chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: FLUA3
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Patient came to pharmacy 2 weeks after vaccination and complained of a sore arm/shoulder. He stated he had normal injection site reaction after receiving the vaccination but the pain continued.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Feeling abnormal, Hyperhidrosis, Insomnia, Pain
Clinical narrative: Flu shot administered at  Approx 8:30 started feeling body aches, very tired. Went to bed, but unable to sleep: body aches, feeling bad. Took aleve, then ibuprofen. Threw up around 3am, sweating and body aches. Fever was 101.7. Took more ibuprofen. Fever went down to 100, then 99.5. Continued taking ibuprofen. Went to urgent care 10/9, fever and vitals all normal, negative rapid Covid test. Low fever all day 10/9, tired and body aches all day 10/9. Finally broke for good during night of 10/9. Woke up drenched, no fever.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, SARS-CoV-2 test negative, Vomiting
Clinical narrative: Flu shot administered at  Approx 8:30 started feeling body aches, very tired. Went to bed, but unable to sleep: body aches, feeling bad. Took aleve, then ibuprofen. Threw up around 3am, sweating and body aches. Fever was 101.7. Took more ibuprofen. Fever went down to 100, then 99.5. Continued taking ibuprofen. Went to urgent care 10/9, fever and vitals all normal, negative rapid Covid test. Low fever all day 10/9, tired and body aches all day 10/9. Finally broke for good during night of 10/9. Woke up drenched, no fever.
Age: 33.0
Sex: F
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 33 year old female was administered second dose of MMR II 1 day prior to the recommended scheduled time; This spontaneous report as received from an unspecified reporter refers to a 33 year old female patient, who was a student. The patient's concurrent conditions, medical history and concomitant medications were not reported.      On 23-SEP-2020, the patient was vaccinated with second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # S013683, expiry date 05-MAY-2021, therapy type rHA, (dose and route of administration unspecified). The dose was administered 1 day prior to the recommended scheduled time according to the vaccine label.
Sex: U
Vaccine: FLUX
Symptoms: Extra dose administered, Headache, Illness, Nausea
Clinical narrative: nurse said it was a double dose; Sick; nauseous; headache; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a 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 1st October 2020, less than 2 months after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced sickness, nausea and headache. On an unknown date, the patient experienced overdose. On an unknown date, the outcome of the sickness, nausea and headache were recovered/resolved and the outcome of the overdose was unknown.   It was unknown if the reporter considered the sickness, nausea and headache 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 got the vaccine few days ago and was sick, nauseous and had headache one day before day of reporting. The patient was fine on the day of reporting. The patient stated that the nurse said that it was a double dose because of the particular strain of the virus this time which led to overdose.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Rash
Clinical narrative: Rash; First dose of Shingrix on 07-May-2018; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 7th May 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, the patient experienced rash and incomplete course of vaccination. On an unknown date, the outcome of the rash and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and developed rash. The reporter asked could receive second dose and how to continue with the schedule as was going to be late for second dose, which led to incomplete course of vaccination. The reporter consented to follow up. The reporter did not had further vaccine details. No further information provided.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Flushing, Hot flush, Hyperhidrosis, Injection site pain, Pyrexia
Clinical narrative: hot flashes; fever; feeling flush; sweating; shoulder achiness; This case was reported by a physician via call center representative and described the occurrence of shoulder pain in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included psoriatic arthritis. Concomitant products included tofacitinib citrate (Xeljanz).   On 23rd September 2020, the patient received Shingrix (intramuscular). On 23rd September 2020, less than a day after receiving Shingrix, the patient experienced shoulder pain. On 29th September 2020, the patient experienced hot flashes, fever, flushing and sweating. On an unknown date, the outcome of the shoulder pain was recovered/resolved and the outcome of the hot flashes, fever, flushing and sweating were not recovered/not resolved.   It was unknown if the reporter considered the shoulder pain, hot flashes, fever, flushing and sweating to be related to Shingrix.  Additional details were provided as follows: The physician called for his wife. The Patient currently taking Xeljanz for the treatment of psoriatic arthritis. The patient received Shingrix in the left deltoid and developed shoulder achiness that resolved on its own later that same day.  6 days after the Shingrix vaccine the patient developed fever, hot flashes, sweating, and feeling of flush which occurs every day in the afternoon and spontaneously resolves by the end of each day.  The events are reported as ongoing The reporter consented to follow up.
Age: 1.08
Sex: F
Vaccine: FLU4, MMR, PNC13
Symptoms: Device connection issue, No adverse event, Syringe issue, Underdose
Clinical narrative: syringe was not attached well to the needle and when the nurse she went to inject the patient did not get a full dose, no AE; syringe was not attached well to the needle and when the nurse she went to inject the patient did not get a full dose, no AE; Initial information received on 02-Oct-2020 regarding an unsolicited valid non-serious case from a physician.  This case involves a 1 years old female patient who received 0.25 mL to 2 mL of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot U704DA  and expiration date: 30-Jun-2021, unknown route, administration site) for prophylactic vaccination. While administering, the syringe was not attached well to the needle and when the nurse she went to inject the patient did not get a full dose and when the shot was being administered the needle came off and the medicine went everywhere on 02-Oct-2020 (PT: underdose, syringe issue).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN) ; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  It was an actual medication error case due to vaccine underdose and syringe issue (same day latency).  No adverse event reported at the time of reporting.  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: 25.0
Sex: F
Vaccine: FLUR4
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Hot, firm red rash on arm discovered 6 inches below injection site. Rash is moving down and across left arm. Rash improves with antihistamines but is continuing to grow.
Age: 88.0
Sex: M
Vaccine: FLUA4
Symptoms: Urticaria
Clinical narrative: pt reported body wide hives
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: throbbing pain from head to toe, gradual onset, continued to wane until 6a this morning.
Age: 63.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: Mild malaise,  fever (99.8), moderate chilling.
Age: 63.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Chills, Injection site pain, Malaise, Pyrexia
Clinical narrative: Mild malaise,  fever (99.8), moderate chilling.
Age: 63.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: Mild malaise,  fever (99.8), moderate chilling, mild injection site tenderness.
Age: 63.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Chills, Injection site pain, Malaise, Pyrexia
Clinical narrative: Mild malaise,  fever (99.8), moderate chilling, mild injection site tenderness.
Age: 14.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given an extra HPV9 vaccine in error after miscommunication between staff (pt had already completed a 2-dose series). Parent was notified by phone after realization of error. The patient has not reported any adverse symptoms or effects to date since the vaccine was given
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Hypoaesthesia, Throat tightness, Tonsillar hypertrophy
Clinical narrative: Shortly after receiving the vaccination, she indicated that he left side of her neck felt number and upon assessment by another provider, her left tonsil reportedly appeared swollen. She was experiencing tightness in her throat. A provider on site ordered 62.5 mg Solumedrol IM one time which was administered. All symptoms resolved with the exception of a slight residual headache.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site reaction, Joint range of motion decreased, Musculoskeletal stiffness, Poor quality sleep
Clinical narrative: Four (4) hours after injection experience pain and stiffness in upper left arm from shoulder to elbow with limited range of motion.  Took ibuprofen and rubbed in Deep Blue before bed.  Did not sleep well.  Symptoms started to improve about 9:00 a.m. 10/8/2020.  Called pharmacy to report and they have called back twice since then.  48 hours after injection only a very slight pain when are was extended at full range of motion.  No symptoms 72 hours after.  (Have never had any reactions to high dose influenza before this year.)
Age: 6.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Peripheral swelling
Clinical narrative: patient had arm swelling and redness starting the day of vaccination through the next day.   **vaccine was administered at school, I am unsure of brand name/manufacturer information, it was an influenza vaccine**
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Malaise
Clinical narrative: More likely malaise from flu shot as temp only 98.2.
Age: 26.0
Sex: M
Vaccine: FLU4
Symptoms: Flushing, Headache
Clinical narrative: flushing right after injection ( about 10 minutes later), severe HA
Age: 22.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: headaches fever muscle pain
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Computerised tomogram normal, Gait inability, Magnetic resonance imaging normal, Muscle spasms, Sensory loss
Clinical narrative: 9/15 could not feel legs.   Unable to walk.   Remittent back spasms.  Went to ER and was admitted for two days.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Wheelchair user
Clinical narrative: 9/15 could not feel legs.   Unable to walk.   Remittent back spasms.  Went to ER and was admitted for two days.
Age: 49.0
Sex: M
Vaccine: FLUR4
Symptoms: Abdominal pain upper, Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Localized arm reaction at injection site: redness, swelling, warm to touch, "rash" appearance.  Patient is going to monitor reaction and apply cold compress to the area. Complaint of stomach pain that started Sunday evening.  No change in diet but did note that he had Celiac disease but has avoided gluten.
Age: 49.0
Sex: M
Vaccine: FLUR4
Symptoms: Local reaction
Clinical narrative: Localized arm reaction at injection site: redness, swelling, warm to touch, "rash" appearance.  Patient is going to monitor reaction and apply cold compress to the area. Complaint of stomach pain that started Sunday evening.  No change in diet but did note that he had Celiac disease but has avoided gluten.
Age: 59.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Pain of skin, Pruritus
Clinical narrative: patient received both immunizations 10/7 on 10/9 she started with a spot or 2 on her back that would hurt when itched. by 10/11-10/12 it has spread around under her breast line to stomach area with same pain when itched. she called to inform us about this reaction and said it seemed to be getting better today. she would call if it got worse or if she has to seek treatment.
Age: 89.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Blister, Burning sensation, Erythema, Rash erythematous, Rash macular
Clinical narrative: RED BLOCHY RASH APPEARED THAT WERE BURNING AND ICHYON  STOMACH, CHEST,  ARM PITS,  BACK BOTH UPPER LEGS, NECK, UNDER CHIN KEEP SPREADING TO ALL ARE BODY LOWER LEG RED BLISTERS
Age: 89.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Rash pruritic
Clinical narrative: RED BLOCHY RASH APPEARED THAT WERE BURNING AND ICHYON  STOMACH, CHEST,  ARM PITS,  BACK BOTH UPPER LEGS, NECK, UNDER CHIN KEEP SPREADING TO ALL ARE BODY LOWER LEG RED BLISTERS
Age: 89.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Rash
Clinical narrative: RED BLOCHY RASH APPEARED THAT WERE BURNING AND ICHYON  STOMACH, CHEST,  ARM PITS,  BACK BOTH UPPER LEGS, NECK, UNDER CHIN KEEP SPREADING TO ALL ARE BODY LOWER LEG RED BLISTERS
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling cold, Injection site pain, Muscle twitching, Neck pain, Pain in extremity
Clinical narrative: Feet started feeling cold and tingling the evening of the injection. Tingling moved up to calves, then thighs. Small amounts of muscle twitching in legs. On Sept. 26, I went to the doctor who did numbness and muscle tests and he said to come back when it was worse.  Arm with injection site became more sore. Developed pain in neck, left shoulder and arm. On Oct. 2 I went to the doctor who did numbness and muscle tests. He said to come back when it is worse. Over two weeks later my arm still feels very sore and I still have tingling in my legs.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia
Clinical narrative: Feet started feeling cold and tingling the evening of the injection. Tingling moved up to calves, then thighs. Small amounts of muscle twitching in legs. On Sept. 26, I went to the doctor who did numbness and muscle tests and he said to come back when it was worse.  Arm with injection site became more sore. Developed pain in neck, left shoulder and arm. On Oct. 2 I went to the doctor who did numbness and muscle tests. He said to come back when it is worse. Over two weeks later my arm still feels very sore and I still have tingling in my legs.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal distension, Abdominal pain, Blood test abnormal, Blood urine present, Fatigue
Clinical narrative: Several hours after, rectal irritation and cramping. Abdomen cramping and pain with bloating. Continued for 4 days with only relief being a heating pad or warm bath.  As days went by the pain seemed to be in the center lower region of the abdomen and painful.  Other symptoms of malaise, sore arm at site, fatigue.  No fever, loss of appetite, diarrhea vomiting .  Contacted Dr. and was examined. Urinalysis saw some blood but it was retaken and normal.  Blood seemed normal with a slight elevation in something but didn't seem to be a concern.,  Retook blood test and then it was normal but another slight elevation in something else.  Ret taking the blood work in 2 weeks.  I am fine now.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Malaise, Muscle spasms, Skin irritation
Clinical narrative: Several hours after, rectal irritation and cramping. Abdomen cramping and pain with bloating. Continued for 4 days with only relief being a heating pad or warm bath.  As days went by the pain seemed to be in the center lower region of the abdomen and painful.  Other symptoms of malaise, sore arm at site, fatigue.  No fever, loss of appetite, diarrhea vomiting .  Contacted Dr. and was examined. Urinalysis saw some blood but it was retaken and normal.  Blood seemed normal with a slight elevation in something but didn't seem to be a concern.,  Retook blood test and then it was normal but another slight elevation in something else.  Ret taking the blood work in 2 weeks.  I am fine now.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Oropharyngeal discomfort, Pain, Pruritus, Swelling
Clinical narrative: Soreness in left triceps. Some swelling. Body aches, feeling of impending cold in throat.  After 1 day: Itching in left calf After 2 days: Itching in left armpit.
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site rash, Injection site urticaria
Clinical narrative: Hives and rash on the arm where the shot was given. The patient reported the hives started about 12 hours after vaccination. The rash has not completely cleared as of 10/12/2020
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Muscle contractions involuntary, Pain in extremity, Paraesthesia oral, Swollen tongue
Clinical narrative: 2 minutes after administration of vaccine, patient reported feeling dizzy, having blurred vision, and right arm pain. Respirations were WNL and patient was placed in reclined position. After an additional 5 minutes (15:12), patient requested to stand up and sit in waiting area. Patient began to feel faint as she walked to the waiting area and needed to be lowered to the ground.  At 15:20, mother gave approval for patient to receive 0.3 ml of epinephrine IM after patient reported severe pain in right, swelling and tingling in tongue and was observed to have muscle contraction in all extremities. 911 was called and arrived at 15:25. Patient taken to nearby hospital for further assessment.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Vision blurred
Clinical narrative: 2 minutes after administration of vaccine, patient reported feeling dizzy, having blurred vision, and right arm pain. Respirations were WNL and patient was placed in reclined position. After an additional 5 minutes (15:12), patient requested to stand up and sit in waiting area. Patient began to feel faint as she walked to the waiting area and needed to be lowered to the ground.  At 15:20, mother gave approval for patient to receive 0.3 ml of epinephrine IM after patient reported severe pain in right, swelling and tingling in tongue and was observed to have muscle contraction in all extremities. 911 was called and arrived at 15:25. Patient taken to nearby hospital for further assessment.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: PAIN IN LEFT SHOULDER LIMITATION OF MOBILITY OF LEFT ARM
Age: 3.0
Sex: F
Vaccine: HEP, PNC13
Symptoms: Induration, Injection site erythema, Injection site swelling, Nodule
Clinical narrative: Swelling and erythema on right lateral thigh at the site of Prevnar immunization noted the following day (uncertain what time). Size 6 cm. Underlying firm nodule. Able to walk without difficulty. Not painful unless palpated.  Mom called the office to report the swelling on Monday and child got the vaccine on Friday. Of note, child got 2 vaccines one week prior, due to preschool requirement. Mom insisted on getting these done a week later due to preschool requirement - as the preschool would not allow child to attend without these vaccines and would not accept a "vaccine in progress" note.
Age: 26.0
Sex: F
Vaccine: DTAP
Symptoms: Dyspnoea, Pain in extremity, Throat tightness
Clinical narrative: Patient reports receiving Tdap at local ER and presented to this clinic 7 days later with reports of arm pain.  She reports shortness of breath and "throat closing" on 10/10/2020, no medical evaluation.  Reports remaining symptoms of arm pain.  Seen in clinic today with no objective skin or deltoid abnormalities.  No objective systematic abnormalities.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Abnormal faeces, Faeces discoloured, Haematochezia, Irritability
Clinical narrative: Symptoms commenced the day following the oral administration of the Rotavirus vaccine. Symptoms included fussiness, green frothy stools, currant jelly stools, suspected mild intussusception
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: temperature excursion for MMR II and VARN AX reporting that those to had been administered; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 28-SEP-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot number T010380, expiration date: 24-MAR-2022 (lot number T010380 is an invalid lot number for varicella virus vaccine live (oka/merck)), lot number: S015460, expiration date: 20-MAY-2021 (dose and route of administration were not reported) or measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot number: S029455, expiration date: 19-SEP-2021, therapy type: rHA; lot number: S001338, expiration date: 14-JAN-2021, therapy type: rha (dose and route of administration were not reported) for prophylaxis. The reporter did not provide which vaccine the patient received.  It was reported that the vaccines were not stored properly for the time frame of 15 minutes in the temperature between 15 degrees Fahrenheit (F) and 46 degrees Fahrenheit (23.9 F). There was no previous temperature excursion for both vaccines. Digital Data Logger was involved.  The outcome of medication error was unknown.
Sex: U
Vaccine: PNC13, PPV
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Received PREVNAR 13 in 2016 and then received PREVNAR 13 in September 2020, instead of intended vaccine receiving PNEUMOVAX 23; This spontaneous information has been received from a pharmacist, concerning a 74-years-old patient of unknown age. The patient's pertinent medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were not provided.  On an unknown date in 2016, the patient received one dose of pneumococcal 13v conj vaccine (crm197)(PREVNAR 13) as prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not provided) and then on an unknown date in September 2020, received another dose of pneumococcal 13v conj vaccine (crm197)(PREVNAR 13) instead of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (wrong vaccine administered).
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: The patient was administered improperly stored VARIVAX; This spontaneous report was received from a medical assistant referring to a 4-year-old patient, gender not reported. The patient's medical history and concurrent conditions were not reported.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (lot # S025608 has been verified to be a valid lot number varicella virus vaccine live (oka/merck), expiration date reported and establish as 18-AUG-2021) (strength, dose, route of administration and anatomical location were not provided), a sterile diluent properly stored, was used to reconstituted the vaccine (lot # S037030 has been verified to be a valid lot number sterile diluent, expiration date not reported, but establish as 18-AUG-2021).   The temperature of storage and time frame of the excursion were -12.50° Celsius (C) for 1 minute and -14° C for 1 minute.  A digital data logger was involved, and but there was no previous temperature excursion.
Age: 8.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no additional adverse event; a boy receiving GARDASIL 9 at 8 years old and 2 month; The patient was supposed to receive the flu vaccine; The patient was supposed to receive the flu vaccine; This spontaneous report as received from medical assistant refers to a 8 year old male patient. His concurrent conditions, pertinent medical history, drug allergies and concomitant therapies were not reported.   On 06-OCT-2020, the patient (also reported as 8 years old and 2 months boy) was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (route of administration was not provided) (lot number S02673 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)) 0.5 milliliter, once for prophylaxis.The patient was supposed to receive the influenza virus vaccine (unspecified) (reported as flu vaccine) instead. The medical assistant did not want to provide any further patient information until she spoke with "GMI". No additional adverse event (AE) reported.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Deafness unilateral, Tinnitus
Clinical narrative: complete hearing loss in left ear / partial hearing returned in left ear; strange noise heard inside the ear; This case was reported by a consumer and described the occurrence of deafness unilateral in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd October 2020, the patient received Shingrix 50 mcg/mg. On 4th October 2020 07:00, 1 days after receiving Shingrix, the patient experienced deafness unilateral (serious criteria GSK medically significant) and ringing in ears. On an unknown date, the outcome of the deafness unilateral and ringing in ears were recovering/resolving.   The reporter considered the deafness unilateral and ringing in ears to be probably related to Shingrix.  Additional details were reported as follows: The case was reported by patient herself. The patient received the vaccination Shingrix 50mcg in upper left arm. On 4th October 2020, the patient woke up at 7 am with complete hearing loss in left ear with strange noise heard inside the ear. The patient called the pharmacist and he/she told that that it was not a side effect and patient should seek medical attention. On 5th October 2020, patient woke up with partial hearing returned in left ear, as the day progressed the hearing in the left ear gradually returned and at 2 pm there was just a little noise in the ear when around sounds such as TV volume. No medical treatment received by patient. For patient it seemed a little odd that shot was received in left arm and she lost hearing in left ear so she made an assumption that there was probably a connection between shot and hearing loss. The patient was on the way to complete resolving of this issue. The patient was concerned whether this would happen again with the booster.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Fatigue, Gait disturbance, Hypoaesthesia, Injected limb mobility decreased
Clinical narrative: Arm soreness; couldn´t lift his arm much; got very tired; slept for 24 hours; leg was partially numb; balance was bad; hard to walk; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included ophthalmic herpes zoster.   On 26th August 2020, the patient received the 1st dose of Shingrix. In August 2020, 2 days after receiving Shingrix, the patient experienced pain in arm, injected limb mobility decreased, fatigue, somnolence, numbness, balance disorder and walking difficulty. On an unknown date, the outcome of the pain in arm, injected limb mobility decreased, fatigue, somnolence, numbness, balance disorder and walking difficulty were recovered/resolved.   It was unknown if the reporter considered the pain in arm, injected limb mobility decreased, fatigue, somnolence, numbness, balance disorder and walking difficulty to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. Patient reported that he received the 1st dose of shingrix on 26th August,2020 and on the second day patient experienced arm soreness, more than normal  on the The third day the patient couldn´t lift his arm much and got very tired in the evening, went to sleep and slept for 24 hours until his wife woke him up and His left leg was partially numb, and balance was bad. On day four patient was still numb and was hard to walk. It was reported that On day 4 and 6 the events gradually resolved and patient is no longer experiencing symptoms. The reporter consented to follow up.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Somnolence
Clinical narrative: Arm soreness; couldn´t lift his arm much; got very tired; slept for 24 hours; leg was partially numb; balance was bad; hard to walk; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included ophthalmic herpes zoster.   On 26th August 2020, the patient received the 1st dose of Shingrix. In August 2020, 2 days after receiving Shingrix, the patient experienced pain in arm, injected limb mobility decreased, fatigue, somnolence, numbness, balance disorder and walking difficulty. On an unknown date, the outcome of the pain in arm, injected limb mobility decreased, fatigue, somnolence, numbness, balance disorder and walking difficulty were recovered/resolved.   It was unknown if the reporter considered the pain in arm, injected limb mobility decreased, fatigue, somnolence, numbness, balance disorder and walking difficulty to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. Patient reported that he received the 1st dose of shingrix on 26th August,2020 and on the second day patient experienced arm soreness, more than normal  on the The third day the patient couldn´t lift his arm much and got very tired in the evening, went to sleep and slept for 24 hours until his wife woke him up and His left leg was partially numb, and balance was bad. On day four patient was still numb and was hard to walk. It was reported that On day 4 and 6 the events gradually resolved and patient is no longer experiencing symptoms. The reporter consented to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Inappropriate schedule of product administration, Injected limb mobility decreased, Injection site pain
Clinical narrative: received the 1st dose of the vaccine back in October 2019 / received the 2nd vaccine this morning at 9am at; Excruciating pain; Shoulder pain; Excruciating pain spreading to the neck; Weakness; not being able to lift her left arm; Using muscle pain creams; This case was reported by a consumer via call center representative and described the occurrence of pain in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 30th october,2019 refer case id US2020AMR197051).   On 30th September 2020, the patient received the 2nd dose of Shingrix. On 30th September 2020, 2 hrs 30 min after receiving Shingrix, the patient experienced pain, shoulder pain, neck pain, weakness, injected limb mobility decreased and myalgia. On an unknown date, the patient experienced drug dose administration interval too long. The patient was treated with hydrocodone bitartrate + paracetamol (Vicodin) and  (Muscle Pain Cream). On an unknown date, the outcome of the pain, neck pain and weakness were not recovered/not resolved and the outcome of the shoulder pain, injected limb mobility decreased, myalgia and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the pain, shoulder pain, neck pain, weakness, injected limb mobility decreased and myalgia to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. It was reported that patient received the 2nd dose of shingrix vaccine at 9 am on 30th september,2020 and at 11:30 am she experienced excruciating pain that seems to be spreading to the shoulders and neck. She also reported not being able to lift her left arm and also stated she took half of a Vicodin and was using muscle pain creams and a cold compress for the pain. Patient stated that the pain from the 2nd dose was worse than the pain from when she "cut half of her finger off. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR197051:same reporter
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Neck pain, Pain
Clinical narrative: received the 1st dose of the vaccine back in October 2019 / received the 2nd vaccine this morning at 9am at; Excruciating pain; Shoulder pain; Excruciating pain spreading to the neck; Weakness; not being able to lift her left arm; Using muscle pain creams; This case was reported by a consumer via call center representative and described the occurrence of pain in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 30th october,2019 refer case id US2020AMR197051).   On 30th September 2020, the patient received the 2nd dose of Shingrix. On 30th September 2020, 2 hrs 30 min after receiving Shingrix, the patient experienced pain, shoulder pain, neck pain, weakness, injected limb mobility decreased and myalgia. On an unknown date, the patient experienced drug dose administration interval too long. The patient was treated with hydrocodone bitartrate + paracetamol (Vicodin) and  (Muscle Pain Cream). On an unknown date, the outcome of the pain, neck pain and weakness were not recovered/not resolved and the outcome of the shoulder pain, injected limb mobility decreased, myalgia and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the pain, shoulder pain, neck pain, weakness, injected limb mobility decreased and myalgia to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. It was reported that patient received the 2nd dose of shingrix vaccine at 9 am on 30th september,2020 and at 11:30 am she experienced excruciating pain that seems to be spreading to the shoulders and neck. She also reported not being able to lift her left arm and also stated she took half of a Vicodin and was using muscle pain creams and a cold compress for the pain. Patient stated that the pain from the 2nd dose was worse than the pain from when she "cut half of her finger off. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR197051:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: felt ill; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The reporter reported that his friend mentioned that 4 to 5 of his friends felt ill for a couple of days after receiving the Shingrix vaccine. The reporter had very limited information to provide about the event. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020200802:same reporter
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Feeling abnormal, Hyperhidrosis, Myalgia
Clinical narrative: chills; fever of 100.3; muscle aches; sweating; dizziness; feeling weird; This case was reported by a consumer via call center representative and described the occurrence of weird feeling in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th October 2020, the patient received the 1st dose of Shingrix. On 6th October 2020, less than a day after receiving Shingrix, the patient experienced weird feeling and dizziness. On 7th October 2020, the patient experienced chills, fever, muscle pain and sweating. On an unknown date, the outcome of the weird feeling and muscle pain were recovering/resolving and the outcome of the chills, fever, sweating and dizziness were recovered/resolved.   It was unknown if the reporter considered the weird feeling, chills, fever, muscle pain, sweating and dizziness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and feeling weird.   The patient run and felt some dizziness afterward.  The patient around 3:00 AM, the symptoms of chills, muscle aches, sweating and fever of 100.3 presented and feels better at the time of reporting. The reporter did not consent to follow up.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: chills; fever of 100.3; muscle aches; sweating; dizziness; feeling weird; This case was reported by a consumer via call center representative and described the occurrence of weird feeling in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th October 2020, the patient received the 1st dose of Shingrix. On 6th October 2020, less than a day after receiving Shingrix, the patient experienced weird feeling and dizziness. On 7th October 2020, the patient experienced chills, fever, muscle pain and sweating. On an unknown date, the outcome of the weird feeling and muscle pain were recovering/resolving and the outcome of the chills, fever, sweating and dizziness were recovered/resolved.   It was unknown if the reporter considered the weird feeling, chills, fever, muscle pain, sweating and dizziness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and feeling weird.   The patient run and felt some dizziness afterward.  The patient around 3:00 AM, the symptoms of chills, muscle aches, sweating and fever of 100.3 presented and feels better at the time of reporting. The reporter did not consent to follow up.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: painful arm; difficulty moving the arm that was used for immunization; This is a spontaneous report from a contactable consumer, the patient.  A 65-year-old male patient received the first dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration in the arm in 2017 (at the age of 65-years-old) as a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient previously received pneumococcal vaccine polysacch 23V (PNEUMOVAX 23) for immunization in 2010.  In 2017, after the vaccination, the patient experienced painful arm and difficulty moving the arm that was used for immunization. The clinical outcomes of painful arm and difficulty moving the arm that was used for immunization was unknown.     No follow-up attempts are possible; information about lot number cannot be obtained.
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Dizziness, Headache, Injected limb mobility decreased, Insomnia, Nasopharyngitis
Clinical narrative: Caller states that he had a hard time sleeping; right arm was painful at the vaccine site; Fever; Headache; Body aches; Dizziness; Cold symptoms; This is a spontaneous report from a contactable consumer. A 53-year-old male patient started to receive pneumococcal 13-val conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration from an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient stated he had what felt like cold symptoms and then in the late afternoon of 30Sep2020, he started to experience fever which got to around 104 but he's not sure of the accuracy, he had a headache, body aches and dizziness. It was reported that his wife is a nurse and she told him that this symptoms are common with vaccines so she advised him to take Tylenol. Caller states that the fever subsided, but then when the Tylenol wore off he had body aches again but the fever was much less compared to Wednesday afternoon. It was also reported that the patient had a hard time sleeping and he did not get up to take more Tylenol because he was unable to get out of bed due to the body aches. Caller reports that he took more Tylenol this morning and his body aches went away. It was also reported that the patient had a hard time lifting his right arm where the Prevnar vaccine was given and further stated that the right arm was painful at the vaccine site. The outcome of the event fever was recovering, recovered on an unspecified date for body aches while unknown for the other event.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Pain, Pyrexia, Vaccination site pain
Clinical narrative: Caller states that he had a hard time sleeping; right arm was painful at the vaccine site; Fever; Headache; Body aches; Dizziness; Cold symptoms; This is a spontaneous report from a contactable consumer. A 53-year-old male patient started to receive pneumococcal 13-val conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration from an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient stated he had what felt like cold symptoms and then in the late afternoon of 30Sep2020, he started to experience fever which got to around 104 but he's not sure of the accuracy, he had a headache, body aches and dizziness. It was reported that his wife is a nurse and she told him that this symptoms are common with vaccines so she advised him to take Tylenol. Caller states that the fever subsided, but then when the Tylenol wore off he had body aches again but the fever was much less compared to Wednesday afternoon. It was also reported that the patient had a hard time sleeping and he did not get up to take more Tylenol because he was unable to get out of bed due to the body aches. Caller reports that he took more Tylenol this morning and his body aches went away. It was also reported that the patient had a hard time lifting his right arm where the Prevnar vaccine was given and further stated that the right arm was painful at the vaccine site. The outcome of the event fever was recovering, recovered on an unspecified date for body aches while unknown for the other event.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Dizziness, Pain, Pyrexia
Clinical narrative: Caller states that he had a hard time sleeping; right arm was painful at the vaccine site; Fever; Headache; Body aches; Dizziness; Cold symptoms; This is a spontaneous report from a contactable consumer. A 53-year-old male patient started to receive pneumococcal 13-val conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration from an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient stated he had what felt like cold symptoms and then in the late afternoon of 30Sep2020, he started to experience fever which got to around 104 but he's not sure of the accuracy, he had a headache, body aches and dizziness. It was reported that his wife is a nurse and she told him that this symptoms are common with vaccines so she advised him to take Tylenol. Caller states that the fever subsided, but then when the Tylenol wore off he had body aches again but the fever was much less compared to Wednesday afternoon. It was also reported that the patient had a hard time sleeping and he did not get up to take more Tylenol because he was unable to get out of bed due to the body aches. Caller reports that he took more Tylenol this morning and his body aches went away. It was also reported that the patient had a hard time lifting his right arm where the Prevnar vaccine was given and further stated that the right arm was painful at the vaccine site. The outcome of the event fever was recovering, recovered on an unspecified date for body aches while unknown for the other event.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: PNC13, PNC13
Symptoms: Dizziness, Headache, Injected limb mobility decreased, Insomnia, Nasopharyngitis
Clinical narrative: fever; ache; dizziness; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot/batch number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization. Medical history and concomitant medications were not reported. The patient reported experiencing side effects (fever, ache, dizziness) after getting Prevnar vaccine. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: PNC13, PNC13
Symptoms: Pain, Pyrexia, Vaccination site pain
Clinical narrative: fever; ache; dizziness; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot/batch number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization. Medical history and concomitant medications were not reported. The patient reported experiencing side effects (fever, ache, dizziness) after getting Prevnar vaccine. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: PNC13, PNC13
Symptoms: Dizziness, Pain, Pyrexia
Clinical narrative: fever; ache; dizziness; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot/batch number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization. Medical history and concomitant medications were not reported. The patient reported experiencing side effects (fever, ache, dizziness) after getting Prevnar vaccine. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.