chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site induration, Injection site swelling, Pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site induration in a 62-year-old female patient who received Shingrix for prophylaxis. On 28th August 2018, the patient received Shingrix. In August 2018, less than a week after receiving Shingrix, the patient experienced injection site induration, injection site swelling, headache and general body pain. On an unknown date, the outcome of the injection site induration, injection site swelling, headache and general body pain were unknown. It was unknown if the reporter considered the injection site induration, injection site swelling, headache and general body pain to be related to Shingrix. Additional details were provided as follows: A patient experienced an indurated area at the injection site after receiving Shingrix. Reporting physician was in a rush at time of call, so no more information was obtained. swelling and headache symptoms were shared by medical information (MI) colleague after physician was escalated to her.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash, Rash pruritic
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of shingles in a 73-year-old male patient who received SHINGRIX for prophylaxis. On 3rd May 2018, the patient received the 1st dose of SHINGRIX. On 9th July 2018, 67 days after receiving SHINGRIX, the patient experienced shingles, painful rash and itchy rash. On an unknown date, the patient experienced post herpetic neuralgia. On an unknown date, the outcome of the shingles, post herpetic neuralgia, painful rash and itchy rash were not recovered/not resolved. It was unknown if the reporter considered the shingles, post herpetic neuralgia, painful rash and itchy rash to be related to SHINGRIX. Additional details were provided as follows: The field-based GlaxoSmithKline sales representative, heard this case from a physician and nurse at a practice. The patient developed rash on midsection of body and was seen at an urgent care on 16th July 2018 and was diagnosed with shingles. On 29th August 2018, the patient was seen in the reporters office and still itching and pain with the rash and it was suspected that, the patient might have post herpetic neuralgia as well. Less than a year after receiving SHINGRIX, the patient experienced post herpetic neuralgia.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Hyperaesthesia, Pruritus, Rash
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of shingles in a 73-year-old male patient who received SHINGRIX for prophylaxis. On 3rd May 2018, the patient received the 1st dose of SHINGRIX. On 9th July 2018, 67 days after receiving SHINGRIX, the patient experienced shingles, painful rash and itchy rash. On an unknown date, the patient experienced post herpetic neuralgia. On an unknown date, the outcome of the shingles, post herpetic neuralgia, painful rash and itchy rash were not recovered/not resolved. It was unknown if the reporter considered the shingles, post herpetic neuralgia, painful rash and itchy rash to be related to SHINGRIX. Additional details were provided as follows: The field-based GlaxoSmithKline sales representative, heard this case from a physician and nurse at a practice. The patient developed rash on midsection of body and was seen at an urgent care on 16th July 2018 and was diagnosed with shingles. On 29th August 2018, the patient was seen in the reporters office and still itching and pain with the rash and it was suspected that, the patient might have post herpetic neuralgia as well. Less than a year after receiving SHINGRIX, the patient experienced post herpetic neuralgia.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 74-year-old female patient who received Shingrix for prophylaxis. On 21st August 2018, the patient received the 1st dose of Shingrix (intramuscular). On 21st August 2018, less than a day after receiving Shingrix, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was recovered/resolved. It was unknown if the reporter considered the injection site rash to be related to Shingrix. Additional details were provided as follows: The patient experienced a rash around the injection site, which spread over several days before it started starting to resolve. The rash reached about 5 by 7 cm at its largest and resolved after 8 days.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Shingrix. Additional details were provided as follows: This case was reported by the patient's wife. In 2018, the patient received Shingrix on the left arm. The patient's arm was sore. This case was linked to the case US2018158194, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a 65-year-old female patient who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to Shingrix. Additional details were provided as follows: The patient was 65 years old at the time of reporting. The age at vaccination was not reported, however, it could be 64 or 65 years old. The patient experienced extreme arm pain that lasted for greater than 3 weeks. The reporter did not agreed to be contacted for follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a 82-year-old female patient who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to Shingrix. Additional details were provided as follows: The patient was 82 years old at the time of reporting. The age at the vaccination was not reported, however, it could be 81 or 82 yeasr old. The patient experienced extreme arm pain for a day and a half.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Headache, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a female patient who received Shingrix for prophylaxis. On 29th August 2018, the patient received the 2nd dose of Shingrix. On 30th August 2018, 1 days after receiving Shingrix, the patient experienced muscle pain, headache, upset stomach and weakness. On an unknown date, the outcome of the muscle pain, headache, upset stomach and weakness were unknown. It was unknown if the reporter considered the muscle pain, headache, upset stomach and weakness to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. On the day before reporting, the patient received Shingrix and on the day of reporting the patient woke up with muscle ache, headache, upset stomach and weakness. The patient was asking how long these side effects would last as she was flying out of town tomorrow (from the date of reporting). Also she was asking, if she would feel well enough to travel.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site pain in a female patient who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain and influenza-like symptoms. On an unknown date, the outcome of the injection site pain and influenza-like symptoms were unknown. It was unknown if the reporter considered the injection site pain and influenza-like symptoms to be related to Shingrix. Additional information was received as follows: The age at vaccination was not reported. The patient experienced pain at injection site and flu like symptoms. The reporter agreed to provide follow up information.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia, Nausea, Pyrexia, Rash
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of joint pain in a 69-year-old female patient who received Shingrix for prophylaxis. On 31st July 2018, the patient received the 2nd dose of Shingrix. On 1st August 2018, 1 days after receiving Shingrix, the patient experienced joint pain, fever, muscle pain and nausea. In August 2018, the patient experienced rash. On an unknown date, the outcome of the joint pain, fever, muscle pain, nausea and rash were unknown. It was unknown if the reporter considered the joint pain, fever, muscle pain, nausea and rash to be related to Shingrix. Additional information was received as follows: The patient has had persistent adverse reactions with onset 24 hours post the dose of Shingrix including joint paint, fever, muscle ache and nausea. The patient also developed a persistent skin rash which started 2 weeks post the dose of Shingrix. The reporter agreed to follow up from GlaxoSmithKline.
Sex: U
Vaccine: VARZOS
Symptoms: Anxiety, Dizziness, Malaise
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of malaise in a adult patient who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced malaise, dizziness and feeling anxious. On an unknown date, the outcome of the malaise, dizziness and feeling anxious were unknown. It was unknown if the reporter considered the malaise, dizziness and feeling anxious to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that the patient reported that with each dose of vaccine they are feeling sense of malaise, dizziness, unsettling feeling. The healthcare professional's call disconnected while providing this information. Tried to call the healthcare professional back but was unable to reach the healthcare professional. This case is linked with US2018156153, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain in extremity
Clinical narrative: 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 Shingrix for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm and chills. On an unknown date, the outcome of the pain in arm and chills were unknown. It was unknown if the reporter considered the pain in arm and chills to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The health care professional reported that, the patient experienced sore arm after both doses of Shingrix vaccine. Soreness seemed to be more pronounced after 2nd dose. The patient also complained of chills. These symptoms were lasted for a few days. This case was linked with case US2018156102, reported by the same reporter for the same patient.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 52-year-old female patient who received Shingrix for prophylaxis. Concomitant products included Shingrix. On 28th August 2018, the patient received the 2nd dose of Shingrix. In August 2018, less than a week after receiving Shingrix, the patient experienced injection site pain, pain and injection site erythema. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, pain and injection site erythema were unknown. It was unknown if the reporter considered the injection site pain, pain and injection site erythema to be related to Shingrix. Additional information was received as follows: The patient experienced soreness at injection site, achy feeling and redness at injection site. For tolerance after the 1st dose of Shingrix, refer case US2018157105, reported by the same reporter. This case was also linked to US2018157107, reported by the same reporter.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse practicioner refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of VAQTA lot # R002086, expiration date: 22-APR-2019 (exact dose, route and site of administration were not reported) for prophylaxis. The vaccine was exposed to temperature in the range of 47 degrees Fahrenheit to 77 degrees Fahrenheit (47.9 degrees Fahrenheit) for 10 minutes. Temperature excursion was detected by a data logger. There was no previous temperature excursion. No adverse events were reported. This is one of three reports from the same reporter. Sender's Comments: US-009507513-1809USA001768: US-009507513-1808USA009171.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided. On 02-JUL-2018, the patient was vaccinated with an improperly stored dose of PROQUAD lot # R003292, expiration date: 31-JUL-2019 (strength, dose, route of administration and anatomical location were not reported) indicated for prophylaxis which was reconstituted with MERCK STERILE DILUENT (lot# and expiration date not reported) properly stored. The administered dose of the vaccine PROQUAD experienced multiple temperature excursions of 6 degrees Fahrenheit (°F) to 14 degrees Fahrenheit (°F) for 303 minutes, as recorded by a data logger. There were no previous excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA002034: US-009507513-1809USA002035: US-009507513-1809USA002036: US-009507513-1809USA002033: US-009507513-1809USA002037: US-009507513-1809USA002032: US-009507513-1809USA002031.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided. On 21-AUG-2018, the patient was vaccinated with an improperly stored dose of PROQUAD lot # R003292, expiration date: 31-JUL-2019 (strength, dose, route of administration and anatomical location were not reported) indicated for prophylaxis which was reconstituted with MERCK STERILE DILUENT (lot# and expiration date not reported) properly stored. The administered dose of the vaccine PROQUAD experienced multiple temperature excursions of 6 degrees Fahrenheit (°F) to 14 degrees Fahrenheit (°F) for 303 minutes, as recorded by a data logger. There were no previous excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA002034: US-009507513-1809USA002035: US-009507513-1809USA002036: US-009507513-1809USA002033: US-009507513-1809USA002037: US-009507513-1809USA001866: US-009507513-1809USA002032.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided. On 27-AUG-2018, the patient was vaccinated with an improperly stored dose of PROQUAD lot # R002939, expiration date: 29-JUL-2019 (strength, dose, route of administration and anatomical location were not reported) indicated for prophylaxis which was reconstituted with MERCK STERILE DILUENT (lot# and expiration date not reported) properly stored. The administered dose of the vaccine PROQUAD experienced multiple temperature excursions of 6 degrees Fahrenheit (°F) to 14 degrees Fahrenheit (°F) for 303 minutes, as recorded by a data logger. There were no previous excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA002035: US-009507513-1809USA002036: US-009507513-1809USA002033: US-009507513-1809USA002037: US-009507513-1809USA001866: US-009507513-1809USA002032: US-009507513-1809USA002031.
Sex: U
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Initial unsolicited report received from a nurse on 31-Aug-2018. This case involves a four-years-old patient who was vaccinated with a dose of 0.5 ml of IMOVAX POLIO lot number: N1J451M via intramuscular route in unknown administration site on 17-Aug-2018 which had a temperature excursion. It was as actual medication error due to due to incorrect product storage. It was unknown that any adverse event was occurred or not. This suspected adverse holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Initial unsolicited report received from a nurse on 31-Aug-2018. This case involves an eight-year-old patient (gender not reported) who was vaccinated with a dose of 0.25 mL of FLUZONE QUADRIVALENT (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient medical history and concomitant therapy not reported. It was as actual medication error due to vaccine underdose. It was unknown that any adverse event was occurred or not. 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. List of documents held by sender: none.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling, Urticaria
Clinical narrative: Injection site Itching, redness, swelling, softball sized welt.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Large red, warm area around injection site, occurred approximately 1 day after immunization.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site with redness and swelling and warmth 2 days after the injection.
Age: 58.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Peripheral swelling
Clinical narrative: Patient went to urgent care today due to swelling of arm and was told she had cellulitis in right arm (same arm PNEUMOVAX was given). Patient was given Rx for cephalexin 500 mg capsule every 8 hours for 10 days.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Feeling cold
Clinical narrative: 9 pm: both left and right palms on pad below thumbs started to itch and hands and fingers looked blotchy red. Itch subsided with in one hour. 11:30 pm: Woke up from sleep because I experienced uncontrollable shivering and was cold. Added a blanket to my bed. Fell back to sleep. 2:30 pm: Woke and knew I had a strong fever but did not have a thermometer to take temperature. Got up to take some Tylenol but had to ask my daughter for assistance because I became very dizzy and immediately went back to bed. I started sweating a lot and felt nauseous. I swallowed two extra strength Tylenol caplets with a large glass of water and fell back asleep. 7:00 am: I woke up and had no fever. The fever never returned but I felt a bit light-headed in the morning and tired all day; took a few naps. By evening I felt more like myself. Gradually gained my usual strength by the end of Monday. On Thursday morning  09/06/2018, I  felt 2-3 times for like 10 minutes each time as if I was fighting some of the ill-feeling symptoms (but it could have been the extremely hot weather we had where we were too, so I kept hydrating. I felt much better by noon).
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Hyperhidrosis, Middle insomnia, Nausea, Pyrexia
Clinical narrative: 9 pm: both left and right palms on pad below thumbs started to itch and hands and fingers looked blotchy red. Itch subsided with in one hour. 11:30 pm: Woke up from sleep because I experienced uncontrollable shivering and was cold. Added a blanket to my bed. Fell back to sleep. 2:30 pm: Woke and knew I had a strong fever but did not have a thermometer to take temperature. Got up to take some Tylenol but had to ask my daughter for assistance because I became very dizzy and immediately went back to bed. I started sweating a lot and felt nauseous. I swallowed two extra strength Tylenol caplets with a large glass of water and fell back asleep. 7:00 am: I woke up and had no fever. The fever never returned but I felt a bit light-headed in the morning and tired all day; took a few naps. By evening I felt more like myself. Gradually gained my usual strength by the end of Monday. On Thursday morning  09/06/2018, I  felt 2-3 times for like 10 minutes each time as if I was fighting some of the ill-feeling symptoms (but it could have been the extremely hot weather we had where we were too, so I kept hydrating. I felt much better by noon).
Age: 52.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Gingival pain, Headache, Insomnia, Pain, Pain in extremity
Clinical narrative: Local arm pain, achey, feverish, insomnia, HA, gum pain, aches all over. Pt was advised these symptoms can happen with SHINGRIX. 09-07-18 per patient she is feeling so much better today.
Age: 52.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Pyrexia
Clinical narrative: Local arm pain, achey, feverish, insomnia, HA, gum pain, aches all over. Pt was advised these symptoms can happen with SHINGRIX. 09-07-18 per patient she is feeling so much better today.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: Pt had swelling of shoulder, did not see it.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Injection site pain, Neck pain, Pain
Clinical narrative: The patient states that she had injection site pain. The pain began to radiate down the arm and up towards the neck. The patient was experiencing a headache. It was recommended that she take some TYLENOL and maybe place an ice pack on soreness if needed. If the pain persisted or got worse, it was recommended she see a doctor.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Pyrexia, Rash, Rash macular, Skin warm
Clinical narrative: Red macular rash on both arms and trunk with warmth. No itching. No large swelling. Not considered adverse: had routine low grade fever for 1 day and mild myalgia.
Age: 73.0
Sex: M
Vaccine: FLUA3
Symptoms: Pain, Sluggishness
Clinical narrative: Body aches. Sluggish.
Age: 62.0
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: Cellulitis, Erythema, Pain, Skin warm, Swelling
Clinical narrative: Next day woke up and was hot to touch, red raised and hard bump inside on left arm. Stated it hurt to touch or any pressure applied. Went to Dr. on day 4 and was diagnosed with cellulitis. Was put on KEFLEX PO for 10 days. Once on antibiotic started redness and heat started to go away and decreased.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site swelling
Clinical narrative: A BRUISE AND SMALL BUMP DEVELOPED IMMEDIATELY AT INJECTION SITE. THE BUMP GREW IN SIZE TO APPOX 2-3 INCHES IN SIZE IN A MATTER OF 60 SECONDS. THE PATIENT FELT FINE AND DOES NOT HAVE AN EGG ALLERGY. SHE TOOK A ZYRTEC WHILE IN THE PRESENCE OF ME. I ADVISED TO ICE AND MASSAGE ARM. I ALSO TOLD HER SHE COULD TAKE TYLENOL TO HELP WITH ANY PAIN THAT MAY HAPPEN. WILL CALL PATIENT IN 2 HOURS TO CHECK IN WITH HER.  PATIENT RECEIVED PREVNAR 13 IN HER LEFT ARM IMMEDIATELY PRIOR TO THIS VACCINATION.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Limb discomfort, Nodule, Peripheral swelling, Tenderness
Clinical narrative: Day after injection given pt noticed knot in his upper arm. Arm was also red, swollen and tender. Today arm is slighly red and tender, swelling and knot are gone.
Age: 69.0
Sex: M
Vaccine: FLUA3
Symptoms: Axillary pain, Mobility decreased, Pain in extremity
Clinical narrative: Patient experiences strong pain which starts from the arm pit and extends through his arm to his fingers. He also reports that he cannot raise his arm because of it. The pain started 2-3 days after the administration of the vaccine. Patient is planning to visit his physical therapist and consult with him in regard to this issue.
Age: 56.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injected limb mobility decreased, Pain in extremity, X-ray limb normal
Clinical narrative: Decreased range of motion of shoulder, significant pain without erythema or evidence of joint infection.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Patient called and reported feeling "terribly nauseated approximately 1 hour after receiving the vaccine. She reports she has never had a reaction like this to a vaccine in the past. She reported having nothing to eat or drink since lunchtime. The patient then took 1 meclizine 25mg tablet and had a snack. When I followed up the next day by phone, she reported feeling some better shortly after consuming meclizine and some food, but did not feel "100% back up to snuff" until the morning.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Per patient report: noticed soreness, warmth in the injection site area the day following the injection, then a round rash, about 3 inches diameter appeared on 9/6/18, about 3-4" below the injection site.
Age: 57.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Fatigue, Pain, Skin warm, Swelling
Clinical narrative: SORENESS /REDNESS / SWELLING, TEMPERATURE IN AREA OF SWELLING, PT IS VERY VERY TIRED.
Age: 56.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis left upper extremity.
Age: 8.0
Sex: F
Vaccine: HEPA
Symptoms: Dyskinesia, Partial seizures, Tardive dyskinesia
Clinical narrative: Child suffered focal seizure on Monday, Sept. 3, 2018 at approximately 11:25 am - a little over 48 hours after receiving the vaccine. Seizure lasted less than 2 minutes and was witnessed by both parents. Parents called 911. First responders suggested that we take child to emergency room. She was seen and released from ER. No tests were completed at the ER. Follow up with a pediatric neurologist was recommended and was completed on 9/7/2018. Child is scheduled to undergo an MRI on 9/15 and EEG 9/25. The seizure causes lip smacking and left arm jerking.
Age: 24.0
Sex: M
Vaccine: TDAP
Symptoms: Dysphagia, Speech disorder, Swelling, Vaccination complication
Clinical narrative: DONOR REPORTED NECK SWELLED, COULD HARDLY TALK, EAT OR DRINK. WENT TO HOSPITAL ER 8/30/18 AND 9/1/18. WAS TOLD HE HAD REACTION TO TETANUS SHOT, BUT IT WOULD GO AWAY ON ITS ON. NO TREATMENT GIVEN.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fall, Pollakiuria, Syncope
Clinical narrative: Excessive urination all day, chills, temp 98.7, 11:30 pm urination, 3AM urination, 5:11AM urination,  fainting, cut head on bathtub, spilled soap and fell an additional 2 times. Pt states she was unaware but was in the bathroom for over 40 minutes. Pt states it was approx. 24 hours after vaccination before she felt better.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt. presented to clinic with swelling redness and warmth at the injection site. No drainage noted Pt injection site. Pt. afebrile.
Age: 35.0
Sex: F
Vaccine: HEP, TD
Symptoms: Discomfort, Hypoaesthesia, Pain in extremity
Clinical narrative: Patient received 2 vaccines and had blood drawn for TB testing from aright antecubital vein. She presented today saying that she has experienced numbness  in area of anterior right wrist extending to her antecubital space. She also reports discomfort in upper arm in deltoid region, especially at night. Patient states the numbness and pain have not gotten better. Upon examination, no redness, swelling or discoloration noted.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Skin lesion
Clinical narrative: Information has been received on 05-SEP-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age and her spouse. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 15-JUL-2015, the patient received ZOSTAVAX (lot number and expiration unknown) unknown route for its intended purpose: the prevention of shingles. As a direct result of the vaccine, on 21-SEP-2016 the patient suffered from a shingles outbreak, in addition to chronic pain, rash and lesions to various parts of his body (in conflict the patient is a female). The patient did not have a shingles outbreak until 21-SEP-2016. As a direct result of the vaccine, the patient suffered mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, the patient suffered permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred medical expenses and other economic harm as a direct result of use of ZOSTAVAX. Shingles outbreak was considered to be disabling. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Diplopia, Headache, VIth nerve paralysis, Vision blurred
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 08-SEP-2016, the patient was vaccinated with ZOSTAVAX (lot number, dosage, site and route of administration not provided) for its intended purpose of prevention of shingles. Shortly thereafter, the patient suffered double vision, constant headaches, and blurry vision. In or around September 2016, the patient presented to his physician for this injury and was diagnosed with sixth nerve palsy. The treatment and outcome of sixth nerve palsy was unknown. Causality assessment was related. Upon internal review, sixth nerve palsy was determined to be a medically significant event. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Incorrect route of product administration
Clinical narrative: The rotavirus vaccine was administered by injection into leg instead of by mouth.
Age: 73.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Fatigue, Heart rate increased, Injection site pain, Injection site pruritus
Clinical narrative: Pain, swelling, itching at injection site 4 hours after administration; mild chills and mild increased heart beat, fatigue, mild body aches. 325 mg TYLENOL taken at onset of side effects. 2 extra strength EXCEDRIN caplets taken 8 hours after onset of side effects which significantly reduced pain and fatigue. Most pain and swelling reduced 16 hours after injection, but mild side effects continued throughout the following day. It should be noted that FLUZONE high-dose 2018-09 0.5ml SYR was administered concurrently at the pharmacy when PNEUMOVAX was administered.
Age: 73.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Pain
Clinical narrative: Pain, swelling, itching at injection site 4 hours after administration; mild chills and mild increased heart beat, fatigue, mild body aches. 325 mg TYLENOL taken at onset of side effects. 2 extra strength EXCEDRIN caplets taken 8 hours after onset of side effects which significantly reduced pain and fatigue. Most pain and swelling reduced 16 hours after injection, but mild side effects continued throughout the following day. It should be noted that FLUZONE high-dose 2018-09 0.5ml SYR was administered concurrently at the pharmacy when PNEUMOVAX was administered.
Age: 63.0
Sex: F
Vaccine: FLU4, VARZOS, FLU4, VARZOS
Symptoms: Gait disturbance, Polyuria, Pyrexia, Urinary incontinence
Clinical narrative: Patient reported the night after she received the vaccines that she had a 103 degree F fever, polyuria with one episode of incontinence, when she tried to walk forward she would walk forward a few steps, then walk backwards involuntarily. She called the pharmacy in the morning to report them, then said she would take an aspirin and rest to see if she recovered.
Age: 63.0
Sex: F
Vaccine: FLU4, VARZOS, FLU4, VARZOS
Symptoms: Nausea, Nervous system disorder, Pyrexia, Urinary incontinence, Vomiting
Clinical narrative: Patient reported the night after she received the vaccines that she had a 103 degree F fever, polyuria with one episode of incontinence, when she tried to walk forward she would walk forward a few steps, then walk backwards involuntarily. She called the pharmacy in the morning to report them, then said she would take an aspirin and rest to see if she recovered.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Circumstance or information capable of leading to device use error, Extra dose administered
Clinical narrative: There was a question about how much of the QUADRACEL was administered secondary to excessive movement of patient during administration and the needle coming out of leg and the remainder of vaccine being injected onto leg and exam paper. Agency was contacted and spoke with Nurse and she advised to repeat QUADRACEL dose ASAP for patient. Parent was contacted and mom returned to clinic with child for administration of vaccine again.
Age: 70.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Dyspnoea, Nausea, Pyrexia
Clinical narrative: Patient have fever and nausea and difficult breathing.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient is pregnant, doctor wanted to have her TDAP vaccination, we admisnistered on 08/29/2018, patient came on 09/04/2018, she said she had a swelling on the injection site, bump, red under skin, no rash, no itching, but it was reducing or going down the extent day by day.
Age: 57.0
Sex: F
Vaccine: FLU4, PPV, TDAP, VARZOS, VARZOS
Symptoms: Cellulitis, Erythema, Pain, Rash
Clinical narrative: History of Present Illness Patient is a  57-year-old female presents today for acute visit related to a rash. Patient was seen here in clinic 3 days ago and she received both nursing works in the pneumonia shot in her left arm. Since that time she has noted redness and pain spreading down towards her elbow. She denies any itchiness. She denies any fevers chills or systemic symptoms at this time. 1 Cellulitis, unspecified: - Will give bactrim DS BID for 10 days for cellulitis. - No signs or symptoms of systemic infection at this time or abscess. - Return precautions given including fever, worsening redness or other concerns.
Age: 57.0
Sex: F
Vaccine: FLU4, PPV, TDAP, VARZOS, VARZOS
Symptoms: Cellulitis, Erythema, Pain
Clinical narrative: History of Present Illness Patient is a  57-year-old female presents today for acute visit related to a rash. Patient was seen here in clinic 3 days ago and she received both nursing works in the pneumonia shot in her left arm. Since that time she has noted redness and pain spreading down towards her elbow. She denies any itchiness. She denies any fevers chills or systemic symptoms at this time. 1 Cellulitis, unspecified: - Will give bactrim DS BID for 10 days for cellulitis. - No signs or symptoms of systemic infection at this time or abscess. - Return precautions given including fever, worsening redness or other concerns.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Dizziness, Herpes zoster, Nausea
Clinical narrative: Had nausea after eating for about a month after the shot. Also dizziness and joint pain for about a month after the shot. Also got shingles after the initial shot. Refused to 2nd dose due to adverse reaction to 1st dose.
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Pt states that they noticed a shingles lesion on their right thigh above the knee 2 days after receiving the vaccine. The rash spread to the groin and outter thigh before the patient went to see the doctor. The pt states they were treated with a 7 day course of an unknown antiviral medication which did not resolve the rash. The rash continued for a total of 4 weeks. Pt states they experienced severe pain throughout the time the rash was present.
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Pt states that they noticed a shingles lesion on their right thigh above the knee 2 days after receiving the vaccine. The rash spread to the groin and outter thigh before the patient went to see the doctor. The pt states they were treated with a 7 day course of an unknown antiviral medication which did not resolve the rash. The rash continued for a total of 4 weeks. Pt states they experienced severe pain throughout the time the rash was present.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Malaise
Clinical narrative: Malaise, erythema 3 inches or more on right upper arm. TX - Tylenol 500 mg prn, Benadryl prn, ice to effected area.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: Fever, aches, chills, nausea, fatigue, headache.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever, aches, chills, nausea, fatigue, headache.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Fever, redness, mild tenderness on left thigh.
Age: 26.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Dizziness, Fall, Haemorrhage intracranial, Skull fracture, Syncope
Clinical narrative: A few minutes after the patient received both immunizations, the patient felt dizzy and fell on the floor, and fainted for about 10 seconds. 911 was called and the EMT came and took him to the hospital. His friend informed me that he has skull fracture and some Internal bleeding. And they were told that he need to rest at home for a month, then see his primary care provider after that.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling, Pruritus
Clinical narrative: Patient reported swollen lips and itchy skin. Sent to Emergency department for evaluation.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Mobility decreased, Pyrexia, Rash erythematous
Clinical narrative: Vaccinated 8/9 in afternoon; sore achy arm at site; difficulty lifting arm above shoulder.  Developed fever (101 °F) and headache 8/10 in afternoon & went to bed early. Fever broke by midnight. Began breaking out in hives on 8/11; hives merged into uniform red-hot rash, neck to feet on 8/12, Hives began fading 8/13 and were gone by 1 week. Skin began peeling about 3 weeks later, similar to sunburn.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin exfoliation, Skin warm, Urticaria
Clinical narrative: Vaccinated 8/9 in afternoon; sore achy arm at site; difficulty lifting arm above shoulder.  Developed fever (101 °F) and headache 8/10 in afternoon & went to bed early. Fever broke by midnight. Began breaking out in hives on 8/11; hives merged into uniform red-hot rash, neck to feet on 8/12, Hives began fading 8/13 and were gone by 1 week. Skin began peeling about 3 weeks later, similar to sunburn.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling, Ultrasound Doppler normal
Clinical narrative: Patient was given PPSV23 in R deltoid, noticed some pain, swelling and redness approx 5 hours later. Pt was seen in the office the following day and treated with antibiotics for possible infection. Pt is improved.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Peripheral swelling, Pruritus
Clinical narrative: 2 1/2-3 INCH RED SWOLLEN ARM - ROUNDED, HURTING AND ITCHING.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous
Clinical narrative: Red rash/bumps on arms, face, neck and stomach.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Cytogenetic analysis, Laboratory test normal, Seizure
Clinical narrative: 40 minute generalized seizure 18 hours after vaccines given. No fever. Father administered rectal Diastat 2.5 mg without effect and the paramedics gave 2 mg of IN midazolam. Mother states that the seizure eventually slowed or stopped but re-started en route to the ER, where he was loaded with Keppra. Patient had a 30 minute seizure following vaccines given at 4 months.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: 5.5 x 5.5 inch area of erythema and warmth with mild edema left thigh. Instructed to monitor, apply cool compresses and give BENADRYL q 6 hours.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Came in today 09/07/2018 over a duration of 7 days: itching, redness & swelling at/around the injection site the size of an orange *painful to the touch starting the almost two days after and lasted for 5 days. Has not seen her physician but nurse from where she gets her allergy shots recommended she talk to her doctor or pharmacist.
Age: 0.83
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Body temperature increased
Clinical narrative: Temp of 103.1 afternoon of shots. Treatment was to give TYLENOL/MOTRIN and watch for any other symptoms.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza, Pain, Pyrexia
Clinical narrative: Patient complained severe flu symptoms after getting the shots. It started about 3 hours after she got vaccinated: aching, chills, fever, pain. Symptoms last till next morning and patient feeling  some relief after taking some TYLENOL.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dizziness, Full blood count, Hyperhidrosis, Metabolic function test
Clinical narrative: Dizziness, Nausea, sweats chills and vertigo. Rest and fluids, broth soup and tea. 5 days and feeling better 6th day.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Vertigo
Clinical narrative: Dizziness, Nausea, sweats chills and vertigo. Rest and fluids, broth soup and tea. 5 days and feeling better 6th day.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Fatigue, Feeling hot, Hyperhidrosis, Hypoacusis
Clinical narrative: Donor completed plasma donation at 2:18 pm and received tetanus immunization at 2:25 pm. Donor then left the plasma center at approximately 3:15 after being observed for any adverse events following immunization. Donor did not exhibit any signs or symptoms of an adverse event and left the plasma center. At approximately 3:25 pm while the donor was waiting outside for the bus she began to feel hot, sweaty, and nauseated, with a decrease in her hearing. She became dizzy and her friend helped walk her to a shaded area where the donor felt like she might pass out, so she sat down and had her friend pour water on her. This was observed by a passerby and the medical staff associate inside the plasma center was alerted. Donor was brought back into the plasma center and was fanned and provided with water and POWERADE, as well as some crackers. Vital signs were monitored and remained stable. Donor recovered and reported that symptoms had resolved, with some persisting tiredness. Donor was able to ambulate independently and left the center in stable condition at approximately 4:05 pm.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea
Clinical narrative: Donor completed plasma donation at 2:18 pm and received tetanus immunization at 2:25 pm. Donor then left the plasma center at approximately 3:15 after being observed for any adverse events following immunization. Donor did not exhibit any signs or symptoms of an adverse event and left the plasma center. At approximately 3:25 pm while the donor was waiting outside for the bus she began to feel hot, sweaty, and nauseated, with a decrease in her hearing. She became dizzy and her friend helped walk her to a shaded area where the donor felt like she might pass out, so she sat down and had her friend pour water on her. This was observed by a passerby and the medical staff associate inside the plasma center was alerted. Donor was brought back into the plasma center and was fanned and provided with water and POWERADE, as well as some crackers. Vital signs were monitored and remained stable. Donor recovered and reported that symptoms had resolved, with some persisting tiredness. Donor was able to ambulate independently and left the center in stable condition at approximately 4:05 pm.
Age: 71.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site warmth, Skin warm, Swelling
Clinical narrative: Arm red, little swelling, and warm. Spoke with patient tonight. She said that she had taken IBU after leaving the pharmacy and the site does not feel as warm and not as red. Patient said if she was still concerned tomorrow, she would seek medical attention.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: Rash head to toe. Lasted 36-40 hours.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Left upper arm became sore, very hot, red spot the size of a an orange, slightly swelled. Stayed that way for 5-6 days before it gradually went away. Also some itchy feeling.