chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Nausea, Pain
Clinical narrative: severe fatigue in bed x 2 days, body aches, headache, nausea. Persistent but improving tiredness x 5 days
Age: 43.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Bursitis
Clinical narrative: Bursitis; steroid injection and NSAID provided at nearby urgent care facility. Symptoms somewhat improved as of today, 12/4/19.
Age: 43.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Asthenia, Bursal fluid accumulation, Bursitis, Inflammation, Injected limb mobility decreased
Clinical narrative: Bursitis; steroid injection and NSAID provided at nearby urgent care facility. Symptoms somewhat improved as of today, 12/4/19.
Age: 43.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Injection site discomfort, Pain, Product administered at inappropriate site, Ultrasound scan abnormal
Clinical narrative: Bursitis; steroid injection and NSAID provided at nearby urgent care facility. Symptoms somewhat improved as of today, 12/4/19.
Age: 15.0
Sex: M
Vaccine: FLU4, HEPA, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Immediate post-injection reaction, Pallor
Clinical narrative: THE STUDENT BECAME PALE AND LIGHTHEADED IMMEDIATELY AFTER ADMINISTRATION OF MCV4, TDAP AND VARICELLA. STUDENT AND PARENT VERBALIZED THAT HE WAS VERY NERVOUS PRIOR TO VACCINE ADMINISTRATION. PLACED STUDENT IN SUPINE POSITION AND RESTED FOR 10 MINUTES. BP IN SUPINE 112/71, HR 86. SITTING 126/85, HR 89. STUDENT STATED HE WAS FEELING BETTER AND AGREED TO THE HEP A AND FLU VACCINE. PARENT DECLINE THE HPV AT THIS TIME. STUDENT RESTED FOR 20 MINUTES MORE WITHOUT INCIDENT.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Echocardiogram normal, Electrocardiogram normal, Electroencephalogram normal, Emotional distress, Full blood count normal
Clinical narrative: Unresponsiveness for approx 20 min, rescue breathing by the mother (she is a nurse), unconsolable/irritable for 2-3 hs
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Irritability, Magnetic resonance imaging brain normal, Metabolic function test normal, Resuscitation, Unresponsive to stimuli
Clinical narrative: Unresponsiveness for approx 20 min, rescue breathing by the mother (she is a nurse), unconsolable/irritable for 2-3 hs
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: White blood cell count normal
Clinical narrative: Unresponsiveness for approx 20 min, rescue breathing by the mother (she is a nurse), unconsolable/irritable for 2-3 hs
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: FEVER (101.4), ARM SWELLING..BENADRYL DID NOT HELP..PT WILL WAIT IF IT GETS WORST HE WILL CONTACT DR
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Bursa injury, Imaging procedure abnormal, Immediate post-injection reaction, Injection site pain, Myalgia
Clinical narrative: Patient received vaccination and felt immediate pain, initially brushing it off as the typical sore muscle pain. She returned after 4 weeks still complaining of pain, RPh at the time told patient the pain was unlikely due to vaccination and that she may have something else going on. Patient visited doctor's office and eventually saw an Orthopedic doctor. Ortho doctor performed imagining and concluded patient had SIRVA due to improper vaccine injection technique (patient most likely received vaccination too high in her arm and it pierced the bursa) leading to indefinite upper arm/shoulder pain.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered at inappropriate site, Shoulder injury related to vaccine administration
Clinical narrative: Patient received vaccination and felt immediate pain, initially brushing it off as the typical sore muscle pain. She returned after 4 weeks still complaining of pain, RPh at the time told patient the pain was unlikely due to vaccination and that she may have something else going on. Patient visited doctor's office and eventually saw an Orthopedic doctor. Ortho doctor performed imagining and concluded patient had SIRVA due to improper vaccine injection technique (patient most likely received vaccination too high in her arm and it pierced the bursa) leading to indefinite upper arm/shoulder pain.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Nodule, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Patient stated that her arm is swollen up like a baseball bat with several knots.  It is so painful she cannot lay on it and it is throbbing.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: I got my second series of the Varicella shot and a day after I noticed a red spot right where I had got my shot and It was itching and burning. Over the course of time my red spot was getting bigger and burnt more and was hot to the touch. I had went to the ER to report a reaction and was told to report it and the nurse I had called told me to be seen within three hours so I went straight to the ER and the doctor said it was Cellulitis and the cause was for bacteria getting in while giving the shot. I do not remember my arm being cleaned with alcohol , I do not remember if the cap was on the shot or not but it was all very quick.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Flushing, Hyperhidrosis, Nausea
Clinical narrative: 15min post injection patient got into his car and started experiencing flushing and severe nausea. he started to sweat and felt as if he was going to vomit. He returned to the pharmacy immediately. pharmacist gave patient some water and he started to feel better immediately. he did not report SOB or any swelling. no injection site reaction was observed. patient remained at the pharmacy for additional 30minutes and left at 2:30pm. Pharmacist followed up with the patient at 5pm and pt reported that he is feeling fine and no further issues. This patient has not had a vaccine since teenage years and this was his first flu shot that he can recall. However, he did say he does not remember having any reactions to vaccines.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Eye discharge, Eye swelling, Pharyngeal swelling
Clinical narrative: PT STATES HER THROAT WAS SWOLLEN WHEN SHE GOT HOME ALSO HER EYES BECAME SWOLLEN THE NEXT MORNING WITH DISCHARGE
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: Patient reported developing fever and headache the morning following vaccination with her 2nd dose of Shingrix.   The patient took a dose of naproxen at around noon that day and her symptoms had improved by that evening.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Severe RIGHT deltoid pain, on-going since 2 days after injection. Pain was progressive since onset but has since stabilized as of 12/1/2019. Pain awakens me from sleep and causes decreased range of motion. Pain is worst when I have been at rest (after work in the evening, at night, early morning) and is improved throughout the day with activity. Pain reasonably well-managed with TID 1000 mg acetaminophen, OTC lidocaine 4% patch at night, and heat PRN. If I do not take these measures, I awaken at night with severe pain and am unable to move my RIGHT arm without the assistance of my LEFT arm.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Impaired work ability, Injection site pain, Neuralgia, Pain in extremity
Clinical narrative: Worsening Left arm pain starting around day 3 after injection.  There was pain at the time of injection that was slightly worse than a usual flu vaccine.  The pain is a constant ache 8/10 at rest, only 2/10 when active.  It has a neuropathic characteristic in that there is no soreness or tenderness at the site anymore; it does not hurt more when I press on the site; it hurts constantly without provocation; ice does not make it better; heat makes it much worse.  It is very difficult to sit at a desk and do work; the pain intensifies the longer I sit.  It is much less intense when I am active and moving the arm.   It is not getting any better with time, in fact, it seems to be getting worse.  I am now almost 6 weeks after the injection.  I do not plan to get the second, booster vaccine since this seems worse than having the shingles.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: The patient reported a sore arm and redness around the injection site.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Nasopharyngitis, Nausea
Clinical narrative: Nausea, extreme headache, chills, fever, fatique (24 Hours) followed by cold symptoms (chest/head) (on going)
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Nausea, extreme headache, chills, fever, fatique (24 Hours) followed by cold symptoms (chest/head) (on going)
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chest pain, Dyspnoea, Headache, Myalgia
Clinical narrative: Severe Muscle Joint pain, fever, headache, difficulty breathing, chest pain.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Severe Muscle Joint pain, fever, headache, difficulty breathing, chest pain.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Mobility decreased, Pain in extremity, Swelling, X-ray limb
Clinical narrative: The patient reported that her arm felt fine after her shot until around bedtime last evening, when it got so sore and painful that she could not lift it at all; she said she could only move her hand a little.  She took an Aleve and went to bed.  When she got up this morning it was still very painful and she could not lift it.  She took another Aleve but it did not help.  I asked if it was red or swollen and she stated she could not even take her arm out of her blouse to look.  I contacted her primary care physician, who advised that she go to the walk-in clinic.  The patient did so, and I talked to her after.  She said the doctor told her there was a little swelling but no redness, and an X-ray of her shoulder showed nothing that would have been caused by the shot.  The doctor concluded it was a bad reaction to the shot.  She was given 2 Tylenol and advised to use cold compresses to help with the discomfort.  If she has any other issues she is to follow up with her primary care physician.
Age: 31.0
Sex: F
Vaccine: UNK
Symptoms: Dysarthria, Dysstasia, Fatigue, Loss of consciousness, Myalgia
Clinical narrative: Received TDaP and Flu vaccine (not sure which-it was preservative free if that helps). About 5 minutes after, experienced presyncope-vision blacking out, slurring words, not able to stand.   About 10 hours post-vaccine, started getting a fever and muscle aches. Lasted for two days. Fatigue is continuing.
Age: 31.0
Sex: F
Vaccine: UNK
Symptoms: Presyncope, Pyrexia
Clinical narrative: Received TDaP and Flu vaccine (not sure which-it was preservative free if that helps). About 5 minutes after, experienced presyncope-vision blacking out, slurring words, not able to stand.   About 10 hours post-vaccine, started getting a fever and muscle aches. Lasted for two days. Fatigue is continuing.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain upper, Antinuclear antibody positive, Anxiety, Arthralgia, Blood test
Clinical narrative: Was to start 6th grade 8/24/2016 received vaccine 8/16/2016. She was happy healthy athletic in gymnastics able to eat anything she wanted. after started gastrointestinal issues (chronic stomachaches, diarrhea, nausea) she has joint pain, rashes, hormonal issues, food allergies and sensitivities, anxiety, POTS syndrome, lots of dizziness and shortness of breath.  Saw many doctors with no answers before making the connection.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Diarrhoea, Dizziness, Dyspnoea, Electrocardiogram, Food allergy
Clinical narrative: Was to start 6th grade 8/24/2016 received vaccine 8/16/2016. She was happy healthy athletic in gymnastics able to eat anything she wanted. after started gastrointestinal issues (chronic stomachaches, diarrhea, nausea) she has joint pain, rashes, hormonal issues, food allergies and sensitivities, anxiety, POTS syndrome, lots of dizziness and shortness of breath.  Saw many doctors with no answers before making the connection.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Gastrointestinal disorder, Hormone level abnormal, Magnetic resonance imaging, Nausea, Postural orthostatic tachycardia syndrome
Clinical narrative: Was to start 6th grade 8/24/2016 received vaccine 8/16/2016. She was happy healthy athletic in gymnastics able to eat anything she wanted. after started gastrointestinal issues (chronic stomachaches, diarrhea, nausea) she has joint pain, rashes, hormonal issues, food allergies and sensitivities, anxiety, POTS syndrome, lots of dizziness and shortness of breath.  Saw many doctors with no answers before making the connection.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Rash
Clinical narrative: Was to start 6th grade 8/24/2016 received vaccine 8/16/2016. She was happy healthy athletic in gymnastics able to eat anything she wanted. after started gastrointestinal issues (chronic stomachaches, diarrhea, nausea) she has joint pain, rashes, hormonal issues, food allergies and sensitivities, anxiety, POTS syndrome, lots of dizziness and shortness of breath.  Saw many doctors with no answers before making the connection.
Age: 65.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Cerebrovascular accident, Guillain-Barre syndrome, Intensive care, Lumbar puncture abnormal, Monoplegia
Clinical narrative: Per patients wife, 8 days post vaccination the patient presented with stroke like symptoms e.g., lower extremity paralysis. After a spinal tap done in the hospital, a diagnosis of Guillain Barre Syndrome was confirmed. The patient spent 5 days in ICU, and the past month in physical therapy. The patient is now using gabapentin, and is using a walker/wheel chair.
Age: 65.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Walking aid user, Wheelchair user
Clinical narrative: Per patients wife, 8 days post vaccination the patient presented with stroke like symptoms e.g., lower extremity paralysis. After a spinal tap done in the hospital, a diagnosis of Guillain Barre Syndrome was confirmed. The patient spent 5 days in ICU, and the past month in physical therapy. The patient is now using gabapentin, and is using a walker/wheel chair.
Age: 60.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: 3 days after vaccination, patient had itching , soreness and swelling at injection site. She was treated with Zyrtec and saw doctor and was prescribed cephalexin for cellulitis.  Patient musch better now, jus a little sore.
Age: 75.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Hypersensitivity, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Doctor's office reported the patient presented with red swelling adjacent to probable injection site. Area was hot to the touch and hard, treated as an allergic reaction and patient was dosed with 60mg of kenalog IM. Patient will continue to follow up with MD.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Developed severe myalgias that has lasted for months
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Patient was treated for cellulitis.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient with mild swelling and redness to LEFT upper arm. Patient advised to start Benadryl for 25 mg for site reaction.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, HIBV, MMRV, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Patient was vaccinated in (R) with Heberix and Proquad at 12:20pm on 12/3/2019. Proquad was administered First, Followed by Heberix immediately after, (R) Deltoid started to turn red and swell, leaving a white blister.
Age: 76.0
Sex: M
Vaccine: FLUA3
Symptoms: Erythema, Pruritus
Clinical narrative: Patient states He had redness and itching on is lower legs and forearms. He had his regular appointment with his doctor and told his doctor about his symptoms. The doctor gave him some hydrocortisone valerate 0.2% to apply to the affected areas.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Asthenia
Clinical narrative: Pt. experienced joint pain about 1 mos following the HPV vaccine. Her joint pain was a #7 on a 1-10 scale affecting her hands, fingers, toes, ankles, and legs. Pt. also C/O weakness.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chiropractic, Injection site pain, Paraesthesia, Skin burning sensation, Spinal X-ray normal
Clinical narrative: Horrific burning upper Left shoulder/back area. Electrical shock sensations. Went to Clinic received steroid pk. Then primary 1 wk later. Another steroid Pk Dr. then Chiropractor making sure not spine related, pinch nerve. No.. Continuing Chiro. Recently sent me to Orth. Now on Neurotin. Anticonvalsent
Age: 11.0
Sex: F
Vaccine: FLU4, MENB, MNQ, TDAP
Symptoms: Wrong product administered
Clinical narrative: MA administered Men B vaccine instead of Menactra. I did explain to MA that patient still indeed needed the menactra vaccine before she leaves our office. Patient received 4 vaccines on Dec. 2, 2019.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness
Clinical narrative: Loss of consciousness; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (agency# 745500), referring to a 12 years old male patient. The patient had upper respiratory tract infection from 26-MAR-2018. Information about medical history, concomitant therapies and drug allergies was not provided. On 20-APR-2018, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # N017542, expiration date: 21-NOV-2019, dose 2, intramuscular in the left arm) for prophylaxis. On the same day, the patient became unconscious shortly after administration of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The patient was sitting on exam table and was lowered down onto the table by the medical assistant. The outcome of loss of consciousness was reported as recovered. The causality assessment was not provided.  Follow-up information was received from the registered nurse via FDA on 29-OCT-2019 (primary reporter was updated). The patient was allergic to milk. The patient was vaccinated with first dose of meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) (lot #: U5917AA, intramuscular (IM) on left arm (LA)) on an unknown date. There was no concomitant therapies or chronic or long-standing health conditions provided. The vaccine administration information was updated. It was reported that, it was the first dose in series (reported as the second previously). The date of vaccination of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was updated as 20-APR-2018 at 16:30. The onset date of the event was updated as 20-APR-2018 at 16:30.  Follow-up information was received from a nurse on 02-DEC-2019. A phone call was received from the nurse in response to the correspondence letter. The nurse questioned the reason for letter and the information from where it had come. VAERS and adverse event process were reviewed. The nurse was unable to locate the patient with out more identifying information.
Age: 76.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Blindness unilateral, Computerised tomogram, Magnetic resonance imaging
Clinical narrative: Patient developed vision loss on the left eye so was sent to ED, had the MRI of brain as well as CTA of the nech/head without any abnormality, has seen neuro ophthalmology who diagnosed him with optic neuritis related to vaccine and has received steroid injections with minimal improvement of the vision.
Age: 76.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Angiogram, Blindness unilateral, Laboratory test, Magnetic resonance imaging brain normal, Optic neuritis
Clinical narrative: Patient developed vision loss on the left eye so was sent to ED, had the MRI of brain as well as CTA of the nech/head without any abnormality, has seen neuro ophthalmology who diagnosed him with optic neuritis related to vaccine and has received steroid injections with minimal improvement of the vision.
Age: 90.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Mobility decreased, Pain
Clinical narrative: Patient said her arm wouldn't raise and was very sore. She couldn't remember her doctor's name. She told me she had seen the doctor since her immunization, but told another pharmacist she hadn't seen her doctor. We recommended she visit her doctor to discuss the arm pain.
Age: 90.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient said her arm wouldn't raise and was very sore. She couldn't remember her doctor's name. She told me she had seen the doctor since her immunization, but told another pharmacist she hadn't seen her doctor. We recommended she visit her doctor to discuss the arm pain.
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnancy discovered post vaccination; This prospective pregnancy report was received from a nurse and referred to a 26 years old female patient. The patient's concomitant therapies, pertinent medical history and drug reactions/allergies was unknown by the reporter.  On 15-OCT-2019, the patient seen in office to receive varicella virus vaccine live (oka/merck)(VARIVAX) (lot number S005079, expiration date 19-FEB-2021; dose number, frequency, anatomical location were unknown) subcutaneously for prophylaxis and sterile diluent ((lot number reported as R01954, expiration date 04-NOV-2020). The patient received the required vaccination for nursing school. The patient had chest x-ray at unspecified time near vaccination without result.  On 23-OCT-2019, the patient returned to office and pregnancy test was performed with positive result. On 04-NOV-2019, the patient was seen by an unspecified gynecologist and was determined to be 5 weeks gestation (exposure during pregnancy). The last menstrual period (LMP) was 30-OCT-2019 and estimated date of delivery (EDD) was 05-AUG-2020. On the same date, the patient had ultrasound without result. The patient was doing fine.  lot # R01954 was evaluated and changed to the valid Lot # R019504.
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Chest X-ray, Exposure during pregnancy, Pregnancy test positive, Ultrasound antenatal screen
Clinical narrative: Pregnancy discovered post vaccination; This prospective pregnancy report was received from a nurse and referred to a 26 years old female patient. The patient's concomitant therapies, pertinent medical history and drug reactions/allergies was unknown by the reporter.  On 15-OCT-2019, the patient seen in office to receive varicella virus vaccine live (oka/merck)(VARIVAX) (lot number S005079, expiration date 19-FEB-2021; dose number, frequency, anatomical location were unknown) subcutaneously for prophylaxis and sterile diluent ((lot number reported as R01954, expiration date 04-NOV-2020). The patient received the required vaccination for nursing school. The patient had chest x-ray at unspecified time near vaccination without result.  On 23-OCT-2019, the patient returned to office and pregnancy test was performed with positive result. On 04-NOV-2019, the patient was seen by an unspecified gynecologist and was determined to be 5 weeks gestation (exposure during pregnancy). The last menstrual period (LMP) was 30-OCT-2019 and estimated date of delivery (EDD) was 05-AUG-2020. On the same date, the patient had ultrasound without result. The patient was doing fine.  lot # R01954 was evaluated and changed to the valid Lot # R019504.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Loss of personal independence in daily activities, Mobility decreased, Pain, Pyrexia
Clinical narrative: pain at injection site; shivering; shaking; fever; rash; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 4th November 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, shivering, tremor, fever and rash. On an unknown date, the outcome of the injection site pain, shivering, tremor, fever and rash were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, shivering, tremor, fever and rash to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient who herself was a Nurse. The patient received Shingrix in the left deltoid. and had injection site pain, shivering, tremor, fever, rash and activities of daily living impaired. The patient reported that she was also a nurse.   The patient was not happy because she had to miss a few days of work because of the side effects from the Shingrix. The patient planned to follow up with her physician on an unknown date. The reporter consented to follow up. This is 1 of the 2 cases reported by the same reporter.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Tremor
Clinical narrative: pain at injection site; shivering; shaking; fever; rash; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 4th November 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, shivering, tremor, fever and rash. On an unknown date, the outcome of the injection site pain, shivering, tremor, fever and rash were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, shivering, tremor, fever and rash to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient who herself was a Nurse. The patient received Shingrix in the left deltoid. and had injection site pain, shivering, tremor, fever, rash and activities of daily living impaired. The patient reported that she was also a nurse.   The patient was not happy because she had to miss a few days of work because of the side effects from the Shingrix. The patient planned to follow up with her physician on an unknown date. The reporter consented to follow up. This is 1 of the 2 cases reported by the same reporter.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Injection site pain, Loss of personal independence in daily activities, Pyrexia, Rash
Clinical narrative: pain at injection site; shivering; shaking; fever; rash; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 4th November 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, shivering, tremor, fever and rash. On an unknown date, the outcome of the injection site pain, shivering, tremor, fever and rash were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, shivering, tremor, fever and rash to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient who herself was a Nurse. The patient received Shingrix in the left deltoid. and had injection site pain, shivering, tremor, fever, rash and activities of daily living impaired. The patient reported that she was also a nurse.   The patient was not happy because she had to miss a few days of work because of the side effects from the Shingrix. The patient planned to follow up with her physician on an unknown date. The reporter consented to follow up. This is 1 of the 2 cases reported by the same reporter.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Tremor
Clinical narrative: pain at injection site; shivering; shaking; fever; rash; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 4th November 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, shivering, tremor, fever and rash. On an unknown date, the outcome of the injection site pain, shivering, tremor, fever and rash were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, shivering, tremor, fever and rash to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient who herself was a Nurse. The patient received Shingrix in the left deltoid. and had injection site pain, shivering, tremor, fever, rash and activities of daily living impaired. The patient reported that she was also a nurse.   The patient was not happy because she had to miss a few days of work because of the side effects from the Shingrix. The patient planned to follow up with her physician on an unknown date. The reporter consented to follow up. This is 1 of the 2 cases reported by the same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Blood test, Musculoskeletal pain, Polymyalgia rheumatica, X-ray
Clinical narrative: Soreness in hip joint / Soreness in shoulder joints; This case was reported by a physician and described the occurrence of pain in hip in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th August 2019, the patient received the 1st dose of Shingrix. In September 2019, couple of weeks after receiving Shingrix, the patient experienced pain in hip. On an unknown date, the outcome of the pain in hip was not recovered/not resolved.   It was unknown if the reporter considered the pain in hip to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had soreness in my hip joint. A few weeks later also got soreness in my shoulder joints. The pain had since increased. The reporter concerned about getting the 2nd shingle shot. The reporter asked how much coverage did get from just having the 1st shot
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia
Clinical narrative: Soreness in hip joint / Soreness in shoulder joints; This case was reported by a physician and described the occurrence of pain in hip in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th August 2019, the patient received the 1st dose of Shingrix. In September 2019, couple of weeks after receiving Shingrix, the patient experienced pain in hip. On an unknown date, the outcome of the pain in hip was not recovered/not resolved.   It was unknown if the reporter considered the pain in hip to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had soreness in my hip joint. A few weeks later also got soreness in my shoulder joints. The pain had since increased. The reporter concerned about getting the 2nd shingle shot. The reporter asked how much coverage did get from just having the 1st shot
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Computerised tomogram, Electrocardiogram, Erythema, Fatigue, Full blood count
Clinical narrative: glared off; arm was red in the deltoid area from the shoulder down to the elbo; painful to the touch; headache; extreme fatigue; She felt like she was coming down with something all day; Arm sore; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 14th November 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On 15th November 2019, the patient experienced tenderness, headache, fatigue and feeling abnormal. On 16th November 2019, the patient experienced erythema of extremities. On 18th November 2019, the patient experienced irritability. On 19th November 2019, the outcome of the fatigue was recovered/resolved. On an unknown date, the outcome of the pain in arm, tenderness, feeling abnormal and erythema of extremities were unknown and the outcome of the headache and irritability were recovered/resolved.   It was unknown if the reporter considered the pain in arm, tenderness, fatigue, feeling abnormal and irritability to be related to Shingrix. The reporter considered the headache and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On 14th November 2019 at 5:30pm, the patient had the dose of Shingrix and her arm started to get sore that evening. One day after receiving vaccination,  the patient's arm was painful to the touch and she had a headache and fatigue. She felt like she was coming down with something all day. Two days after receiving vaccination on  Saturday evening, she noticed her arm was red in the deltoid area from the shoulder down to the elbow. On Monday 4 days after receiving vaccination, she felt as if she had periods where she lost time or glared off.  On the advice of her doctor, she went to the emergency room on Tuesday morning and had blood work and CT scans performed but all were normal
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Injection site pain, Malaise, Urine analysis
Clinical narrative: glared off; arm was red in the deltoid area from the shoulder down to the elbo; painful to the touch; headache; extreme fatigue; She felt like she was coming down with something all day; Arm sore; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 14th November 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On 15th November 2019, the patient experienced tenderness, headache, fatigue and feeling abnormal. On 16th November 2019, the patient experienced erythema of extremities. On 18th November 2019, the patient experienced irritability. On 19th November 2019, the outcome of the fatigue was recovered/resolved. On an unknown date, the outcome of the pain in arm, tenderness, feeling abnormal and erythema of extremities were unknown and the outcome of the headache and irritability were recovered/resolved.   It was unknown if the reporter considered the pain in arm, tenderness, fatigue, feeling abnormal and irritability to be related to Shingrix. The reporter considered the headache and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On 14th November 2019 at 5:30pm, the patient had the dose of Shingrix and her arm started to get sore that evening. One day after receiving vaccination,  the patient's arm was painful to the touch and she had a headache and fatigue. She felt like she was coming down with something all day. Two days after receiving vaccination on  Saturday evening, she noticed her arm was red in the deltoid area from the shoulder down to the elbow. On Monday 4 days after receiving vaccination, she felt as if she had periods where she lost time or glared off.  On the advice of her doctor, she went to the emergency room on Tuesday morning and had blood work and CT scans performed but all were normal
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test normal, Computerised tomogram normal, Erythema, Fatigue, Feeling abnormal
Clinical narrative: glared off; arm was red in the deltoid area from the shoulder down to the elbo; painful to the touch; headache; extreme fatigue; She felt like she was coming down with something all day; Arm sore; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 14th November 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On 15th November 2019, the patient experienced tenderness, headache, fatigue and feeling abnormal. On 16th November 2019, the patient experienced erythema of extremities. On 18th November 2019, the patient experienced irritability. On 19th November 2019, the outcome of the fatigue was recovered/resolved. On an unknown date, the outcome of the pain in arm, tenderness, feeling abnormal and erythema of extremities were unknown and the outcome of the headache and irritability were recovered/resolved.   It was unknown if the reporter considered the pain in arm, tenderness, fatigue, feeling abnormal and irritability to be related to Shingrix. The reporter considered the headache and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On 14th November 2019 at 5:30pm, the patient had the dose of Shingrix and her arm started to get sore that evening. One day after receiving vaccination,  the patient's arm was painful to the touch and she had a headache and fatigue. She felt like she was coming down with something all day. Two days after receiving vaccination on  Saturday evening, she noticed her arm was red in the deltoid area from the shoulder down to the elbow. On Monday 4 days after receiving vaccination, she felt as if she had periods where she lost time or glared off.  On the advice of her doctor, she went to the emergency room on Tuesday morning and had blood work and CT scans performed but all were normal
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Irritability, Pain in extremity, Tenderness
Clinical narrative: glared off; arm was red in the deltoid area from the shoulder down to the elbo; painful to the touch; headache; extreme fatigue; She felt like she was coming down with something all day; Arm sore; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 14th November 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On 15th November 2019, the patient experienced tenderness, headache, fatigue and feeling abnormal. On 16th November 2019, the patient experienced erythema of extremities. On 18th November 2019, the patient experienced irritability. On 19th November 2019, the outcome of the fatigue was recovered/resolved. On an unknown date, the outcome of the pain in arm, tenderness, feeling abnormal and erythema of extremities were unknown and the outcome of the headache and irritability were recovered/resolved.   It was unknown if the reporter considered the pain in arm, tenderness, fatigue, feeling abnormal and irritability to be related to Shingrix. The reporter considered the headache and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On 14th November 2019 at 5:30pm, the patient had the dose of Shingrix and her arm started to get sore that evening. One day after receiving vaccination,  the patient's arm was painful to the touch and she had a headache and fatigue. She felt like she was coming down with something all day. Two days after receiving vaccination on  Saturday evening, she noticed her arm was red in the deltoid area from the shoulder down to the elbow. On Monday 4 days after receiving vaccination, she felt as if she had periods where she lost time or glared off.  On the advice of her doctor, she went to the emergency room on Tuesday morning and had blood work and CT scans performed but all were normal
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Axillary pain, Pain
Clinical narrative: soreness; pain; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number N99P3, expiry date 19th October 2021) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on a nunknown date).   On 21st October 2019, the patient received the 2nd dose of Shingrix. On 22nd October 2019, 1 days after receiving Shingrix, the patient experienced injection site pain and radiating pain. On 26th October 2019, the outcome of the injection site pain and radiating pain were recovered/resolved.   It was unknown if the reporter considered the injection site pain and radiating pain to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient had a little soreness in her arm at the injection site, but she also had fairly severe pain radiating through her armpit.  This is 1 of the 2 linked case reported for same patient.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Axillary pain, Injection site pain, Pain in extremity
Clinical narrative: soreness; pain; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number N99P3, expiry date 19th October 2021) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on a nunknown date).   On 21st October 2019, the patient received the 2nd dose of Shingrix. On 22nd October 2019, 1 days after receiving Shingrix, the patient experienced injection site pain and radiating pain. On 26th October 2019, the outcome of the injection site pain and radiating pain were recovered/resolved.   It was unknown if the reporter considered the injection site pain and radiating pain to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient had a little soreness in her arm at the injection site, but she also had fairly severe pain radiating through her armpit.  This is 1 of the 2 linked case reported for same patient.
Age: 66.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Bursal fluid accumulation, Injection site pain, Insomnia, Magnetic resonance imaging abnormal, Muscular weakness
Clinical narrative: Shoulder pain at the site of inoculation. Suspicion is that subcutaneous injection may have entered the subacromial bursa. Previously, no problems with shoulder, but acute and persistent pain withing 24hrs. No trauma
Age: 66.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain, Product administered at inappropriate site, Rotator cuff syndrome
Clinical narrative: Shoulder pain at the site of inoculation. Suspicion is that subcutaneous injection may have entered the subacromial bursa. Previously, no problems with shoulder, but acute and persistent pain withing 24hrs. No trauma
Age: 66.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site pain, Magnetic resonance imaging, Product administered at inappropriate site
Clinical narrative: Shoulder pain at the site of inoculation. Suspicion is that subcutaneous injection may have entered the subacromial bursa. Previously, no problems with shoulder, but acute and persistent pain withing 24hrs. No trauma
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Diarrhoea, Myalgia, Nausea, Vomiting
Clinical narrative: Myalgias, chills, nausea, vomiting, diarrhea.  VS nml in clinic the following day, treated for symptoms
Age: 2.0
Sex: F
Vaccine: UNK
Symptoms: C-reactive protein normal, Injection site erythema, Injection site induration, Injection site oedema, Red blood cell sedimentation rate increased
Clinical narrative: Given influenza vaccine at PCP 's office (specific information on vaccine administered is not available to me). Administered in left upper arm. Developed erythema and edema of left upper arm on day after vaccine administration -- approximately 1/3 of upper arm area inovlved . Associated with smaller area of induration. Treated in ED with Benadryl and admitted to the hospital for observation. No systemic symptoms; no fever, no hives or other diffuse/generalized rash, no vomiting, no wheezing/cough/difficulty breathing. No facial swelling.  Already improving on admission to the inpatient service approximately 2 hours after administration of Benadryl (1mg/kg/dose IV x1).
Age: 2.0
Sex: F
Vaccine: UNK
Symptoms: Ultrasound scan normal, White blood cell count normal
Clinical narrative: Given influenza vaccine at PCP 's office (specific information on vaccine administered is not available to me). Administered in left upper arm. Developed erythema and edema of left upper arm on day after vaccine administration -- approximately 1/3 of upper arm area inovlved . Associated with smaller area of induration. Treated in ED with Benadryl and admitted to the hospital for observation. No systemic symptoms; no fever, no hives or other diffuse/generalized rash, no vomiting, no wheezing/cough/difficulty breathing. No facial swelling.  Already improving on admission to the inpatient service approximately 2 hours after administration of Benadryl (1mg/kg/dose IV x1).
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Headache, Myalgia, Neck pain
Clinical narrative: Very aches muscles and joints in entire body, headache, sore neck
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site reaction, Muscular weakness
Clinical narrative: Patient received influenza vaccine on 7 October. Was seen in clinic on 17 October for generalized pain and weakness to the left shoulder that began 11 October. Following visit patient was encouraged to take over the counter pain medications as needed and utilize ice intermittently. Patient continued to have weakness and pain to the left shoulder with minimal to no relief with current pain regimen. Was seen again in clinic 05 December. NSAID (naproxen) and physical therapy ordered.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported.; a patient was administered a dose of improperly stored ROTATEQ; Information has been received from a medical assistant, referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not provided.  On 05-NOV-2019, the patient was vaccinated with a dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # S000961, expiration date 19-OCT-2019, dose and strength were unknown) orally for prophylaxis, which was exposed to a temperature excursion at above 47 degrees Fahrenheit (46.9 degrees Fahrenheit) for 37 minutes prior to administration. There was no previous temperature excursion. The digital data logger was involved. Upon this report, no adverse effect was reported.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effects reported.; one patient received MMR II and VARIVAX via intramuscular route; This spontaneous report was received from a nurse referring to a patient of unknown age and gender.  Concomitant therapies included sterile diluent. Information about pertinent medical history, drug reactions or allergies was not provided.          On 11-NOV-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S021926, expiration date 15-JUL-2021; dosage detail and strength were ot provided) intramuscularly in the left thigh and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (recombinant Human albumin (rHA)) (lot # S013539, expiration date 02-MAY-2021; dosage detail and strength were not provided) intramuscularly in the right thigh for prophylaxis (Inappropriate route of vaccination). No adverse effects were reported.