chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 54-year-old male patient who received SHINGRIX for prophylaxis. On 3rd November 2018 17:00, the patient received the 1st dose of SHINGRIX. On 3rd November 2018 21:00, 4 hrs after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling, injection site warmth and injection site tenderness. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site warmth and injection site tenderness were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site warmth and injection site tenderness to be related to SHINGRIX. Additional details were provided as follows: The reporting nurse's husband got the dose of SHINGRIX, at around 5 PM and by 9 PM he had redness, swelling, heat and tenderness at the injections site. The reporting nurse consented to be followed up.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Musculoskeletal pain, Pain, Rotator cuff syndrome
Clinical narrative: Patient did not report until 11/13/2018 but said she had soreness in her shoulder and that the pain radiated up to her neck and down her arm to her thumb. She was seen by Dr on the 13th and he thinks it may have been shoulder impingement.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Mother noticed Left lateral thigh swollen morning of 11/15/18, 11/15/18 lrg red hot area to LT lat thigh4" x 4" w/ "stamp" size area to center darker.
Age: 39.0
Sex: F
Vaccine: DTAP, FLU4, PPV
Symptoms: Chest X-ray normal, Chills, Dyspnoea, Hypersensitivity, Infection
Clinical narrative: 9:30 am November 7, 2018 - - 17 hours after vaccines a fever of 103.3; Accompanied with chills, body aches, difficulty breathing. Major pain in right arm. Advil would take down the fever for a few hours and it will rise back. 9:00 am November 8, 2018 -- 41 hours after vaccine fever of 102.3. Blood pressure 80/50. Heart rate 110-130. Diagnosed at emergency room with Sepsis and Sepsis treatment started.  Chest X-ray clean. Urine clean. Blood White cells 19.9 x 1000. Slight discoloration and major pain in right arm. November 9, 2018 Blood White cells 24 x 1000 Major infection / Edima in the right arm.
Age: 39.0
Sex: F
Vaccine: DTAP, FLU4, PPV
Symptoms: Laboratory test normal, Oedema peripheral, Pain, Pain in extremity, Pyrexia
Clinical narrative: 9:30 am November 7, 2018 - - 17 hours after vaccines a fever of 103.3; Accompanied with chills, body aches, difficulty breathing. Major pain in right arm. Advil would take down the fever for a few hours and it will rise back. 9:00 am November 8, 2018 -- 41 hours after vaccine fever of 102.3. Blood pressure 80/50. Heart rate 110-130. Diagnosed at emergency room with Sepsis and Sepsis treatment started.  Chest X-ray clean. Urine clean. Blood White cells 19.9 x 1000. Slight discoloration and major pain in right arm. November 9, 2018 Blood White cells 24 x 1000 Major infection / Edima in the right arm.
Age: 39.0
Sex: F
Vaccine: DTAP, FLU4, PPV
Symptoms: Sepsis, Skin discolouration, Urine analysis normal, White blood cell count increased
Clinical narrative: 9:30 am November 7, 2018 - - 17 hours after vaccines a fever of 103.3; Accompanied with chills, body aches, difficulty breathing. Major pain in right arm. Advil would take down the fever for a few hours and it will rise back. 9:00 am November 8, 2018 -- 41 hours after vaccine fever of 102.3. Blood pressure 80/50. Heart rate 110-130. Diagnosed at emergency room with Sepsis and Sepsis treatment started.  Chest X-ray clean. Urine clean. Blood White cells 19.9 x 1000. Slight discoloration and major pain in right arm. November 9, 2018 Blood White cells 24 x 1000 Major infection / Edima in the right arm.
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Blood immunoglobulin E, Full blood count, Paraesthesia, Rash
Clinical narrative: Rash on hands and feet, paresthesia on hand.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Paraesthesia, Vaccine positive rechallenge
Clinical narrative: Within days of receiving Influenza vaccine, I experienced tingling in my legs and feet and occasionally in my face. Patient still has tingling and some numbness in her right great toe and right 2nd digit. Also have tingling in her legs, especially in the am. Patient also reports that this has occurred each year for the past 3 years after receiving the vaccine. This is the first time she reported the symptoms.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Back pain, Chills, Fatigue, Headache
Clinical narrative: Uncontrolled shivering. High fever 103.9 (my regular core body temp is consistently 98.6). Weakness. Fainted twice - once in bed and once crawling to bathroom. Back area (felt like kidneys but most likely just back muscles) sore and aching. Moving in bed between sore left arm at injection site and back muscles acutely uncomfortable. Headache, muscle ache, fatigue. 2 days after injection, site is still red and warm, BUT improving. Handout stated: "About 12 out of 6 people who got recombinant zoster vaccine experienced side effects that prevented them from doing regular activities." COULD not do anything but stay in bed. Improving 2 days later.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Laboratory test, Musculoskeletal discomfort
Clinical narrative: Uncontrolled shivering. High fever 103.9 (my regular core body temp is consistently 98.6). Weakness. Fainted twice - once in bed and once crawling to bathroom. Back area (felt like kidneys but most likely just back muscles) sore and aching. Moving in bed between sore left arm at injection site and back muscles acutely uncomfortable. Headache, muscle ache, fatigue. 2 days after injection, site is still red and warm, BUT improving. Handout stated: "About 12 out of 6 people who got recombinant zoster vaccine experienced side effects that prevented them from doing regular activities." COULD not do anything but stay in bed. Improving 2 days later.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia, Syncope
Clinical narrative: Uncontrolled shivering. High fever 103.9 (my regular core body temp is consistently 98.6). Weakness. Fainted twice - once in bed and once crawling to bathroom. Back area (felt like kidneys but most likely just back muscles) sore and aching. Moving in bed between sore left arm at injection site and back muscles acutely uncomfortable. Headache, muscle ache, fatigue. 2 days after injection, site is still red and warm, BUT improving. Handout stated: "About 12 out of 6 people who got recombinant zoster vaccine experienced side effects that prevented them from doing regular activities." COULD not do anything but stay in bed. Improving 2 days later.
Age: 22.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Incorrect dose administered
Clinical narrative: At Hepatitis A clinic, box of pediatric vaccine in cooler instead of Adult dose. Dose taken out and given. Revaccinated on 11-2-2018 with adult Hepatitis A VAQTA, R018775, 2019Aug09, in Right Deltoid.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen painful L supraclavicular lymph nodes.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Abdominal pain upper, Alopecia, Blood aluminium, Electroencephalogram normal, Food intolerance
Clinical narrative: FULL BODY CONVOLUTIONS, BODY TICKS, STOMACH PAINS, INCREASE IN FOOD SENSITIVITY, SIGNIFICANT HAIR LOSS, FLU LIKE FEELING FIRST COUPLE DAYS, RANDOM PASSING OUT.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Influenza like illness, Laboratory test, Loss of consciousness, Seizure, Tic
Clinical narrative: FULL BODY CONVOLUTIONS, BODY TICKS, STOMACH PAINS, INCREASE IN FOOD SENSITIVITY, SIGNIFICANT HAIR LOSS, FLU LIKE FEELING FIRST COUPLE DAYS, RANDOM PASSING OUT.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Vitamin D decreased, Vitamin D deficiency
Clinical narrative: FULL BODY CONVOLUTIONS, BODY TICKS, STOMACH PAINS, INCREASE IN FOOD SENSITIVITY, SIGNIFICANT HAIR LOSS, FLU LIKE FEELING FIRST COUPLE DAYS, RANDOM PASSING OUT.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza like illness, Loss of personal independence in daily activities, Lower respiratory tract infection, Myalgia, Oropharyngeal pain
Clinical narrative: Within hours after the injection, I felt a sore throat and muscle aches. The muscle aches have lasted for the past two days, and I feel as though I have the flu. I was unable to pursue my normal routines, but had to stay in bed for the last two days. I have bronchial congestion that appears to be infected. Prior to the injection, I had no cold symptoms whatsoever. This appears to be a direct result of the vaccine.
Age: 60.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Incorrect dose administered
Clinical narrative: At Hepatitis A outreach box of Hepatitis A pediatric dose put in cooler instead of adult dose. Used vial of pediatric instead of adult. Revaccinated on 11-2-18 with Hep A Vaqta R018775, 2019Aug09.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Feeling abnormal, Pruritus, Skin warm
Clinical narrative: Patient states arm was not feeling normal after shot. A week ago it started to become itchy and now it is red and hot. I advised patient to call their medical doctor today to get an appointment
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Malaise, Myalgia, Swelling
Clinical narrative: Swelling, redness, muscle pain, malaise.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 18-OCT-2018, the patient was vaccinated with an expired dose of ROTATEQ, lot # N005972, expiration date 12-OCT-2018 (strength and dose were not reported). No adverse effects were reported. The outcome of the event expired product administered was not provided.
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a male patient of unknown age. Information about concurrent condition, concomitant medication and medical history was not provided. On 24-OCT-2018, the patient was vaccinated with an expired dose of VAQTA lot # N020689, expiration date 22-OCT-2018, intramuscularly for prophylaxis. No adverse effects.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions or concomitant medications was not provided. The patient's healthcare provider (unspecified healthcare professional), recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2015, a pharmacist at a pharmacy administered the ZOSTAVAX (dose, route of administration, and lot # were not reported) to the patient. On or about 2016, the patient was treated by a physician/MD for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earning capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Causality assessment was related. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider/healthcare providers recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 03-JUN-2010, a healthcare provider (not further specified) administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2015, the patient was treated by Healthcare provider(s) (unspecified health care professional) for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Causality assessment considered events to be related to the use of ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site urticaria
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of injection site wheal in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site wheal. On an unknown date, the outcome of the injection site wheal was unknown. It was unknown if the reporter considered the injection site wheal to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. The reporter stated that she had some patients with very large welts at the injection site after the administration of SHINGRIX. The reporter did not agree to provide follow up information.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a 56-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (on an unknown date, the patient received 1st dose). On 30th October 2018, the patient received the 2nd dose of SHINGRIX. In October 2018, less than a week after receiving SHINGRIX, the patient experienced shivering. On an unknown date, the outcome of the shivering was unknown. It was unknown if the reporter considered the shivering to be related to SHINGRIX. Additional details were received as follows: The patient was experiencing shivering. The reporter did not consent to follow-up. There was no contact. This case was linked with case US2018198693, reported by the same reporter for the same patient.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site extravasation, Pain in extremity, Underdose
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) and the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced pain in arm and accidental underdose. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the accidental underdose was unknown. The reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient got the 1st dose of SHINGRIX about 4 months ago from the date of reporting. Afterwards his arm was sore for 2 to 3 days. About 1 week ago from the date of reporting he got the 2nd dose of SHINGRIX and after the injection a lot of fluid leaked out of the injection site. The patient thought he did not receive much, if any, of the dose, which led to accidental underdose. The patient arm had not hurt at all after the 2nd dose and he could not tell that he received anything at all. There was no consent to follow up.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 56-year-old male patient who received SHINGRIX for prophylaxis. On 28th August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were reported as follows: The patient presented with soreness in arm. The reporter did not consent to follow up. There was no contact. For tolerance to 2nd dose, refer case US2018GSK203632.
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 adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The pharmacist reported that the patient called in the day before reporting and reported that he was experiencing a rash after being vaccinated with SHINGRIX. No additional details were available. The reporter did not consent to follow-up.
Sex: M
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a male patient who received BEXSERO for prophylaxis. Previously administered products included BEXSERO with an associated reaction of injection site pain (1st dose received few years before the date of reporting, for tolerance refer case US2018GSK207716). On an unknown date, the patient received the 2nd dose of BEXSERO. On an unknown date, less than a day after receiving BEXSERO, the patient experienced injection site pain. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to BEXSERO. Additional details were reported as follows: This case was reported by a nurse who gave the injection. The age at vaccination was not reported. The nurse reported that the patient stated this BEXSERO injection was 10 times as painful as the first dose of BEXSERO. The patient took Advil on the 2nd day and the pain resolved by the 3rd day. The nurse gave consent to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Erythema, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 70-year-old female patient who received SHINGRIX (batch number 9NJ59, expiry date unknown) for prophylaxis. On 16th July 2018, the patient received the 1st dose of SHINGRIX. On 16th July 2018, less than a day after receiving SHINGRIX, the patient experienced erythema of extremities, pain in arm and upset stomach. On an unknown date, the outcome of the erythema of extremities, pain in arm and upset stomach were unknown. It was unknown if the reporter considered the erythema of extremities, pain in arm and upset stomach to be related to SHINGRIX. Additional details were provided as follows: The patient received the dose of SHINGRIX in the left arm and experienced pain, redness with red streaks down the arm and upset stomach that all began on the day of vaccination. The reporting pharmacist was unsure of the duration of the patient's symptoms. The reporting pharmacist consented to be followed up. The expiration date of the SHINGRIX was not available.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tiredness in a adult female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (at 18 years of age). In August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, less than a day after receiving SHINGRIX, the patient experienced tiredness, pain and rash urticaria-like. On an unknown date, the outcome of the tiredness, pain and rash urticaria-like were recovered/resolved. It was unknown if the reporter considered the tiredness, pain and rash urticaria-like to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. Sometime in August 2018, the patient received SHINGRIX. After vaccination, the patient experienced tiredness, achiness and a hive-like rash on both her thighs. The reporter did not give consent to follow-up as she did not wish to be contacted.
Age: 87.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 87-year-old female patient who received SHINGRIX for prophylaxis. On 13th September 2018, the patient received SHINGRIX (intramuscular). On 13th September 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient reported that her arm hurt since she received a dose of SHINGRIX. The pain was at the injection site and not severe but noticeable throughout most of the day. The patient saw her physician about it, who suggested she take some pain medication, but she had not taken any. The patient gave consented to follow up. Emergency room (ER) visit required.
Age: 87.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 87-year-old female patient who received SHINGRIX for prophylaxis. On 13th September 2018, the patient received SHINGRIX (intramuscular). On 13th September 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient reported that her arm hurt since she received a dose of SHINGRIX. The pain was at the injection site and not severe but noticeable throughout most of the day. The patient saw her physician about it, who suggested she take some pain medication, but she had not taken any. The patient gave consented to follow up. Emergency room (ER) visit required.
Sex: F
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of Guillain Barre syndrome in a elderly female patient who received Flu Seasonal QIV Dresden for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced Guillain Barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the Guillain Barre syndrome was recovered/resolved. It was unknown if the reporter considered the Guillain Barre syndrome to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist called to ask whether Guillain Barre had been seen in any patients who received SHINGRIX. During the call the pharmacist stated that the patient received a flu vaccine 4 years before the time of reporting and developed Guillain Barre. The pharmacist did not know the name of actual Flu vaccine, and patient did not remember as per the pharmacist since it had been 4 years. Very limited information was provided.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site haemorrhage, Injection site induration, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 76-year-old female patient who received SHINGRIX (batch number EY93J, expiry date 13th April 2021) for prophylaxis. On 8th November 2018, the patient received the 2nd dose of SHINGRIX. On 8th November 2018, immediately after receiving SHINGRIX, the patient experienced injection site swelling, injection site induration, injection site erythema and injection site hemorrhage. On an unknown date, the outcome of the injection site swelling, injection site induration, injection site erythema and injection site hemorrhage were unknown. It was unknown if the reporter considered the injection site swelling, injection site induration, injection site erythema and injection site hemorrhage to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional (HCP) reported that the patient developed a hardened red swollen area with minimal bleeding at the injection site. No further information reported regarding the event. The reporter did not give consent to follow-up.
Age: 71.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Erythema, Feeling abnormal, Swelling
Clinical narrative: Patient reported a 3 x 5 inch very swollen red area about 2 inches below the injection site which is self-resolving. She reported that it is almost back to normal. She felt "kind of icky" for a few days, which I explained is a normal side effect.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Vomiting
Clinical narrative: Large local erythema (L) deltoid 2 d prior. Vomiting.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered at inappropriate site
Clinical narrative: Patient states injection went into bursa - is being seen by an orthopedic MD.
Age: 24.0
Sex: F
Vaccine: FLU4, HEP
Symptoms: Dyspnoea, Palpitations, Pruritus, Urticaria
Clinical narrative: Itching, hives, shortness of breath, heart palpitations.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Pain, Swelling
Clinical narrative: Pt. experienced sore redness that night and the next day swelling/cellulitis.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: Swelling on L leg from hip to knee. Provider recommends BENADRYL, MOTRIN and ice as needed.
Age: 1.0
Sex: M
Vaccine: PNC13
Symptoms: Gait inability, Injection site pain, Pyrexia, Weight bearing difficulty
Clinical narrative: Fever- 102 degrees F. Also severe pain at injection site - was unable to walk or bear weight for hours after waking up the morning after the vaccine. He had this same reaction with the previous 3 as well but this seemed worse/ more severe this time.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Patient has a bright red rash starting right under her chin and continuing down to her arms and waist.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, Product preparation error
Clinical narrative: 8.21.2018 I was doing shots on a child with coworker one today. We did a Meningo shot. Coworker one taught me how to mix the power Meningo with the specific meningo saline. The package has us mix an 'orange' topped powder vial with a 'gray' topped specific saline vial. I then realized that coworker two and I gave a Meningo shot before with an orange topped Meningo power and a vial of normal saline rather than the specific gray topped saline that goes with the Meningo powder. Coworker two was the individual who mixed the medications together, but I gave the Meningo injection. I started to worry if the immunization would work for the patient that coworker two and I took care of. I asked coworker one and coworker three because coworker two was not in the building. We looked on the CDC website. I found out that the Meningo powder CANNOT be mixed with normal saline and that it must be mixed with the specific saline that the manufacturer sends with the immunization powder. If I had known that Meningo vaccine had to be mixed with a specific diluent, I would have had coworker two draw up a new vaccine for the client. However, since coworker two has given these vaccines many times before, she should've known this information. Coworker one and I are looking into the next steps we need to take in order to report this immunization error. Patient has been notified via mail. The telephone we have for the client does not have a voicemail box set up and does not answer our phone calls. Incident report was filed. Patient notified via mail again on 10/29/2018.
Age: 46.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Effusion, Inflammation, Joint range of motion decreased, Musculoskeletal pain, Sleep disorder
Clinical narrative: Shoulder pain, loss of range of motion almost immediately on administration. Pain disrupting sleep. Better with NSAIDS and rest.
Age: 46.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Ultrasound scan abnormal, X-ray abnormal
Clinical narrative: Shoulder pain, loss of range of motion almost immediately on administration. Pain disrupting sleep. Better with NSAIDS and rest.
Age: 46.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia, Pain
Clinical narrative: Shoulder pain, loss of range of motion almost immediately on administration. Pain disrupting sleep. Better with NSAIDS and rest.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea, Erythema, Joint range of motion decreased, Nausea, Pain
Clinical narrative: "Today for left arm pain, swelling, increased warmth, decreased ROM in left arm, and body aches since she had her pneumonia shot on 11/8/18. She notes that the redness of her left arm has been getting worse over time. Pain is plus 8-9/10 with rest plus 10/10 with movement. She had a low grade fever, nausea, and diarrhea a few days ago but this has resolved. Denies any chills, SOB, chest pain, vomiting, numbness, or tingling. She is taking MOTRIN 800 mg every 6 hours with slight improvement in pain".
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: "Today for left arm pain, swelling, increased warmth, decreased ROM in left arm, and body aches since she had her pneumonia shot on 11/8/18. She notes that the redness of her left arm has been getting worse over time. Pain is plus 8-9/10 with rest plus 10/10 with movement. She had a low grade fever, nausea, and diarrhea a few days ago but this has resolved. Denies any chills, SOB, chest pain, vomiting, numbness, or tingling. She is taking MOTRIN 800 mg every 6 hours with slight improvement in pain".
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling at flu shot site.
Age: 35.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Extreme fever chills. Unknown if actually had fever. Chills were so violent hot shower could not subside them. Slept under 4 blankets until I sweated it out. Approximately a 60 minute episode.
Age: 78.0
Sex: M
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: Patient does not report any symptoms.
Age: 33.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injected limb mobility decreased, Joint range of motion decreased, Pain in extremity, Urticaria
Clinical narrative: "Patient received vaccines last week. She did get pneumonia vaccine in the left arm which did create a welt, but this resolved on its own. She denies any issues other than a slight reason the skin. She denies any pain. However, on the right arm she received her influenza vaccine. She states later that day she had some soreness which she has had in the past, however at night it significantly worsened. She states initially she cannot move her arm much at all. This progressed and she has been able to move it slightly more, however does still have trouble with internal rotation and needs assistance stressing. She has a hard time breast-feeding as well as picking up her child hurts her shoulders well. She has not had a reaction like this in the past. She does feel as if her vaccination may been given too high. She has been doing ice in trying different position changes but is having difficulty sleeping".
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, and refers to a female patient of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 22-OCT-2018, the patient was vaccinated with an expired dose of PNEUMOVAX 23, lot # M029680, expiration date 17-JAN-2018, for prophylaxis (route not provided). No adverse effects reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and unknown gender. No information regarding the patients pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On 02-NOV-2018, the patient was vaccinated with M-M-R II injection, lot # M039914,albumin status: rHA (recombinant Human albumin), expiration date: 26-SEP-2018, 1 dosage form, intramuscularly(Incorrect route of product administration) for prophylaxis. The reporter stated that the patient received an expired dose of M-M-R II, also reported that product as well as sterile diluent was stored properly. No adverse effects were reported. No further information provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 12-NOV-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There is no information regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2014, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. In 2015, the patient was treated by the patient's healthcare provider at a hospital for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is unknown. The causality of the events is related. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Seizure like phenomena, Syncope
Clinical narrative: This spontaneous report was received from a pharmacist via company representative and refers to a 23-year-old female patient. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported. On an unspecified date, the patient was vaccinated with second dose of GARDASIL 9 intramuscularly (concentration, exact dose, lot number and expiration date were not reported) for human papillomavirus (HPV) prevention. At an unspecified time after administration, she "fainted and experienced seizure like activity". The outcome of syncope and seizure was reported as recovered. The causal relationship between the event and the vaccine was not reported. Upon internal review, the events of syncope and seizure were determined to be medically significant.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Chemotherapy, Pain in extremity
Clinical narrative: Patient came in on November 15th, 2018 and stated that his arm is still sore from May when he got the shot. His PCP recommended that he come to the pharmacy for us to complete the form. Since receiving the shot, he also started chemotherapy.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever, vomiting for 36 hours.
Age: 71.0
Sex: M
Vaccine: FLUC4
Symptoms: Death
Clinical narrative: DIED AT HOME, UNATTENDED? 11-10-2018.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site oedema, Injection site swelling
Clinical narrative: Swelling, fluid build up in right arm from shoulder to elbow.
Age: 64.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site discomfort, Injection site pain, Malaise, Pyrexia
Clinical narrative: Patient received vaccines around 11:30AM and called later that night stating she now has a fever and "thinks she is coming down with something". She also stated that her arm was sore where she received the vaccines and it felt like "a golf ball" in her arm. We explained that you can't get sick from either vaccine since they are both dead viruses and came to the conclusion with the patient she might have been sick prior to the vaccines being introduced to her system. She stated she was going to put heat on the injection site to help with the discomfort. She was advised to use ice, but denied it stating she doesn't want to use it since she has a fever. Also discussed other remedies to help her treat symptomatically.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dizziness, Headache, Lethargy, Loss of consciousness
Clinical narrative: Approximately 3 1/2 hrs post vaccine administration I experienced onset severe headache which over the next hour progressed to generalized body aches, chills and nausea. I then began to feel lightheaded and dizzy and over a period of about 15 minutes I gradually lost consciousness. I quickly regained consciousness but continued with severe chills and aches over the next several hours. The next day I experienced some lethargy but was back to normal state 48 hrs after the vaccine.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Pain
Clinical narrative: Approximately 3 1/2 hrs post vaccine administration I experienced onset severe headache which over the next hour progressed to generalized body aches, chills and nausea. I then began to feel lightheaded and dizzy and over a period of about 15 minutes I gradually lost consciousness. I quickly regained consciousness but continued with severe chills and aches over the next several hours. The next day I experienced some lethargy but was back to normal state 48 hrs after the vaccine.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Nausea, Paraesthesia
Clinical narrative: Per EE she got flu vaccine on 10/16/18 in left deltoid: flu infromation: FLULAVAL multi dose 0.5mL 2B55B Manufacturer: ID Biomedical Corporation at 11:58am. On 10/18 EE started to feel "off" during the day at work. She had dizziness, and felt as if " the world was spinning", she had nausea, no vomiting, and every now and then would have to hold onto railing or the computer cart to keep from falling over. She also states she has episodes during the dizziness where she would go to stand up and start walking and her toes, fingertips, and jaw would tingle like it was going to go to sleep or become numb. This lasted the whole time from 10/16-10/29 as well. On 10/29 EE reports feeling 100% better. Over this period of time EE reports constant dizziness that was intermittently worse at times. She did have a doctor on the unit look in her ears and no fluid was seen. She had to take ZOFRAN and PHENERGAN for the nausea to keep from vomiting. EE does have a history of dizziness in general, no specific diagnosis of vertigo. Also has had fluid in her ears before but not within the last year. No viral illness before flu vaccine. No diarrhea or other symptoms. No doctor visit.
Age: 37.0
Sex: M
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Injection site pain, Neuralgia
Clinical narrative: Patient said they had the normal sore arm for a couple days but it turned into nerve pain where he could not lift his arm very far above his head. No redness or irritation at the site. Will make doctors appt and call us back.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Headache, Myalgia, Nasal congestion
Clinical narrative: Morning after: Muscular pain, arm pain, headache, tiredness. 2nd morning after: All of above plus nasal congestion, sore throat, runny nose, diarrhea. 3rd day, still had headache and tiredness. 4th day, back to normal.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Pain in extremity, Rhinorrhoea
Clinical narrative: Morning after: Muscular pain, arm pain, headache, tiredness. 2nd morning after: All of above plus nasal congestion, sore throat, runny nose, diarrhea. 3rd day, still had headache and tiredness. 4th day, back to normal.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Headache, Injection site pain, Injection site swelling
Clinical narrative: Pt says she felt fine the day of the shot, but starting the next day, she experienced fever/chills, nausea, diarrhea, headache, and pain/swelling at the injection site. She missed a day of work due to these symptoms.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Nausea, Pyrexia
Clinical narrative: Pt says she felt fine the day of the shot, but starting the next day, she experienced fever/chills, nausea, diarrhea, headache, and pain/swelling at the injection site. She missed a day of work due to these symptoms.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient complained of redness in arm and swelling and some pain.
Age: 79.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Pt says she has right arm and shoulder pain.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: BOTH INJECTION SITES BECAME BRUISED, THERE WAS A RED SWOLLEN 5 INCH DIAMETER BAND BELOW INJECTION SITE AND THE BAND WAS FEVERISH.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Rash erythematous
Clinical narrative: Received vaccine in underpart of left arm - fleshy part. (not in muscle by shoulder). I broke out in hives inside both arms, inside of both legs, and on buttock area. It was a red rash, hives, not itchy but, raised. At the injection site, I had bright red patch, swelling, heat, and pain. Injection site was VERY tender for 3 days. Hives lasted for 4 days. I did not have any trouble breathing.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Received vaccine in underpart of left arm - fleshy part. (not in muscle by shoulder). I broke out in hives inside both arms, inside of both legs, and on buttock area. It was a red rash, hives, not itchy but, raised. At the injection site, I had bright red patch, swelling, heat, and pain. Injection site was VERY tender for 3 days. Hives lasted for 4 days. I did not have any trouble breathing.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient states arm is still slightly sore after 1 week, but no sharp pain, no swelling, no redness, no rash.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Soreness, redness, swelling within a few inches of the injection site in the medial upper arm. Told patient to take BENADRYL for a few days to see if it improved. Told to contact doctor and pharmacy if reaction worsened or didn't improve.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Malaise, Myalgia, Nausea, Pain in extremity
Clinical narrative: Nausea, muscle aches, fever, extremely sore left arm (not resolved yet).
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Nausea, muscle aches, fever, extremely sore left arm (not resolved yet).
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Asthenia, Dizziness, Fatigue, Myalgia, Pain in extremity
Clinical narrative: Parent of child contacted clinic 11/15/2018 reporting that child had muscle soreness since vaccination 11/14/2018. Child reported feeling dizzy and tired after leaving the clinic yesterday. He says that he went home and fell asleep and felt weak when he woke up. He stayed home from school today because he continued to feel dizzy, weak, and tired, and still has muscle soreness. He reports more pain in right arm than left arm.
Age: 26.0
Sex: M
Vaccine: FLUC4
Symptoms: Abdominal pain upper, Vomiting
Clinical narrative: Vomiting and stomach cramps starting a couple hours after vaccination.