chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: FLUC4
Symptoms: Fall, Loss of consciousness, Syncope
Clinical narrative: Patient fainted and fell to the floor shortly after receiving flu shot. Patient had regained consciousness by the time I arrived. Patient was alert and responding to questions at that time. EMS arrived within about 5 to 10 minutes and transported her to the hospital.
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Needle issue
Clinical narrative: After pharmacist injected the flu shot, she noticed that the needle was shorter. She checked the needle and it was 5/8" in 1" box. She notified the patient and asked for her Doctor information so pharmacist can discuss if patient will need the 2nd dose of flu shot. Patient stated she will talk to Doctor herself. Also, pharmacist spoke to pharmacy manager who refilled the wrong needle size in 1in needle box. We will double check the size of needles before refilling as well as injecting to make sure the right size.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Eye swelling
Clinical narrative: Woke up with swollen eyes
Age: 60.0
Sex: F
Vaccine: FLUR4
Symptoms: Arthralgia
Clinical narrative: Noticed shoulder pain and joint pain after receiving Flublok in Left arm within a day
Age: 57.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient had swelling and redness approximately 3 to 4 inches in diameter surrounding the injection site.  Patient works in a doctor's office, and she was instructed to return to the pharmacy to see if follow-up care would be needed.  Patient came to pharmacy during the afternoon of October 6th, and was instructed to use a cold compress and take ibuprofen or acetaminophen for pain.  Patient was also instructed to seek medical care if the reaction continued for another 24 hours.  The patient opted to go to urgent care that evening.  Outcome of urgent care visit is unknown.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site rash
Clinical narrative: Rash at site of injection for 2 weeks
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Itching, ReD SPOT - HIiVES
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Fatigue
Clinical narrative: Late 10/6 11 pm - midnight developed fatigue that was severe & chills. Still present today 10/7/20 1130 am
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Lymph node pain, Lymphadenopathy, Swelling
Clinical narrative: Developed marble sized lump near Left side collar bone. Was seen in office 10/7/20. US of neck was ordered. Swollen painful lymph node the next day
Age: 88.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis (Left Deltoid) Area of reaction increased from 3 inches to 8 inches. Patient went to urgent care and was prescribed Keflex. Patient will follow-up with pediatrician.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Diarrhoea, Injection site pain, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, diarrhea & abd pain (severe) Diffuse erythema, pain at injection site (R) deltoid about 3/4 to elbow.
Age: 60.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Injected limb mobility decreased, Product administered at inappropriate site
Clinical narrative: Pt was administered a Shingrix shot. called Next day & said he could barely move his (R) arm. Taking ibuprofen & somewhat better today. States shot was too high on shoulder.
Age: 68.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Hello. Patient received both the high dose flu shot and a Shingrix vaccine in his left deltoid on 9-28-20. Patient called pharmacy 10-7-20 to say he has a red patch on left arm 3 inches long from mid bicep to tripcep that hurts in in the shower and if scratched. Patient said this has not impeded his daily living activities. He said it is getting better and he has been putting a moisturizing cream on it. He wanted to know if this reaction was normal. I told him it was not. I asked him if it seemed to be infected and he said he did not think so. He asked about getting the second Shingrix after having this reaction and I told him to ask you your opinion. I am providing you this information as it is part of pharmacys policy and procedure with reporting of adverse vaccine events. Thank you.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: red warm raised area to injection site
Age: 65.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: red warm raised area at injection site
Age: 63.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Blister, Breast pain, Erythema, Headache, Injection site pain
Clinical narrative: Patient states experienced soreness on arms where shingrix shot was administered on the day she received vaccination. Two days later, she developed swelling, blistering, itchiness, redness on arms, & redness spread to almost the armpit. Soreness and red rash on left breast seen. Patient experienced headache but no fever. Right eyelid & tongue are swollen. Pharmacist advised patient to promptly seek medical attention with physician when she called pharmacy to report symptoms. Patient went to see her primary physician the same day. Pharmacist followed up with patient and patient says her physician advised her to take benadryl & ice pack, as it appears to be a reaction from vaccine & follow up in a week
Age: 63.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Peripheral swelling, Pruritus, Rash erythematous, Swelling of eyelid, Swollen tongue
Clinical narrative: Patient states experienced soreness on arms where shingrix shot was administered on the day she received vaccination. Two days later, she developed swelling, blistering, itchiness, redness on arms, & redness spread to almost the armpit. Soreness and red rash on left breast seen. Patient experienced headache but no fever. Right eyelid & tongue are swollen. Pharmacist advised patient to promptly seek medical attention with physician when she called pharmacy to report symptoms. Patient went to see her primary physician the same day. Pharmacist followed up with patient and patient says her physician advised her to take benadryl & ice pack, as it appears to be a reaction from vaccine & follow up in a week
Age: 87.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red warm raised area at injection site
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: redness, induration to site onset 1 day after injection (approximately 30 hours from injection time) unclear if cellulitis started on Keflex.
Age: 19.0
Sex: F
Vaccine: FLUC4
Symptoms: Fall, Immediate post-injection reaction, Loss of consciousness, Muscle tightness, Unresponsive to stimuli
Clinical narrative: Patient had Influenza Vaccine administered, then second later stated she felt that she was going to pass out. Patients Body went tense and pt became unresponsive and was slowly allowed to fall to the floor (Rph had her By the arm) 40 seconds later pt Regained consciousness & Breathing was normal, Pt oriented, EMT arrived to assess. EMT assessed pt and determined pt passed out and was now fully responsive and did not need further treatment or to be taken to the hospital. Pt Reports she passes out / Faints each time she gets blood drawn & this type of event has occured many times previously, but not with a Flu shot.
Age: 29.0
Sex: F
Vaccine: FLUC4
Symptoms: Contusion, Haemorrhage, Immediate post-injection reaction, Pain
Clinical narrative: "excessive" bleeding, bruising size of golf ball. pain the day of and right after administration
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Fall, Gait disturbance, Loss of consciousness
Clinical narrative: Patient given vaccines. Upon leaving room patient stumbled forward hitting wall, then fell backwards hitting wall behind. Pt had passed out. This happened about 10 mins after shots. Pt assisted up once alert and taken back to a room to be assessed. Pt admitted to not eating or drinking all day.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen & warm upper arm from injection site down to elbow. No fever. Symptoms started the next day following injection & fully resolved after 4 days.
Age: 57.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Abdominal discomfort, Fatigue, Injection site erythema, Injection site swelling, Malaise
Clinical narrative: -Red swelling at inject site 10/5/20 spread to halfway down left arm -Somewhat "splotchy" down left arm on 10/7/20 - Fever of 101.6 10/5/20 evening. Down to 99.2 10/7/20. -Upset Stomach, fatigue -Overall felling of illness 10/5/20-10/7/20
Age: 57.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pyrexia, Rash macular
Clinical narrative: -Red swelling at inject site 10/5/20 spread to halfway down left arm -Somewhat "splotchy" down left arm on 10/7/20 - Fever of 101.6 10/5/20 evening. Down to 99.2 10/7/20. -Upset Stomach, fatigue -Overall felling of illness 10/5/20-10/7/20
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: red warm raised area at injection site
Age: 85.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: red warm raised area at injection site
Age: 90.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red warm raised area at injection site
Age: 79.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red warm raised area at injection site
Age: 81.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: red warm raised area to injection site
Age: 54.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: red warm raised area at injection site
Age: 73.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: red warm raised area at injection site
Age: 39.0
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral, Pruritus, Rash, Urticaria
Clinical narrative: Rash, UrticariaPruritus & EDEMA OF ARM
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Pt developed Shingles  5 days after Shingrix  at pharmacy
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Pt developed Shingles  5 days after Shingrix  at pharmacy
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Anxiety, Diarrhoea, Dizziness, Nausea
Clinical narrative: I received the vaccine around 8:00am at my workplace health clinic after my work shift. Around 8:20, I suddenly felt very nauseous, faint, dizzy, light-headed and dazed. A minute or two later I felt tingling over my entire face and tongue and anxiety. About 5-10 minutes after that, I had severe abdominal cramps and diarrhea. These symptoms worsened over the next 20 minutes.  After I arrived home, I took 50mg of Benadryl and went to bed. After 8 hours, I woke up and no longer had any of these sypmtoms.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: I received the vaccine around 8:00am at my workplace health clinic after my work shift. Around 8:20, I suddenly felt very nauseous, faint, dizzy, light-headed and dazed. A minute or two later I felt tingling over my entire face and tongue and anxiety. About 5-10 minutes after that, I had severe abdominal cramps and diarrhea. These symptoms worsened over the next 20 minutes.  After I arrived home, I took 50mg of Benadryl and went to bed. After 8 hours, I woke up and no longer had any of these sypmtoms.
Age: 64.0
Sex: F
Vaccine: FLUR4
Symptoms: Erythema, Pain, Skin warm, Swelling, Tenderness
Clinical narrative: Minutes after shot: swelling appeared about more than 3 inches below shot site on the left arm Morning after shot: swelling about the area of a softball, warm to touch, tender/painful when pressed down; redness appears mainly at the site of swelling; redness, but no swelling also noticed on the area below main swelling site and continues to a little pass elbow (the area tapers down as it reaches elbow area) Pt went to ER around 1140am, they think this is an adverse reaction (possible allergic?) to Flublok. Pt is refered to see primary care MD on Thurs (10/8/2020)
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Anxiety, Chest pain, Neuropathy peripheral, Vaccine positive rechallenge
Clinical narrative: On Saturday afternoon, I began to experience chest pain, and the nerves in my arms and legs felt like they were rubber bands pulled tight, and someone flicked them.  This is typical s/s of my anxiety attacks, my Klonopin was not addressing the s/s.  I contacted practicing Psychology doctor, who prescribes my meds for mental health.  Because I was unable to see him in person he said it seems like you are having a strong immune response.   I continued to have increased episodes of the s/s, but I have been able to return to work.  This same thing happened last year when I received my Influenza vaccine.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: improperly stored; Information has been received from an unknown age and gender consumer referring to himself/herself. The patient's concomitant therapy included sterile diluent. The patient's other concurrent condition and medical history were not reported.  On 28-SEP-2020, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live ( PROQUAD) (1 dose, lot# T013537, expiration date 17-OCT-2021; strength and route were not reported) for prophylaxis (Incorrect product storage). The vaccine was exposed to temperature excursion of 22.4 degrees Fahrenheit for 44 hours 10 minutes and the data logger was involved. There was no previous temperature excursion.
Age: 37.0
Sex: M
Vaccine: VARCEL
Symptoms: Wrong technique in product usage process
Clinical narrative: Pharmacist is reporting that a patient received VARIVAX Intramuscular route instead of subcutaneous route.; This spontaneous report was received from a pharmacist referring to a 37-year-old male patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 28-SEP-2020, the patient received an intramuscular dose instead of a subcutaneous one of varicella virus vaccine live (oka/merck)(VARIVAX), 1 dosage form, lot number T012551 and expiration date 10-APR-2022 for prophylaxis.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: administration of VARIVAX which was stored at -11.1 C for 4 hours and 30 minutes; This spontaneous report was received from a medical assistant (MA) and refers to a patient of an unknown age and gender. Information concerning the patient's past medical history, concurrent conditions, concomitant medications and historical drugs/allergies was not provided.   On 02-OCT-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 1 injection, lot # S003447, expiration date 04-FEB-2021 (dosage regimen and route of administration were not reported) as prophylaxis.  The improperly stored suspect vaccine experienced a temperature excursion of -14 Celsius degrees (C) to -10 C (average temperature was -11.1 C) for 4 hours and 53 minutes. No previous temperature excursion was reported.The call was due a digital data logger.  This is one of two cases recieved from the same reporter.; Sender's Comments:  US-009507513-2010USA001537:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: The nurse reported that a child was administered a Varivax vaccine that underwent a temperature excursion; This spontaneous report was received from a nurse referring to a child of unknown gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided    In October 2020, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, lot number T002846 and expiration date of 23-JAN-2022 for prophylaxis (route of administration not provided) that had underwent a temperature excursion.    The reported stated that some varicella virus vaccine live (oka/merck)(VARIVAX) were put in the refrigerator instead of the freezer.  Besides the previously mentioned lot number, there was another one involved in the temperature excursion, S035124 with expiration date 04-NOV-2021. The temperature excursion occurred from 01-OCT-2020 at 4:30 pm to 02-OCT-2020 at 9:30 am, with a total time frame of 17 hours over 5 Fahrenheit degrees (F), and a highest temperature of 44.6 F. The vaccine had not had any prior temperature excursion. A total of 10 units of each lot were affected. The call was due to a digital data logger.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a physician via sales rep and described the occurrence of shingles in a 70-year-old male patient who received Herpes zoster (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 unknown.   The reporter considered the shingles to be unrelated to Shingrix.  Additional details were provided as follows: The age vaccination was not reported. The patient was vaccinated with 1st dose of Shingrix and had shingles between 1st and 2nd dose. The physician understand that shingles was not associated with vaccine but to patient compliance with second dose.
Sex: F
Vaccine: FLUX
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 63-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Previously administered products included Influenza quadrivalent with an associated reaction of abdominal discomfort (received vaccine on unknown date for tolerance refer case US2020198044).   In December 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season. In December 2019, 1 week after receiving Influenza vaccine Quadrivalent 2019-2020 season, 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 Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient was vaccinated with Flu vaccine in last December 2019. After 1 week of vaccination patient developed Shingles. The reporter consent to follow up. No additional contact information for physician was provided. This case was linked with case US2020198044 by patient link.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020198047:same reporter US-GLAXOSMITHKLINE-US2020198044:same reporter
Sex: F
Vaccine: FLUX
Symptoms: Herpes zoster
Clinical narrative: Shingles on right shoulder and back after receiving "Flu Shot"; This case was reported by a consumer via call center representative and described the occurrence of shingles in a elderly female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2020-2021 season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent 2020-2021 season and an unknown time after starting Valacyclovir, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valacyclovir) and tramadol. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were reported as follows: The age at vaccination was not reported. The patient reported that she had a shingles on right shoulder and back after receiving Flu shot in left arm. The reporter did not know the name of the flu vaccine. The patient was prescribed Valacyclovir and Tramadol to treat shingles. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: dose 1 of Shingrix / large rash at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (diagnosed in 2003, and had outbreaks since then every 2-3 months).   In April 2019, the patient received the 1st dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was recovered/resolved.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was reported. The patient had a medical history of Shingles, diagnosis in 2003 and shingles outbreaks since then every 2-3 months. The patient was allergic to many different medications. The patient received 1st dose of Shingrix in April 2019, and 2 days after developed large rash  at the injection site and lasted for 4 days and resolved till the time of reporting. For further tolerance of 2nd dose of Shingrix, refer case ID US2020AMR195837. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR195837:same patient, same reporter, different dose
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: red / at the injection site; swollen / at the injection site; warm / at the injection site; itchy / at the injection site; painful /  at the injection site; Increased Neutrophils; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included cyclic neutropenia (being treated while vaccinated with Shingrix injection).   In September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site warmth, injection site itching, injection site pain and neutrophils increased. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site warmth, injection site itching, injection site pain and neutrophils increased were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site warmth, injection site itching, injection site pain and neutrophils increased to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received the Shingrix injection while being treated for Cyclic Neutropenia. The patient received 1 st dose of Shingrix 2 weeks ago on right arm. The patient reported that she developed a red, swollen, warm itchy painful area at the injection site which lasted for 3 to 4 days. The patient stated that injection site still got itchy and was slightly pink. The patient  was in the process of determining if she had cyclical Neutropenia and was required to had blood drawn 3 times a week for 6 weeks. The patient stated 1 week later, neutrophils increased. The patient wondered if Shingrix had an effect on her blood work. The reported did not consent to follow up. All information was not available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020193856:FU1 deleted
Sex: F
Vaccine: VARZOS
Symptoms: Neutrophil count increased
Clinical narrative: red / at the injection site; swollen / at the injection site; warm / at the injection site; itchy / at the injection site; painful /  at the injection site; Increased Neutrophils; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included cyclic neutropenia (being treated while vaccinated with Shingrix injection).   In September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site warmth, injection site itching, injection site pain and neutrophils increased. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site warmth, injection site itching, injection site pain and neutrophils increased were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site warmth, injection site itching, injection site pain and neutrophils increased to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received the Shingrix injection while being treated for Cyclic Neutropenia. The patient received 1 st dose of Shingrix 2 weeks ago on right arm. The patient reported that she developed a red, swollen, warm itchy painful area at the injection site which lasted for 3 to 4 days. The patient stated that injection site still got itchy and was slightly pink. The patient  was in the process of determining if she had cyclical Neutropenia and was required to had blood drawn 3 times a week for 6 weeks. The patient stated 1 week later, neutrophils increased. The patient wondered if Shingrix had an effect on her blood work. The reported did not consent to follow up. All information was not available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020193856:FU1 deleted
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain at injection site; swelling at injection site; redness injection site; Ringing in left ear; Shaking; Lethargy; Chills; Headache; Fever; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included paracetamol (Acetaminophen).   On 12th September 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 12th September 2020, 8 hrs after receiving Shingrix, the patient experienced injection site pain, injection site swelling, injection site erythema, ringing in ears, tremor, lethargy, chills, headache and fever. On 15th September 2020, the outcome of the tremor, lethargy, chills, headache and fever were recovered/resolved. On 22nd September 2020, the outcome of the injection site pain, injection site swelling and injection site erythema were recovered/resolved. On an unknown date, the outcome of the ringing in ears was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, ringing in ears, tremor, lethargy, chills, headache and fever to be related to Shingrix. The reporter considered the injection site swelling and injection site erythema to be related to Shingrix.  Additional details were as follows: After receiving 1st dose of Shingrix, the patient experienced injection site erythema, injection site pain, injection site swelling recovery taken more than a week., fever, headache, chills, lethargy, shaking lasted 2 to 3 days until recovery and ringing in the left ear . The reporter reported that, limited information available. The reporter reported that, patient refused to provide any other details. The reporter said she sounded a patient was less than than 50 years old but agent could not confirm as patient was an angry caller. The patient mentioned that after starting to experience symptoms, she started taking Tylenol. The reporter consented to follow up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Pyrexia, Tinnitus, Tremor
Clinical narrative: Pain at injection site; swelling at injection site; redness injection site; Ringing in left ear; Shaking; Lethargy; Chills; Headache; Fever; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included paracetamol (Acetaminophen).   On 12th September 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 12th September 2020, 8 hrs after receiving Shingrix, the patient experienced injection site pain, injection site swelling, injection site erythema, ringing in ears, tremor, lethargy, chills, headache and fever. On 15th September 2020, the outcome of the tremor, lethargy, chills, headache and fever were recovered/resolved. On 22nd September 2020, the outcome of the injection site pain, injection site swelling and injection site erythema were recovered/resolved. On an unknown date, the outcome of the ringing in ears was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, ringing in ears, tremor, lethargy, chills, headache and fever to be related to Shingrix. The reporter considered the injection site swelling and injection site erythema to be related to Shingrix.  Additional details were as follows: After receiving 1st dose of Shingrix, the patient experienced injection site erythema, injection site pain, injection site swelling recovery taken more than a week., fever, headache, chills, lethargy, shaking lasted 2 to 3 days until recovery and ringing in the left ear . The reporter reported that, limited information available. The reporter reported that, patient refused to provide any other details. The reporter said she sounded a patient was less than than 50 years old but agent could not confirm as patient was an angry caller. The patient mentioned that after starting to experience symptoms, she started taking Tylenol. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Cough, Headache, Influenza like illness, Injection site pain, Pain
Clinical narrative: mild shaking; sore left arm  at injection site; Severe headache; flu-like symptoms; mild aches and pains; cough; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VIRUS VACCINE INACTIVATED (AFLURIA QUAD) for prophylaxis.   Concurrent medical conditions included allergy (was unspecified).   On 28th September 2020, the patient received the 1st dose of Shingrix and the 1st dose of AFLURIA QUAD. On 28th September 2020, less than a day after receiving Shingrix and an unknown time after receiving AFLURIA QUAD, the patient experienced injection site pain, headache, flu-like symptoms, pain and cough. On an unknown date, the patient experienced tremor. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the injection site pain, headache, flu-like symptoms, pain, cough and tremor were unknown.   It was unknown if the reporter considered the injection site pain, headache, flu-like symptoms, pain, cough and tremor to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of Shingrix and flu vaccine Afluria Quad on the same day. The patient reported that she developed a severe headache, flu like symptoms, mild shaking, a sore left arm at injection site, cough, mild aches and pains. The patient stated that developed the symptoms within 10 hours of receiving the 1st dose of Shingrix. The patient  took Advil for the symptoms. No further information was available. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Tremor
Clinical narrative: mild shaking; sore left arm  at injection site; Severe headache; flu-like symptoms; mild aches and pains; cough; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VIRUS VACCINE INACTIVATED (AFLURIA QUAD) for prophylaxis.   Concurrent medical conditions included allergy (was unspecified).   On 28th September 2020, the patient received the 1st dose of Shingrix and the 1st dose of AFLURIA QUAD. On 28th September 2020, less than a day after receiving Shingrix and an unknown time after receiving AFLURIA QUAD, the patient experienced injection site pain, headache, flu-like symptoms, pain and cough. On an unknown date, the patient experienced tremor. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the injection site pain, headache, flu-like symptoms, pain, cough and tremor were unknown.   It was unknown if the reporter considered the injection site pain, headache, flu-like symptoms, pain, cough and tremor to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of Shingrix and flu vaccine Afluria Quad on the same day. The patient reported that she developed a severe headache, flu like symptoms, mild shaking, a sore left arm at injection site, cough, mild aches and pains. The patient stated that developed the symptoms within 10 hours of receiving the 1st dose of Shingrix. The patient  took Advil for the symptoms. No further information was available. The reporter consented to follow up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: hives on both her forearms, mid to lower back, general stomach area, and on the left area of her chest going into the left arm; This case was reported by a consumer via call center representative and described the occurrence of hives in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included hives (experiences hives when gets anesthesia).   On 29th September 2020, the patient received Shingrix (intramuscular). On 1st October 2020, 2 days after receiving Shingrix, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional details were provided as follows: The patient was vaccinated with Shingrix on right deltoid. On 1st Octomber 2020 patient experinced  hives on both her forearms, mid to lower back, general stomach area, and on the left area of her chest going into the left arm. Hive was part of patients past medical history, she usually experiences hives when she gets anesthesia. The reporter consent to follow up.
Age: 52.0
Sex: F
Vaccine: FLUR4
Symptoms: Feeling abnormal, Hypoaesthesia, Injection site reaction, Limb discomfort
Clinical narrative: Numbing sensation in left arm; weird feeling in the left arm, arm feeling heavy, the arm having a weighty feeling and the feeling might be moving down to the forearm, the feeling for a while was down to the  elbow; Initial information was received on 17-Sep-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient).  This case involves a 52 years old female patient who experienced numbing sensation in left arm (hypoaesthesia) and weird feeling in the left arm, arm feeling heavy, the arm having a weighty feeling and the feeling might be moving down to the forearm, the feeling for a while was down to the  elbow (limb discomfort), while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past vaccination(s) included INFLUENZA VACCIN with patient gets flu shot yearly with no issues.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) in right arm for immunisation.  On 12-Sep-2020, the patient received a 0.5 mL once dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2001 and expiry date 17-May-2021) via intramuscular route in the left arm for prophylactic vaccination.  On 12-Sep-2020, the patient developed a non-serious numbing sensation in left arm (hypoaesthesia) and weird feeling in the left arm, arm feeling heavy, the arm having a weighty feeling and the feeling might be moving down to the forearm, the feeling for a while was down to the  elbow (limb discomfort) on same day following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Case details: Reporter stated that after vaccination with Flublok she experienced the adverse events and stated that the left arm was where she had the Flublok that the feeling was not uncomfortable and that there were no physical signs that can be seen or felt on the arm and that the feeling has not changed in severity but has just extended down the arm more and the feeling began the day of the injection. She stated that she gets this flu shot yearly with no issues.   Details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment.  The patient was not recovered from the events.
Age: 63.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: No adverse event, Overdose, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a 63 years-old patient inadvertently received Fluzone High-Dose Quadrivalent instead of Fluzone Quadrivalent/ no AE; a 63 years-old patient inadvertently received Fluzone High-Dose Quadrivalent/ no AE; a 63 years-old patient inadvertently received Fluzone High-Dose Quadrivalent/ no AE; Initial information was received on 17-Sep-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 63 years-old male patient who was inadvertently vaccinated with 0.5 mL (once) dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (prefilled syringe; batch number UJ469AB and expiry date 30-Jun-2021) via intramuscular route in unknown administration site on 15-Sep-2020 for prophylactic vaccination instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (batch number and expiry date not applicable)(Wrong product administered), (Product administered to patient of inappropriate age) and (Overdose).  Medical history, medical treatments, past vaccinations and family history were not provided.  Patient did not receive any other concomitant vaccines.  This was a case of actual medication error due to inappropriate age at vaccine administration, wrong vaccine administered and it was also a case of overdose (latency was on same day).  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.5
Sex: F
Vaccine: DTAPIPV, HEP, PNC13, RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a 6 months old female patient received Quadracel instead of Pentacel/ NO AE; 6 months old female patient received Quadracel/ NO AE; Initial information received on 21-Sep-2020 regarding an unsolicited valid non-serious case from the other health care professional.  This case involves a 6-months-old female patient who received once 0.5 mL third dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (strength: standard, lot number: C5635AA, expiry date: 18-JUN-2021, via an intramuscular in the right thigh) instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (product administered to patient of inappropriate age and wrong product administered) on 10-Sep-2020 prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE, ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  It was an actual medication error case due to inappropriate age at vaccine administration and wrong vaccine administered (latency: same day).   At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Needle issue, No adverse event, Underdose
Clinical narrative: a patient received a partial dose of Fluzone High Dose Quadrivalent/ NO AE; a patient received partial dose of Fluzone High Dose Quadrivalent due to a needle malfunction/ NO AE; Initial information received on 22-Sep-2020 regarding an unsolicited valid non-serious case from the other health care professional.  This case involves a 65-years-old female patient who received a partial dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (single dose vial, frequency: yearly, lot number: UJ450AB, expiry date: 30-Jun-2021 via an intramuscular route in the left deltoid) due to a needle malfunction (underdose and needle issue) on 22-Sep-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment, concomitant medication and family history were not provided.  No other vaccinations were used.  It was a case of vaccine underdose and needle issue (latency: same day)  The patient experienced no adverse event.  Product technical complaint (PTC) assessment: Physical.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 84.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site bruising
Clinical narrative: bruising from shoulder down to the elbow and across the injection site on the inside of the arm, area is yellow now; Initial information received on 22-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 84-years-old male patient who experienced bruising from shoulder down to the elbow across the injection site on the inside of the arm (contusion), while he received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, past medical treatment and family history were not provided.   No other vaccination were used.  On 17-Sep-2020, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (strength: Fluzone High Dose, lot number: UJ484AB, expiry date: 30-Jun-2021) via an intramuscular route in the left arm for prophylactic vaccination.  On an unknown date, the patient developed a non-serious bruising from shoulder down to the elbow and across the injection site on the inside of the arm (contusion) unknown latency following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Event details: Two days later the area of bruising was yellow at the time of reporting.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The patient was recovering from bruising at the time of reporting (two days later and the area of bruising was yellow).
Age: 7.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 7 years female patient received FLUBLOK QUADRIVALENT vaccine/ NO AE; Initial information received on 22-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves 7-years-old female patient who received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (full prefilled syringe, lot number: 2FAA2016, expiry date: 30-Jun-2021, strength: standard, via an intramuscular route in the left deltoid) (product administered to patient of inappropriate age) on 22-Sep-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination and family history were not provided.  No concomitant medications were used.  It was an actual medication error case due to inappropriate age at vaccine administration (latency: same day).  At the time of reporting, no adverse event was reported.  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.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: a patient received only the DTaP-IPV portion of PENTACEL vaccine/ No AE; Initial information received on 22-Sep-2020 regarding an unsolicited valid non-serious case received from the nurse.  This case involves a 16 months old patient who received only the DTaP-IPV portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number: U6395AA, expiry date: 24-Apr-2021, dose: 0.5 mL) via intramuscular route in left vastus lateralis site on 03-Sep-2020 for prophylactic vaccination (product preparation issue).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE.  It was an actual medication error due to inappropriate reconstitution technique (latency: same day).  At the time of report, no adverse event was reported.  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.