chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site swelling, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 63-year-old female patient who received SHINGRIX (batch number T5242, expiry date 31st March 2020). On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site swelling, fever and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site swelling and fever were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site swelling and fever to be related to SHINGRIX. Additional information was reported as follows: The healthcare professional reported that the patient was administered with SHINGRIX vaccine via the subcutaneous route, led to incorrect route of drug administration. Due to the administration error, the patient had bouts of fever and swelling at the injection site.  The healthcare professional was advised that adverse events could be higher or more prominent due to the incorrect route of administration. Adverse events had all resolved.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a 70-year-old female patient who received 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, shivering and fatigue. On an unknown date, the outcome of the pain, shivering and fatigue were recovered/resolved. The reporter considered the pain, shivering and fatigue to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's friend. The age at vaccination was not reported, however it could be 69 or 70 years. The reporter stated that the patient experienced some side effects such as pain, shivering and fatigue for a week after receiving the SHINGRIX vaccine. The patient had denied permission to contact their physician. The reporter did not know any other information about the patient or the patient's healthcare provider.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: Vomiting, fever (101 degrees) - woke up around 2:00 am and started throwing up. Had fever when woke up in the morning - responded to TYLENOL.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Ingrown hair, Injection site discolouration, Injection site pain, Injection site pustule, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 61-year-old male patient who received SHINGRIX. Concomitant products included Diltiazem, LIPITOR, Losartan and hydrochlorothiazide. On 11th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 30th May 2018, 19 days after receiving SHINGRIX, the patient experienced injection site swelling, injection site pustule, ingrown hair, injection site pain and injection site hyperpigmentation. On an unknown date, the outcome of the injection site swelling, injection site pustule, ingrown hair, injection site pain and injection site hyperpigmentation were not recovered/not resolved. It was unknown if the reporter considered the injection site swelling, injection site pustule, ingrown hair, injection site pain and injection site hyperpigmentation to be related to SHINGRIX. Additional details were provided as follows: The reported caller pharmacist was the patient. The patient received SHINGRIX vaccine on left deltoid.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of tenderness in a 76-year-old male patient who received SHINGRIX. On 24th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 25th May 2018, 1 days after receiving SHINGRIX, the patient experienced tenderness. On 27th May 2018, the outcome of the tenderness was recovered/resolved. The reporter considered the tenderness to be related to SHINGRIX. Additional information was reported as follows: This case was reported by patient who is a physician. The patient was vaccinated by intramuscular route. The patient experienced tenderness which lasted for about 2 days. The patient's wife notified to their physician about the event. The patient wanted to know, if the same events would be expected with the 2nd dose of SHINGRIX vaccine. The patient had denied permission to contact their physician. This case was linked with case US2018097672 (wife case), reporter by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site discolouration, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult male patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, immediately after receiving SHINGRIX, the patient experienced injection site pain, injection site bruising and injection site discoloration. On an unknown date, the outcome of the injection site pain, injection site bruising and injection site discoloration were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site bruising and injection site discoloration to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient who is a healthcare professional. The age at vaccination was not reported. The patient experienced pain while receiving the SHINGRIX vaccine. The patient stated that, SHINGRIX vaccine was the most painful shot they ever received. The vaccine was administered by an experienced nurse so the patient did not felt that it was administration error that caused the pain. The patient experienced bruising (purplish or yellow) and pain which lasted 4 to 5 days after the injection. This event was reported to Medical Information by an inside sales representative.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Immediate post-injection reaction, Influenza like illness, Injection site pain, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received SHINGRIX. Concurrent medical conditions included arthritis. Concomitant products included Aspirin, Calcium, Magnesium, vitamin D, ZYRTEC, MOTRIN, SYNTHROID and Turmeric. On 14th May 2018, the patient received the 2nd dose of SHINGRIX. On 14th May 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain, influenza-like symptoms, fever and tiredness. On 17th May 2018, the outcome of the injection site pain, influenza-like symptoms, fever and tiredness were recovered/resolved. The reporter considered the injection site pain, influenza-like symptoms, fever and tiredness to be related to SHINGRIX. Additional details were provided as follows: The patient was retired cardiac Catheterization Technician. The patient experienced pain at injection site immediately upon receiving dose. Less than a day after receiving vaccination, the patient experienced tiredness, flu like symptoms and low-grade fever that worsened next day. The patient was unable to provide full demographics for hospital where she received the SHINGRIX or for the prescriber. This case was linked to the case US2018GSK097130, reported by the same reporter for her husband.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Abnormal behaviour, Agitation
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of agitation in a 77-year-old male patient who received SHINGRIX (batch number G47M2, expiry date 11th October 2020). The patient's past medical history included dementia. Concomitant products included citalopram. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced agitation and behavior abnormal. On an unknown date, the outcome of the agitation and behavior abnormal were recovering/resolving. It was unknown if the reporter considered the agitation and behavior abnormal to be related to SHINGRIX. Additional details were provided as follows: The patient's wife called to the pharmacy and reported to healthcare professional (HCP) that, the patient experienced increased agitation and his behavior being different for the 24 hours following administration. The patient became more agitated than normal. The patient was up and down all night out of bed, to the bathroom. They spoke with his primary care physician who told him to discontinue the citalopram that he recently started. The primary case physician taught, this might have been the cause. The reporter was unsure if this was vaccine or citalopram related, or both. The reporter was unsure the level of cognitive function the patient had at baseline. The common adverse events were discussed with the reporter and stated that gastrointestinal (GI) complaints might had caused him to get up repeatedly. However no such complaints were verbally stated.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a 65-year-old female patient who received SHINGRIX. Previously administered products included SHINGRIX (1st dose, no reaction experienced). Concurrent medical conditions included leukemia (diagnosed in 2012). Concomitant products included Aspirin, CRESTOR and vitamin D. On 30th May 2018 01:00, the patient received the 2nd dose of SHINGRIX. On 30th May 2018 08:00, 7 hrs after receiving SHINGRIX, the patient experienced pain, shivering, vomiting and headache. On 31st May 2018, the patient experienced fever. On an unknown date, the outcome of the pain, shivering, vomiting, headache and fever were not recovered/not resolved. The reporter considered the pain, shivering, vomiting, headache and fever to be related to SHINGRIX. Additional information was reported as follows: The patient received the dose of SHINGRIX at her doctor's office. The patient reported that around 8 pm on the evening of vaccination, she experienced severe achiness, bad headache, throwing up, shivering and on the morning of reporting day she had fever (1 day after vaccination). The patient declined to provide prescriber or practice demographics where she received the injection. The patient had denied permission to contact their physician.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of herpes zoster in a 80-year-old male patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced herpes zoster. On an unknown date, the outcome of the herpes zoster was unknown. It was unknown if the reporter considered the herpes zoster to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but it could be 79 year or 80 year. The patient came to see doctor 2 weeks after receiving a dose of SHINGRIX. The patient was having an herpes zoster outbreak.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, MMRV, PNC13
Symptoms: Decreased appetite, Feeling abnormal, Gait disturbance, Injection site pain, Injection site swelling
Clinical narrative: Had vaccine on 5/17/18 at 12:40 and started not feeling herself around 6:00 pm. Dad states had fever under arm 100 degrees c/o not wanting to walk and leg hurting where she got her shots. C/o right leg swollen with pain and walks with limp. Also c/o no appetite but is drinking fluids.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, MMRV, PNC13
Symptoms: Pyrexia
Clinical narrative: Had vaccine on 5/17/18 at 12:40 and started not feeling herself around 6:00 pm. Dad states had fever under arm 100 degrees c/o not wanting to walk and leg hurting where she got her shots. C/o right leg swollen with pain and walks with limp. Also c/o no appetite but is drinking fluids.
Sex: F
Vaccine: VARZOS
Symptoms: 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. 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 unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The pharmacist was notified by another employee that the patient experienced arm pain after receiving the SHINGRIX vaccine. No additional details were available.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Pallor, Rash papular
Clinical narrative: Mild erythematous popular rash, blanching on sides of torso b/l, 4 days after administration - no discomfort. No Tx indicated.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Injection site pain, Mobility decreased
Clinical narrative: Patient returned after about 3 weeks stating arm still sore. Stated it was very sore evening of and several days after injection. Wanted us to report due to still being sore after 3 weeks. She reported to VAERS I believe and had temporary number #137829 give to her.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Pain
Clinical narrative: Patient returned after about 3 weeks stating arm still sore. Stated it was very sore evening of and several days after injection. Wanted us to report due to still being sore after 3 weeks. She reported to VAERS I believe and had temporary number #137829 give to her.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient returned after about 3 weeks stating arm still sore. Stated it was very sore evening of and several days after injection. Wanted us to report due to still being sore after 3 weeks. She reported to VAERS I believe and had temporary number #137829 give to her.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Patient reports sharp pain/ache in left arm that comes and goes since receiving the vaccine. Pain is from injection site and down towards elbow. Patient reports no redness or swelling at injection site. He has not taken anything for the pain. Incident was reported to pharmacy 4 days after receiving vaccine. Patient did not follow up with doctor yet but will be contacting doctor if pain continues.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Abdominal pain upper, Dyspnoea, Feeling hot, Hyperhidrosis, Speech disorder
Clinical narrative: She instantly had a very bad stomach ache and didn't know to either vomit or go to the bath room. We were checking out of the doctor and she fainted. She said she felt like she couldn't talk and breathe. She was very hot and sweaty.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Syncope
Clinical narrative: She instantly had a very bad stomach ache and didn't know to either vomit or go to the bath room. We were checking out of the doctor and she fainted. She said she felt like she couldn't talk and breathe. She was very hot and sweaty.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Influenza like illness, Pain, Pyrexia
Clinical narrative: Flu-like symptoms- tired, weak, pain throughout body, fever (99-102 F) which lasted from the morning after the immunization until approx. the next day.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity, Pyrexia, Vaccination site rash
Clinical narrative: Pt came on 06/08/2018 saying has rash below the site of vaccine and had low grade fever, fatigue and pain in the arm after vaccination, and now it hurts her arm with sharp pain on and off. Pt had in past ZOSTAVAX and had shingles previously. She was advised to see MD walkin clinic as MD office closed and it was late Friday. Pt was suppose to report back with MD evalation, but did not left message for pt Saturday. So waiting for response.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: Swelling, erythema.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site indentation, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Injection was given 3 inches above the site that showed reaction; extreme redness, swelling, hot to touch for several weeks. When the site redness resolved, an indentation resulted demonstrating tissue degradation. In other words, there was a 1/2 inch deep hole in my arm. 4 weeks later, there are still a lot of mottled red spots surrounding the hole.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Livedo reticularis
Clinical narrative: Injection was given 3 inches above the site that showed reaction; extreme redness, swelling, hot to touch for several weeks. When the site redness resolved, an indentation resulted demonstrating tissue degradation. In other words, there was a 1/2 inch deep hole in my arm. 4 weeks later, there are still a lot of mottled red spots surrounding the hole.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site indentation, Injection site pain, Injection site swelling
Clinical narrative: Injection was given 3 inches above the site that showed reaction; extreme redness, swelling, hot to touch for several weeks. When the site redness resolved, an indentation resulted demonstrating tissue degradation. In other words, there was a 1/2 inch deep hole in my arm. 4 weeks later, there are still a lot of mottled red spots surrounding the hole.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Muscle atrophy, Pain, Swelling
Clinical narrative: Injection was given 3 inches above the site that showed reaction; extreme redness, swelling, hot to touch for several weeks. When the site redness resolved, an indentation resulted demonstrating tissue degradation. In other words, there was a 1/2 inch deep hole in my arm. 4 weeks later, there are still a lot of mottled red spots surrounding the hole.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Developed hives on Left arm about 4 days after injection. They are mostly upper arm, but as of today may have spread to lower arm as well. Have not subsided.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia, Rash, Swelling
Clinical narrative: PT COMPLAINS OF RASH, FEVER, HEADACHE, SWELLING AND CHILLS THROUGHOUT THE EVENING AND CONTINUING THROUGH 24 HOURS AFTER VACCINATION.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Headache, Inflammation, Injection site pain, Pyrexia
Clinical narrative: Severe pain at injection site both arms, min-mod inflammation, fever 102 F, headache all worsening in first 24 hours.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Erythema, Headache, Inflammation, Injection site pain, Pain
Clinical narrative: Pain at injection site, minimal inflammation, mild redness, headache, body aches.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Malaise, Nausea, Pyrexia, Vertigo
Clinical narrative: PATIENT REPORTED A FEVER OF 101.6, MALASE, VERTIGO, NAUSEA, AND RIGHT KNEE PAIN.
Age: 38.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Diarrhoea
Clinical narrative: Abdominal pain and diarrhea.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, Pain in extremity, Peripheral swelling, Pruritus, Rash
Clinical narrative: Pain at injection site day 2. Left arm rash and swelling and itching. Slowly dissipating over five days. Pain in arm.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Injected limb mobility decreased, Musculoskeletal pain
Clinical narrative: I have severe shoulder pain and am unable to lift my left shoulder away from my body.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Malaise, Middle insomnia, Pain
Clinical narrative: I started to feel fatigued and tired so I went to bed early 2.5 hours after getting the shot. I woke up several times during the night (2:00am and 5:30am) because I did not feel well. I feel achy all over and my joints were sore. By morning (8:30) I had full blown flu symptoms including nausea, chills, joint soreness and achy all over. I felt better the second day; however, it took another day to really feel like I had gotten back to being healthy again.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Hot flush, Hyperhidrosis
Clinical narrative: Patient experienced hot flashes and sweating for 10 minutes. He was sitting down and didn't appear to be dizzy. He remained seated until the hot flashes subsided. He came back in the following day and told me about his experience
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on neck and also on head as describe by patient representative.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Patient started feeling tired and getting a headache at 4:00pm. She developed full body aches around 7:30pm. The next day these symptoms continued and she had a fever of 100 degrees.  She didn't recover until Monday and the vaccine was administered on Friday morning.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Immune system disorder, Pain, Pyrexia, Swelling face
Clinical narrative: During a follow-up call, patient explained that she had severe body aches and fever for ~2 days post vaccination. On day 2 post vaccination, she also noticed some facial swelling around the nose and lips. On day 3 she felt completely fine and "normal." She stated her husband is a doctor and he does not believe she had an allergic reaction, but just a reaction of the immune system to the vaccination.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 3 inch red radius around injection site, warm to touch, no fever.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Arthritis, Asthenia, Heart rate increased, Myalgia
Clinical narrative: Though I had no adverse events after the first SHINGRIX dose, this second one was followed, surprisingly, by a number of symptoms after about three hours, lasting acutely during the night and calming somewhat after 18 hours or so. They include: Shakes, feverish feeling, accelerated heartbeat (to about 88 from normal 65), weakness, and acute muscular aches and aches in joints suffering from arthritis. I believe I also panicked somewhat before calming myself down and getting to sleep. I did not call 911 or other help, but I reported the events to the pharmacist the next day to ascertain that I could keep taking a course of LOTEMAX I've been on for two weeks.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Tremor
Clinical narrative: Though I had no adverse events after the first SHINGRIX dose, this second one was followed, surprisingly, by a number of symptoms after about three hours, lasting acutely during the night and calming somewhat after 18 hours or so. They include: Shakes, feverish feeling, accelerated heartbeat (to about 88 from normal 65), weakness, and acute muscular aches and aches in joints suffering from arthritis. I believe I also panicked somewhat before calming myself down and getting to sleep. I did not call 911 or other help, but I reported the events to the pharmacist the next day to ascertain that I could keep taking a course of LOTEMAX I've been on for two weeks.
Age: 1.5
Sex: M
Vaccine: PNC13
Symptoms: Balance disorder, Chest X-ray, Chills, Coordination abnormal, Decreased appetite
Clinical narrative: Developed a fever at 0400, had a fever of 102.5 throughout the day. Tried to control fever with 1.875ML of Ibuprofen every 5 hours. Child had chills and sweats, very little appetite for food or liquids, but did eat and drink some. At 9PM the child's fever spiked to 105.00F. Child was transported to Hospital, where he was given Ibuprofen and Acetaminophen every three hours to control fever. Rectal temp at hospital was 104.5 and lowered to 100 with meds. 6/06/2018-Child was taken to primary care doctor the following day for a follow-up. As of 6/09/2018 child is not as energetic, appetite hasn't recovered and seems to have a slight difficulty with balance/coordination.
Age: 1.5
Sex: M
Vaccine: PNC13
Symptoms: Hyperhidrosis, Influenza virus test, Pyrexia, Respiratory syncytial virus test
Clinical narrative: Developed a fever at 0400, had a fever of 102.5 throughout the day. Tried to control fever with 1.875ML of Ibuprofen every 5 hours. Child had chills and sweats, very little appetite for food or liquids, but did eat and drink some. At 9PM the child's fever spiked to 105.00F. Child was transported to Hospital, where he was given Ibuprofen and Acetaminophen every three hours to control fever. Rectal temp at hospital was 104.5 and lowered to 100 with meds. 6/06/2018-Child was taken to primary care doctor the following day for a follow-up. As of 6/09/2018 child is not as energetic, appetite hasn't recovered and seems to have a slight difficulty with balance/coordination.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, IPV, MMR
Symptoms: Abnormal behaviour, Crying, Emotional disorder, Extra dose administered, Pain
Clinical narrative: Pain and inconsolable crying the day of. Continued inconsolable crying, abnormal behavior, emotional fits, inability to regulate emotions and reactions for 1 month. This was also a vaccine error. A human error was made on May 7, 2018, when the nurse assembled patient's vaccines. Instead of receiving DTP, MMR, and Polio vaccines, patient instead received PENTACEL (DTP + Hib + Polio), MMR, and Polio.  When asked how this occurred and why no one checked or double-checked the syringes, the doctor stated that the office usually has an oversight or check system, but it was not done for patient.  We were notified of the vaccine error on May 15, 2018.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, IPV, MMR
Symptoms: Wrong drug administered
Clinical narrative: Pain and inconsolable crying the day of. Continued inconsolable crying, abnormal behavior, emotional fits, inability to regulate emotions and reactions for 1 month. This was also a vaccine error. A human error was made on May 7, 2018, when the nurse assembled patient's vaccines. Instead of receiving DTP, MMR, and Polio vaccines, patient instead received PENTACEL (DTP + Hib + Polio), MMR, and Polio.  When asked how this occurred and why no one checked or double-checked the syringes, the doctor stated that the office usually has an oversight or check system, but it was not done for patient.  We were notified of the vaccine error on May 15, 2018.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Headache, nausea, diarrhea, chills, rash on arm, soreness at injection site, joint and muscle pain, extreme fatigue. Basically ALL the side effects known with this drug.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Myalgia, Nausea, Rash
Clinical narrative: Headache, nausea, diarrhea, chills, rash on arm, soreness at injection site, joint and muscle pain, extreme fatigue. Basically ALL the side effects known with this drug.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Malaise, Vaccination complication
Clinical narrative: Headache, nausea, diarrhea, chills, rash on arm, soreness at injection site, joint and muscle pain, extreme fatigue. Basically ALL the side effects known with this drug.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Arthritis, Immediate post-injection reaction, Musculoskeletal pain, Pain
Clinical narrative: Immediately after receiving the vaccine injection I began experiencine acute pain at the vaccination site. After almost 4 months, the pain has persisted and gotten much worse. The pain now radiates down from the injection site in my upper right shoulder down to my right elbow.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Ultrasound scan abnormal, Vaccination site pain, X-ray limb abnormal
Clinical narrative: Immediately after receiving the vaccine injection I began experiencine acute pain at the vaccination site. After almost 4 months, the pain has persisted and gotten much worse. The pain now radiates down from the injection site in my upper right shoulder down to my right elbow.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Patient started developing signs and symptoms of shingles on 06/5/18 which included extreme pain and rash. MD prescribed NORCO, VALTREX and Prednisone for treatment.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Injection site pain, Pain, Skin discolouration
Clinical narrative: Patient started developing signs and symptoms of shingles on 06/5/18 which included extreme pain and rash. MD prescribed NORCO, VALTREX and Prednisone for treatment.
Age: 81.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site reaction -> 8 am erythematous, pruritic swelling. No signs of infection. Area tender to palpation. No continuous symptoms.
Age: 0.33
Sex: M
Vaccine: HIBV, IPV, DTAP, PNC13
Symptoms: Condition aggravated, Crying, Dyskinesia, Electroencephalogram normal, Emotional distress
Clinical narrative: Fever over 101. Inconsolable, thrashing head about and high pitch screaming for > 3 hours.  Screaming a lot for next 3 days for several hours. Muscle rigidity was noted after these vaccines and child did not develop further with gross motor skills from 4 months until 7.5 month vaccines.  Laryngomalacia worsened and I stayed up with baby checking on him for next 5 nights as periodic breathing got much worse. Muscle rigidity was bad for 3 to 4 weeks after vaccine and got worse with next round of vaccines given on 12/19/2017 (Polio and Hib). Child currently in physical therapy and being evaluated to start occupational therapy and speech therapy. Child's doctor office was called for fever and child's high pitch screaming (inconsolable) on after hours line.
Age: 0.33
Sex: M
Vaccine: HIBV, IPV, DTAP, PNC13
Symptoms: Erythema, Infantile back arching, Irritability, Laryngomalacia, Musculoskeletal stiffness
Clinical narrative: Fever over 101. Inconsolable, thrashing head about and high pitch screaming for > 3 hours.  Screaming a lot for next 3 days for several hours. Muscle rigidity was noted after these vaccines and child did not develop further with gross motor skills from 4 months until 7.5 month vaccines.  Laryngomalacia worsened and I stayed up with baby checking on him for next 5 nights as periodic breathing got much worse. Muscle rigidity was bad for 3 to 4 weeks after vaccine and got worse with next round of vaccines given on 12/19/2017 (Polio and Hib). Child currently in physical therapy and being evaluated to start occupational therapy and speech therapy. Child's doctor office was called for fever and child's high pitch screaming (inconsolable) on after hours line.
Age: 0.33
Sex: M
Vaccine: HIBV, IPV, DTAP, PNC13
Symptoms: Pyrexia, Respiration abnormal, Seizure like phenomena
Clinical narrative: Fever over 101. Inconsolable, thrashing head about and high pitch screaming for > 3 hours.  Screaming a lot for next 3 days for several hours. Muscle rigidity was noted after these vaccines and child did not develop further with gross motor skills from 4 months until 7.5 month vaccines.  Laryngomalacia worsened and I stayed up with baby checking on him for next 5 nights as periodic breathing got much worse. Muscle rigidity was bad for 3 to 4 weeks after vaccine and got worse with next round of vaccines given on 12/19/2017 (Polio and Hib). Child currently in physical therapy and being evaluated to start occupational therapy and speech therapy. Child's doctor office was called for fever and child's high pitch screaming (inconsolable) on after hours line.
Age: 0.33
Sex: M
Vaccine: HIBV, IPV, DTAP, PNC13
Symptoms: Condition aggravated, Crying, Developmental delay, Laryngomalacia, Muscle rigidity
Clinical narrative: Fever over 101. Inconsolable, thrashing head about and high pitch screaming for > 3 hours.  Screaming a lot for next 3 days for several hours. Muscle rigidity was noted after these vaccines and child did not develop further with gross motor skills from 4 months until 7.5 month vaccines.  Laryngomalacia worsened and I stayed up with baby checking on him for next 5 nights as periodic breathing got much worse. Muscle rigidity was bad for 3 to 4 weeks after vaccine and got worse with next round of vaccines given on 12/19/2017 (Polio and Hib). Child currently in physical therapy and being evaluated to start occupational therapy and speech therapy. Child's doctor office was called for fever and child's high pitch screaming (inconsolable) on after hours line.
Age: 0.33
Sex: M
Vaccine: HIBV, IPV, DTAP, PNC13
Symptoms: Pyrexia, Respiration abnormal, Screaming
Clinical narrative: Fever over 101. Inconsolable, thrashing head about and high pitch screaming for > 3 hours.  Screaming a lot for next 3 days for several hours. Muscle rigidity was noted after these vaccines and child did not develop further with gross motor skills from 4 months until 7.5 month vaccines.  Laryngomalacia worsened and I stayed up with baby checking on him for next 5 nights as periodic breathing got much worse. Muscle rigidity was bad for 3 to 4 weeks after vaccine and got worse with next round of vaccines given on 12/19/2017 (Polio and Hib). Child currently in physical therapy and being evaluated to start occupational therapy and speech therapy. Child's doctor office was called for fever and child's high pitch screaming (inconsolable) on after hours line.
Age: 1.25
Sex: F
Vaccine: IPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Swelling & redness at injection site with fever.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Blood test normal, CSF protein increased, Computerised tomogram normal, Electroencephalogram normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Multiple and ongoing seizures. Seizures started two days after vaccinations and have continued currently but are less intense with medical intervention.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Seizure, Stool analysis normal, Urine analysis normal
Clinical narrative: Multiple and ongoing seizures. Seizures started two days after vaccinations and have continued currently but are less intense with medical intervention.
Age: 46.0
Sex: F
Vaccine: HEPA
Symptoms: Arthralgia, Diarrhoea, Eyelid oedema, Headache, Pyrexia
Clinical narrative: Fever, severe pains in all joints, vomiting, diarrhea, severe headache, puffy eyes.
Age: 46.0
Sex: F
Vaccine: HEPA
Symptoms: Vomiting
Clinical narrative: Fever, severe pains in all joints, vomiting, diarrhea, severe headache, puffy eyes.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Dizziness, Headache, Nausea, Pain in extremity
Clinical narrative: Headache (very strong): (Lasting 5 to 36 hours after injection).  Stomachache (sharp and stabbing): (5 to 24 hours after injection). Fever (low-grade, between 99 and 101): (5 to 36 hours after injection). Light sensitivity: (5 to 36 hours after injection). Dizziness: (5 to 36 hours after injection). Nausea: (24 to 36 hours after injection). Jaw pain: (24 to 72 hours after injection). Arm soreness (at site of injection): (5 to 72 hours after injection). Headache and fever were temporarily relieved (somewhat) by ibuprofen.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in jaw, Photophobia, Pyrexia
Clinical narrative: Headache (very strong): (Lasting 5 to 36 hours after injection).  Stomachache (sharp and stabbing): (5 to 24 hours after injection). Fever (low-grade, between 99 and 101): (5 to 36 hours after injection). Light sensitivity: (5 to 36 hours after injection). Dizziness: (5 to 36 hours after injection). Nausea: (24 to 36 hours after injection). Jaw pain: (24 to 72 hours after injection). Arm soreness (at site of injection): (5 to 72 hours after injection). Headache and fever were temporarily relieved (somewhat) by ibuprofen.
Age: 35.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Back pain, Body temperature increased, Erythema
Clinical narrative: Arm slightly achy the evening of administration; as to be expected. The following morning, pt woke up with arm very sore, swollen, visibly red, and hot to the touch. All-over muscle aches; felt like she "had the flu." Joints also affected/very stiff, especially knees & ankles. Lower back/hip pain forced pt to stretch/reposition stance at work every 3-5 mins. Took 800mg of ibuprofen around 10:15am; gelcap form. No noticeable difference. By 1pm, pt's oral temp was 101.8F and she felt very tired and nauseous. Pt complained of being "freezing cold" despite other coworkers in the area feeling hot and it being a +80F day. Heat from injection site could be felt by coworkers through uniform scrubs. Large knot had formed around injection site, approx. 2.5" diameter. By 4pm, pt's mobility had become limited due to pain/swelling at injection site. Pt was very weak/lethargic, had a headache, and was extremely thirsty, almost as if dehydrated. Sent home from work early. Pt applied ice to arm at home and went to bed around 8pm. Woke several times throughout the night due to arm pain when shifting/repositioning during sleep. The following morning, 6/9/2018, two days post-vaccine, pt woke feeling even worse. Body aches, headache, arm pain, redness, swelling, etc all worse than previous day. Knot on arm approx. 4" diameter, dark red/purple, and extremely hot. Pt. could barely move arm to dress self, drive, etc. Oral temp 99.3F upon arrival at immediate care center. Pt. given shot of TORADOL and ODT ZOFRAN. Sent home with Rx for 4mg ZOFRAN, 650mg TYLENOL, 600mg ibuprofen. Improvement of body aches, headache, and arm mobility after TORADOL shot by that afternoon. Injection site knot, redness, heat, and pain persist despite treatment.
Age: 35.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling cold, Headache, Influenza like illness, Injected limb mobility decreased
Clinical narrative: Arm slightly achy the evening of administration; as to be expected. The following morning, pt woke up with arm very sore, swollen, visibly red, and hot to the touch. All-over muscle aches; felt like she "had the flu." Joints also affected/very stiff, especially knees & ankles. Lower back/hip pain forced pt to stretch/reposition stance at work every 3-5 mins. Took 800mg of ibuprofen around 10:15am; gelcap form. No noticeable difference. By 1pm, pt's oral temp was 101.8F and she felt very tired and nauseous. Pt complained of being "freezing cold" despite other coworkers in the area feeling hot and it being a +80F day. Heat from injection site could be felt by coworkers through uniform scrubs. Large knot had formed around injection site, approx. 2.5" diameter. By 4pm, pt's mobility had become limited due to pain/swelling at injection site. Pt was very weak/lethargic, had a headache, and was extremely thirsty, almost as if dehydrated. Sent home from work early. Pt applied ice to arm at home and went to bed around 8pm. Woke several times throughout the night due to arm pain when shifting/repositioning during sleep. The following morning, 6/9/2018, two days post-vaccine, pt woke feeling even worse. Body aches, headache, arm pain, redness, swelling, etc all worse than previous day. Knot on arm approx. 4" diameter, dark red/purple, and extremely hot. Pt. could barely move arm to dress self, drive, etc. Oral temp 99.3F upon arrival at immediate care center. Pt. given shot of TORADOL and ODT ZOFRAN. Sent home with Rx for 4mg ZOFRAN, 650mg TYLENOL, 600mg ibuprofen. Improvement of body aches, headache, and arm mobility after TORADOL shot by that afternoon. Injection site knot, redness, heat, and pain persist despite treatment.
Age: 35.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Arm slightly achy the evening of administration; as to be expected. The following morning, pt woke up with arm very sore, swollen, visibly red, and hot to the touch. All-over muscle aches; felt like she "had the flu." Joints also affected/very stiff, especially knees & ankles. Lower back/hip pain forced pt to stretch/reposition stance at work every 3-5 mins. Took 800mg of ibuprofen around 10:15am; gelcap form. No noticeable difference. By 1pm, pt's oral temp was 101.8F and she felt very tired and nauseous. Pt complained of being "freezing cold" despite other coworkers in the area feeling hot and it being a +80F day. Heat from injection site could be felt by coworkers through uniform scrubs. Large knot had formed around injection site, approx. 2.5" diameter. By 4pm, pt's mobility had become limited due to pain/swelling at injection site. Pt was very weak/lethargic, had a headache, and was extremely thirsty, almost as if dehydrated. Sent home from work early. Pt applied ice to arm at home and went to bed around 8pm. Woke several times throughout the night due to arm pain when shifting/repositioning during sleep. The following morning, 6/9/2018, two days post-vaccine, pt woke feeling even worse. Body aches, headache, arm pain, redness, swelling, etc all worse than previous day. Knot on arm approx. 4" diameter, dark red/purple, and extremely hot. Pt. could barely move arm to dress self, drive, etc. Oral temp 99.3F upon arrival at immediate care center. Pt. given shot of TORADOL and ODT ZOFRAN. Sent home with Rx for 4mg ZOFRAN, 650mg TYLENOL, 600mg ibuprofen. Improvement of body aches, headache, and arm mobility after TORADOL shot by that afternoon. Injection site knot, redness, heat, and pain persist despite treatment.
Age: 35.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint stiffness, Lethargy, Myalgia, Nausea, Pain
Clinical narrative: Arm slightly achy the evening of administration; as to be expected. The following morning, pt woke up with arm very sore, swollen, visibly red, and hot to the touch. All-over muscle aches; felt like she "had the flu." Joints also affected/very stiff, especially knees & ankles. Lower back/hip pain forced pt to stretch/reposition stance at work every 3-5 mins. Took 800mg of ibuprofen around 10:15am; gelcap form. No noticeable difference. By 1pm, pt's oral temp was 101.8F and she felt very tired and nauseous. Pt complained of being "freezing cold" despite other coworkers in the area feeling hot and it being a +80F day. Heat from injection site could be felt by coworkers through uniform scrubs. Large knot had formed around injection site, approx. 2.5" diameter. By 4pm, pt's mobility had become limited due to pain/swelling at injection site. Pt was very weak/lethargic, had a headache, and was extremely thirsty, almost as if dehydrated. Sent home from work early. Pt applied ice to arm at home and went to bed around 8pm. Woke several times throughout the night due to arm pain when shifting/repositioning during sleep. The following morning, 6/9/2018, two days post-vaccine, pt woke feeling even worse. Body aches, headache, arm pain, redness, swelling, etc all worse than previous day. Knot on arm approx. 4" diameter, dark red/purple, and extremely hot. Pt. could barely move arm to dress self, drive, etc. Oral temp 99.3F upon arrival at immediate care center. Pt. given shot of TORADOL and ODT ZOFRAN. Sent home with Rx for 4mg ZOFRAN, 650mg TYLENOL, 600mg ibuprofen. Improvement of body aches, headache, and arm mobility after TORADOL shot by that afternoon. Injection site knot, redness, heat, and pain persist despite treatment.
Age: 35.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Skin warm, Thirst
Clinical narrative: Arm slightly achy the evening of administration; as to be expected. The following morning, pt woke up with arm very sore, swollen, visibly red, and hot to the touch. All-over muscle aches; felt like she "had the flu." Joints also affected/very stiff, especially knees & ankles. Lower back/hip pain forced pt to stretch/reposition stance at work every 3-5 mins. Took 800mg of ibuprofen around 10:15am; gelcap form. No noticeable difference. By 1pm, pt's oral temp was 101.8F and she felt very tired and nauseous. Pt complained of being "freezing cold" despite other coworkers in the area feeling hot and it being a +80F day. Heat from injection site could be felt by coworkers through uniform scrubs. Large knot had formed around injection site, approx. 2.5" diameter. By 4pm, pt's mobility had become limited due to pain/swelling at injection site. Pt was very weak/lethargic, had a headache, and was extremely thirsty, almost as if dehydrated. Sent home from work early. Pt applied ice to arm at home and went to bed around 8pm. Woke several times throughout the night due to arm pain when shifting/repositioning during sleep. The following morning, 6/9/2018, two days post-vaccine, pt woke feeling even worse. Body aches, headache, arm pain, redness, swelling, etc all worse than previous day. Knot on arm approx. 4" diameter, dark red/purple, and extremely hot. Pt. could barely move arm to dress self, drive, etc. Oral temp 99.3F upon arrival at immediate care center. Pt. given shot of TORADOL and ODT ZOFRAN. Sent home with Rx for 4mg ZOFRAN, 650mg TYLENOL, 600mg ibuprofen. Improvement of body aches, headache, and arm mobility after TORADOL shot by that afternoon. Injection site knot, redness, heat, and pain persist despite treatment.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: PATIENT CAME BACK IN AND REPORTED (AND SHOWED ME) A RAISED ERYTHEMATOUS RASH ON RIGHT FOREARM THAT APPEARED 24-48 HOURS AFTER THE VACCINE WAS GIVEN. RASH DOES ITCH AND HAS NOT SPREAD PER PATIENT REPORT.
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure increased, Haematoma, Injection site swelling, Pain in extremity, Ultrasound scan abnormal
Clinical narrative: About 3 hours after patient was given the vaccine he had intense pain in his left arm and it started to swell into his shoulder,his blood pressure went up due to the intense pain, he went to the emergency room and had a sonogram, his shoulder swelled up and it looked to be about the size of a grapefruit,not hot to touch and no streaking,they discovered that he had a bursa and after the injection the doctor thinks that it caused the hematoma,he was given steroids and pain medicine.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Complex febrile seizure last about 40 minutes requiring midazolam and lorazepam for lysis. No seizures since. No signs of infectious vector.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Headache, Lymph node pain, Muscle tightness, Pain in extremity
Clinical narrative: Extremely sore arm from the top of arm right down to the finger tips; Tightening of chest, throat and side of outer neck the glands were tender to touch, Sharp pains going up the side of my head on the right side.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness, Throat tightness
Clinical narrative: Extremely sore arm from the top of arm right down to the finger tips; Tightening of chest, throat and side of outer neck the glands were tender to touch, Sharp pains going up the side of my head on the right side.
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Given to 18 yr old. Wasn't aware that 18 yr old was to be given pediatric dose.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: At 1:30 am (10 hours after injection) I woke up with chills and fever. I took two ibuprofen and went back to bed. Felt feverish after getting up later that morning and the rest of the day. Fever was 100.6, then broke around 8 o'clock on the evening of 9 June.