chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 17-DEC-2018, the patient was vaccinated with PEDVAXHIB (lot # N003698 with expiry date 31-OCT-2019, dose, strength, route, vaccination site unspecified) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 47 degrees Fahrenheit (53.37 F) for 3 hours and 46 minutes, as recorded by a data logger. There was no previous temperature excursion. There was no adverse effect reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1903USA010362: Original Case: 1903USA004795; US-009507513-1903USA010363: Original Case: 1903USA004795; US-009507513-1903USA010364: Original Case: 1903USA004795; US-009507513-1903USA010361: Original Case: 1903USA004795; US-009507513-1903USA010360: Original Case: 1903USA004795; US-009507513-1903USA004795: Original Case: 1903USA004795; US-009507513-1903USA010358: Original Case: 1903USA004795; US-009507513-1903USA010359: Original Case: 1903USA004795.
Sex: U
Vaccine: VARCEL
Symptoms: Bradycardia, Tachycardia
Clinical narrative: This spontaneous report was received from a physician via Pfizer regarding a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (manufacture unknown) (dosing details, frequency, route of administration, lot number and expiration date were unknown) for prophylaxis. On an unknown date, the patient experienced bradycardia and tachycardia (moderate). Outcome of bradycardia and tachycardia was unknown. The reporter considered the events, bradycardia and tachycardia to be related to varicella virus vaccine live (Oka/Merck) (manufacture unknown). Upon internal review, the event bradycardia was determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of pain in arm in a 65-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included PNEUMOVAX with an associated reaction of pain in extremity (received dose on an unknown date). On 17th March 2019, the patient received the 1st dose of SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced pain in arm and fever. On an unknown date, the outcome of the pain in arm and fever were unknown. It was unknown if the reporter considered the pain in arm and fever to be related to SHINGRIX. Additional details were reported as follows: Age at vaccination was not reported. The patient received SHINGRIX dose in the left deltoid and his arm really hurts. The patient had slight fever but he had not checked till the reporting time. The reporter declined consent for follow up.
Age: 71.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Arthralgia, Bedridden, Dizziness, Headache, Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 71-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included PNEUMOCOCCAL VACCINE for prophylaxis. The patient's past medical history included shingles (at the age of 40 years). Previously administered products included ZOSTAVAX (at or around the age of 60 years). On 4th November 2018, the patient received the 1st dose of SHINGRIX and PNEUMONIA VACCINE. On 4th November 2018, less than a day after receiving SHINGRIX, the patient experienced dizziness and feeling unwell. In November 2018, the patient experienced headache, influenza-like symptoms, joint pain, muscle pain, mobility decreased, bedridden and pain upon movement. In November 2018, the outcome of the dizziness, feeling unwell, headache, influenza-like symptoms, joint pain, muscle pain, mobility decreased, bedridden and pain upon movement were recovered/resolved. It was unknown if the reporter considered the dizziness, feeling unwell, headache, influenza-like symptoms, joint pain, muscle pain, mobility decreased, bedridden and pain upon movement to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the patient for herself. The patient reported she had a severe reaction to the 1st dose of SHINGRIX. The patient stated that within 3 hours of the first vaccine she was light headed, dizzy and not feeling well. She had the worst headache she had ever had, she couldn't lift her head up off the pillow, it hurt so bad. She was bed ridden for a day. She had muscle and joint aches, flu like symptoms, and her doctor had her take a flu test at urgent care that was negative. She stated that the events lasted for about 2 to 3 days. She had a pneumonia vaccine on the same day, but could not recall the location. She was referred to that manufacturer to discuss potential side effects with that product, as she wondered if the combination caused such a bad reaction. The patient stated that she was not sure if she would get the 2nd vaccine or not. The patient stated that she went back for the second dose, but the pharmacist was hesitant to give it since she had the reaction that she did to the first. She was encouraged to contact GlaxoSmithKline to determine if she should receive it. The prescribing information was reviewed for the adverse events seen with vaccination and those more prevalent with dose 2 versus dose 1 and the duration of events. The patient was emailed the prescribing information and encouraged to speak with her physician. The patient visited the emergency room. The patient stated that she reported these events to her pharmacist and thought the pharmacist had reported them to GlaxoSmithKline but was not sure. It was unknown if the reporter considered the dizziness, feeling unwell, headache, influenza-like symptoms, joint pain, muscle pain, mobility decreased, bedridden and pain upon movement to be related to pneumonia vaccine.
Age: 71.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Influenza virus test negative, Malaise, Mobility decreased, Myalgia, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 71-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included PNEUMOCOCCAL VACCINE for prophylaxis. The patient's past medical history included shingles (at the age of 40 years). Previously administered products included ZOSTAVAX (at or around the age of 60 years). On 4th November 2018, the patient received the 1st dose of SHINGRIX and PNEUMONIA VACCINE. On 4th November 2018, less than a day after receiving SHINGRIX, the patient experienced dizziness and feeling unwell. In November 2018, the patient experienced headache, influenza-like symptoms, joint pain, muscle pain, mobility decreased, bedridden and pain upon movement. In November 2018, the outcome of the dizziness, feeling unwell, headache, influenza-like symptoms, joint pain, muscle pain, mobility decreased, bedridden and pain upon movement were recovered/resolved. It was unknown if the reporter considered the dizziness, feeling unwell, headache, influenza-like symptoms, joint pain, muscle pain, mobility decreased, bedridden and pain upon movement to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the patient for herself. The patient reported she had a severe reaction to the 1st dose of SHINGRIX. The patient stated that within 3 hours of the first vaccine she was light headed, dizzy and not feeling well. She had the worst headache she had ever had, she couldn't lift her head up off the pillow, it hurt so bad. She was bed ridden for a day. She had muscle and joint aches, flu like symptoms, and her doctor had her take a flu test at urgent care that was negative. She stated that the events lasted for about 2 to 3 days. She had a pneumonia vaccine on the same day, but could not recall the location. She was referred to that manufacturer to discuss potential side effects with that product, as she wondered if the combination caused such a bad reaction. The patient stated that she was not sure if she would get the 2nd vaccine or not. The patient stated that she went back for the second dose, but the pharmacist was hesitant to give it since she had the reaction that she did to the first. She was encouraged to contact GlaxoSmithKline to determine if she should receive it. The prescribing information was reviewed for the adverse events seen with vaccination and those more prevalent with dose 2 versus dose 1 and the duration of events. The patient was emailed the prescribing information and encouraged to speak with her physician. The patient visited the emergency room. The patient stated that she reported these events to her pharmacist and thought the pharmacist had reported them to GlaxoSmithKline but was not sure. It was unknown if the reporter considered the dizziness, feeling unwell, headache, influenza-like symptoms, joint pain, muscle pain, mobility decreased, bedridden and pain upon movement to be related to pneumonia vaccine.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Patient was being seen for well baby visit. He has not received initial Hep B vaccine at birth. Vaccine was given in clinic. After administration, vaccine noted to be expired on 1/29/2019. 06/01/2019: Mother reports no adverse effect noted.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Insomnia, Myalgia
Clinical narrative: Joint, muscular pain. Pain was so intense could not sleep. ADVIL helped but very little. Lasted a little more than 24 hours.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Urticaria
Clinical narrative: About 40 minutes after the injection I developed itching of my face and neck and a large hive on my forehead.
Age: 57.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Hep B #1: 11/28/18; Hep B #2: 12/28/18; Gave Hep B #3 on 3/4/19 too close to #2. Used Agency  assessment tool which stated accelerated date was 2/22/18 and recommended date was 2/28/18 and Checked Minimum interval chart from CDC and failed to read footnote #11 on Hep B 3#. Instead looked at minimum interval to #3 and saw 8 weeks, therefore gave dose #3. Immunization coordinator reported the assessment glitch to the Agency staff, and inquired of CDC staff recommendation for next vaccine which it was recommended to give a 4th dose on or after April 29, 2019. Client did not have any adverse reactions and was not upset.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Autoimmune disorder, C-reactive protein increased, Pain in extremity, Red blood cell sedimentation rate increased, White blood cell count increased
Clinical narrative: Pain in legs, that progressed to arms over 24 hours.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Joint noise
Clinical narrative: Popping joints in shoulder and elbow...daily for weeks.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Body temperature increased, Erythema, Local reaction, Skin warm
Clinical narrative: Temperature 101.5 tympanic reading...local reaction: red area from shoulder to just above the elbow/warm to touch.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Chills, Fatigue, Flushing, Headache, Heart rate increased
Clinical narrative: 10:30 pm 03/26/2019: fatigue. 11:00 pm 03/26/2019: face feeling flushed. 11:30 pm 03/26/2019: headache, chills, body aches, fever of 100.1 degrees, fast pulse (109). Still feeling all symptoms 11:30 am 03/27/2019, but to lesser degree.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: 10:30 pm 03/26/2019: fatigue. 11:00 pm 03/26/2019: face feeling flushed. 11:30 pm 03/26/2019: headache, chills, body aches, fever of 100.1 degrees, fast pulse (109). Still feeling all symptoms 11:30 am 03/27/2019, but to lesser degree.
Age: 90.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Vaccination complication
Clinical narrative: Patient had a terrible reaction, causing a lot of pain for him after receiving the shot. He was admitted to the hospital after getting the shot.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Paraesthesia, Tenderness
Clinical narrative: Vaccine given at 10:23am. 10:27am 10/10 sharp lower back pain. 10:32am 4/10 lower back pain felt like needles in lower back. No swelling. No rash. Slight tenderness with palpation. 10:43am 1/10 lower back pain. 10:52am no lower back pain. Lungs clear. 11:08am No lower back pain. Lungs clear. Per Dr.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Localized erythema and edema to the right thigh larger than left thigh. No shortness of breath and no hives.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Clostridium test positive, Fatigue, Vaccination site erythema, Vaccination site induration, Vaccination site oedema
Clinical narrative: Day 1 post receipt she was very fatigued, and they noted severe erythema, edema, pain, induration, pruritis and tenderness at the vaccine site with peripheral involvement from above her knee to her upper thigh, almost groin. They were unsure which vaccine given at that site. She was seen in Urgent Care on day 2 and treated with ZYRTEC, TYLENOL and MOTRIN and cold compresses. The symptoms improved and were mostly resolved in another 2 days.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: Day 1 post receipt she was very fatigued, and they noted severe erythema, edema, pain, induration, pruritis and tenderness at the vaccine site with peripheral involvement from above her knee to her upper thigh, almost groin. They were unsure which vaccine given at that site. She was seen in Urgent Care on day 2 and treated with ZYRTEC, TYLENOL and MOTRIN and cold compresses. The symptoms improved and were mostly resolved in another 2 days.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Incorrect diluent was used. Patient's parents notified and will come in to get this vaccine again.
Age: 17.0
Sex: F
Vaccine: DTAP
Symptoms: Blood pressure immeasurable, Brain injury, Consciousness fluctuating, Eye movement disorder, Loss of consciousness
Clinical narrative: Within a minute patient felt the vaccine enter her heart then she passed out while standing up. She did not have a measurable blood pressure or heartbeat. Did not wake up for over 3 minutes. Upon awakening, went in and out of consciousness and spasmed, eyes rolled back with each seizure. Continues to have spasms years later. One pupil is larger than the other due to brain damage.
Age: 17.0
Sex: F
Vaccine: DTAP
Symptoms: Muscle spasms, Pulse absent, Pupils unequal, Seizure
Clinical narrative: Within a minute patient felt the vaccine enter her heart then she passed out while standing up. She did not have a measurable blood pressure or heartbeat. Did not wake up for over 3 minutes. Upon awakening, went in and out of consciousness and spasmed, eyes rolled back with each seizure. Continues to have spasms years later. One pupil is larger than the other due to brain damage.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Nausea
Clinical narrative: Hi fever, excruciating headache, shivering, vomiting, nausea, pain and red big mark on side of injection looks like a spider bite and still very sore tireless. Still red and sore the arm and today is day three and I still have a headache.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Hi fever, excruciating headache, shivering, vomiting, nausea, pain and red big mark on side of injection looks like a spider bite and still very sore tireless. Still red and sore the arm and today is day three and I still have a headache.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Piloerection
Clinical narrative: Chills and goosebumps for 2 days. Injection site soreness.
Age: 61.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Guillain-Barre syndrome, Muscular weakness, Pain in extremity
Clinical narrative: Developed left arm weakness and pain on March 13, 2019 with progressive generalized muscle weakness was hospitalized with presumed Guillain-Barre.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Rash, Rash erythematous
Clinical narrative: Patient had redness/rash outbreak and go up shoulder into neck and face. Patient has been administered corticosteroids by his physician.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, DTAPIPVHIB, FLU4, HIBV
Symptoms: Wrong product administered
Clinical narrative: APRN inadvertently clicked on the PENTACEL tab in EHR rather than the PREVNAR tab.  LPN followed orders then after administering realized that signed consent form had PREVNAR signed for.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain, Peripheral swelling, Skin warm
Clinical narrative: Was sore, swollen up for his shoulder to his elbow red and warm to the touch. When patient came into clinic for his 2nd dose is when he told us about the reaction.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain, Ultrasound therapy
Clinical narrative: Approximately 2 weeks after receiving the injection site became red, swollen and painful. I was concerned I had a sterile abscess at the injection site but the symptoms resolved after 48 hours. However, this progressed to pain on raising my arm particularly when bent at a 90 degree angle. My right arm dangles due to my radial head excision so my left arm is my only functional arm. In Feb 2019 I asked my orthopedic oncologist to evaluate my arm and he gave me a PT prescription. With the use of US treatments I can now raise my arm with only occasional slight twinges of discomfort but have two distinct points of pain with pressure - 1) the injection site and 2) on the back of my shoulder near my armpit.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rotator cuff syndrome, Shoulder injury related to vaccine administration
Clinical narrative: Approximately 2 weeks after receiving the injection site became red, swollen and painful. I was concerned I had a sterile abscess at the injection site but the symptoms resolved after 48 hours. However, this progressed to pain on raising my arm particularly when bent at a 90 degree angle. My right arm dangles due to my radial head excision so my left arm is my only functional arm. In Feb 2019 I asked my orthopedic oncologist to evaluate my arm and he gave me a PT prescription. With the use of US treatments I can now raise my arm with only occasional slight twinges of discomfort but have two distinct points of pain with pressure - 1) the injection site and 2) on the back of my shoulder near my armpit.
Age: 0.25
Sex: M
Vaccine: RV5
Symptoms: Constipation, Crying, Diarrhoea, Flatulence, Haematochezia
Clinical narrative: 03/21/2019 Given ROTATEQ vaccine. 03/23/2019 mom spoke with dr on call pt fussy, gassy. Cried for 1 hr. no stool for 3 days. Given glycerine supp. Discussed signs of intussusception to watch out for. 03/24/2019 mom called Dr on call again. Now pt had flecks of blood in the stool. Pt sent to ER. Ultrasound normal. Stool guaiac positive. Discharged home. 03/26/2019 pt seen by pcp Dr. Pt continues to have loose mucoid stool, guaiac positive. Sent a Diarrheal PCR Panel to Lab and came back positive for Rotavirus. Pt is taking probiotics once a day per mom.
Age: 0.25
Sex: M
Vaccine: RV5
Symptoms: Irritability, Mucous stools, Occult blood positive, Polymerase chain reaction positive, Rotavirus test positive
Clinical narrative: 03/21/2019 Given ROTATEQ vaccine. 03/23/2019 mom spoke with dr on call pt fussy, gassy. Cried for 1 hr. no stool for 3 days. Given glycerine supp. Discussed signs of intussusception to watch out for. 03/24/2019 mom called Dr on call again. Now pt had flecks of blood in the stool. Pt sent to ER. Ultrasound normal. Stool guaiac positive. Discharged home. 03/26/2019 pt seen by pcp Dr. Pt continues to have loose mucoid stool, guaiac positive. Sent a Diarrheal PCR Panel to Lab and came back positive for Rotavirus. Pt is taking probiotics once a day per mom.
Age: 0.25
Sex: M
Vaccine: RV5
Symptoms: Ultrasound abdomen normal
Clinical narrative: 03/21/2019 Given ROTATEQ vaccine. 03/23/2019 mom spoke with dr on call pt fussy, gassy. Cried for 1 hr. no stool for 3 days. Given glycerine supp. Discussed signs of intussusception to watch out for. 03/24/2019 mom called Dr on call again. Now pt had flecks of blood in the stool. Pt sent to ER. Ultrasound normal. Stool guaiac positive. Discharged home. 03/26/2019 pt seen by pcp Dr. Pt continues to have loose mucoid stool, guaiac positive. Sent a Diarrheal PCR Panel to Lab and came back positive for Rotavirus. Pt is taking probiotics once a day per mom.
Sex: F
Vaccine: HEPA, MENB, MNQ
Symptoms: Asthenia, Nasal congestion, Nasopharyngitis, Nausea, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 16-year-old female patient received TRUMENBA, via an unspecified route of administration, on an unspecified date, at single dose, for immunization; MENVEO, via an unspecified route of administration, on an unspecified date, at unspecified dose, for immunisation and HAVRIX, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced fever, nausea, nasal congestion, cold like syndrome and weakness all on an unspecified date with outcome of unknown. The information on the lot number has been requested.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 3-year-old female patient. The patient's medical history included being very behind on immunizations. On 23-FEB-2015 and 19-FEB-2016, the patient received an unspecified hepatitis B vaccination. Additionally, on 19-FEB-2016, she received unspecified medication reported as "PENTACIL" and unspecified rotavirus and pneumococcal vaccines as well. On 19-MAR-2019, the patient was vaccinated with third dose of (Thimerosal Free) RECOMBIVAX HB injection, lot # R021370 with expiration date of 07-NOV-2020, 0.5 milliliter (dose also reported as 0.5 mgl) (route of administration and vaccination site were not provided), to immunize against hepatitis B and with a dose of PEDIARIX (dose, route of administration, vaccination site, lot # and expiration date were not provided) as prophylaxis. The patient accidentally received both suspect vaccines together. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1903USA010012: US-009507513-1903USA010026.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Product supply issue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown. Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient was due for second before 1st April. Every pharmacy the patient had called listed on site as having the vaccine was out. The patient asked that what the company was doing to get the second dose to those who need it. The patient asked that the company should not be allowed to sell a first dose until those needing the second have received. Follow up received from consumer on 18th March 2019: The patient had the first Zoster vaccine and was persuaded by the advertising to switch to SHINGRIX. The patient had the 1st SHINGRIX shot in October 2018. The flu like side effects of the 1st shot were the worst the patient experienced. Six months was nearly up, the patient on several lists and have made numerous calls trying to get the 2nd shot. At the time of reporting, the patient said that the company oversold the SHINGRIX and promoted, but could not provide the supply come out for it and asked whether the 2nd shot would have some protection even if given late. The patient was actively looking for the 2nd shot. The patient was also looking to join any class action lawsuit against GlaxoSmithKline for taking his money, putting him through pain, and not delivering on product promised.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Vaccine positive rechallenge
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site tenderness in a 68-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received on 10th September 2018, refer case US2019GSK054970). On 15th November 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site tenderness. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site tenderness was recovered/resolved. It was unknown if the reporter considered the injection site tenderness to be related to SHINGRIX. Additional details were provided as follows: The reporter indicated that she had a consumer that received dose of the SHINGRIX vaccine and stated that the consumer indicated that the only adverse event she experienced was tenderness at the injection site. The field representative was unable to provide any additional information. The reporter did not consent to follow up. This case linked with case US2019052087 and US2019GSK054970, reported by same reporter for the same patient.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site tenderness in a 68-year-old female patient who received SHINGRIX for prophylaxis. On 10th September 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 tenderness. On an unknown date, the outcome of the injection site tenderness was recovered/resolved. It was unknown if the reporter considered the injection site tenderness to be related to SHINGRIX. Additional details were provided as follows: The reporter indicated that she has a consumer that received dose of the SHINGRIX vaccine and stated that the consumer indicated that the only adverse event she experienced was tenderness at the injection site. Did not consent to follow up. The field representative was unable to provide any additional information. This case linked with case US2019052087 and US2019GSK054969, reported by same reporter for the same patient.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult male patient who received SHINGRIX for prophylaxis. On 18th March 2019, the patient received SHINGRIX. On 18th March 2019, less than a day after receiving SHINGRIX, the patient experienced pain in arm, pain, headache and chills. On an unknown date, the outcome of the pain in arm, pain, headache and chills were unknown. It was unknown if the reporter considered the pain in arm, pain, headache and chills to be related to SHINGRIX. Additional details were provided as follows: The patient experienced pain in arm, pain, headache and chills after receiving SHINGRIX vaccine. There was no consent to follow up.
Age: 72.0
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 72-year-old female patient who received SHINGRIX for prophylaxis. On 22nd February 2019, the patient received the 1st dose of SHINGRIX. On 23rd February 2019, 1 days after receiving SHINGRIX, the patient experienced fatigue. SHINGRIX was continued with no change. 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 provided as follows: This case was reported by the patient's friend. The patient was very fatigued on the following day after receiving 1st dose of SHINGRIX. No further details were provided.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Injection site pain, Vaccine positive rechallenge
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site tenderness in a 69-year-old female patient who received SHINGRIX for prophylaxis.  Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received on 10th September 2018, refer case US2019GSK054970) and SHINGRIX with an associated reaction of injection site pain (2nd dose received on 15th November 2018, refer case US2019GSK054969). On 31st January 2019, the patient received the 3rd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site tenderness and extra dose administered. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site tenderness and extra dose administered were unknown.  It was unknown if the reporter considered the injection site tenderness to be related to SHINGRIX. Additional details were provided as follows: The reporter indicated that she had a consumer that received dose of the SHINGRIX vaccine and stated that the consumer indicated that the only adverse event she experienced was tenderness at the injection site. The field representative was unable to provide any additional information. The reporter did not consent to follow up.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site reaction, Injection site swelling, Rash pruritic
Clinical narrative: This is a spontaneous report from a contactable nurse (medical assistant) on behalf of the physician. A 65-year-old male patient received PREVNAR 13 with NDC number: 0005-1971-02, lot number: X35262 and expiry date: Oct2020, intramuscularly at the right deltoid in the physician office on 11Mar2019 09:30 at 0.5 ml, single for immunization, and VITAMIN B12 (manufactured by American Regent) with lot number: 8131 and expiry date: Mar2020, intramuscularly at the left deltoid from 11Mar2019 to 11Mar2019 at 1 ml, at an unknown frequency for an unspecified indication. The patient's medical history included ongoing hypertension, ongoing hyperlipidemia, ongoing diabetes, and ongoing enlarged prostate; the patient takes medication for all of these. There were no concomitant medications. On 11Mar2019, the patient experienced itchy, swollen rash at injection site that moved down arm. It was reported that the doctor prescribed AUGMENTIN for treatment of the itchy swollen rash. The pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) was administered on 11Mar2019 and the patient called today (18Mar2019). The patient thought the rash would go away but it did not so he ended up coming into the office today around noon to report the rash. He made an appointment for follow up on 15Apr2019 and she told the patient if his symptoms happen to get worse they will see him at the office sooner than 15Apr2019. This was the patient's first time receiving pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein). The patient received vitamin B12 the same date (11Mar2019). The patient comes in every month for Vitamin B12 since Apr2015. The patient has been a patient of theirs since 2008. Therapeutic measures were taken as a result of itchy, swollen rash at injection site that moved down arm includes amoxicillin/clavulanate. The action taken in response to the events for cyanocobalamin, and outcome of the events were unknown.
Age: 89.0
Sex: F
Vaccine: PNC13
Symptoms: Blood cholesterol decreased, Chest pain, Chills, Dizziness, Fatigue
Clinical narrative: This is a spontaneous report from a contactable consumer reported that an 89-year-old female patient received PREVNAR 13, (lot number and expiration date were not reported), via an unspecified route of administration on 04Mar2019 at single dose for immunisation. Medical history included sinus infection, have been coughing, have infection for several months, have been bleeding mucus and "the doctor thought that I should have a pneumonia". There were no concomitant medications. That first night after the injection (04Mar2019), she had "chills so much her teeth were chattering" but went back to bed and did not think anything of it. Later on, she developed a "big red patch from the injection site area to the elbow, about 6 inches long". Her tongue was double the size. She saw her cardiologist on 08Mar2019 due to pains in her chest. She went to the ER on 10Mar2019. Since the injection, she is so tired all the time so slept one night for 9 hours and another night for 14 hours. She also has headaches, muscle pain in thighs, is lightheaded, and her heart is racing. She was given a shot in the ER and given antibiotics, which she just finished up. Her tongue still feels swollen now but better than it was. She still feels some effects. She planned to discuss further with her cardiologist for a second opinion. The patient also has been sick for a couple of days. On Sunday morning when the patient's arm was itching really bad where the shot was given, it was bright red and itching. They did lab work in the hospital (later clarified by the consumer as ER). Everything and they said cholesterol dropped 50 points. The outcome of tongue was double the size was recovering and other events was unknown. Information on the batch number has been requested.
Age: 89.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Hypersomnia, Injection site erythema, Injection site pruritus, Malaise
Clinical narrative: This is a spontaneous report from a contactable consumer reported that an 89-year-old female patient received PREVNAR 13, (lot number and expiration date were not reported), via an unspecified route of administration on 04Mar2019 at single dose for immunisation. Medical history included sinus infection, have been coughing, have infection for several months, have been bleeding mucus and "the doctor thought that I should have a pneumonia". There were no concomitant medications. That first night after the injection (04Mar2019), she had "chills so much her teeth were chattering" but went back to bed and did not think anything of it. Later on, she developed a "big red patch from the injection site area to the elbow, about 6 inches long". Her tongue was double the size. She saw her cardiologist on 08Mar2019 due to pains in her chest. She went to the ER on 10Mar2019. Since the injection, she is so tired all the time so slept one night for 9 hours and another night for 14 hours. She also has headaches, muscle pain in thighs, is lightheaded, and her heart is racing. She was given a shot in the ER and given antibiotics, which she just finished up. Her tongue still feels swollen now but better than it was. She still feels some effects. She planned to discuss further with her cardiologist for a second opinion. The patient also has been sick for a couple of days. On Sunday morning when the patient's arm was itching really bad where the shot was given, it was bright red and itching. They did lab work in the hospital (later clarified by the consumer as ER). Everything and they said cholesterol dropped 50 points. The outcome of tongue was double the size was recovering and other events was unknown. Information on the batch number has been requested.
Age: 89.0
Sex: F
Vaccine: PNC13
Symptoms: Myalgia, Palpitations, Swollen tongue
Clinical narrative: This is a spontaneous report from a contactable consumer reported that an 89-year-old female patient received PREVNAR 13, (lot number and expiration date were not reported), via an unspecified route of administration on 04Mar2019 at single dose for immunisation. Medical history included sinus infection, have been coughing, have infection for several months, have been bleeding mucus and "the doctor thought that I should have a pneumonia". There were no concomitant medications. That first night after the injection (04Mar2019), she had "chills so much her teeth were chattering" but went back to bed and did not think anything of it. Later on, she developed a "big red patch from the injection site area to the elbow, about 6 inches long". Her tongue was double the size. She saw her cardiologist on 08Mar2019 due to pains in her chest. She went to the ER on 10Mar2019. Since the injection, she is so tired all the time so slept one night for 9 hours and another night for 14 hours. She also has headaches, muscle pain in thighs, is lightheaded, and her heart is racing. She was given a shot in the ER and given antibiotics, which she just finished up. Her tongue still feels swollen now but better than it was. She still feels some effects. She planned to discuss further with her cardiologist for a second opinion. The patient also has been sick for a couple of days. On Sunday morning when the patient's arm was itching really bad where the shot was given, it was bright red and itching. They did lab work in the hospital (later clarified by the consumer as ER). Everything and they said cholesterol dropped 50 points. The outcome of tongue was double the size was recovering and other events was unknown. Information on the batch number has been requested.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, Product preparation issue
Clinical narrative: Initial information received on 19-Mar-2019 regarding an unsolicited valid non-serious case received from an other health care professional. This case involves a five-months-old male patient who received a 0.5ml dose of PENTACEL lot C5518AA, expiration date: 15-Sep-2019 via unknown route in unknown administration site on 07-Mar-2019. 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 reconstitution technique. A young child was administered only the diluent of PENTACEL that it DTAP, IPV and ACT-HIB lyophilized powder was not administered. No side effects 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.
Sex: F
Vaccine: TYP
Symptoms: Incorrect route of product administration
Clinical narrative: Initial information received on 19-Mar-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 26 years old female patient who received a 0.5 ml TYPHIM VI, standard single dose syringe, lot N1K121M, expiration date: 30-Oct-2019 via subcutaneous 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 route of vaccination. Patient received a dose of TYPHIM VI subcutaneous instead of Intramuscular. 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: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 19-Mar-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 18 months old male patient who received a expired dose of DAPTACEL lot C5169AA, expiration date: 16-Mar-2019 via unknown route in the left thigh on 19-Mar-2019. The patient's past vaccination(s) included was 3 DAPTACEL doses. The patient's past medical history, medical treatment(s) and family history were not provided. Concomitant medications included was HIB VACCINE and HEPATITIS A. It was an actual medication error due to expired vaccine used. A 18 month old boy received a expired dose of DAPTACEL. No adverse events 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: 0.5
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Expired product administered
Clinical narrative: Initial information received on 18-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2019SA077678 (same reporter). This case involves a 6 months old female patient who received an expired dose of vaccine DAPTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR for Immunisation; ROTATEQ for Immunisation; HIB VACCINE for Immunisation; and POLIO VACCINE for Immunisation. On 18-Mar-2019, the patient received a dose dose of suspect DAPTACEL lot C5157AA via unknown route in the right leg. It was a case of actual medication error due to expired vaccine used. It was unknown whether adverse event was experienced. 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 and Module VI of the 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: 56.0
Sex: M
Vaccine: HEP
Symptoms: Injected limb mobility decreased, Injection site discomfort, Injection site pain, Injection site swelling
Clinical narrative: Initially was experiencing the typical injection/inoculation site symptoms. After the second day discomfort continued for several more days, causing decreased range of motion, pain and localized tenderness. There was more tenderness at original site and some localized swelling. Treated by usual methods of cold and warm compress, OTC anti-inflammatory and rest, without any improvement. No signs of infection were noted local or systemic. Symptoms persisted for following 12 days without improvement, with some days being worse than others. Mild activity does cause some increase discomfort. Contacted dispensing medical facility and was advised to return for follow up. On their review was advised to file a report, they will be further researching and am to report any VAERS info and follow return in two weeks.
Age: 5.0
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, Redness, and Warmth at injection site.
Age: 32.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Amniorrhoea, Amniotic membrane rupture test positive, Caesarean section, Exposure during pregnancy, Malaise
Clinical narrative: G2P1, EDD: 03/17/2016, 7lbs 2oz male, Pt c/o vertigo and nausea the night before. She did not feel well and went to bed at 7:30pm. At 6:30am, pt started leaking amniotic fluid, called our office for an appt which confirmed ROM and emergency repeat C-section was scheduled for that day.
Age: 32.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Nausea, Premature rupture of membranes, Vertigo
Clinical narrative: G2P1, EDD: 03/17/2016, 7lbs 2oz male, Pt c/o vertigo and nausea the night before. She did not feel well and went to bed at 7:30pm. At 6:30am, pt started leaking amniotic fluid, called our office for an appt which confirmed ROM and emergency repeat C-section was scheduled for that day.
Age: 32.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Caesarean section, Exposure during pregnancy, Neonatal disorder, Premature rupture of membranes
Clinical narrative: G2P1, EDD: 03/17/2016, 7lbs 2oz male, Pt c/o vertigo and nausea the night before. She did not feel well and went to bed at 7:30pm. At 6:30am, pt started leaking amniotic fluid, called our office for an appt which confirmed ROM and emergency repeat C-section was scheduled for that day.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Chest X-ray abnormal, Influenza virus test negative, Lung infiltration, Pneumonia, Pyrexia
Clinical narrative: Pt developed fever on 3/17/19 that persisted, Tmax 104. Seen in UC on 3/18/19 and Dx with viral illness. Then seen again in my office on 3/21/19 given continued fever and found to have pneumonia on exam. Started on amoxicillin which resolved fever by 3/23/19.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Viral infection
Clinical narrative: Pt developed fever on 3/17/19 that persisted, Tmax 104. Seen in UC on 3/18/19 and Dx with viral illness. Then seen again in my office on 3/21/19 given continued fever and found to have pneumonia on exam. Started on amoxicillin which resolved fever by 3/23/19.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Patient reported feeling a lump in her sholder on 3/14/2019 after receiving her HPV immunization on 2/21/2019. Plan to cover for possible secondary cellulitis. Area of erythema and induration outlined on 3/25/2019 with sterile pen.
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: Decreased appetite, Fatigue, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Red swollen sight from injection. These listed reactions took place within 4-5 hours of injection, and on the third day, I am just starting to be better. Severe headache, Body aches. Loss of appetite. Low grade fever. Fatigue.
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: Pain, Pyrexia
Clinical narrative: Red swollen sight from injection. These listed reactions took place within 4-5 hours of injection, and on the third day, I am just starting to be better. Severe headache, Body aches. Loss of appetite. Low grade fever. Fatigue.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Raised reddened area 5 in diameter to left upper quadrant thigh. MOTRIN, TYLENOL, and ice applied by mother upon noticing swelling yesterday. Office visit today, mother reports slightly better.