chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Herpes zoster, Pyrexia, Rash, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 75-year-old female patient who received SHINGRIX (batch number 9NJ59, expiry date 8th February 2021) for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. Concurrent medical conditions included thrombophilia (latent factor five disorder). Concomitant products included warfarin sodium (Warfarin). On 10th August 2018, the patient received the 1st dose of SHINGRIX. In October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 13th August 2018, 3 days after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced rash. On 3rd December 2018, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced fatigue and fever. The patient was treated with cortisone (non-proprietary) (Cortisone Cream) and antivirals for systemic use (Antiviral). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, rash, fatigue and fever were recovered/resolved. It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to SHINGRIX. It was unknown if the reporter considered the vaccination failure, shingles, fatigue and fever to be related to SHINGRIX. Additional details were received as follows: The patient experienced a rash on her face which was treated with cortisone cream and it resolved in a week. After 2nd dose of SHINGRIX, the patient experienced fatigue and fever of 103 degrees F which resolved. On 3rd December 2018, the patient was diagnosed with shingles outbreak on her right shoulder area and close region on trunk to that shoulder. The patient was seen by dermatologist and diagnosed shingles and given antiviral to treat and it cleared up in 2 weeks. The patient provided lot number or expiration for the first dose of SHINGRIX. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 80-year-old male patient who received SHINGRIX for prophylaxis. On 18th December 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not 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, however it could be 79 or 80 years old. The patient received the vaccine in the unknown deltoid. The healthcare professional reported that on 3rd January 2019, the patient stated that the injection site still had soreness in the shoulder.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Insomnia, Loss of personal independence in daily activities
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 71-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included Flu vaccine (received on an unknown date). On 4th January 2019 09:30, the patient received the 1st dose of SHINGRIX (intramuscular). On 4th January 2019, unknown after receiving SHINGRIX, the patient experienced vaccine administered at inappropriate site. On 4th January 2019 16:00, the patient experienced joint pain, injected limb mobility decreased, injection site pain, rotator cuff injury and muscle pain. The patient was treated with TYLENOL EXTRA STRENGTH. On an unknown date, the outcome of the joint pain and injected limb mobility decreased were not recovered/not resolved and the outcome of the injection site pain, rotator cuff injury, muscle pain and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the joint pain, injected limb mobility decreased, injection site pain, rotator cuff injury and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX on 4th January 2019 around 9:30 AM and around 4:00 - 5:00 PM, the patient experienced joint pain, injection site soreness and movement of left arm was inhibited. The patient claims that the pain is not normal muscle pain from an immunization injection. The pain has moved to her left pectoral muscle above her left breast. The described the pain as similar to a rotator cuff injury in the joint. The patient received sleep aid medication. The patient can move her arm with less pain after receiving TYLENOL EXTRA STRENGTH. The patient was concerned that the pharmacy administered the vaccine too high in her deltoid or in the joint. The patient had to take some medication to help her sleep because she couldn't move and she wants to go back to playing yoga and tennis because she is a very active senior.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain, Product administered at inappropriate site, Rotator cuff syndrome
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 71-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included Flu vaccine (received on an unknown date). On 4th January 2019 09:30, the patient received the 1st dose of SHINGRIX (intramuscular). On 4th January 2019, unknown after receiving SHINGRIX, the patient experienced vaccine administered at inappropriate site. On 4th January 2019 16:00, the patient experienced joint pain, injected limb mobility decreased, injection site pain, rotator cuff injury and muscle pain. The patient was treated with TYLENOL EXTRA STRENGTH. On an unknown date, the outcome of the joint pain and injected limb mobility decreased were not recovered/not resolved and the outcome of the injection site pain, rotator cuff injury, muscle pain and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the joint pain, injected limb mobility decreased, injection site pain, rotator cuff injury and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX on 4th January 2019 around 9:30 AM and around 4:00 - 5:00 PM, the patient experienced joint pain, injection site soreness and movement of left arm was inhibited. The patient claims that the pain is not normal muscle pain from an immunization injection. The pain has moved to her left pectoral muscle above her left breast. The described the pain as similar to a rotator cuff injury in the joint. The patient received sleep aid medication. The patient can move her arm with less pain after receiving TYLENOL EXTRA STRENGTH. The patient was concerned that the pharmacy administered the vaccine too high in her deltoid or in the joint. The patient had to take some medication to help her sleep because she couldn't move and she wants to go back to playing yoga and tennis because she is a very active senior.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 73-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. In July 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, 1 day after receiving SHINGRIX, the patient experienced fatigue, chills and pain in arm. On an unknown date, the outcome of the fatigue, chills and pain in arm were recovered/resolved. It was unknown if the reporter considered the fatigue, chills and pain in arm to be related to SHINGRIX. Additional details were provided as follows: This case was reported by patient's wife. The patient received the 2nd shot of the SHINGRIX vaccine in left arm and experienced chills, fatigue and soreness in the arm. The fatigue lasted for about 1 to 2 days, and he was in bed all day. The chills and arm soreness lasted for about 24 hours. The reporter gave consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal pain, Diarrhoea, Nausea
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of diarrhea in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patients received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patients experienced diarrhea, nausea and abdominal pain. On an unknown date, the outcome of the diarrhea, nausea and abdominal pain were unknown. It was unknown if the reporter considered the diarrhea, nausea and abdominal pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable. Age group was not reported but was captured as adult as per vaccine indication. The nurse stated that they had a lot of patients who experienced gastrointestinal symptoms such as diarrhea, nausea and abdominal pain after vaccination with SHINGRIX. The reporter had not consent to follow up.
Sex: F
Vaccine: PNC13
Symptoms: Headache, Pain
Clinical narrative: This is a spontaneous report from a contactable physician calling on behalf of his wife (patient). A female patient of an unspecified age and ethnicity received PREVNAR 13 via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. About 5 days after the injection she started getting pain which had a trigger point, it was a headache and it was a trigger point on the side of her face, on her scalp. The reporter stated that in reading about on the web regarding side effect, headache is fairly common side effect, she was having severe lancinating pain on an unspecified date. The outcome of the event was unknown. The reporter stated that next step was to go to a neurologist.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis, Herpes zoster
Clinical narrative: Patient reported on 1/10/2019 a minor case of shingles behind her left ear and also Bell's palsy on the left side of her face which lasted 5 weeks.
Age: 26.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness (L) side of face, tingling (L) pinky finger.
Sex: F
Vaccine: FLU4
Symptoms: Dysphagia, Paraesthesia oral, Sensation of foreign body
Clinical narrative: Tingling in mouth, difficulty swallowing, felt like a lump in my throat.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient had a rash on the whole arm lasting 3-4 weeks post vaccination.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia, Nausea, Pyrexia
Clinical narrative: Patient  states as soon as she left the office on 12/31/18 she started having chills, low grade fever, very fatigued, slight nausea x 48 hours. Pt also reports her skin feeling burning and muscle pain when having any pressure applied. Pt states this side effect is still going on and has been causing her to lose sleep.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin burning sensation
Clinical narrative: Patient  states as soon as she left the office on 12/31/18 she started having chills, low grade fever, very fatigued, slight nausea x 48 hours. Pt also reports her skin feeling burning and muscle pain when having any pressure applied. Pt states this side effect is still going on and has been causing her to lose sleep.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, HPV9, RV5, DTAPHEPBIP, HIBV, HPV9, RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: None yet. HPV vaccine was just given today.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site nodule, Injection site warmth
Clinical narrative: Pt received vaccines 12/31/18. 1 week after administration mom noted red area with lump to left upper lateral thigh. In office for assessment 01/10/19. Noting red area 1 x 3 cm, hard knot, slight warmth to skin. No blisters or open areas noted. Mom denies bothering pt. Mom denies pt bothering area.  Treatment is observation.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: After 2 hours post injection to Left arm, parents noticed swelling, redness, and painful area on the Left deltoid area.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Injection site erythema, Injection site warmth, Pruritus generalised, Rash
Clinical narrative: Rash/hives with swelling and redness on right side of face, and right orbit. Redness and warmth at injection site for first 48 hours after injection. Generalized itching to her back and face.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Swelling face, Urticaria
Clinical narrative: Rash/hives with swelling and redness on right side of face, and right orbit. Redness and warmth at injection site for first 48 hours after injection. Generalized itching to her back and face.
Age: 94.0
Sex: F
Vaccine: PNC13
Symptoms: Wrong product administered
Clinical narrative: Resident received PCV13 05/26/2015. Resident should have received PPSV23 on 12/17/2018; a second PCV13 was given on 12/17/2018. No injury apparent.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache
Clinical narrative: Mild headache and shivers.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Patient broke out with 2 spots that acted and looked like shingles according to the patient. She applied a soy shingle relief product that she bought at the fair and the spots went away.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Due to language barrier and lag in HL7, patient received a High Dose flu vaccine at a walk-in clinic on 01/04/19 at approximately 9:20AM. After leaving the walk-in clinic patient  went to the pharmacy and requested a flu vaccine. When pharmacist checked LINKS there was no record of any vaccines given on 01/04/19. Pharmacist and PharmD proceeded per protocol and vaccinated patient with the requested flu vaccine. When pharmacist went to enter vaccine in to LINKS at approximately 9:50am on 01/04/19 LINKS would not accept the vaccine given at the pharmacy due to same vaccine group given on same day.  Patient, husband, and daughter, per HIPAA, contacted and were made aware. Daughter reports patient is doing fine with no signs or symptoms noted.
Age: 19.0
Sex: F
Vaccine: FLU4, VARCEL
Symptoms: Erythema, Pain, Skin irritation, Swelling, Tenderness
Clinical narrative: Redness, mild swelling, tenderness. PCP- NP reviewed and assessed patient, advised patient to use cold moist cloth to ease the irritation and pain, or take Tylenol for the pain as needed, f/u if needed if symptoms getting worse.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Shot was given 1-7-19 in the evening pt woke up at 5 am with aches, and chills had to stay in bed - then had high fever symptoms lasted about 24 hours.
Age: 14.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Adult Hep A given instead of pediatric.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 04-JAN-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 01-JAN-2015, a healthcare provider at a community health center administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On or about 02-AUG-2016, the patient was treated by a healthcare provider at a community health center for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is not recovered. The causality of the events is related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 04-JAN-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2015, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. In 2016, the patient was treated by a physician at a clinic for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is not recovered. The causality of the events is related. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Body temperature increased, Erythema
Clinical narrative: 12/29 red spots showed up on forehead. Low grade temp not exceeding 100.4 started 12/27 and resolved by 12/29. No rash. Injection site WNL. Stooling and Voiding WNL. PO WNL.
Age: 1.25
Sex: F
Vaccine: DTAP, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: LT thigh redness, area was hard. Slight swelling.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Starting (1/08/19), started with redness, swelling, tenderness, pruritis, surrounding injection site in L arm s/p vaccines. Received 11 year old vaccines on 1/08/19. No fevers, has no change in ROM. No shortness of breath, cough. Received MC4 and Tdap in the same location (L upper extremity) and HPV on the (R)-Has had no signs of anaphylaxis. Avoid touching, scratching affected area-OK to use cool compresses-Take antihistamine as prescribed for itching-F/U in 2 days to ensure improvement of symptoms-Education: Education provided considers health literacy level. Patient/caregiver states/demonstrates understanding of the assessment, plan and health education provided. He is to schedule a follow-up visit for Recheck/Follow-Up 2  Days.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Malaise, Pyrexia
Clinical narrative: Flu-like symptoms, fever, malaise, fatigue.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Orthopaedic examination abnormal, Pain, Rotator cuff syndrome, Tenderness
Clinical narrative: Persistent right shoulder pain since receiving FLULAVAL immunization in right deltoid. Pain is worse at night and with raising arm in front. During exam, pt exhibited tenderness in the biceps tendon, anterior/lateral shoulder over deltoid. Positive NEER test. Diagnosis: impingement syndrome of right shoulder. Pt/caregiver to use ice, ibuprofen and stretches/exercises. Pt declined PT referral at this time. Due to timing and location, MD thinks tendinitis is due to adverse vaccine reaction.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Tendonitis, Vaccination complication
Clinical narrative: Persistent right shoulder pain since receiving FLULAVAL immunization in right deltoid. Pain is worse at night and with raising arm in front. During exam, pt exhibited tenderness in the biceps tendon, anterior/lateral shoulder over deltoid. Positive NEER test. Diagnosis: impingement syndrome of right shoulder. Pt/caregiver to use ice, ibuprofen and stretches/exercises. Pt declined PT referral at this time. Due to timing and location, MD thinks tendinitis is due to adverse vaccine reaction.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Mass, Pain, Pruritus
Clinical narrative: Blisters and itching on fingers on the hand of the arm that received the vaccine. She also stated she had multiple red lumps on the arm and intense pain. Pain started the day of vaccine, red lumps, itching and blisters night of 1/9.
Age: 84.0
Sex: M
Vaccine: FLUA3
Symptoms: Chest pain, Dyspnoea
Clinical narrative: Shortness of breath, chest pain; with the symptoms patient tried antihistamine medication and they are relieved in 3 days.
Age: 81.0
Sex: F
Vaccine: FLUA3
Symptoms: Lethargy, Somnolence
Clinical narrative: Lethargic, Sleepy: patient tried antihistamine drugs to relieve symptoms and has been resolved after 2 days.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Haematochezia, Occult blood positive, Rotavirus test positive
Clinical narrative: Bloody stools about 3-4 weeks after vaccine. Stool sample taken and submitted for testing. Tested positive for rotavirus.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Urticaria
Clinical narrative: The night after getting the flu shot, patient developed a head ache  and started getting hives. The hives went away and then came back again on Monday and lasted until Wednesday. Patient took Benadryl and is getting better.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient presents to clinic with redened area surrounding puncture site approximately 4cm x 6 cm no edema. Patient states that it is itchy and if she itches it, then it gets really red. Denies pain or limited arm movement. Patient instructed to monitor site for continued healing. Educated on signs of infection such as increased redness/swelling/fever. Instructed patient to see PCP if any of the symptoms occur.
Age: 6.0
Sex: M
Vaccine: DTAPHEPBIP, MMR
Symptoms: Expired product administered
Clinical narrative: The MMR vaccine had expiration date of 11/14/2018. The MMR was given on 11/27/2018. The MA that gave the vaccine only looked at the month and year of expiration and did not realize the vaccine had expired.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Pain in extremity
Clinical narrative: Patient complaining of body aches, redness and sore arm 4 days post injection. Client states she took ADVIL for pain and states it has not gotten any worse but she is still very sore and red. Client will follow up with primary care if symptoms continue.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypersensitivity, Laboratory test, Pruritus generalised, Rash generalised, Vaccination complication
Clinical narrative: The night of the vaccine, patient said, he was itchy all over his body, but stopped the next day. He does not recall any other symptoms. However, on Wednesday 1/9/2019, he said, he got out of the shower, and noticed rashes all over his body. He did mention that he used a new Aveeno bar soap that morning. He went to an allergist that day, and allergist told him he doesn't think it's from the new Aveeno bar soap, and it's an allergic reaction to the SHINGRIX (second dose).
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Middle insomnia, Pain in extremity
Clinical narrative: Patient reports that she woke up in the middle of the night after the shot with severe pain in her arm.
Age: 78.0
Sex: U
Vaccine: VARZOS
Symptoms: Blindness unilateral, Eye patch application, Impaired driving ability, Optic ischaemic neuropathy, Retinal artery occlusion
Clinical narrative: This case was reported by a consumer and described the occurrence of retinal artery occlusion in a elderly patient who received SHINGRIX for prophylaxis. The patient's past medical history included cataract operation (In 2015) and ophthalmic herpes zoster (In 2015, four days later after cataract operation patient developed Shingles in that eye.). Previously administered products included ZOSTAVAX, Prednisone and Acylovir. In October 2018, the patient received the 1st dose of SHINGRIX. In November 2018, less than a month after receiving SHINGRIX, the patient experienced retinal artery occlusion (serious criteria GSK medically significant), retinal vein occlusion (serious criteria GSK medically significant), loss of vision (serious criteria GSK medically significant) and anterior ischemic optic neuropathy (serious criteria GSK medically significant). The patient was treated with acyclovir, medication unknown (Patch) and prednisone. On an unknown date, the outcome of the retinal artery occlusion, retinal vein occlusion, loss of vision and anterior ischemic optic neuropathy were unknown. It was unknown if the reporter considered the retinal artery occlusion, retinal vein occlusion, loss of vision and anterior ischemic optic neuropathy to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not provided however, it could be 77 or 78 years. The patient had 2 prior cases of Shingles before starting SHINGRIX. Earlier patient treated her shingles with old Shingles vaccine ZOSTAVAX and was treated with Prednisone and Acylovir. In late October 2018, the patient received new Shingles vaccine SHINGRIX and in mid November 2018, the patient had venous and arterial occlusion in the retina of that eye. The patient have no vision in that eye and worded an eye patch. The patient has lost vision in her right eye therefore cannot drive anymore. They has gone to retina specialists and were told that it was an eye stroke due to age. The patient was aware that the two Shingles vaccines were very different. The patient wanted to question that, was there any indication of interaction between SHINGRIX and the Prednisone and Acylovir that she was still being treated with. The patient's internet searches stated that the SHINGRIX interaction data base was incomplete at the time of reporting. The physician contact information was not provided.
Age: 78.0
Sex: U
Vaccine: VARZOS
Symptoms: Retinal vein occlusion
Clinical narrative: This case was reported by a consumer and described the occurrence of retinal artery occlusion in a elderly patient who received SHINGRIX for prophylaxis. The patient's past medical history included cataract operation (In 2015) and ophthalmic herpes zoster (In 2015, four days later after cataract operation patient developed Shingles in that eye.). Previously administered products included ZOSTAVAX, Prednisone and Acylovir. In October 2018, the patient received the 1st dose of SHINGRIX. In November 2018, less than a month after receiving SHINGRIX, the patient experienced retinal artery occlusion (serious criteria GSK medically significant), retinal vein occlusion (serious criteria GSK medically significant), loss of vision (serious criteria GSK medically significant) and anterior ischemic optic neuropathy (serious criteria GSK medically significant). The patient was treated with acyclovir, medication unknown (Patch) and prednisone. On an unknown date, the outcome of the retinal artery occlusion, retinal vein occlusion, loss of vision and anterior ischemic optic neuropathy were unknown. It was unknown if the reporter considered the retinal artery occlusion, retinal vein occlusion, loss of vision and anterior ischemic optic neuropathy to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not provided however, it could be 77 or 78 years. The patient had 2 prior cases of Shingles before starting SHINGRIX. Earlier patient treated her shingles with old Shingles vaccine ZOSTAVAX and was treated with Prednisone and Acylovir. In late October 2018, the patient received new Shingles vaccine SHINGRIX and in mid November 2018, the patient had venous and arterial occlusion in the retina of that eye. The patient have no vision in that eye and worded an eye patch. The patient has lost vision in her right eye therefore cannot drive anymore. They has gone to retina specialists and were told that it was an eye stroke due to age. The patient was aware that the two Shingles vaccines were very different. The patient wanted to question that, was there any indication of interaction between SHINGRIX and the Prednisone and Acylovir that she was still being treated with. The patient's internet searches stated that the SHINGRIX interaction data base was incomplete at the time of reporting. The physician contact information was not provided.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Fatigue, Pyrexia
Clinical narrative: Fever/chills, severe diarrhea, tiredness for four days.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Apnoea, Bradycardia, Continuous positive airway pressure, Cyanosis, Haematocrit decreased
Clinical narrative: Event: 60 second cluster of apnea and periodic breathing episode, bradycardia rate 59 for 210 seconds, SpO2 less than 20, color change (pale, dusky, circumoral cyanosis). Treatment: Moderate stimulation, nasal CPAP, positive pressure ventilation, increased oxygen, airway clearance, gave PRBC transfusion after event on 1/9/2019 at 16:30 (Hct=27 on 1/7/2019). Outcome: patient recovered and off oxygen, continued existing hospitalization.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Packed red blood cell transfusion, Pallor, Respiration abnormal, Skin discolouration
Clinical narrative: Event: 60 second cluster of apnea and periodic breathing episode, bradycardia rate 59 for 210 seconds, SpO2 less than 20, color change (pale, dusky, circumoral cyanosis). Treatment: Moderate stimulation, nasal CPAP, positive pressure ventilation, increased oxygen, airway clearance, gave PRBC transfusion after event on 1/9/2019 at 16:30 (Hct=27 on 1/7/2019). Outcome: patient recovered and off oxygen, continued existing hospitalization.
Age: 76.0
Sex: F
Vaccine: YF
Symptoms: Abdominal pain lower, Appendicitis, Computerised tomogram abdomen abnormal, Computerised tomogram pelvis abnormal, Pathology test
Clinical narrative: The patient describes a fever which began a day or two after the vaccination, this gradually improved and as it was disappearing on about 1/4/2019 she began getting intermittent abdominal pain, localized to the RLQ. Overnight on 1/8/2019-1/9/2019 the pain became steady, and then worsened. I am an Emergency Physician, she presented to me in the E.R.  in the afternoon of 1/9/2019 with acute appendicitis.
Age: 76.0
Sex: F
Vaccine: YF
Symptoms: Pyrexia, Scan with contrast abnormal, White blood cell count increased
Clinical narrative: The patient describes a fever which began a day or two after the vaccination, this gradually improved and as it was disappearing on about 1/4/2019 she began getting intermittent abdominal pain, localized to the RLQ. Overnight on 1/8/2019-1/9/2019 the pain became steady, and then worsened. I am an Emergency Physician, she presented to me in the E.R.  in the afternoon of 1/9/2019 with acute appendicitis.
Age: 23.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Persistent swelling, redness and pain on left arm (site of injections) for 2 weeks following visit on 11/28/2018. Resolved spontaneously.
Age: 15.0
Sex: F
Vaccine: FLU4, HPV9, FLU4, HPV9
Symptoms: Loss of consciousness, Neurological examination normal, Pallor, Syncope
Clinical narrative: Patient gradually fainted from one chair to other chair and head down first after injection of immunization. Patient regain consciousness about 1 to 2 minutes after doctor went to patient's room. Facial color from pale to pink about 1 to 2 minutes. Patient has normal conversation with doctor and family after regain consciousness. BP 110/70 and HR 88. Neurological exam normal.
Age: 15.0
Sex: F
Vaccine: FLU4, HPV9, FLU4, HPV9
Symptoms: Head injury, Loss of consciousness, Neurological examination normal, Pallor, Syncope
Clinical narrative: Patient gradually fainted from one chair to other chair and head down first after injection of immunization. Patient regain consciousness about 1 to 2 minutes after doctor went to patient's room. Facial color from pale to pink about 1 to 2 minutes. Patient has normal conversation with doctor and family after regain consciousness. BP 110/70 and HR 88. Neurological exam normal.
Age: 53.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Condition aggravated, Eczema, Periorbital oedema, Swelling face
Clinical narrative: Periorbital edema, facial swelling, joint pain and flare of eczema on upper and lower eye lids. Over the counter Zyrtec, cool compress.
Age: 55.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site bruising, Injection site swelling, Swelling
Clinical narrative: Pt had a bruise and some swelling at site, however patient also had swelling in the neck far away from vaccine site on the same side of body.
Age: 55.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site discolouration, Pain in extremity, Swelling
Clinical narrative: Pt had a bruise and some swelling at site, however patient also had swelling in the neck far away from vaccine site on the same side of body.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Biopsy skin, Burning sensation, Lymphadenopathy, Pruritus, Rash
Clinical narrative: She noticed an increase every day of a burning sensation happening in rectum 24 hours a day and then lymph nodes in neck were swollen and then many bumps came out in the entire neck area as well as the entire scalp area along with itching in the stomach area. Had a biopsy but they diagnosed her with an explosion of hives.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Stool analysis, Urticaria
Clinical narrative: She noticed an increase every day of a burning sensation happening in rectum 24 hours a day and then lymph nodes in neck were swollen and then many bumps came out in the entire neck area as well as the entire scalp area along with itching in the stomach area. Had a biopsy but they diagnosed her with an explosion of hives.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anorectal discomfort, Condition aggravated, Discomfort, Insomnia, Lymphadenopathy
Clinical narrative: She noticed an increase every day of a burning sensation happening in rectum 24 hours a day and then lymph nodes in neck were swollen and then many bumps came out in the entire neck area as well as the entire scalp area along with itching in the stomach area. Had a biopsy but they diagnosed her with an explosion of hives.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Urticaria
Clinical narrative: She noticed an increase every day of a burning sensation happening in rectum 24 hours a day and then lymph nodes in neck were swollen and then many bumps came out in the entire neck area as well as the entire scalp area along with itching in the stomach area. Had a biopsy but they diagnosed her with an explosion of hives.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Bedridden, Dizziness, Headache, Pain, Pyrexia
Clinical narrative: High fever (104F), extreme body aches, headache, raw mouth, dizziness, bedridden.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Stomatitis
Clinical narrative: High fever (104F), extreme body aches, headache, raw mouth, dizziness, bedridden.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Influenza like illness, Injection site pain
Clinical narrative: Pain at injection site the next day. Headache, tired, feel like I'm getting the flu.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Dysstasia, Fatigue, Insomnia
Clinical narrative: I had chills, fever and muscle aches and pains during the night. I got up at 2:30 am and used the bathroom and walked in the house without any problems. At 6:15 am I got up because sleeping I was having difficulty sleeping. I went to the bathroom and after urinating I became extremely fatigued, lightheaded and was unable to stand up. I eased my self to the floor laid there for several minutes. I tried to get up I must of passed out because when I was able to get up off the floor I had a bump on the back of my head. To the best of my knowledge I was only unconscious for a very brief time. I believe the whole episode was < 5 min.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of consciousness, Myalgia, Pyrexia, Swelling
Clinical narrative: I had chills, fever and muscle aches and pains during the night. I got up at 2:30 am and used the bathroom and walked in the house without any problems. At 6:15 am I got up because sleeping I was having difficulty sleeping. I went to the bathroom and after urinating I became extremely fatigued, lightheaded and was unable to stand up. I eased my self to the floor laid there for several minutes. I tried to get up I must of passed out because when I was able to get up off the floor I had a bump on the back of my head. To the best of my knowledge I was only unconscious for a very brief time. I believe the whole episode was < 5 min.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Feeling abnormal, Head banging, Influenza like illness, Injection site erythema
Clinical narrative: Patient reported flu-like symptoms the day after the vaccine - headache, lightheaded, and nausea. Also said had injection site reaction of redness, swollen, and hot to the touch. Rash still present as of 1/10/19 when patient reported event, but stated that it had decreased in size and swelling had also decreased. Patient did not have to make a doctor's visit as of 1/10/19 when adverse reaction was reported, but did have to stay home from work for 2 days because she felt so bad.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Loss of personal independence in daily activities, Nausea, Rash
Clinical narrative: Patient reported flu-like symptoms the day after the vaccine - headache, lightheaded, and nausea. Also said had injection site reaction of redness, swollen, and hot to the touch. Rash still present as of 1/10/19 when patient reported event, but stated that it had decreased in size and swelling had also decreased. Patient did not have to make a doctor's visit as of 1/10/19 when adverse reaction was reported, but did have to stay home from work for 2 days because she felt so bad.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Sore Muscles, High Fever, Chills occurred roughly 12 hours after injection. Lasted roughly 9 hours. Resolved within 24 hours of initial injection.
Age: 11.0
Sex: M
Vaccine: UNK
Symptoms: Presyncope
Clinical narrative: Patient had a vasovagal reaction after HPV vaccine reaction.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea
Clinical narrative: Patient said 4 to 5 months after getting vaccination she started having trouble with her breathing and started oxygen--she thinks the vaccination is the cause of this.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pallor
Clinical narrative: With 3-5 minutes of receiving the above vaccinations, my baby became extremely pale.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Headache, Hypoaesthesia, Limb mass, Skin warm
Clinical narrative: Right arm was hot, red, numb, it also had a small soft lump, Also some facial swelling with a headache. Jan10, arm is much better swelling, redness, lump have gone down considerably. She did not go to her doctor. All resolved on its own.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Swelling face
Clinical narrative: Right arm was hot, red, numb, it also had a small soft lump, Also some facial swelling with a headache. Jan10, arm is much better swelling, redness, lump have gone down considerably. She did not go to her doctor. All resolved on its own.
Age: 52.0
Sex: M
Vaccine: FLU4, PPV, VARZOS
Symptoms: Hypotension, Injection site pain, Pyrexia, Syncope, Ultrasound scan normal
Clinical narrative: Hypotension, syncope, fever, presented to emergency department and then admitted for IVFs and continued monitoring. Patient's BP improved, fever controlled with Tylenol. In addition, exquisitely painful right deltoid, bedside ultrasound did not show signs of abscess or cellulitis.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Death, Pain in extremity
Clinical narrative: On Monday 1/7 my mother had her yearly physical and reported everything was fine and she was in good health. This was confirmed by the physician's assistant. My mother reported getting the PNEUMOVAX 23 vaccine at pharmacy around 12:30 p.m. on 1/9/2019. That evening at 6:25 she sent a text message saying "my right arm is achy from my pneumonia shot and I'm getting chills. I'll go home and take Tylenol."  Then at 7:11 p.m. she reported "I am lying down at home."  This was her last communication. The next morning she was found dead. THIS MUST BE INVESTIGATED IMMEDIATELY IN CASE THERE IS A BROADER ISSUE WITH THIS VACCINE LOT.
Age: 14.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Ear pruritus, Erythema, Feeling hot, Flushing, Presyncope
Clinical narrative: Patient was asked to wait 15min in office after immunization as per office policy with HPV vaccination. She has not had prior issues with HPV #1 or with prior annual influenza immunizations. She had a presyncopal episode but also had a blood draw at this time. She went home and approximately 12hr later she began having a feeling of her face being warm, facial flushing, flushing spread to neck and ears and the face/neck/ears became pruritic. This morning she woke up and it was even more swollen, especially just below her eyes. No medications administered by family and when I evaluated her she had pink face, slightly swollen and erythematous pinna bilaterally, and a mild pink coloring to her neck and upper chest/shoulders. She denied headache, vomiting, diarrhea, difficulty breathing, feeling like her throat was closing. No other rash elsewhere on the body. No hives. BENADRYL 25mg was administered in clinic and patient was sent home. Patient denies new soaps, makeup, facial products. She washed her face with water before the symptoms started.
Age: 14.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Pruritus, Swelling face
Clinical narrative: Patient was asked to wait 15min in office after immunization as per office policy with HPV vaccination. She has not had prior issues with HPV #1 or with prior annual influenza immunizations. She had a presyncopal episode but also had a blood draw at this time. She went home and approximately 12hr later she began having a feeling of her face being warm, facial flushing, flushing spread to neck and ears and the face/neck/ears became pruritic. This morning she woke up and it was even more swollen, especially just below her eyes. No medications administered by family and when I evaluated her she had pink face, slightly swollen and erythematous pinna bilaterally, and a mild pink coloring to her neck and upper chest/shoulders. She denied headache, vomiting, diarrhea, difficulty breathing, feeling like her throat was closing. No other rash elsewhere on the body. No hives. BENADRYL 25mg was administered in clinic and patient was sent home. Patient denies new soaps, makeup, facial products. She washed her face with water before the symptoms started.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities, Musculoskeletal pain
Clinical narrative: Immediately felt pain when I received the injection, and was unable to lift that arm or have normal range of motion. Continued to get worse and now unable to sleep on that side. Shoulder continues to be more painful and I am unable to continue my exercise classes as I am unable to lift my arm with any weight. After 8 weeks it has not gotten any better and is life altering. Contacted PCP who recommended heat 3 times a day for minutes. Went to Express Care on 12/14/18. Attending physician asst. felt swelling and scheduled an ultrasound.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Sleep disorder, Ultrasound scan abnormal
Clinical narrative: Immediately felt pain when I received the injection, and was unable to lift that arm or have normal range of motion. Continued to get worse and now unable to sleep on that side. Shoulder continues to be more painful and I am unable to continue my exercise classes as I am unable to lift my arm with any weight. After 8 weeks it has not gotten any better and is life altering. Contacted PCP who recommended heat 3 times a day for minutes. Went to Express Care on 12/14/18. Attending physician asst. felt swelling and scheduled an ultrasound.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Abdominal pain, Diarrhoea, Injection site induration, Injection site swelling, Rash
Clinical narrative: Stomach rash, diarrhea, abdominal pain, and hard bump at injection spot. Diarrhea lasted 6 days, rash lasted 2 days, stomach pain lasted 1-2 days, and injection site is still present.
Age: 49.0
Sex: F
Vaccine: HEPA
Symptoms: Lip swelling, Swollen tongue, Urticaria
Clinical narrative: Hives, tongue swelling lip swelling. Lasted approximately 12 hrs- Improved with BENADRYL.
Age: 1.33
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Rash, Urticaria
Clinical narrative: Got shots yesterday morning, this morning mom noticed rash on back, gave a bath, got worse, spreading. By the time I saw him in the afternoon, 1/10/19-still some urticarial with back, monitor rash on face.
Age: 39.0
Sex: M
Vaccine: HEPA
Symptoms: Diarrhoea, Dizziness, Headache, Injection site pain
Clinical narrative: Patient was administered the HAVRIX at approximately 16:30 on 1/9/19 without apparent complications. Patient called approximately 3 hours later at 19:30 stating he was feeling light headed along with Inj. site soreness. Called patient at approx. 10 - 1/10/19 - pt. stated was feeling fine. Patient called back at approximately 19:30 stated some pain has intensified along with a headache since late 1/9/19 night. has also been experiencing diarrhea.
Age: 36.0
Sex: M
Vaccine: ANTH, HEP, TYP
Symptoms: Adverse reaction, Arthralgia, Arthritis, Arthropathy, Burning sensation
Clinical narrative: Severe reaction. Swelling, redness, pain, burning, hot to touch - within weeks, ligament, tendon, joint pain and inflammation. Continues to this day.
Age: 36.0
Sex: M
Vaccine: ANTH, HEP, TYP
Symptoms: Erythema, Ligament pain, Ligamentitis, Pain, Skin warm
Clinical narrative: Severe reaction. Swelling, redness, pain, burning, hot to touch - within weeks, ligament, tendon, joint pain and inflammation. Continues to this day.