chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of erythema in a female patient who received SHINGRIX for prophylaxis. On 11th May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema, swelling and pruritus. On an unknown date, the outcome of the erythema, swelling and pruritus were recovered/resolved. It was unknown if the reporter considered the erythema, swelling and pruritus to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced redness, itching and swelling for 8 days.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Fall, Gait inability, Speech disorder, Tremor
Clinical narrative: This case was reported by a consumer and described the occurrence of unable to walk in a 86-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included Albuterol, amlodipine, Aspirin, Furosemide, gabapentin, Levothyroxine, MUCINEX, SOLOSTAR Insulin, COLACE, dorzolamide eye drops, hydralazine, ophthalmologicals (Eye Drop), metolazone, metoprolol, repaglinide and ATIVAN. On 7th June 2018, the patient received the 1st dose of SHINGRIX(intramuscular). On 8th June 2018, 1 days after receiving SHINGRIX, the patient experienced unable to walk, tremor and speech disorder. On 18th June 2018, the patient experienced fall. On an unknown date, the outcome of the unable to walk, speech disorder and fall were unknown and the outcome of the tremor was not recovered/not resolved. It was unknown if the reporter considered the unable to walk, tremor, speech disorder and fall to be related to SHINGRIX. Additional details were received as follows: The concomitant medications also included ELIQUIS and DILATIN. The patient reported that she received SHINGRIX on the right arm. The concomitant medications also included ELIQUIS and DILATIN. On the next day, the patient experienced tremors and they were bad enough that she was not able to walk around and it was difficult for her to talk. The patient was in hospice and was prior to receiving SHINGRIX. The patient had spoken with her hospice physician and he did not know a way to treat the tremors. The patient thought that the tremors were getting better, but before the date of reporting the patient fell because of the tremors and was taken to the Emergency Room (ER) to make sure that she was not injured. On the same day, the patient was sent home.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of chills in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced chills, fever and nausea. On an unknown date, the outcome of the chills, fever and nausea were unknown. It was unknown if the reporter considered the chills, fever and nausea to be related to SHINGRIX. Additional details were provided as follows: This case was received from an office manager. The age at vaccination was not reported. The patient had no pain at injection however that evening presented with fever, chills and nausea. The reporter agreed to follow up.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a 85-year-old female patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX .5 ml. In June 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, injection site erythema, injection site warmth, itchy upper limbs and injected limb mobility decreased. The patient was treated with non-drug therapy (Hot Compresses) and non-drug therapy (Cold Compress). On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema, injection site warmth, itchy upper limbs and injected limb mobility decreased were recovering/resolving. The reporter considered the injection site pain, injection site swelling, injection site erythema, injection site warmth, itchy upper limbs and injected limb mobility decreased to be related to SHINGRIX. Additional information was received as follows: The patient reported being vaccinated with SHINGRIX in left arm at a pharmacy about 9 or 10 days before the date of reporting. The patient stated that her arm was itchy immediately after vaccination. The patient did not specify after vaccination when redness, warmth, swelling and pain extending to the top of the left arm began but reported that it was started about 9 days before the date of reporting. The patient reported that she experienced pain, redness, warmth, and swelling extending to the top of the left arm. The patient had difficulty in moving arm and could hardly use it. The symptoms was getting better. The reporter did not have more information on pain symptoms like pain scale, radiation, sharp or dull. The physician in office recommended the patient to use hot and cold compress to treat the symptoms and increase circulation. The reporter was pretty sure that this symptoms were due to the vaccine. The reporter reported that the patient was doing better on the 9th day. The reporter planned to have patient come back in 5 months to get 2nd dose of SHINGRIX. Upon follow up, MSL (Medical Science Liaison) had called and emailed health care professional (HCP) to learn more about event reported. There were no response from HCP has been received. The reporter was questioning if the patient could still get the second dose 2-6 months later.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pruritus
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a 85-year-old female patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX .5 ml. In June 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, injection site erythema, injection site warmth, itchy upper limbs and injected limb mobility decreased. The patient was treated with non-drug therapy (Hot Compresses) and non-drug therapy (Cold Compress). On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema, injection site warmth, itchy upper limbs and injected limb mobility decreased were recovering/resolving. The reporter considered the injection site pain, injection site swelling, injection site erythema, injection site warmth, itchy upper limbs and injected limb mobility decreased to be related to SHINGRIX. Additional information was received as follows: The patient reported being vaccinated with SHINGRIX in left arm at a pharmacy about 9 or 10 days before the date of reporting. The patient stated that her arm was itchy immediately after vaccination. The patient did not specify after vaccination when redness, warmth, swelling and pain extending to the top of the left arm began but reported that it was started about 9 days before the date of reporting. The patient reported that she experienced pain, redness, warmth, and swelling extending to the top of the left arm. The patient had difficulty in moving arm and could hardly use it. The symptoms was getting better. The reporter did not have more information on pain symptoms like pain scale, radiation, sharp or dull. The physician in office recommended the patient to use hot and cold compress to treat the symptoms and increase circulation. The reporter was pretty sure that this symptoms were due to the vaccine. The reporter reported that the patient was doing better on the 9th day. The reporter planned to have patient come back in 5 months to get 2nd dose of SHINGRIX. Upon follow up, MSL (Medical Science Liaison) had called and emailed health care professional (HCP) to learn more about event reported. There were no response from HCP has been received. The reporter was questioning if the patient could still get the second dose 2-6 months later.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient had pain in arm for 2-3 days, and it ached for weeks and continued to ache till the date of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of influenza-like symptoms in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the vaccine coordinator. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. This case has been linked to US2018GSK111891 and US2018GSK111892, reported by the same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of influenza-like symptoms in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the vaccine coordinator. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient experienced flu like symptoms for 24 hours. This case has been linked to US2018GSK111890 and US2018GSK111892, reported by the same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Swelling
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of swelling in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced swelling. On an unknown date, the outcome of the swelling was unknown. It was unknown if the reporter considered the swelling to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a vaccine coordinator. The age at vaccination was not reported. The age group was not reported, but was selected as adult as per vaccine indication. The healthcare professional reported about the patient who, upon receiving the SHINGRIX vaccine experienced severe swelling. The reporter agreed to follow up. This incident was originally reported by a physician. This case was linked with US2018GSK112760, reported by the same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Swelling
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of swelling in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced swelling. On an unknown date, the outcome of the swelling was unknown. It was unknown if the reporter considered the swelling to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a vaccine coordinator. The age at vaccination was not reported. The age group was not reported, but was selected as adult as per vaccine indication. The healthcare professional reported about the patient who, upon receiving the SHINGRIX vaccine experienced severe swelling. The reporter agreed to follow up. This incident was originally reported by a physician. This case was linked with US2018GSK112757, reported by the same reporter.
Age: 63.0
Sex: F
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 63-year-old female patient who received SHINGRIX for prophylaxis. On 2nd March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported case for herself. The patient received SHINGRIX in an unknown arm. The patient experienced pain in her arm at site of injection. For tolerance after 2nd dose refer US2018110582.
Age: 22.0
Sex: M
Vaccine: MMR, TDAP, VARCEL
Symptoms: Hyperhidrosis, Insomnia, Myalgia, Nausea, Pyrexia
Clinical narrative: Initially had fever had fevers of 101 - 104F or 4 days after getting the vaccines. He took acetaminophen for the fevers and got better for about a week then started fevers again on the 29th that went up to 105F on the thermometer. Went to the ER on the 30th and was told likely from the varicella vaccine and to continue to take acetaminophen for fevers. By the next day, he was diaphoretic with the fevers then noticed rash to trunk, was nauseated and had myalgias and unable to sleep comfortably. Still taking acetaminophen 500mg every 4-6 hours.
Age: 22.0
Sex: M
Vaccine: MMR, TDAP, VARCEL
Symptoms: Rash
Clinical narrative: Initially had fever had fevers of 101 - 104F or 4 days after getting the vaccines. He took acetaminophen for the fevers and got better for about a week then started fevers again on the 29th that went up to 105F on the thermometer. Went to the ER on the 30th and was told likely from the varicella vaccine and to continue to take acetaminophen for fevers. By the next day, he was diaphoretic with the fevers then noticed rash to trunk, was nauseated and had myalgias and unable to sleep comfortably. Still taking acetaminophen 500mg every 4-6 hours.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Malaise, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Headache, fever, malaise, joint pain primarily in hands. Symptoms initiated faster this time than with first dose taken 4/12/2018. Continue to have daytime sleepiness and stiff neck.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: Headache, fever, malaise, joint pain primarily in hands. Symptoms initiated faster this time than with first dose taken 4/12/2018. Continue to have daytime sleepiness and stiff neck.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Headache, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swollen red arm at injection site, headache, body aches, stomach discomfort. 7 days now after injection still slightly red and itching. Spoke with my doctor and she suggests not getting the second injection. Please advise.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Swollen red arm at injection site, headache, body aches, stomach discomfort. 7 days now after injection still slightly red and itching. Spoke with my doctor and she suggests not getting the second injection. Please advise.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Eye pain, Fatigue, Myalgia, Nausea
Clinical narrative: Fever, Muscle Aches, Chills, Nausea, Fatigue, Left eye pain/tenderness, Monday 7/2/18 - still having all the above symptoms.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever, Muscle Aches, Chills, Nausea, Fatigue, Left eye pain/tenderness, Monday 7/2/18 - still having all the above symptoms.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Abnormal behaviour, Chills, Crying, Headache, Injection site pain
Clinical narrative: 3 hours s/p vaccine patient experienced fever, chills, muscle aches, headache, nausea. Crying and "acting bizarre" per mom's report.  She took 600 mg ibuprofen and went to bed; woke feeling fine the next morning with the exception of soreness at injection site.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: 3 hours s/p vaccine patient experienced fever, chills, muscle aches, headache, nausea. Crying and "acting bizarre" per mom's report.  She took 600 mg ibuprofen and went to bed; woke feeling fine the next morning with the exception of soreness at injection site.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Injection site erythema, Middle insomnia, Myalgia
Clinical narrative: Received shot in left arm about 5 pm on 6/29/18  started to feel pain in the mussel about 8 pm  The pain during the night woke me up  about 3 am when I went to turn over. In morning arm started to swell and became red. I didn't think too much of it since I had previous shots in the arm., by Saturday night it became red below the shot almost down to the elbow. I experienced  itch throat and headache. I took Advil. Today (July 2) the arm is still red and itchy.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pruritus, Throat irritation
Clinical narrative: Received shot in left arm about 5 pm on 6/29/18  started to feel pain in the mussel about 8 pm  The pain during the night woke me up  about 3 am when I went to turn over. In morning arm started to swell and became red. I didn't think too much of it since I had previous shots in the arm., by Saturday night it became red below the shot almost down to the elbow. I experienced  itch throat and headache. I took Advil. Today (July 2) the arm is still red and itchy.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient of unknown age. The patient's concurrent condition, medical history, drug reactions/allergies and concomitant medications were not reported. On 21-JUN-2018 the patient was vaccinated with improperly stored dose of VARIVAX (dose, frequency and route were not reported) (lot # N027000, expiry date: 28-SEP-2019) for prophylaxis. It was unknown if sterile diluent (dose, frequency, lot #, expiry date, route and indication were not reported) used for reconstitution of VARIVAX was properly stored. The vaccines were stored in temperature of 6 degree Fahrenheit (F) to 14 F for 5 hours 40 minutes. There was no previous temperature excursion reported. A digital data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is one of two reports received from the same reporter.
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a male patient of unknown age. The patient's concurrent condition, medical history, drug reactions/allergies and concomitant medications were not reported. On 20-JUN-2018 the patient was vaccinated with improperly stored dose of VARIVAX (dose and frequency: not reported) (lot # N019608, expiry date: 09-JUL-2019 (reported as: 08-JUN-2270) and/or (lot # R002057, expiry date: 22-JAN-2020) and/or (lot # N027619, expiry date: 04-OCT-2019) intramuscularly for prophylaxis. The patient also received sterile diluent (MERCK) dose, frequency, lot #, expiry date: not reported). The vaccines were stored in temperature of 6 degree Fahrenheit (F) to 14 F (11 F) for 15 minutes and 15 F to 46 F (10 F-17 F) for 15 minutes. There was no previous temperature excursion reported. A digital data logger was involved. No adverse effects were reported. No product quality complaint was involved. Lot number [R002057] has been verified to be a valid lot number for varicella virus vaccine live (oka/merck).
Sex: U
Vaccine: HEPA, HIBV, VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported. On an unknown date, the patient was inadvertently vaccinated with improperly stored doses of PEDVAXHIB (lot# N007751, expiration date 30-NOV-2019); VAQTA (lot# N017094, expiration date 31-AUG-2018); and VARIVAX (lot# M033906, expiration date 20-JUL-2018) reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) (unknown lot # and expiration date) (for all vaccines exact doses, dose # and routes of administration were not reported). Administered doses of PEDVAXHIB and VAQTA experienced the temperature excursion of 47 Fahrenheit degrees to 77 Fahrenheit degrees for 30 minutes. Administered dose of VARIVAX experienced the temperature excursion of 15 Fahrenheit degrees to 46 Fahrenheit degrees for 30 minutes. Regarding all vaccines, there were no previous excursions reported and the digital data logger was involved to capture the temperature excursion. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1806USA008595:
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient of unknown age. The patient's concurrent condition, medical history, drug reactions/allergies and concomitant medications were not reported. On 21-JUN-2018 the patient was vaccinated with improperly stored dose of VARIVAX (dose, frequency and route were not reported) (lot # N027000, expiry date: 28-SEP-2019) for prophylaxis. It was unknown if sterile diluent (dose, frequency, lot #, expiry date, route and indication were not reported) used for reconstitution of VARIVAX was properly stored. The VARIVAX was stored in temperature of 6 degree Fahrenheit (F) to 14 F for 5 hours 40 minutes. There was no previous temperature excursion reported. A digital data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is one of two reports received from the same reporter.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included Shingles vaccine. On 15th March 2018, the patient received the 1st dose of SHINGRIX. On 15th March 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. The reporter considered the injection site pain to be related to SHINGRIX. Additional information was reported as follows: The pain lasted a couple of days and resolved. This case was linked with US2018111419 (2nd dose), reported by the same reporter for the same patient.
Age: 0.33
Sex: M
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 5-month old male patient (child). The patient's pertinent medical history and concomitant therapies were not reported. The patient had a complex list of medical problems including respiratory conditions and had been in and out of the PICU (pediatric intensive care unit) ever since he was born. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dosing details, lot # and expiration date were not reported) for prophylaxis. Other suspect therapies included PREVNAR (dosing details, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the reporter stated that the patient was to receive PREVNAR at 4 months old as part of his routine vaccinations at this age, but received PNEUMOVAX 23 (wrong drug administered). It was reported that the pharmacist thought this would have been the initial vaccination with PREVNAR for the patient.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: The patient has itchiness and swelling at the site of the injection. She has had the symptoms for a week and has been taking BENADRYL to treat.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Body temperature increased, Chills, Headache
Clinical narrative: Got very weak, chills, had a temperature, upset stomach, headache, arms and legs felt like I was beat up didn't do anything just waiting for it to wear off.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Limb discomfort
Clinical narrative: Got very weak, chills, had a temperature, upset stomach, headache, arms and legs felt like I was beat up didn't do anything just waiting for it to wear off.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash located on trunk and bilateral armpits onto chest, between and below breasts onto upper abdominal wall. No fevers/chills. Not itchy or painful.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: After patient received second dose, her injection arm had redness and warm to the touch a few inches below the injection site.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Faeces pale, Malaise
Clinical narrative: Vaccine was SHINGRIX. I did not feel well. I felt light headed, dizzy like vertigo and I had light colored stools for a week.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Condition aggravated, Muscle tightness, Vaccination site bruising, Vaccination site pain, Vaccination site swelling
Clinical narrative: 7-2-18, Today vaccine site feels bruised and sore. Vaccine site swollen and puffy. Neck muscle that is always tight, feels more tight.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Eye pain, Herpes zoster, Influenza like illness, Paraesthesia
Clinical narrative: Reactivation of previous shingles. Tingling on side of face, eye pain, ear pain.  Flu like symptoms.   I had 1 episode of shingles 15 years ago in which I loss about 50% of my hearing in my left ear.   Symptoms this time were all on the left side of my face.
Age: 1.17
Sex: M
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PENTACEL and PEDVAXHIB given on same visit, no s/s of adverse reaction after given injections, pt monitored after injections given.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache
Clinical narrative: By 8 pm, I had significant pain in all my joints. By 6 am the next morning, I had a headache and was having chills. I still had significant pain in all my joints. By 5 pm that day, symptoms were gone.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Body aches, slight fever, nausea, headache, tachycardia, fatigue.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Tachycardia
Clinical narrative: Body aches, slight fever, nausea, headache, tachycardia, fatigue.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Burning sensation, Discomfort, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: SORENESS & STIFFNESS ALL OVER BODY. THEN BURNING IN LOWER BACK AND AROUND AND UNDER LEFT SHOULDER BLADE INTO NECK AREA AND INABILITY TO TURN NECK FULLY TO THE LEFT. LASTED 10 DAYS. DID NOT NOTICE REDNESS OR RASH BUT CLOTHING RUBBING ON NECK AND SHOULDER BLADE WAS VERY UNCOMFORTABLE. LACK OF ENERGY.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: SORENESS & STIFFNESS ALL OVER BODY. THEN BURNING IN LOWER BACK AND AROUND AND UNDER LEFT SHOULDER BLADE INTO NECK AREA AND INABILITY TO TURN NECK FULLY TO THE LEFT. LASTED 10 DAYS. DID NOT NOTICE REDNESS OR RASH BUT CLOTHING RUBBING ON NECK AND SHOULDER BLADE WAS VERY UNCOMFORTABLE. LACK OF ENERGY.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site warmth, Local reaction
Clinical narrative: Large local reaction around injection site with redness, pain, and warmth. Fever (Tmax 102F) for 36 hours, fatigue.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Pyrexia
Clinical narrative: Large local reaction around injection site with redness, pain, and warmth. Fever (Tmax 102F) for 36 hours, fatigue.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site rash, Pyrexia
Clinical narrative: I developed a rash on the backside of of my right arm accompanied with fever 18 hours after injection. Went to a clinic 2 days after inject and was diagnosed with cellulitis. The attending NP suggested I submit a report even though it may be unrelated. Was prescribed 10 days, 4x per day, 500 mg cephalexin (KEFLEX) this was the second injection and there were no known issues with the first injection.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Balance disorder, Blindness, Paralysis
Clinical narrative: Totally paralyzed. Hospitalized for 12 days. Went blind x 48 hrs while in hospital. Went into rehab for 20 days. Then had PT till May 2018. Not 100% better. Currently has bad balance and no strength or stamina.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, DTAPIPV, RV5
Symptoms: Extra dose administered
Clinical narrative: Myself, the medical assistant, in preparing shots for patient gave patient PEDIARIX, KINRIX, and ROTATEQ resulting in a double dose of DTaP and IVP. I immediately called the state in which they said it is still valid and I needed to inform the family and submit a VAERS.
Age: 20.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Pruritus, Swelling
Clinical narrative: Patient Complaint of Itching, Swelling after receiving Vaccine.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Erythema, Hyperhidrosis, Pyrexia
Clinical narrative: Fever (low, 100 degrees) for day and a half, chills, sweats, lighheadedness followed by hives/rash on arm (but not at injection site). Saw Dr. He prescribed an antibiotic and a cortisone cream. Suggested followup in four days unless there wasimprovement. Immediate contact if worse. I slowly got better and I canceled followup appointment. There is still some residucal redness  and swelling in rash area.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Swelling, Urticaria
Clinical narrative: Fever (low, 100 degrees) for day and a half, chills, sweats, lighheadedness followed by hives/rash on arm (but not at injection site). Saw Dr. He prescribed an antibiotic and a cortisone cream. Suggested followup in four days unless there wasimprovement. Immediate contact if worse. I slowly got better and I canceled followup appointment. There is still some residucal redness  and swelling in rash area.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Barium enema, Intussusception
Clinical narrative: 4 month old developed intussusception and was hospitalized 05/05/2018, after two trips to the emergency room. The initial visit at the ER was on 05/04/2018.
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Disorientation, Immediate post-injection reaction, Syncope, Tonic clonic movements, Unresponsive to stimuli
Clinical narrative: Immediately following vaccine administration, patient with syncopal episode. Patient experienced tonic-clonic movements lasting less than one minute and was unresponsive. After approx. one minute, patient awake, pink in color, and slowly became oriented back to person, place, and time.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection site turned red, swelled, and was painful for 6 days.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site reaction, Rash
Clinical narrative: Child developed a rash after going to daycare on Friday 6/29/18. Mom reports that there was no rash visible when she dropped her off. She did not have a fever and per mom and daycare provider she was acting normal. Rash was reported by daycare to mom about midday Friday and Mom called me about 1:30PM. Mom reported there were no chickenpox type lesions at that time. Called mom to check on child on Monday, 7/2/18 and rash is going away. Still no fever over the weekend although there are 2 "bug-bite" like spots on left thigh.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Per patients mother the patient did not express any kind of discomfort at the site that the injections were given. After a day at the beach is when the redness, and swelling was noticed. Patients mother called on 06/28/2018 @ 8:30 to report the reaction. Patients mother stated that the arm did have direct sun exposure and sun tan lotion was not put on the site of the redness. Patients mother gave the patient MOTRIN to help with the swelling and did cool compresses to the area. Patients mother states that the patients arm was red and swollen from the shoulder to the elbow. Patients mother states that the patient has improved 100%, and does not have any further concern at this time.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Per Foster mom pt's right leg red, puffy, and hard to touch. Pt does not complain of any pain.  Symptoms started on Saturday, day after vaccine given. LPN.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Musculoskeletal stiffness, Peripheral swelling, Poor peripheral circulation
Clinical narrative: Patient's first dose of SHINGRIX was in April 2018; arm was sore for a few days. In the afternoon, about 6-7 hours later, patient reports headaches, and stiffness around shoulderknown vaccine adverse events. Patient did not take any medication. Later in the night extra tiredness began. In the morning, while driving patient nodded off 3 times; patient did not feel that tired just started nodding off without feeling that it was happening--uncontrollably falling sleep. It is hard to classify it as fatigue it was extreme drowsiness. Patient went to pharmacist to check in and was told other patients had reported extreme tiredness as well. Literature should specify that patient can experience extreme fatigue and  should not operate machinery. By day 3, patient reports that fatigue subsided. Patient also reports that left foot was swollen for 3-5 days due to poor circulation--similar to when patient receives anesthetic for surgery.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: Patient's first dose of SHINGRIX was in April 2018; arm was sore for a few days. In the afternoon, about 6-7 hours later, patient reports headaches, and stiffness around shoulderknown vaccine adverse events. Patient did not take any medication. Later in the night extra tiredness began. In the morning, while driving patient nodded off 3 times; patient did not feel that tired just started nodding off without feeling that it was happening--uncontrollably falling sleep. It is hard to classify it as fatigue it was extreme drowsiness. Patient went to pharmacist to check in and was told other patients had reported extreme tiredness as well. Literature should specify that patient can experience extreme fatigue and  should not operate machinery. By day 3, patient reports that fatigue subsided. Patient also reports that left foot was swollen for 3-5 days due to poor circulation--similar to when patient receives anesthetic for surgery.
Sex: F
Vaccine: HPV9
Symptoms: Skin papilloma
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of an unknown age. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On an unknown date, the patient was vaccinated with GARDASIL 9 injection (dose, route of administration, lot number and expiration date were not reported) for prophylaxis. On an unknown date (reported as 2 weeks after the vaccination), the patient developed warts all over her legs (further described as rash on top of thigh, in the armpits and all over the back; from the rear end down to the calf; individual warts; not pus-filled hives).  The outcome of the event was unknown. Causality assessement was not provided.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 61-year-old female patient who received SHINGRIX for prophylaxis. On 20th June 2018, the patient received the 2nd dose of SHINGRIX. In June 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth and injection site lump. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site lump were unknown. It was unknown if the reporter considered the injection site erythema, injection site warmth and injection site lump to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The reporter who was a pharmacist administered the SHINGRIX to the patient in an unknown deltoid. The pharmacist stated that, the patient had a possible injection site reaction and requested to be transferred to GlaxoSmithKline's Medical Information team to discuss her inquiry of whether or not the reported reaction could be considered an injection site reaction since it was located about 4 inches down from the site of the injection on the patient's deltoid. The pharmacist described the reaction as red and warm. The patient still wore a Band-Aid at the injection site and told the reporter that, she felt a lump there. Due to time constraints, the reporter was not able to complete the form. No further details were provided due to time constraints. The reported agreed to be contacted for further details.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a adult male patient who received ENGERIX B for prophylaxis. Co-suspect products included ENGERIX B for prophylaxis and ENGERIX B for prophylaxis. On an unknown date, the patient received the 1st dose of ENGERIX B, the 2nd dose of ENGERIX B and the 3rd dose of ENGERIX B. On an unknown date, unknown after receiving ENGERIX B, ENGERIX B and ENGERIX B the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to ENGERIX B, ENGERIX B and ENGERIX B. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that the patient who completed their series of ENGERIX B did not achieve immunity after 3rd dose. The health care professional was unsure when 3rd dose of series was administered. However, it was intended to administer additional booster dose and re-check titers at some point thereafter. No further information was reported. Lab Comments: Lab test was performed on an unknown date.
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Injection site pain, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a child male patient who received KINRIX (batch number 53NB2, expiry date 10th November 2018) for prophylaxis. Concomitant products included PROQUAD. On an unknown date, the patient received KINRIX. On an unknown date, several hours after receiving KINRIX, the patient experienced fever and pain in arm. The patient was treated with ADVIL and TYLENOL. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the pain in arm was unknown. It was unknown if the reporter considered the fever and pain in arm to be related to KINRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient developed high fevers within hours after receiving the KINRIX vaccine. In addition to the fever the patient also experienced sore in arm. The health care professional recommended TYLENOL or ADVIL for the fever. This case has been linked with US2018112030 and US2018112033 reported by same reporter.
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Eye pain, Pyrexia, Vomiting
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a child male patient who received KINRIX (batch number 53NB2, expiry date 10th November 2018) for prophylaxis. Concomitant products included PROQUAD. On an unknown date, the patient received KINRIX. On an unknown date, several hours after receiving KINRIX, the patient experienced fever and pain in arm. The patient was treated with ADVIL and TYLENOL. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the pain in arm was unknown. It was unknown if the reporter considered the fever and pain in arm to be related to KINRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient developed high fevers within hours after receiving the KINRIX vaccine. In addition to the fever the patient also experienced sore in arm. The health care professional recommended TYLENOL or ADVIL for the fever. This case has been linked with US2018112030 and US2018112033 reported by same reporter.
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a child male patient who received KINRIX (batch number 53NB2, expiry date 10th November 2018) for prophylaxis. Concomitant products included PROQUAD. On an unknown date, the patient received KINRIX. On an unknown date, several hours after receiving KINRIX, the patient experienced fever and pain in arm. The patient was treated with ADVIL and TYLENOL. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the pain in arm was unknown. It was unknown if the reporter considered the fever and pain in arm to be related to KINRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient developed high fevers within hours after receiving the KINRIX vaccine. In addition to the fever the patient also experienced sore in arm. The health care professional recommended TYLENOL or ADVIL for the fever. This case has been linked with US2018112030 and US2018112033 reported by same reporter.
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Injection site pain, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a child male patient who received KINRIX (batch number 53NB2, expiry date 10th November 2018) for prophylaxis. Concomitant products included PROQUAD. On an unknown date, the patient received KINRIX. On an unknown date, several hours after receiving KINRIX, the patient experienced fever, eye pain and vomiting. The patient was treated with ADVIL and TYLENOL. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the eye pain and vomiting were unknown. It was unknown if the reporter considered the fever, eye pain and vomiting to be related to KINRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient developed high fevers within hours after receiving the KINRIX vaccine. In addition to the fever the patient also experienced vomiting and eyes were hurting. The health care professional recommended TYLENOL or ADVIL for the fever. This case has been linked with US2018112032 and US2018112033 reported by same reporter.
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Eye pain, Pyrexia, Vomiting
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a child male patient who received KINRIX (batch number 53NB2, expiry date 10th November 2018) for prophylaxis. Concomitant products included PROQUAD. On an unknown date, the patient received KINRIX. On an unknown date, several hours after receiving KINRIX, the patient experienced fever, eye pain and vomiting. The patient was treated with ADVIL and TYLENOL. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the eye pain and vomiting were unknown. It was unknown if the reporter considered the fever, eye pain and vomiting to be related to KINRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient developed high fevers within hours after receiving the KINRIX vaccine. In addition to the fever the patient also experienced vomiting and eyes were hurting. The health care professional recommended TYLENOL or ADVIL for the fever. This case has been linked with US2018112032 and US2018112033 reported by same reporter.
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a child male patient who received KINRIX (batch number 53NB2, expiry date 10th November 2018) for prophylaxis. Concomitant products included PROQUAD. On an unknown date, the patient received KINRIX. On an unknown date, several hours after receiving KINRIX, the patient experienced fever, eye pain and vomiting. The patient was treated with ADVIL and TYLENOL. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the eye pain and vomiting were unknown. It was unknown if the reporter considered the fever, eye pain and vomiting to be related to KINRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient developed high fevers within hours after receiving the KINRIX vaccine. In addition to the fever the patient also experienced vomiting and eyes were hurting. The health care professional recommended TYLENOL or ADVIL for the fever. This case has been linked with US2018112032 and US2018112033 reported by same reporter.
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Injection site pain, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a male patient who received KINRIX for prophylaxis. Concomitant products included PROQUAD. On an unknown date, the patient received KINRIX at an unknown dose. On an unknown date, several hours after receiving KINRIX, the patient experienced fever. The patient was treated with ADVIL and TYLENOL. On an unknown date, the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the fever to be related to KINRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient developed high fever within hours after receiving the KINRIX vaccine. The health care professional recommended TYLENOL or ADVIL for the fever. This case has been linked with US2018112030 and US2018112032 reported by same reporter.