chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Cough, Dyspnoea, Immediate post-injection reaction, Peripheral swelling, Swelling face
Clinical narrative: My (L) arm started to swell immediately. A little while later my face started swelling. I was coughing and wheezing (I felt short of breath).
Age: 40.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Wheezing
Clinical narrative: My (L) arm started to swell immediately. A little while later my face started swelling. I was coughing and wheezing (I felt short of breath).
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Agitation, Anxiety
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of agitation aggravated in a 65-year-old male patient who received FLULAVAL QUADRIVALENT (batch number 7929M, expiry date 30th April 2018). Co-suspect products included FLUZONE. The patient's past medical history included autism. In January 2018, the patient received FLULAVAL QUADRIVALENT. In October 2017, the patient received FLUZONE. On an unknown date, less than a year after receiving FLULAVAL QUADRIVALENT, the patient experienced agitation aggravated and anxiety. On an unknown date, the outcome of the agitation aggravated and anxiety were unknown. It was unknown if the reporter considered the agitation aggravated and anxiety to be related to FLULAVAL QUADRIVALENT. Additional information was reported as follows: The patient was diagnosed with autism after receiving FLUZONE and FLULAVAL QUADRIVALENT. No additional information was provided.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received SHINGRIX. On 6th March 2018, the patient received SHINGRIX. On 7th March 2018, 1 days after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. 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. The patient's arm was sore. This case has been linked to case US2018039391, reported by the same reporter.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Chills, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a 53-year-old female patient who received SHINGRIX (batch number 5Z5LX, expiry date 30th January 2020). Previously administered products included ZOSTAVAX (received before and the injection site was hard and red). Concurrent medical conditions included sulfonamide allergy. On 21st February 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced shivering, muscle pain, fever and burning sensation. On an unknown date, the outcome of the shivering and fever were recovered/resolved and the outcome of the muscle pain was recovering/resolving and the outcome of the burning sensation was not recovered/not resolved. The reporter considered the shivering, muscle pain and fever to be probably related to SHINGRIX. It was unknown if the reporter considered the burning sensation to be related to SHINGRIX. Additional details were reported as follows: The patient received lots of other concomitant medications. The patient received SHINGRIX on left deltoid. The patient stated that her arm still hurts 8 days after the vaccination. The area was burning and she could not sleep on the arm due to the pain. The batch number reported for SHINGRIX (525LX) did not exist and was updated to 5Z5LX as per sales database.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Sleep disorder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a 53-year-old female patient who received SHINGRIX (batch number 5Z5LX, expiry date 30th January 2020). Previously administered products included ZOSTAVAX (received before and the injection site was hard and red). Concurrent medical conditions included sulfonamide allergy. On 21st February 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced shivering, muscle pain, fever and burning sensation. On an unknown date, the outcome of the shivering and fever were recovered/resolved and the outcome of the muscle pain was recovering/resolving and the outcome of the burning sensation was not recovered/not resolved. The reporter considered the shivering, muscle pain and fever to be probably related to SHINGRIX. It was unknown if the reporter considered the burning sensation to be related to SHINGRIX. Additional details were reported as follows: The patient received lots of other concomitant medications. The patient received SHINGRIX on left deltoid. The patient stated that her arm still hurts 8 days after the vaccination. The area was burning and she could not sleep on the arm due to the pain. The batch number reported for SHINGRIX (525LX) did not exist and was updated to 5Z5LX as per sales database.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: White blood cell count increased
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of white blood cell count increased in a 60-year-old male patient who received SHINGRIX (batch number 9XC39, expiry date 30th January 2020). On 20th February 2018, the patient received 1st dose of SHINGRIX (intramuscular) .5 ml. In February 2018, 2 days after receiving SHINGRIX, the patient experienced white blood cell count increased. On an unknown date, the outcome of the white blood cell count increased was unknown. It was unknown if the reporter considered the white blood cell count increased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. At 13:40 hours, the patient received SHINGRIX on left deltoid. The health care professional reported that 2 days after receiving  SHINGRIX, the patient experienced increase in white blood cell count (abnormal lab results) in their lab report. The patient had blood drawn 2 days after SHINGRIX dose. The health care professional was notified about lab results 6 days after blood was drawn.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Injection site pain, Nausea, Pyrexia, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received SHINGRIX. On 28th February 2018, the patient received the 1st dose of SHINGRIX. On 28th February 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 1st March 2018, the patient experienced fever, feeling cold, nausea and vomiting. On an unknown date, the outcome of the injection site pain, fever, feeling cold, nausea and vomiting were unknown. It was unknown if the reporter considered the injection site pain, fever, feeling cold, nausea and vomiting to be related to SHINGRIX. Additional details were provided as follows: The reporter was reporting for wife who received a first dose of SHINGRIX vaccine yesterday on 28th February 2018. The patient had pain at the injection site. At the time of reporting she had a fever and feels cold. The patient also had nausea and vomited on the morning of reporting date. The reporter asked that whether she had a worse reaction on her next shot and should she stop receiving the second shot. The representative stated that for this type of concern, they need to had one of our product specialists call to accurately discuss this concern. The product specialists just need to get a few bits of information and they could have call the reporter to discuss the reactions.
Sex: F
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of shivering in a female patient who received SHINGRIX. 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 shivering. On an unknown date, the outcome of the shivering was unknown. It was unknown if the reporter considered the shivering to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced high level of shivering.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: On January 30, 2018 got a flu shot by Dr. That night I noticed that my arm was sore and very stiff. I didn't think anything of it because in the past whenever I've gotten flu shots my arm was sore for a few days, which is perfectly normal. The problem I'm having is that the stiff arm is now followed by pain and burning sensation to this day. I saw Dr. two weeks after getting the flu shot to let him know. He examined my arm and said, pain the arm from a shot is common. He sent me for physical therapy. I started last week. My physical therapist has scheduled me for 10 sessions. In the past I've gotten flu shots and never had this kind of reaction. Yes, my arm is sore for a few days, but then it goes away and my arm feels fine. This time, my arm feels like it's been injured some how. I can move it up to a certain point, when I go beyond a certain point, I feel my arm very stiff followed by pain and burning sensation. I am very worried that my arm will never be the same again. Not sure what to do at this point.
Age: 67.0
Sex: F
Vaccine: PNC13, PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given pneumococcal polysaccharide vaccine and pneumococcal conjugate vaccine on the same day. Patient does not report any adverse events. We emailed the CDC to find out if vaccines needed to be repeated. Per CDC recommendations they stated to report error to VAERS.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain in extremity, Peripheral swelling, Skin warm, Urticaria
Clinical narrative: Red swollen pain in same arm, hive like bump under injection site and down.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Axillary pain, Breast pain, Erythema, Injected limb mobility decreased, Injection site discomfort
Clinical narrative: Red swollen pain in same arm, hive like bump under injection site and down.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site swelling, Musculoskeletal stiffness, Pain, Swelling
Clinical narrative: Red swollen pain in same arm, hive like bump under injection site and down.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Urticaria
Clinical narrative: Red swollen pain in same arm, hive like bump under injection site and down.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain in extremity, Peripheral swelling, Skin warm, Urticaria
Clinical narrative: Had no discomfort for most of the day until late afternoon when I experienced discomfort at the site of the injection. Next morning my upper left arm from the elbow up was very stiff and sore and difficult to bend without extreme pain.  I observed a bright red swelling, not at the injection site but at a level with my arm pit toward the inside of my arm extending down about 1 1/2 inches above the crook of my elbow and going around the inside of my arm toward my breast . It appeared as having a large area of fluid almost an extremely enormous hive with a bright red ring around it and some hive like area below it. It was very painful. Had pain in my arm pit and left breast. Call my primary care at Health Center. Spoke with a nurse and she advised me to go to the Walk in Clinic and be seen. Which I did. By time they saw me it was much worse. Painful to touch and could barely move my arm. They prescribed Prednisone and said I was having a pretty unusual reaction to the vaccine I received the day before at the Pharmacy. I have reported this to the pharmacy. I was told by the NP that they had seen other people who had reactions bad enough to send them to the doctors, all given at Pharmacy.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Axillary pain, Breast pain, Erythema, Injected limb mobility decreased, Injection site discomfort
Clinical narrative: Had no discomfort for most of the day until late afternoon when I experienced discomfort at the site of the injection. Next morning my upper left arm from the elbow up was very stiff and sore and difficult to bend without extreme pain.  I observed a bright red swelling, not at the injection site but at a level with my arm pit toward the inside of my arm extending down about 1 1/2 inches above the crook of my elbow and going around the inside of my arm toward my breast . It appeared as having a large area of fluid almost an extremely enormous hive with a bright red ring around it and some hive like area below it. It was very painful. Had pain in my arm pit and left breast. Call my primary care at Health Center. Spoke with a nurse and she advised me to go to the Walk in Clinic and be seen. Which I did. By time they saw me it was much worse. Painful to touch and could barely move my arm. They prescribed Prednisone and said I was having a pretty unusual reaction to the vaccine I received the day before at the Pharmacy. I have reported this to the pharmacy. I was told by the NP that they had seen other people who had reactions bad enough to send them to the doctors, all given at Pharmacy.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site swelling, Musculoskeletal stiffness, Pain, Swelling
Clinical narrative: Had no discomfort for most of the day until late afternoon when I experienced discomfort at the site of the injection. Next morning my upper left arm from the elbow up was very stiff and sore and difficult to bend without extreme pain.  I observed a bright red swelling, not at the injection site but at a level with my arm pit toward the inside of my arm extending down about 1 1/2 inches above the crook of my elbow and going around the inside of my arm toward my breast . It appeared as having a large area of fluid almost an extremely enormous hive with a bright red ring around it and some hive like area below it. It was very painful. Had pain in my arm pit and left breast. Call my primary care at Health Center. Spoke with a nurse and she advised me to go to the Walk in Clinic and be seen. Which I did. By time they saw me it was much worse. Painful to touch and could barely move my arm. They prescribed Prednisone and said I was having a pretty unusual reaction to the vaccine I received the day before at the Pharmacy. I have reported this to the pharmacy. I was told by the NP that they had seen other people who had reactions bad enough to send them to the doctors, all given at Pharmacy.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Urticaria
Clinical narrative: Had no discomfort for most of the day until late afternoon when I experienced discomfort at the site of the injection. Next morning my upper left arm from the elbow up was very stiff and sore and difficult to bend without extreme pain.  I observed a bright red swelling, not at the injection site but at a level with my arm pit toward the inside of my arm extending down about 1 1/2 inches above the crook of my elbow and going around the inside of my arm toward my breast . It appeared as having a large area of fluid almost an extremely enormous hive with a bright red ring around it and some hive like area below it. It was very painful. Had pain in my arm pit and left breast. Call my primary care at Health Center. Spoke with a nurse and she advised me to go to the Walk in Clinic and be seen. Which I did. By time they saw me it was much worse. Painful to touch and could barely move my arm. They prescribed Prednisone and said I was having a pretty unusual reaction to the vaccine I received the day before at the Pharmacy. I have reported this to the pharmacy. I was told by the NP that they had seen other people who had reactions bad enough to send them to the doctors, all given at Pharmacy.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Muscular weakness, Nausea
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in a female patient who received SHINGRIX. 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, nausea, muscle weakness, joint pain and headache. On an unknown date, the outcome of the pain, nausea, muscle weakness, joint pain and headache were recovered/resolved. It was unknown if the reporter considered the pain, nausea, muscle weakness, joint pain and headache to be related to SHINGRIX. Additional details were reported as follows: The patient experienced a reaction after receiving 1st and 2nd dose of SHINGRIX. The patient experienced joint pain, a headache, soreness, nausea, and muscle weakness which resolved after about a day. It was reported that she felt like she got hit by a mac truck. This case has been linked with case US2018GSK039262, same patient 2nd dose and US2018GSK040393, reported by the same reporter for other patient.
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in a female patient who received SHINGRIX. 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, nausea, muscle weakness, joint pain and headache. On an unknown date, the outcome of the pain, nausea, muscle weakness, joint pain and headache were recovered/resolved. It was unknown if the reporter considered the pain, nausea, muscle weakness, joint pain and headache to be related to SHINGRIX. Additional details were reported as follows: The patient experienced a reaction after receiving 1st and 2nd dose of SHINGRIX. The patient experienced joint pain, a headache, soreness, nausea, and muscle weakness which resolved after about a day. It was reported that she felt like she got hit by a mac truck. This case has been linked with case US2018GSK039262, same patient 2nd dose and US2018GSK040393, reported by the same reporter for other patient.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Inappropriate schedule of drug administration, Muscular weakness, Nausea
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in a female patient who received SHINGRIX. Concomitant products included SHINGRIX. 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, nausea, muscle weakness, joint pain, headache and drug dose administration interval too short. On an unknown date, the outcome of the pain, nausea, muscle weakness, joint pain, headache and drug dose administration interval too short were unknown. It was unknown if the reporter considered the pain, nausea, muscle weakness, joint pain and headache to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced a reaction after receiving 1st and 2nd dose of SHINGRIX. The patient experienced joint pain, a headache, soreness, nausea, and muscle weakness. The patient received second dose at a shorter than recommended interval at 36 days after the first dose, which led to shortening of the vaccination schedule. This case has been linked with case US2018035442, same patient 2nd dose and US2018GSK040393, reported by the same reporter for the patient.
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in a female patient who received SHINGRIX. Concomitant products included SHINGRIX. 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, nausea, muscle weakness, joint pain, headache and drug dose administration interval too short. On an unknown date, the outcome of the pain, nausea, muscle weakness, joint pain, headache and drug dose administration interval too short were unknown. It was unknown if the reporter considered the pain, nausea, muscle weakness, joint pain and headache to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced a reaction after receiving 1st and 2nd dose of SHINGRIX. The patient experienced joint pain, a headache, soreness, nausea, and muscle weakness. The patient received second dose at a shorter than recommended interval at 36 days after the first dose, which led to shortening of the vaccination schedule. This case has been linked with case US2018035442, same patient 2nd dose and US2018GSK040393, reported by the same reporter for the patient.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative described the occurrence of generalized muscle aches in a 64-year-old male patient who received SHINGRIX. Concomitant products included lisinopril, calcium and fish oil. In February 2018, the patient received the 1st dose of SHINGRIX. In March 2018, 15 hrs after receiving SHINGRIX, the patient experienced generalized muscle aches, shivering and headache. The patient was treated with meloxicam. On an unknown date, the outcome of the generalized muscle aches, shivering and headache were recovering/resolving. The reporter considered the generalized muscle aches, shivering and headache to be probably related to SHINGRIX. Additional details were provided as follows: The patient never had a reaction to a vaccine in the past. The patient was also receiving multivitamin as concomitant drugs. On 28th February 2018 at 15:00, the patient received the SHINGRIX vaccine in the left deltoid and did not have any immediate side effects. On 1st March 2018 at 06:00, the patient woke up in the morning and had myalgia/muscle aches all over his body. The muscle aches improved as he started moving around. The patient also developed a mild headache and shivering. The patient had a prescription for Meloxicam and took a dose on the reporting date morning and the symptoms were beginning to resolve.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 56-year-old male patient who received SHINGRIX. On 28th February 2018, the patient received SHINGRIX (intramuscular) 1 ml. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. The reporter considered the injection site pain to be almost certainly related to SHINGRIX. Additional details were provided as follows: The reporter stated he had pain in the injection site after receiving the vaccine. The vaccine was administered left upper arm. The reporter did not have the lot or expiration date. No additional details were provided. The reporter did not have complete demographics for the health care professional. The vaccine was administered at a pharmacy.
Age: 56.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Chest discomfort, Pharyngeal oedema
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of throat swelling in a 56-year-old female patient who received ENGERIX B adult (batch number 9T25S, expiry date 3rd April 2020). Co-suspect products included HAVRIX (batch number 3PJ73, expiry date 27th February 2020). On 6th March 2018, the patient received the 1st dose of ENGERIX B adult (intramuscular) 1 ml and the 1st dose of HAVRIX (intramuscular) 1 m. On 6th March 2018, less than an hour after receiving ENGERIX B adult and HAVRIX, the patient experienced throat swelling and chest heaviness. The patient was treated with epinephrine. On an unknown date, the outcome of the throat swelling and chest heaviness were unknown. It was unknown if the reporter considered the throat swelling and chest heaviness to be related to ENGERIX B adult and HAVRIX. Additional information was received as follows: At 14:15, the patient received ENGERIX B in the left deltoid and HAVRIX in the right deltoid. Within 30 to 45 minutes of ENGERIX B and HAVRIX vaccination, the patient experienced throat swelling and chest heaviness. The patient was administered a dose of epinephrine and taken to the Emergency Room (ER). It was noted that the patient experienced immediate relief after receiving Epinephrine. Reporter was unable to provide any additional information. They had not received information at the reporting time as to the result of the patient's ER visit.
Age: 1.25
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, mild induration, warmth on left anterior thigh starting on 3/8/18, continues to appear some today (3/9/18) per mother.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration
Clinical narrative: Vaccine was give subcutaneously instead of intramuscularly.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Rash vesicular, Skin lesion, Varicella virus test positive
Clinical narrative: Pt received VARIVAX on 2/10/18 after delivery of child while in hospital due to non-immune varicella status on prenatal labs. Pt seen in the office on 2/26/18 due to having developed pruritic skin lesions on back, chest wall, face, and arms. Lesions had erythematous base with vesicular appearance. Pt denied fever, rhinorrhea, or cough.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Blister, Erythema, Pyrexia, Varicella post vaccine
Clinical narrative: Active chicken pox developed morning of 3/9/18. Patient presented with red fluid filled blisters, low grade fever and his right ear was slightly red.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Arm swollen down to elbow and red.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 20-FEB-2018 the patient was vaccinated with one dose improperly stored PROQUAD (lot # N010865, expiry date: 01-OCT-2018) one dose (dosing details were not reported) which was reconstituted with properly stored sterile diluent (lot # M014034, expiry date: 20-NOV-2018) or (lot # N015631, expiry date: 18-MAR-2019 (also reported 18-OCT-2019)) for prophylaxis at a temperature of 15 degree Fahrenheit  to 46 degree Fahrenheit for 40 minutes time frame, also 6 degree Fahrenheit to 14 degree Fahrenheit for 30 minutes (incorrect product stored). No adverse effects reported. No previous temperature excursion reported. There was a digital data logger involved. No product quality complaint involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # N017698; expiration date: 09-JUN-2019) or (lot # N017701; expiration date: 09-JUN-2019) for prophylaxis, which had a temperature excursion of 6F to 14F for 2 hours 12 minutes on an unknown date. Previous temperature excursions included the same previous temperature for 2 hours 48 minutes and 15F to 46F for 1 hour 59 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1801USA005992.
Sex: M
Vaccine: PPV
Symptoms: Back pain, Diarrhoea, Pyrexia
Clinical narrative: This spontaneous report was received via a voicemail from a male consumer of unknown age referring to himself. Medical history and concomitant medications were not reported. On an unspecified date the consumer was administered a vaccination with PNEUMOVAX 23 for prophylaxis (dose, route of administration, anatomical location, lot# and expiration date were not reported) and experienced "fever, diarrhea and back pain" on unspecified dates. It is unknown if the patient received treatment for the events. The outcome the events was unknown. The reporter considered the events to be related to PNEUMOVAX 23. No further information was provided by the consumer on the voicemail. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, MNQ, TDAP, UNK
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Per nurse call 3/18/18 redness, swelling, hard and tender to touch on (R) deltoid no fever. Stated symptoms began 3/7/18. Saw PCP 3/9/18 with resolving swelling.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, MNQ, TDAP, UNK
Symptoms: Adverse event
Clinical narrative: Per nurse call 3/18/18 redness, swelling, hard and tender to touch on (R) deltoid no fever. Stated symptoms began 3/7/18. Saw PCP 3/9/18 with resolving swelling.
Age: 20.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: She had 4 vaccines, the following night developed pain and swelling with redness in the left deltoid. Has body aches that she expected from immunizations but the pain in the deltoid is unusual. Has never had this type of reaction in past.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Pyrexia
Clinical narrative: Fever of 101.2 48 hours after injection, fever of 99.8 72 hours after injection, inflammation at injection site 3-4" wide and long with a hard red raised center.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Soreness continued weeks and months after the high dose flu vaccine was received on the left hand below shoulder. Pain continues and has spread around the muscles in the area. Reported to my doctor during physical on February 14, 2018. He did not have any explanation for the muscle pain.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration
Clinical narrative: Vaccination give subcutaneously instead of intramuscularly.
Age: 48.0
Sex: M
Vaccine: HEPAB, IPV, MMR, TDAP, TYP
Symptoms: Drooling, Electromyogram, Muscle disorder, Nerve conduction studies, Nuclear magnetic resonance imaging brain
Clinical narrative: Pt wrote: "My tongue dries out so that my speech is affected. Drinking water helps for a while. It was infrequent at first, now it is almost continuous. My muscles around my mouth feel tired and I was drooling last night. It seems my salivary glands work more at night than in the day. I have to think about keeping my tongue moist to speak correctly. Drinking water helps my symptoms."
Age: 48.0
Sex: M
Vaccine: HEPAB, IPV, MMR, TDAP, TYP
Symptoms: Speech disorder, Tongue dry
Clinical narrative: Pt wrote: "My tongue dries out so that my speech is affected. Drinking water helps for a while. It was infrequent at first, now it is almost continuous. My muscles around my mouth feel tired and I was drooling last night. It seems my salivary glands work more at night than in the day. I have to think about keeping my tongue moist to speak correctly. Drinking water helps my symptoms."
Age: 5.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Medical Assistant administered the HPV9 vaccine in error to patient. The vaccine which was ordered by provider was the Influenza vaccine. MA immediately made her supervisor aware of situation. CDC was consulted about any adverse reaction to be expected. Mother of child was informed any reaction would be mostly localized to injection site. Patient monitored by provider and nurse. Patient did not have any symptoms while in office.
Age: 42.0
Sex: M
Vaccine: TDAP
Symptoms: Agitation, Confusional state, Disturbance in attention, Hyperaesthesia, Hypertonia
Clinical narrative: Sudden onset confusion and agitation over two hours after vaccination. Patient admitted to the hospital for confusion and additional findings on clinical exam include hyperalgesia, increased tone to upper extremities, and inattention.
Age: 42.0
Sex: M
Vaccine: TDAP
Symptoms: Lumbar puncture, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal
Clinical narrative: Sudden onset confusion and agitation over two hours after vaccination. Patient admitted to the hospital for confusion and additional findings on clinical exam include hyperalgesia, increased tone to upper extremities, and inattention.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Gait disturbance, Pain in extremity, Paraesthesia
Clinical narrative: Both legs starting hurting, tingling and was not able to climb stairs without assistance. This started on 3/6/2018 and eased up on 3/8/18 at 4:00am.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Hyperhidrosis, Immediate post-injection reaction, Malaise, Pallor
Clinical narrative: During administration of vaccine, client complained of feeling dizzy. Immediately after, she complained of increased dizziness, ear-ringing, and "feeling sick." She appeared pale and diaphoretic. Nurse instructed client to remain seated and stayed next to client. About 1 minute after the vaccine had been given, client slumped over in chair and fainted. Episode of syncope lasted about 20-30 seconds. Client recovered fully after 5 minutes, and was given water and crackers.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Syncope, Tinnitus
Clinical narrative: During administration of vaccine, client complained of feeling dizzy. Immediately after, she complained of increased dizziness, ear-ringing, and "feeling sick." She appeared pale and diaphoretic. Nurse instructed client to remain seated and stayed next to client. About 1 minute after the vaccine had been given, client slumped over in chair and fainted. Episode of syncope lasted about 20-30 seconds. Client recovered fully after 5 minutes, and was given water and crackers.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain
Clinical narrative: Pt that states she received a flu vaccine from our clinic at the school in October. 2-3 days later, it was worse; very painful, difficult to use. States that it is hard to get left arm into sleeve, or to reach/grab for a file, shut off alarm clock. The pain stops her dead in her tracks. Saw PCP in January who advised her to call us.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Soreness at injection site 3+ weeks after injection. Patient reports only occasional soreness that "comes and goes" depending on what she is doing. Mainly noticeable when the site is touched or pressure is applied. Patient has not yet seen a doctor for this.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Exposure during pregnancy, Gait disturbance, Immediate post-injection reaction, Impaired driving ability
Clinical narrative: I received the shot in my left arm on May 11th 2017 with my due date estimated to be August 1st 2017. My son was born weighing 7 pounds. I never felt sick my whole pregnancy and was very healthy. After I received the vaccine I immediately had a horrible pain in my arm and it felt like it was in my bone. It hurt to kiddy my arm and two days later became very sick. I was very dizzy to the point I could barely walk or drive. I had a fever and just did not feel good for about a week. The dizzy spell continued well after I had my child and the pain in my arm never went away it was difficult to use my arm at all and to hold my baby with my left arm was impossible. It left a mark where the vaccine was given and to this day it hurts and still have the mark. I was not given informed consent or was I informed of the side effects or ingredients of the vaccine.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site reaction, Malaise, Pain in extremity
Clinical narrative: I received the shot in my left arm on May 11th 2017 with my due date estimated to be August 1st 2017. My son was born weighing 7 pounds. I never felt sick my whole pregnancy and was very healthy. After I received the vaccine I immediately had a horrible pain in my arm and it felt like it was in my bone. It hurt to kiddy my arm and two days later became very sick. I was very dizzy to the point I could barely walk or drive. I had a fever and just did not feel good for about a week. The dizzy spell continued well after I had my child and the pain in my arm never went away it was difficult to use my arm at all and to hold my baby with my left arm was impossible. It left a mark where the vaccine was given and to this day it hurts and still have the mark. I was not given informed consent or was I informed of the side effects or ingredients of the vaccine.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Patient as well as her husband who is about the same age both experienced severe dizziness for approximately 10 days. Once this subsided there were no issues.
Age: 3.0
Sex: F
Vaccine: HEP
Symptoms: Alopecia areata
Clinical narrative: This literature marketed report was received and refers to a 3 year old female patient. The patient had no significant medical history. Her family history included mother with positive antinuclear antibody (ANA) and alopecia areata (AA) and a sister with positive thyroid antibodies. Antinuclear Antibody (ANA), complete Blood Count (CBC), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and rheumatoid factor performed on an unspecified date were normal. On an unknown date, the patient was vaccinated with her third dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (dose, route, anatomical place of vaccination, lot # and expiration date were not provided), for prophylaxis. On an unknown date (also reported as "4 days after receiving the third dose of hepatitis b vaccine (recombinant) (manufacturer unknown)), the patient experienced alopecia areata (AA). Physical examination performed on an unknown date showed widespread and well demarcated alopecic patches on the scalp without scarring, erythema, or scale. There were no nail changes. Therefore, the patient was prescribed with clobetasol with tacrolimus. At 6 weeks on an unspecified date, her scalp examination was largely unchanged and therapy was continued. After 2 months, an ophiasis pattern had developed, in addition to persistent alopecia on the crown. Clobetasol and tacrolimus were discontinued, and tretinoin was applied, with which there was minimal response over 4 months. Five months later, at which time the patient had stopped al prescription medication and had started a herbal remedy, examination revealed diffuse new hair growth on the scalp of a few inches in length, with one patch of alopecia on the right scalp and some irregularity of the hair line. The reporter considered alopecia areata to be related to Hepatitis B Vaccine (Recombinant) (manufacturer unknown). This is one of several reports from the same reporter. Sender's Comments: US-009507513-1803USA003425.
Age: 19.0
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 19 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 06-MAR-2018, the patient was inadvertently vaccinated with a pediatric dose of VAQTA injection (dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. Was stated that the patient should had received the adult dose, however no adverse effects were reported.
Sex: F
Vaccine: HEP
Symptoms: Alopecia, Alopecia areata
Clinical narrative: This literature marketed report was received and refers to a 15 month old female patient (21 month old at clinic visit). Her family history and family history were non-contributory. Antinuclear Antibody (ANA), rheumatoid factor, double-stranded DNA (dsDNA), antibody (Ab), thyroid-stimulating hormone (TSH), antithyroglobulin Ab, venereal disease research laboratory test and glucose performed on an unspecified date were normal. On an unknown date, the patient was vaccinated with her third dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (dose, route, anatomical place of vaccination, lot # and expiration date were not provided), for prophylaxis. On an unknown date (also reported as "2 weeks after receiving the third dose of hepatitis b vaccine (recombinant) (manufacturer unknown) at the age of 15 months), the patient experienced hair loss. Physical examination performed on an unknown date showed 80% of hair loss of the scalp, with downy brown hair on the temples and occiput. The body was without hair, although the eyebrows and eyelashes were intact. No nail changes were noted. Diffuse alopecia of the scalp, with a few sparse hairs on the occiput. No other changes from prior examination were noted. Treatment was begun with pimecrolimus. At 3 months her examination was unchanged. The patient was instructed to continue the treatment and start amcinolone. The reporter considered alopecia areata to be related to Hepatitis B Vaccine (Recombinant) (manufacturer unknown). This is one of several reports from the same reporter. Sender's Comments: US-009507513-1802USA010505.
Age: 0.5
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a 6 month old infant patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 08-MAR-2018, the patient was vaccinated with a dose of VAQTA lot # N026997 with expiration date 10-NOV-2018, for prophylaxis (route of administration was not reported). No adverse effects were reported.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Inflammation, Mobility decreased, Tenderness
Clinical narrative: Local inflammation tenderness with decreased mobility of arm (50% ROM) worsening over 24 to 48 hours.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Dizziness, Injection site pain, Musculoskeletal pain, Nausea, Neck pain
Clinical narrative: Significant pain in left deltoid after administered- later right deltoid, neck & shoulder pain 4 hours later dizziness & nausea.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: Significant pain in left deltoid after administered- later right deltoid, neck & shoulder pain 4 hours later dizziness & nausea.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Child started developing redness and swelling at both injection sites on 3-8-2018. Both sites are raised. Parents gave child BENADRYL on 3-8-2018. Today, the right leg, KINRIX site, measured 4.2 cm X 5.5 cm. The left leg, PROQUAD site, measures 15 cm X 8 cm. Both sites had a line drawn around. There is no drainage.
Age: 55.0
Sex: F
Vaccine: HEPA
Symptoms: Chest discomfort, Dyspnoea, Injection site erythema, Injection site oedema, Pruritus
Clinical narrative: Chest tightness, wheezing due to shortness of breath, as well as itching, slight edema, and redness at injection site. This reaction occured appr. 10 minutes after injection whilst the patient was smoking a cigarette. Patient responded to the SOB with her VENTOLIN inhaler, which resolved her shortness of breath. After that she rested around the pharmacy for 1 hour before heading home and then took a BENADRYL (about 80 minutes after injection). Complete resolution of symptoms after 2 hours per patient.
Age: 55.0
Sex: F
Vaccine: HEPA
Symptoms: Wheezing
Clinical narrative: Chest tightness, wheezing due to shortness of breath, as well as itching, slight edema, and redness at injection site. This reaction occured appr. 10 minutes after injection whilst the patient was smoking a cigarette. Patient responded to the SOB with her VENTOLIN inhaler, which resolved her shortness of breath. After that she rested around the pharmacy for 1 hour before heading home and then took a BENADRYL (about 80 minutes after injection). Complete resolution of symptoms after 2 hours per patient.
Age: 32.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Headache, Injection site erythema, Injection site pain, Injection site streaking
Clinical narrative: On 17 Jan 2018 he received PNEUMOVAX 23 and several hours later noted onset of headache, dizziness, and blurred vision. He then developed fever to 102 F overnight; his symptoms (fever, blurred vision) persisted for the next 24 hours. He was seen in the ER on 18 Jan where he was treated with BENADRYL and Acetaminophen with resolution of his symptoms over the next several hours. He denies generalized cutaneous symptoms but notes pain/swelling at the injection site associated with localized redness and streaking which persisted for three days prior to resolving. No rhinoconjunctival, laryngeal, pulmonary, or GI symptoms.
Age: 32.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Pyrexia, Vision blurred
Clinical narrative: On 17 Jan 2018 he received PNEUMOVAX 23 and several hours later noted onset of headache, dizziness, and blurred vision. He then developed fever to 102 F overnight; his symptoms (fever, blurred vision) persisted for the next 24 hours. He was seen in the ER on 18 Jan where he was treated with BENADRYL and Acetaminophen with resolution of his symptoms over the next several hours. He denies generalized cutaneous symptoms but notes pain/swelling at the injection site associated with localized redness and streaking which persisted for three days prior to resolving. No rhinoconjunctival, laryngeal, pulmonary, or GI symptoms.
Age: 71.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Chills, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Patients wife reported sore and stiff arm with chills. Didn't know if patient had fever. Advised patient to take APAP and if soreness didn't resolve or worsened to call MD.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site swelling
Clinical narrative: Redness and swelling to skin around the vaccine site, itching.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site induration
Clinical narrative: Induration of injection site that hasn't resolved yet.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Nausea, Pain in extremity
Clinical narrative: Patient had severe right arm pain within a few hours after injection resulting in an emergency room visit. Patient was also nauseous and lightheaded after vaccine.
Age: 33.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Diarrhoea, Injection site erythema, Nausea, Pyrexia, Vomiting
Clinical narrative: Pt reports she developed erythema at site of the varicella vaccine injection (RUE), N/V/D and fever on 3-3-18 (1 day after MMR II and Varicella vaccines and Tubersol were administered) and her symptoms resolved on 3-7-18. Pt is asymptomatic. For the record, pt never contacted Clinic to inform us of her symptoms nor she presented to another clinic, urgent care or emergency center to seek for care.