chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Syncope
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fainting in a 60-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of fatigue (1st dose received on 26th October 2018, refer case: US2019GSK016718). On 22nd January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 23rd January 2019, 1 days after receiving SHINGRIX, the patient experienced fainting (serious criteria GSK medically significant), feeling unwell, chills, low blood pressure, pulse rapid and sweating. On an unknown date, the outcome of the fainting was recovered/resolved and the outcome of the feeling unwell, chills, low blood pressure, pulse rapid and sweating were recovering/resolving. It was unknown if the reporter considered the fainting, feeling unwell, chills, low blood pressure, pulse rapid and sweating to be related to SHINGRIX. Additional details were received as follows: The case was reported by the patient's husband. At the time of reporting, in the morning patient woke up with not feeling good and she presented with chills as well.  The patient got up and tried to do some stuff, but she ended up fainting 3 times. The patient's blood pressure was very low, which was showed to be 20 points lower than normal range. The patient's pulse was up and sweaty. The patient was laying down helped and went back to sleep. At the time of reporting, the patient was not awake again and was feeling better.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a adult female patient who received SHINGRIX (batch number 9277N, expiry date 27th June 2021) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (subcutaneous). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm and intramuscular formulation administered by other route. On an unknown date, the outcome of the pain in arm and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. SHINGRIX was inadvertently administered subcutaneously, which led to incorrect route of vaccination. The patient returned to the pharmacy because her arm hurt. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were reported as follows: The age group was not reported but was selected adult as per vaccine indication. The age at vaccination was not reported. The pharmacist reported via online chat. The reporter said that a patient developed shingles after the 1st dose. The reporter asked was it still recommended for the patient to received the 2nd dose. As the reporter had a patient currently in this situation. The reporter did not consent to follow up. The reporter stated, This was a question that the reporter received from a provider. The reporter did not know the background information about the patient.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of rash in a 72-year-old female patient who received SHINGRIX (batch number 2AH5M, expiry date 18th May 2021) for prophylaxis. On 31st December 2018, the patient received SHINGRIX. In January 2019, less than a month 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 provided as follows: The patient developed a rash that was currently present for 2 weeks that appeared within a few days of vaccination with SHINGRIX.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 60-year-old female patient who received SHINGRIX for prophylaxis. On 26th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was recovered/resolved. It was unknown if the reporter considered the fatigue to be related to SHINGRIX. Additional details were received as follows: The case was reported by the patient's husband. The patient felt a little fatigued after 1st dose. For tolerance to 2nd dose, refer case US2019012853.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes ophthalmic
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of herpes ophthalmic in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced herpes ophthalmic (serious criteria GSK medically significant). On an unknown date, the outcome of the herpes ophthalmic was unknown. It was unknown if the reporter considered the herpes ophthalmic to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient developed ocular herpes sometime after receiving the dose of SHINGRIX. The episode was resolved and then flared back up. The reporter consented to follow up. The healthcare professional requested to contact her to get additional information at later time.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 57-year-old female patient who received SHINGRIX for prophylaxis. On 23rd January 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 23rd January 2019, 6 hrs after receiving SHINGRIX, the patient experienced joint pain and shivering. On an unknown date, the outcome of the joint pain and shivering were not recovered/not resolved. The reporter considered the joint pain and shivering to be related to SHINGRIX. Additional details were reported as follows: The patient stated she started to experience joint pain and shivering 6 to 7 hours after the vaccination. The reporter did not consent to follow up. The lot number and expiration date were unknown by the patient.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of pain in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain, swelling and erythema. On an unknown date, the outcome of the pain, swelling and erythema were unknown. It was unknown if the reporter considered the pain, swelling and erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional had no vaccine or patient information except patient's gender. The patient experienced pain, redness and swelling after receiving a dose of SHINGRIX.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of erythema of extremities in a 60-year-old male patient who received SHINGRIX (batch number 49R72, expiry date 13th March 2021) for prophylaxis. On 20th November 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema of extremities, skin warm and itchy upper limbs. On an unknown date, the outcome of the erythema of extremities, skin warm and itchy upper limbs were unknown. It was unknown if the reporter considered the erythema of extremities, skin warm and itchy upper limbs to be related to SHINGRIX. Additional details were provided as follows: The patient experienced redness, itching, warmth to the touch that extended from 1 inch above the site to his elbow. The reporter consented to follow up.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fall, Head injury, Loss of consciousness, Rhinorrhoea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of unconscious in a 80-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date). On 21st January 2019, the patient received the 2nd dose of SHINGRIX. On 22nd January 2019, 1 days after receiving SHINGRIX, the patient experienced unconscious (serious criteria GSK medically significant), dizziness, fall, head injury, runny nose and sneezing. On 24th January 2019, the outcome of the unconscious, dizziness, fall, head injury, runny nose and sneezing were recovered/resolved. It was unknown if the reporter considered the unconscious, dizziness, fall, head injury, runny nose and sneezing to be related to SHINGRIX. Additional details were provided as follows: It was not known when dose one occurred, but no events were noted with that dose of SHINGRIX. The patient experienced dizziness, fell down, hit her head, and was unconscious from the fall for a few minutes. The patient also experienced a runny nose and sneezing attacks. The patient slept a few hours and felt better. Symptoms began the next day, after receiving SHINGRIX and at time of report had resolved. The patient did not consent to follow-up.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Sneezing
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of unconscious in a 80-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date). On 21st January 2019, the patient received the 2nd dose of SHINGRIX. On 22nd January 2019, 1 days after receiving SHINGRIX, the patient experienced unconscious (serious criteria GSK medically significant), dizziness, fall, head injury, runny nose and sneezing. On 24th January 2019, the outcome of the unconscious, dizziness, fall, head injury, runny nose and sneezing were recovered/resolved. It was unknown if the reporter considered the unconscious, dizziness, fall, head injury, runny nose and sneezing to be related to SHINGRIX. Additional details were provided as follows: It was not known when dose one occurred, but no events were noted with that dose of SHINGRIX. The patient experienced dizziness, fell down, hit her head, and was unconscious from the fall for a few minutes. The patient also experienced a runny nose and sneezing attacks. The patient slept a few hours and felt better. Symptoms began the next day, after receiving SHINGRIX and at time of report had resolved. The patient did not consent to follow-up.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Mobility decreased, Nausea, Pain in extremity, Periarthritis
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for herself, a 65-year-old female patient who received PREVNAR 13 (lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced nauseous, pain in arm, limitation of arm movement, frozen shoulder, fever 102.2, fatigued and swelling. The outcome of the events was unknown. Information on the lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Swelling
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for herself, a 65-year-old female patient who received PREVNAR 13 (lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced nauseous, pain in arm, limitation of arm movement, frozen shoulder, fever 102.2, fatigued and swelling. The outcome of the events was unknown. Information on the lot/batch number has been requested.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Fatigue, Malaise, Musculoskeletal stiffness, Pallor, Urinary incontinence
Clinical narrative: Mother reports patient stated he didn't feel well 5 minutes after vaccination. She assisted him off the exam table to the garbage can in case he needed to vomit. Mom reports his body stiffened, his eyes widened, so she laid him on the ground. She states his body felt stiff. He urinated wile laying on the ground. Mom called for help and staff immediately responded. He was pale, but started to speak when we entered the room asking what happened. BP 110/60, pulse 70. He was given a lollipop. After several minutes he was assisted to a sitting position. He had no complaints other than feeling tired. His lips were now pink. He was assisted to the chair where he sat for several minutes. He drank and retained a cup of water. He was then assisted to standing position, and took steps around the office. He stated he felt himself, just tired. After several minutes he was ambulated out of the office without incidence. Time in office, approximately 45 minutes.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema
Clinical narrative: Medication should have been administered IM and it was administered Sub Q.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Eye irritation, Influenza like illness, Nausea, Pain
Clinical narrative: Patient was fine in the time period immediately after the injection. However, beginning 1/14/19 patient reported flu-like symptoms. These symptoms included chills, fever, nausea, body aches and her eyes burning. She reports that these symptoms lasted 4-5 days. She reported this reaction to the pharmacy on 1/24/19.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient was fine in the time period immediately after the injection. However, beginning 1/14/19 patient reported flu-like symptoms. These symptoms included chills, fever, nausea, body aches and her eyes burning. She reports that these symptoms lasted 4-5 days. She reported this reaction to the pharmacy on 1/24/19.
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain, Shoulder injury related to vaccine administration
Clinical narrative: Localized pain. Suspect SIRVA. Ongoing treatment. Pain has not resolved. Currently in therapy.
Age: 22.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth, Muscular weakness
Clinical narrative: On 1-28-19, patient reported that vaccine given in left arm got hot, red and was itching. Left arm felt weak, area of injection was hard.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Feeling abnormal, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Within 15 minutes of received vaccination: muscle stiffness at injection site, muscle warmth at injection site, redness at injection site, overall fatique, body aches and sore throat. Within 2-4 hours of received vaccination: Severe debilitating muscle stiffness of right arm, unable to raise arm, extreme soreness and hardening of muscle at injection site, persistent redness at the injection site, worsening fatigue, body aches and sore throat and a feeling of sore neck lymph nodes 24-48 hours after received vaccination: Lessening of all symptoms over time with sleep/rest, ibuprofen Overall experience: I was alarmed at how quickly I started feeling ill (within the 15 mins the facility asked me to wait in the lobby after receiving the injection was when symptoms began). By the time I left the facility, all I wanted to do was lie down. My throat hurting was the most alarming initial symptom, feeling sore within 15 min of receiving injection, which I felt was concerning. By the time I got home and lied down, symptoms were worsening and at one point I felt like I was "dying" with soreness, fatigue and arm pain. Overall, it was a terrible experience. I'm lucky I was able to go home and rest it off and sleep through it. I was not able to carry on with normal activities for 2 days. I felt like I had come down with the flu. Being that I was coming off of having an upper resp infection with cough and asthma in weeks prior and was just starting to feel better, the Pneumo vaccine was ill timed in my opinion.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Injection site warmth, Loss of personal independence in daily activities, Lymph node pain, Malaise
Clinical narrative: Within 15 minutes of received vaccination: muscle stiffness at injection site, muscle warmth at injection site, redness at injection site, overall fatique, body aches and sore throat. Within 2-4 hours of received vaccination: Severe debilitating muscle stiffness of right arm, unable to raise arm, extreme soreness and hardening of muscle at injection site, persistent redness at the injection site, worsening fatigue, body aches and sore throat and a feeling of sore neck lymph nodes 24-48 hours after received vaccination: Lessening of all symptoms over time with sleep/rest, ibuprofen Overall experience: I was alarmed at how quickly I started feeling ill (within the 15 mins the facility asked me to wait in the lobby after receiving the injection was when symptoms began). By the time I left the facility, all I wanted to do was lie down. My throat hurting was the most alarming initial symptom, feeling sore within 15 min of receiving injection, which I felt was concerning. By the time I got home and lied down, symptoms were worsening and at one point I felt like I was "dying" with soreness, fatigue and arm pain. Overall, it was a terrible experience. I'm lucky I was able to go home and rest it off and sleep through it. I was not able to carry on with normal activities for 2 days. I felt like I had come down with the flu. Being that I was coming off of having an upper resp infection with cough and asthma in weeks prior and was just starting to feel better, the Pneumo vaccine was ill timed in my opinion.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Musculoskeletal stiffness, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: Within 15 minutes of received vaccination: muscle stiffness at injection site, muscle warmth at injection site, redness at injection site, overall fatique, body aches and sore throat. Within 2-4 hours of received vaccination: Severe debilitating muscle stiffness of right arm, unable to raise arm, extreme soreness and hardening of muscle at injection site, persistent redness at the injection site, worsening fatigue, body aches and sore throat and a feeling of sore neck lymph nodes 24-48 hours after received vaccination: Lessening of all symptoms over time with sleep/rest, ibuprofen Overall experience: I was alarmed at how quickly I started feeling ill (within the 15 mins the facility asked me to wait in the lobby after receiving the injection was when symptoms began). By the time I left the facility, all I wanted to do was lie down. My throat hurting was the most alarming initial symptom, feeling sore within 15 min of receiving injection, which I felt was concerning. By the time I got home and lied down, symptoms were worsening and at one point I felt like I was "dying" with soreness, fatigue and arm pain. Overall, it was a terrible experience. I'm lucky I was able to go home and rest it off and sleep through it. I was not able to carry on with normal activities for 2 days. I felt like I had come down with the flu. Being that I was coming off of having an upper resp infection with cough and asthma in weeks prior and was just starting to feel better, the Pneumo vaccine was ill timed in my opinion.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Pyrexia, Tremor
Clinical narrative: Headache, shaking, vomiting, chills, fever 102.7, joint pain.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Headache, shaking, vomiting, chills, fever 102.7, joint pain.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Headache, Hyperhidrosis
Clinical narrative: The usual listed on the paper given to me: redness on the arm, swelling at the injection site, muscle pain, tiredness, headache, shivering AND, one not listed was blurred vision for about 20 minutes upon waking in the a.m. as I was sweating at the time.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Myalgia, Vision blurred
Clinical narrative: The usual listed on the paper given to me: redness on the arm, swelling at the injection site, muscle pain, tiredness, headache, shivering AND, one not listed was blurred vision for about 20 minutes upon waking in the a.m. as I was sweating at the time.
Age: 36.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Impaired work ability, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initially pt felt malaise and fatigue 2 hours post vaccine. At 4 hours the injection site was red, swollen and hot. Pt called in sick to work the next day. By Wednesday her upper arm was bright red in area measuring 100 x 50 mm. On Friday she sought medical treatment from her PCP for pain, swelling, redness and burning of upper arm and distally to her elbow.
Age: 36.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth, Malaise
Clinical narrative: Initially pt felt malaise and fatigue 2 hours post vaccine. At 4 hours the injection site was red, swollen and hot. Pt called in sick to work the next day. By Wednesday her upper arm was bright red in area measuring 100 x 50 mm. On Friday she sought medical treatment from her PCP for pain, swelling, redness and burning of upper arm and distally to her elbow.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Wrong product administered
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician referring to a female patient of unknown age. No information was provided regarding the patient's medical history or concurrent conditions. Concomitant therapies included sterile diluent (MERCK). On an unspecified date, the patient had titers drawn which showed she had low titers for measles, mumps, and rubella. Physician did not know whether patient was ever administered M-M-R II prior to the titers being drawn. Due to the low titers, patient came into the office on 16-JAN-2019 to receive a dose of M-M-R II. Patient indicated on a pre-vaccination consent form that she may be pregnant, however, this was not noticed by the office. Then, the patient was inadvertently administered a dose of VARIVAX subcutaneous, for prophylaxis (dose, lot number and expiration date were not reported), instead of the intended dose of M-M-R II (wrong product administered). Physician reported this error occurred because VARIVAX was stored in a location where only M-M-R II was usually stored, and the provider who administered the dose simply did not notice that she had picked up a dose of VARIVAX instead of M-M-R II (product storage error); there was no confusion between the two products. Once the error was noticed, patient was called back into the office to receive the intended dose of M-M-R II on or after 16-JAN-2019; however, at that time the patient confirmed she was 31 weeks pregnant, therefore the intended dose of M-M-R II was still not administered. On an unspecified date, the patient became pregnant. The last menstrual period was 13-JUN-2018 and estimated delivery date was 20-MAR-2019. Initial exposure to VARIVAX was at 31 week(s). No adverse effect were reported following administration of VARIVAX. The pregnancy outcome was pending. The outcome of wrong product administered and product storage error was unknown.
Age: 0.75
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a medical assistant concerning to a 9 month old patient, of unknown gender. Information regarding concurrent condition, medical history and concomitant medication was not provided. On an unknown date (reported as on an unspecified recent date), the patient was vaccinated with an unspecified dose of VAQTA, intramuscularly, indicated for prophylaxis (strength, dose, lot # and expiration date were not provided). The reporter did not indicate any adverse effects.
Age: 0.17
Sex: U
Vaccine: RV1, RV5
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representative and refers to a 3 month old patient of unknown gender. The patient concomitant medication, pertinent medical history, drug reactions and allergies were not provided. On an unknown date (reported as at age 3 months), the patient was vaccinated with ROTATEQ, orally (strength, dose, lot number and expiry date were not reported) for prophylaxis. Other suspect therapies included ROTARIX (strength, dose, frequency, route of administration, lot number, expiry date and indication were not reported), which was administered when the patient was 2 months old. No adverse effect was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of chronic obstructive airways disease exacerbated in a female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included chronic obstructive pulmonary disease. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, unknown after receiving SHINGRIX, the patient experienced chronic obstructive airways disease exacerbated (serious criteria hospitalization), injection site pain, injection site erythema and injection site swelling. On an unknown date, the outcome of the chronic obstructive airways disease exacerbated, injection site pain, injection site erythema and injection site swelling were unknown. It was unknown if the reporter considered the chronic obstructive airways disease exacerbated, injection site pain, injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a severe local reaction with pain, redness and swelling. The patient also had an increase in her chronic obstructive airways disease (COPD) symptoms and was hospitalized. The reporter did not agree for follow up contact.
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of chronic obstructive airways disease exacerbated in a female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included chronic obstructive pulmonary disease. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, unknown after receiving SHINGRIX, the patient experienced chronic obstructive airways disease exacerbated (serious criteria hospitalization), injection site pain, injection site erythema and injection site swelling. On an unknown date, the outcome of the chronic obstructive airways disease exacerbated, injection site pain, injection site erythema and injection site swelling were unknown. It was unknown if the reporter considered the chronic obstructive airways disease exacerbated, injection site pain, injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a severe local reaction with pain, redness and swelling. The patient also had an increase in her chronic obstructive airways disease (COPD) symptoms and was hospitalized. The reporter did not agree for follow up contact.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Influenza, Malaise, Myalgia, Palpitations
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fainting in a 72-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 4 days after receiving SHINGRIX, the patient experienced fainting (serious criteria GSK medically significant), fever, muscle pain, flu symptoms, cough, palpitation, tremor and sickness. On an unknown date, the outcome of the fainting, fever, muscle pain, flu symptoms, cough, palpitation, tremor and sickness were recovered/resolved. It was unknown if the reporter considered the fainting, fever, muscle pain, flu symptoms, cough, palpitation, tremor and sickness to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's neighbor who himself was the physician. The age at vaccination was not reported. About 4 days after vaccination, the patient experienced fever, muscle ache, flu symptoms, palpitations, cough, fainting, trembling and sick for about 2 weeks. The patient did not receive the vaccine from the reporter. This reporter was just calling on behalf of her neighbor.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Syncope, Tremor
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fainting in a 72-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 4 days after receiving SHINGRIX, the patient experienced fainting (serious criteria GSK medically significant), fever, muscle pain, flu symptoms, cough, palpitation, tremor and sickness. On an unknown date, the outcome of the fainting, fever, muscle pain, flu symptoms, cough, palpitation, tremor and sickness were recovered/resolved. It was unknown if the reporter considered the fainting, fever, muscle pain, flu symptoms, cough, palpitation, tremor and sickness to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's neighbor who himself was the physician. The age at vaccination was not reported. About 4 days after vaccination, the patient experienced fever, muscle ache, flu symptoms, palpitations, cough, fainting, trembling and sick for about 2 weeks. The patient did not receive the vaccine from the reporter. This reporter was just calling on behalf of her neighbor.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient called Pharmacy on 1/25/19 complaining of a "big red area" around where the injection was given. Patient said not painful, no fever, no other reaction - but was concerned about it being so red. Also reported it was warm to the touch. Patient was instructed to call physician. We also called physician and left a message stating incident, but no call back. Instructed patient that she could use a pain reliever if needed to ice the area. We also instructed patient that if the area got bigger, she developed a fever, and/or if she was concerned about infection that she should go to ER or walk-in clinic.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Limb mass, Pain in extremity, Peripheral swelling
Clinical narrative: Pt described pain and swelling in the arm. Initially a lump. Reports swelling increased to include shoulder. Pt was referred to PCP for evaluation. RPh calling later today to follow up on outcome.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Rash generalised, Urticaria
Clinical narrative: Flu shot provided. Grandmother comes in for an appointment the next day and states he had a rash all over his body that evening. It went away after she gave Benadryl but it returned the next morning.  Rash/hives noted to torso, arms, neck and face. No respiratory stress or throat swelling/irritation noted. Lungs CTA all lobes. Child does not appear to be in distress.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Diarrhoea, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient had previous documentation of a single varicella vaccine as a child and reports she had the chicken pox as a child as well. Received the 2nd dose for pre-employment purposes following a negative titre at hospital in the Employee Health department on 01/28/19, at 1:03pm. Immunization given subcutaneously to the right upper arm. No initial acute reaction at time of  administration. Patient reports to Employee Health office on 01/30/19 at 1:30pm with a 70mm reaction to the injection site. Site is hot to touch, erythema and swelling present. She reports the reaction began the morning after the immunization and coincided with nausea and diarrhea. GI symptoms resolved by day 2 (01/30/19). She has not taken any medication specifically for the reaction, but states she is going to try PO BENADRYL, as the site is "very itchy."
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Nausea
Clinical narrative: Patient had previous documentation of a single varicella vaccine as a child and reports she had the chicken pox as a child as well. Received the 2nd dose for pre-employment purposes following a negative titre at hospital in the Employee Health department on 01/28/19, at 1:03pm. Immunization given subcutaneously to the right upper arm. No initial acute reaction at time of  administration. Patient reports to Employee Health office on 01/30/19 at 1:30pm with a 70mm reaction to the injection site. Site is hot to touch, erythema and swelling present. She reports the reaction began the morning after the immunization and coincided with nausea and diarrhea. GI symptoms resolved by day 2 (01/30/19). She has not taken any medication specifically for the reaction, but states she is going to try PO BENADRYL, as the site is "very itchy."
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Left arm cellulitis, treated with medication.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Respiratory disorder
Clinical narrative: Patient says he has had some Coughing/breathing issues 2 weeks after the immunization and has not gone away.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site reaction, Pain in extremity
Clinical narrative: Pt presents w/red edema medial left arm yesterday, the day after getting pneumonia vaccination. Low grade fever and soreness left arm 10 cm2 red indurated lesion medial aspect proximal left arm. No pus, no exudate. Limits of lesion scribed in indelible ink, I rx'd prednisone taper to be taken if Sx escalate. Pt advised to take benadryl 25 mg po q 6-8 hr as needed recheck if monday, or go to ER if worse or changes.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Skin lesion
Clinical narrative: Pt presents w/red edema medial left arm yesterday, the day after getting pneumonia vaccination. Low grade fever and soreness left arm 10 cm2 red indurated lesion medial aspect proximal left arm. No pus, no exudate. Limits of lesion scribed in indelible ink, I rx'd prednisone taper to be taken if Sx escalate. Pt advised to take benadryl 25 mg po q 6-8 hr as needed recheck if monday, or go to ER if worse or changes.
Age: 1.33
Sex: F
Vaccine: UNK
Symptoms: Crying, Diarrhoea, Gait disturbance, Injection site erythema, Injection site swelling
Clinical narrative: We were told it was the dTAP, but unsure of the specific one or lot number etc. Pt started crying and screaming around 430 the evening she got her vaccinations. The second injection site was red and swelling. She was having trouble walking. We gave her motrin and it helped her sleep a little. She woke screaming several times through the night. We called the doc to report her symptoms. They told us to alternate tylenol/motrin to help with her pain/malase and to rub the injection site. She has had diarrhea since that day as well (noone else in the house does). This is the same way she reacted to the first dose of dTAP (extreme screaming and swelling of the injection site). All reactions were reported to the pediatrician.
Age: 1.33
Sex: F
Vaccine: UNK
Symptoms: Malaise, Pain, Screaming
Clinical narrative: We were told it was the dTAP, but unsure of the specific one or lot number etc. Pt started crying and screaming around 430 the evening she got her vaccinations. The second injection site was red and swelling. She was having trouble walking. We gave her motrin and it helped her sleep a little. She woke screaming several times through the night. We called the doc to report her symptoms. They told us to alternate tylenol/motrin to help with her pain/malase and to rub the injection site. She has had diarrhea since that day as well (noone else in the house does). This is the same way she reacted to the first dose of dTAP (extreme screaming and swelling of the injection site). All reactions were reported to the pediatrician.
Age: 0.08
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial and follow up information was received from a medical assistant, and refers to a 4 week old patient of unknown gender. Information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies was not provided. On 15-JAN-2019, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB injection, (lot # R001529 with an expiration date in 07-NOV-2020), for prophylaxis (strength, dose, route and frequency were not provided), that underwent a temperature excursion above of 47 degrees Fahrenheit during a time frame of seven minute, but it was stated that her vaccine storage issue was not a problem. Digital data logger was involved and no previous temperature excursion was reported. Moreover, it was also reported that, the dose of RECOMBIVAX HB and other vaccine doses were found viable and ok to use. No adverse effect reported.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were no provided. On 29-JAN-2019,  the patient was inadvertently vaccinated with M-M-R II intramuscularly (incorrect route of product administration) lot # R000556,  expiration date on 08-JAN-2020, for prophylaxis (strength, dosage and frequency were not provided).
Age: 74.0
Sex: M
Vaccine: FLU4
Symptoms: Influenza, Wrong product administered
Clinical narrative: Initial information received on 22-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2019SA023042 (same reporter). This case involves a 74 years old male patient who got FLUZONE QUADRIVALENT instead of FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy was given. On 28-Sep-2018, the patient received 0.5 ml single first dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6331LA, expiry date 30 June 2019 via intramuscular route in the right upper arm (deltoid). On an unknown date, patient presented with flu post vaccination with INFLUENZA QUADRIVAL A-B VACCINE. It was also a case of actual medication error due to wrong vaccine administered. No lab test was reported. As corrective treatment, patient received Tamiflu. Outcome of the event was unknown. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Initial information received on 23-Jan-2019 regarding an unsolicited valid non-serious case received from a other health care professional. This case involves a 17 months old female patient who received a 0.5ml 4th dose of DAPTACEL batch number: C5117AA, expiration date: 19-Jan-2019 via intramuscular route in the right thigh on 23-Jan-2019. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to expired vaccine used. A patient was injected with DAPTACEL after the expiration date on the vial. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 23-Jan-2019 regarding an unsolicited valid non-serious case received from a physician. This case involves a 72 years old patient who received a dose of MENACTRA batch number not reported via unknown route in unknown administration site on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to inappropriate age at vaccine administration. A 72 years old patient received MENACTRA. No adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 75.0
Sex: U
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: Initial information received on 24-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 75 years old patient of unknown gender who received 0.5 ml expired dose of vaccine TENIVAC (lot number: U5525AA, expiry date: 07-Jan-2019, frequency once, dose in series not reported) via unknown route in left deltoid on 24-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s), and family history were not provided. Patient received no concomitant medication. It was a case of actual medication error due to expired vaccine used. It was unknown if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Dysphemia, Speech disorder
Clinical narrative: Child began to stutter within 24 hrs of vaccine, forgetting words and pronouncing words strangely. Marked change over 24 hrs according to mother.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: Patient became pregnant around the time of her 1st varicella vaccination.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Myalgia
Clinical narrative: Severe deltoid muscle pain, requiring an emergency room visit and pain meds (Morphine, Hydrocodone).
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site induration, Injection site pain, Muscular weakness, Pain in extremity
Clinical narrative: I received the vaccine Oct 8, 2018 (right arm) and on the morning of Oct 19, 2019  when I woke up my arm hurt, the injection site was very firm, I could bend my arm, but was very weak with arm abduction, to the point that I almost had to assist my right arm with my left  with abduction. The right arm hurt down into the bicep and tricep region. This lasted until the evening of Oct 21 when it diminished.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash pruritic, Skin warm
Clinical narrative: Hot, itchy rash on right side of trunk, went to doctor and determined to have shingles, obtained prescription for valacyclovir 1gm PO TID to start on 1/30/19. Symptoms started two days prior to seeing physician and reporting to pharmacy.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Hot, itchy rash on right side of trunk, went to doctor and determined to have shingles, obtained prescription for valacyclovir 1gm PO TID to start on 1/30/19. Symptoms started two days prior to seeing physician and reporting to pharmacy.
Age: 65.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Arthralgia, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: Pt was given PREVNAR 13 on 01/25/19 at about almost 1:00 pm. After the injection, pharmacist put ice pack on the site to prevent pain as usual for any patient. Pt complained about the pain and headache but it was not severe. Pt stayed at the pharmacy for avoer 30 minutes for pharmacist to observe and advised that pt should take some Tylenol or Advil. on 01/30/19, pt called back and complained about the pain continue, after 2 days of vaccination, he found the redness above the injection site, feeling fatigue, chills, pain in the joints, He also stated that he lost his appetite, only want to eat sour fruit, feeling like having flu. He reported that the pain went down  a bit compare to few days ago. (7 now  versus 10 before). Pharmacist contacted the manufacture Pfizer to report the issue. Pharmacist also advised patient to use ice pack, take NSAIDS and followed up with his PCP. However, pt.'s PCP office is closed today so pharmacist will follow up tomorrow. Pt is currently traveling out of state, pharmacist advised patient  to seek medical help if he feel uncomfortable.