chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site erythema in a 73-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included shingles Vaccine (many years ago, received older shingles vaccination with no problems.).  On 31st December 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site pain were recovering/resolving. It was unknown if the reporter considered the injection site erythema, injection site warmth and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The fair overall healthy patient received SHINGRIX from the pharmacist at local store. At the time of reporting nearly two weeks later the patient had arm by the injection site was still red and somewhat hot and minor pain. It was far better than it was a few days after the injection. But, the patient concerned the side-effect had lasted this long. The patient asked, what should he do besides waiting.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Influenza like illness, Miliaria, Myalgia, Pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of shingles in a 56-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (Severe). On 27th July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving Shingrix, the patient experienced shingles, pain, heat rash, myalgia and influenza-like symptoms. On an unknown date, the outcome of the shingles, pain and heat rash were recovered/resolved and the outcome of the myalgia and influenza-like symptoms were unknown. It was unknown if the reporter considered the shingles, pain, heat rash, myalgia and influenza-like symptoms to be related to SHINGRIX.  Additional details were provided as follows: The registered nurse reported this case for herself. The age at vaccination was not reported but it could be 55 years or 56 years. Sometime before Thanksgiving, the patient experienced very mild shingles. The shingles resolved after 3 days of intense pain, heat rash but no blisters. The reporter gave consent to follow up.
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Abdominal discomfort, Incomplete course of vaccination, Malaise, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sickness in a elderly female patient who received SHINGRIX for prophylaxis. Co-suspect products included Influenza vaccine Quadrivalent 2017-2018 season for prophylaxis and SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX, Influenza vaccine Quadrivalent 2017-2018 season at an unknown dose and the 2nd dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX and Influenza vaccine Quadrivalent 2017-2018 season and not applicable after receiving SHINGRIX, the patient experienced sickness, fever, stomach discomfort and incomplete course of vaccination. On an unknown date, the outcome of the sickness, fever and stomach discomfort were recovered/resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the sickness, fever and stomach discomfort to be related to SHINGRIX and Influenza vaccine Quadrivalent 2017-2018 season. Additional details were provided as follows: This case was reported by the patient's husband. The age at vaccination was not reported but the patient could be 64 or 65 years old. The patient on Thursday had a SHINGRIX and a flu vaccine at least 6 to 8 months prior to the date of reporting. After the first dose of SHINGRIX, the patient was sick, had fever and sick to her stomach for the weekend following the Thursday she received it on. The patient was told she could get her SHINGRIX vaccine in one dose and would not need to return. The patient had not returned for a 2nd dose of SHINGRIX vaccine, which led to incomplete course of vaccination. The reporter did not know what flu vaccine the patient got, but did believe the shots were given separately during that visit. It was given at a physician office, but caller doesn't know any details of it. The overdose was not reported, as the reporter was unsure if two doses were given at same time. Case number was provided for the patient if she wanted to callback and give additional details.
Sex: U
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 an adult patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included arthritis. On 7th January 2019, the patient received SHINGRIX. On 8th January 2019, 1 days after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovering/resolving. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient, a day before date of reporting experienced aches in their arms and legs following vaccination. The patient had arthritis and was unsure if it was related to SHINGRIX or not. On the date of reporting, the patient reported that their symptoms were feeling a little better. The reporter consented to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Anorectal discomfort, Proctalgia, Pruritus, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hives in a 62-year-old female patient who received SHINGRIX for prophylaxis. On 21st October 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced hives, itchy scalp, rectal pain and burning rectal. The patient was treated with cetirizine hydrochloride (Zyrtec) and prednisone. On an unknown date, the outcome of the hives, itchy scalp, rectal pain and burning rectal were not recovered/not resolved. It was unknown if the reporter considered the hives, itchy scalp, rectal pain and burning rectal to be related to SHINGRIX. Additional details were provided as follows: The patient after getting the dose of SHINGRIX she started getting hives, her whole scalp and her stomach started itching. She had burning pain inside her rectum.  The patient had consented to follow up and provided contact details of her treating physicians. For tolerance to 2nd dose see case US2019004268, reported for the same patient.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest X-ray abnormal, Cough, Pneumonia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pneumonia in a 72-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 15th December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 29th December 2018, 14 days after receiving SHINGRIX, the patient experienced pneumonia (serious criteria GSK medically significant) and cough. On an unknown date, the outcome of the pneumonia was not recovered/not resolved and the outcome of the cough was unknown. It was unknown if the reporter considered the pneumonia and cough to be related to SHINGRIX. Additional details were received as follows: On 15th September 2018, the patient received 1st dose SHINGRIX in the left arm. On 29th December 2018, the patient reported that she started coughing. On 5th January 16, 2019, the patient went to physician and had a chest x-ray. From that it was determined that the patient had pneumonia. The patient did not consent to follow up. The representative unable to obtain additional information.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 74-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received in past) and Chicken pox vaccine (received in past). On 10th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). In January 2019, 12 hrs after receiving SHINGRIX, the patient experienced muscle pain, chills and headache. On an unknown date, the outcome of the muscle pain, chills and headache were unknown. It was unknown if the reporter considered the muscle pain, chills and headache to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The patient experienced muscle ache, chills and headache. The reporter did not consent for follow up. No further details were provided and the patient would follow up with their health care professional.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 58-year-old female patient who received SHINGRIX for prophylaxis. On 30th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm, pain and chills. On an unknown date, the outcome of the pain in arm, pain and chills were recovered/resolved. It was unknown if the reporter considered the pain in arm, pain and chills to be related to SHINGRIX. Additional details were provided as follows: The patient experienced sore arm, aching and chills for 3 to 4 days and then those events resolved. The reporter did not gave consent to follow up. The reporter declined prescriber to follow up.
Sex: U
Vaccine: PNC13
Symptoms: Essential hypertension
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program Pfizer RXPathways. A contactable physician reported that a 79 years old patient received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient medical history and concomitant medications were not reported. It's reported ''Diagnosis: Essential hypertension''. The outcome of the event was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Induration, Pain
Clinical narrative: Patient developed an erythematous area of induration (less than 1 cm) that was sore for 24hrs. This was first noted greater than 12 hrs post vaccination.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Allergy test, Full blood count, Injection site swelling
Clinical narrative: SEVERE SWELLING AROUNG INJECTION SITES, BOTH ARMS.
Sex: M
Vaccine: PPV
Symptoms: Wrong product administered
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 67 year old male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date in 2018 (also reported as last year), the patient was vaccinated with PNEUMOVAX 23 (dosing details, strength, route, frequency were unknown) for an unknown indication and again yesterday instead of receiving PREVNAR 13 (wrong product administered)(Interchange of vaccine products).
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Dizziness, Headache, Injection site pain
Clinical narrative: 3 days of soreness in site of injection, muscle soreness, joint pain, chills, nausea, fever,  headaches, light headedness.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: 3 days of soreness in site of injection, muscle soreness, joint pain, chills, nausea, fever,  headaches, light headedness.
Age: 78.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Injection site reaction, Lip oedema, Swelling face
Clinical narrative: Left arm red, swelling of  the face, large  site reaction  - lip edema w/o other symptoms.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Muscular weakness, Paraesthesia
Clinical narrative: Possible poor administration technique leading to tingling and weakness in left arm since time of shot.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Dizziness, Fall
Clinical narrative: Patient was able to ambulate out of clinic on own but while in the parking lot became lightheaded and weak. Patient walked several steps while leaning against her mother and had a controlled fall to the ground where she laid on her back for a moment but was able to sit up until nurse arrived. Patient denies syncope and injury or pain related to fall.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Dehydration, Diarrhoea, Dizziness, Fall, Feeding disorder
Clinical narrative: Nausea, runs, dehydrated. Couldn't eat dizzy falling. Mind not functioning. Arm hurt. Body aches Vertigo. Had to use cane. (Out of touch with life til November). Lost 20 pounds.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Mental disorder, Nausea, Pain, Pain in extremity, Vertigo
Clinical narrative: Nausea, runs, dehydrated. Couldn't eat dizzy falling. Mind not functioning. Arm hurt. Body aches Vertigo. Had to use cane. (Out of touch with life til November). Lost 20 pounds.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Walking aid user, Weight decreased
Clinical narrative: Nausea, runs, dehydrated. Couldn't eat dizzy falling. Mind not functioning. Arm hurt. Body aches Vertigo. Had to use cane. (Out of touch with life til November). Lost 20 pounds.
Age: 12.0
Sex: M
Vaccine: HPV9, TDAP
Symptoms: Dyskinesia, Head injury, Immediate post-injection reaction, Injection site pain, Musculoskeletal stiffness
Clinical narrative: Immediately after vaccine administration patient stated that "Oh that hurt."  Slumped down to the left, I caught him and he flung his trunk back hitting his head on the left side of the exam bed. He was stiff and hands were stiff and jerking. I called for help and RN, came in immediately. She put a wet washcloth on head while I concentrated on keeping his body on the exam bed. The whole event probably lasted 45 seconds. Patient came to and denied feeling bad. Denied nausea, headache, or feeling ill in any way. Reports he did not eat any breakfast prior to coming to the health department, was given a sucker. Noted to be pale. Sat on exam bed for approximately 10 minutes. Reported that he was "feeling fine." Walked to the waiting room with his mother, sat for another 5 minutes. Reported he was still feeling fine prior to leaving. Denies any recollection of event.
Age: 12.0
Sex: M
Vaccine: HPV9, TDAP
Symptoms: Pallor, Syncope
Clinical narrative: Immediately after vaccine administration patient stated that "Oh that hurt."  Slumped down to the left, I caught him and he flung his trunk back hitting his head on the left side of the exam bed. He was stiff and hands were stiff and jerking. I called for help and RN, came in immediately. She put a wet washcloth on head while I concentrated on keeping his body on the exam bed. The whole event probably lasted 45 seconds. Patient came to and denied feeling bad. Denied nausea, headache, or feeling ill in any way. Reports he did not eat any breakfast prior to coming to the health department, was given a sucker. Noted to be pale. Sat on exam bed for approximately 10 minutes. Reported that he was "feeling fine." Walked to the waiting room with his mother, sat for another 5 minutes. Reported he was still feeling fine prior to leaving. Denies any recollection of event.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pyrexia
Clinical narrative: Patient described flu-like symptoms starting the day following injection including low-grade fever and chills. Patient self-treated with OTC analgesics.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Feeling abnormal, Nausea, Vaccine positive rechallenge
Clinical narrative: EXTREME WEAKNESS, FATIGUE, NAUSEA AND VOMITING. I SPOKE TO PATIENT AND LET HER KNOW THAT THESE EFFECTS ARE IN THE VIS THAT SHE RECIEVED. SHE WAS GREATLY CONCERNED BECAUSE SHE FELT REALLY BAD FOR 1 DAY AFTER THE VACCINATION.  SHE ALSO SAID THAT THE SAME THING HAPPENED WITH THE FIRST DOSE BUT SHE ONLY CALLED ME TO REPORT AFTER THE SECOND DOSE.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: EXTREME WEAKNESS, FATIGUE, NAUSEA AND VOMITING. I SPOKE TO PATIENT AND LET HER KNOW THAT THESE EFFECTS ARE IN THE VIS THAT SHE RECIEVED. SHE WAS GREATLY CONCERNED BECAUSE SHE FELT REALLY BAD FOR 1 DAY AFTER THE VACCINATION.  SHE ALSO SAID THAT THE SAME THING HAPPENED WITH THE FIRST DOSE BUT SHE ONLY CALLED ME TO REPORT AFTER THE SECOND DOSE.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Myalgia
Clinical narrative: PATIENT REPORTED HAVING MUSCLE PAIN LASTING FOR A FEW MONTHS.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Cold sweat, Cyanosis, Pallor, Pyrexia, Vomiting
Clinical narrative: Past history of high fever and perioral cyanosis with MMR dose #1 given  at 1 year old. Less than 30 minutes after pt received her MMR vaccine #2 on 1/18/19, her mother brought her back into the clinic to report she had vomited as she was getting into their car. Pt appeared pale, was clammy to the touch and vomited x1. She was afebrile, steady pulse, and regular, non-labored respirations. She had no facial swelling or rash.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Urticaria
Clinical narrative: PATIENT CALLED AND STATED AFTER A COUPLE OF DAYS SHE NOTICED A HIVE LIKE AREA ON HER ARM AND OTHER PLACES ON BODY, STATED SHE HAD ALSO WORKED OUTSIDE IN A BARN RIGHT AFTER. PT WAS TOLD TO GO SEE A DOCTOR.
Age: 61.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Erythema, Peripheral swelling, Tenderness
Clinical narrative: Redness, Swollen, Tenderness on L Arm.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Migraine, Myalgia
Clinical narrative: I experienced fever that did not respond to TYLENOL, shivering, muscle aches, fatigue, headache and nausea. All of these symptoms were very severe and kept me in bed through Monday, January 7th. The fever took approximately 36 hours to resolve. I would classify the headache as a migraine. I was unable to eat during most of this and tried to keep water down. I spoke with an on-call physician on Sunday, January 6th, who didn't have a lot to offer except to attempt to stay hydrated and if I could not then proceed to the ER. The headache and fatigue resolved almost a week later on January 10th.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: I experienced fever that did not respond to TYLENOL, shivering, muscle aches, fatigue, headache and nausea. All of these symptoms were very severe and kept me in bed through Monday, January 7th. The fever took approximately 36 hours to resolve. I would classify the headache as a migraine. I was unable to eat during most of this and tried to keep water down. I spoke with an on-call physician on Sunday, January 6th, who didn't have a lot to offer except to attempt to stay hydrated and if I could not then proceed to the ER. The headache and fatigue resolved almost a week later on January 10th.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Herpes zoster, Lethargy, Muscular weakness
Clinical narrative: This was a second shot of the SHINGRIX vaccine for shingles. I had no adverse reaction to the first shot. Was given the vaccine on Thursday afternoon at 2:45 pm. Woke up at 4:00 am Friday morning with chills, lethargy, muscle weakness, nausea, fever of 100.5 and a horrible headache. Spent most of Friday either sleeping or resting. Felt some better by Saturday, but still had fever and persistent headache. Headache remained through Sunday but was gone by Monday morning. I have never ever had a reaction like this to ANY vaccine.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: This was a second shot of the SHINGRIX vaccine for shingles. I had no adverse reaction to the first shot. Was given the vaccine on Thursday afternoon at 2:45 pm. Woke up at 4:00 am Friday morning with chills, lethargy, muscle weakness, nausea, fever of 100.5 and a horrible headache. Spent most of Friday either sleeping or resting. Felt some better by Saturday, but still had fever and persistent headache. Headache remained through Sunday but was gone by Monday morning. I have never ever had a reaction like this to ANY vaccine.
Age: 38.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site was red, hot, and swollen. No fever.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Arthritis, Bursitis, Contusion, Immediate post-injection reaction, Injection site pain
Clinical narrative: Pt reports she Immediately felt pain with injection. 10 days later reported ongoing pain, bruising high on shoulder and decreased mobility. Referred to orthopedics and diagnosed with left shoulder bursitis following XRay and treated with Medrol Dose Pak and diclofenac due to vaccine entering subacromial space. No improvement with conservative management. 12/11/18 received Depomedrol injection with no improvement. MRI 1/15/19 diagnosed with left shoulder AC arthritis, adhesive capsulitis and partial tear supraspinatous tendon with tendinosis. small effusion subacromial subdeltoid bursa. Referred to orthopedic surgery for possible arthroscopic subacromial decompression and manipulation under anesthesia. She was seen 1/21/19  Assessment indicated mild left shoulder adhesive capsulitis with AC arthritis. Partial-thickness rotator cuff tear. Surgical and nonsurgical interventions were discussed and she received injection of the left AC joint with 1 cc of 1% lidocaine and 1 cc of 40 mg/cc Kenalog with significant relief of pain and improved motion. Will begin physical therapy but  may ultimately need surgery.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Joint effusion, Mobility decreased, Nuclear magnetic resonance imaging abnormal, Periarthritis, Rotator cuff syndrome
Clinical narrative: Pt reports she Immediately felt pain with injection. 10 days later reported ongoing pain, bruising high on shoulder and decreased mobility. Referred to orthopedics and diagnosed with left shoulder bursitis following XRay and treated with Medrol Dose Pak and diclofenac due to vaccine entering subacromial space. No improvement with conservative management. 12/11/18 received Depomedrol injection with no improvement. MRI 1/15/19 diagnosed with left shoulder AC arthritis, adhesive capsulitis and partial tear supraspinatous tendon with tendinosis. small effusion subacromial subdeltoid bursa. Referred to orthopedic surgery for possible arthroscopic subacromial decompression and manipulation under anesthesia. She was seen 1/21/19  Assessment indicated mild left shoulder adhesive capsulitis with AC arthritis. Partial-thickness rotator cuff tear. Surgical and nonsurgical interventions were discussed and she received injection of the left AC joint with 1 cc of 1% lidocaine and 1 cc of 40 mg/cc Kenalog with significant relief of pain and improved motion. Will begin physical therapy but  may ultimately need surgery.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Tendon disorder, X-ray limb abnormal
Clinical narrative: Pt reports she Immediately felt pain with injection. 10 days later reported ongoing pain, bruising high on shoulder and decreased mobility. Referred to orthopedics and diagnosed with left shoulder bursitis following XRay and treated with Medrol Dose Pak and diclofenac due to vaccine entering subacromial space. No improvement with conservative management. 12/11/18 received Depomedrol injection with no improvement. MRI 1/15/19 diagnosed with left shoulder AC arthritis, adhesive capsulitis and partial tear supraspinatous tendon with tendinosis. small effusion subacromial subdeltoid bursa. Referred to orthopedic surgery for possible arthroscopic subacromial decompression and manipulation under anesthesia. She was seen 1/21/19  Assessment indicated mild left shoulder adhesive capsulitis with AC arthritis. Partial-thickness rotator cuff tear. Surgical and nonsurgical interventions were discussed and she received injection of the left AC joint with 1 cc of 1% lidocaine and 1 cc of 40 mg/cc Kenalog with significant relief of pain and improved motion. Will begin physical therapy but  may ultimately need surgery.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Muscle spasms, Muscular weakness, Musculoskeletal pain, Pain in extremity
Clinical narrative: Arm and shoulder and elbow aches with very strong muscle cramping with weakness in the arm since the shot was given 6-7 weeks ago.
Age: 1.42
Sex: F
Vaccine: DTAPIPV, FLU4, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report refers to a 17 month old female patient. The patient did not have any pre-existing physician-diagnosed allergy, birth defects, medical conditions or illness at time of vaccination. Historical vaccines included ROTATEQ, RECOMBIVAX HB,  PREVNAR 13, and FLUBLOK. On 18-SEP-2018 the patient was vaccinated with VARIVAX lot # N035940, expiration date: 18-DEC-2019; M-M-R II lot # N025894, expiration date: 19-SEP-2019; VAQTA lot # R006210, expiration date: 22-APR-2019; PREVNAR 13 lot # W11304, expiration date :31-MAY-2020; FLUBLOK lot # UT6259KA, expiration date: 30-JUN-2019; QUADRACEL, lot # C5254AA, expiration date: 18-SEP-2019; ACTHIB, lot # UI899AA, expiration date; 17-SEP-2019 (dose number, route and anatomical location were not provided). All the vaccines were administered for prophylaxis and purchased with public funds. The administered doses of the vaccines experienced a freezer temperature excursion (not specified) as recorded from a digital data logger which ocurred at the time of storage in clinical practice. No adverse effect was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA002756: US-009507513-1901USA002757: US-009507513-1901USA002758: US-009507513-1901USA002760: US-009507513-1901USA002761: US-009507513-1901USA002762: US-009507513-1901USA002763: US-009507513-1901USA002764: US-009507513-1901USA002765: US-009507513-1901USA002753: US-009507513-1901USA002754: US-009507513-1901USA002755: US-009507513-1809USA010598.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Henoch-Schonlein purpura
Clinical narrative: This spontaneous report was received from a physician via company representative, referring to a 1 year old male patient. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were unknown by the reporter. On 15-DEC-2018, the patient was vaccinated with PROQUAD lot# R013126, expiration date 04-NOV-2019, for prophylaxis (strength, dose, route and frequency were not reported) and with VAQTA lot# R006210, expiration date 22-APR-2019, for prophylaxis (strength, dose, route and frequency were not reported). On 05-JAN-2019 to 07-JAN-2019, the patient was admitted for unspecified reasons (adverse event). On an unknown date in January 2019, the patient was diagnosed with Henoch-Schonlein Purpura (HSP) at the hospital. The patient sought medical attention but was unknown if the patient received treatment or if diagnostic laboratories were performed. At the time of reporting, the outcome of henoch-schonlein purpura was recovering. The outcome of adverse event was recovered on an unknown date in January 2019  (reported as the patient is fine now). The causality assessment was not provided.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Based on follow-up information received on 15-Jan-2019, the case was assessed as non-case previously has become valid upon follow-up. Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 31 years old female patient who experienced urticaria on arms and legs, while she received vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant therapy were not provided. On 18-Sep-2012, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot UH7321AB via intramuscular route in upper extremities. On 18-Sep-2012, the patient developed a non-serious urticaria on arms and legs 1-4 hours following the administration of INFLUENZA VACCINE. No other associated symptoms observed. No lab test reported. Final diagnosis was urticaria on arms and legs. Patient received antihistamines as corrective treatment. The patient outcome is reported as Recovered / Resolved on an unknown date for urticaria on arms and legs (lasted for 1 week).
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Haematuria, Injection site cellulitis, Injection site discolouration, Injection site erythema
Clinical narrative: 12-14-18 Nurse Practitioner, showed me the SHINGRIX vials and expiry date. She injected on my left arm 2 inches below the arm pit. I could feel the vaccine spraying underneath my skin. This was a very difference experience compared to my first SHINGRIX shot on 9-7-18 administered by a different nurse practitioner. In my opinion, nurse did not follow CDC administering guidelines for SHINGRIX. 12-15-18 woke up at 1AM due to pain on injections site which now has a bump. Took TYLENOL at 2PM had fever and chills. Injection site swollen, red, warm. Had gross hematuria. 12-16/18 no more fever and chills. Injection site dark like sunburn, warm, painful. 12-17-18 9 AM showed my arm to employee health nurse at work. She advised me to return to advocate clinic at Pharmacy because I may need antibiotic. 12-17-18 4PM nurse practitioner diagnosed cellulitis and ordered cephalexin 500 MG for 10 days. 12-18-18 injection site less red. Swollen area diminished, smaller than original. 12-19-18 no more gross hematuria.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: 12-14-18 Nurse Practitioner, showed me the SHINGRIX vials and expiry date. She injected on my left arm 2 inches below the arm pit. I could feel the vaccine spraying underneath my skin. This was a very difference experience compared to my first SHINGRIX shot on 9-7-18 administered by a different nurse practitioner. In my opinion, nurse did not follow CDC administering guidelines for SHINGRIX. 12-15-18 woke up at 1AM due to pain on injections site which now has a bump. Took TYLENOL at 2PM had fever and chills. Injection site swollen, red, warm. Had gross hematuria. 12-16/18 no more fever and chills. Injection site dark like sunburn, warm, painful. 12-17-18 9 AM showed my arm to employee health nurse at work. She advised me to return to advocate clinic at Pharmacy because I may need antibiotic. 12-17-18 4PM nurse practitioner diagnosed cellulitis and ordered cephalexin 500 MG for 10 days. 12-18-18 injection site less red. Swollen area diminished, smaller than original. 12-19-18 no more gross hematuria.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Gait disturbance, Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Patient described a fever 101-102 the night of receiving the immunization. She felt achy, had difficulty walking due to pain in feet. Bright red lump and swelling at injection site very sore arm. Fever and chills all night. Wanted to stay home from work but couldn't.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Patient described a fever 101-102 the night of receiving the immunization. She felt achy, had difficulty walking due to pain in feet. Bright red lump and swelling at injection site very sore arm. Fever and chills all night. Wanted to stay home from work but couldn't.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Blood potassium decreased, Blood test, Diarrhoea, Dysphagia, Dyspnoea
Clinical narrative: Per pt: when got home, started feeling couldn't swallow, mucus build up, nauseous, SOB. Had to get up, spit, lay down. Threw up and diarrhea forcefully. Called EMS for ER. Lost a lot of potassium thru blood work. After giving the patient the flu shot, we talked for a few minutes, she went home and seemed ok as she left. She came back the next day saying she went to the ER.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Secretion discharge, Vomiting
Clinical narrative: Per pt: when got home, started feeling couldn't swallow, mucus build up, nauseous, SOB. Had to get up, spit, lay down. Threw up and diarrhea forcefully. Called EMS for ER. Lost a lot of potassium thru blood work. After giving the patient the flu shot, we talked for a few minutes, she went home and seemed ok as she left. She came back the next day saying she went to the ER.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Crying, Oropharyngeal pain
Clinical narrative: Influenza vaccine given at school. Mom reports that when she picked child up at school child was crying, complained of her throat hurting and complained of her stomach hurting. Mom took child to Hospital. Mom reports that child received TYLENOL and BENADRYL and was sent home. Child went to school 10/5/18.
Age: 33.0
Sex: F
Vaccine: MMR, RAB
Symptoms: Exposure during pregnancy
Clinical narrative: Unknown pregnancy at time of vaccination pt is being followed by MD was an employee.
Age: 64.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site warmth, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient presents to clinic on 9/13/18. Patient states, "My left arm has been sore, hot to the touch, and a little swollen since a few hours after I got the shot," Denies any other complaints or prior injury to left arm. Reports she took 400mg MOTRIN on 9/12/18 with some relief. 4 inch area of erythema and warmth noted to area of left deltoid. Advised patient to report to ER if symptoms worsen.
Age: 37.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Ear pain, Laboratory test normal, Lymphadenopathy, Ultrasound scan normal
Clinical narrative: Vaccines received 9/6/18. Contacted clinic 9/10/18 and stated she went to ER 9/9/18 because she had 2 walnut sized lymph nodes to (L) collar bone. She C/O stiffed neck and (L) ear pain. ER prescribed KEFLEX and told her maybe not to get vaccines in (L) arm. She has also made appointment with MD that performed (L) breast biopsy a couple of years ago to make sure everything is ok.
Age: 52.0
Sex: F
Vaccine: FLU4, PPV, VARZOS
Symptoms: Blood pressure decreased, Blood test, Chest X-ray, Chills, Dyspnoea
Clinical narrative: Severe pain in left arm at site. Fever 102.8, blood pressure dropped so low, I passed out twice. Chills, Vomiting, Difficulty breathing over two days.
Age: 52.0
Sex: F
Vaccine: FLU4, PPV, VARZOS
Symptoms: Injection site pain, Loss of consciousness, Pyrexia, Vomiting
Clinical narrative: Severe pain in left arm at site. Fever 102.8, blood pressure dropped so low, I passed out twice. Chills, Vomiting, Difficulty breathing over two days.
Age: 27.0
Sex: M
Vaccine: FLU4
Symptoms: Angina pectoris, Blood test, Disorientation, Dizziness, Electrocardiogram abnormal
Clinical narrative: An hour or so after injection pt became very dizzy and disoriented and a very fast pounding heart with sharp pains,heart palpitations and extreme fatigue and increased these symptoms with exersice. This has continued for a month now.
Age: 27.0
Sex: M
Vaccine: FLU4
Symptoms: Electrocardiogram ambulatory, Exercise tolerance decreased, Fatigue, Heart rate increased, Palpitations
Clinical narrative: An hour or so after injection pt became very dizzy and disoriented and a very fast pounding heart with sharp pains,heart palpitations and extreme fatigue and increased these symptoms with exersice. This has continued for a month now.
Age: 27.0
Sex: M
Vaccine: FLU4
Symptoms: Sweat test, Tilt table test
Clinical narrative: An hour or so after injection pt became very dizzy and disoriented and a very fast pounding heart with sharp pains,heart palpitations and extreme fatigue and increased these symptoms with exersice. This has continued for a month now.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Patient had a cellulitis type reaction at injection site. Sought medical care and was prescribed an antibiotic for cellulitis by physician assistant. Patient presented to pharmacy 3 days after injection with prescription for the antibiotic.
Age: 0.08
Sex: F
Vaccine: HEP
Symptoms: Crying, Diarrhoea, Opisthotonus, Screaming, Somnolence
Clinical narrative: The day of was very sleepy, I know that is normal. The next day she was screaming and crying inconsolably and arching back in pain all day and night. She never normally cries. Also had diarrhea all day and night. Normally poops 1-2 times a day.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: After receiving injection, patient developed a quarter sized area that was red, inflamed, and painful around the injection site. This reaction area continued to spread throughout the last week.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Hepatic enzyme increased, Pyrexia, Vomiting
Clinical narrative: Patient states she experienced high fever and vomiting. She was hospitalized and the physician also noted she had high liver enzymes which have since resolved and gone back to being within normal limits. Her symptom onset was within 24 hours of the immunization.
Age: 23.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash, Rash maculo-papular
Clinical narrative: Patient is here today for evaluation of rash beginning underneath her breasts, and spreading to her upper chest and neck beginning 1 week ago (2-3 days after receipt of her second MMR and varicella vaccines on 1/7/19. She otherwise feels well and has no fever, chills, or joint pain. The rash is nonpruritic. No treatment thus far. No similar problems with previous vaccination. The patient was initially evaluated by nurse practitioner earlier today and referred to me for further evaluation. Otherwise, she denies any new household or cosmetic products. Skin: Under the breast, with extension into the axillary and onto the neck there is maculopapular rash without vesiculation. see photos tab of pt's EMR.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 30-MAY-2017, the patient was vaccinated with an expired dose of, PNEUMOVAX 23 (lot # L035882 and expiration date: 19-APR-2017), for prophylaxis (dose, frequency, route of administration were not reported).
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Nerve injury, Nuclear magnetic resonance imaging
Clinical narrative: Patient couldn't move arm 3 days after vaccine and couldn't get out of bed. Patient got an MRI and was told it caused nerve damage. She also needed physical therapy and couldn't move her arm for almost a year.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site mass, Injection site pain
Clinical narrative: PAIN AND LUMP AT SITE OF INJECTION.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Injection site pain
Clinical narrative: I experienced much pain at the injection site but the worst was a pain in my upper abdomen that began about 9 hours after the shot and has persisted for 24 hours or so. Some relief with eating and ibuprofen. Pain still very real and uncomfortable.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: 24 HOURS AFTER INJECT PT HAD FEVER, HEADACHE, BODY PAIN, SWELLING RED HOT AT SITE. TAKING TYLENOL, COLD COMPRESS AT SITE.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: 24 HOURS AFTER INJECT PT HAD FEVER, HEADACHE, BODY PAIN, SWELLING RED HOT AT SITE. TAKING TYLENOL, COLD COMPRESS AT SITE.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site rash, Injection site swelling, Pain
Clinical narrative: Fever/chill (for 1 day), body ache (for 1 day), swollen red rash on injection area, itchiness persisted for 4 days.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia
Clinical narrative: Fever/chill (for 1 day), body ache (for 1 day), swollen red rash on injection area, itchiness persisted for 4 days.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Fluid retention, Mass
Clinical narrative: Patient went to med express sunday following administration of vaccine Friday 1-11, signs of redness and "lumps with fluid".
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Rash generalised
Clinical narrative: Donor stated having a head to toe rash a few days after the injection, donor took a z-pack.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature, Chills, Diarrhoea, Fatigue, Pain in extremity
Clinical narrative: Extreme fatigue, temperature, shivering, diarrhea, pain in the left arm way below injection site.
Age: 58.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Immediate post-injection reaction, Pain in extremity
Clinical narrative: Patient claims immediate left arm pain that has persisted since 10/25/2018. Patient visited primacy care provider after incident who recommended physical therapy. Per patient, underwent 2 weeks of physical therapy which exacerbated arm pain.
Age: 58.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Musculoskeletal pain, Pain in extremity, Sleep disorder
Clinical narrative: Patient claims immediate left arm pain that has persisted since 10/25/2018. Patient visited primacy care provider after incident who recommended physical therapy. Per patient, underwent 2 weeks of physical therapy which exacerbated arm pain.
Age: 58.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Immediate post-injection reaction, Pain in extremity
Clinical narrative: Pain in upper left arm, radiating to shoulder. Saw P.A. who prescribed physical therapy. Completed two weeks of physical therapy but experienced worsening pain so stopped. Researched SIRVA online and determined that rest and time were reported to be best for recovery. Three months later, still experiencing pain in arm and shoulder. Three months now of interrupted sleep and pain. Unsure of how to resolve. I will be returning to primary for guidance.
Age: 58.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Musculoskeletal pain, Pain in extremity, Sleep disorder
Clinical narrative: Pain in upper left arm, radiating to shoulder. Saw P.A. who prescribed physical therapy. Completed two weeks of physical therapy but experienced worsening pain so stopped. Researched SIRVA online and determined that rest and time were reported to be best for recovery. Three months later, still experiencing pain in arm and shoulder. Three months now of interrupted sleep and pain. Unsure of how to resolve. I will be returning to primary for guidance.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy breast normal, Biopsy skin abnormal, Breast swelling, Erythema, Hypersensitivity
Clinical narrative: Vaccine given on left arm. Left breast swelled and turned red. Faded but still showing 6 months later.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Ultrasound breast normal
Clinical narrative: Vaccine given on left arm. Left breast swelled and turned red. Faded but still showing 6 months later.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness
Clinical narrative: Patient was light headed and dizzy almost immediately after injection. She had not eaten so provided patient with orange juice. After 5 minutes or so, patient requested emergency services be called. They cleared the patient, she was not taken elsewhere for treatment.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Hypersensitivity, Lethargy, Pain, Peripheral swelling
Clinical narrative: Pt. states lethargy, aching, and swelling of left arm, Tuesday, night of vaccination. Wednesday and Thursday fever, sweating, and itching began. Symptoms subsided on Friday. Patient contacted pharmacy on Friday to report adverse reactions. Pt. stated she is hypersensitive and MD told her to inform anyone whom may give her injections and she did not inform pharmacy at time of her vaccination. Patient took TYLENOL and rested. Patient is symptom free and feeling better. Pharmacist followed up with patient on Monday 01/21/19 to complete report and retrieve necessary info to complete form.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia
Clinical narrative: Pt. states lethargy, aching, and swelling of left arm, Tuesday, night of vaccination. Wednesday and Thursday fever, sweating, and itching began. Symptoms subsided on Friday. Patient contacted pharmacy on Friday to report adverse reactions. Pt. stated she is hypersensitive and MD told her to inform anyone whom may give her injections and she did not inform pharmacy at time of her vaccination. Patient took TYLENOL and rested. Patient is symptom free and feeling better. Pharmacist followed up with patient on Monday 01/21/19 to complete report and retrieve necessary info to complete form.
Age: 12.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: After leaving the pharmacy area she became dizzy and passed out. Patient recovered after resting a while and left with her family.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: PATIENT CLAIMED FELT LIGHT HEADED AND DIZZINESS AND WHEN AT HOME HAD PASSED OUT FOR 5 MINUTES.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Flank pain, Ocular hyperaemia, Pericarditis, Rheumatoid arthritis
Clinical narrative: Two days after receiving vaccination patient started getting joint pain, pain in his side and bloodshot eyes. Patient went to a physician office and got Prednisone. He went to the emergency room 5 days later and was referred to his PCP. He went to his primary care doctor about 4 days later and was sent to the emergency room. He was diagnosed with rheumatoid arthritis and pericarditis.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia oral
Clinical narrative: Tingling of the tongue. Told her to stick around the store so I could monitor her but put said she was all right and that it may have been due to not eating breakfast and drinking coffee before coming.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient states arm hurt during the day then by evening about 5 pm she couldn't lift her arm. She couldn't lift up through the night and next day. She began to apply ice packs on and off for several days. By evening of the next day she could lift her left arm again but not fully. The arm continues to be sore and difficult to lift above her shoulder without assistance. She felt the injection was given too high. Healthcare provider administering did feel the dose was difficult to inject with resistance when pushing plunger. She did speak to a doctor but not her PCP who stated to her the injection was a "bad" one and the reason for the pain.
Age: 32.0
Sex: F
Vaccine: HPV9
Symptoms: Migraine, Rash erythematous, Rash generalised
Clinical narrative: The night I received the GARDASIL vaccination I developed a migraine that lasted about 3 day. The next day I noticed I developed a full body rash. Rash was red and raised. It was not itchy. I went to the Dr.'s office the next day and saw by the PA. I was put on prednisone as well as ZYRTEC. The rash resolved within a week's time span.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: At site of immunization erythema and induration about 2x1 on Rt upper arm.