chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Limb discomfort, Muscle disorder, Pain, Vaccine positive rechallenge
Clinical narrative: only exercise for 15 minutes and he has to go to bed and rest; Terrible pain; slight dizziness; feet felt heavy; muscle collapse; threw out his knee; Discomfort; This case was reported by a consumer via call center representative and described the occurrence of muscle disorder in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included sinus operation. Previously administered products included Shingrix with an associated reaction of discomfort (received 1st dose on an unknown date and experienced discomfort).   On 7th August 2019, the patient received the 2nd dose of Shingrix. In August 2019, 6 days after receiving Shingrix, the patient experienced muscle disorder, knee pain and discomfort. On an unknown date, the patient experienced energy decreased, pain, dizziness and heaviness in extremities. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the muscle disorder, knee pain, energy decreased, dizziness and heaviness in extremities were unknown and the outcome of the discomfort and pain were recovered/resolved.   It was unknown if the reporter considered the muscle disorder, knee pain, discomfort, energy decreased, pain, dizziness and heaviness in extremities to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient received his second dose and experienced muscle collapse and he threw out his knee. The patient also experienced mild discomfort for about 3 days. The patient gone to 6 doctors and all of his blood tests come back as normal. The patient was very healthy and used to work out 5 days per week and go dancing regularly. After vaccination patient can only exercise for 15 minutes and he has to go to bed and rest. For 1 month he was in terrible pain, but it had passed. The patient began a mild exercise routine for 4 weeks, but developed slight dizziness and his feet felt heavy.      Lab Comments: On an unknown date blood test was done
Sex: U
Vaccine: HPV4
Symptoms: Death
Clinical narrative: died; Information has been received from a consumer who saw a report on the internet concerning two patients (unspecified ages) who were vaccinated with 3 doses of HPV rL1 6 11 16 18 VLP vaccine (yeast) (dates were not reported). Subsequently the patients died, the cause of death was unknown.   This is one of several reports received from the same source. This is a hearsay report, attempts are being made to obtain identifying information to distinguish individual patients.  Additional information has been requested.  This is an amended report: HCP confirmed has been changed to no for regulatory consumer. Company Causality Assessment: Episode Profile: Medically Confirmed: N
Age: 78.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia
Clinical narrative: Onset of joint pain 2 days after vaccination. This has continued for 10 days so far
Age: 24.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Injection site swelling
Clinical narrative: Redness, minimal swelling at site of injection. No burning, bruising, pain reported by patient
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Feeling abnormal, Hypoaesthesia, Muscle tightness
Clinical narrative: Patient received Tdap (Boostrix) on 12/30/19 at pharmacy. Patient reporting numbness on tips of 2 fingers of right hand (IMZ given on left arm) - middle 2 fingers just the tip or pads of 1st digit of fingers; patient describes he doesn't seem to feel sensation when touching surfaces. Patient recalls started day after vaccine. No other symptoms. Just felt odd. He came by following week to discuss with RPh on duty who counseled patient to monitor symptoms,discussed common side effects and adverse effects -counseled patient that if gets more severe, progresses to other parts or doesn't resolve in a week then see an MD. Patient reported seeing urgent care on 1/8 because started to feel tightness on shoulder or near back of neck. Urgent Care MD could not verify if caused by vaccine. Urgent care MD did not prescribe any medical treatment. Urgent care recommended patient go to ER if continues or gets more severe or for another opinion.   At this time (1/09/2020) patient has not seeked further care. Patient reported to pharmacy manager on 1/9/20 and expressed concerns at this point that symptoms not going away. Numbness has not worsen nor spread (only in those 2 fingers) but has not gone away either. No numbness elsewhere. No symptoms on arm vaccine was administered to. Pharmacy manager counseled patient about further known side effects and adverse effects and stated will report on VAERS and internally with Pharmacy. Patient wants to go to ER but concerned about cost. Asked what can be done or if can provide any help to cover cost for patient to seek additional medical care or opinion (patient is who requested to get tetanus vaccine for personal reasons but mainly for work).
Age: 61.0
Sex: M
Vaccine: FLUC4
Symptoms: Antineutrophil cytoplasmic antibody negative, Antinuclear antibody negative, Blood folate normal, C-reactive protein increased, Complement factor C3
Clinical narrative: Pt presented to clinic one week after flu shot. Two days after flu shot developed cold like symptoms, Developed generalized body swelling, tender scalp including temples, gained 10 pounds in one week, Vision dimmed off and one, temples feeling swollen, No difficulties with swallowing or loss of strength. Initial labs normal including normal ESR and Sed Rate. Patient returned with continued symptoms. Prednisone started with much improvement in symptoms. Continued prednisone for about a week, symptoms went away. Prednisone stopped and some symptoms returned especially temple swelling and vision changes. Patient had normal exam with Opthalmology. On 12/31/19 CRP was 15.7 off prednisone. Patient elected not to have biopsy of temporal arteries as symptoms bilateral. Patient now being treated for possible Temporal Arteritis / Giant Cell Arteritis.
Age: 61.0
Sex: M
Vaccine: FLUC4
Symptoms: Complement factor C4, Electrophoresis protein normal, Full blood count normal, HIV test negative, Hepatitis B test negative
Clinical narrative: Pt presented to clinic one week after flu shot. Two days after flu shot developed cold like symptoms, Developed generalized body swelling, tender scalp including temples, gained 10 pounds in one week, Vision dimmed off and one, temples feeling swollen, No difficulties with swallowing or loss of strength. Initial labs normal including normal ESR and Sed Rate. Patient returned with continued symptoms. Prednisone started with much improvement in symptoms. Continued prednisone for about a week, symptoms went away. Prednisone stopped and some symptoms returned especially temple swelling and vision changes. Patient had normal exam with Opthalmology. On 12/31/19 CRP was 15.7 off prednisone. Patient elected not to have biopsy of temporal arteries as symptoms bilateral. Patient now being treated for possible Temporal Arteritis / Giant Cell Arteritis.
Age: 61.0
Sex: M
Vaccine: FLUC4
Symptoms: Hepatitis C test negative, Metabolic function test normal, Nasopharyngitis, Ophthalmological examination normal, Pain of skin
Clinical narrative: Pt presented to clinic one week after flu shot. Two days after flu shot developed cold like symptoms, Developed generalized body swelling, tender scalp including temples, gained 10 pounds in one week, Vision dimmed off and one, temples feeling swollen, No difficulties with swallowing or loss of strength. Initial labs normal including normal ESR and Sed Rate. Patient returned with continued symptoms. Prednisone started with much improvement in symptoms. Continued prednisone for about a week, symptoms went away. Prednisone stopped and some symptoms returned especially temple swelling and vision changes. Patient had normal exam with Opthalmology. On 12/31/19 CRP was 15.7 off prednisone. Patient elected not to have biopsy of temporal arteries as symptoms bilateral. Patient now being treated for possible Temporal Arteritis / Giant Cell Arteritis.
Age: 61.0
Sex: M
Vaccine: FLUC4
Symptoms: Red blood cell sedimentation rate normal, Swelling, Treponema test negative, Urine analysis normal, Visual impairment
Clinical narrative: Pt presented to clinic one week after flu shot. Two days after flu shot developed cold like symptoms, Developed generalized body swelling, tender scalp including temples, gained 10 pounds in one week, Vision dimmed off and one, temples feeling swollen, No difficulties with swallowing or loss of strength. Initial labs normal including normal ESR and Sed Rate. Patient returned with continued symptoms. Prednisone started with much improvement in symptoms. Continued prednisone for about a week, symptoms went away. Prednisone stopped and some symptoms returned especially temple swelling and vision changes. Patient had normal exam with Opthalmology. On 12/31/19 CRP was 15.7 off prednisone. Patient elected not to have biopsy of temporal arteries as symptoms bilateral. Patient now being treated for possible Temporal Arteritis / Giant Cell Arteritis.
Age: 61.0
Sex: M
Vaccine: FLUC4
Symptoms: Vitamin B12 normal, Vitamin D, Weight increased
Clinical narrative: Pt presented to clinic one week after flu shot. Two days after flu shot developed cold like symptoms, Developed generalized body swelling, tender scalp including temples, gained 10 pounds in one week, Vision dimmed off and one, temples feeling swollen, No difficulties with swallowing or loss of strength. Initial labs normal including normal ESR and Sed Rate. Patient returned with continued symptoms. Prednisone started with much improvement in symptoms. Continued prednisone for about a week, symptoms went away. Prednisone stopped and some symptoms returned especially temple swelling and vision changes. Patient had normal exam with Opthalmology. On 12/31/19 CRP was 15.7 off prednisone. Patient elected not to have biopsy of temporal arteries as symptoms bilateral. Patient now being treated for possible Temporal Arteritis / Giant Cell Arteritis.
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Patient reported sore shoulder and difficulty lifting arm. Followed up in one week and patient still had soreness, showed some improvement in range of motion.
Age: 12.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain, Cough, Dyspnoea, Erythema, Lip swelling
Clinical narrative: Date of event: 01/09/2020 . At 14:55- Received report from medical assistant. Patient's temp 97.2 F. Mom reports patient's been doing well, denies recent illness. Confirmed patient's name and DOB. Obtained vaccination- had vaccine checked by 2 RNs. Vaccine given in the left deltoid IM. Patient immediately complains of belly hurting. Within seconds then begins complaining of seeing spots, begins coughing, and complaining of not being able to breathe. Obtained help from all staff. Immediately obtained pOx of 81% while coughing.  Facial and lip swelling, redness, and facial rash began to occur.  1500- Dr. in  room. Pox 95% on room air. RR 24.  BP 116/70. HR 100. Epi IM 0.37ml given in the left thigh  1505- Benadryl IM 0.74 ML given IM in the right thigh by myself. 1506- Albuterol given via nebulizer. HR 110. RR 30 pOX 98%, BP 104/70.  RR 30.  1510: BP 97/64. HR 108. pOx 97% room air Still unable to obtain accurate RR.  1515: Albuterol completed 97/66 HR 94 Pox 98% on room air.  1520: Pox 98% room air HR 100. RR 24 Pox. BP 101/64.  1525- Per Dr. -EMS to be called for transport to closest ER. Mom aware. Staff RN calling ER to notify.  1531- 104/69  RR 24 Pulse 104.  EMS arrives- vitals prior to EMS hand off- 100/54. HR 110 RR 98% pOx 22. I stayed at patient bedside throughout this event. EMS arrived and Report given to EMS squad by Dr.  Physician to physician report done.  Patient transported to ER for observation period. Per ER note patient remained stable. Was given dose of steroid. Facial swelling improved over time. Patient d/c to home after observation period.
Age: 12.0
Sex: F
Vaccine: PPV
Symptoms: Rash, Swelling face, Visual impairment
Clinical narrative: Date of event: 01/09/2020 . At 14:55- Received report from medical assistant. Patient's temp 97.2 F. Mom reports patient's been doing well, denies recent illness. Confirmed patient's name and DOB. Obtained vaccination- had vaccine checked by 2 RNs. Vaccine given in the left deltoid IM. Patient immediately complains of belly hurting. Within seconds then begins complaining of seeing spots, begins coughing, and complaining of not being able to breathe. Obtained help from all staff. Immediately obtained pOx of 81% while coughing.  Facial and lip swelling, redness, and facial rash began to occur.  1500- Dr. in  room. Pox 95% on room air. RR 24.  BP 116/70. HR 100. Epi IM 0.37ml given in the left thigh  1505- Benadryl IM 0.74 ML given IM in the right thigh by myself. 1506- Albuterol given via nebulizer. HR 110. RR 30 pOX 98%, BP 104/70.  RR 30.  1510: BP 97/64. HR 108. pOx 97% room air Still unable to obtain accurate RR.  1515: Albuterol completed 97/66 HR 94 Pox 98% on room air.  1520: Pox 98% room air HR 100. RR 24 Pox. BP 101/64.  1525- Per Dr. -EMS to be called for transport to closest ER. Mom aware. Staff RN calling ER to notify.  1531- 104/69  RR 24 Pulse 104.  EMS arrives- vitals prior to EMS hand off- 100/54. HR 110 RR 98% pOx 22. I stayed at patient bedside throughout this event. EMS arrived and Report given to EMS squad by Dr.  Physician to physician report done.  Patient transported to ER for observation period. Per ER note patient remained stable. Was given dose of steroid. Facial swelling improved over time. Patient d/c to home after observation period.
Sex: M
Vaccine: FLU4
Symptoms: Injection site swelling, Peripheral swelling, Wrong product administered
Clinical narrative: An RN meant to give the hepatitis B vaccine. She grabbed the vaccine from the automated dispensing cabinet fridge, gave them medication, and then scanned it AFTER it was administered to document as given. When scanned, the RN realized she gave the wrong vaccine. Since this vaccine is not indicated in patients < 6 months of age, she notified her supervisors and called pharmacy for recommendations. Poison control was contacted and did not recommend any intervention as long as the patient remained asymptomatic. There was swelling bilaterally on the anterolatera thighs. All vital signs were normal and check Q1hr x 6 times.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Dizziness, Facial pain, Flank pain, Head injury
Clinical narrative: Less than two hours after injection, patient (me) experienced novel flank pain on both sides of chest, wrapping around the sides. Immediately after the injection, patient shopped for groceries and went home: found it very painful to unload the groceries because of the flank pain. By evening patient had a fever of 102 (mercury thermometer), pain all over her body, including buttocks (also never had before) and joint pain. Shoulder that received injection was very sore and redness covered about 3-4 inches of upper arm.   Patient took 600 mg of  ibuprofen and went to sleep. In the middle of the night, woke with urge to urinate, but light headed and nauseated. After using the bathroom, passed out and hid head on tub, awaking on the floor. Returned to bed and woke with a lower fever and diffuse pain, which lasted all day. On the third day, awoke without fever. Pain was much less bad.  Cheek bone hurt from fall for about 4 weeks. Acute shoulder pain and redness lasted 1 week. Seven days after Shingrix was injected, developed a stinging rash on right cheek, an arc of pustules running from the corner of the mouth in the direction of ear. These dried out the next day and the rash healed over the next several days.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Loss of consciousness, Micturition urgency
Clinical narrative: Less than two hours after injection, patient (me) experienced novel flank pain on both sides of chest, wrapping around the sides. Immediately after the injection, patient shopped for groceries and went home: found it very painful to unload the groceries because of the flank pain. By evening patient had a fever of 102 (mercury thermometer), pain all over her body, including buttocks (also never had before) and joint pain. Shoulder that received injection was very sore and redness covered about 3-4 inches of upper arm.   Patient took 600 mg of  ibuprofen and went to sleep. In the middle of the night, woke with urge to urinate, but light headed and nauseated. After using the bathroom, passed out and hid head on tub, awaking on the floor. Returned to bed and woke with a lower fever and diffuse pain, which lasted all day. On the third day, awoke without fever. Pain was much less bad.  Cheek bone hurt from fall for about 4 weeks. Acute shoulder pain and redness lasted 1 week. Seven days after Shingrix was injected, developed a stinging rash on right cheek, an arc of pustules running from the corner of the mouth in the direction of ear. These dried out the next day and the rash healed over the next several days.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Middle insomnia, Nausea, Pain, Pustule, Pyrexia
Clinical narrative: Less than two hours after injection, patient (me) experienced novel flank pain on both sides of chest, wrapping around the sides. Immediately after the injection, patient shopped for groceries and went home: found it very painful to unload the groceries because of the flank pain. By evening patient had a fever of 102 (mercury thermometer), pain all over her body, including buttocks (also never had before) and joint pain. Shoulder that received injection was very sore and redness covered about 3-4 inches of upper arm.   Patient took 600 mg of  ibuprofen and went to sleep. In the middle of the night, woke with urge to urinate, but light headed and nauseated. After using the bathroom, passed out and hid head on tub, awaking on the floor. Returned to bed and woke with a lower fever and diffuse pain, which lasted all day. On the third day, awoke without fever. Pain was much less bad.  Cheek bone hurt from fall for about 4 weeks. Acute shoulder pain and redness lasted 1 week. Seven days after Shingrix was injected, developed a stinging rash on right cheek, an arc of pustules running from the corner of the mouth in the direction of ear. These dried out the next day and the rash healed over the next several days.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Seizure
Clinical narrative: Less than two hours after injection, patient (me) experienced novel flank pain on both sides of chest, wrapping around the sides. Immediately after the injection, patient shopped for groceries and went home: found it very painful to unload the groceries because of the flank pain. By evening patient had a fever of 102 (mercury thermometer), pain all over her body, including buttocks (also never had before) and joint pain. Shoulder that received injection was very sore and redness covered about 3-4 inches of upper arm.   Patient took 600 mg of  ibuprofen and went to sleep. In the middle of the night, woke with urge to urinate, but light headed and nauseated. After using the bathroom, passed out and hid head on tub, awaking on the floor. Returned to bed and woke with a lower fever and diffuse pain, which lasted all day. On the third day, awoke without fever. Pain was much less bad.  Cheek bone hurt from fall for about 4 weeks. Acute shoulder pain and redness lasted 1 week. Seven days after Shingrix was injected, developed a stinging rash on right cheek, an arc of pustules running from the corner of the mouth in the direction of ear. These dried out the next day and the rash healed over the next several days.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: Less than 24 hours after vaccination 102 fever, headache, nausea.  Took Motrin. Chills at night. the next day woke with 101 fever and slight headache. Pajamas soaked with sweat.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. In 2010, the pt was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, route of administration, anatomical location, lot#, expiration date were unknown) by a healthcare provider for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to zoster vaccine live(ZOSTAVAX) inoculation, pt was treated by a physician for shingles.  As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy
Clinical narrative: administered with MMRII during pregnancy; This spontaneous prospective pregnancy report was received from a medical assistant and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA), lot # R031681, expiration date 01-NOV-2020 (dose and route of administration were not reported) for prophylaxis. The patient was 24 weeks and 6 days pregnant at time of administration. The Last Menstrual Period (LMP) and Estimated Date of Delivery (EDD) were not known and could not be calculated. The pregnancy outcome was pending.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Influenza like illness
Clinical narrative: Headache; influenza-like symptoms; feeling abnormal; This case was reported by a consumer via call center representative and described the occurrence of headache in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date, refer case US2019AMR238304).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache, influenza-like symptoms and feeling abnormal. On an unknown date, the outcome of the headache, influenza-like symptoms and feeling abnormal were unknown.   It was unknown if the reporter considered the headache, influenza-like symptoms and feeling abnormal to be related to Shingrix.  Additional information was received as follows: The patients had the second dose of Shingrix and experinced flu like symptoms and feeling out of it.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Feverish, but no fever; Chills; Total body aches; This case was reported by a consumer via call center representative and described the occurrence of fever in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included sinus infection.   On 5th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced fever, chills and general body pain. The patient was treated with azithromycin (Z-Pak). On an unknown date, the outcome of the fever, chills and general body pain were recovered/resolved.   It was unknown if the reporter considered the fever, chills and general body pain to be related to Shingrix.  Additional details were provided as follows: The patient after vaccination was feverish, chills, total body aches and had went to bed. The patient already had a sinus infection that she had not gotten rid of. The patient consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: injection site pain for 5 days; rednesss for 5 days; This case was reported by a consumer via other manufacturer and described the occurrence of injection site pain in a female patient who received Herpes zoster (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 injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the patient experienced injection site pain and redness for 5 days after vaccination. The patient applied ice and it resolved. This case has been linked with case US2020AMR004282, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Vaccine positive rechallenge
Clinical narrative: injection site pain for 5 days; rednesss for 5 days; This case was reported by a consumer via other manufacturer and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on unknown date, refer case US2020AMR002156.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain and injection site erythema. The patient was treated with non-drug therapy (Ice Pack (No Medication)). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the patient experienced injection site pain and redness for 5 days after vaccination. The patient applied ice and it resolved.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody positive, Hepatitis B virus test positive
Clinical narrative: Positives antigens for Hepatitis B virus; hepatitis B antibody positive; This case was reported by a nurse via call center representative and described the occurrence of hepatitis b virus test positive in a 23-year-old female patient who received HBV (Engerix B) (batch number N754X, expiry date 11th November 2001) for prophylaxis.   On 19th September 2019, the patient received Engerix B. On 12th December 2019, 84 days after receiving Engerix B, the patient experienced hepatitis b virus test positive and hepatitis b antibody positive. On an unknown date, the outcome of the hepatitis b virus test positive and hepatitis b antibody positive were unknown.   It was unknown if the reporter considered the hepatitis b virus test positive and hepatitis b antibody positive to be related to Engerix B.  Additional details were provided as follows: The age at vaccination was not reported. A nurse reported that a patient received Engerix B vaccine and after the test it was confirmed that they had positive results for hepatitis B virus, and positive antibodies as well. The precise virus test and antibody test were not specified. The reporter denied consent to follow-up.      Lab Comments: On 12th December 2019, they had positive results for Hepatitis B virus, and positive antibodies
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Bedridden, Chills, Feeding disorder, Feeling hot
Clinical narrative: Pain in arm; Armpit tender; couldn't eat; headache; shivering; sweating; heat; muscle tightness; This case was reported by a consumer via call center representative and described the occurrence of feeling hot in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Concurrent medical conditions included back disorder.   On 31st December 2019 14:00, the patient received the 1st dose of Shingrix. On 31st December 2019, less than a day after receiving Shingrix, the patient experienced feeling hot, muscle tightness, shivering and sweating. On 31st December 2019 19:00, the patient experienced headache. On 1st January 2020, the patient experienced bedridden and unable to eat. On an unknown date, the patient experienced pain in arm and axillary pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the feeling hot, muscle tightness, shivering, sweating, bedridden, unable to eat and axillary pain were unknown and the outcome of the headache was resolved with sequelae and the outcome of the pain in arm was recovering/resolving.   It was unknown if the reporter considered the feeling hot, muscle tightness, headache, shivering, sweating, bedridden, unable to eat, pain in arm and axillary pain to be related to Shingrix.  Additional details were received as follows: The patient stated that after vaccination she felt heat running through her veins. The patient started feeling muscle tightness that got worse and worse until she could not even sit on the couch. The patient had a bad headache that progressed to the worst headache she had ever had. The patient stated that the head was in a vice with constant pressure. The patient also had some shivering and sweating, but the headache was the part that was very bad. The patient lay in bed all day because she could not do much and could not eat. The patient arm was little sore and her armpit was very tender. The patient does not want to get the 2nd dose. The patient stated that would rather have shingles again. The patient did not consent to follow up.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hyperhidrosis, Muscle tightness, Pain in extremity
Clinical narrative: Pain in arm; Armpit tender; couldn't eat; headache; shivering; sweating; heat; muscle tightness; This case was reported by a consumer via call center representative and described the occurrence of feeling hot in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Concurrent medical conditions included back disorder.   On 31st December 2019 14:00, the patient received the 1st dose of Shingrix. On 31st December 2019, less than a day after receiving Shingrix, the patient experienced feeling hot, muscle tightness, shivering and sweating. On 31st December 2019 19:00, the patient experienced headache. On 1st January 2020, the patient experienced bedridden and unable to eat. On an unknown date, the patient experienced pain in arm and axillary pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the feeling hot, muscle tightness, shivering, sweating, bedridden, unable to eat and axillary pain were unknown and the outcome of the headache was resolved with sequelae and the outcome of the pain in arm was recovering/resolving.   It was unknown if the reporter considered the feeling hot, muscle tightness, headache, shivering, sweating, bedridden, unable to eat, pain in arm and axillary pain to be related to Shingrix.  Additional details were received as follows: The patient stated that after vaccination she felt heat running through her veins. The patient started feeling muscle tightness that got worse and worse until she could not even sit on the couch. The patient had a bad headache that progressed to the worst headache she had ever had. The patient stated that the head was in a vice with constant pressure. The patient also had some shivering and sweating, but the headache was the part that was very bad. The patient lay in bed all day because she could not do much and could not eat. The patient arm was little sore and her armpit was very tender. The patient does not want to get the 2nd dose. The patient stated that would rather have shingles again. The patient did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash in the leg; This case was reported by a physician via call center representative and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd December 2019, the patient received the 1st dose of Shingrix. In December 2019, 3 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were reported as follows: The age group was not reported but was selected as adult as per vaccine indication. The patient received Shingrix and experienced a rash in the leg.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Influenza, Injection site pain, Ocular hyperaemia, Vaccine positive rechallenge, Vision blurred
Clinical narrative: cannot see out right eye; Flu; Red right eye; Blurry vision from right eye; Soreness at injection site; This case was reported by a consumer via call center representative and described the occurrence of visual disturbance in a 63-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for prophylaxis.   Previously administered products included Fluarix Quadrivalent with an associated reaction of ocular hyperaemia (for tolerance of 1st dose refer case US2020AMR002438).   On 23rd November 2019, the patient received the 2nd dose of Fluarix Quadrivalent 2019-2020 season (intramuscular). On 23rd November 2019, less than a day after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site pain. On 25th November 2019, the patient experienced eye red and blurred vision. On 28th November 2019, the patient experienced influenza. On 3rd January 2020, the patient experienced visual disturbance (serious criteria GSK medically significant). Rechallenge with Fluarix Quadrivalent 2019-2020 season was positive. On an unknown date, the outcome of the visual disturbance was unknown and the outcome of the influenza, eye red and blurred vision were recovering/resolving and the outcome of the injection site pain was resolved with sequelae.   The reporter considered the visual disturbance, influenza, injection site pain, eye red and blurred vision to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient had soreness at the injection site after receiving the vaccine. Two days later, the patient had redness and blurry vision in her right eye.  The patient also experienced flu. The patient reported that the eye redness and blurry vision had not resolved and the intensity fluctuated, sometimes it was better in the morning then the following day it got worse.  On the day of reporting the patient could not see out the right eye and was asking for how to manage with it. The patient had not fully recovered from the flu so far. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Visual impairment
Clinical narrative: cannot see out right eye; Flu; Red right eye; Blurry vision from right eye; Soreness at injection site; This case was reported by a consumer via call center representative and described the occurrence of visual disturbance in a 63-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for prophylaxis.   Previously administered products included Fluarix Quadrivalent with an associated reaction of ocular hyperaemia (for tolerance of 1st dose refer case US2020AMR002438).   On 23rd November 2019, the patient received the 2nd dose of Fluarix Quadrivalent 2019-2020 season (intramuscular). On 23rd November 2019, less than a day after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site pain. On 25th November 2019, the patient experienced eye red and blurred vision. On 28th November 2019, the patient experienced influenza. On 3rd January 2020, the patient experienced visual disturbance (serious criteria GSK medically significant). Rechallenge with Fluarix Quadrivalent 2019-2020 season was positive. On an unknown date, the outcome of the visual disturbance was unknown and the outcome of the influenza, eye red and blurred vision were recovering/resolving and the outcome of the injection site pain was resolved with sequelae.   The reporter considered the visual disturbance, influenza, injection site pain, eye red and blurred vision to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient had soreness at the injection site after receiving the vaccine. Two days later, the patient had redness and blurry vision in her right eye.  The patient also experienced flu. The patient reported that the eye redness and blurry vision had not resolved and the intensity fluctuated, sometimes it was better in the morning then the following day it got worse.  On the day of reporting the patient could not see out the right eye and was asking for how to manage with it. The patient had not fully recovered from the flu so far. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Pain in the arm were received the injection; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per the vaccine indication. Post vaccination the patient experienced pain in the arm for about two months. The reporter did not consent to follow up.
Sex: F
Vaccine: FLUX
Symptoms: Documented hypersensitivity to administered product, Rash
Clinical narrative: Rash; Documented hypersensitivity to administered product; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a elderly female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Concurrent medical conditions included egg allergy.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced rash and documented hypersensitivity to administered product. On an unknown date, the outcome of the rash and documented hypersensitivity to administered product were unknown.   It was unknown if the reporter considered the rash to be related to Flu vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient got rash after vaccination in the past because she had an egg allergy. The reporter stated that the type or brand of flu vaccine was unknown and she does not have further details available. The reporter consented to follow up
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; a possible adverse event of shingles in a patient after Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The pharmacist reported a possible adverse event of shingles in a patient after Shingrix. The reporter asked if the patient get shingles from the Shingrix shot and conservatively recorded the adverse event. The reporter did not consent to follow-up. This case was considered as suspected vaccination failure, since the details regarding the dose number, time to onset for event and laboratory confirmation for shingles were not provided.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Deafness
Clinical narrative: hearing loss; This case was reported by a consumer via call center representative and described the occurrence of hearing loss in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number MX2LT, expiry date 29th May 2021) for prophylaxis.   On 7th November 2019, the patient received the 1st dose of Shingrix (intramuscular). In December 2019, less than 2 months after receiving Shingrix, the patient experienced hearing loss (serious criteria GSK medically significant). On an unknown date, the outcome of the hearing loss was unknown.   It was unknown if the reporter considered the hearing loss to be related to Shingrix.  Additional details were provided as follows: The patient received the first does of Shingrix and In December 2019 she noticed some hearing loss. The reporter consented to follow up. Emergency room visit required.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Feeling tired, Muscle pain, Headache, Shivering, Nausea
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient stated that she has a 4"x4" red square area on her arm below the area that the shot was administered.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Pain in upper arm daily since injection (6 months).
Age: 71.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left arm redness & swelling at elbow and upper arm
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site urticaria
Clinical narrative: After MMRV subQ admin to LA, few minutes later patient had reaction of two hives appearing near site of admin. Two Hives about 8mm in diameter, and about 5mm. NP then administered Benadryl to patient; ice packs were placed on arm. Patient was observed for another 30m, post reaction. No further reactions, or symptoms noted.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Extreme pain and loss of range of motion in left arm/shoulder.  Doctor 12/6, and subsequently on 12/17 after symptoms did not get better.  Cortisone shot on 12/17.  Prednisone prescribed  this week.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Swelling and redness approx. 4.0cm x 3.0 cm swelling , sore warm to touch. Started this am. Declines to have evaluated at this time.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Hypotonia, Swelling face
Clinical narrative: AFTER VACCINES WERE ADMINSTERED PATIENT LEFT, 15 MINUTES AFTER THEY HAD LEFT PATIENT WAS BROUGHT BACK INTO THE OFFICE. SWELLING AND REDNESS OF HIS FACE WAS PRESENT. PATIENT DID BECOME LIMP, PATIENT DID NOT LOSE CONSCIOUSNESS IN THE OFFICE AND WAS SENT TO EMERGENCY DEPARTMENT FOR FURTHER EVALUATION.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: Local site reaction with Shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Dyspnoea, Interstitial lung disease
Clinical narrative: interstitial lung disease; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 12-JAN-2012, the patient was vaccinated with the zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, reported as shortly after zoster vaccine live (ZOSTAVAX) the patient suffered shortness of breath, dry and hacking cough in which symptoms did not resolve. The patient was diagnosed with interstitial lung disease. Symptoms resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition; sustained severe and permanent personal injuries suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury; suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered to be not recovered. The reporter considered interstitial lung disease to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review interstitial lung disease was determined to be medically significant. Interstitial lung disease was considered to be disabling.
Age: 68.0
Sex: F
Vaccine: PPV, PNC13
Symptoms: Blood pressure increased, Cardiac discomfort, Diplopia, Fatigue, Feeling abnormal
Clinical narrative: Pt reported began having reaction about 16 hours after vaccine. She noted symptoms of hallucination and took a Seroquel tablet. Also described feeling of pain in her arm that felt like acid running through her arm to her chest that made her have a panic attack. Began having vision changes and felt like pulse elevated after the panic set in. Also reported feeling of throat swelling, runny nose, migraine, and "flu-like" symptoms of fever and chills. She called the nurse line for her insurance who assisted her in contacting the on call physician for her PCP. On call provider recommended she take Benadryl. Unclear if pt took Benadryl. Patient proceeded to urgent care 22 hours after vaccine. Flu test was negative. Pt declined any lab tests. Provider did note a heart murmur that patient has previously been diagnosed with - mid systolic click per pt report - but pt declined EKG. Urgent care administered steroid shot per patient report. Patient visited her Primary care doctor on Monday, 1.6 at 4pm, due to ongoing symptoms that may or may not be related to vaccine. MD again tested for flu. Pt declined any lab tests again. Pt reported her physician gave her another steroid shot. Patient contacted pharmacy on Tuesday 1.7 to report reaction. She did not report any specific injection site reaction except for some bruising at the site that is improved.