chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Axillary mass, Erythema, Feeling hot, Infection
Clinical narrative: arm was bruised / around the injection site; redness / around the injection site; pain / around the injection site; swelling, / around the injection site; hot skin around the injection site; bruising / spread / into the shoulder; bruising / spread into the axillary area; redness/ spread into the axillary area of her arm and into the shoulder; swelling, / into the axillary area of her arm and into the shoulder; pain / into the shoulder; hot feeling spread into the axillary area of her arm and into the shoulder; infection/and she was diagnosed with an; This case was reported by a consumer via call center representative and described the occurrence of injection site bruising in a 42-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number AB374, expiry date 21st November 2022) for prophylaxis.   On 29th October 2020, the patient received Boostrix (intramuscular). On 4th November 2020, 6 days after receiving Boostrix, the patient experienced infection. On an unknown date, the patient experienced injection site bruising, injection site erythema, injection site pain, injection site swelling, injection site warmth, contusion of shoulder region, axillary lump, erythema, swelling, shoulder pain and extremities hot feeling of. The patient was treated with sulfamethoxazole + trimethoprim (Bactrim). On an unknown date, the outcome of the injection site bruising, injection site erythema, injection site pain, injection site swelling, injection site warmth and infection were not recovered/not resolved and the outcome of the contusion of shoulder region, axillary lump, erythema, swelling, shoulder pain and extremities hot feeling of were unknown.   It was unknown if the reporter considered the injection site bruising, injection site erythema, injection site pain, injection site swelling, injection site warmth, infection, contusion of shoulder region, axillary lump, erythema, swelling, shoulder pain and extremities hot feeling of to be related to Boostrix.  Additional details were provided as follows: The patient received Boostrix vaccine in her left arm and within 2 days of receiving the vaccine her whole left arm was bruised, had redness, pain, swelling, and hot skin around the injection site.  The patient reported the bruising, redness, swelling, pain, and hot feeling spread into the axillary area of her arm and into the shoulder and she was diagnosed with an infection at an urgent care doctor's office.  The patient was prescribed Bactrim as a 7 day course of antibiotic for the infection.  The patient reported these events are subsiding but still ongoing currently. The reporter did not consent to follow up. The patient did not give consent to follow up with HCP because did not had a primary care doctor.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: arm was bruised / around the injection site; redness / around the injection site; pain / around the injection site; swelling, / around the injection site; hot skin around the injection site; bruising / spread / into the shoulder; bruising / spread into the axillary area; redness/ spread into the axillary area of her arm and into the shoulder; swelling, / into the axillary area of her arm and into the shoulder; pain / into the shoulder; hot feeling spread into the axillary area of her arm and into the shoulder; infection/and she was diagnosed with an; This case was reported by a consumer via call center representative and described the occurrence of injection site bruising in a 42-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number AB374, expiry date 21st November 2022) for prophylaxis.   On 29th October 2020, the patient received Boostrix (intramuscular). On 4th November 2020, 6 days after receiving Boostrix, the patient experienced infection. On an unknown date, the patient experienced injection site bruising, injection site erythema, injection site pain, injection site swelling, injection site warmth, contusion of shoulder region, axillary lump, erythema, swelling, shoulder pain and extremities hot feeling of. The patient was treated with sulfamethoxazole + trimethoprim (Bactrim). On an unknown date, the outcome of the injection site bruising, injection site erythema, injection site pain, injection site swelling, injection site warmth and infection were not recovered/not resolved and the outcome of the contusion of shoulder region, axillary lump, erythema, swelling, shoulder pain and extremities hot feeling of were unknown.   It was unknown if the reporter considered the injection site bruising, injection site erythema, injection site pain, injection site swelling, injection site warmth, infection, contusion of shoulder region, axillary lump, erythema, swelling, shoulder pain and extremities hot feeling of to be related to Boostrix.  Additional details were provided as follows: The patient received Boostrix vaccine in her left arm and within 2 days of receiving the vaccine her whole left arm was bruised, had redness, pain, swelling, and hot skin around the injection site.  The patient reported the bruising, redness, swelling, pain, and hot feeling spread into the axillary area of her arm and into the shoulder and she was diagnosed with an infection at an urgent care doctor's office.  The patient was prescribed Bactrim as a 7 day course of antibiotic for the infection.  The patient reported these events are subsiding but still ongoing currently. The reporter did not consent to follow up. The patient did not give consent to follow up with HCP because did not had a primary care doctor.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling
Clinical narrative: arm was bruised / around the injection site; redness / around the injection site; pain / around the injection site; swelling, / around the injection site; hot skin around the injection site; bruising / spread / into the shoulder; bruising / spread into the axillary area; redness/ spread into the axillary area of her arm and into the shoulder; swelling, / into the axillary area of her arm and into the shoulder; pain / into the shoulder; hot feeling spread into the axillary area of her arm and into the shoulder; infection/and she was diagnosed with an; This case was reported by a consumer via call center representative and described the occurrence of injection site bruising in a 42-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number AB374, expiry date 21st November 2022) for prophylaxis.   On 29th October 2020, the patient received Boostrix (intramuscular). On 4th November 2020, 6 days after receiving Boostrix, the patient experienced infection. On an unknown date, the patient experienced injection site bruising, injection site erythema, injection site pain, injection site swelling, injection site warmth, contusion of shoulder region, axillary lump, erythema, swelling, shoulder pain and extremities hot feeling of. The patient was treated with sulfamethoxazole + trimethoprim (Bactrim). On an unknown date, the outcome of the injection site bruising, injection site erythema, injection site pain, injection site swelling, injection site warmth and infection were not recovered/not resolved and the outcome of the contusion of shoulder region, axillary lump, erythema, swelling, shoulder pain and extremities hot feeling of were unknown.   It was unknown if the reporter considered the injection site bruising, injection site erythema, injection site pain, injection site swelling, injection site warmth, infection, contusion of shoulder region, axillary lump, erythema, swelling, shoulder pain and extremities hot feeling of to be related to Boostrix.  Additional details were provided as follows: The patient received Boostrix vaccine in her left arm and within 2 days of receiving the vaccine her whole left arm was bruised, had redness, pain, swelling, and hot skin around the injection site.  The patient reported the bruising, redness, swelling, pain, and hot feeling spread into the axillary area of her arm and into the shoulder and she was diagnosed with an infection at an urgent care doctor's office.  The patient was prescribed Bactrim as a 7 day course of antibiotic for the infection.  The patient reported these events are subsiding but still ongoing currently. The reporter did not consent to follow up. The patient did not give consent to follow up with HCP because did not had a primary care doctor.
Sex: F
Vaccine: FLUX, TDAP, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site nodule
Clinical narrative: bright red knot on her arm (at injection site) the size of a baseball; bright red knot on her arm the size of a baseball; pharmacist "made a mistake" / by administering the Shingrix, Tdap, and flu shot all in one arm; This case was reported by a consumer via call center representative and described the occurrence of injection site induration in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis and DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Shingrix, Influenza vaccine Quadrivalent unspecified season and Tdap Vaccine. On an unknown date, unknown after receiving Shingrix, Influenza vaccine Quadrivalent unspecified season and Tdap Vaccine, the patient experienced injection site induration, injection site erythema and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site induration was recovered/resolved and the outcome of the injection site erythema and vaccine administered at inappropriate site were unknown.   The reporter considered the injection site induration and injection site erythema to be related to Shingrix, Influenza vaccine Quadrivalent unspecified season and Tdap Vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that the pharmacist made a mistake by administering the Shingrix, Tdap, and flu shot all in one arm which resulted in a bright red knot on her arm (at injection site) the size of a baseball and vaccine administered at inappropriate site. The reporter was the husband and patient were the wife and provided email address but did not want to provide a personal fax number. No further information gathered and did not specify if it was the right or left arm. The reporter did not consent to follow up. The reporter did not want to provide his wife's MD contact information because says her doctor was retiring and did not yet know who new doctor would be.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020220484:same reporter (reporter´s case)
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site pain
Clinical narrative: muscle pain in the left deltoid; didn't look but it felt like it went into the muscle; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (about 10 years before reporting). Concurrent medical conditions included tinnitus.   On 8th September 2020, the patient received the 1st dose of Shingrix. On 8th September 2020, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On 9th September 2020, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix shot in the left deltoid.  The patient asked if it was given intramuscularly, the patient stated that, he said he was not sure because he did not look but it felt like it went into the muscle, which led to intramuscular formulation administered by other route. The patient had muscle pain in the left deltoid which occurred the following day and resolved after 3 to 4 days.  The reporter did not have the lot/exp of the shot because he did not know what he did with the paperwork but he did provide his pharmacy's name and location. The reporter did not consent to follow up. This is 1 of 4 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020220483:same reporter (reporter´s case) US-GLAXOSMITHKLINE-US2020AMR222096:same patient
Age: 82.0
Sex: M
Vaccine: TDAP
Symptoms: Carpal tunnel syndrome, Mobility decreased, Muscle spasms, Pain, Pain in extremity
Clinical narrative: carpal tunnel syndrome; 2 middle fingers cramped and closed on him and he could not open them without manually pulling on the fingers; pain in the whole left arm that radiated down to his fingers; 2 middle fingers cramped and closed on him and he could not open them without manually pulling on the fingers; This case was reported by a pharmacist via call center representative and described the occurrence of carpal tunnel syndrome in a 82-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 4F99G, expiry date 19th August 2022) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th August 2020, the patient received Boostrix (intramuscular) and Boostrix Pre-Filled Syringe Device. On 17th August 2020, 1 days after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced carpal tunnel syndrome, finger cramps, radiating pain and mobility decreased. On an unknown date, the outcome of the carpal tunnel syndrome, finger cramps, radiating pain and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the carpal tunnel syndrome, finger cramps, radiating pain and mobility decreased to be related to Boostrix and Boostrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received the vaccine in the left arm. On 17th August 2020 the patient had pain in the whole left arm that radiated down to his fingers and the patient's 2 middle fingers cramped and closed on him and he could not open them without manually pulling on the fingers and this was ongoing at the time of reporting. The patient's physician diagnosed him with carpal tunnel syndrome and he had been going to physical therapy.  The patient did not consent to follow-up.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Balance disorder, Burning sensation, Dizziness, Flushing, Pallor
Clinical narrative: 2 hours after vaccination felt flush, was pale, felt unsteady and dizzy. Developed rash down arm that burned. Took Benadryl routinely for 24 hours. Rash gone within 48 hours.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: 2 hours after vaccination felt flush, was pale, felt unsteady and dizzy. Developed rash down arm that burned. Took Benadryl routinely for 24 hours. Rash gone within 48 hours.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia, Rash
Clinical narrative: Within a month from vaccine developed rash over body, worse to scalp; also paresthesia when heated from working outside or taking warm bath.  Rash persists but is improved slightlly 5 months after injection, paresthesias persist when body becomes heated.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Neck pain, Pain, Pain of skin, Peripheral coldness
Clinical narrative: Woke up around 4 AM in pain with 102 F fever, shakes, frozen finger tips, then needle feeling like after mild frostbite, complete body aches,  neck and pain in the back of skull.    Took Tylenol x2 extra strength at 6 AM, fever went down to 99.8 (normal is 98).  Fever returned to 101.5 by 5 PM.  Took 2 extra strength Tylenol at 6 PM and fever went to 99.4.  The next morning temperature was 98.5 and only mild head pain.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Tremor
Clinical narrative: Woke up around 4 AM in pain with 102 F fever, shakes, frozen finger tips, then needle feeling like after mild frostbite, complete body aches,  neck and pain in the back of skull.    Took Tylenol x2 extra strength at 6 AM, fever went down to 99.8 (normal is 98).  Fever returned to 101.5 by 5 PM.  Took 2 extra strength Tylenol at 6 PM and fever went to 99.4.  The next morning temperature was 98.5 and only mild head pain.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Chills, Lethargy, Myalgia
Clinical narrative: This was the second of two vaccinations. Fever, chills, muscle ache, mild upset stomach, general lethargy/weakness. Symptoms persisted from 7pm on 11/11/202 till abut 10 am on 11/12/202. All symptoms returned at about 6pm on 11/12/2020 till I slept at about 8 pm 11/12/20. No symptoms on 11/13/2020.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, SARS-CoV-2 test negative
Clinical narrative: This was the second of two vaccinations. Fever, chills, muscle ache, mild upset stomach, general lethargy/weakness. Symptoms persisted from 7pm on 11/11/202 till abut 10 am on 11/12/202. All symptoms returned at about 6pm on 11/12/2020 till I slept at about 8 pm 11/12/20. No symptoms on 11/13/2020.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Chills, Hypotension, Laboratory test, Pain
Clinical narrative: sore arm,fever, body aches, chills, severely low blood pressure
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: sore arm,fever, body aches, chills, severely low blood pressure
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood pressure decreased, Dehydration, Dizziness, Laboratory test, Pyrexia
Clinical narrative: sore arm,fever, body aches, chills, severely low blood pressure
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Urine analysis
Clinical narrative: sore arm,fever, body aches, chills, severely low blood pressure
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Electrocardiogram, Feeling abnormal, Feeling hot, Full blood count, Palpitations
Clinical narrative: About 20 minutes after receiving the injection I experienced a pounding heart, warmth in my upper body and tingling around my lips and a feeling that something was not right. I was driving home at the time and immediately turned around and drove myself to the ER.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia oral, Troponin
Clinical narrative: About 20 minutes after receiving the injection I experienced a pounding heart, warmth in my upper body and tingling around my lips and a feeling that something was not right. I was driving home at the time and immediately turned around and drove myself to the ER.
Age: 66.0
Sex: F
Vaccine: FLUA4, VARZOS
Symptoms: Facial paralysis
Clinical narrative: She experienced Bell's palsy
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: Patient received vaccine in office between 3:30 PM- 4 PM.  About 3.5 hours later developed fever, chills with complaints of left arm pain.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Extra dose administered, Pain in extremity
Clinical narrative: Contacted client's mother on 10/28/20 and received verbal consent to administer Tdap and meningococcal conjugate vaccines. On 11/11/2020, this RN prepared the vaccinations and administered Boostrix and Menactra. Upon rereivew of registry, documentation noted that client had received Tdap on 06/30/2020. Contacted client's mother to notify her of immunization error and education provided on potential side effects. Client's mother denied that client had redness or local reaction at injection site but did state that client's arm was mildly sore. Client's mother stated she had forgotten client received a Tdap vaccine on 06/30/2020 due to getting stitches. Client's mother denied questions or concerns.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: sharp pains and sensitivity in elbows, and the next day in hip bones.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Presyncope, Pyrexia, Tinnitus, Urticaria
Clinical narrative: Zinging sound in head Almost passed out Hives Fever body aches
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site macule, Injection site pain, Injection site rash
Clinical narrative: Patient seen in the office 11/12/2020 with adverse reaction. Patient noted to have macular, erythematous rash on right deltoid, tender to palpation at injection site, no fevers
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Hyperhidrosis, Pain, Tenderness
Clinical narrative: after vax rec'vd. Came home and took tylenol, later same night, felt aching, and went to bed. Awoke, and took bandaid off, took more tylenol, still aching. That evening, started sweating, and noticed that redness was on arm where shot was, which was 6 inch down arm and was bright red (christmas color red) was really tender, and was 2 inch wide at top. Sore to touch area on arm. When awoke next day after that, still red, still taking tylenol extra strength. On 11.13.20 still having itching and still red a little. Still same length, still itch, and color is getting lighter.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Hyperhidrosis, Nausea, Pain in extremity
Clinical narrative: After receiving the vaccine 10:20 AM on 11/11, I woke up with a mild fever and crushing headache at 1 AM on 11/12 for which I took some aspirin.  I was extremely fatigued and nauseated all day on 11/12 as well as sweating a lot and still had an intensive headache.  I continued to treat with aspirin, which did help somewhat..  on 11/13 I noticed a large red, hot circle around the area of the vaccine.  Nausea and fatigue are much improved on 11/13, but still not totally back to normal.  My arm still hurts a lot.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: After receiving the vaccine 10:20 AM on 11/11, I woke up with a mild fever and crushing headache at 1 AM on 11/12 for which I took some aspirin.  I was extremely fatigued and nauseated all day on 11/12 as well as sweating a lot and still had an intensive headache.  I continued to treat with aspirin, which did help somewhat..  on 11/13 I noticed a large red, hot circle around the area of the vaccine.  Nausea and fatigue are much improved on 11/13, but still not totally back to normal.  My arm still hurts a lot.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dizziness, Exposure during pregnancy, Fatigue, Headache
Clinical narrative: I have had a healthy pregnancy so far, with 2 other healthy pregnancies. I am due 4/10/2021. I woke up the morning following my flu vaccine with headache, muscle aches, and became dizzy and had to lay down as my vision was spotty and blacking out. After attempting to eat and drink, I became nauseated and vomited. Muscle aches increased throughout the day, and by approximately noon that day I had a 100.3  fever, which persisted throughout the night, during which I had chills and night sweats. The following day (today) I am still fatigued and light-headed with mild muscle aches,  no fever at this time.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia, Nausea, Night sweats, Pyrexia, Visual impairment
Clinical narrative: I have had a healthy pregnancy so far, with 2 other healthy pregnancies. I am due 4/10/2021. I woke up the morning following my flu vaccine with headache, muscle aches, and became dizzy and had to lay down as my vision was spotty and blacking out. After attempting to eat and drink, I became nauseated and vomited. Muscle aches increased throughout the day, and by approximately noon that day I had a 100.3  fever, which persisted throughout the night, during which I had chills and night sweats. The following day (today) I am still fatigued and light-headed with mild muscle aches,  no fever at this time.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: I have had a healthy pregnancy so far, with 2 other healthy pregnancies. I am due 4/10/2021. I woke up the morning following my flu vaccine with headache, muscle aches, and became dizzy and had to lay down as my vision was spotty and blacking out. After attempting to eat and drink, I became nauseated and vomited. Muscle aches increased throughout the day, and by approximately noon that day I had a 100.3  fever, which persisted throughout the night, during which I had chills and night sweats. The following day (today) I am still fatigued and light-headed with mild muscle aches,  no fever at this time.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Upper arm, between shoulder and elbow extremely sore.
Age: 60.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Body aches Headache Chills Soreness/redness/swelling at site of vaccine tiredness Nausea
Age: 60.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site swelling, Nausea
Clinical narrative: Body aches Headache Chills Soreness/redness/swelling at site of vaccine tiredness Nausea
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Computerised tomogram, Electrocardiogram, Heart rate decreased, Hypertension
Clinical narrative: Extreme site pain High blood pressure low pulse rate
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Extreme site pain High blood pressure low pulse rate
Age: 88.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Pain in extremity, Swelling
Clinical narrative: LEFT ARM PAIN AND SWELLING
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Mobility decreased, Muscular weakness
Clinical narrative: 4 hours after vaccine patient experience hard chills. Took Tylenol and wrapped herself in blankets and went to bed. Next day her legs gave out and she fell to the floor. After that she was in bed for 3 days.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Pain, Pain in extremity
Clinical narrative: Arm was in instant pain. Arm is still achy over three weeks later. Hurts to lift arm above head. Hurts to turn steering wheel. Hurts to take off and put on clothes. Hurts to bear any weight- even my own arm weight at times.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Blood bicarbonate decreased, Blood chloride increased, Blood creatinine normal, Blood glucose increased, Blood pH decreased
Clinical narrative: At about 10pm hat home on 11/9/2020 patient's CPAP and pulse ox alarms were going off,  parents tried to troubleshoot and a company representative came to the house to switch out the machinery, but after it was replaced the alarms persisted, dad noted the CPAP made an abnormal sound "like the air was hitting a wall" and took the equipment off him, saw that the patient "was blue around his mouth" and "did not look like he was breathing" around midnight so mom called 911 and dad did 2 rounds of CPR immediately (by this time around 12-12:30am). EMS arrived and reportedly patient was taking irregular breaths at that time and they initiated bag-mask ventilation. Patient arrived in the Emergency room at about 1:13 AM being bag mask ventilated. His initial pH was 6.796. He was intubated, placed on a ventilator and brought to the Intensive Care Unit. He was placed on Video Electroencephalogram at 10:57 am and found to be in status epilepticus.  Brain MRI performed on 11/12/2020 with extensive regions of restricted diffusion with ischemic injury.  As of this submission (11/13/2020) patient remains intubated, mechanically ventilated, and on vasopressors with unclear neurologic prognosis.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Blood potassium decreased, Blood sodium normal, Blood urea increased, Brain midline shift, Brain oedema
Clinical narrative: At about 10pm hat home on 11/9/2020 patient's CPAP and pulse ox alarms were going off,  parents tried to troubleshoot and a company representative came to the house to switch out the machinery, but after it was replaced the alarms persisted, dad noted the CPAP made an abnormal sound "like the air was hitting a wall" and took the equipment off him, saw that the patient "was blue around his mouth" and "did not look like he was breathing" around midnight so mom called 911 and dad did 2 rounds of CPR immediately (by this time around 12-12:30am). EMS arrived and reportedly patient was taking irregular breaths at that time and they initiated bag-mask ventilation. Patient arrived in the Emergency room at about 1:13 AM being bag mask ventilated. His initial pH was 6.796. He was intubated, placed on a ventilator and brought to the Intensive Care Unit. He was placed on Video Electroencephalogram at 10:57 am and found to be in status epilepticus.  Brain MRI performed on 11/12/2020 with extensive regions of restricted diffusion with ischemic injury.  As of this submission (11/13/2020) patient remains intubated, mechanically ventilated, and on vasopressors with unclear neurologic prognosis.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Cerebral ischaemia, Continuous positive airway pressure, Cyanosis, Electroencephalogram abnormal, Endotracheal intubation
Clinical narrative: At about 10pm hat home on 11/9/2020 patient's CPAP and pulse ox alarms were going off,  parents tried to troubleshoot and a company representative came to the house to switch out the machinery, but after it was replaced the alarms persisted, dad noted the CPAP made an abnormal sound "like the air was hitting a wall" and took the equipment off him, saw that the patient "was blue around his mouth" and "did not look like he was breathing" around midnight so mom called 911 and dad did 2 rounds of CPR immediately (by this time around 12-12:30am). EMS arrived and reportedly patient was taking irregular breaths at that time and they initiated bag-mask ventilation. Patient arrived in the Emergency room at about 1:13 AM being bag mask ventilated. His initial pH was 6.796. He was intubated, placed on a ventilator and brought to the Intensive Care Unit. He was placed on Video Electroencephalogram at 10:57 am and found to be in status epilepticus.  Brain MRI performed on 11/12/2020 with extensive regions of restricted diffusion with ischemic injury.  As of this submission (11/13/2020) patient remains intubated, mechanically ventilated, and on vasopressors with unclear neurologic prognosis.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Haemoglobin normal, Intensive care, Irregular breathing, Magnetic resonance imaging brain abnormal, Mechanical ventilation
Clinical narrative: At about 10pm hat home on 11/9/2020 patient's CPAP and pulse ox alarms were going off,  parents tried to troubleshoot and a company representative came to the house to switch out the machinery, but after it was replaced the alarms persisted, dad noted the CPAP made an abnormal sound "like the air was hitting a wall" and took the equipment off him, saw that the patient "was blue around his mouth" and "did not look like he was breathing" around midnight so mom called 911 and dad did 2 rounds of CPR immediately (by this time around 12-12:30am). EMS arrived and reportedly patient was taking irregular breaths at that time and they initiated bag-mask ventilation. Patient arrived in the Emergency room at about 1:13 AM being bag mask ventilated. His initial pH was 6.796. He was intubated, placed on a ventilator and brought to the Intensive Care Unit. He was placed on Video Electroencephalogram at 10:57 am and found to be in status epilepticus.  Brain MRI performed on 11/12/2020 with extensive regions of restricted diffusion with ischemic injury.  As of this submission (11/13/2020) patient remains intubated, mechanically ventilated, and on vasopressors with unclear neurologic prognosis.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Oxygen saturation abnormal, PCO2 increased, Platelet count normal, Respiratory arrest, Resuscitation
Clinical narrative: At about 10pm hat home on 11/9/2020 patient's CPAP and pulse ox alarms were going off,  parents tried to troubleshoot and a company representative came to the house to switch out the machinery, but after it was replaced the alarms persisted, dad noted the CPAP made an abnormal sound "like the air was hitting a wall" and took the equipment off him, saw that the patient "was blue around his mouth" and "did not look like he was breathing" around midnight so mom called 911 and dad did 2 rounds of CPR immediately (by this time around 12-12:30am). EMS arrived and reportedly patient was taking irregular breaths at that time and they initiated bag-mask ventilation. Patient arrived in the Emergency room at about 1:13 AM being bag mask ventilated. His initial pH was 6.796. He was intubated, placed on a ventilator and brought to the Intensive Care Unit. He was placed on Video Electroencephalogram at 10:57 am and found to be in status epilepticus.  Brain MRI performed on 11/12/2020 with extensive regions of restricted diffusion with ischemic injury.  As of this submission (11/13/2020) patient remains intubated, mechanically ventilated, and on vasopressors with unclear neurologic prognosis.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Seizure, Status epilepticus, White blood cell count
Clinical narrative: At about 10pm hat home on 11/9/2020 patient's CPAP and pulse ox alarms were going off,  parents tried to troubleshoot and a company representative came to the house to switch out the machinery, but after it was replaced the alarms persisted, dad noted the CPAP made an abnormal sound "like the air was hitting a wall" and took the equipment off him, saw that the patient "was blue around his mouth" and "did not look like he was breathing" around midnight so mom called 911 and dad did 2 rounds of CPR immediately (by this time around 12-12:30am). EMS arrived and reportedly patient was taking irregular breaths at that time and they initiated bag-mask ventilation. Patient arrived in the Emergency room at about 1:13 AM being bag mask ventilated. His initial pH was 6.796. He was intubated, placed on a ventilator and brought to the Intensive Care Unit. He was placed on Video Electroencephalogram at 10:57 am and found to be in status epilepticus.  Brain MRI performed on 11/12/2020 with extensive regions of restricted diffusion with ischemic injury.  As of this submission (11/13/2020) patient remains intubated, mechanically ventilated, and on vasopressors with unclear neurologic prognosis.
Sex: F
Vaccine: RV5
Symptoms: Underdose
Clinical narrative: During administration her daughter continuously spat the medication out as it was getting administered.; No additional AE information reported; This spontaneous report was received from a pharmacist and refers to her daughter of unknown age. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally (dose number, dose, lot# and expiration date were not reported) for prophylaxis. During administration she continuously spat the medication out. The reporter was not sure how much was consumed. There was no additional adverse event reported.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: incorrect product storage; This spontaneous report has been received from an other healthcare professional referring to a patient of unknown age and unknown gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.     On 26-OCT-2020, the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # T007035 with expiration date 01-MAY-2022; route and dose details were unknown) was administered to the patient for prophylaxis, after a temperature excursion (product storage error). The vaccine was stored below 36 degrees Fahrenheit/ 2 degree Celsius (0.9 degree Celsius to 1.9 degree Celsius) for 10 hours and above 47 degrees Fahrenheit/ 9 degree Celsius (9.1 degree Celsius) for 30 minutes. There were no previous temperature excursions. There was no digital data logger was involved.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T007035; expirationdate: 01-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA011203: US-009507513-2010USA011367: US-009507513-2010USA011375:
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient not experiencing any side effects; patient receivedan expired dose of VARIVAX; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 27-OCT-2020, the patient was vaccinated with expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) dose reported as 1 injection, lot # R022116, expiration date 02-AUG-2020 (dose number and route of administration were not reported) for prophylaxis. The patient was not experiencing any side effects.
Sex: U
Vaccine: HEPA, HPV9, MMR, PPV, RV5
Symptoms: Product storage error
Clinical narrative: temperature excursion; the ROTATEQ was administered two times; This spontaneous report was received from a nurse referring to a patient of unknown age and unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not reported.       On 20-OCT-2020, hepatitis a vaccine, inactivated (VAQTA) (lot # T008697 with expiration date 04-JUN-2021), hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and rotavirus vaccine, live, oral, pentavalent(ROTATEQ) ((lot # and expiration date were not provided) experienced a temperature excursion (incorrect product storage). The patient was vaccinated with the hepatitis a vaccine, inactivated (VAQTA) one time and rotavirus vaccine, live, oral, pentavalent(ROTATEQ) two times (dose and route were not provided) (inappropriate schedule of vaccine administered) for prophylaxis after the temperature excursion. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T008697; expirationdate: 04-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of VARIVAX administered to a patient; This spontaneous report was received from registered nurse (inconsistent information: also reported as a consumer) referring to a patient of unknown age and gender. The patient's concomitant therapies included sterile diluent (manufacture unknown).  The patient's pertinent medical history, concurrent condition and previous drug reaction or allergy were not reported.   On 05-NOV-2020, the patient was vaccinated with expired varicella virus vaccine live (oka/merck) (VARIVAX) (1 dose, strength, route of administration and anatomical site of vaccination were not reported, lot # R029517, expiration date reported and validated as 14-OCT-2020) for prophylaxis (expired product administered). The action taken of varicella virus vaccine live (oka/merck)(VARIVAX) was not provided. No additional adverse event was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Mobility decreased, Myalgia, Nausea, Pain in extremity
Clinical narrative: very sore and swollen upper arm / upper arm is still painful; very sore and swollen upper arm; upper arm is still painful, to the extent that I have trouble raising it above my head, fastening my bra; overall muscle aches; upset stomach; nausea; temp between 99.5 and 100.; This case was reported by a consumer and described the occurrence of pain in arm in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1dose received on unknown date. please refer the case US2020AMR219429).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm, swelling arm, mobility decreased, muscle pain, upset stomach, nausea and fever. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm and mobility decreased were not recovered/not resolved and the outcome of the swelling arm, muscle pain, upset stomach, nausea and fever were unknown.   It was unknown if the reporter considered the pain in arm, swelling arm, mobility decreased, muscle pain, upset stomach, nausea and fever to be related to Shingrix.   Additional details were provided as follows: The age at vaccination was not reported. The patient had a full-blown reaction of upset stomach, nausea, very sore and swollen upper arm, overall muscle aches, temperature between 99.5 and 100 degree F. Most of these reactions lasted for about 3 days. The reporter stated that now, 6 weeks later, the patient's upper arm was still painful, to the extent that she had trouble raising it above her head, fastening my bra, etc. The patient asked if it was normal.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR222147:1st dose
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: very sore and swollen upper arm / upper arm is still painful; very sore and swollen upper arm; upper arm is still painful, to the extent that I have trouble raising it above my head, fastening my bra; overall muscle aches; upset stomach; nausea; temp between 99.5 and 100.; This case was reported by a consumer and described the occurrence of pain in arm in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1dose received on unknown date. please refer the case US2020AMR219429).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm, swelling arm, mobility decreased, muscle pain, upset stomach, nausea and fever. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm and mobility decreased were not recovered/not resolved and the outcome of the swelling arm, muscle pain, upset stomach, nausea and fever were unknown.   It was unknown if the reporter considered the pain in arm, swelling arm, mobility decreased, muscle pain, upset stomach, nausea and fever to be related to Shingrix.   Additional details were provided as follows: The age at vaccination was not reported. The patient had a full-blown reaction of upset stomach, nausea, very sore and swollen upper arm, overall muscle aches, temperature between 99.5 and 100 degree F. Most of these reactions lasted for about 3 days. The reporter stated that now, 6 weeks later, the patient's upper arm was still painful, to the extent that she had trouble raising it above her head, fastening my bra, etc. The patient asked if it was normal.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR222147:1st dose
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Injection site pain, Pain in extremity
Clinical narrative: Got the second dose 3 weeks after the first dose; Soreness with both doses at the injection site / 2nd dose; Left arm is still sore / described her arm as being sore as heck; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknwon date, refer case US2020223058).   On 9th November 2020, the patient received the 2nd dose of Shingrix. On 9th November 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. In November 2020, the patient experienced injection site pain and pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, pain in arm and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the injection site pain and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose of Shingrix in left arm as early as two weeks after the first dose, which led to shortening of vaccination. The patient experienced soreness at the injection site and the left arm was still sore and described arm as being sore as heck.  The reporter consented to follow up and could follow up with the patient directly.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020223058:Same reporter
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Erythema, Pruritus, Swelling, Swelling face, Urticaria
Clinical narrative: ingredients in flu vaccine from 2009 / that year she got it and was allergic; gradual swelling; itching; redness; hives; face swelling; This case was reported by a nurse via call center representative and described the occurrence of allergic reaction in a 36-year-old female patient who received Flu Seasonal TIV Dresden (Influenza vaccine unspecified 2009-10 season) (batch number AFLUA456AA, expiry date unknown) for prophylaxis.   Concurrent medical conditions included drug allergy.   On an unknown date, the patient received Influenza vaccine unspecified 2009-10 season (intramuscular). On an unknown date, less than a month after receiving Influenza vaccine unspecified 2009-10 season, the patient experienced allergic reaction, swelling, pruritus, erythema, hives and facial swelling. On an unknown date, the outcome of the allergic reaction, swelling, pruritus, erythema, hives and facial swelling were recovered/resolved.   It was unknown if the reporter considered the allergic reaction, swelling, pruritus, erythema, hives and facial swelling to be related to Influenza vaccine unspecified 2009-10 season.  Additional details were provided as follows: The age at vaccination was not reported, but could be 35 or 36 years. The reporter called asking for full list of ingredients in flu vaccine from 2009 with lot number AFLUA456AA. She did not knew the name of the flu vaccine, only lot number. The reporter stated that she always used to get a flu vaccine but that year she got it and was allergic. The reporter stated that she was allergic to thimerosal but that did not mean she was not allergic to rest of the ingredients. Upon follow up received on 5th November 2010, it was confirmed that the vaccine received was Fluarix from 2009. The reporter believed the vaccine was given intramuscular. The patient experienced gradual swelling, itching, redness and hives following vaccination that was generalized. The reporter remembered face swelling.  She is unsure how long it lasted but stated a handful of days as she went to see her doctor of medicine and then allergist so at least a week. The reporter gave permission to contact again for further information.