chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Urticaria
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of hives in a female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced hives, injection site erythema, injection site swelling and injection site pain. The patient was treated with BENADRYL. On an unknown date, the outcome of the hives, injection site erythema, injection site swelling and injection site pain were recovered/resolved. It was unknown if the reporter considered the hives, injection site erythema, injection site swelling and injection site pain to be related to SHINGRIX. Additional details were provided as follows: A GlaxoSmithKline Medical Information Scientist in the field called the GlaxoSmithKline Response Center today (on the reporting day) and said that yesterday afternoon around 2 PM central time. The reporting pharmacist attending 2018 annual conference told him that the patient who was older than fifty years of age got hives the morning following her first dose of SHINGRIX. The patient also had redness, swelling, and pain of her arm described as all being symptoms occurring at the site of injection which occurred within 6 hours of after the SHINGRIX was received. The patient's symptoms was treated with BENADRYL. The sales representative did not have contact information for the reporting pharmacist. The reporting pharmacist said that the patient was one her patient but it was unknown where the vaccine was administered at this time. No further details were provided. The reporting pharmacist planned to call back GlaxoSmithKline's response center with reference number with any further details learned.
Sex: U
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of erythematous rash in a patient who received SHINGRIX. 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 erythematous rash. On an unknown date, the outcome of the erythematous rash was recovered/resolved. It was unknown if the reporter considered the erythematous rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a red rash after receiving SHINGRIX. It was less than 100 mm in size and resolved within 3 days. The reporter had a picture of the rash. No additional information was available.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Neck pain, Pain, Pain in extremity
Clinical narrative: Following FLUCELVAX QUAD vaccine administration experienced pain from neck/collarbone to elbow and hand. Sometimes shooting pain worse at night when trying to sleep.
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pain, Restlessness
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of restlessness in a male patient who received SHINGRIX. On 12th March 2018, the patient received SHINGRIX. In March 2018, less than a day after receiving SHINGRIX, the patient experienced restlessness, pain and headache. On an unknown date, the outcome of the restlessness, pain and headache were unknown. It was unknown if the reporter considered the restlessness, pain and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received first dose of SHINGRIX and experienced soreness, restlessness and headache at night. This case has been linked with case US2018GSK047416, reported by the same reporter.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of leg pain in a 66-year-old male patient who received SHINGRIX (batch number P3777, expiry date 30th January 2020). Concurrent medical conditions included diabetes mellitus and stroke. On 7th December 2017, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In December 2017, 7 days after receiving SHINGRIX, the patient experienced leg pain. On an unknown date, the outcome of the leg pain was recovered/resolved. The reporter considered the leg pain to be almost certainly related to SHINGRIX. Additional details were reported as follows: The patient received the vaccine on right arm. Approximately 1 week after receiving the 1st dose of SHINGRIX, the patient experienced bilateral leg pain from thigh to calf. He rated the pain as 3 on a scale of 1 to 5. The patient did not report the event immediately or seek treatment. The pain resolved within 2 to 3 weeks. This case has been linked with case US2018GSK048555 (same patient) for 2nd suspect.
Sex: M
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site swelling, Pain, Pain in extremity
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site swelling in a 61-year-old male patient who received SHINGRIX. Previously administered products included Flu vaccine and Tdap vaccine. On 16th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In February 2018, less than a day after receiving SHINGRIX, the patient experienced radiating pain and allergic reaction. On 16th February 2018, the patient experienced injection site swelling and pain in arm. On an unknown date, the outcome of the injection site swelling, pain in arm and radiating pain were recovering/resolving and the outcome of the allergic reaction was unknown. The reporter considered the injection site swelling to be probably related to SHINGRIX. It was unknown if the reporter considered the pain in arm, radiating pain and allergic reaction to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the registered nurse (RN). The age at vaccination was not reported but it could be 60 or 61 year old. The patient had no other reactions to other previous vaccines. The patient received SHINGRIX in left arm. The patient experienced softball size swelling on left arm at injection site and severe pain in their left shoulder radiating down the left arm, down through the abdomen, hip, and ankle all on left side. The patient was not hospitalized and symptoms were resolving at the time they were reported to their physician. The physician recommended patient not get 2nd dose of SHINGRIX due to the potential that these experiences were an allergic reaction to the vaccine. Nurse stated possibly related to either the SHINGRIX or the administration of the SHINGRIX, but no further details were available. The patient was instructed to report the experience also to pharmacy where they received the vaccination.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Extensive swelling of vaccinated limb, Headache, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 61-year-old female patient who received SHINGRIX. Concomitant products included simvastatin, carvedilol, hydrochlorothiazide and potassium gluconate. On 27th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site pain, injection site erythema, injection site warmth, injection site itching, generalized joint pain and headache. The patient was treated with Aspirin and BENADRYL. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain, injection site erythema, injection site warmth, injection site itching, generalized joint pain and headache were recovered/resolved. The reporter considered the extensive swelling of vaccinated limb, injection site pain, injection site erythema, injection site warmth, injection site itching, generalized joint pain and headache to be related to SHINGRIX. Additional information was reported as follows: The patient received the vaccine at a local pharmacy. The batch number for SHINGRIX was not reported. The patient stated that after vaccination, she experienced injection site pain, injection site swelling to the size of a grapefruit, injection site warmth and injection site itching, which lasted for 9 days. Three days after the vaccination the patient experienced generalized joint pain. The patient took Aspirin and BENADRYL as treatment drugs, to treat the events. The patient reported that, there was no healthcare professional, who instructed to take the vaccine. The local pharmacist suggested her to take the vaccine. The agent instructed the patient to contact her healthcare professional. The patient had denied permission to contact her physician.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 61-year-old female patient who received SHINGRIX. Concomitant products included simvastatin, carvedilol, hydrochlorothiazide and potassium gluconate. On 27th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site pain, injection site erythema, injection site warmth, injection site itching, generalized joint pain and headache. The patient was treated with Aspirin and BENADRYL. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain, injection site erythema, injection site warmth, injection site itching, generalized joint pain and headache were recovered/resolved. The reporter considered the extensive swelling of vaccinated limb, injection site pain, injection site erythema, injection site warmth, injection site itching, generalized joint pain and headache to be related to SHINGRIX. Additional information was reported as follows: The patient received the vaccine at a local pharmacy. The batch number for SHINGRIX was not reported. The patient stated that after vaccination, she experienced injection site pain, injection site swelling to the size of a grapefruit, injection site warmth and injection site itching, which lasted for 9 days. Three days after the vaccination the patient experienced generalized joint pain. The patient took Aspirin and BENADRYL as treatment drugs, to treat the events. The patient reported that, there was no healthcare professional, who instructed to take the vaccine. The local pharmacist suggested her to take the vaccine. The agent instructed the patient to contact her healthcare professional. The patient had denied permission to contact her physician.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Myalgia
Clinical narrative: 9 hours after injection had uncontrollable shivering and intense joint and muscle pain.
Age: 3.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Patient was given KINRIX too early, no adverse reactions.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Type 1 diabetes mellitus
Clinical narrative: As a Type 1 Diabetic, I had to double my fast acting insulin the first 24 hours after the vaccination. Similar to a cortisone injection. Other than that, I had quite a bit of soreness at the injection site but no other symptoms.
Sex: U
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Urticaria
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of welts in a patient who received SHINGRIX. In March 2018, the patient received the 1st dose of SHINGRIX. In March 2018, immediately after receiving SHINGRIX, the patient experienced welts. The patient was treated with ibuprofen. On an unknown date, the outcome of the welts was unknown. It was unknown if the reporter considered the welts to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX dose about 2 days ago before the time of reporting and developed a whelp on the arm almost immediately after the dose of the vaccine. The patient was treated with ice and ibuprofen. This case has been linked with case US2018GSK047411, reported by the same reporter.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 57-year-old male patient who received SHINGRIX. Concomitant products included Blood Pressure Medicine (Unknown) and doxycycline. On 16th March 2018, the patient received SHINGRIX (intramuscular). On 18th March 2018, 2 days after receiving SHINGRIX, the patient experienced injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site swelling and injection site erythema were recovering/resolving. The reporter considered the injection site swelling to be probably related to SHINGRIX. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The patient had a course of doxycycline 15 days prior to the vaccination. The patient received SHINGRIX in left deltoid. The patient developed a 3 inch swollen red spot on his arm at the injection site.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Scratch, Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of hives in a 65-year-old female patient who received SHINGRIX. On 3rd February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In February 2018, 14 days after receiving SHINGRIX, the patient experienced hives, pruritus and scratch. On an unknown date, the outcome of the hives, pruritus and scratch were not recovered/not resolved. The reporter considered the hives to be possibly related to SHINGRIX. It was unknown if the reporter considered the pruritus and scratch to be related to SHINGRIX. Additional details were reported as follows: This case was previously reported to physician. The patient received SHINGRIX on an unknown arm, at an outside pharmacy. Two weeks after receiving the SHINGRIX vaccine, the patient developed hives and urticaria. The hives would resolve in one area of her body and develop at another part of the body. Less than a month after receiving SHINGRIX, the patient had scratch marks from where she had been itching them. On the day of reporting, the patient was admitted in the hospital. In response to the questions asked about the patient's admission, the reason was not disclosed. Additional details could not be obtained.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a pharmacist via cell center representative and described the occurrence of rash in a 69-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). On 14th March 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 16th March 2018, 2 days after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right deltoid. The patient experienced rash on her abdomen that wrapped around to her back.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Patient broke out in hives on the day of vaccine administration - vaccine at 9 am hives at 3 pm - continued hives for several 5-7 days - responded well to oral BENADRYL - 3-30-2018 - hives are gone.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Injection site discolouration, Injection site induration, Injection site nodule, Injection site swelling
Clinical narrative: Body turned purple 1 hour after administration. Diarrhea, fever, rib muscle pain and soreness, vomiting, discoloration, swelling and hard knot at injection site.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia, Skin discolouration, Vomiting
Clinical narrative: Body turned purple 1 hour after administration. Diarrhea, fever, rib muscle pain and soreness, vomiting, discoloration, swelling and hard knot at injection site.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia, Rash erythematous, Rash pruritic
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 50-year-old male patient who received SHINGRIX (batch number NX952, expiry date 6th March 2020). The patient's past medical history included shingles. Concurrent medical conditions included diabetes mellitus. On 13th March 2018 15:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, several hours after receiving SHINGRIX, the patient experienced chills, fever, erythematous rash and itchy rash. On an unknown date, the outcome of the chills, fever, erythematous rash and itchy rash were recovered/resolved. The reporter considered the chills, fever, erythematous rash and itchy rash to be almost certainly related to SHINGRIX. Additional details were provided as follows: On awakening the morning after receiving the SHINGRIX, the patient noticed chills, fever and the body temperature was recorded as 102 degree F and a red, itchy rash from chest to navel. No pain or blisters were associated with the rash. All of these symptoms had resolved by the afternoon and the patient then reported to work.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 25-JAN-2018, the patient was vaccinated with an improperly stored dose of PEDVAXHIB injection, lot # L014426 with expiration date on 08-MAR-2018 (dose and route of administration were not reported). The vaccine underwent a temperature excursion of 47 (46.9) to 77 degrees Fahrenheit for 10 minutes. Digital Data Logger was not involved in recording of the excursion. No previous temperature excursions were reported. No adverse effects were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1803USA013072: US-009507513-1803USA013073: US-009507513-1803USA013074.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions and allergies were reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX injection (strength, dose and frequency were not reported) (lot # N022986, expiration date: 23-AUG-2019) subcutaneously for prophylaxis. The vaccine was stored in between -14 degrees Celsius (C) to -10 C for 1 hour. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effect was reported. No additional information was provided. There was no product quality complaint (PQC) reported.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Amnesia, Fatigue, Immune system disorder, Tremor
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to a female patient, currently 17 year old. The patient's concurrent condition, medical history, drug reactions/allergies and concomitant medications were not reported. On 06-JAN-2015 the patient was vaccinated with GARDASIL (dose and frequency were not reported) (lot # K006191, expiry date: February 2017) intramuscularly for prophylaxis. The patient experienced memory loss, fatigue, tremors and immune problems on unspecified date. The patient reported that, memory loss was continuing. The outcome of tremor, immune system disorder, fatigue and amnesia was reported as not recovered/not resolved. The relationship between the events and GARDASIL was not reported. No product quality complaint was involved.
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from office manager via a company representative refers to a multiple unspecified male patients of unknown age. The patient's concurrent condition, medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date the patients were vaccinated with GARDASIL 9 (dose, frequency, lot #, expiry date and route were not reported) for prophylaxis. On an unknown date the patients experienced a higher incidence of syncope after receiving GARDASIL 9. The outcome of syncope was unknown. The relationship between the event (syncope) and GARDASIL 9 was not provided. No product quality complaint was involved.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 25-JAN-2018, the patient was vaccinated with an improperly stored dose of PEDVAXHIB injection, lot # L014426 with expiration date on 08-MAR-2018 (dose and route of administration were not reported). The vaccine underwent a temperature excursion of 47 (46.9) to 77 degrees Fahrenheit for 10 minutes. Digital Data Logger was not involved in recording of the excursion. No previous temperature excursions were reported. No adverse effects were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1803USA007590: US-009507513-1803USA013073: US-009507513-1803USA013074.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 21-FEB-2018, the patient was vaccinated with an improperly stored dose of PEDVAXHIB injection, lot # N031493 with expiration date on 03-OCT-2019 (dose and route of administration were not reported). The vaccine underwent a temperature excursion of 47 (46.9) to 77 degrees Fahrenheit for 10 minutes. Digital Data Logger was not involved in recording of the excursion. No previous temperature excursions were reported. No adverse effects were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1803USA007590: US-009507513-1803USA013072: US-009507513-1803USA013074.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 21-FEB-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB injection, lot # N031493 with expiration date on 03-OCT-2019 (dose and route of administration were not reported). The vaccine underwent a temperature excursion of 47 (46.9) to 77 degrees Fahrenheit for 10 minutes. Digital Data Logger was not involved in recording of the excursion. No previous temperature excursions were reported. No adverse effects were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1803USA007590:US-009507513-1803USA013072:US-009507513-1803USA013073.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 82-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). On 16th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reported batch number of SHINGRIX was updated from 3Z414 to 3Z4KL, as per sales data sheet. The patient received SHINGRIX in left arm and experienced redness and swelling below the injection site. The pharmacist reported that the patient was already followed-up with her physician. The reporter reported that the date of onset for the redness and swelling was unknown.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Redness, swelling and warmth to the left thigh small skin bulla at center of redness. Mom first noticed the morning of 3-28-18. Mom brought child in for an office visit the afternoon of 3-28-18. Doctor started pt. on cephalexin and advised Mom to give diphenhydramine as directed.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received second flu shot in 2017-18 season. No adverse effects reported from patient. Corporate policy requires reporting since standing order only covers 1 flu shot per patient per season.
Age: 39.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain, Injection site swelling, Neck pain
Clinical narrative: On 3/30/18 patient reports swelling, severe pain to site of injection that extends up to her neck and collar bone area. Taking ibuprofen 750mg - 1000mg (states does not help much with the pain).
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: Employee had varicella titer done- negative. Varicella immunity required for employment. Varicella vaccine #1 given on 2/21/18- employee did not know she was pregnant at that time. Employer asked whether employee was pregnant prior to administering vaccine, employee denied that she was pregnant. Upon receipt of reminder for Varicella vaccine #2, employee informed NP on 3/29/18 that she was about 8 weeks pregnant, and thus was pregnant when she received the first Varicella vaccine. She was not given varicella #2 vaccine.
Age: 12.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Malaise, Oropharyngeal pain, Rash, Rash erythematous, Rash pruritic
Clinical narrative: 6-10 Red, raised, very itchy bumps. One on neck, all others on torso. General malaise, sore throat, runny nose.
Age: 12.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Rhinorrhoea
Clinical narrative: 6-10 Red, raised, very itchy bumps. One on neck, all others on torso. General malaise, sore throat, runny nose.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pain, Swelling
Clinical narrative: Redness(presently over 3 days) which grew in size (approx. 4"x 1/2")swelling, soreness, hardness. Appears to be lighter on 3rd days. Used ice, took TYLENOL, applied hydocotizone cream lightly over period of days. Received the one shot shingles vaccine in 2009. Consent form only said Zoster. Not sure of which Zoster to check. This was the first of two shots to be given. It's the newest 2-shot one. Not sure if I should get the 2nd part of this vaccine.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Tenderness
Clinical narrative: RED, PAINFULL TO THE TOUCH.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Mobility decreased
Clinical narrative: Patient reported next day, difficulty lifting arm and feeling faint.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Rash
Clinical narrative: The patient developed a rash on both arms, both legs, and around his neck. He took a BENADRYL tablet and the rash disappeared within a few hours.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema
Clinical narrative: Immediately after MMR and Varicella was given in the thigh SQ in the vastus lateralis, injection site started getting red and Dr. was informed and told patient to put ice on the area and to go to the emergency room if patient started having difficulty breathing.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Laboratory test, Lumbar puncture, Mobility decreased, Myalgia, Poisoning
Clinical narrative: Within 24 hours I ended up in the hospital! Muscles so painful I couldn't move! This happened a VERY long time ago, but I wanted you to have record of my Adverse Reaction. I ended up being hospitalized twice (had a relapse after the first hospital stay). After what seemed like EVERY test in the book, my "illness" (vaccine reaction) was labeled "blood poisoning". Well, yes, my blood was poisoned!!  My kidneys were also affected. My parents did not report this, as at that time it was unknown how or even it was possible to do so. I was a totally healthy child until my mother took me in for that damn flu shot!  Guessing my body did sustain some kind of permanent damage. I did almost die, though, at the time.  I don't know the exact type of influenza shot it was (you didn't give an option for that).
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Renal disorder, Vaccination complication
Clinical narrative: Within 24 hours I ended up in the hospital! Muscles so painful I couldn't move! This happened a VERY long time ago, but I wanted you to have record of my Adverse Reaction. I ended up being hospitalized twice (had a relapse after the first hospital stay). After what seemed like EVERY test in the book, my "illness" (vaccine reaction) was labeled "blood poisoning". Well, yes, my blood was poisoned!!  My kidneys were also affected. My parents did not report this, as at that time it was unknown how or even it was possible to do so. I was a totally healthy child until my mother took me in for that damn flu shot!  Guessing my body did sustain some kind of permanent damage. I did almost die, though, at the time.  I don't know the exact type of influenza shot it was (you didn't give an option for that).
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Full blood count, Metabolic function test, Urticaria
Clinical narrative: PARENT CALLED MD ON CALL AND REPORTED PT DEVELOPED "HIVES ALL OVER" "A FEW HOURS AFTER" IMMUNIZATION WAS GIVEN. HE WAS INSTRUCTED TO TAKE BENADRYL. THE NEXT DAY THEY HAD BEEN REPORTED BY PHONE TO BE RESOLVED. THEN CONTACED AGAIN TO REPORT RETURN. PT HAS CONTINUED WITH HIVES EACH AM THAT DO RESPOND TO BENADRYL TO THIS DATE 3/30/18. PREDNISONE FOR 7 DAYS HAS NOW BEEN STARTED WITH REF. TO ALLERGY/IMMUNOLOGY.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: PATIENT ARM SWELLED FROM ELBOW TO SHOULDER. PATIENT WAS ADVISED TO ICE ARM AND TAKE BENADRYL IF IT GOT WORSE THEN PATIENT WAS INSTRUCTED TO GO TO EMERGENCY OR CALL 911.
Age: 31.0
Sex: M
Vaccine: HEP
Symptoms: Pain in extremity
Clinical narrative: Patient is reporting soreness in arm since vaccination.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Feeling hot, Hunger, Nausea, Pallor
Clinical narrative: Patient got hot, nauseous and dizzy 30 minutes after vaccine administration and told her Mom she was very hungry. Patient was also very pale.
Age: 79.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Patient began to experience shingles like outbreak from the back of his neck to his forehead. Patient also had shingles like outbreak approaching his left eye. Patient went to visit doctor's office and Dr. confirmed a case of shingles. Patient was prescribed valacyclovir, and followed up with a visit to his ophthalmologist who also prescribed TOBRADEX ointment and ZIRGAN.
Age: 79.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: Patient began to experience shingles like outbreak from the back of his neck to his forehead. Patient also had shingles like outbreak approaching his left eye. Patient went to visit doctor's office and Dr. confirmed a case of shingles. Patient was prescribed valacyclovir, and followed up with a visit to his ophthalmologist who also prescribed TOBRADEX ointment and ZIRGAN.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, pain and swelling at injection site. Muscle pain, headache and fatigue for the following 20 hours.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Redness, pain and swelling at injection site. Muscle pain, headache and fatigue for the following 20 hours.
Age: 14.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Erythema, Fall, Head injury, Nausea, Swelling face
Clinical narrative: Client received vaccines in a sitting position at 2:15pm. After administration, this nurse asked client how they were feeling and if she was feeling lightheaded at all. Client stated she felt good and not lightheaded. Client stood and waited in room while brother received vaccinations. At 2:20 pm, banging noise occurred in room. This nurse viewed client sitting on ground with eyes closed. When this nurse approached client, she woke up. Client was oriented to person and place. Able to speak clearly. Ice pack placed on back of neck while cot being set up. Client transferred to cot and legs placed in bent position. Blood pressure taken at 2:24pm as 100/70, pulse 100BPM. Client alert. Red bump appeared on left side of forehead. Ice pack placed on forehead. Client stated she was feeling nauseas. at 2:27pm, pulse was 72BPM.  at 2:31pm, blood pressure reading was 100/60 and pulse was 72 while laying on back with legs bent. at 2:35pm, client was able to sit up and drink juice. Stated she was not nauseas anymore. Client transferred to sitting position in chair at 2:38pm. Alert and Oriented to person, place, time, and situation. Blood pressure was 100/78 and pulse 80BPM. Client stated she was not feeling light headed or nauseas. Able to stand on own and walk on own. This nurse walked client out to car at 2:50pm.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Blindness unilateral, Herpes zoster
Clinical narrative: This initial spontaneous report was received from a 72 year old female patient concerning herself.  Medical history included shingles in 2010. Concurrent conditions included diabetes. She stated she was taking no concomitant medications. The patient reported that she got shingles in 2010, and then later on, on 16-JUN-2010, she went to a drug store where she picked up ZOSTAVAX, then took it to her physician to have it administered.  The patient stated she became blind in her left eye and was losing sight in her right eye after administration of ZOSTAVAX. About three to six months after she was administered ZOSTAVAX, she got up one morning and could not see out of her left eye. She saw an eye doctor and was given a "shot" in her left eye once per month and was placed on four different eye drops to try and save the eye. She went blind in her left eye. Then, an unspecified time later, she began to experience loss of sight in her right eye. She also got a "shot" in her right eye once per month but was now at once per three months. She still took unspecified eye drops. The patient did not think they would be able to save the sight in her right eye. The patient called because she received a letter from an unspecified lawyer inviting her to join a lawsuit related to ZOSTAVAX. She was not sure if she wanted to join the lawsuit. The events were not resolved at the time of the report. Causality assessment was not specified. Upon internal review, blindness in left and right eye was considered medically significant. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: RECEIVED FLU VACCINE ON 3/23/18. ON 3/24/18 REPORTED TO FATHER THAT LT ARM WAS SORE AND PAINFUL WHEN MOVING IT. I OBSERVED THAT ARM APPEARED SWOLLEN AND WARM TO THE TOUCH. PT STATED NO PAIN ANYWHERE ELSE. PT HAD NOT TAKEN ANY PAIN RELIEVER PRIOR TO REPORTING EVENT TO US.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: Patient woke up the next morning with low grade fever and tingling sensation on both arms.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Hypoaesthesia, Injected limb mobility decreased, Lymphadenopathy, Neuralgia
Clinical narrative: Two days after receiving the vaccination, patient reported arm pain and numbness in left arm. Patient saw multiple doctors on 10/3, 10/6, 10/7, and 10/19. She displayed a bruise on her left arm, continued numbness, and swollen lymph nodes for which she was given antibiotics (not disclosed). One of her doctors gave Gabapentin for the nerve pain. To compensate for not using her left arm during subsequent physical activities, patient over-worked her right arm, lower back, and upper back. No further details of dates, diagnoses, and physical evaluations were given by patient.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Repetitive strain injury
Clinical narrative: Two days after receiving the vaccination, patient reported arm pain and numbness in left arm. Patient saw multiple doctors on 10/3, 10/6, 10/7, and 10/19. She displayed a bruise on her left arm, continued numbness, and swollen lymph nodes for which she was given antibiotics (not disclosed). One of her doctors gave Gabapentin for the nerve pain. To compensate for not using her left arm during subsequent physical activities, patient over-worked her right arm, lower back, and upper back. No further details of dates, diagnoses, and physical evaluations were given by patient.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site urticaria
Clinical narrative: Patient has a 5 inch long rash/welt around the area of injection, says it is painful/burning (7 out of 10).
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Cold sweat, Dizziness, Fall, Feeling cold, Pain
Clinical narrative: At 10 pm the patient woke up feeling cold, clammy, dizzy and feverish. On the way to the bathroom he fell from excessive dizziness and had a fever of 102 degrees. His wife encouraged him to go to the Emergency Room and the patient wanted to just go back to bed. He woke up again at 4 am, took 1000 mg of acetaminophen and went to work. He still had general body aches and continued to run a fever until noon the following day.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: At 10 pm the patient woke up feeling cold, clammy, dizzy and feverish. On the way to the bathroom he fell from excessive dizziness and had a fever of 102 degrees. His wife encouraged him to go to the Emergency Room and the patient wanted to just go back to bed. He woke up again at 4 am, took 1000 mg of acetaminophen and went to work. He still had general body aches and continued to run a fever until noon the following day.
Age: 46.0
Sex: F
Vaccine: RAB, YF
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia, Neck pain, Pain in extremity
Clinical narrative: Approximately 3 weeks after receiving 2 vaccines in right arm - RABAVERT in right deltoid; STAMARIL (yellow fever) in right upper arm SQ tissue; began having right upper arm pain. Pain causing difficulty sleeping, as she usually sleeps on right side. Pain & difficulty raising right arm overhead & moving right arm behind back. Unable to straighten right arm overhead. Pt reports that pain sometimes radiates into neck or down arm. No fever or chills reported. No arm swelling noted.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Migraine
Clinical narrative: Customer stated arm was red and hard for approximately 1 and 1/2 weeks, redness went down arm and also had a migraine.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Malaise, Pruritus, Rash erythematous
Clinical narrative: Patient stated that she felt very ill the day after the vaccine with a severe headache and stayed in bed all day. She also noticed itching in her arm. On the morning of Friday, March 30, she noticed a circular, red rash on the front of her upper arm. It was not at the injection site, but about an inch lower and towards the front of her arm. She said it was hot to the touch but not painful and it had stopped itching by the time the rash appeared. It is a flat rash with no visible swelling or bumps. I advised her to take some BENADRYL today and watch the rash. I advised if it got worse or spread, to see her doctor.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Miliaria, Rash erythematous
Clinical narrative: Patient stated that she felt very ill the day after the vaccine with a severe headache and stayed in bed all day. She also noticed itching in her arm. On the morning of Friday, March 30, she noticed a circular, red rash on the front of her upper arm. It was not at the injection site, but about an inch lower and towards the front of her arm. She said it was hot to the touch but not painful and it had stopped itching by the time the rash appeared. It is a flat rash with no visible swelling or bumps. I advised her to take some BENADRYL today and watch the rash. I advised if it got worse or spread, to see her doctor.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Injection site pain, Pain, Pruritus
Clinical narrative: Shot given on 03/16/18 was painful, the next day she developed swelling, itching, and felt feverish and achy. She started to get better and then on 03/21/18 she developed redness, more swelling, and aching to the circumscribed area distal to the shot site.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Swelling
Clinical narrative: Shot given on 03/16/18 was painful, the next day she developed swelling, itching, and felt feverish and achy. She started to get better and then on 03/21/18 she developed redness, more swelling, and aching to the circumscribed area distal to the shot site.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: 10 to 12minutes after injection of vaccine pt began to feel dizziness and nausea, followed by vomiting. After pt vomited and felt better pt asked to lay on examination table at Semi-Fowler's with knees bent position. Vitals taken WNL (B/P=111/67, Temp=98.8, HR=92, R=17). Pt offered apple juice and granola bar. Pt remained at semi-Fowler's position for 10 to 15min afterward pt stated she felt fine. Pt keep sipping apple juice little by little till she felt better. Pt left home accompanied by father.
Age: 33.0
Sex: F
Vaccine: HEPAB
Symptoms: Loss of consciousness, Seizure like phenomena, Syncope
Clinical narrative: The patient experienced syncope around 1 minute following administration of vaccination. After which the patient experienced seizure-like activity shortly after syncope which lasted for around 1 or 2.  Patient then regained consciousness and stated she was okay. We called 911 which paramedics came to the pharmacy and assessed the patient. The patient was let go after they assessed her. We advised her to contact her PCP regarding the event. We also contacted both the prescribing doctor as well as her PCP to make them aware of the situation.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Blood glucose increased, Cyanosis, Seizure like phenomena, Somnolence, Tremor
Clinical narrative: Increased sleepyness for several hours after receiving vaccine. Then had brief seizure-like event -whole body shaking and face turning blue that lasted estimated less than 1 minute. Of note, patient also received Rotavirus vaccine and PREVNAR at the same time
Sex: U
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shivering in a patient who received SHINGRIX. In March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, 1 day after receiving SHINGRIX, the patient experienced shivering. In March 2018, the outcome of the shivering was recovered/resolved. The reporter considered the shivering to be almost certainly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The site of injection was either the right or left arm, the reporter could not remember. The healthcare professional stated a patient (could not remember which patient so did not have details) reported shivering. It resolved quickly and no action was taken.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a 66-year-old female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling and fever. On an unknown date, the outcome of the injection site pain and fever were recovered/resolved and the outcome of the injection site swelling was unknown. It was unknown if the reporter considered the injection site pain, injection site swelling and fever to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the medical assistant (MA). The age at vaccination was not reported. The patient developed a fever of 102 degrees. The pain and fever resolved within 2 days.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a adult male patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). On 2nd March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 3rd March 2018, 1 days after receiving SHINGRIX, the patient experienced pain in arm. In March 2018, the outcome of the pain in arm was recovered/resolved. The reporter considered the pain in arm to be almost certainly related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient was administered SHINGRIX in the left arm and experienced sore arm on next day. Till 15th March 2018 (Monday), it only felt like a minor bee sting. The caller was not aware of it or when this resolved and was unaware of patient's initials or date of birth.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 52-year-old female patient who received SHINGRIX (batch number ZY3X4, expiry date 28th April 2020). 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 chills. On an unknown date, the outcome of the chills was unknown. It was unknown if the reporter considered the chills to be related to SHINGRIX. Additional information was received as follows: The health care professional reported that the patient experienced chills or shivering after receiving SHINGRIX. No additional information was provided. This case has been linked with case US2018047705, reported by the same reporter.