chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 63-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included Pneumonia Vaccine for prophylaxis. On 28th September 2018 11:31, the patient received SHINGRIX. On 28th September 2018, the patient received PNEUMONIA VACCINE. On 28th September 2018, less than a day after receiving SHINGRIX, the patient experienced fever. In October 2018, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, injection site erythema, injection site rash and injection site itching. The patient was treated with Valacyclovir. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, injection site erythema, injection site rash and injection site itching were not recovered/not resolved and the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the vaccination failure, shingles, fever, injection site erythema, injection site rash and injection site itching to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for herself. The patient received SHINGRIX in the left arm and pneumonia vaccine in right arm. That night she had a fever of 103 degree F. The fever lasted for 2 days. Four weeks following the vaccination, the patient reported a red, itchy rash at the injection site. This case was considered as suspected vaccination failure, since the details regarding the details regarding the completion of the primary immunization for influenza and laboratory confirmation for shingles were not provided. On 4th November 2018, it was diagnosed as shingles. She was started on valacyclovir that day to treat the shingles and was on a maintenance dose of 500 mg per day currently. It was unknown if the reporter considered the fever to be related to Pneumonia Vaccine. Consent to follow up was given.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of shingles in a 61-year-old female patient who received SHINGRIX for prophylaxis. On 19th June 2018, the patient received the 1st dose of SHINGRIX. In August 2018, 45 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: About a month and half later after vaccination, the patient developed a case of the shingles. The reporter consented to follow up.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 82-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included drug allergy. On 2nd July 2018, the patient received the 1st dose of SHINGRIX. On 2nd July 2018, less than a day after receiving SHINGRIX, the patient experienced pruritus and nausea. On 4th July 2018, the outcome of the pruritus and nausea were recovered/resolved. It was unknown if the reporter considered the pruritus and nausea to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm around 2:00 or 3:00 pm. The patient reported that around dinner time that evening, she felt nauseous and then the joints on both hands, feet, and elbows became itchy. By Wednesday, all symptoms had resolved. The patient gave consent to follow up. The patient gave permission for her physician to be contacted and provided details of the same. Unable to obtain additional information. For tolerance to 2nd dose, refer case US2018GSK213571.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 62-year-old male patient who received SHINGRIX (batch number 27J4P, expiry date 12th April 2021) for prophylaxis. On 5th November 2018, the patient received SHINGRIX. In November 2018, less than a week 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 on left deltoid. The patient experienced a rash on the neck. The exact time to onset was unknown. The pharmacist did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a female patient who received SHINGRIX for prophylaxis. On 30th June 2018, the patient received the 1st dose of SHINGRIX. On 30th June 2018, less than a day after receiving SHINGRIX, the patient experienced feeling unwell. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the feeling unwell was unknown. It was unknown if the reporter considered the feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient asked about second dose and ended the phone call by briefly reporting that she felt sick and took an Advil and went to bed after 1st dose. The patient had consented to follow up.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin irritation
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of skin irritation in a 61-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included FLUARIX QUADRIVALENT 2018-2019 season for prophylaxis. Previously administered products included ZOSTAVAX (In December 2016 received ZOSTAVAX). Concurrent medical conditions included neuropathy and type II diabetes mellitus. On 8th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 31st October 2018, the patient received FLUARIX QUADRIVALENT 2018-2019 season. On 9th November 2018, 1 days after receiving SHINGRIX and 9 days after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced skin irritation. On an unknown date, the outcome of the skin irritation was not recovered/not resolved. It was unknown if the reporter considered the skin irritation to be related to SHINGRIX and FLUARIX QUADRIVALENT 2018-2019 season. Additional details were reported as follows: The patient had the flu shot on his left arm and SHINGRIX vaccine on his right shoulder. The patient received he noticed an irritation on his skin that felt like an intense sunburn. The irritation started on his left thigh and hamstring on Friday then moved to his chest on Saturday. On Sunday and Monday he had the irritation on his chest and back. On the reporting date, he had the irritation under both of his arms. The patient claimed that the irritation was more extensive on the reporting date and the issue was still unresolved. The patient had consented to follow up. The patient had provided contact details of the nurse.
Sex: M
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of generalized rash in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was unknown. It was unknown if the reporter considered the generalized rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. For generalized rash emergency room visit was required.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Injection site pain, Injection site paraesthesia, Muscle spasms, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, general body pain, weakness, muscle cramp, tingling of extremity and pain in arm. The patient was treated with BENGAY. On an unknown date, the outcome of the injection site pain, general body pain and weakness were recovered/resolved and the outcome of the muscle cramp and tingling of extremity were not recovered/not resolved and the outcome of the pain in arm was unknown. It was unknown if the reporter considered the injection site pain, general body pain, weakness, muscle cramp, tingling of extremity and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 51 or 52 years old. The patient received her 1st dose of SHINGRIX in an unknown arm. The patient was not sure when she received it, but her calendar notes that she could get the 2nd dose of SHINGRIX anytime after 28th October 2018. After the SHINGRIX vaccine, the patient had pain in her arm at the injection site and also felt weak and achy. The symptoms resolved after a couple of days. More recently the patient had started experiencing muscle cramps in the arm where she received the injection. The patient had been using BENGAY pads on her shoulder, but she had pain and tingling around the injection site and down into her forearm. The patient did not consent to be followed up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, general body pain, weakness, muscle cramp, tingling of extremity and pain in arm. The patient was treated with BENGAY. On an unknown date, the outcome of the injection site pain, general body pain and weakness were recovered/resolved and the outcome of the muscle cramp and tingling of extremity were not recovered/not resolved and the outcome of the pain in arm was unknown. It was unknown if the reporter considered the injection site pain, general body pain, weakness, muscle cramp, tingling of extremity and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 51 or 52 years old. The patient received her 1st dose of SHINGRIX in an unknown arm. The patient was not sure when she received it, but her calendar notes that she could get the 2nd dose of SHINGRIX anytime after 28th October 2018. After the SHINGRIX vaccine, the patient had pain in her arm at the injection site and also felt weak and achy. The symptoms resolved after a couple of days. More recently the patient had started experiencing muscle cramps in the arm where she received the injection. The patient had been using BENGAY pads on her shoulder, but she had pain and tingling around the injection site and down into her forearm. The patient did not consent to be followed up.
Age: 5.0
Sex: F
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a 5-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis. Concurrent medical conditions included fish allergy and allergic to dogs (and gelatin). On 9th November 2018, the patient received Influenza vaccine Quadrivalent 2018-2019 season. On 9th November 2018, less than a day after receiving Influenza vaccine Quadrivalent 2018-2019 season, 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 Influenza vaccine Quadrivalent 2018-2019 season. Additional details were reported as follows: The caller was the mother of the patient who received flu shot on Friday. The caller was unsure of name of the flu shot and lot number was not available. The caller reported that the patient broke out in a rash after receiving the injection. The reporter gave consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 5 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. The pharmacist stated that in 2018, the patient got SHINGRIX a few months before reporting date, and she developed shingles. The healthcare professional stated that this was the patient's first episode of shingles. The reporter gave consent to follow up.
Age: 72.0
Sex: M
Vaccine: FLU4
Symptoms: Influenza, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 72-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included Influenza vaccine Quadrivalent 2018-2019 season for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In October 2018, the patient received Influenza vaccine Quadrivalent 2018-2019 season (intramuscular). In November 2018, not applicable after receiving SHINGRIX and less than a year after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. The patient was treated with TAMIFLU. On an unknown date, the outcome of the vaccination failure and influenza were unknown. It was unknown if the reporter considered the influenza to be related to SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. It was unknown if the reporter considered the vaccination failure to be related to Influenza vaccine Quadrivalent 2018-2019 season. Additional details were provided as follows: The patient received SHINGRIX dose about 2 months ago and a flu shot in early October 2018. The patient reported that about 3 days ago, he developed the flu and was seen by urgent care clinic and prescribed TAMIFLU to treat. The reporter did not consent to follow up. The reporter was unable to verify which flu shot he received.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: REDNESS, SWELLING, PAIN, WARM TO TOUCH AT INJECTION SITE.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Electroencephalogram, Essential tremor, Headache, Myoclonus, Neurological symptom
Clinical narrative: Nov. 2 severe headaches began....other neurological symptoms followed...now developed essential tremors and myoclonus.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: Nov. 2 severe headaches began....other neurological symptoms followed...now developed essential tremors and myoclonus.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Cold sweat, Confusional state, Dizziness, Fall, Hyperhidrosis
Clinical narrative: Patient received his flu vaccine and stood up to rejoin his family members and immediately (within one minute) felt dizzy and lightheaded. He proceeded to pass out and fall to the ground. He seemed mostly out of it mentally but his grandpa and I helped helped him to the the ground to lay down. We kept him talking and continued to monitor his mental status changes. He came out of it pretty quickly but was very sweaty, clammy, and a little confused. After resting a few minutes, he drank some water and moved up to a chair. He felt back to normal after about 10 minutes.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Patient received his flu vaccine and stood up to rejoin his family members and immediately (within one minute) felt dizzy and lightheaded. He proceeded to pass out and fall to the ground. He seemed mostly out of it mentally but his grandpa and I helped helped him to the the ground to lay down. We kept him talking and continued to monitor his mental status changes. He came out of it pretty quickly but was very sweaty, clammy, and a little confused. After resting a few minutes, he drank some water and moved up to a chair. He felt back to normal after about 10 minutes.
Age: 33.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, pain, erythema in left deltoid muscle where injection was given.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Tenderness
Clinical narrative: Tenderness in the shoulder starting the day after immunization and progressing to pain radiating down the arm in the weeks following. Pain persisting for greater than 2 months.
Age: 15.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood pressure decreased, Syncope
Clinical narrative: Patient fainted a few moments after administering FLUCELVAX QUADRIVALENT vaccine. Patient has a history of seizures, but has been receiving the vaccine every year according to mother of the patient. Ambulance was called and they confirmed the patient's blood pressure dropped and will monitor her in the ambulance to make sure she is ok. Mom of the patient insisted on not going to the hospital.
Age: 70.0
Sex: F
Vaccine: FLUA3
Symptoms: Immediate post-injection reaction, Injection site discomfort
Clinical narrative: Patient states that immediately after the injection she felt a "jolt" from the injection site to the elbow. Discomfort is still present as of this filing.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient stated that a few days after the vaccine his arm was red and swollen. By the time he came in to notify us of the ADR the symptoms had already subsided.
Age: 87.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site swelling
Clinical narrative: Left Arm Swelling at injection site.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Restless legs syndrome
Clinical narrative: Felt fine immediately after injection and rest of the day but at the 11 hour mark I began to get chilled. At 12 hours after injection I experienced what felt like my torso being tightly wrapped tightly in a blanket and about 15 minutes later I got off my stability ball to brush my teeth and immediately  experienced severe shivers to the point of having to use one hand holding my toothbrush and my other hand to hold that steady so as not to jab the inside of my mouth. I took some aspirin and went to bed. Experienced restless sleep. At no time was my breathing effected.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Muscle twitching, Musculoskeletal pain, Pain in extremity
Clinical narrative: When flu shot was administered my arm twitched like a reflex was hit. The pharmacist noticed it also. About two weeks after flu shot had pain in left arm and shoulder. Difficulty lifting arm. A week later both arms and shoulders became very painful. Doctor advised PT which I am currently going to I have never had this type of reaction to a flu shot in the past. My PT said they are treating several people with the same type issue after getting flu shots.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Computerised tomogram head, Generalised tonic-clonic seizure
Clinical narrative: Patient had 5 minute generalized tonic clonic seizure on 11/26 (7 days after flu vaccine admin). Had never had a seizure before. No fever. No other cause found. Has had multiple flu vaccines in previous seasons without any reaction.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain
Clinical narrative: Patient states that her arm is immobile and has shooting pains.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Within 24 hours of dose, patient experienced headache (which lasted several days and was not relieved by any ibuprofen or APAP), fever, chills, body aches, "stiffness", mouth swelling, vomiting, raised and red at injection site for approximately 2 weeks; Within "a few hours" of second dose, she had headache, fever/chills, body aches, sore joints and muscles, raised and red at injection site, she claims after the second dose the symptoms only lasted a few days.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Mouth swelling, Musculoskeletal stiffness, Myalgia, Pain, Pyrexia
Clinical narrative: Within 24 hours of dose, patient experienced headache (which lasted several days and was not relieved by any ibuprofen or APAP), fever, chills, body aches, "stiffness", mouth swelling, vomiting, raised and red at injection site for approximately 2 weeks; Within "a few hours" of second dose, she had headache, fever/chills, body aches, sore joints and muscles, raised and red at injection site, she claims after the second dose the symptoms only lasted a few days.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Within 24 hours of dose, patient experienced headache (which lasted several days and was not relieved by any ibuprofen or APAP), fever, chills, body aches, "stiffness", mouth swelling, vomiting, raised and red at injection site for approximately 2 weeks; Within "a few hours" of second dose, she had headache, fever/chills, body aches, sore joints and muscles, raised and red at injection site, she claims after the second dose the symptoms only lasted a few days.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pruritus, Swelling
Clinical narrative: Pt noticed itching, swelling 7 hrs after injection. Used ice. Next AM had 3x 4 inch slightly red, swelling at injection site. Seems to be improving. Doesn't drive refused appointment.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Induration, Inflammation, Pruritus, Rash
Clinical narrative: Rash, erythema, pruritus, red, swelling, inflammation, hard, hot, warm, urticarial, antihistamine, cold compress, ice, moved arm a lot and mod. outcome. Sxs started w/n 30 mins. of immunization until today.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm, Swelling, Urticaria
Clinical narrative: Rash, erythema, pruritus, red, swelling, inflammation, hard, hot, warm, urticarial, antihistamine, cold compress, ice, moved arm a lot and mod. outcome. Sxs started w/n 30 mins. of immunization until today.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Nuclear magnetic resonance imaging, Pain, Rotator cuff syndrome
Clinical narrative: Patient complains of pain starting within hours of injection, consulted doctor 3 days later and was diagnosed with tendinitis of left shoulder. Patient was prescribed a sling and hydrocodone/APAP for pain (unable to take ibuprofen due to XARELTO) and was also given a cortisone shot by the doctor. Patient will be starting physical therapy 3 times a week going forward.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Localized Redness, warmth to the touch. Appeared 3-4 hours after vaccine was given. When patient arrived at the office reaction had improved. Given TYLENOL for pain and advised to monitor.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Genital herpes, Herpes virus test, Herpes zoster
Clinical narrative: Pt received SHINGRIX vaccine September 1st, 2018. He went to the hospital on 11-10-18 and was diagnosed with shingles and genital herpes. Testing not done. Wife states ER doctor just looked at patient and told pt it was from the shingles vaccine.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient has experienced extensive linear swelling, redness, and raised temperature around the upper area of her right arm. She stated she felt her arm getting hot and becoming swollen later in the evening on the date of her Pneumovax 23 immunization, November 19th. She came in on the November 20th with the reaction and was advised to seek consult with the healthcare clinic. She was seen by the nurse practitioner and was given medications in case of an allergic reaction as well as antibiotic therapy in case of an infection. Patient is starting to feel a little bit better.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent condition, concurrent medications and drug reactions/allergies were not reported. On 20-NOV-2018, the patient was vaccinated with an expired dose of M-M-R II (strength and dose were not reported) (lot # M045395 and expiry date: 14-NOV-2018) subcutaneously for prophylaxis. The administered dose of M-M-R II was reconstituted with sterile diluent (manufacturer unknown) (lot# M044950 and expiry date: 30-MAY-2019). No adverse effects were reported. There was no product quality complaint (PQC) reported.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient developed large raised area at site of injection. Tender, red, mild itching. Swelling resolved over the next 5 days.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Loss of personal independence in daily activities, Myalgia, Nausea
Clinical narrative: Symptoms started approx 12 hr after dose (duration below) nausea -5 hr fatigue-36h headache-36h myalgia- 24h fever- 8h. Patient was unable to perform any physical or mental tasks and remained inactive the day following dosing. Note: none of the above were seen on first dose.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Symptoms started approx 12 hr after dose (duration below) nausea -5 hr fatigue-36h headache-36h myalgia- 24h fever- 8h. Patient was unable to perform any physical or mental tasks and remained inactive the day following dosing. Note: none of the above were seen on first dose.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Pain
Clinical narrative: Patient complains 1 week after shot she experienced shooting pain and numbness to her fingers starting at the muscle radiating to the fingers. She reports it is getting a bit better.
Age: 1.25
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Adult dose of 0.5ml given to patient under 3yr of age. Health Department contacted as well as patients parents. No symptoms.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Gait disturbance, Injection site induration, Injection site swelling, Weight bearing difficulty
Clinical narrative: Right upper thigh tense/tight and swollen. No redness. Pt limping, not bearing weight on right leg. Taken to ED and assessed. Told it was a reaction to flu vaccination and told to take ibuprofen and TYLENOL.
Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Patient received flu shot over a month ago and still sore at the injection site.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Neck pain
Clinical narrative: Patient experienced mild soreness for the first 2-3 days as expected from the flu shot. First severe pain occurred about a week after the shot. It was dull pain at the time but every now and then, he is experiencing excruciating pain that feels like he was stabbed in the neck or shoulder which lasts about 1-3 minutes, then returns to dull pain.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Musculoskeletal stiffness
Clinical narrative: She has a very bad stiff neck.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site urticaria, Pain, Swelling
Clinical narrative: Swollen red welt at injection site and radiating nerve pain to hands for about 3 days after injection.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Neuropathy peripheral
Clinical narrative: Patient reports neuropathy.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal pain, Myalgia
Clinical narrative: Per patient, she called the pharmacy on 11/27/18 saying she had pain on deltoid muscle a couple days after the immunization. But now she thinks it has radiated to her shoulder and clavicle pain. She will see the doctor in a couple days, so I told her to discuss that with her PCP.
Age: 66.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Myalgia, Pain
Clinical narrative: Pain.muscle ache.low energy.
Age: 37.0
Sex: M
Vaccine: FLUC4
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain barre syndrome.
Age: 0.75
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness, Respiratory arrest, Syncope
Clinical narrative: Syncopal episodes where he passed out and quit breathing a few times.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Back pain, Balance disorder, Cough, Dizziness
Clinical narrative: Day one after vaccine, extreme joint pain, head and neck pain. Day 2 extreme neck and low back pain/widespread muscle pain/aches. Day 3 Vertigo, headache, neck pain, nauseous. Day 4 sore throat, nasal congestion, ringing in Right ear, with fullness on R side of head, continued Vertigo for 10 days. Currently dizzy, uneasy on feet, ear fullness, post nasal drip, slight sore throat, cough.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Ear discomfort, Headache, Myalgia, Nasal congestion, Nausea
Clinical narrative: Day one after vaccine, extreme joint pain, head and neck pain. Day 2 extreme neck and low back pain/widespread muscle pain/aches. Day 3 Vertigo, headache, neck pain, nauseous. Day 4 sore throat, nasal congestion, ringing in Right ear, with fullness on R side of head, continued Vertigo for 10 days. Currently dizzy, uneasy on feet, ear fullness, post nasal drip, slight sore throat, cough.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Neck pain, Oropharyngeal pain, Tinnitus, Upper-airway cough syndrome, Vertigo
Clinical narrative: Day one after vaccine, extreme joint pain, head and neck pain. Day 2 extreme neck and low back pain/widespread muscle pain/aches. Day 3 Vertigo, headache, neck pain, nauseous. Day 4 sore throat, nasal congestion, ringing in Right ear, with fullness on R side of head, continued Vertigo for 10 days. Currently dizzy, uneasy on feet, ear fullness, post nasal drip, slight sore throat, cough.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Hypersensitivity
Clinical narrative: Also pneumonia vaccine and shingles vaccine in left arm.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Pyrexia, Vaccination complication
Clinical narrative: Patient called to let us know she was experience adverse effects from the vaccine. Stated she had fever, chills, and muscle pain at injection site. Admitted no adverse effects after the 1st dose.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Hyperhidrosis, Insomnia, Malaise
Clinical narrative: Symptoms at first were soreness in the arm, later in the evening, I developed strong chills, a severe headache, neck stiffness and pain, nausea, and sweating alternating with chills. These symptoms were pretty strong, lasted through the night, and kept me awake. I felt sick enough to go to urgent care, but I was alone and did not feel up to driving myself. This lasted about 10 hours. I took 600mg of MOTRIN the next morning, and felt better. The chills and sweating stopped and the headache was much more mild by mid morning.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Nausea, Neck pain, Pain in extremity
Clinical narrative: Symptoms at first were soreness in the arm, later in the evening, I developed strong chills, a severe headache, neck stiffness and pain, nausea, and sweating alternating with chills. These symptoms were pretty strong, lasted through the night, and kept me awake. I felt sick enough to go to urgent care, but I was alone and did not feel up to driving myself. This lasted about 10 hours. I took 600mg of MOTRIN the next morning, and felt better. The chills and sweating stopped and the headache was much more mild by mid morning.
Age: 45.0
Sex: M
Vaccine: HEP
Symptoms: Eye swelling
Clinical narrative: Patient states that his left eye swelled after the vaccination and lasted a few days, and resolved on it's own. He went to his primary care doctor for a regular check-up and she did not advise him anything at that time because it had already resolved, she informed him to continue his regular medications as prescribed. I called the patient to remind him of his second vaccination and that's when he informed me about the eye swelling. Will not give second dose until advised and safe to do so.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Pain in extremity, Rotator cuff syndrome
Clinical narrative: Patient experienced soreness and restricted movement in the arm/shoulder. Patient addressed with PCP. Upon assessment, PCP ordered an MRI which indicated injury to the rotator cuff. Patient has referral appt with orthopedic.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Joint swelling
Clinical narrative: Upper right arm swelled more than twice its normal size and became extremely red and extremely painful the first day. By the next morning my elbow and lower arm swelled also and was so bad I could not use or bend my arm. I had pain on the right side of my neck and throat that ran down my arm to my fingertips. This lasted for for 4 days before the swelling started going down. It took more than a week for me to get back to normal use. I did not go to the doctor because of snow.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Neck pain, Oropharyngeal pain, Pain in extremity, Peripheral swelling
Clinical narrative: Upper right arm swelled more than twice its normal size and became extremely red and extremely painful the first day. By the next morning my elbow and lower arm swelled also and was so bad I could not use or bend my arm. I had pain on the right side of my neck and throat that ran down my arm to my fingertips. This lasted for for 4 days before the swelling started going down. It took more than a week for me to get back to normal use. I did not go to the doctor because of snow.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Dry skin, Peripheral swelling, Rash, Skin discolouration, Skin exfoliation
Clinical narrative: Patient stated that after receiving the PREVNAR 13 vaccination the next day her arm swelled up, she developed a rash within a week and the area turned blue, started healing and then her skin started peeling and her skin around the area was very dry and continued to peel.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Injection site pain, Injection site warmth, Pain
Clinical narrative: Patient received a PNEUMOVAX-23 IM injection in the left deltoid. Patient returned the next day stated that her arm had severe pain radiating from mid-way up the upper arm and into the shoulder cap. The upper arm was warmer to the touch, but did not have any clearly defined redness or raised area around the injection site. Patient also stated she had began feeling light headed and dizzy. Patient stated she would monitor and seek medical attention if not resolved or worsens.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Decreased appetite, Fatigue, Heart rate increased, Injection site erythema
Clinical narrative: Patient reported she experienced shaking, chills, and fever on the first night. She did not check her temperature but took a honey-lemon mixture. Patient experienced fatigue but reported was able to sleep it off. She also experienced loss of appetite and pain around kidney areas. Did have redness  around injection site and some whelps. Patient experienced an increase in heart rate of around 50 points greater than her normal of around 83. This lasted about 3 days but did not contact her doctor or be seen by a doctor due to symptoms resolving itself.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site urticaria, Pyrexia, Renal pain, Tremor
Clinical narrative: Patient reported she experienced shaking, chills, and fever on the first night. She did not check her temperature but took a honey-lemon mixture. Patient experienced fatigue but reported was able to sleep it off. She also experienced loss of appetite and pain around kidney areas. Did have redness  around injection site and some whelps. Patient experienced an increase in heart rate of around 50 points greater than her normal of around 83. This lasted about 3 days but did not contact her doctor or be seen by a doctor due to symptoms resolving itself.
Age: 55.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Injection site swelling
Clinical narrative: A few hours after the vaccination, I felt very tired, had a headache, shivering, fever, and muscle pain. It lasted about 24 hours and then I felt completely better. I stayed in bed and took acetaminophen. Also, my arm was swollen and painful at the injection site for about one week. I also had a flu vaccine (right arm), but I'm not sure which one so I didn't add it to the question above.
Age: 55.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: A few hours after the vaccination, I felt very tired, had a headache, shivering, fever, and muscle pain. It lasted about 24 hours and then I felt completely better. I stayed in bed and took acetaminophen. Also, my arm was swollen and painful at the injection site for about one week. I also had a flu vaccine (right arm), but I'm not sure which one so I didn't add it to the question above.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Agitation, Back pain, Body temperature fluctuation, Chest discomfort, Dyspnoea
Clinical narrative: This spontaneous case, initially received from other non-health care professional (consumer) on 14-Nov-2018, concerning a 43-year-old, adult female patient. The patient had no medical history. The patient did not receive any concomitant medications. On 31-Oct-2018, the patient was administered AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, batch number: YF40008, expiry date: 30-Jun-2019 (reported as 30Jun9) and anatomical location: not reported). On the same day, 8 hours after vaccination, the patient developed febrile seizure and convulsion. The patient's body temperature was fluctuated in between 96 Fahrenheit and fever ranges. The patient's body temperature had spiked, and the patient felt extremely hot for which she had to cool down her body with wet rags. The patient had developed chest tightness, difficulty in breathing and her heart raced as in panic attack. The patient experienced pain at the back of her neck, upper back and spinal cord which lasted for 10-12 days. The pain had lessened but still a little sore. The patient had also complained of mood swing, extreme agitation and suicidal tendencies. On 01-Nov-2018, the patient went to the clinic and consult her primary care physician (PCP) 3 times. At the time of this report, the patient was recovering from the events neck pain, spinal pain and upper back pain. The patient had not recovered from the events- febrile seizure, convulsion, chest tightness, breathing difficult, body temperature fluctuation, body temperature increased, feeling hot, heart racing, suicidal ideation, mood swings and agitation. The reporter assessed this case as serious (medically significant) and considered the causality of the neurological events as related to the suspect vaccine.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Febrile convulsion, Feeling hot, Mood swings, Neck pain, Palpitations
Clinical narrative: This spontaneous case, initially received from other non-health care professional (consumer) on 14-Nov-2018, concerning a 43-year-old, adult female patient. The patient had no medical history. The patient did not receive any concomitant medications. On 31-Oct-2018, the patient was administered AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, batch number: YF40008, expiry date: 30-Jun-2019 (reported as 30Jun9) and anatomical location: not reported). On the same day, 8 hours after vaccination, the patient developed febrile seizure and convulsion. The patient's body temperature was fluctuated in between 96 Fahrenheit and fever ranges. The patient's body temperature had spiked, and the patient felt extremely hot for which she had to cool down her body with wet rags. The patient had developed chest tightness, difficulty in breathing and her heart raced as in panic attack. The patient experienced pain at the back of her neck, upper back and spinal cord which lasted for 10-12 days. The pain had lessened but still a little sore. The patient had also complained of mood swing, extreme agitation and suicidal tendencies. On 01-Nov-2018, the patient went to the clinic and consult her primary care physician (PCP) 3 times. At the time of this report, the patient was recovering from the events neck pain, spinal pain and upper back pain. The patient had not recovered from the events- febrile seizure, convulsion, chest tightness, breathing difficult, body temperature fluctuation, body temperature increased, feeling hot, heart racing, suicidal ideation, mood swings and agitation. The reporter assessed this case as serious (medically significant) and considered the causality of the neurological events as related to the suspect vaccine.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Seizure, Spinal pain, Suicidal ideation
Clinical narrative: This spontaneous case, initially received from other non-health care professional (consumer) on 14-Nov-2018, concerning a 43-year-old, adult female patient. The patient had no medical history. The patient did not receive any concomitant medications. On 31-Oct-2018, the patient was administered AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, batch number: YF40008, expiry date: 30-Jun-2019 (reported as 30Jun9) and anatomical location: not reported). On the same day, 8 hours after vaccination, the patient developed febrile seizure and convulsion. The patient's body temperature was fluctuated in between 96 Fahrenheit and fever ranges. The patient's body temperature had spiked, and the patient felt extremely hot for which she had to cool down her body with wet rags. The patient had developed chest tightness, difficulty in breathing and her heart raced as in panic attack. The patient experienced pain at the back of her neck, upper back and spinal cord which lasted for 10-12 days. The pain had lessened but still a little sore. The patient had also complained of mood swing, extreme agitation and suicidal tendencies. On 01-Nov-2018, the patient went to the clinic and consult her primary care physician (PCP) 3 times. At the time of this report, the patient was recovering from the events neck pain, spinal pain and upper back pain. The patient had not recovered from the events- febrile seizure, convulsion, chest tightness, breathing difficult, body temperature fluctuation, body temperature increased, feeling hot, heart racing, suicidal ideation, mood swings and agitation. The reporter assessed this case as serious (medically significant) and considered the causality of the neurological events as related to the suspect vaccine.
Age: 7.0
Sex: F
Vaccine: RAB, TYP
Symptoms: Expired product administered, Limb discomfort
Clinical narrative: Patient given expired rabies (IMOVAX) vaccine. Patient with slight arm discomfort one day after vaccinations given on 10/30/2018.
Sex: M
Vaccine: FLUX
Symptoms: Multiple sclerosis, Myelitis transverse
Clinical narrative: This spontaneous case, initially received on 14-Nov-2018, reported by physician via Merck, concerning a 29-year-old, adult male patient. On an unspecified date, the patient was administered influenza vaccine, [dose, route of administration, anatomical location, batch number, expiry date, manufacturer and trade name: not reported]. On an unspecified date, after vaccination, the patient experienced symptoms of transverse myelitis, however on an unspecified date, the patient was diagnosed with multiple sclerosis. At the time of this report, the patient had not recovered from the event. The reporter assessed the case as non-serious.
Age: 10.0
Sex: F
Vaccine: RAB, TYP
Symptoms: Expired product administered, Limb discomfort
Clinical narrative: Patient given expired rabies (IMOVAX) vaccine. Patient with slight arm discomfort one day after vaccinations given on 10/30/2018.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR
Symptoms: Rash vesicular
Clinical narrative: Vesicular rash.
Age: 67.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Cellulitis, Injection site cellulitis, White blood cell count increased
Clinical narrative: Pt has cellulitis of left deltoid then spread to left arm. Pt was treated with oral cephalexin and is not improving and pt was admitted, treated with IV ZOSYN at hospital discharged with Levofloxacin x 7 days.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Bronchitis, Cough, Decreased appetite, Dizziness
Clinical narrative: 3PM on 10/20/2018 dizziness, weakness, nausea. 10/21/2018 severe headache at 2am, followed by loss of consciousness at 3am, followed by diaphoresis, vomiting, followed by dizziness, weakness, loss of appetite for 3 days. On 4th day on 10/24/2018 sore throat, cough, postnasal drip. On 8th day on 10/28/2018 bronchitis dx by M.D. at urgent care.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Hyperhidrosis, Loss of consciousness, Nausea, Oropharyngeal pain
Clinical narrative: 3PM on 10/20/2018 dizziness, weakness, nausea. 10/21/2018 severe headache at 2am, followed by loss of consciousness at 3am, followed by diaphoresis, vomiting, followed by dizziness, weakness, loss of appetite for 3 days. On 4th day on 10/24/2018 sore throat, cough, postnasal drip. On 8th day on 10/28/2018 bronchitis dx by M.D. at urgent care.
Sex: U
Vaccine: VARZOS
Symptoms: Upper-airway cough syndrome, Vomiting
Clinical narrative: 3PM on 10/20/2018 dizziness, weakness, nausea. 10/21/2018 severe headache at 2am, followed by loss of consciousness at 3am, followed by diaphoresis, vomiting, followed by dizziness, weakness, loss of appetite for 3 days. On 4th day on 10/24/2018 sore throat, cough, postnasal drip. On 8th day on 10/28/2018 bronchitis dx by M.D. at urgent care.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Fall, Presyncope, Syncope
Clinical narrative: Patient was in for flu vaccine, tolerated well, pt sitting on table had just finished shot administration. MA and mother of pt. were discussing interactions; pt. fainted and fell off bed; Emergency response team called and Nurse and PA evaluated pt. Instructions for fainting and concussions given. Dx w/vasovagal episode and instructions to monitor pt. and ice head given by nurse.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC13, RV5
Symptoms: Glassy eyes, Lethargy, Muscle twitching, Pyrexia
Clinical narrative: Nov. 3 fever 99.4, lethargic, glassy eyes, involuntary twitching of jaw.
Age: 0.33
Sex: F
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No Adverse event. Report only of vaccine given too early in error. Was in office - told what to watch for and follow up calls made. No adverse event noted.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site urticaria, Local reaction, Pain
Clinical narrative: Afebrile. Pt c/o red, hived area around deltoid area 6 days after injection. Size approx. 70 mm x 50 mm. Pt c/o increased body aches x 4 days after injection. No tx given. Per health department d/t size of local reaction Vaccine Adverse Event form need to be filled out.