chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Antibody test negative, Vaccination failure
Clinical narrative: This spontaneous report was received from a Nurse, concerning a 3 year old patient of unknown gender with multiple medical conditions including cerebral palsy, asthma and tympanic ear membrane disorder (without cochlear implant). The patient had history of weak antibody response to pneumococcal vaccine. On unspecified dates in the past, the patient received four doses of PREVNAR 13 according to PREVNAR 13 schedule. On an unknown date (reported as "after the fourth dose of PREVNAR 13 two years ago"), the patient received a dose of PNEUMOVAX 23 for prophylaxis. Other suspect therapies included PREVNAR 13 for an unknown indication (dose, route of administration, anatomical location, lot numbers and expiration dates were not reported). On an unknown date, the patient developed weak antibody response to pneumococcal vaccine (vaccination failure), however, the nurse could not specify if it applied for both suspect therapies or only for one of the products. The outcome of vaccination failure and the causal relationship between the event and the suspect vaccines were not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the dermatologist (on voicemail). The patient developed Shingles after receiving SHINGRIX and it resolved after 24 hours.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site discolouration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site bruising in a 52-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included FLONASE, Albuterol, Aspirin, Atorvastatin, diazepam, Hydroxyzine, levetiracetam, diphtheria toxoid + tetanus toxoid (Td), hydrochlorothiazide and Oxycodone + Apap. On 21st May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site bruising, injection site discoloration, injection site burning, injection site swelling and injection site itching. On an unknown date, the outcome of the injection site bruising, injection site burning, injection site swelling and injection site itching were recovered/resolved and the outcome of the injection site discoloration was not recovered/not resolved. The reporter considered the injection site bruising, injection site discoloration, injection site burning, injection site swelling and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The concomitant medication included high BP pill and potassium. The reporter stated that her friend received SHINGRIX on left arm at 9:00. In 2018, after the vaccination, the site was bruised, swollen and itched really bad. The itching turned into a burning sensation, and then it started growing into a large dark spot on her arm. The swelling, itching and burning lasted for one week before resolving, but the dark spot was still there and had not gotten any better.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Abdominal pain, Irritability, Surgery
Clinical narrative: Fussiness, admitted abdomen pain, surgery.
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis
Clinical narrative: Pt had the shot on Friday and went to the ER on Saturday and was placed on KEFLEX and doxycycline for cellulitis. Rph used aseptic technique.
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site cellulitis
Clinical narrative: Pt had the shot on Friday and went to the ER on Saturday and was placed on KEFLEX and doxycycline for cellulitis. Rph used aseptic technique.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: The patient came into the office today for his 19 year PE. He was given his first dose of Hep A at his last years PE. The provider wanted to complete the series and ordered the second dose today and the medical assistant administered it. The patient was given Hep A 0.5 ml not the 1.0 ml needed at age 19.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Local reaction, Peripheral swelling
Clinical narrative: Localized reaction, swelling from shoulder to mid bicep.
Age: 23.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Rash, Rash pruritic
Clinical narrative: Per Patient: 3 days after the vaccine she start developing rashes. They look round (ring form) with lighter color inside and little rough around the edges of the rings. It is itching and primarily are all over trunk and neck and some on hands. Pt advised to see doctor for further clinical evauation and recommendation. For itching, anti itch medication was recommended.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Syncope
Clinical narrative: Syncopal episode after immunization.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Infectious mononucleosis, Injection site pain, Myalgia
Clinical narrative: In addition to very sore arm at the injection site for 4-5 days, symptoms similar to mononucleosis which I suffered 10 years ago recurred. Chills, fatigue, sore throat, burning mouth and tongue, muscle aches - all of which I had for most of 2008 with mono. I have been free from these symptoms until having the SHINGRIX vaccine.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral discomfort, Oropharyngeal pain, Tongue discomfort
Clinical narrative: In addition to very sore arm at the injection site for 4-5 days, symptoms similar to mononucleosis which I suffered 10 years ago recurred. Chills, fatigue, sore throat, burning mouth and tongue, muscle aches - all of which I had for most of 2008 with mono. I have been free from these symptoms until having the SHINGRIX vaccine.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Heart rate increased, Nausea
Clinical narrative: The day after receiving the vaccine, patient reported increased heart rate most of the day which she noticed when she was at the gym. Self-reported HR of 195 when she was at the gym and said her HR stayed above 130 all day. She also experienced nausea and a dull headache.
Age: 69.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Pain
Clinical narrative: 4 hours after vaccination patients arm started swelling and pain radiated down arm from injection site. Arm swelled, was red to the touch and hard from the deltoid muscle all the way to the inner elbow. Vaccinated on 6/22/18 and symptoms subsided on 6/26/18 with arm elevation, alternating hot and cold compress and taking Naproxen PRN.
Age: 69.0
Sex: F
Vaccine: TD
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: 4 hours after vaccination patients arm started swelling and pain radiated down arm from injection site. Arm swelled, was red to the touch and hard from the deltoid muscle all the way to the inner elbow. Vaccinated on 6/22/18 and symptoms subsided on 6/26/18 with arm elevation, alternating hot and cold compress and taking Naproxen PRN.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Nausea, Pruritus, Urticaria
Clinical narrative: Itching and hives on right arm and leg, scalp. Fatigue, mild nausea.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Eye swelling, Ocular hyperaemia
Clinical narrative: Patient states that her right eye was swollen and blood shot the day after she received vaccine. She also had trouble breathing and had to use her oxygen more than usual for the next 2 or 3 days.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test normal, Neuralgia, Pain in extremity
Clinical narrative: Patient received the vaccine on 6/7/18; Pt called today to report that she had a severe leg pain a day or 2 after she received the vaccine. She was referred to a specialist to check if she had DVT but it was ruled out. The primary care told the patient that the leg pain, was a nerve pain due to the vaccine and put her on steroids which is helping with the pain now.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Loss of personal independence in daily activities, Serum sickness
Clinical narrative: Serum sickness, headache, weakness. Onset of symptoms, 4 to 6 hours after IMZ administration.  Symptoms lasted 24 hours. Patient missed worked the day after IMZ.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Rash, Rash pruritic
Clinical narrative: Fine rash noted face, arms, legs and abdomen. Rash was very itchy. No respiratory distress or swelling at injection site.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: CSF test, Guillain-Barre syndrome, Immunoglobulin therapy, Lumbar puncture, Monoplegia
Clinical narrative: Onset of Guillain-Barre Syndrome 2-3 days after vaccination with resultant hospitalization/IVIG and sequelae of leg paralysis and paresthesia.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging spinal, Paraesthesia
Clinical narrative: Onset of Guillain-Barre Syndrome 2-3 days after vaccination with resultant hospitalization/IVIG and sequelae of leg paralysis and paresthesia.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Serum sickness
Clinical narrative: Serum sickness, headache, weakness. Onset of symptoms, 4 to 6 hours following IMZ administration. Symptoms lasted 24 hours.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Blood culture negative, Injection site erythema, Injection site pain, Injection site warmth, Malaise
Clinical narrative: Pt seen in clinic on 6/20/18 given pneumonia vaccine. Last 2 days or starting 6/21 has been feeling ill then yesterday noticed L arm injection site red/warm and TTP. States is not itchy but hurts to touch. She was found to have a 8x6cm urticarial lesion on left arm. Initially treated with vancomycin, de-escalated abx therapy to KEFLEX for cellulitis.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria, White blood cell count increased
Clinical narrative: Pt seen in clinic on 6/20/18 given pneumonia vaccine. Last 2 days or starting 6/21 has been feeling ill then yesterday noticed L arm injection site red/warm and TTP. States is not itchy but hurts to touch. She was found to have a 8x6cm urticarial lesion on left arm. Initially treated with vancomycin, de-escalated abx therapy to KEFLEX for cellulitis.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site rash
Clinical narrative: Patient described the injection site as getting red and hard. A rash developed around the area.  No complications were reported and resolved on its own.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Abdominal pain upper, Blood test, Chest pain, Computerised tomogram, Depression
Clinical narrative: Screaming Pain upper chest left arm. Stomach pain. Insomnia. Fatigue. Migraines. Pounding chest. Feeling hot with no irregular temperatures. Depression. Dizziness. Couldn't get out of bed for two months. Inability to participate in school.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Electromyogram, Fatigue, Feeling hot, Insomnia
Clinical narrative: Screaming Pain upper chest left arm. Stomach pain. Insomnia. Fatigue. Migraines. Pounding chest. Feeling hot with no irregular temperatures. Depression. Dizziness. Couldn't get out of bed for two months. Inability to participate in school.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Loss of personal independence in daily activities, Migraine, Mobility decreased, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Screaming Pain upper chest left arm. Stomach pain. Insomnia. Fatigue. Migraines. Pounding chest. Feeling hot with no irregular temperatures. Depression. Dizziness. Couldn't get out of bed for two months. Inability to participate in school.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Palpitations, Screaming
Clinical narrative: Screaming Pain upper chest left arm. Stomach pain. Insomnia. Fatigue. Migraines. Pounding chest. Feeling hot with no irregular temperatures. Depression. Dizziness. Couldn't get out of bed for two months. Inability to participate in school.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Fever to 105 F degrees for 24 hours.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Discomfort, Urticaria
Clinical narrative: Within 12 hours, developed total body urticaria that lasted for approximately 1 week. Child was very uncomfortable and required an ER visit, multiple doses of BENADRYL throughout the week and visits to our office along with an evaluation by an allergist.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Feeling abnormal, Nausea, Pain in extremity
Clinical narrative: Diarrhea, nausea, soreness in arm, mind fog, fatigue.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site rash, Injection site swelling, Injection site urticaria, Rash, Skin warm
Clinical narrative: Rash/hives on upper and lower arms (both), 2 inch diameter of swelling around the injection point, Small hard lump where needle was injected into the arm, Area around arm is warm to the touch.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: Rash/hives on upper and lower arms (both), 2 inch diameter of swelling around the injection point, Small hard lump where needle was injected into the arm, Area around arm is warm to the touch.
Age: 42.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Erythema, Injection site pain, Injection site warmth, Pain in extremity
Clinical narrative: The patient came to the pharmacy today with a sore red arm. She said it started on 06/20/18 that evening and it became progressively worse the last couple of days. She said the site feels hot to the touch and painful. She just puts ice pack on it to relieve the pain. I told her to take some MOTRIN to alleviate some of the pain and to see her doctor.
Age: 68.0
Sex: U
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth, Pyrexia
Clinical narrative: Injection site reactions (5 inches hard lump, redness, pain for 1 week) and fever for 2 days.
Age: 68.0
Sex: U
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Pyrexia
Clinical narrative: Injection site reactions (5 inches hard lump, redness, pain for 1 week) and fever for 2 days.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Headache, Injection site pain, Injection site warmth, Nausea
Clinical narrative: Shot given at 1130 AM on 6/21/18. Symptoms started at 100 AM on 6/22/18, included fever, nausea and headache. Also soreness/warmth at injection site. Diagnosed with cellulitis and prescribed KEFLEX 500mg and ZOFRAN 4mg.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Shot given at 1130 AM on 6/21/18. Symptoms started at 100 AM on 6/22/18, included fever, nausea and headache. Also soreness/warmth at injection site. Diagnosed with cellulitis and prescribed KEFLEX 500mg and ZOFRAN 4mg.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Peripheral swelling, Tenderness
Clinical narrative: Left arm swollen and tender.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site swelling
Clinical narrative: Swelling to right and left thigh.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Pt refers to pain in the area of injection since Monday 6/18/18 presenting inflammation, hot to touch.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Influenza like illness, Muscle spasms, Seizure
Clinical narrative: Pt. was vaccinated in pharmacy clinic at 3:00pm. At home on same day at 8:00pm pt. began convulsing, body cramps, flu-like SXS, SOB that lasted 18-20 hrs. Pt. has a caregiver with him. Major ice storm was happening so he did not seek medical attention. SXS went away in 18-20 hrs as quick as onset. Pt. ate, rehydrated. Pt. broke out mild with shingles outbreak previously.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pyrexia, Swelling
Clinical narrative: Patient states redness, fever, and swelling, arm swollen and extremely painful from shoulder to elbow.
Age: 54.0
Sex: F
Vaccine: HEPA
Symptoms: Abdominal pain upper, Aphasia, Arthralgia, Back pain, Chest discomfort
Clinical narrative: Very lightheaded-LD-sore-after 48 hours nausea "dizziness muscle pain, neck stiff, light head has to think before she talks. Wording not the same" stomach, back, (L) hip hurts worst of flu and chest tightness.
Age: 54.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Influenza, Injection site pain, Musculoskeletal stiffness, Myalgia
Clinical narrative: Very lightheaded-LD-sore-after 48 hours nausea "dizziness muscle pain, neck stiff, light head has to think before she talks. Wording not the same" stomach, back, (L) hip hurts worst of flu and chest tightness.
Age: 54.0
Sex: F
Vaccine: HEPA
Symptoms: Nausea
Clinical narrative: Very lightheaded-LD-sore-after 48 hours nausea "dizziness muscle pain, neck stiff, light head has to think before she talks. Wording not the same" stomach, back, (L) hip hurts worst of flu and chest tightness.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Contusion, Pain, Rash erythematous, Rash pruritic
Clinical narrative: Patient had pain and rash from injection of vaccine - itchy red spotted rash - pain/bruise at deltoid. Rash on forearm.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Erythema, Peripheral swelling
Clinical narrative: Patient presented and said her arm from shoulder to elbow was red and had a big amount of swelling and wished to let us know. Some bruising as well.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Lethargy, Oral herpes, Pyrexia
Clinical narrative: Not hungry or thirsty and completely lethargic day after. She was sweating profusely (had to change clothes), had a fever, and got a cold sore.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Had shingles on 6-7-18.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Infant had vomiting for 3 days after rotavirus vaccine per father's history.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site swelling, Injection site warmth
Clinical narrative: Warm at injection site. Swollen arm at injection site. Saw MD 6-23-18 diagnosed cellulitis. Per call 6-26-18 it is improving w/Antibiotic Tx.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Laboratory test normal, Myalgia, Nausea, Pain in extremity
Clinical narrative: Pt had very bad nausea all night after shot, severe muscle pain, severe bone pain, lower limbs pain. This all happened within 24-48 hours after shot.
Age: 74.0
Sex: M
Vaccine: FLUX
Symptoms: Biopsy, Blood test, Chemotherapy, Feeling abnormal, Injection site pain
Clinical narrative: This spontaneous case, initially received on 27-Mar-2018, was reported by a physician and concerns a 74-year-old, elderly, male patient. The patient's current condition included anemia (since an unspecified date). The concomitant medication included VICODIN, magnesium, vitamin D3 for unknown indications. Since 22-Dec-2017, the patient was taking non-company suspect product JAKAFI (dose: 5 mg, route of administration: oral, frequency: qd (daily once), batch number, expiry date: not reported). On 05-Jan-2018, the patient was administered with Influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On 06-Jan-2018, the next day of vaccination, the patient experienced pain in the same shoulder (described as miserable for next 2 days). The patient consulted medical doctor and was prescribed with unspecified pain medication, which relieved the pain. On an unspecified date, during a follow-up, it was reported that, the patient was off from JAKAFI regimen for an unspecified reason. Later, JAKAFI 5 mg bid (twice-a-day) was included in the care plan. On an unspecified date, JAKAFI 10 mg bid was initiated. On 16-Jan-2018, the patient had recovered from the event shoulder pain. On 06-Feb-2018, the patient underwent unspecified blood tests, biopsy and chemotherapy. The reporter assessed this case as non-serious and the causality of the event (shoulder pain) was considered as related to the flu shot.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This is a non-serious spontaneous case, initially received from other non-health professional via pharmaceutical manufacturer (Merck) on 07-May-2018, concerning a female patient of unspecified age. On an unspecified date, the patient was administered with Influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported) and PNEUMOVAX 23 (dose, route of administration, anatomical location, batch number, expiry date: not reported). On an unspecified date, next day of vaccination, the patient experienced redness and swelling at injection site. At the time of this report, the outcome of the events was not reported.
Age: 11.0
Sex: F
Vaccine: FLUX
Symptoms: Adverse reaction
Clinical narrative: This is a spontaneous case, initially received from other health professional via pharmaceutical manufacturer (Merck) on 07-May-2018, concerning an 11-year-old, female child. On 05-Oct-2011, the patient was administered with Influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date, the patient experienced severe reaction (unspecified). At the time of this report, the outcome of the event was not reported.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site rash, Rash, Rash erythematous
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a 71-year-old female patient who received SHINGRIX (batch number 79N59, expiry date unknown) for prophylaxis. Concomitant products included SYNTHROID. On 15th April 2018, the patient received SHINGRIX. On 16th April 2018, 1 days after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The patient reported that about 24 hours after receiving her first dose of SHINGRIX, the patient experienced a rash on her midriff and stomach.The patient was prescribed BENADRYL. The rash began to improve after 4 days and resolved 10 days later. The patient had denied permission to contact their physician. The patient said that a report was sent to VAERS and could not locate the expiration date from the lot number. The lot number was valid, but no expiration date could be found, and the reporting pharmacist did not provide one.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a 71-year-old female patient who received SHINGRIX (batch number 79N59, expiry date unknown) for prophylaxis. Concomitant products included SYNTHROID. On 15th April 2018, the patient received SHINGRIX. On 16th April 2018, 1 days after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The patient reported that about 24 hours after receiving her first dose of SHINGRIX, the patient experienced a rash on her midriff and stomach.The patient was prescribed BENADRYL. The rash began to improve after 4 days and resolved 10 days later. The patient had denied permission to contact their physician. The patient said that a report was sent to VAERS and could not locate the expiration date from the lot number. The lot number was valid, but no expiration date could be found, and the reporting pharmacist did not provide one.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a 71-year-old female patient who received SHINGRIX (batch number 79N59, expiry date unknown) for prophylaxis. Concomitant products included SYNTHROID. On 15th April 2018, the patient received SHINGRIX. On 16th April 2018, 1 days after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The patient reported that about 24 hours after receiving her first dose of SHINGRIX, the patient experienced a rash on her midriff and stomach.The patient was prescribed BENADRYL. The rash began to improve after 4 days and resolved 10 days later. The patient had denied permission to contact their physician. The patient said that a report was sent to VAERS and could not locate the expiration date from the lot number. The lot number was valid, but no expiration date could be found, and the reporting pharmacist did not provide one.
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Gait inability, Pain in extremity, Paraesthesia
Clinical narrative: Last December 12, I had the ZOSTAVAX shingles vaccine. By January I was having difficulty walking and experienced fatigue. Had a flu shot in September and had flu symptoms in February, for which I got a TAMIFLU treatment. Had SHINGRIX shot mid-April and within a week was having greater difficulty walking and within two weeks needed a walker and cane. Fell on May 20 and admitted to the hospital May 21, 16 days in hospital included steroid IV for five days and PT/OT. Now in outpatient therapy and am recovering gradually.
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Fall, Gait disturbance, Lumbar puncture, Spinal myelogram
Clinical narrative: Last December 12, I had the ZOSTAVAX shingles vaccine. By January I was having difficulty walking and experienced fatigue. Had a flu shot in September and had flu symptoms in February, for which I got a TAMIFLU treatment. Had SHINGRIX shot mid-April and within a week was having greater difficulty walking and within two weeks needed a walker and cane. Fell on May 20 and admitted to the hospital May 21, 16 days in hospital included steroid IV for five days and PT/OT. Now in outpatient therapy and am recovering gradually.
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Walking aid user
Clinical narrative: Last December 12, I had the ZOSTAVAX shingles vaccine. By January I was having difficulty walking and experienced fatigue. Had a flu shot in September and had flu symptoms in February, for which I got a TAMIFLU treatment. Had SHINGRIX shot mid-April and within a week was having greater difficulty walking and within two weeks needed a walker and cane. Fell on May 20 and admitted to the hospital May 21, 16 days in hospital included steroid IV for five days and PT/OT. Now in outpatient therapy and am recovering gradually.
Age: 69.0
Sex: M
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Computerised tomogram head normal, Corneal abrasion, Electrocardiogram normal, Facial paralysis, Lacrimation disorder
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of Bell's palsy in a 69-year-old male patient who received SHINGRIX (batch number 49ST9, expiry date 4th July 2020) for prophylaxis. Co-suspect products included dTpa vaccine (batch number U5748AA ?, expiry date 23rd August 2019) (the reported lot number did not match with any GSK lot number) for prophylaxis. Concomitant products included FLONASE, LIPITOR, Losartan, VOLTAREN, ZANTAC, atenolol, KENALOG, MYOLAXIN, VIAGRA and TYLENOL. On 27th April 2018 11:38, the patient received the 1st dose of SHINGRIX .5 ml. On 27th April 2018, the patient received dTpa vaccine. On an unknown date, less than a month after receiving SHINGRIX and dTpa vaccine, the patient experienced Bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the Bell's palsy was recovering/resolving. The reporter considered the Bell's palsy to be possibly related to SHINGRIX. It was unknown if the reporter considered the Bell's palsy to be related to dTpa vaccine. Additional details were provided as follows: The patient received SHINGRIX and dTpa vaccine in right deltoid. The patient was treated in the emergency room but not admitted overnight.
Age: 69.0
Sex: M
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Tinnitus, Tongue paralysis
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of Bell's palsy in a 69-year-old male patient who received SHINGRIX (batch number 49ST9, expiry date 4th July 2020) for prophylaxis. Co-suspect products included dTpa vaccine (batch number U5748AA ?, expiry date 23rd August 2019) (the reported lot number did not match with any GSK lot number) for prophylaxis. Concomitant products included FLONASE, LIPITOR, Losartan, VOLTAREN, ZANTAC, atenolol, KENALOG, MYOLAXIN, VIAGRA and TYLENOL. On 27th April 2018 11:38, the patient received the 1st dose of SHINGRIX .5 ml. On 27th April 2018, the patient received dTpa vaccine. On an unknown date, less than a month after receiving SHINGRIX and dTpa vaccine, the patient experienced Bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the Bell's palsy was recovering/resolving. The reporter considered the Bell's palsy to be possibly related to SHINGRIX. It was unknown if the reporter considered the Bell's palsy to be related to dTpa vaccine. Additional details were provided as follows: The patient received SHINGRIX and dTpa vaccine in right deltoid. The patient was treated in the emergency room but not admitted overnight.
Age: 69.0
Sex: M
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Facial paralysis
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of Bell's palsy in a 69-year-old male patient who received SHINGRIX (batch number 49ST9, expiry date 4th July 2020) for prophylaxis. Co-suspect products included dTpa vaccine (batch number U5748AA ?, expiry date 23rd August 2019) (the reported lot number did not match with any GSK lot number) for prophylaxis. Concomitant products included FLONASE, LIPITOR, Losartan, VOLTAREN, ZANTAC, atenolol, KENALOG, MYOLAXIN, VIAGRA and TYLENOL. On 27th April 2018 11:38, the patient received the 1st dose of SHINGRIX .5 ml. On 27th April 2018, the patient received dTpa vaccine. On an unknown date, less than a month after receiving SHINGRIX and dTpa vaccine, the patient experienced Bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the Bell's palsy was recovering/resolving. The reporter considered the Bell's palsy to be possibly related to SHINGRIX. It was unknown if the reporter considered the Bell's palsy to be related to dTpa vaccine. Additional details were provided as follows: The patient received SHINGRIX and dTpa vaccine in right deltoid. The patient was treated in the emergency room but not admitted overnight.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Vaccine was administered incorrectly. If was not injected into the muscled. It was injected subcutaneously. Redness, pain, hot to the touch, swelling at injection site. This area grew every day since getting the shot. Currently, a 5 x 8 inch area, which spread daily. I went to Urgent Care on 6/24/2018. I was given a prescription for AUGMENTIN and told it was cellulitis. Symptoms worsened. I saw Dr. on 6/25/2018. Conditions still worsened. Antibiotic was changed to Doxycycline on 6/26/2018 after talking to Dr. office. I notified pharmacy on 6/24 and 6/26. My doctor called pharmacy on 6/24.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Cellulitis, Incorrect route of drug administration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Vaccine was administered incorrectly. If was not injected into the muscled. It was injected subcutaneously. Redness, pain, hot to the touch, swelling at injection site. This area grew every day since getting the shot. Currently, a 5 x 8 inch area, which spread daily. I went to Urgent Care on 6/24/2018. I was given a prescription for AUGMENTIN and told it was cellulitis. Symptoms worsened. I saw Dr. on 6/25/2018. Conditions still worsened. Antibiotic was changed to Doxycycline on 6/26/2018 after talking to Dr. office. I notified pharmacy on 6/24 and 6/26. My doctor called pharmacy on 6/24.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Incorrect route of drug administration, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Vaccine was administered incorrectly. If was not injected into the muscled. It was injected subcutaneously. Redness, pain, hot to the touch, swelling at injection site. This area grew every day since getting the shot. Currently, a 5 x 8 inch area, which spread daily. I went to Urgent Care on 6/24/2018. I was given a prescription for AUGMENTIN and told it was cellulitis. Symptoms worsened. I saw Dr. on 6/25/2018. Conditions still worsened. Antibiotic was changed to Doxycycline on 6/26/2018 after talking to Dr. office. I notified pharmacy on 6/24 and 6/26. My doctor called pharmacy on 6/24.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site swelling, Injection site warmth, Overdose
Clinical narrative: Vaccine was administered incorrectly. If was not injected into the muscled. It was injected subcutaneously. Redness, pain, hot to the touch, swelling at injection site. This area grew every day since getting the shot. Currently, a 5 x 8 inch area, which spread daily. I went to Urgent Care on 6/24/2018. I was given a prescription for AUGMENTIN and told it was cellulitis. Symptoms worsened. I saw Dr. on 6/25/2018. Conditions still worsened. Antibiotic was changed to Doxycycline on 6/26/2018 after talking to Dr. office. I notified pharmacy on 6/24 and 6/26. My doctor called pharmacy on 6/24.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: Pt called today and stated she has diarrhea cause by vaccine. I called patient twice throughout the day to check to see how she was feeling. Last call was at 5PM and pt stated diarrhea had slowed down and was feeling better.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Today the site of the shot was raised, red and warm.
Sex: F
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received via company representative from a physician who was also a 60 year old female patient referring to herself. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On an unknown date in 2018, the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose, strength and route of administration were not provided) for prophylaxis. The patient was 60 years old at the time of vaccination. No adverse event was reported.
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions and past drug reactions/allergies were not reported. The patient's concomitant therapies included sterile diluent. On 13-JUN-2018, the patient was vaccinated with an expired dose of VARIVAX lot # M028546 with expiration date: 07-JUN-2018 (strength, dose, route and anatomical location) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: This spontaneous report was received from a physician via company representative, concerning a currently 67 year old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 for prophylaxis (dose #, route, lot # and expiration date were unknown). Concomitant medications were not reported. On an unknown date, the patient experienced injection site erythema, injection site swelling, injection site warmth, and nausea. The physician did not provide treatment as "it was a normal injection site reaction". At the time of reporting, the outcome of injection site erythema, injection site swelling, injection site warmth, and nausea was unknown. The causality assessment between the adverse events and PNEUMOVAX 23 was not provided.
Age: 4.0
Sex: M
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: This spontaneous report was received from a healthcare professional via Poison And Drug Center (PDC) regarding a 4 year old male patient. Information on medical history, current conditions and concomitant therapies were not reported. On 16-JUN-2018, the patient was inadvertently vaccinated with GARDASIL 9 once (Strength, dose and anatomical location were not reported) of lot # N023828 with an expiry date of 25-JUN-2020 for prophylaxis. The outcome of wrong drug administered and drug administered to patient of inappropriate age was unknown.
Age: 0.33
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a Nurse, referring to a 4 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 18-JUN-2018, the patient was inadvertently vaccinated with GARDASIL 9, intramuscularly (anatomical location, lot number and expiration date were not reported) for prophylaxis. The nurse reported it was a human error. No adverse effects were reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant 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 01-JUN-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB, lot # N022167, expiration date: 08-FEB-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1806USA001505: US-009507513-1806USA009026: US-009507513-1806USA009027: US-009507513-1806USA009028: US-009507513-1806USA009029: US-009507513-1806USA009030: US-009507513-1806USA009031: US-009507513-1806USA009032: US-009507513-1806USA009033: US-009507513-1806USA009034: US-009507513-1806USA009035: US-009507513-1806USA009036: US-009507513-1806USA009037: US-009507513-1806USA009038: US-009507513-1806USA009039: US-009507513-1806USA009040: US-009507513-1806USA009041: US-009507513-1806USA009042: US-009507513-1806USA009043: US-009507513-1806USA009044: US-009507513-1806USA009045: US-009507513-1806USA009046: US-009507513-1806USA009047: US-009507513-1806USA009048: US-009507513-1806USA009049: US-009507513-1806USA009050: US-009507513-1806USA009051: US-009507513-1806USA009052: US-009507513-1806USA009053: US-009507513-1806USA009054: US-009507513-1806USA009055:
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2010, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles and other complications. In 2012, the patient was treated at a medical center for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse concerning to a 20 year old female patient. Medical history, concomitant medication and concurrent conditions were not provided. On 27-NOV-2017, the patient was vaccinated with the first dose of VAQTA (adult dose) (dose, route, frequency, lot# and the expiration date were not reported) for prophylaxis. On 19-JUN-2018, the patient was inadvertently administered a second dose of VAQTA (pediatric dose) (underdose) lot # N026997, the expiration date: 10-NOV-2018 (dose and route were not reported). No adverse effects.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On 25-JUN-2018, the patient was inadvertently vaccinated with an expired dose of PROQUAD lot # M049122, expiration date 13-JUN-2018, for prophylaxis (strength, dose, frequency and route of administration were not provided). No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 10 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. The reporter considered the shingles to be unrelated to SHINGRIX. Additional details were provided as follows: This case was reported via click to chat. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The healthcare professional (HCP) reported that he had a patient who developed shingles after receiving SHINGRIX vaccine. The HCP stated it was most likely unrelated but wanted to see if increased episodes of shingles were observed during first two weeks post-intervention. Additional information was not obtained as the HCP ended the chat abruptly.
Age: 75.0
Sex: F
Vaccine: PNC13, TDAP, VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 75-year-old female patient who received SHINGRIX (batch number C523T, expiry date 4th July 2020) for prophylaxis. Concomitant products included ADACEL and PREVNAR. On 16th June 2018, the patient received the 1st dose of SHINGRIX (subcutaneous) .5 ml. In June 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema. On 16th June 2018, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site erythema and intramuscular formulation administered by other route were unknown. The reporter considered the injection site erythema to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on the left arm. The patient received ADACEL and PREVNAR on the right deltoid. The patient who was administered the SHINGRIX vaccine subcutaneously, which led to intramuscular formulation administered by other route. The reporter indicated that she called the consumer's physician and left a message regarding what happened. Unable to obtain additional information.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: International normalised ratio increased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of international normalized ratio increased in a 63-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included open heart surgery. Concomitant products included carvedilol, COUMADIN, PLAVIX, spironolactone and fluoxetine. In June 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 14th June 2018, less than a week after receiving SHINGRIX, the patient experienced international normalized ratio increased. On an unknown date, the outcome of the international normalized ratio increased was recovered/resolved. It was unknown if the reporter considered the international normalized ratio increased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the SHINGRIX vaccine about a week before the date of reporting. On Thursday, 14th June 2018, the patient went have her INR tested and it was over 8. It normally was 2.3. The patient's heart doctor was called and wanted her to go to the hospital however she stopped the COUMADIN, ate a lot of foods with Vitamin K and when she went the date of reporting to have her INR tested, her levels were normal. The patient had started back on the COUMADIN.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of facial swelling in a 76-year-old female patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2020) for prophylaxis. On 19th June 2018, the patient received the 1st dose of SHINGRIX. On 20th June 2018, 1 days after receiving SHINGRIX, the patient experienced facial swelling. On an unknown date, the outcome of the facial swelling was unknown. It was unknown if the reporter considered the facial swelling to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. On the day of reporting, the patient woke up with facial and cheek swelling on the opposite side of the injection site. No further information was reported regarding the event.