chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Injection site pain, Nausea
Clinical narrative: Headache, body aches, chills, nausea, sore arm at site of injection - all started around 10 hours after shot. This was 2nd dose - I had no adverse reaction to first dose except for some soreness and redness on arm. This feels like I have the flu.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Headache, body aches, chills, nausea, sore arm at site of injection - all started around 10 hours after shot. This was 2nd dose - I had no adverse reaction to first dose except for some soreness and redness on arm. This feels like I have the flu.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Cough, Fatigue, Myalgia, Pain
Clinical narrative: First was extreme muscle pain in injection arm a few hours after shot. Extreme fatigue and in bed at 6:00 PM that day. Continued pain and weakness and fatigue on the second day. By evening of second day (today) I have developed a chest cough. I did call the doctor the first day and they told me to use a warm compress. When I do that it does help but the fatigue is still there and extreme.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site inflammation, Injection site paraesthesia, Injection site pruritus, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Patient said day after shots she felt tingling/itching at the sites of injection then had shooting electric-like sensations shooting up and down her arms sporadically. The next morning she had muscle stiffness that made it difficult for her to get out of bed. She says she had to lift her legs out. She also started to get an expanding area of inflammation around her left arm (SHINGRIX shot) that she monitored with a sharpie. By the weekend she said she was much improved and was fine.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Paraesthesia
Clinical narrative: Patient said day after shots she felt tingling/itching at the sites of injection then had shooting electric-like sensations shooting up and down her arms sporadically. The next morning she had muscle stiffness that made it difficult for her to get out of bed. She says she had to lift her legs out. She also started to get an expanding area of inflammation around her left arm (SHINGRIX shot) that she monitored with a sharpie. By the weekend she said she was much improved and was fine.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Erythema, Fatigue, Nausea
Clinical narrative: 8:00 pm on the day of vaccine I started getting the chills and having some body aches and queasy stomach. During the night my arms started hurting a lot with pain all the way up into the side of my neck. Took 1 tablet ALEVE during the night. The following day I had chills, body aches, no appetite and very sore arm. Stayed in bed and slept all day. Took ALEVE during the day, but it didn't really seem to help. The next day I felt better, less chills, fatigue and body aches.  Continued to take ALEVE twice a day. My arm continued to be very sore, itchy and felt like it had pins and needles in it. Continued to experience fatigue for up to a week after the vaccine. Four days after the vaccine, my arm continued to be red, swollen down to the elbow, and warm to the touch.  Made an appt to see the doctor. Saw the doctor not he 5th day after vaccine. Doctor suggested I take prescription strength of ALEVE..2 in am and pm. I also took some BENADRYL. This seemed to help. More then 1 week after shot my arm is not red or swollen, but it is tender to the touch in certain spots.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain, Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: 8:00 pm on the day of vaccine I started getting the chills and having some body aches and queasy stomach. During the night my arms started hurting a lot with pain all the way up into the side of my neck. Took 1 tablet ALEVE during the night. The following day I had chills, body aches, no appetite and very sore arm. Stayed in bed and slept all day. Took ALEVE during the day, but it didn't really seem to help. The next day I felt better, less chills, fatigue and body aches.  Continued to take ALEVE twice a day. My arm continued to be very sore, itchy and felt like it had pins and needles in it. Continued to experience fatigue for up to a week after the vaccine. Four days after the vaccine, my arm continued to be red, swollen down to the elbow, and warm to the touch.  Made an appt to see the doctor. Saw the doctor not he 5th day after vaccine. Doctor suggested I take prescription strength of ALEVE..2 in am and pm. I also took some BENADRYL. This seemed to help. More then 1 week after shot my arm is not red or swollen, but it is tender to the touch in certain spots.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Skin warm, Somnolence, Tenderness
Clinical narrative: 8:00 pm on the day of vaccine I started getting the chills and having some body aches and queasy stomach. During the night my arms started hurting a lot with pain all the way up into the side of my neck. Took 1 tablet ALEVE during the night. The following day I had chills, body aches, no appetite and very sore arm. Stayed in bed and slept all day. Took ALEVE during the day, but it didn't really seem to help. The next day I felt better, less chills, fatigue and body aches.  Continued to take ALEVE twice a day. My arm continued to be very sore, itchy and felt like it had pins and needles in it. Continued to experience fatigue for up to a week after the vaccine. Four days after the vaccine, my arm continued to be red, swollen down to the elbow, and warm to the touch.  Made an appt to see the doctor. Saw the doctor not he 5th day after vaccine. Doctor suggested I take prescription strength of ALEVE..2 in am and pm. I also took some BENADRYL. This seemed to help. More then 1 week after shot my arm is not red or swollen, but it is tender to the touch in certain spots.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Pain
Clinical narrative: It is 3 weeks past date of Tdap booster in left arm. Experiencing sharp pain, inability to raise left arm above head or cross over chest or push left elbow backward. Getting dressed/undressed is painful. Cannot sleep on left side.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Diarrhoea, Ear infection
Clinical narrative: Ear Infections every 4-6 weeks and diarrhea every 6 weeks.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Eczema, Food allergy, Fungal infection
Clinical narrative: Eczema rash on scalp, took him to the doctors and they said it was cradle cap. Went back another month and still had it on his scalp and doctor said it was a fungus infection. Then he got patches of eczema on his cheeks, went to a chiropractor who determined that he was probably allergic to wheat/gluten and dairy. We still have outbreaks of eczema on his cheeks and other body parts (arms, legs, stomach and buttocks) from dairy and wheat products.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Chlamydia test, Cold sweat, Dizziness, Dyspnoea, Flushing
Clinical narrative: Pt. present around 215p feeling SOB, clammy, dizzy. Pt mom stated that she would go cool/clammy/calm and then in the next few mins would be flushed and looking like she was going to Jump out of her skin. Vitals as followed temp 97.9, O2 99, P-83, BP 90/50. Dr. asked for Orthostatic BPs.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Neisseria test, Pregnancy test negative
Clinical narrative: Pt. present around 215p feeling SOB, clammy, dizzy. Pt mom stated that she would go cool/clammy/calm and then in the next few mins would be flushed and looking like she was going to Jump out of her skin. Vitals as followed temp 97.9, O2 99, P-83, BP 90/50. Dr. asked for Orthostatic BPs.
Age: 1.17
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: None stated.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Anxiety, Dizziness, Injection site erythema, Injection site warmth
Clinical narrative: Injection Rxn at lower left arm, not at injection site, redness, slight warmer temp at lower arm (above elbow), Pt felt dizzy and anxious. Was given Loratadine to Pt, instructed to take if feel any worse.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Local reaction
Clinical narrative: Severe local reaction.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Injection site reaction, Product complaint
Clinical narrative: Severe local reaction.
Age: 60.0
Sex: F
Vaccine: HEP
Symptoms: Eye pain, Headache, Pyrexia, Rash generalised, Rash pruritic
Clinical narrative: Pt received her third dose of Hep B vaccine on 3/1/19 and reported on 3/2/19 she woke up with a HA, eye pain and an itchy rash all over her body. Pt called her insurance nurse hotline and was advised to take BENADRYL and to go to an urgent care for further follow-up. Pt went to an urgent care clinic. Reports she had a low grade fever and was given an rx for steroids. Clinic RN spoke with pt on 3/4/19 at which time pt reported she was feeling better since starting the steroids and would contact clinic if her sx continue or worsen. PCP, Dr. informed. Patient is a 60 y.o. female. Patient has chronic depression with insomnia, COPD with asthma, hep C and GERD and chronic pain from osteoarthritis severe of the hip and knees.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Crying, Urticaria
Clinical narrative: 2 month old had been fine not crying or fussy after shots. Took a 30 minute nap at 3pm and woke up screaming not crying. Was unable to soothe or Calm baby after many different methods. Refused to eat. During the diaper change I noticed red raised hives from neck down to toe. They were worse on belly and back. I called the pediatrician and she said to give weight based BENADRYL every 6-8 hrs for the next 48 hrs. It did take that long to clear up.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Diet refusal, Emotional distress, Screaming, Urticaria
Clinical narrative: 2 month old had been fine not crying or fussy after shots. Took a 30 minute nap at 3pm and woke up screaming not crying. Was unable to soothe or Calm baby after many different methods. Refused to eat. During the diaper change I noticed red raised hives from neck down to toe. They were worse on belly and back. I called the pediatrician and she said to give weight based BENADRYL every 6-8 hrs for the next 48 hrs. It did take that long to clear up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Rash, Vaccination failure
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX and 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 and SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporting pharmacist was the patient who continued to have outbreaks after the completed series with SHINGRIX. The healthcare professional wanted more information on why it was not working for her as the patient. The patient asked for any information available. This case was considered as suspected vaccination failure case as the time to event onset and laboratory results were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX and 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 and SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporting pharmacist was the patient who continued to have outbreaks after the completed series with SHINGRIX. The healthcare professional wanted more information on why it was not working for her as the patient. The patient asked for any information available. This case was considered as suspected vaccination failure case as the time to event onset and laboratory results were unknown at the time of reporting.
Age: 74.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Immediate post-injection reaction, Influenza like illness, Injection site erythema, 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 74-year-old patient who received 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 product storage error. On an unknown date, the outcome of the product storage error was unknown. Additional details were provided as follows: The age at vaccination was not applicable, but age group was captured as adult as per indication for SHINGRIX vaccine. The SHINGRIX vaccine was stored in freezer which led to product storage error. Follow up information was received from pharmacist on 4th March 2019: The patient's demographic details were updated. The patient received 2nd dose of SHINGRIX on 1st March 2019. The patient experienced injection site pain immediately and was also feeling light headed rigth after SHINGRIX vaccination. The next day after vaccination, the patient experienced redness and soreness which resolved. At the time this report, the outcome of the injection site pain and light headed was unknown. It was unknown if the reporter considered the injection site pain, light headedness, erythema and pain to be related to SHINGRIX.
Age: 74.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Product storage error
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 74-year-old patient who received 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 product storage error. On an unknown date, the outcome of the product storage error was unknown. Additional details were provided as follows: The age at vaccination was not applicable, but age group was captured as adult as per indication for SHINGRIX vaccine. The SHINGRIX vaccine was stored in freezer which led to product storage error. Follow up information was received from pharmacist on 4th March 2019: The patient's demographic details were updated. The patient received 2nd dose of SHINGRIX on 1st March 2019. The patient experienced injection site pain immediately and was also feeling light headed rigth after SHINGRIX vaccination. The next day after vaccination, the patient experienced redness and soreness which resolved. At the time this report, the outcome of the injection site pain and light headed was unknown. It was unknown if the reporter considered the injection site pain, light headedness, erythema and pain to be related to SHINGRIX.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Muscular weakness, Pain
Clinical narrative: Extreme pain. Unable to lift left arm.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Pain
Clinical narrative: Extreme pain. Unable to lift left arm.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Confusional state, Cough, Fatigue, Increased viscosity of upper respiratory secretion, Lacrimation increased
Clinical narrative: Friday 8 am: Cough and runny nose. 11 am: Fever of 101.5ºF, cough, runny nose, watery eyes. 1:30 pm: Fever of 103.5ºF, fatigue, malaise, cough, runny nose, watery eyes. 5:30 pm:  Fever of 104.5ºF, fatigue, malaise, cough, runny nose, watery eyes, ADVIL administered. Saturday 1:30 am: Fever of 103.2ºF, general confusion, cough, watery eyes, ADVIL administered. 9:00 am: Continued monitoring fever and if it went over 104ºF, ADVIL was administered. Sunday 8 am: Fever broke and was below 100.4ºF after this point. Cough lingered and runny nose with slightly thicker mucus.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Malaise, Pyrexia, Rhinorrhoea
Clinical narrative: Friday 8 am: Cough and runny nose. 11 am: Fever of 101.5ºF, cough, runny nose, watery eyes. 1:30 pm: Fever of 103.5ºF, fatigue, malaise, cough, runny nose, watery eyes. 5:30 pm:  Fever of 104.5ºF, fatigue, malaise, cough, runny nose, watery eyes, ADVIL administered. Saturday 1:30 am: Fever of 103.2ºF, general confusion, cough, watery eyes, ADVIL administered. 9:00 am: Continued monitoring fever and if it went over 104ºF, ADVIL was administered. Sunday 8 am: Fever broke and was below 100.4ºF after this point. Cough lingered and runny nose with slightly thicker mucus.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Headache, Impaired work ability, Injection site swelling
Clinical narrative: Massive/Painful headache. Member was not able to complete the work day or tasks given. Slight swelling in right shoulder.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, drug allergies/reactions and concurrent condition were not reported. In November of unspecified year, the patient was vaccinated with improperly stored VARIVAX (lot# R018140, expiration date: 25-JUN-2020; strength and dose detail were not reported) subcutaneously for prophylaxis, which was reconstituted with properly stored sterile diluent. Current temperature excursion: 15 Fahrenheit degree to 46 Fahrenheit degree (27.5 F) for 30 minutes. There was no previous temperature excursion. No Adverse effects were reported. Data logger was involved. The physician also reported that unspecified amount of improperly stored improperly stored VARIVAX and PROQUAD were administered between "October and December" (linked case#1903USA005021). Sender's Comments: US-009507513-1903USA005021:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided). 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 03-OCT-2016, a pharmacist administered the ZOSTAVAX (lot# and route unknown) vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 08-MAY-2017, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. As a direct and proximate result of the ZOSTAVAX vaccine, 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. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of rash in an elderly female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. On 22nd January 2019, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rash and blister. On an unknown date, the outcome of the rash and blister were unknown. It was unknown if the reporter considered the rash and blister to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX and experienced rash and blistering. The reporter did agree to follow up from GlaxoSmithKline.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Injection site pain, Musculoskeletal pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 36-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shoulder pain (already had that shoulder injured before). In February 2019, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced shoulder pain, condition aggravated and injection site pain. On an unknown date, the outcome of the shoulder pain, condition aggravated and injection site pain were unknown. It was unknown if the reporter considered the shoulder pain, condition aggravated and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but the patient was 36 years old at the time of reporting. The patient received SHINGRIX in the shoulder, above the deltoid (unknown deltoid). The patient was hoping for the best, but It hurt so bad that she hardly was able to sleep due to the pain. The patient already had shoulder injured before receiving vaccine and so it got aggravated. The patient asked for any suggestions.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Herpes zoster, Product supply issue, Rash vesicular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 61-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. The patient's past medical history included breast cancer. Concurrent medical conditions included lymphedema. In September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient received the 2nd dose of SHINGRIX. In January 2019, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced cellulitis (serious criteria hospitalization and GSK medically significant) and blistery rash. On 1st March 2019, the patient experienced shingles (serious criteria hospitalization). On an unknown date, the patient experienced product supply issue. The patient was treated with nystatin. On an unknown date, the outcome of the shingles and blistery rash were not recovered/not resolved and the outcome of the cellulitis and product supply issue were unknown. It was unknown if the reporter considered the shingles, cellulitis and blistery rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on either 7th September 2018 or 14th September 2018. The patient thought that the rash might be fungal, so tried treating it with Nystatin cream, but the rash continued to spread. A couple weeks before the date of reporting,  she was admitted to the hospital for cellulitis. While at the hospital, she showed the doctors her rash and they also treated it Nystatin. The cellulitis and rash were on the same side, but not at the same location. She was in the hospital for a week. on 1st March 2019, after discharge from the hospital, she saw her regular physician. Her regular physician looked at her rash and diagnosed it as shingles. The rash has blistered, but was not as bad as it could have been. She is upset that she developed shingles before getting the 2nd dose, and that she could not get the second dose months ago due to the shortage.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Blood potassium increased, Product administered to patient of inappropriate age, Vomiting
Clinical narrative: Patient was seen on 3/8/19 at medical practice for a well child check with CRNP. At the time of service, patient was 36 days old. CRNP put orders in for DTaP/Hib/IPV, Pneumococcal 13, Rotavirus and Hep B (2nd dose). The MA administered the vaccines per the CRNP orders. These shots were given too early. First round of vaccines should not be given until 2 months old. Dr was on call for the weekend and mom, called into medical to advise that the baby was vomiting through her nose after having her bottle. Mom took her to urgent care prior to Dr responding to the call and urgent care advised shots were given too soon. Dr spoke to mom and he said if she continues to vomit to taker her to the ER. Mom took patient to ER and potassium levels were increased, but per Dr this would have been due to the vomiting and not the vaccines. Patent has a follow up with Dr on 3/14/2019. Per mom, patient seems to be doing fine and baby was eating normally.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus, Injection site warmth
Clinical narrative: Large edematous area to injection site. Warm to touch. Patient states it itches but is trying not to scratch it. Small red area to injection site.
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Pain at time of injection. Left deltoid. Pain persisted in left shoulder for months accompanied by decreased range of motion. Individual did not seek healthcare until 3/12/19. 03/12/19: (L) shoulder FROJM with discomfort with max abduction and introtation with adduction. Physical therapy ordered.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Nausea, Pain in extremity
Clinical narrative: Nausea, sore arm, fatigue.
Age: 29.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Seizure
Clinical narrative: Patient received SHINGRIX and several minutes afterwards the patient had what appeared to be a seizure. Patient was very nervous before getting the vaccine but received the vaccination without issue. A few minutes later, the patient went to get up and said she "felt funny" and sat back down. She then appeared to have a seizure but recovered about a minute later. The pharmacist on duty went to call 9-1-1 but the patient insisted that she was fine and did not want to call 9-1-1. The patient claims that this has happened her in the past and denies that it was a seizure. She claims she had "an adrenaline rush" and "just passed out." Patient was alert and oriented. She drank some water, ate an apple and rested about 30 minutes before her sister took her home.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Headache, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Severs Red Swelling in the left arm area of the injection site and below. Rash on both arms and upper body. Fever, slight headache. Dr at Urgent Care prescribed Cephalexin 500 MG Capsules for 10 days  Cellulitis diagnosis.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Severs Red Swelling in the left arm area of the injection site and below. Rash on both arms and upper body. Fever, slight headache. Dr at Urgent Care prescribed Cephalexin 500 MG Capsules for 10 days  Cellulitis diagnosis.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Malaise, Nausea, Night sweats, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 77-year-old male patient who received SHINGRIX (batch number 9CC72, expiry date 18th May 2021) for prophylaxis. Previously administered products included SHINGRIX (1st dose received in July 2018 at an outside facility, batch number and expiry date was not provided). In February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, several days after receiving SHINGRIX, the patient experienced shingles, malaise, nausea, night sweat, tingling and pain. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles, malaise, nausea, night sweat, tingling and pain were not recovered/not resolved. It was unknown if the reporter considered the shingles, malaise, nausea, night sweat, tingling and pain to be related to SHINGRIX. Additional details were reported as follows: In early February 2019, the patient received SHINGRIX. The exact date was not provided. The patient was diagnosed with shingles a couple of days after receiving SHINGRIX vaccine. In 2019, less than year after receiving SHINGRIX, the patient experienced classic symptoms of shingles, including malaise, nausea, night sweats, tingling at the sore site. The patient was being treated with Valtrex for the shingles.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 77-year-old male patient who received SHINGRIX (batch number 9CC72, expiry date 18th May 2021) for prophylaxis. Previously administered products included SHINGRIX (1st dose received in July 2018 at an outside facility, batch number and expiry date was not provided). In February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, several days after receiving SHINGRIX, the patient experienced shingles, malaise, nausea, night sweat, tingling and pain. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles, malaise, nausea, night sweat, tingling and pain were not recovered/not resolved. It was unknown if the reporter considered the shingles, malaise, nausea, night sweat, tingling and pain to be related to SHINGRIX. Additional details were reported as follows: In early February 2019, the patient received SHINGRIX. The exact date was not provided. The patient was diagnosed with shingles a couple of days after receiving SHINGRIX vaccine. In 2019, less than year after receiving SHINGRIX, the patient experienced classic symptoms of shingles, including malaise, nausea, night sweats, tingling at the sore site. The patient was being treated with Valtrex for the shingles.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Headache, Injection site pain, Pain
Clinical narrative: Pain left deltoid; hurts when raising arm, headache, and temp of 99. No treatment recommended.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site pain, Malaise, Nausea, Pyrexia
Clinical narrative: Arm hurt for 2 weeks at site on injection inflammation on underside of arm 2 weeks. Tendons underarm felt tight when lifting arm then experience nausea, malaise, fever and every side effect on list for 2 days.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Tendon discomfort
Clinical narrative: Arm hurt for 2 weeks at site on injection inflammation on underside of arm 2 weeks. Tendons underarm felt tight when lifting arm then experience nausea, malaise, fever and every side effect on list for 2 days.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient described swelling in his arm down to elbow. He came in to show me on 3/11/19. It was a little swollen and a little red. Not hot and no fever since the time of vaccination on 3/1/19. Patient was not in any pain, but was questioning swelling. Told him to show physician since he was going that afternoon for an appointment. Told him that swelling is a reported reaction of the vaccination, but was not completely sure it was related since so many days had passed. Patient stated he did get a steroid injection in his shoulder of the same arm.
Age: 18.0
Sex: F
Vaccine: FLU4, HEPA, HPV9, MENB, MMRV, MNQ, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: VACCINE GIVEN OUTSIDE OF LICENSED AGE RANGE. NO ADVERSE EFFECTS REPORTED.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Activated partial thromboplastin time shortened, Arthralgia, Band neutrophil percentage, Basophil count normal, Basophil percentage
Clinical narrative: Unexplained bruising on abdomen, arms, legs and back. Pain under ribs, both sides, knee pain, Left knee, dizzy upon standing, nausea after eating, headaches, feels like her insides  are "shivering", tired.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Blood thyroid stimulating hormone, Chills, Contusion, Dizziness postural, Eosinophil count normal
Clinical narrative: Unexplained bruising on abdomen, arms, legs and back. Pain under ribs, both sides, knee pain, Left knee, dizzy upon standing, nausea after eating, headaches, feels like her insides  are "shivering", tired.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Eosinophil percentage, Factor VIII inhibition, Fatigue, Haematocrit normal, Haemoglobin normal
Clinical narrative: Unexplained bruising on abdomen, arms, legs and back. Pain under ribs, both sides, knee pain, Left knee, dizzy upon standing, nausea after eating, headaches, feels like her insides  are "shivering", tired.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, International normalised ratio normal, Lymphocyte count normal, Lymphocyte morphology normal, Lymphocyte percentage
Clinical narrative: Unexplained bruising on abdomen, arms, legs and back. Pain under ribs, both sides, knee pain, Left knee, dizzy upon standing, nausea after eating, headaches, feels like her insides  are "shivering", tired.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Mean cell haemoglobin concentration normal, Mean cell haemoglobin increased, Mean cell haemoglobin normal, Mean cell volume increased, Mean cell volume normal
Clinical narrative: Unexplained bruising on abdomen, arms, legs and back. Pain under ribs, both sides, knee pain, Left knee, dizzy upon standing, nausea after eating, headaches, feels like her insides  are "shivering", tired.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Monocyte count normal, Monocyte percentage, Musculoskeletal chest pain, Nausea, Neutrophil count normal
Clinical narrative: Unexplained bruising on abdomen, arms, legs and back. Pain under ribs, both sides, knee pain, Left knee, dizzy upon standing, nausea after eating, headaches, feels like her insides  are "shivering", tired.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Neutrophil percentage, Platelet count normal, Red blood cell count normal, Red cell distribution width normal, Serum ferritin normal
Clinical narrative: Unexplained bruising on abdomen, arms, legs and back. Pain under ribs, both sides, knee pain, Left knee, dizzy upon standing, nausea after eating, headaches, feels like her insides  are "shivering", tired.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Thyroxine, Transferrin, White blood cell count normal
Clinical narrative: Unexplained bruising on abdomen, arms, legs and back. Pain under ribs, both sides, knee pain, Left knee, dizzy upon standing, nausea after eating, headaches, feels like her insides  are "shivering", tired.
Age: 41.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: VACCINE GIVEN OUTSIDE OF LICENSED AGE RANGE. NO ADVERSE EVENT REPORTED.
Age: 62.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Chills, Injection site erythema, Injection site macule, Injection site warmth, Night sweats
Clinical narrative: Patient reported fever, night sweats, chills 1 day after receiving two vaccines on the right deltoid with presence of erythematous warm macule on right arm at area of injection.
Age: 62.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient reported fever, night sweats, chills 1 day after receiving two vaccines on the right deltoid with presence of erythematous warm macule on right arm at area of injection.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Blindness, Ophthalmological examination abnormal
Clinical narrative: PATIENT HAD VACCINE ON 3/1/19. ON THE FOLLOWING WEDNESDAY PX NOTICED SEVERE VISION LOSS (VISION WAS 20/50). BY THE FOLLOWING MONDAY (3/11/19) PX VISION HAD DIMINISHED TO 20/350 AT EYE EXAMINATION.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: SHINGRIX.
Age: 0.17
Sex: F
Vaccine: HEP, HIBV
Symptoms: Wrong product administered
Clinical narrative: On 12/27 ordered PEDIARIX, HIB, PREVNAR. Given DtaP not PEDIARIX and HIB and PREVNAR. On 1/2 instead of being given IPV and Hep B given Hib and Hep B.
Age: 0.5
Sex: F
Vaccine: DTAP, RV5
Symptoms: Affective disorder, Aggression, Anger, Anxiety, Condition aggravated
Clinical narrative: She screamed 75% of day for over 1 1/2 years, thrashing in sleep and while awake, violent anger trying to hurt you, inflammation of brain according to her doctor, very large head had x rayed, sensory processing disorder, she missed all her milestones at the pediatricians office, no eye contact, wouldn't respond to name at 9 months, extreme anxiety, food allergies, very similar symptoms as autism. Our family was debilitated by what happened to her. We stopped vaccines, found a Dr who actually helped us with extensive tests and supplements, we changed her diet to all organic and dairy, gluten free and she was in occupational therapy for sensory and speech and developmental delays. She has improved very slowly over time as we have put countless hours in research and with doctors who have helped her. She is currently on several supplements that help her through the day and is extremely improved. I don't know what would happen if we took her off the supplements though. She still struggles with sleep and mood and allergies and anxiety but great improvement has occurred since we've taken these measures but it's been a slow traumatic process.
Age: 0.5
Sex: F
Vaccine: DTAP, RV5
Symptoms: Decreased eye contact, Developmental delay, Food allergy, Gene mutation identification test positive, Laboratory test
Clinical narrative: She screamed 75% of day for over 1 1/2 years, thrashing in sleep and while awake, violent anger trying to hurt you, inflammation of brain according to her doctor, very large head had x rayed, sensory processing disorder, she missed all her milestones at the pediatricians office, no eye contact, wouldn't respond to name at 9 months, extreme anxiety, food allergies, very similar symptoms as autism. Our family was debilitated by what happened to her. We stopped vaccines, found a Dr who actually helped us with extensive tests and supplements, we changed her diet to all organic and dairy, gluten free and she was in occupational therapy for sensory and speech and developmental delays. She has improved very slowly over time as we have put countless hours in research and with doctors who have helped her. She is currently on several supplements that help her through the day and is extremely improved. I don't know what would happen if we took her off the supplements though. She still struggles with sleep and mood and allergies and anxiety but great improvement has occurred since we've taken these measures but it's been a slow traumatic process.
Age: 0.5
Sex: F
Vaccine: DTAP, RV5
Symptoms: Methylenetetrahydrofolate reductase gene mutation, Noninfective encephalitis, Poor quality sleep, Screaming, Sensory processing disorder
Clinical narrative: She screamed 75% of day for over 1 1/2 years, thrashing in sleep and while awake, violent anger trying to hurt you, inflammation of brain according to her doctor, very large head had x rayed, sensory processing disorder, she missed all her milestones at the pediatricians office, no eye contact, wouldn't respond to name at 9 months, extreme anxiety, food allergies, very similar symptoms as autism. Our family was debilitated by what happened to her. We stopped vaccines, found a Dr who actually helped us with extensive tests and supplements, we changed her diet to all organic and dairy, gluten free and she was in occupational therapy for sensory and speech and developmental delays. She has improved very slowly over time as we have put countless hours in research and with doctors who have helped her. She is currently on several supplements that help her through the day and is extremely improved. I don't know what would happen if we took her off the supplements though. She still struggles with sleep and mood and allergies and anxiety but great improvement has occurred since we've taken these measures but it's been a slow traumatic process.
Age: 0.5
Sex: F
Vaccine: DTAP, RV5
Symptoms: Skull X-ray, Sleep disorder, Speech disorder developmental, Unresponsive to stimuli
Clinical narrative: She screamed 75% of day for over 1 1/2 years, thrashing in sleep and while awake, violent anger trying to hurt you, inflammation of brain according to her doctor, very large head had x rayed, sensory processing disorder, she missed all her milestones at the pediatricians office, no eye contact, wouldn't respond to name at 9 months, extreme anxiety, food allergies, very similar symptoms as autism. Our family was debilitated by what happened to her. We stopped vaccines, found a Dr who actually helped us with extensive tests and supplements, we changed her diet to all organic and dairy, gluten free and she was in occupational therapy for sensory and speech and developmental delays. She has improved very slowly over time as we have put countless hours in research and with doctors who have helped her. She is currently on several supplements that help her through the day and is extremely improved. I don't know what would happen if we took her off the supplements though. She still struggles with sleep and mood and allergies and anxiety but great improvement has occurred since we've taken these measures but it's been a slow traumatic process.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, RV5
Symptoms: Diarrhoea, Irritability, Wheezing
Clinical narrative: At 4 month well child check, Mom reported baby had wheezing soon after receiving the vaccine from her 2month visit, that lasted 2 days, and frothy green diarrhea that lasted 3 weeks, with general fussiness during that time. Mom said she was very concerned about these symptoms at the time, but did not call or f/u in any office.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Erythema, Induration, Papule
Clinical narrative: VARIVAX given on 2/25 in patient's right arm. On 3/6, parents noticed a 5-8 mm induration with surrounding erythema. On 3/7 it became larger and a second smaller papule appeared above it.
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Headache, Musculoskeletal stiffness, Neck pain
Clinical narrative: Woke up with a stiff neck and pain in his neck and a headache.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Breath holding, Flushing, Irritability, Nasal congestion, Pyrexia
Clinical narrative: Fever of 101.3, flushed face, holding breath slightly before exhaling, fussiness, vomiting, stuffy nose from vomit coming up through nose. All symptoms lasted about 12 hours. Vomiting lasted 2+ days.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Fever of 101.3, flushed face, holding breath slightly before exhaling, fussiness, vomiting, stuffy nose from vomit coming up through nose. All symptoms lasted about 12 hours. Vomiting lasted 2+ days.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Pyrexia
Clinical narrative: Injection site pain, headache, fever, chills.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Loss of personal independence in daily activities
Clinical narrative: The patient reported being extremely dizzy to the point where she couldn't get out of bed for a day.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Computerised tomogram, Febrile convulsion, Influenza virus test, Mobility decreased, Pyrexia
Clinical narrative: Febrile seizure along with fever of 101.3. Complex febrile seizure lasting about 15min, child was not able to move head, right side of body or eyes.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Ultrasound scan
Clinical narrative: Febrile seizure along with fever of 101.3. Complex febrile seizure lasting about 15min, child was not able to move head, right side of body or eyes.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Back pain, Chills, Dizziness, Fatigue, Feeling cold
Clinical narrative: Patient received TRUMENBA vaccine on 02/25/19 in our office, she was fine immediately after the vaccination. Child was seen next day in our office. Mom reports that she called our office that evening but she hung up rather than requesting answering service to connect to the doctor on call. She never called again that evening or night as child was doing better. She called next day and was seen immediately. Visit note from DOS 02/26/19 Mom reports that in the evening after few hours of vaccination, she started c/o pain in the left arm and felt very cold and chills. She also felt pain on her left side of body and back. It was associated with headache and dizziness and she felt very tired. Mom reports that she saw the patient's both hands turning purplish for few minutes. Mom gave her blanket and warm towel and immediately her hands became normal, after sometime she felt a little better but kept c/o pain in the left arm which is still there but less than yesterday. Still c/o mild dizziness and headache. No vision changes, no fainting, no vomiting, no chest pain, no palpitations, no abdominal pain, no weakness of any part of the body, no breathing difficulty. Injection site is hurting today when touched but pain over left side and back is much better. She noted swelling and redness over the injection site yesterday night which slightly increased today. Orthostatic BP normal, pulse ox normal in both upper limbs, neurovascular examination is normal, patient is well looking, no distress, no weakness will consider augmentin if not better Motrin as advised Observe closely for additional symptoms, call office/go to ER if worsening symptoms, any skin color change,any cyanosis/blue or purple discoloration, difficulty breathing, any fever, increasing redness or swelling, lethargy, persistent dizziness or headache, any vomiting, vision changes, chest pain/palpitations/persistent or worsening pain/tingling or numbness,any weakness. Call office immediately if any new concern or persistent symptoms. Mom and patient verbalized understanding will f/u tomorrow via phone call.