chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, drug allergies or reactions were no provided. On an unknown date, the patient was vaccinated with improperly stored doses of VARIVAX, lot # N031003, expiration date on 03-NOV-2019, for prophylaxis (strength, dosage, route and frequency were no provided). It was stated that the sterile diluent was properly stored. Also it was explained that the VARIVAX, was during 8 hours in a temperature of 8F, and that there were previously excursions: 41F for 62 hours, 6F to 14F for 72 hours. Data logger was positive. No adverse events were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1809USA000594: US-009507513-1809USA000595: US-009507513-1809USA000596: US-009507513-1809USA000592: US-009507513-1809USA000587:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, drug allergies or reactions were no provided. On an unknown date, the patient was vaccinated with improperly stored doses of VARIVAX (lot # N031003), expiration date on 03-NOV-2019, for prophylaxis (strength, dosage, route and frequency were no provided). It was stated that the sterile diluent was properly stored. Also it was explained that the VARIVAX, was during 8 hours in a temperature of 8F, and that there were previously excursions: 41F for 62 hours, 6F to 14F for 72 hours. Data logger was positive. No adverse events were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA000587; US-009507513-1809USA000595; US-009507513-1809USA000596; US-009507513-1809USA000592; US-009507513-1809USA000593.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, drug allergies or reactions were no provided. On an unknown date, the patient was vaccinated with improperly stored doses of VARIVAX, lot # N031003, expiration date on 03-NOV-2019, for prophylaxis (strength, dosage, route and frequency were no provided). It was stated that the sterile diluent was properly stored. Also it was explained that the VARIVAX, was during 8 hours in a temperature of 8F, and that there were previously excursions: 41F for 62 hours, 6F to 14F for 72 hours. Data logger was positive. No adverse events were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1809USA000594: US-009507513-1809USA000587: US-009507513-1809USA000596: US-009507513-1809USA000592: US-009507513-1809USA000593:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, drug allergies or reactions were no provided. On an unknown date, the patient was vaccinated with improperly stored doses of VARIVAX, lot # N031003, expiration date on 03-NOV-2019, for prophylaxis (strength, dosage, route and frequency were no provided). It was stated that the sterile diluent was properly stored. Also it was explained that the VARIVAX, was during 8 hours in a temperature of 8F, and that there were previously excursions: 41F for 62 hours, 6F to 14F for 72 hours. Data logger was positive. No adverse events were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA000594: US-009507513-1809USA000595: US-009507513-1809USA000587: US-009507513-1809USA000592: US-009507513-1809USA000593.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Injection site bruising, Injection site warmth, Myalgia
Clinical narrative: Patient developed flu like symptoms 4 1/2 hours later. Patient had muscle aches, nausea, fever, and chills. Patient also developed raised bruised and also hot to touch at injection site.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Patient developed flu like symptoms 4 1/2 hours later. Patient had muscle aches, nausea, fever, and chills. Patient also developed raised bruised and also hot to touch at injection site.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient developed what appears to be zoster on her left neck and shoulder region within 24 hours of the vaccine.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Pyrexia
Clinical narrative: Patient reports she developed a fever and a headache in the evening after receiving the Tdap (8/29/18). She stated the headache and fever were worse the next day (8/30/18). When she was seen in the clinic her temperature was 101.3F. Recommended patient take Tylenol for her symptoms.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Fatigue, Musculoskeletal stiffness, Pain
Clinical narrative: Stiff, Achy, fatigued, generally very uncomfortable. This started two hours after the vaccination and lasted through the night. I took 500 mg Naproxen at 2 pm and another at 9 p.m. The next morning I was no longer stiff and achy, but is was still tired and took a nap about noon. I RECEIVED A FLU SHOT EVERY YEAR FOR 20? YEARS, AND THIS IS THE FIRST TIME I HAD AN ADVERSE REACTION. THIS REACTION WAS VERY SIMILAR TO THE REACTION I GOT FROM THE SHINGLES VACCINES IN APRIL AND JUNE THIS YEAR.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Dehydration, Dizziness, Hyperhidrosis, Pallor, Seizure like phenomena
Clinical narrative: About 1-4 minutes following vaccine administration patient stated he was becoming lightheaded. He became increasingly sweaty and pale over the next few minutes. His eyes closed and he appeared to be having seizure activity. EMT's arrived within 10 minutes when the patient exhibited similar seizure activity. He was started on IV fluids as EMT's stated he seemed dehydrated. He was then transported to the ER for further eval and treatment.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Patient  had fever, aches from 8/31 until 9/2.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Diarrhoea, Dizziness, Myalgia, Nausea
Clinical narrative: Pt said suffered from fever, pain, nausea, diarrhea, upset stomache,  dizziness and muscle aches.   Enough to go to the doctor.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Pt said suffered from fever, pain, nausea, diarrhea, upset stomache,  dizziness and muscle aches.   Enough to go to the doctor.
Age: 56.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: ITCHING, SWOLLEN LUMP AT INJECTION SITE.
Age: 1.0
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Pt presented to Urgent Care on 9/3/18 with a three day history of rash that was consistent with the appearance of Variicella, though it started on the face and spread to the trunk and child was not itchy or feverish. Child had received VARIVAX on 8/14/18.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Myosclerosis, Skin warm, Swelling
Clinical narrative: Red, warm, pain, feels like muscle is hard underneath, swollen.
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Chills, Erythema, Headache, Nausea, Skin warm
Clinical narrative: Headache, nausea, chills, red upper arm, hot to touch.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Tremor, Vision blurred
Clinical narrative: Patient reported nausea, blurred vision, and shakiness 20 mins after the shot. She called and asked if that was normal. I told her it wasnt unheard of but that she should go to an urgent care clinic to be safe. She called after being released from the clinic and was told she was going to be ok and that her reaction was normal after a shot.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Muscle strain, Musculoskeletal pain, Rotator cuff syndrome
Clinical narrative: Patient reports right shoulder pain not relieved by NSAID and ice therapy. We are treated her as muscle strain or rotator cuff injury with rehab and continued NSAID use. Will order MRI of shoulder for no improvement and give steroid injection in 2 weeks if needed.
Age: 98.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: Cellulitis left arm.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Feeling hot, Loss of personal independence in daily activities, Pyrexia
Clinical narrative: 3/23 I felt cold and shivery, had to rest and not do normal activities. 3/24 I felt like I have a fever and was hot and had to stay in bed to rest.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Pt reports nausea, fever, and severe headache with onset approximately 12 hours after second dose of SHINGRIX. Said symptoms lasted approximately 1 day.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Insomnia
Clinical narrative: 0n 8/27/2018 at 10:00 pm experienced severe shivering and chattering teeth. Difficult time sleeping. On 8/28/2018 I was very fatigued and napped several times that day. On 8/29/2018 I tried to restart my usual actives but became fatigued again.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt came to pharmacy day after injection with redness and swelling below the injection site, pt was concerned and RPh counseled them to follow up with MD. Office was closed when pt presented at pharmacy, pt and RPh to follow up with PCP tomorrow. Pt was counseled if got worse or any other concerns to go to urgent care or ER. Pt may need to see MD. Was not sure yet.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Red swelling in arm, warm to the touch.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Decreased appetite, Fatigue, Influenza like illness, Malaise
Clinical narrative: This was my 2nd dose of SHINGRIX. I had the exact same reaction as the first time although not as severe. Still awful. I was sick for 2 days, felt just like the flu. I had 99-100 degree temperature, body/muscle aches, no appetite, fatigue for the 2 days. I took 2 extra strength 650 mg capsules every 6-8 hours. Slept & stayed in bed for 2 days. On the evening of the 2nd day, I was feeling much better. I resumed my normal schedule the following (3rd day).
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: This was my 2nd dose of SHINGRIX. I had the exact same reaction as the first time although not as severe. Still awful. I was sick for 2 days, felt just like the flu. I had 99-100 degree temperature, body/muscle aches, no appetite, fatigue for the 2 days. I took 2 extra strength 650 mg capsules every 6-8 hours. Slept & stayed in bed for 2 days. On the evening of the 2nd day, I was feeling much better. I resumed my normal schedule the following (3rd day).
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Rash, Rash pruritic
Clinical narrative: Patient came in the next day after vaccine and showed me her left side over rib area. Patient had a visible raised rash, looked like bad poison ivy, but she said it started in the previous evening, same day as getting vaccine in the morning. She also had a streak of similar rash over her left collar bone area previous evening, but it seems to be going away. Both areas are very itchy. She did not say if she had gotten into poison ivy. She felt it was due to the vaccine. I told her I would report it. I don't believe she called her doctor about it either, just asked me what she should do for itch and I suggested hydrocortisone cream. Patient seemed at ease with this suggestion.
Age: 70.0
Sex: F
Vaccine: FLUA3
Symptoms: Erythema, Skin discolouration, Urticaria
Clinical narrative: Patient went to take a shower a day after recieving the shot ( about 24hours) and noticed a large red welt on arm, not rash but discoloring "as if someone punched her arm".
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Pt has red , painful, swollen, arm. Pt went to doctors due to adverse reaction.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia oral, Nerve injury, Nuclear magnetic resonance imaging brain normal, Pain, Pain in jaw
Clinical narrative: 1 HOUR AFTER RECIEVING A SHINGRIX VACCINATION, PATIENT EXPERIENCED EXCRUCIATING PAIN IN THE LEFT JAW UNILATERALLY EXTENDING FROM IN FRONT OF THE LEFT EAR TO THE MIDDLE OF THE FRONT TEETH AND NUMBNESS IN THE BOTTOM LIP. ICE PACK AND ADVIL PROVIDED SOME RELIEF. THE PAIN CONTINUED TO RETURN ABOUT EVERY 3 HOURS. AFTER 2 WEEKS PAIN DEMINISHED IN STRENGHT AND FREQUENCY. NOW IT IS TRIGGERED BY CHEWING AND TALKING. CONTINES TO TREAT WITH ADVIL. 7/31/18- DR, INTERNAL MEDICINE CONSULTATION, DIAGNOSED WITH TRIGEMINAL NEURALGIA/TGN, REFERRED TO NEUROLOGIST. 8/2/18- DR, NEUROLOGIST, CONSULTATION CONFIRMED TGN DIAGNOSED AND ORDERED BRAIN MRI AND MRA. 8/14/18- DR DDS. COSULTATION WITH XRAY OF UPPER MOLARS TAKEN. TGN MAY GO INTO REMISSION BUT DOES NOT GO AWAY. OXCARBAZEPINE PRESCRIBED. NOT TAKING BECAUSE OF POSSIBLE SIDE EFFECTS.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Trigeminal neuralgia, X-ray dental abnormal
Clinical narrative: 1 HOUR AFTER RECIEVING A SHINGRIX VACCINATION, PATIENT EXPERIENCED EXCRUCIATING PAIN IN THE LEFT JAW UNILATERALLY EXTENDING FROM IN FRONT OF THE LEFT EAR TO THE MIDDLE OF THE FRONT TEETH AND NUMBNESS IN THE BOTTOM LIP. ICE PACK AND ADVIL PROVIDED SOME RELIEF. THE PAIN CONTINUED TO RETURN ABOUT EVERY 3 HOURS. AFTER 2 WEEKS PAIN DEMINISHED IN STRENGHT AND FREQUENCY. NOW IT IS TRIGGERED BY CHEWING AND TALKING. CONTINES TO TREAT WITH ADVIL. 7/31/18- DR, INTERNAL MEDICINE CONSULTATION, DIAGNOSED WITH TRIGEMINAL NEURALGIA/TGN, REFERRED TO NEUROLOGIST. 8/2/18- DR, NEUROLOGIST, CONSULTATION CONFIRMED TGN DIAGNOSED AND ORDERED BRAIN MRI AND MRA. 8/14/18- DR DDS. COSULTATION WITH XRAY OF UPPER MOLARS TAKEN. TGN MAY GO INTO REMISSION BUT DOES NOT GO AWAY. OXCARBAZEPINE PRESCRIBED. NOT TAKING BECAUSE OF POSSIBLE SIDE EFFECTS.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Swelling on arm.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Injection site erythema, Injection site swelling, Musculoskeletal pain
Clinical narrative: Sore shoulder, overnight developed ashiness across shoulder blades and throughout body. Fatigue, nausea and diarrhea. Puffy red area adjacent to site of shot about 5" circumference.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain
Clinical narrative: Sore shoulder, overnight developed ashiness across shoulder blades and throughout body. Fatigue, nausea and diarrhea. Puffy red area adjacent to site of shot about 5" circumference.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain
Clinical narrative: Cannot lift arm past shoulder or extend without extreme pain. He can pinpoint the exact point that is causing pain. Advised to call doctor.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Feeling abnormal, Headache, Hypoaesthesia, Pain
Clinical narrative: For 2 days after vaccine on 8/29/18 patient reported "normal" side effects (headache, fever). At around 11pm on 8/31/18 pt started to get "sensation waves" down both arms and felt a burning pain.  She felt coldness and numbness down her legs. Pt also reported a "vibration feeling in head". When asked to elaborate she said it wasn't like a headache but felt like her "brain was vibrating". These symptoms lasted for a few days and patient described the feeling, discomfort, and pain as "awful". On 9/4/18 when this was reported to the pharmacy patient said she feels much better and feels like she "just crawled out of a cave".  She has some burning in her hands but the burning increases with activity. She has minor numbness in legs which also increases with activity. Patient has scheduled a follow-up appointment with her Primary Care Physician for 9/5/18.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral coldness, Pyrexia, Sensory disturbance, Vibratory sense increased
Clinical narrative: For 2 days after vaccine on 8/29/18 patient reported "normal" side effects (headache, fever). At around 11pm on 8/31/18 pt started to get "sensation waves" down both arms and felt a burning pain.  She felt coldness and numbness down her legs. Pt also reported a "vibration feeling in head". When asked to elaborate she said it wasn't like a headache but felt like her "brain was vibrating". These symptoms lasted for a few days and patient described the feeling, discomfort, and pain as "awful". On 9/4/18 when this was reported to the pharmacy patient said she feels much better and feels like she "just crawled out of a cave".  She has some burning in her hands but the burning increases with activity. She has minor numbness in legs which also increases with activity. Patient has scheduled a follow-up appointment with her Primary Care Physician for 9/5/18.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP
Symptoms: Vomiting
Clinical narrative: Vomiting every 5 minutes for 45 minutes.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Headache, Hypersomnia, Pain in extremity
Clinical narrative: 2 day severe headache. Vomiting-6 hrs, 12-15 hrs after shot. No appetite even 1 week later. Slept 16+ hours on first 24. Usual sore arm-total body fatigue.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: 2 day severe headache. Vomiting-6 hrs, 12-15 hrs after shot. No appetite even 1 week later. Slept 16+ hours on first 24. Usual sore arm-total body fatigue.
Age: 43.0
Sex: M
Vaccine: FLU4, PPV, TDAP, FLU4, PPV, TDAP
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Very sore swollen, red, slightly warm to touch, stiff neck, chills off and on. This is at a flu shot site. On Prednisone, TYLENOL, ice.
Age: 43.0
Sex: M
Vaccine: FLU4, PPV, TDAP, FLU4, PPV, TDAP
Symptoms: Musculoskeletal stiffness
Clinical narrative: Very sore swollen, red, slightly warm to touch, stiff neck, chills off and on. This is at a flu shot site. On Prednisone, TYLENOL, ice.
Age: 43.0
Sex: M
Vaccine: FLU4, PPV, TDAP, FLU4, PPV, TDAP
Symptoms: Chills, Erythema, Musculoskeletal stiffness, Pain in extremity, Peripheral swelling
Clinical narrative: Very sore swollen, red, slightly warm to touch, stiff neck, chills off and on. This is at a flu shot site. On Prednisone, TYLENOL, ice.
Age: 43.0
Sex: M
Vaccine: FLU4, PPV, TDAP, FLU4, PPV, TDAP
Symptoms: Pyrexia, Skin warm
Clinical narrative: Very sore swollen, red, slightly warm to touch, stiff neck, chills off and on. This is at a flu shot site. On Prednisone, TYLENOL, ice.
Age: 5.0
Sex: U
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient should have received DTaP.
Age: 70.0
Sex: M
Vaccine: HEPA, TDAP, TYP, VARZOS
Symptoms: Basedow's disease, Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Client had a generalized very itchy red rash/not hives that has persisted since shortly after 4/13/18. Clinic visit to date of call 6/15/18. On 7/27/18 client reported that he had been Dx with Graves Disease and is on medication. Rash is improving.
Age: 87.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Red and pain starting 8/31/18 after lunch. Used ice pack and TYLENOL. Some swelling. Appointment scheduled 9/5/18.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13, TDAP, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left arm extremely red/swollen and painful from a couple inches lower than shoulder all the way until the elbow.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood gases, Dyspnoea, Herpes zoster, Injection site erythema, Injection site pain
Clinical narrative: This initial spontaneous report was received from a 62 year old female patient referring to herself. Concurrent conditions included chronic obstructive pulmonary disease (COPD). Concomitant medications included an unspecified rescue inhaler and albuterol. She also receives allergy injections (not further specified) from her primary care physician for allergies of unknown case. She is allergic to BENADRYL. On 14-SEP-2016, the patient was vaccinated with ZOSTAVAX subcutaneously at a pharmacy for prevention of herpes zoster (dose and lot # not provided). The patient reported a "reaction" shortly after receiving the ZOSTAVAX (onset also reported as 14-SEP-2016). She described the reaction as injection site pain, redness, and swelling and developed a rash in an unspecified location. She stated the rash was shingles which has been persistently recurrent intermittently and was causing extreme pain. The patient was seen at an urgent care clinic (date unspecified). She felt the following were life threatening symptoms: initially she could not breathe due to throat swelling. When asked if the events required intervention to prevent serious criteria, the patient answered yes and described the intervention as: initially, she received an injection for inflammation and steroid medication. She was "recently" started on an oral medication twice per day (patient could not recall what type of medication it was). When asked if the events resulted in significant disability or incapacity, the replied yes and described this as: severe pain with intermittent outbreaks. She was not hospitalized for the events. The patient said she has pictures and doctors office visit reports. When asked if any lab diagnostics/studies were performed, the patient answered yes, a recent blood gas test for unrelated, pre-existing lung condition (considered referring to COPD). The outcome of shingles was not recovered. The outcomes of the remaining events were unknown. Causality assessment was considered related as the patient requested compensation for pain and suffering due to a possible adverse reaction to ZOSTAVAX. The patient considered shingles to be disabling. The patient considered could not breathe due to throat swelling to be life-threatening. The patient considered injection site pain, redness, and swelling, shingles, could not breath, and throat tightness to be medically significant (as they required intervention to prevent serious criteria). Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pain, Pharyngeal oedema, Rash
Clinical narrative: This initial spontaneous report was received from a 62 year old female patient referring to herself. Concurrent conditions included chronic obstructive pulmonary disease (COPD). Concomitant medications included an unspecified rescue inhaler and albuterol. She also receives allergy injections (not further specified) from her primary care physician for allergies of unknown case. She is allergic to BENADRYL. On 14-SEP-2016, the patient was vaccinated with ZOSTAVAX subcutaneously at a pharmacy for prevention of herpes zoster (dose and lot # not provided). The patient reported a "reaction" shortly after receiving the ZOSTAVAX (onset also reported as 14-SEP-2016). She described the reaction as injection site pain, redness, and swelling and developed a rash in an unspecified location. She stated the rash was shingles which has been persistently recurrent intermittently and was causing extreme pain. The patient was seen at an urgent care clinic (date unspecified). She felt the following were life threatening symptoms: initially she could not breathe due to throat swelling. When asked if the events required intervention to prevent serious criteria, the patient answered yes and described the intervention as: initially, she received an injection for inflammation and steroid medication. She was "recently" started on an oral medication twice per day (patient could not recall what type of medication it was). When asked if the events resulted in significant disability or incapacity, the replied yes and described this as: severe pain with intermittent outbreaks. She was not hospitalized for the events. The patient said she has pictures and doctors office visit reports. When asked if any lab diagnostics/studies were performed, the patient answered yes, a recent blood gas test for unrelated, pre-existing lung condition (considered referring to COPD). The outcome of shingles was not recovered. The outcomes of the remaining events were unknown. Causality assessment was considered related as the patient requested compensation for pain and suffering due to a possible adverse reaction to ZOSTAVAX. The patient considered shingles to be disabling. The patient considered could not breathe due to throat swelling to be life-threatening. The patient considered injection site pain, redness, and swelling, shingles, could not breath, and throat tightness to be medically significant (as they required intervention to prevent serious criteria). Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Body temperature increased, Chills, Fatigue, Headache, Hypersomnia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fatigue in a 60-year-old female patient who received SHINGRIX (batch number JC92P, expiry date 22nd November 2020) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received on 22nd May 2018 (see case US2018GSK159916)). On 17th August 2018 09:45, the patient received the 2nd dose of SHINGRIX .5 ml. In August 2018, 11 hrs after receiving SHINGRIX, the patient experienced fatigue, shivering and fever. On an unknown date, the outcome of the fatigue, shivering and fever were unknown. It was unknown if the reporter considered the fatigue, shivering and fever to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional (HCP) reported that on 17th August 2018, the patient developed fever, chills, shivering, and extreme fatigue about 11 hours after the dose of the SHINGRIX. These symptoms went away after a couple of days except the patient was still tired. Then a few days later these symptoms fever, chills, shivering, and fatigue returned. The HCP was unaware of whether these symptoms had resolved.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fatigue in a 60-year-old female patient who received SHINGRIX (batch number JC92P, expiry date 22nd November 2020) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received on 22nd May 2018 (see case US2018GSK159916)). On 17th August 2018 09:45, the patient received the 2nd dose of SHINGRIX .5 ml. In August 2018, 11 hrs after receiving SHINGRIX, the patient experienced fatigue, shivering and fever. On an unknown date, the outcome of the fatigue, shivering and fever were unknown. It was unknown if the reporter considered the fatigue, shivering and fever to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional (HCP) reported that on 17th August 2018, the patient developed fever, chills, shivering, and extreme fatigue about 11 hours after the dose of the SHINGRIX. These symptoms went away after a couple of days except the patient was still tired. Then a few days later these symptoms fever, chills, shivering, and fatigue returned. The HCP was unaware of whether these symptoms had resolved.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fatigue in a 60-year-old female patient who received SHINGRIX (batch number JC92P, expiry date 22nd November 2020) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received on 22nd May 2018 (see case US2018GSK159916)). On 17th August 2018 09:45, the patient received the 2nd dose of SHINGRIX .5 ml. In August 2018, 11 hrs after receiving SHINGRIX, the patient experienced fatigue, shivering and fever. On an unknown date, the outcome of the fatigue, shivering and fever were unknown. It was unknown if the reporter considered the fatigue, shivering and fever to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional (HCP) reported that on 17th August 2018, the patient developed fever, chills, shivering, and extreme fatigue about 11 hours after the dose of the SHINGRIX. These symptoms went away after a couple of days except the patient was still tired. Then a few days later these symptoms fever, chills, shivering, and fatigue returned. The HCP was unaware of whether these symptoms had resolved.
Age: 10.0
Sex: M
Vaccine: FLUR4, FLUR4
Symptoms: Wrong drug administered
Clinical narrative: Initial information received on 20-Aug-2018 regarding an unsolicited valid non-serious case received from a Pharmacist. This case involves a 11 years old male patient who was administered FLUBLOK QIV instead of FLUZONE QUADRIVALENT (Flu shot was not part of a series). The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 20-Aug-2018, the patient received a dose of suspect Influenza Quadrivalent Recombinant Vaccine (lot QFAA1801, exp date: 29-May-2019), via intramuscular route in the left deltoid. This was the case of actual medication error case due to wrong vaccine administered and inappropriate age at vaccine administration. It was not reported if the patient experienced any adverse event. 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. Documents held by sender: none.
Age: 10.0
Sex: M
Vaccine: FLUR4, FLUR4
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Initial information received on 20-Aug-2018 regarding an unsolicited valid non-serious case received from a Pharmacist. This case involves a 11 years old male patient who was administered FLUBLOK QIV instead of FLUZONE QUADRIVALENT (Flu shot was not part of a series). The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 20-Aug-2018, the patient received a dose of suspect Influenza Quadrivalent Recombinant Vaccine (lot QFAA1801, exp date: 29-May-2019), via intramuscular route in the left deltoid. This was the case of actual medication error case due to wrong vaccine administered and inappropriate age at vaccine administration. It was not reported if the patient experienced any adverse event. 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. Documents held by sender: none.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of an unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 06-AUG-2018, the patient was supposed to receive a dose of VARIVAX and a dose of M-M-R II but instead inadvertently was vaccinated with a 0.5 ml dose of VARIVAX subcutaneously, lot# N034552, expiration date: 05-DEC-2019 and a 0.5 ml dose of PROQUAD subcutaneously, lot# N013863, expiration date: 31-OCT-2018, for prophylaxis during the same appointment. Both of the administered vaccines were reconstituted with sterile diluent lot # M009789, expiration date: 10-SEP-2018. No symptoms were reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 (dose, route of administration, lot # and expiration date were not provided) for prophylaxis. Administered dose of vaccine experienced temperature excursion below 32 degrees Fahrenheit (30 degrees Fahrenheit for 4 cycles) for 12 hours. There was no previous temperature excursion reported. Digital data logger was involved. No adverse effects were reported. This is a non-valid case due to lack of patient identifier.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site reaction, Injection site warmth
Clinical narrative: This spontaneous report was received from a 31-year-old non pregnant female patient who referred to herself. The patient's pertinent medical history included some unspecified allergies and drug reaction or allergy to MONISTAT. On 30-JUL-2018, the patient was vaccinated with VARIVAX, one dose, intramuscular injection (concentration, lot # and expiration date were not reported) for prophylaxis (reported as immunity to chickenpox). It was reported that a sterile diluent (lot # and expiration date were not reported) was used to reconstitute the VARIVAX. Concomitant therapies included sertraline, ZYRTEC, SINGULAIR and XYZAL (also reported as SYZAL). On 09-AUG-2018, the patient developed a single red, warm, hard lump and itchy rash by the injection site. Since the initial appearance of the adverse effect on 09-AUG-2018, the rash has spread and she has developed more lumps. The patient sought medical attention and there was given treatment for the events. No lab diagnostic or studies were performed. The outcome of the events was reported as not recovered. The causality assessment between the events and suspect therapies was not provided.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash pruritic
Clinical narrative: This spontaneous report was received from a 31-year-old non pregnant female patient who referred to herself. The patient's pertinent medical history included some unspecified allergies and drug reaction or allergy to MONISTAT. On 30-JUL-2018, the patient was vaccinated with VARIVAX, one dose, intramuscular injection (concentration, lot # and expiration date were not reported) for prophylaxis (reported as immunity to chickenpox). It was reported that a sterile diluent (lot # and expiration date were not reported) was used to reconstitute the VARIVAX. Concomitant therapies included sertraline, ZYRTEC, SINGULAIR and XYZAL (also reported as SYZAL). On 09-AUG-2018, the patient developed a single red, warm, hard lump and itchy rash by the injection site. Since the initial appearance of the adverse effect on 09-AUG-2018, the rash has spread and she has developed more lumps. The patient sought medical attention and there was given treatment for the events. No lab diagnostic or studies were performed. The outcome of the events was reported as not recovered. The causality assessment between the events and suspect therapies was not provided.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple unspecified, newborn patients of unknown age and ender. The patients' pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (exact dose, site and route of administration, lot# and expiration date were not reported) for prophylaxis. The registered nurse reported, that it was a routine practice at the hospital unit where the newborns are delivered to remove RECOMBIVAX HB from refrigeration and to store it at room temperature of an unknown amount of time until administration. Administered doses of vaccine experienced a temperature excursion between 47 degrees Fahrenheit to 77 degrees Fahrenheit for unknown amount of time. There was no previous temperature excursion. Digital data logger was not involved. No adverse effects were reported.
Sex: F
Vaccine: HPV9
Symptoms: Nausea, Oropharyngeal pain
Clinical narrative: This spontaneous report was received from a medical assistant via a company representative and refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with the second dose of GARDASIL 9 (dose, route of administration, lot # and expiration date were not provided) as prevention of Human Papilloma Virus (HPV). On an unknown date, after receiving GARDASIL 9, the patient experienced sore throat and nausea. The patient sought medical attention via calling physician. The outcome of sore throat and nausea was unknown. The relatedness between the events and GARDASIL 9 was not reported.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician referring to an adult patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 29-AUG-2018, the patient was vaccinated with VAQTA, 50/1.0 U/ml subcutaneous, (lot number and expiration date were not reported) for prophylaxis. On 29-AUG-2018, the physician reported that an unspecified adult patient received a dose of VAQTA, via subcutaneous route, no adverse effect reported.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a nurse, referring to a 24 year old female patient. Information about medical history, concurrent condition and concomitant therapy was unknown. On unknown dates (also reported as over a year ago), at the physician's office, the patient was vaccinated with the first two doses of GARDASIL 9 (dose, strength, lot# and expiration date unknown) intramuscularly for prophylaxis. On 31-AUG-2018, the patient returned to the physician's office and vaccinated with the third dose of GARDASIL 9 (inappropriate schedule of drug administration). No adverse effect reported.
Sex: U
Vaccine: TDAP
Symptoms: Booster dose missed
Clinical narrative: Initial unsolicited report received from pharmacist on 29-Aug-2018. This case involves an unknown patient who was vaccinated with a dose of vaccine ADACEL and did not receive 10 year booster dose of TD (DIPHTHERIA VACCINE TOXOID, TETANUS VACCINE TOXOID) (Batch number, expiration date, dose, route and site of administration was not reported) on an unknown date. The patients medical history and concomitant medications were not reported. It was an actual medication error due to missed dose (patient received ADACEL in 2011, did not receive ten year booster of Td per CDC recommendations). 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 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: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: March 2018:Patient had itching, pain, and a firm raised area over the muscle where she received her flu shot on 11/1/17. May 2018: Patient reported that she had used cortisone cream and is doing better. She plans to avoid that arm for her shot this year.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: PATIENT WAS TREATED WITH MEDICATION.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Abnormal dreams, Chills, Fatigue, Feeling abnormal, Feeling of body temperature change
Clinical narrative: At bedtime he began feeling chills, achiness, hot then cold, and fatigue.  He also reported having bizarre "fever" dreams. Symptoms continued throughout the night and he was up all night feeling lousy.  This morning he is still feeling sick.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: At bedtime he began feeling chills, achiness, hot then cold, and fatigue.  He also reported having bizarre "fever" dreams. Symptoms continued throughout the night and he was up all night feeling lousy.  This morning he is still feeling sick.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 12 year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. The nurse reported that the patient was vaccinated with GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported) on 30-NOV-2016 and 10-MAY-2017. No adverse symptoms were reported. No product quality complaint (PQC) was involved.
Sex: M
Vaccine: VARCEL
Symptoms: Infective myositis, Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: This spontaneous report was received from a patien's mother who refers to a 15-month-old son. The patient did not have any pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies. On 17-AUG-2018, the patient was vaccinated with VARIVAX lot # N023956 with expiration date: 01-SEP-2019 (dose and route of administration were not reported) for prophylaxis. On an unknown date in August 2018, the patient experienced injection site redness, tenderness and inflammation. The patient seek medical attention and was diagnosed with an infection in the muscle. A treatment with cephalexin antibiotc was introduced. No laboratory diagnostics or studies were performed. The outcome of the events was reported as not recovered/not resolved. The relatedness between the events and VARIVAX  was not provided.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Back pain, Burning sensation, Muscle spasms, Musculoskeletal discomfort, Musculoskeletal pain
Clinical narrative: Evaluated 2 days post injection (8/22/18): Subjective: CC: rt. upper arm pain Received hep B#3 vaccine on 8-20-18. Seemed to be administered higher up in the arm than previous vaccines. Noted burning discomfort rt. upper arm. Since that time, has had paresthesias into hand, as well as some shoulder and upper back pain and towards neck. Pt. is left handed. Injection site without erythema or drainage. Objective: Alert, WDWN, NAD. VS as noted. Afebrile. Nontoxic appearing. Mood/affect: appropriate Cor: well perfused Lungs: easy work of breathing Musculoskeletal: C-spine nontender to palpation. Rt. cervical paraspinal tenderness. Rt. upper trapezius tenderness/supraspinatus tenderness with spasm. Rt. upper arm: no erythema at injection site puncture. Mod. tender rt. upper lateral arm. Rt. shoulder: diffuse tenderness of the superior/lateral shoulder area; decreased ROM all directions. Jobe's empty can test: neg Subscapularis push off test: + Belly press: mild pain. Yergason's: neg Speed's: neg Neuro: DTR's 2+/2+ biceps, 0/0 triceps Motor strength exam intact: Deltoids (C5-axillary) Triceps (C6-C7-radial) Wrist extensors (C6-C7-radial) Finger flexion (C8-median) Finger abduction (T1-ulnar) Sensory exam intact to pinprick: Lateral aspect of upper arms (C5) Tip of thumb (C6) Tip of middle finger (C7) Tip of pinky finger (C8) Radial pulse 2+ symmetric Assessment: Adverse effect of other viral vaccines, initial encounter - T50.B95A Pain in right arm - M79.601 Pain in right shoulder - M25.511 Dorsalgia, unspecified - M54.9 Paresthesia Of Skin - R20.2 probable associated muscle spasm Sx developed after receiving hepatitis B vaccination Differential incl. Parsonnage-Turner syndrome (brachial neuritis) referred to primary workers' comp carrier for follow up care.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Myalgia, Pain in extremity, Paraesthesia
Clinical narrative: Evaluated 2 days post injection (8/22/18): Subjective: CC: rt. upper arm pain Received hep B#3 vaccine on 8-20-18. Seemed to be administered higher up in the arm than previous vaccines. Noted burning discomfort rt. upper arm. Since that time, has had paresthesias into hand, as well as some shoulder and upper back pain and towards neck. Pt. is left handed. Injection site without erythema or drainage. Objective: Alert, WDWN, NAD. VS as noted. Afebrile. Nontoxic appearing. Mood/affect: appropriate Cor: well perfused Lungs: easy work of breathing Musculoskeletal: C-spine nontender to palpation. Rt. cervical paraspinal tenderness. Rt. upper trapezius tenderness/supraspinatus tenderness with spasm. Rt. upper arm: no erythema at injection site puncture. Mod. tender rt. upper lateral arm. Rt. shoulder: diffuse tenderness of the superior/lateral shoulder area; decreased ROM all directions. Jobe's empty can test: neg Subscapularis push off test: + Belly press: mild pain. Yergason's: neg Speed's: neg Neuro: DTR's 2+/2+ biceps, 0/0 triceps Motor strength exam intact: Deltoids (C5-axillary) Triceps (C6-C7-radial) Wrist extensors (C6-C7-radial) Finger flexion (C8-median) Finger abduction (T1-ulnar) Sensory exam intact to pinprick: Lateral aspect of upper arms (C5) Tip of thumb (C6) Tip of middle finger (C7) Tip of pinky finger (C8) Radial pulse 2+ symmetric Assessment: Adverse effect of other viral vaccines, initial encounter - T50.B95A Pain in right arm - M79.601 Pain in right shoulder - M25.511 Dorsalgia, unspecified - M54.9 Paresthesia Of Skin - R20.2 probable associated muscle spasm Sx developed after receiving hepatitis B vaccination Differential incl. Parsonnage-Turner syndrome (brachial neuritis) referred to primary workers' comp carrier for follow up care.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: Patient compliant of having the area as very red and hot.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Hardness, swelling, redness at injection sight, fever of 103 for 3 days, fatigue,  body aches, headache.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Hardness, swelling, redness at injection sight, fever of 103 for 3 days, fatigue,  body aches, headache.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Area around vaccine site swollen the size of a golf ball and warm to the touch this morning when she woke up the day after the vaccine was given. Benadryl was given as treatment. Patient was told to monitor reaction for further symptoms and to do benadryl for the next two days .