chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Accidental underdose, Exposure via skin contact, Injection site bruising, Injection site erythema
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pain in a 79-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 28th July 2018, the patient received SHINGRIX and SHINGRIX. On 28th July 2018, less than a day after receiving SHINGRIX and SHINGRIX, the patient experienced pain, injection site bruising, injection site erythema, injection site tenderness, inadvertent exposure to vaccine, exposure via skin contact and accidental underdose. On an unknown date, the outcome of the pain, injection site bruising, injection site erythema and injection site tenderness were not recovered/not resolved and the outcome of the inadvertent exposure to vaccine, exposure via skin contact and accidental underdose were unknown. It was unknown if the reporter considered the pain and injection site bruising to be related to SHINGRIX. It was unknown if the reporter considered the pain, injection site erythema and injection site tenderness to be related to SHINGRIX. Additional details reported as follows: The retired physician received an injection in her right arm and said that most of it ran down her arm at the time of injection, which led to inadvertent exposure to vaccine, exposure via skin contact and accidental underdose. The pharmacist injected a second dose into the left arm without incident. She had experienced aches and pains and left arm had some redness and was sore and was tender at the injection site on the left arm. The right arm only had a little bruising at the injection site.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pain in a 79-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 28th July 2018, the patient received SHINGRIX and SHINGRIX. On 28th July 2018, less than a day after receiving SHINGRIX and SHINGRIX, the patient experienced pain, injection site bruising, injection site erythema, injection site tenderness, inadvertent exposure to vaccine, exposure via skin contact and accidental underdose. On an unknown date, the outcome of the pain, injection site bruising, injection site erythema and injection site tenderness were not recovered/not resolved and the outcome of the inadvertent exposure to vaccine, exposure via skin contact and accidental underdose were unknown. It was unknown if the reporter considered the pain and injection site bruising to be related to SHINGRIX. It was unknown if the reporter considered the pain, injection site erythema and injection site tenderness to be related to SHINGRIX. Additional details reported as follows: The retired physician received an injection in her right arm and said that most of it ran down her arm at the time of injection, which led to inadvertent exposure to vaccine, exposure via skin contact and accidental underdose. The pharmacist injected a second dose into the left arm without incident. She had experienced aches and pains and left arm had some redness and was sore and was tender at the injection site on the left arm. The right arm only had a little bruising at the injection site.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 70-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 30th July 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 30th July 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms. The patient was treated with TYLENOL. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the influenza-like symptoms was not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient reported that after receiving the second dose of SHINGRIX at 6:00 PM on left deltoid, he was experiencing flu like symptoms that was more intense than his first shot. He claims that his second shot symptoms were kicking his butt. He was treating the symptoms currently with extra strength TYLENOL. The patient indicated that he was in good shape physically. This case has been linked with US2018GSK143654, reported by the same reporter (case reported for 1st dose).
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Fatigue, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 57-year-old male patient who received SHINGRIX for prophylaxis. On 30th July 2018, the patient received the 1st dose of SHINGRIX .5 ml. In July 2018, less than a week after receiving SHINGRIX, the patient experienced muscle pain, body temperature increased, chills and fatigue. On an unknown date, the outcome of the muscle pain, body temperature increased, chills and fatigue were unknown. It was unknown if the reporter considered the muscle pain, body temperature increased, chills and fatigue to be related to SHINGRIX. Additional details were provided as follows: The patient experienced muscle aches, fatigue, elevated temperature and chills.
Sex: M
Vaccine: RAB
Symptoms: Antibody test negative, Serology negative, Therapeutic response decreased
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of therapeutic response decreased in a adult male patient who received Rabies Vaccine for prophylaxis. On an unknown date, the patient received Rabies Vaccine at an unknown dose. On an unknown date, unknown after receiving Rabies Vaccine, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased was unknown. It was unknown if the reporter considered the therapeutic response decreased to be related to Rabies Vaccine. Additional information was received as follows: The age at vaccination was not reported. The patient received pre-exposure prophylaxis with an unknown brand of rabies vaccine at an unknown time. The titers were drawn recent to the reporting date, and they were fount to be low, thus leading to the therapeutic response decreased. Lab Comments: In 2018, the patient underwent serology test which was resulted as low antibody titer for rabies.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 15th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 15th May 2018, less than a day after receiving SHINGRIX, the patient experienced feeling bad. On 22nd May 2018, the outcome of the feeling bad was recovered/resolved. It was unknown if the reporter considered the feeling bad to be related to SHINGRIX. Additional details were provided as follows: The caller reported that, the patient was her son's mother-in-law. The age at vaccination was not reported. The patient received SHINGRIX on an unknown arm. The patient felt bad. No further descriptive information was provided about reported adverse event. This case has been linked to the US2018139533 and US2018139534, reported by the same reporter.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a 75-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included amlodipine, biotin, folic acid, Levothyroxine, Metformin, Pravastatin, ramipril, Vitamin B12, Vitamin B6, Vitamin D3, ZYRTEC, glimepiride and CoQ10. On 3rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 1st July 2018, 59 days after receiving SHINGRIX, the patient experienced rash, erythematous rash and pruritus. On an unknown date, the outcome of the rash, erythematous rash and pruritus were recovered/resolved. It was unknown if the reporter considered the rash, erythematous rash and pruritus to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. The age at vaccination was not reported. The patient received the SHINGRIX, on the left arm. The patient's rash was on his legs, groin and feet. The patient followed up with his physician.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm, headache, weakness and fever. On an unknown date, the outcome of the pain in arm, headache, weakness and fever were recovered/resolved. It was unknown if the reporter considered the pain in arm, headache, weakness and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in the right deltoid. The patient experienced a sore arm, fever, headache, and weakness for approximately 2 days. The reporter stated that the pharmacy would have lot and expiry date information.
Sex: U
Vaccine: TDAP
Symptoms: Anaphylactic reaction
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of anaphylaxis in a 57-year-old patient who received DTaP vaccine for prophylaxis. On an unknown date, the patient received DTaP vaccine at an unknown dose. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced anaphylaxis (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylaxis was unknown. It was unknown if the reporter considered the anaphylaxis to be related to DTaP vaccine. Additional details were provided as follows: The case was received via Webform. The age at the vaccination was not reported. The patient was 57 years old at the reporting time. The health care professional stated that she had a patient who had a history of severe anaphylaxis to Tdap. It was unsure if vaccine was BOOSTRIX or another TDaP.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The reporter reported this case for her daughter-in-law's father. The age at vaccination was not reported. In March or April 2018, the patient received SHINGRIX. The patient denied permission to contact their physician. The reporter did not want to provide any additional information.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On 3rd August 2018, less than a year after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The pharmacist reported this case for a family member. The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. The pharmacist did not administer the SHINGRIX vaccine. The patient had 4 inch circle of redness around the injection site.
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Computerised tomogram, Guillain-Barre syndrome, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of Guillain Barre syndrome in a 54-year-old female patient who received BOOSTRIX for prophylaxis. On 22nd June 2018, the patient received BOOSTRIX. On 16th July 2018, 24 days after receiving BOOSTRIX, the patient experienced Guillain Barre syndrome (serious criteria hospitalization and GSK medically significant), tingling of extremity (serious criteria hospitalization), numbness in feet (serious criteria hospitalization), back pain (serious criteria hospitalization), lip pain (serious criteria hospitalization) and numbness of tongue (serious criteria hospitalization). The patient was treated with Immunoglobulin. On an unknown date, the outcome of the Guillain Barre syndrome was not recovered/not resolved and the outcome of the tingling of extremity, numbness in feet, back pain, lip pain and numbness of tongue were unknown. It was unknown if the reporter considered the Guillain Barre syndrome, tingling of extremity, numbness in feet, back pain, lip pain and numbness of tongue to be related to BOOSTRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician reported that a nurse practitioner who works in her office received BOOSTRIX. On 16th July 2018, she started experiencing numbness and tingling in her hands and feet. This got worse and worse and she experienced severe back and lip pain and her tongue went numb. She sent to the emergency room previous week of reporting date, had multiple laboratory tests, computed tomography (CT) and Magnetic Resonance Imaging (MRI). She saw a neurologist and had a repeat MRI and Guillain-Barre was eventually diagnosed based upon a lumbar puncture. On Friday, 3rd August 2018, she was admitted to the hospital and was currently in progressive care unit (PCU) getting intravenous immunoglobulin (IVIG).
Sex: F
Vaccine: TDAP
Symptoms: Immunoglobulin therapy, Laboratory test, Lip pain, Lumbar puncture abnormal, Nuclear magnetic resonance imaging abnormal
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of Guillain Barre syndrome in a 54-year-old female patient who received BOOSTRIX for prophylaxis. On 22nd June 2018, the patient received BOOSTRIX. On 16th July 2018, 24 days after receiving BOOSTRIX, the patient experienced Guillain Barre syndrome (serious criteria hospitalization and GSK medically significant), tingling of extremity (serious criteria hospitalization), numbness in feet (serious criteria hospitalization), back pain (serious criteria hospitalization), lip pain (serious criteria hospitalization) and numbness of tongue (serious criteria hospitalization). The patient was treated with Immunoglobulin. On an unknown date, the outcome of the Guillain Barre syndrome was not recovered/not resolved and the outcome of the tingling of extremity, numbness in feet, back pain, lip pain and numbness of tongue were unknown. It was unknown if the reporter considered the Guillain Barre syndrome, tingling of extremity, numbness in feet, back pain, lip pain and numbness of tongue to be related to BOOSTRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician reported that a nurse practitioner who works in her office received BOOSTRIX. On 16th July 2018, she started experiencing numbness and tingling in her hands and feet. This got worse and worse and she experienced severe back and lip pain and her tongue went numb. She sent to the emergency room previous week of reporting date, had multiple laboratory tests, computed tomography (CT) and Magnetic Resonance Imaging (MRI). She saw a neurologist and had a repeat MRI and Guillain-Barre was eventually diagnosed based upon a lumbar puncture. On Friday, 3rd August 2018, she was admitted to the hospital and was currently in progressive care unit (PCU) getting intravenous immunoglobulin (IVIG).
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of Guillain Barre syndrome in a 54-year-old female patient who received BOOSTRIX for prophylaxis. On 22nd June 2018, the patient received BOOSTRIX. On 16th July 2018, 24 days after receiving BOOSTRIX, the patient experienced Guillain Barre syndrome (serious criteria hospitalization and GSK medically significant), tingling of extremity (serious criteria hospitalization), numbness in feet (serious criteria hospitalization), back pain (serious criteria hospitalization), lip pain (serious criteria hospitalization) and numbness of tongue (serious criteria hospitalization). The patient was treated with Immunoglobulin. On an unknown date, the outcome of the Guillain Barre syndrome was not recovered/not resolved and the outcome of the tingling of extremity, numbness in feet, back pain, lip pain and numbness of tongue were unknown. It was unknown if the reporter considered the Guillain Barre syndrome, tingling of extremity, numbness in feet, back pain, lip pain and numbness of tongue to be related to BOOSTRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician reported that a nurse practitioner who works in her office received BOOSTRIX. On 16th July 2018, she started experiencing numbness and tingling in her hands and feet. This got worse and worse and she experienced severe back and lip pain and her tongue went numb. She sent to the emergency room previous week of reporting date, had multiple laboratory tests, computed tomography (CT) and Magnetic Resonance Imaging (MRI). She saw a neurologist and had a repeat MRI and Guillain-Barre was eventually diagnosed based upon a lumbar puncture. On Friday, 3rd August 2018, she was admitted to the hospital and was currently in progressive care unit (PCU) getting intravenous immunoglobulin (IVIG).
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Injection site swelling, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of fever in a adult female patient who received SHINGRIX for prophylaxis. On 3rd August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 3rd August 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain and injection site swelling. On 4th August 2018, the patient experienced fever, headache and general body pain. SHINGRIX was continued with no change. On an unknown date, the outcome of the fever, headache and general body pain were recovered/resolved and the outcome of the injection site pain and injection site swelling were not recovered/not resolved. It was unknown if the reporter considered the fever, injection site pain, injection site swelling, headache and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. However, it could be 51 or 52 years old. The patient experienced soreness at injection site and swelling at injection site. 1 day after receiving SHINGRIX, the patient experienced fever (the patient's body temperature was recorded as 102 degrees), headache and body aches. The patient was referred to her physician.
Sex: F
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 female patient who received SHINGRIX for prophylaxis. The patient's past medical history included lymphoma (lymphoma in remission). On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, 14 days 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. The patient broke out with lumbar distribution zoster, 2 weeks after receiving SHINGRIX. The reporter asked should the patient get second immunization of SHINGRIX, and if yes what should be the timing and the results studies in potentially immunosuppressed patients. The patient had already reported to centers for disease control (self-reported). The reporter did not agree to be contacted for follow up.
Age: 0.17
Sex: U
Vaccine: RVX
Symptoms: Expired product administered
Clinical narrative: This case was reported by a other health professional via patient support programs and described the occurrence of expired vaccine used in a 2-month-old patient who received Rotavirus vaccine (batch number 5816085452 ?, expiry date 22nd July 2018 GSK note: the reported lot number did not match with any GSK lot number) for prophylaxis. On 31st July 2018, the patient received Rotavirus vaccine. On 31st July 2018, unknown after receiving Rotavirus vaccine, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional details were provided as follows: This case had been reported through the GlaxoSmithKline's help desk. The caller administered expired rotavirus product to a 2 month old patient. The reporter did not confirm, whether the expired vaccine was ROTARIX or not. The call was very short and unfortunately not much information was provided. All the information available from the call had been provided and the caller did not callback.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of pain in arm in a 62-year-old female patient who received SHINGRIX for prophylaxis. On 1st August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient herself. The age at vaccination was not reported, but could be 61 years or 62 years. In August 2018, the patient experienced sore arm for 1 week. No other local reactions or general adverse events were experienced.
Sex: M
Vaccine: DTAP
Symptoms: Crying, Musculoskeletal stiffness, Pyrexia, Swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of stiffness in a adult male patient who received DTaP vaccine for prophylaxis. On an unknown date, the patient received the 1st dose of DTaP vaccine. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced stiffness, swelling, fever and crying. On an unknown date, the outcome of the stiffness, swelling, fever and crying were recovered/resolved. It was unknown if the reporter considered the stiffness, swelling, fever and crying to be related to DTaP vaccine. Additional details were provided as follows: The age at the vaccination was not reported, however at the time of the event the patient's age group was infant. The healthcare professional stated, the patient's mother reported that when patient was infant and received dose of DTaP vaccine, the patient experienced lot of stiffness, swelling, high fever, inconsolable crying for couple days after the vaccination. The healthcare professional did not have vaccine information or if it was a GlaxoSmithKline vaccine. This case was linked to the case US2018137399, reported by the same reporter for the same patient for 2nd dose with same adverse events.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 70-year-old male patient who received SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced influenza-like symptoms. The patient was treated with TYLENOL. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient received his first shot in the left deltoid and although he experienced flu like symptoms the following day, they dissipated after a couple of days and were not as intense as the second shot. He was treating the symptoms currently with extra strength TYLENOL. The patient indicated that he was in good shape physically. This case has been linked with US2018137496, reported by the same reporter.
Age: 0.17
Sex: U
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Product preparation error
Clinical narrative: Initial information received on 06-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 2 months old patient (gender not reported), who was vaccinated with a 0.5 ml dose of PENTACEL (Batch number:C5466AB) (expiry date and dose in series not reported) via intramuscular route in the right leg. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DTAP for Immunisation; HEPATITIS B VACCINE for Immunisation; and PREVENAR 13 and ROTATEQ for Immunisation on an unknown date. It was a case of actual medication error due to inappropriate reconstitution technique because the nurse gave mixed the Hib portion sterile water and administered it with that. It was unknown if any adverse event was occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Agitation, Balance disorder, Feeling abnormal
Clinical narrative: During  the night on 8/7/18, I experienced difficulty in maintaining my balance when getting out of bed and going to the bathroom. I had to be ready to grab an object as furniture to prevent falling while leaving the bed to the bathroom and  back to the bed. Yesterday, 8/8/18, I felt very agitated in general. I mentioned to my Wife that "I felt agitated and angry."  Today, 8/9/18 I feel somewhat spacey, but can functio w/o any problem.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, IPV, DTAPIPVHIB, IPV
Symptoms: Extra dose administered
Clinical narrative: Miss Communication between Dr. and myself. Pt was given PEDIARIX which contains polio and Polio.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Dizziness, Injection site pain, Nausea
Clinical narrative: Body aches, nausea, dizziness, weakness lasting, pain at injection site, stomach upset lasting about 36 hours.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Body aches, nausea, dizziness, weakness lasting, pain at injection site, stomach upset lasting about 36 hours.
Age: 50.0
Sex: F
Vaccine: JEV1
Symptoms: Needle issue
Clinical narrative: Client came in to receive dose #2 of Japanese Encephalitis. Upon receiving screening, this RN went and prepared prefilled syringe vaccine for administration using sterile technique, ensuring that no air was inside the syringe, and leaving the needle side of the syringe in it's original wrapper. After preparing the left deltoid for administration via an alcohol swab, and allowing to dry, this RN inserted the needle into the deltoid muscle and pushed the plunger to insert the vaccine.  However, upon pressing the plunger, the vaccine leaked out of the prefilled syringe, so much so that it was dripping down client's arm. This RN removed the needle, and upon closer inspection, noted that the needle was loosened from the syringe. Upon discussing with the client, she stated that "I didn't feel like I got very much, if any". Upon attempting to call the manufacturer with no answer, my coworker, spoke with Associate with Vaccine Preventable Diseases who confirmed that readministering was not contraindicated due to the fact that the client did not receive the full dose. The client agreed. Another dose was prepared and given in the right deltoid via the technique previously described. No evidence of spilling or leaking noted with this dose, and upon inspection of the syringe, client received the entire dose.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site papule, Injection site urticaria, Local reaction, Rash papular
Clinical narrative: Local reaction to left thigh - red, raised wheal with papules 3 cm. Also, scattered pink papular eruptions on face, trunk & pubis.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Culture, Injection site discharge, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Injection site on left leg reddened and swollen immediately following injection per father. Mother states that it kept getting larger as time went on. Over the next few days, there was progressive redness and hardness that continues until today. Today the mother was pushing on it when white pus-like material came out.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Nasopharyngitis, Tremor
Clinical narrative: Patient states that at approximately 3:00 AM on 8/9/18 she started having violent tremors that lasted about 45 minutes to an hour. Since, she has felt ill with viral like cold symptoms.
Age: 88.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Neuralgia, Paraesthesia
Clinical narrative: Pt developed nerve pain/tingles in legs--has not subsided at this time--Dr.  thinks it could be a peripheral neuropathy.
Age: 88.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fear of falling, Gait disturbance, Mobility decreased, Musculoskeletal disorder, Paraesthesia
Clinical narrative: Pt developed nerve pain/tingles in legs--has not subsided at this time--Dr.  thinks it could be a peripheral neuropathy.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Atrial fibrillation, Chest discomfort, Dyspnoea, Erythema
Clinical narrative: About 24 hrs after vaccine on August 7, 2018, inflammation, heat, large, hard swelling at injection site approximately 9cm x 9cm, extremely sensitive to touch. Throughout the day and night, experienced tachycardia (107-114 bpm) including previously diagnosed idiopathic A-fib, periods of diaphoresis, hypertensive (168/101, 159/100, 158/110) episodes, chest discomfort and shortness of breath, anxiety, and from shoulders up, feeling like my head and neck were being electrocuted (like a shock from an outlet). Extreme migraine for which medications did not help, ringing and other sounds that only I could hear. I took benadryl every 3-5 hours, along with regular medications and added a Nadalol  when I saw how high my BP was. Used ice for the redness and drew circles around the inflammation. The next morning the inflammation was still present and had enlarged.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Hypertension, Injection site induration, Injection site inflammation, Injection site pain
Clinical narrative: About 24 hrs after vaccine on August 7, 2018, inflammation, heat, large, hard swelling at injection site approximately 9cm x 9cm, extremely sensitive to touch. Throughout the day and night, experienced tachycardia (107-114 bpm) including previously diagnosed idiopathic A-fib, periods of diaphoresis, hypertensive (168/101, 159/100, 158/110) episodes, chest discomfort and shortness of breath, anxiety, and from shoulders up, feeling like my head and neck were being electrocuted (like a shock from an outlet). Extreme migraine for which medications did not help, ringing and other sounds that only I could hear. I took benadryl every 3-5 hours, along with regular medications and added a Nadalol  when I saw how high my BP was. Used ice for the redness and drew circles around the inflammation. The next morning the inflammation was still present and had enlarged.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Migraine, Paraesthesia, Tachycardia
Clinical narrative: About 24 hrs after vaccine on August 7, 2018, inflammation, heat, large, hard swelling at injection site approximately 9cm x 9cm, extremely sensitive to touch. Throughout the day and night, experienced tachycardia (107-114 bpm) including previously diagnosed idiopathic A-fib, periods of diaphoresis, hypertensive (168/101, 159/100, 158/110) episodes, chest discomfort and shortness of breath, anxiety, and from shoulders up, feeling like my head and neck were being electrocuted (like a shock from an outlet). Extreme migraine for which medications did not help, ringing and other sounds that only I could hear. I took benadryl every 3-5 hours, along with regular medications and added a Nadalol  when I saw how high my BP was. Used ice for the redness and drew circles around the inflammation. The next morning the inflammation was still present and had enlarged.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: About 24 hrs after vaccine on August 7, 2018, inflammation, heat, large, hard swelling at injection site approximately 9cm x 9cm, extremely sensitive to touch. Throughout the day and night, experienced tachycardia (107-114 bpm) including previously diagnosed idiopathic A-fib, periods of diaphoresis, hypertensive (168/101, 159/100, 158/110) episodes, chest discomfort and shortness of breath, anxiety, and from shoulders up, feeling like my head and neck were being electrocuted (like a shock from an outlet). Extreme migraine for which medications did not help, ringing and other sounds that only I could hear. I took benadryl every 3-5 hours, along with regular medications and added a Nadalol  when I saw how high my BP was. Used ice for the redness and drew circles around the inflammation. The next morning the inflammation was still present and had enlarged.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site dryness, Injection site erythema, Injection site pain, Injection site pruritus, Injection site urticaria
Clinical narrative: Patient has a red welt on left thigh at injection site about 4 cm in circumference. The area is itchy, painful, dry and very red. The welt developed the same day he received the vaccine. It did start to improve after the 6th day.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Peripheral swelling
Clinical narrative: Patient presented to clinic 24 hours after receiving dose 1 of anthrax with swelling of the right arm. Denied pain or itching. Patient came in 48 hours after vaccine and left arm was also swollen. Patient was seen in urgent care and prescribed ZYRTEC and methylprednisolone to resolve inflammation. Will follow up with primary care manager in the next couple days to follow up.
Age: 64.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Body temperature increased, Rash
Clinical narrative: Patient had low grade temperature starting the night of vaccination that lasted for two days then approximately 4 day after vaccination patient start breaking out in a rash on his torso.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Erythema, Fatigue, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: Very sore arm, limited movement in arm, redness and swollen, VERY tired, no appetite, unable to do anything, fever (38C). Started getting better after 1.5 days.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Swelling
Clinical narrative: Very sore arm, limited movement in arm, redness and swollen, VERY tired, no appetite, unable to do anything, fever (38C). Started getting better after 1.5 days.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Loss of consciousness, Pain in extremity, Peripheral swelling, Tenderness, Unresponsive to stimuli
Clinical narrative: Patient was in today for first TRUMENBA and second MCV4. MA administered injections and approximately 5 minutes later the patient walked out of the exam room to the front to make an appointment. At that time the patient passed out and was caught by MA before hitting the floor. LVN and provider was called immediately. She was laid on the ground with legs up. Vital signs were taken B/P was 98/56 O2 99 initially. Patient was unresponsive for 2 minutes. We placed ammonia inhalant under her nose and she was aroused shortly after. The Dr repeated vital signs about 5 minutes after and they were 103/71. After she woke back up she began to regain color. There was no loss is pulse or respirations. Patient stayed for 20 minutes after episode before MD allowed her to leave. Also was given ER precautions. Then today at 430 the patient came in with complaints of R arm pain and swelling. Dr went in to assess the patient and saw that her arm was not red or hard, however her right arm was visibly swollen and tender to touch. She was advised by the provider to ice it 3x's a day and take MOTRIN. She may return in 1 week if the swelling continues.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Loss of consciousness, Pain in extremity, Peripheral swelling, Syncope
Clinical narrative: Patient was in today for first TRUMENBA and second MCV4. MA administered injections and approximately 5 minutes later the patient walked out of the exam room to the front to make an appointment. At that time the patient passed out and was caught by MA before hitting the floor. LVN and provider was called immediately. She was laid on the ground with legs up. Vital signs were taken B/P was 98/56 O2 99 initially. Patient was unresponsive for 2 minutes. We placed ammonia inhalant under her nose and she was aroused shortly after. The Dr repeated vital signs about 5 minutes after and they were 103/71. After she woke back up she began to regain color. There was no loss is pulse or respirations. Patient stayed for 20 minutes after episode before MD allowed her to leave. Also was given ER precautions. Then today at 430 the patient came in with complaints of R arm pain and swelling. Dr went in to assess the patient and saw that her arm was not red or hard, however her right arm was visibly swollen and tender to touch. She was advised by the provider to ice it 3x's a day and take MOTRIN. She may return in 1 week if the swelling continues.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Rash
Clinical narrative: Pt came in about 4 days after the vaccination and presented with a rash/bruising on the same arm as the vaccination. She later reported that it only lasted for 2 days and disappeared.
Age: 1.17
Sex: F
Vaccine: FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Crying, Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: Minutes after vaccination, a bump appeared on the right arm about 1 inch below the injection site. Lump was raised and firm and measured 1.5 cm by 0.5 cm. Child was crying and was breathing normally. Due to the appearance of the bump, which looked like a possible hive, parent elected to have patient seen in ER. Mom later reported that bump remained for 10 days after the injection, and did not change in size.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Headache, Injection site pain, Nausea
Clinical narrative: Chills, severe headache, nausea, stomach pain, pain to left arm, (unable to touch site or lie on arm). Duration 9:00pm-8:00am (11 hours).
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Chills, severe headache, nausea, stomach pain, pain to left arm, (unable to touch site or lie on arm). Duration 9:00pm-8:00am (11 hours).
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Peripheral swelling, Skin warm, Tremor
Clinical narrative: Sore, shaky arm, warm to touch and swelled for 2 days now. No fever reported.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13
Symptoms: Erythema, Rash macular, Urticaria
Clinical narrative: Patient developed hives on face and blotchy erythematous skin around eyes approximately 15 minutes after vaccination.
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Patient needed the second dose, his mom said at first there was a small rash, now the site is swollen the size of a palm of his hand.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash, Rash erythematous, Skin warm
Clinical narrative: PATIENT RECEIVED SHOT ON 8/3/18. ON 8/4/18 PATIENT BEGAN HAVING SYMPTOMS. HER ARM IS RED AND WARM. ON 8/9/18, THE RASH IS LESS RED, BUT HAS EXTENDED TO BELOW THE ELBOW.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Blood lactate dehydrogenase normal, Blood uric acid normal, C-reactive protein normal, Chest X-ray normal, Full blood count normal
Clinical narrative: Patient found a supraclavicular mass about 6 days after receiving vaccination. The lymph node was about 1 cm in size, firm and fixed. Given the concerning location of the supraclavicular node, labwork was performed and chest X-Ray was done. All labwork and X-Ray findings were reassuring. Patient was scheduled with otolaryngology for evaluation and possible biopsy, but lymph node had improved in size on the morning of 8/7, so further evaluation was postponed. By the morning of 8/9, the lymph node had almost completely resolved.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Induration, Lymphadenopathy
Clinical narrative: Patient found a supraclavicular mass about 6 days after receiving vaccination. The lymph node was about 1 cm in size, firm and fixed. Given the concerning location of the supraclavicular node, labwork was performed and chest X-Ray was done. All labwork and X-Ray findings were reassuring. Patient was scheduled with otolaryngology for evaluation and possible biopsy, but lymph node had improved in size on the morning of 8/7, so further evaluation was postponed. By the morning of 8/9, the lymph node had almost completely resolved.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, HIBV, OPV, PPV
Symptoms: Muscle spasms, Urine analysis
Clinical narrative: Facial and body spasm. Patient was having facial spasms 3x in a row and about 1 hr apart on Sunday. Monday still having them. Tuesday 1x about every 4 hours. Wed same. Thursday same.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Cellulitis, Injection site swelling
Clinical narrative: 08/09/18 @ 3:48pm. Mother reports swelling and redness occurred the evening of 8/7/18 after receiving vaccines, she expected this, applied ice and administered TYLENOL. Wednesday, left arm was very swollen, up to shoulder, under arm and chest, she thought it would get better, it got worse. Reports today, child went to school, arm is much worse, with swelling of arm, under arm and chest to shoulder blade, brought child to Urgent Care and was referred to the Emergency Room, where she is calling from. Doctors have diagnosed condition as Cellulitis.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Autopsy, Crying, Death, Diet refusal, Middle insomnia
Clinical narrative: Our daughter was healthy with no issues whatsoever until after her four month shots. She had them and she changed. From the day she was born she slept through the night and always woke up at 6am which was so different from our son who was up multiple times in the night. But after her four month shots. We noticed that she would wake up through night a lot more. She wouldn't want to eat through the night. She would cry and scream like she was in pain. But there was never anything wrong. She was always a happy baby and so healthy. I also had a normal pregnancy. It was unlike her. However she had her bottom teeth and was chewing a lot on things so my husband and I thought it was just teething. About a month after her vaccinations she passed away. On August 6th of 2017 She had stopped breathing and was having issues August 5th late ate night and was pronounced dead on August 6th around 1 am.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pain, Respiratory arrest, Screaming, Sudden infant death syndrome, Teething
Clinical narrative: Our daughter was healthy with no issues whatsoever until after her four month shots. She had them and she changed. From the day she was born she slept through the night and always woke up at 6am which was so different from our son who was up multiple times in the night. But after her four month shots. We noticed that she would wake up through night a lot more. She wouldn't want to eat through the night. She would cry and scream like she was in pain. But there was never anything wrong. She was always a happy baby and so healthy. I also had a normal pregnancy. It was unlike her. However she had her bottom teeth and was chewing a lot on things so my husband and I thought it was just teething. About a month after her vaccinations she passed away. On August 6th of 2017 She had stopped breathing and was having issues August 5th late ate night and was pronounced dead on August 6th around 1 am.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Heart rate increased, Night sweats, Pain
Clinical narrative: Shivering, rapid heart rate, dizziness, night sweats, aches, sore arm (all occurred over 3 days after vaccination, sore arm persisted for more than a week), took Tylenol for pain, rash appeared on arm approximately 2 weeks after, remained for several more weeks, treated rash with triamcinolone acetonide 0.1 % cream.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash
Clinical narrative: Shivering, rapid heart rate, dizziness, night sweats, aches, sore arm (all occurred over 3 days after vaccination, sore arm persisted for more than a week), took Tylenol for pain, rash appeared on arm approximately 2 weeks after, remained for several more weeks, treated rash with triamcinolone acetonide 0.1 % cream.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Influenza like illness, Injection site pain, Myalgia
Clinical narrative: DOCTOR ALREADY NOTIFIED. Strong flu-like response with headache, muscle ache, slight fever, and exhaustion. Pain at injection site. Lasted for full 72 hours.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: DOCTOR ALREADY NOTIFIED. Strong flu-like response with headache, muscle ache, slight fever, and exhaustion. Pain at injection site. Lasted for full 72 hours.
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, C-reactive protein increased, Diarrhoea, Fatigue, Hypersensitivity
Clinical narrative: Allergic reaction to Pneumonia vaccine. Injection site redness, itching, swelling (softball size), fatigue, high fever 102F, muscle aches, joint pain, nausea, vomiting, diarrhea, elevated CRP.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Myalgia, Nausea
Clinical narrative: Allergic reaction to Pneumonia vaccine. Injection site redness, itching, swelling (softball size), fatigue, high fever 102F, muscle aches, joint pain, nausea, vomiting, diarrhea, elevated CRP.
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Vaccination complication, Vomiting
Clinical narrative: Allergic reaction to Pneumonia vaccine. Injection site redness, itching, swelling (softball size), fatigue, high fever 102F, muscle aches, joint pain, nausea, vomiting, diarrhea, elevated CRP.