more pronounced after 2nd dose. The patient also complained of chills. These symptoms were lasted for a few days. This case has been linked with case US2018GSK161059, reported by the same reporter for the same patient.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Pain in extremity, Tenderness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of limbs stiffness in a 70-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included breast cancer (didn't get any vaccine or bloodwork done in right arm). Previously administered products included herpes zoster live-attenuated vaccine (received ZVL vaccine 5 years before the reporting date) and Flu vaccine (received every year). On 17th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, 1 day after receiving SHINGRIX, the patient experienced limbs stiffness and pain in arm. In April 2018, the outcome of the limbs stiffness was recovered/resolved. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the limbs stiffness and pain in arm to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX in left arm. The caller reported that, the day after vaccination with SHINGRIX experienced stiff arm, lasted 3 days. It was like a tenderness, which the patient experienced when vaccinated with flu vaccine. Every year, the patient received flu vaccine, but did not always experience tenderness. The health care professional (HCP) not asked. This case linked with US2018GSK162375 and US2018156131, reported by the same reporter.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: 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 74-year-old male patient who received Shingrix for prophylaxis. The patient's past medical history included breast cancer (didn't get any vaccine or blood work done in right arm). Previously administered products included herpes zoster (received ZVL vaccine 5 years before the reporting date) and Shingrix (1st dose received on an unknown date). In July 2018, the patient received the 2nd dose of Shingrix. In July 2018, 1 day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to Shingrix. Additional details were reported as follows: The patient received 1st dose of Shingrix without any issue. The age at vaccination was not reported. The patient received shingrix vaccine in left arm. The patient experienced minimal achiness in arm and it resolved quickly. This case was linked with case US2018156128 (wife's case), reported by the same reporter for the same patient. The reporter's healthcare professional was not asked.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Cheilitis, Oral mucosal eruption, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash mouth in a 60-year-old female patient who received Shingrix (batch number Y24KE, expiry date 11th October 2020) for prophylaxis. On 27th July 2018, the patient received Shingrix (intramuscular) .5 ml. On an unknown date, less than a month after receiving Shingrix, the patient experienced rash mouth and rash. The patient was treated with emollients and protectives (Moisturizing Cream). On an unknown date, the outcome of the rash mouth and rash were not recovered/not resolved. The reporter considered the rash mouth and rash to be related to Shingrix. Additional details were provided as follows: Pharmacist reported that a patient was complaining of a rash around her lips and sometimes in her mouth since getting Shingrix. The patient thought it was caused by Shingrix. The patient had been treating the rash with moisturizing cream, but it was not going away.
Sex: U
Vaccine: VARZOS
Symptoms: Anxiety, Dizziness, Malaise
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of malaise 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 malaise, dizziness and feeling anxious. On an unknown date, the outcome of the malaise, dizziness and feeling anxious were unknown. It was unknown if the reporter considered the malaise, dizziness and feeling anxious to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that the patient reported that with each dose of vaccine they are feeling sense of malaise, dizziness, unsettling feeling. The healthcare professional's call disconnected while providing this information. Tried to call the healthcare professional back but was unable to reach the healthcare professional. This case is linked with US2018GSK159750, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of erythematous rash in a 78-year-old female patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, 4 days after receiving Shingrix, the patient experienced erythematous rash. On an unknown date, the outcome of the erythematous rash was unknown. It was unknown if the reporter considered the erythematous rash to be related to Shingrix. Additional information was received as follows: The age at vaccination was not reported. But, it could be 77 or 78 years old. The patient received Shingrix on the left arm. The healthcare professional stated that the patient experienced a unilateral right sided bright red rash that went from her right arm down to her right breast. The healthcare professional did not have vaccine information, patient's date of birth and would not provide any more details about the patient's adverse event.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapeutic response decreased
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of therapeutic response decreased in a 20-year-old male patient who received Hepatitis B vaccine for prophylaxis. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased was unknown. It was unknown if the reporter considered the therapeutic response decreased to be related to Hepatitis B vaccine. Additional details were provided as follows: The health care professional stated that the patient she assumed completed the Hepatitis B series (did not confirm if it was ENGERIX-B) as a baby needed to get evaluated for Hepatitis B protection for nursing. Last month the patient's titers came back low so physician's office gave a Hepatitis B shot (did not confirm it was ENGERIX-B) to the patient.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Insomnia, Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 73-year-old male patient who received Shingrix for prophylaxis. On 28th August 2018, the patient received the 1st dose of Shingrix. On 28th August 2018, 9 hrs after receiving Shingrix, the patient experienced general body pain, pain in arm, chills and sleeplessness. On an unknown date, the outcome of the general body pain and pain in arm were not recovered/not resolved and the outcome of the chills was recovered/resolved and the outcome of the sleeplessness was unknown. It was unknown if the reporter considered the general body pain, pain in arm, chills and sleeplessness to be related to Shingrix. Additional details were provided as follows: At 11:00, the patient received the Shingrix the day before reporting on the right arm. On the same day evening, his whole right arm was hurting and also his whole body. The patient experienced difficulty laying on his side due to his arm and he could not sleep. The patient noted chills also but did not believe that he had a fever. The patient was unhappy because this representative could not to provide medical advice.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapeutic response decreased
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of therapeutic response decreased in a female patient who received Engerix B for prophylaxis. Co-suspect products included Engerix B for prophylaxis and Engerix B for prophylaxis. On an unknown date, the patient received the 1st dose of Engerix B, the 2nd dose of Engerix B and the 3rd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, Engerix B and Engerix B, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased was unknown. It was unknown if the reporter considered the therapeutic response decreased to be related to Engerix B, Engerix B and Engerix B. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional stated that the patient received 3 dose series of Engerix B about 4 to 5 years ago from the date of reporting. On an unknown date, the patient's antibody titer were found low. The healthcare professional was not sure of antibody levels as lab was done by patient's doctor. The healthcare professional was not sure of patient's initials or date of birth or vaccine information of the Engerix B that was administered. Lab Comments: On an unknown date, antibody titre/ level was low.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 52-year-old female patient who received Shingrix for prophylaxis. In June 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In June 2018, less than a month after receiving Shingrix, the patient experienced injection site pain, pain and injection site erythema. On an unknown date, the outcome of the injection site pain, pain and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site pain, pain and injection site erythema to be related to Shingrix. Additional information was received as follows: The patient received the Shingrix vaccine on the left arm. The patient experienced soreness at injection site, achy feeling and redness at injection site. This has been linked to the case US2018157107 and US2018GSK162355, reported by the same reporter.
Age: 80.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site pain, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 80-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included INFLUENZA VACCINE for prophylaxis. On 24th August 2018, the patient received the 1st dose of SHINGRIX and INFLUENZA VACCINE. On 24th August 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 29th August 2018, the patient experienced nausea. On 27th August 2018, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the nausea was not recovered/not resolved. It was unknown if the reporter considered the injection site pain and nausea to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm and flu vaccine in right arm. Before being given the vaccines, the patient did ask if there would be a problem with taking both vaccines together. She was told by the pharmacist that it should be fine. She did mention that the arm she received SHINGRIX in was worse as far as soreness. The nausea started on the day of reporting and it had been very bad, she said. She did not know if it could be from both vaccines or not. The manufacturer for the flu vaccine was Seqirus.
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Chills, Feeling cold, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male patient who received SHINGRIX for prophylaxis. Co-suspect products included INFLUENZA VACCINE for prophylaxis. On 24th August 2018, the patient received the 1st dose of SHINGRIX and INFLUENZA VACCINE. On 24th August 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain and shivering. On 24th August 2018, the outcome of the shivering was recovered/resolved. On 27th August 2018, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain and shivering to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. The patient received SHINGRIX in left arm and flu vaccine in right arm. Before being given the vaccines, the patient's wife did ask if there would be a problem with taking both vaccines together to the pharmacist. The reporter was told by the pharmacist that it should be fine. The reporter did not know if it could be from both vaccines or not. Later in the evening, the patient experienced shivering. He could not seem to get warm but it resolved later that night, she said. The manufacturer for the flu vaccine was Seqirus. This case has been linked with the case US2018157116, reported by the wife of the patient.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Neck pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 68-year-old female patient who received Shingrix (batch number 3AF9E, expiry date 2nd February 2021) for prophylaxis. On 29th June 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site erythema, injection site pain, neck pain and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site pain, neck pain and injection site swelling were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site pain, neck pain and injection site swelling to be related to Shingrix. Additional details were provided as follows: The healthcare professional stated that the patient received their 1st dose of Shingrix 2 months ago, presented on the day of reporting for dose 2. The patient developed an injection site reaction quickly after the dose of Shingrix. The patient was unsure how long after exactly he experienced events. The healthcare professional stated that the patient reported the injection site soreness spread to the patients neck and lasted for about 2 weeks.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Headache, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site muscle pain in a 61-year-old female patient who received Shingrix for prophylaxis. Concomitant products included Tylenol. On 28th August 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 28th August 2018, immediately after receiving Shingrix, the patient experienced injection site muscle pain, sleeplessness, muscle pain, headache, pain in arm and skin warm. On 29th August 2018, the patient experienced red blotches, back pain, sniffles and injected limb mobility decreased. The patient was treated with Advil and Lidocaine Patch. On 29th August 2018, the outcome of the back pain was recovered/resolved. On an unknown date, the outcome of the injection site muscle pain, sleeplessness, headache and skin warm were recovered/resolved and the outcome of the red blotches was not recovered/not resolved and the outcome of the muscle pain, sniffles and pain in arm were unknown and the outcome of the injected limb mobility decreased was recovering/resolving. It was unknown if the reporter considered the injection site muscle pain, red blotches, sleeplessness, muscle pain, headache, back pain, sniffles, pain in arm, injected limb mobility decreased and skin warm to be related to Shingrix. Additional details were reported as follows: At 1:00 pm, the patient received Shingrix in left deltoid. The nurse reported that the patient experienced severe deltoid pain and red splotches on her deltoid. The splotches were not raised but it was big and red. The patient also experienced bad pain the night after the vaccination and couldn't sleep and her whole muscle was sore. The patient also experienced headache and severe back pain next day and sniffles. The day before the reporting date, her arm was so sore that she couldn't raise her arm but by noon it was better with Tylenol. The patient's arm was warm and ached with soreness on the deltoid after injection with Shingrix vaccine. The patient developed 3 separate red spots on her arm. The patient did not believe they were hives, were more pronounced at the time of reporting rather than before. Till the time of reporting, the patient's arm was still little sore. The patient used a lidocaine patch on her back for her back pain. The patient took Advil for back pain and arm pain. The patient also stated that, when the medicine was injected into the muscle in her arm it burned going in and her arm got more sore as the day went on. Further details shared upon transfer to MACC.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Myalgia, Pain in extremity, Rash macular, Rhinorrhoea
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site muscle pain in a 61-year-old female patient who received Shingrix for prophylaxis. Concomitant products included Tylenol. On 28th August 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 28th August 2018, immediately after receiving Shingrix, the patient experienced injection site muscle pain, sleeplessness, muscle pain, headache, pain in arm and skin warm. On 29th August 2018, the patient experienced red blotches, back pain, sniffles and injected limb mobility decreased. The patient was treated with Advil and Lidocaine Patch. On 29th August 2018, the outcome of the back pain was recovered/resolved. On an unknown date, the outcome of the injection site muscle pain, sleeplessness, headache and skin warm were recovered/resolved and the outcome of the red blotches was not recovered/not resolved and the outcome of the muscle pain, sniffles and pain in arm were unknown and the outcome of the injected limb mobility decreased was recovering/resolving. It was unknown if the reporter considered the injection site muscle pain, red blotches, sleeplessness, muscle pain, headache, back pain, sniffles, pain in arm, injected limb mobility decreased and skin warm to be related to Shingrix. Additional details were reported as follows: At 1:00 pm, the patient received Shingrix in left deltoid. The nurse reported that the patient experienced severe deltoid pain and red splotches on her deltoid. The splotches were not raised but it was big and red. The patient also experienced bad pain the night after the vaccination and couldn't sleep and her whole muscle was sore. The patient also experienced headache and severe back pain next day and sniffles. The day before the reporting date, her arm was so sore that she couldn't raise her arm but by noon it was better with Tylenol. The patient's arm was warm and ached with soreness on the deltoid after injection with Shingrix vaccine. The patient developed 3 separate red spots on her arm. The patient did not believe they were hives, were more pronounced at the time of reporting rather than before. Till the time of reporting, the patient's arm was still little sore. The patient used a lidocaine patch on her back for her back pain. The patient took Advil for back pain and arm pain. The patient also stated that, when the medicine was injected into the muscle in her arm it burned going in and her arm got more sore as the day went on. Further details shared upon transfer to MACC.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site muscle pain in a 61-year-old female patient who received Shingrix for prophylaxis. Concomitant products included Tylenol. On 28th August 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 28th August 2018, immediately after receiving Shingrix, the patient experienced injection site muscle pain, sleeplessness, muscle pain, headache, pain in arm and skin warm. On 29th August 2018, the patient experienced red blotches, back pain, sniffles and injected limb mobility decreased. The patient was treated with Advil and Lidocaine Patch. On 29th August 2018, the outcome of the back pain was recovered/resolved. On an unknown date, the outcome of the injection site muscle pain, sleeplessness, headache and skin warm were recovered/resolved and the outcome of the red blotches was not recovered/not resolved and the outcome of the muscle pain, sniffles and pain in arm were unknown and the outcome of the injected limb mobility decreased was recovering/resolving. It was unknown if the reporter considered the injection site muscle pain, red blotches, sleeplessness, muscle pain, headache, back pain, sniffles, pain in arm, injected limb mobility decreased and skin warm to be related to Shingrix. Additional details were reported as follows: At 1:00 pm, the patient received Shingrix in left deltoid. The nurse reported that the patient experienced severe deltoid pain and red splotches on her deltoid. The splotches were not raised but it was big and red. The patient also experienced bad pain the night after the vaccination and couldn't sleep and her whole muscle was sore. The patient also experienced headache and severe back pain next day and sniffles. The day before the reporting date, her arm was so sore that she couldn't raise her arm but by noon it was better with Tylenol. The patient's arm was warm and ached with soreness on the deltoid after injection with Shingrix vaccine. The patient developed 3 separate red spots on her arm. The patient did not believe they were hives, were more pronounced at the time of reporting rather than before. Till the time of reporting, the patient's arm was still little sore. The patient used a lidocaine patch on her back for her back pain. The patient took Advil for back pain and arm pain. The patient also stated that, when the medicine was injected into the muscle in her arm it burned going in and her arm got more sore as the day went on. Further details shared upon transfer to MACC.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Rash papular
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of herpes zoster in a 81-year-old female patient who received Shingrix for prophylaxis. On 20th August 2018, the patient received the 1st dose of Shingrix. On 27th August 2018, 7 days after receiving Shingrix, the patient experienced herpes zoster, papular rash and burning sensation. On an unknown date, the outcome of the herpes zoster, papular rash and burning sensation were unknown. It was unknown if the reporter considered the herpes zoster, papular rash and burning sensation to be related to Shingrix. Additional details were provided as follows: The patient experienced, burning in the right lower back, which radiated to anterior abdomen, then noticed papular lesions in the area. On 29th August 2018, the patient presented to her primary care physician with full blown zoster. The lot number and expiry dates were unknown. The Shingrix vaccine might have been administered by a pharmacy and not the reporting pharmacy.
Sex: U
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of blister 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 blister. On an unknown date, the outcome of the blister was unknown. It was unknown if the reporter considered the blister to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The patient received Shingrix at least a month ago and developed blisters on their chest and neck. The pharmacy intern did not have any other information.