chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU4
Symptoms: Cough, Malaise, Pain, Upper respiratory tract congestion, Wheezing
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of upper respiratory tract congestion in a elderly female patient who received Influenza vaccine Quadrivalent. Concomitant products included BREO. On 19th October 2017, the patient received Influenza vaccine Quadrivalent. On 20th October 2017, 1 days after receiving Influenza vaccine Quadrivalent, the patient experienced upper respiratory tract congestion, wheezing, cough, general body pain and sickness. On an unknown date, the outcome of the upper respiratory tract congestion, wheezing, cough, general body pain and sickness were not recovered/not resolved. It was unknown if the reporter considered the upper respiratory tract congestion, wheezing, cough, general body pain and sickness to be related to Influenza vaccine Quadrivalent. Additional details were provided as follows: The age at vaccination was not reported. The patient planned to follow-up with the physician on an unknown date. It was reported that the patient had a flu shot (unknown manufacturer) and got sick from the flu shot the next day and experienced congestion, body aches, wheezing and coughing. The reporter wanted to remain anonymous and wanted to disconnect and limited information was provided. This case was linked with case US2017165608, reported by same reporter for same event.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Anxiety, Dizziness, Hyperhidrosis, Injection site erythema, Nausea
Clinical narrative: Patient returned to administration area saying her left arm was very itchy, feeling anxious, light headed and nauseated. We had her sit down immediately. She then said she thought she was going to vomit and became diaphoretic. She then started complaining of itchy feeling all over with tongue and throat feeling fuzzy and swollen. Only redness noted to left deltoid area. EPI PEN auto injector 0.3 mg given by RN at 0845. Emergency services call placed at the same time by RN. BP 140/100 to right upper arm per RN at 0850 HR 72-We assisted patient down to the floor in supine position with legs elevated. Patient said the itching, tongue and throat symptoms were feeling better but anxiety is worse. I reassured her that this is a side effect of that medication that was administered. BP 176/110 to upper right arm. HR 96. Emergency personnel arrived at 8:53 AM. Oxygen saturation per EMS was 99% and BP 172/108 to left arm. Patient was then transported to Hospital for further evaluation.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia oral, Pharyngeal oedema, Pruritus, Pruritus generalised, Swollen tongue
Clinical narrative: Patient returned to administration area saying her left arm was very itchy, feeling anxious, light headed and nauseated. We had her sit down immediately. She then said she thought she was going to vomit and became diaphoretic. She then started complaining of itchy feeling all over with tongue and throat feeling fuzzy and swollen. Only redness noted to left deltoid area. EPI PEN auto injector 0.3 mg given by RN at 0845. Emergency services call placed at the same time by RN. BP 140/100 to right upper arm per RN at 0850 HR 72-We assisted patient down to the floor in supine position with legs elevated. Patient said the itching, tongue and throat symptoms were feeling better but anxiety is worse. I reassured her that this is a side effect of that medication that was administered. BP 176/110 to upper right arm. HR 96. Emergency personnel arrived at 8:53 AM. Oxygen saturation per EMS was 99% and BP 172/108 to left arm. Patient was then transported to Hospital for further evaluation.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Throat irritation
Clinical narrative: Patient returned to administration area saying her left arm was very itchy, feeling anxious, light headed and nauseated. We had her sit down immediately. She then said she thought she was going to vomit and became diaphoretic. She then started complaining of itchy feeling all over with tongue and throat feeling fuzzy and swollen. Only redness noted to left deltoid area. EPI PEN auto injector 0.3 mg given by RN at 0845. Emergency services call placed at the same time by RN. BP 140/100 to right upper arm per RN at 0850 HR 72-We assisted patient down to the floor in supine position with legs elevated. Patient said the itching, tongue and throat symptoms were feeling better but anxiety is worse. I reassured her that this is a side effect of that medication that was administered. BP 176/110 to upper right arm. HR 96. Emergency personnel arrived at 8:53 AM. Oxygen saturation per EMS was 99% and BP 172/108 to left arm. Patient was then transported to Hospital for further evaluation.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a physician via a company representative, referring to a 45 year old non-pregnant female patient. The patient's had no drug reactions/allergies, concurrent conditions, nor concomitant medications. On 09-OCT-2017 (reported as "a week and half ago on Monday"), the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscularly or subcutaneously, for prophylaxis (dose, lot # and expiration date were not reported). In October 2017 (reported as "a few days later"), the patient called her physician and complained that she had pain, swelling and redness at the injection site. It was stated that her physician instructed her to put ice on the injection site and to take some aspirin. On 13-OCT-2017 (reported as " on a Friday"), the patient went to her physician's office and upon be examined, the injection site was "still swollen" and looked as though there was a "knot on their arm" (injection site nodule). The physician also stated that the injection site "was still red and warm to touch". It was reported that the patient was treated with an unspecified steroid and that the patient would have a follow up in the physician's office "in a week" to see if the symptoms had subsided. At the time of reporting, the outcome of the events was reported as not recovered. A product quality complaint was not involved. The causality assessment between injection site pain, injection site swelling, injection site redness, injection site nodule, and injection site warmth with PNEUMOVAX 23 was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 17-OCT-2017, the patient was vaccinated with an improperly stored dose of VARIVAX  for prophylaxis, lot # N014630 with expiration date of 11-MAY-2019 (strength, dose, route and frequency were not reported). The sterile diluent (manufacturer unknown) that was used to reconstitute the VARIVAX was not improperly stored.  No adverse effects were reported. It was stated that the vaccine underwent a temperature excursion of 6°F (degrees Fahrenheit) to 14°F for 48 minutes; previous temperature excursion was done, 6°F to 14°F (34.68) for 54 minutes (worse case). The call was because of a "data logger".
Sex: M
Vaccine: VARZOS
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a male patient of unknown age. The patient's concurrent conditions included prostate cancer which was treated with an unspecified treatment every 6 months for an unspecified duration. Known allergies and concomitant medications was not provided. On 02-NOV-2017, the patient was vaccinated with ZOSTAVAX 19400 PFU with lot # M041085 and expiration date on 30-JAN-2018 (anatomical route of vaccination was not provided) for prophylaxis reconstituted on sterile diluent (MERCK STERILE DILUENT) lot # M034444 with expiration date on 27-MAR-2019 (product use issue). No adverse effects were reported.
Sex: U
Vaccine: MMRV, RV5, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant concerning to unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient were VARIVAX lot number M034586, expiration date 27-JUL-2018 or lot number N001530, expiration date 13-JAN-2019 or lot number N007930, expiration date 08-MAR-2019 or lot number N014368, expiration date 09-MAY-2019, or ROTATEQ lot number M041184, expiration date 31-MAY-2018 or PROQUAD lot number N014759, expiration date 08-NOV-2018 or lot number N015624, expiration date 15-NOV-2018 (strengths and doses were not reported) all of them for prophylaxis. The sterile diluent (manufacture unknown) used were stored properly. The temperature of excursion for ROTATEQ was 47 to 77 Fahrenheit degrees during 2 hours and the temperature of excursion for  VARIVAX and PROQUAD was 6 to 14 Fahrenheit degrees during 48 hours. No previous temperature of excursion was performed. The temperature of excursion was detected by a data logger. No adverse effects were reported.
Sex: F
Vaccine: PNC13
Symptoms: Haemorrhage, Injury associated with device, Needle issue
Clinical narrative: This is a spontaneous report from a contactable consumer (medical assistant) reporting for herself. A 44-year-old Hispanic female patient was exposed to PREVNAR 13 (lot number: S58704, expiration date: Oct2019), when she was capping a syringe, and the needle broke off above the hub and scraped her right thumb. This occurred on 27Oct2017, when she was putting the needle on. The patient further described the event as; she was holding the syringe with her left hand and was holding the needle with her right hand. When she was putting the needle onto the syringe, it broke off, and the syringe scraped her right thumb because the needle stayed in her hand. She did have some bleeding and covered it with a band aid. The patient had no relevant medical history, concomitant medications or relevant investigations. The patient recovered from the events on the same day of 27Oct2017.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Body temperature increased, Discomfort, Swelling
Clinical narrative: Temperature 100.6, discomfort, swelling.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash. Prednisone 40 mg every day, hydrocortisone 1 units BID.
Sex: F
Vaccine: FLU3
Symptoms: Cough, Malaise, Pain, Respiratory tract congestion, Wheezing
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of respiratory tract congestion in a adult female patient who received Influenza vaccine Quadrivalent. Concomitant products included BREO. In October 2017, the patient received Influenza vaccine Quadrivalent. In October 2017, less than a month after receiving Influenza vaccine Quadrivalent, the patient experienced respiratory tract congestion, wheezing, cough, general body pain and sickness. On an unknown date, the outcome of the respiratory tract congestion, wheezing, cough, general body pain and sickness were unknown. It was unknown if the reporter considered the respiratory congestion, wheezing, cough, general body pain and sickness to be related to Influenza vaccine Quadrivalent. Additional details were provided as follows: The caller wanted to remain anonymous and wanted to disconnect. Limited information was provided. The caller reported that the patient who was her friend, was younger than her, also had a flu shot (unknown manufacture), and got sick from the flu shot and experienced the same issue of congestion, body aches, wheezing and coughing. This case has been linked to case US2017165605 reported by same reporter.
Sex: F
Vaccine: MENB
Symptoms: Induration, Mass, Swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of swelling in a female patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On 24th October 2017, unknown after receiving BEXSERO, the patient experienced swelling, induration and mass. On an unknown date, the outcome of the swelling, induration and mass were unknown. It was unknown if the reporter considered the swelling, induration and mass to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The reporter reported on behalf of physician and reported that he went in today and gave her the label update for BEXSERO with post-marketing experience and she said she had two patients with extensive swelling and the persistent hard lump, a boy and a girl. That was all the information she could remember but asked to feel free to reach out to her and contact her if would like. This case is linked with case US2017GSK164006, reported by the same reporter.
Age: 64.0
Sex: M
Vaccine: PNC13
Symptoms: Myalgia, Swelling
Clinical narrative: And swelling, muscle pain.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Oedema, Peripheral swelling
Clinical narrative: Patient reported to clinic that left arm injection site for PNEUMOVAX started to itch and get sore on June 15 after June 14 vaccines provided. Patient called triage when swelling was in deltoid area, proceeded to elbow area and into forearm and took 4 days to resolve the edema, itching.
Sex: M
Vaccine: MENB
Symptoms: Induration, Mass, Swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of swelling in a male patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On 24th October 2017, unknown after receiving BEXSERO, the patient experienced swelling, induration and mass. On an unknown date, the outcome of the swelling, induration and mass were unknown. It was unknown if the reporter considered the swelling, induration and mass to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The reporter reported on behalf of physician and reported that he went in today and gave her the label update for BEXSERO with post-marketing experience and she said she had two patients with extensive swelling and the persistent hard lump, a boy and a girl. That was all the information she could remember but asked to feel free to reach out to her and contact her if would like. This case is linked with case US2017GSK164004, reported by the same reporter.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Rash macular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of skin blotches in a 64-year-old male patient who received FLUARIX QUADRIVALENT (batch number 4XH59, expiry date 2nd June 2018). Concomitant products included Atorvastatin. On 19th October 2017, the patient received the 1st dose of FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 21st October 2017, 2 days after receiving FLUARIX QUADRIVALENT, the patient experienced skin blotches. On an unknown date, the outcome of the skin blotches was not recovered/not resolved. The reporter considered the skin blotches to be possibly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient received FLUARIX QUADRIVALENT in left arm. The patient developed blotches on his ankles 2 days after receiving the vaccine. Blotches also developed on his thighs the next day. On the date of reporting, some of the blotches were appeared to be clearing up. The patient would consult with his physician to assess further. He had received previous flu vaccines, but did not know if any of them were FLUARIX and he never had a effect like this before. The batch number reported for FLUARIX QUADRIVALENT (UXH59) did not exist and was updated to 4XH59, as per sales database.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Rash
Clinical narrative: Pt. stated she has been experiencing swelling, soreness, rash like symptoms in her (R) arm recommended pt. to take NSAID, antihistamine, elevate arm and monitor/contact MD if worsens.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Rash, Skin warm, Tenderness
Clinical narrative: Redness, localized tenderness, rash, warmth to touch.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Insomnia, Nodule, Pruritus generalised, Urticaria
Clinical narrative: Patient developed fist size red knot on arm a few hours after vaccine was administered. The knot has decreased in size. On 11/6/17 started to itch all over and hives on face. Also trouble sleeping. Dr advised BENADRYL and pt doing better.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: Developed a rash 10 days post immunizations at 12 mo. visit. Rec'd MMR, VAR, Hep. A, and PCV 4.
Age: 58.0
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Exanthem appeared on day 12 post vaccination.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Pain, Tenderness
Clinical narrative: Lower back pain in the Kidney area. Tender to touch and movement in the Kidney location.
Age: 31.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Autism spectrum disorder, Basophil count normal, Basophil percentage
Clinical narrative: Patient in Clinic for counseling/vaccinations in preparation for trip planned for December. He was counseled on need for Hepatitis A and Typhoid vaccines and was advised that these vaccines were generally well tolerated, and provided with CDC VIS educational material. Typhoid vaccine was administered to left deltoid, with no immediate reaction. Hep A was administered and patient described discomfort at the injection site, which is a common reaction since the vaccine is a larger volume (1mL) than other vaccines. He was instructed to move his arm to disperse the medication in his muscle. Within a few seconds he stated that he felt hot and dizzy. He became very pallid, clammy and his head fell to his right side, he had uncoordinated movements of BUE. He remained unresponsive for approx. one minute. His breathing was shallow but regular, no difficulty breathing. SpO2 >97%. He returned to consciousness, and was able to answer orientation questions and follow simple commands. He then had an episode of emesis and lost consciousness for a second time. He was unresponsive for approx. 20-30 secs. He was incontinent of bladder and possibly of stool. When he returned to consciousness he remained so. He was supported by nursing staff and remained seated throughout. Attending physician called to clinic at onset of symptoms. Rapid response team alerted - transported patient to ED for further eval. At time of transfer he was alert, oriented, VS WNL, pallor resolving.
Age: 31.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium normal, Blood chloride normal
Clinical narrative: Patient in Clinic for counseling/vaccinations in preparation for trip planned for December. He was counseled on need for Hepatitis A and Typhoid vaccines and was advised that these vaccines were generally well tolerated, and provided with CDC VIS educational material. Typhoid vaccine was administered to left deltoid, with no immediate reaction. Hep A was administered and patient described discomfort at the injection site, which is a common reaction since the vaccine is a larger volume (1mL) than other vaccines. He was instructed to move his arm to disperse the medication in his muscle. Within a few seconds he stated that he felt hot and dizzy. He became very pallid, clammy and his head fell to his right side, he had uncoordinated movements of BUE. He remained unresponsive for approx. one minute. His breathing was shallow but regular, no difficulty breathing. SpO2 >97%. He returned to consciousness, and was able to answer orientation questions and follow simple commands. He then had an episode of emesis and lost consciousness for a second time. He was unresponsive for approx. 20-30 secs. He was incontinent of bladder and possibly of stool. When he returned to consciousness he remained so. He was supported by nursing staff and remained seated throughout. Attending physician called to clinic at onset of symptoms. Rapid response team alerted - transported patient to ED for further eval. At time of transfer he was alert, oriented, VS WNL, pallor resolving.
Age: 31.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Blood creatinine normal, Blood glucose normal, Blood potassium normal, Blood sodium normal, Blood urea normal
Clinical narrative: Patient in Clinic for counseling/vaccinations in preparation for trip planned for December. He was counseled on need for Hepatitis A and Typhoid vaccines and was advised that these vaccines were generally well tolerated, and provided with CDC VIS educational material. Typhoid vaccine was administered to left deltoid, with no immediate reaction. Hep A was administered and patient described discomfort at the injection site, which is a common reaction since the vaccine is a larger volume (1mL) than other vaccines. He was instructed to move his arm to disperse the medication in his muscle. Within a few seconds he stated that he felt hot and dizzy. He became very pallid, clammy and his head fell to his right side, he had uncoordinated movements of BUE. He remained unresponsive for approx. one minute. His breathing was shallow but regular, no difficulty breathing. SpO2 >97%. He returned to consciousness, and was able to answer orientation questions and follow simple commands. He then had an episode of emesis and lost consciousness for a second time. He was unresponsive for approx. 20-30 secs. He was incontinent of bladder and possibly of stool. When he returned to consciousness he remained so. He was supported by nursing staff and remained seated throughout. Attending physician called to clinic at onset of symptoms. Rapid response team alerted - transported patient to ED for further eval. At time of transfer he was alert, oriented, VS WNL, pallor resolving.
Age: 31.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Cold sweat, Coordination abnormal, Dizziness, Electrocardiogram QT interval, Eosinophil percentage
Clinical narrative: Patient in Clinic for counseling/vaccinations in preparation for trip planned for December. He was counseled on need for Hepatitis A and Typhoid vaccines and was advised that these vaccines were generally well tolerated, and provided with CDC VIS educational material. Typhoid vaccine was administered to left deltoid, with no immediate reaction. Hep A was administered and patient described discomfort at the injection site, which is a common reaction since the vaccine is a larger volume (1mL) than other vaccines. He was instructed to move his arm to disperse the medication in his muscle. Within a few seconds he stated that he felt hot and dizzy. He became very pallid, clammy and his head fell to his right side, he had uncoordinated movements of BUE. He remained unresponsive for approx. one minute. His breathing was shallow but regular, no difficulty breathing. SpO2 >97%. He returned to consciousness, and was able to answer orientation questions and follow simple commands. He then had an episode of emesis and lost consciousness for a second time. He was unresponsive for approx. 20-30 secs. He was incontinent of bladder and possibly of stool. When he returned to consciousness he remained so. He was supported by nursing staff and remained seated throughout. Attending physician called to clinic at onset of symptoms. Rapid response team alerted - transported patient to ED for further eval. At time of transfer he was alert, oriented, VS WNL, pallor resolving.
Age: 31.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Feeling hot, Granulocyte count, Granulocyte percentage, Haematocrit normal, Haemoglobin normal
Clinical narrative: Patient in Clinic for counseling/vaccinations in preparation for trip planned for December. He was counseled on need for Hepatitis A and Typhoid vaccines and was advised that these vaccines were generally well tolerated, and provided with CDC VIS educational material. Typhoid vaccine was administered to left deltoid, with no immediate reaction. Hep A was administered and patient described discomfort at the injection site, which is a common reaction since the vaccine is a larger volume (1mL) than other vaccines. He was instructed to move his arm to disperse the medication in his muscle. Within a few seconds he stated that he felt hot and dizzy. He became very pallid, clammy and his head fell to his right side, he had uncoordinated movements of BUE. He remained unresponsive for approx. one minute. His breathing was shallow but regular, no difficulty breathing. SpO2 >97%. He returned to consciousness, and was able to answer orientation questions and follow simple commands. He then had an episode of emesis and lost consciousness for a second time. He was unresponsive for approx. 20-30 secs. He was incontinent of bladder and possibly of stool. When he returned to consciousness he remained so. He was supported by nursing staff and remained seated throughout. Attending physician called to clinic at onset of symptoms. Rapid response team alerted - transported patient to ED for further eval. At time of transfer he was alert, oriented, VS WNL, pallor resolving.
Age: 31.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Hypopnoea, Injection site discomfort, Lymphocyte count normal, Lymphocyte percentage, Mean cell haemoglobin concentration normal
Clinical narrative: Patient in Clinic for counseling/vaccinations in preparation for trip planned for December. He was counseled on need for Hepatitis A and Typhoid vaccines and was advised that these vaccines were generally well tolerated, and provided with CDC VIS educational material. Typhoid vaccine was administered to left deltoid, with no immediate reaction. Hep A was administered and patient described discomfort at the injection site, which is a common reaction since the vaccine is a larger volume (1mL) than other vaccines. He was instructed to move his arm to disperse the medication in his muscle. Within a few seconds he stated that he felt hot and dizzy. He became very pallid, clammy and his head fell to his right side, he had uncoordinated movements of BUE. He remained unresponsive for approx. one minute. His breathing was shallow but regular, no difficulty breathing. SpO2 >97%. He returned to consciousness, and was able to answer orientation questions and follow simple commands. He then had an episode of emesis and lost consciousness for a second time. He was unresponsive for approx. 20-30 secs. He was incontinent of bladder and possibly of stool. When he returned to consciousness he remained so. He was supported by nursing staff and remained seated throughout. Attending physician called to clinic at onset of symptoms. Rapid response team alerted - transported patient to ED for further eval. At time of transfer he was alert, oriented, VS WNL, pallor resolving.
Age: 31.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal, Metabolic function test abnormal, Monocyte count normal
Clinical narrative: Patient in Clinic for counseling/vaccinations in preparation for trip planned for December. He was counseled on need for Hepatitis A and Typhoid vaccines and was advised that these vaccines were generally well tolerated, and provided with CDC VIS educational material. Typhoid vaccine was administered to left deltoid, with no immediate reaction. Hep A was administered and patient described discomfort at the injection site, which is a common reaction since the vaccine is a larger volume (1mL) than other vaccines. He was instructed to move his arm to disperse the medication in his muscle. Within a few seconds he stated that he felt hot and dizzy. He became very pallid, clammy and his head fell to his right side, he had uncoordinated movements of BUE. He remained unresponsive for approx. one minute. His breathing was shallow but regular, no difficulty breathing. SpO2 >97%. He returned to consciousness, and was able to answer orientation questions and follow simple commands. He then had an episode of emesis and lost consciousness for a second time. He was unresponsive for approx. 20-30 secs. He was incontinent of bladder and possibly of stool. When he returned to consciousness he remained so. He was supported by nursing staff and remained seated throughout. Attending physician called to clinic at onset of symptoms. Rapid response team alerted - transported patient to ED for further eval. At time of transfer he was alert, oriented, VS WNL, pallor resolving.
Age: 31.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Monocyte percentage, Neutrophil count normal, Neutrophil percentage, Pallor, Platelet count normal
Clinical narrative: Patient in Clinic for counseling/vaccinations in preparation for trip planned for December. He was counseled on need for Hepatitis A and Typhoid vaccines and was advised that these vaccines were generally well tolerated, and provided with CDC VIS educational material. Typhoid vaccine was administered to left deltoid, with no immediate reaction. Hep A was administered and patient described discomfort at the injection site, which is a common reaction since the vaccine is a larger volume (1mL) than other vaccines. He was instructed to move his arm to disperse the medication in his muscle. Within a few seconds he stated that he felt hot and dizzy. He became very pallid, clammy and his head fell to his right side, he had uncoordinated movements of BUE. He remained unresponsive for approx. one minute. His breathing was shallow but regular, no difficulty breathing. SpO2 >97%. He returned to consciousness, and was able to answer orientation questions and follow simple commands. He then had an episode of emesis and lost consciousness for a second time. He was unresponsive for approx. 20-30 secs. He was incontinent of bladder and possibly of stool. When he returned to consciousness he remained so. He was supported by nursing staff and remained seated throughout. Attending physician called to clinic at onset of symptoms. Rapid response team alerted - transported patient to ED for further eval. At time of transfer he was alert, oriented, VS WNL, pallor resolving.
Age: 31.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Posture abnormal, Protein total normal, Red blood cell count normal, Red cell distribution width normal, Unresponsive to stimuli
Clinical narrative: Patient in Clinic for counseling/vaccinations in preparation for trip planned for December. He was counseled on need for Hepatitis A and Typhoid vaccines and was advised that these vaccines were generally well tolerated, and provided with CDC VIS educational material. Typhoid vaccine was administered to left deltoid, with no immediate reaction. Hep A was administered and patient described discomfort at the injection site, which is a common reaction since the vaccine is a larger volume (1mL) than other vaccines. He was instructed to move his arm to disperse the medication in his muscle. Within a few seconds he stated that he felt hot and dizzy. He became very pallid, clammy and his head fell to his right side, he had uncoordinated movements of BUE. He remained unresponsive for approx. one minute. His breathing was shallow but regular, no difficulty breathing. SpO2 >97%. He returned to consciousness, and was able to answer orientation questions and follow simple commands. He then had an episode of emesis and lost consciousness for a second time. He was unresponsive for approx. 20-30 secs. He was incontinent of bladder and possibly of stool. When he returned to consciousness he remained so. He was supported by nursing staff and remained seated throughout. Attending physician called to clinic at onset of symptoms. Rapid response team alerted - transported patient to ED for further eval. At time of transfer he was alert, oriented, VS WNL, pallor resolving.
Age: 31.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Urinary incontinence, Vomiting, White blood cell count normal
Clinical narrative: Patient in Clinic for counseling/vaccinations in preparation for trip planned for December. He was counseled on need for Hepatitis A and Typhoid vaccines and was advised that these vaccines were generally well tolerated, and provided with CDC VIS educational material. Typhoid vaccine was administered to left deltoid, with no immediate reaction. Hep A was administered and patient described discomfort at the injection site, which is a common reaction since the vaccine is a larger volume (1mL) than other vaccines. He was instructed to move his arm to disperse the medication in his muscle. Within a few seconds he stated that he felt hot and dizzy. He became very pallid, clammy and his head fell to his right side, he had uncoordinated movements of BUE. He remained unresponsive for approx. one minute. His breathing was shallow but regular, no difficulty breathing. SpO2 >97%. He returned to consciousness, and was able to answer orientation questions and follow simple commands. He then had an episode of emesis and lost consciousness for a second time. He was unresponsive for approx. 20-30 secs. He was incontinent of bladder and possibly of stool. When he returned to consciousness he remained so. He was supported by nursing staff and remained seated throughout. Attending physician called to clinic at onset of symptoms. Rapid response team alerted - transported patient to ED for further eval. At time of transfer he was alert, oriented, VS WNL, pallor resolving.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Impaired work ability, Inflammation, Injected limb mobility decreased, Injection site pain
Clinical narrative: Reports she received flu vaccine on 10/20/17 in right arm at office. She reports she did not receive a copy of the flu vaccine consent form. Pt reports she looks away when she receives vaccines, but did turn her head while the needle was still in her arm and "felt it was very high up on the shoulder". She reports within 2-3 hours her shoulder became very sore, to the point where she didn't have "any mobility" in her shoulder. She was able to move her arm at the elbow. She reports the pain was so severe her husband had to help her get undressed. She reports she has this pain up until starting prednisone on 11/1/17. The provider is treating her with prednisone through 11/8/17 for inflammation. She has noticed a decrease in pain since starting the prednisone. She reports she is doing in home PT exercises for the next couple of weeks. Spoke to pt, she reports she was not scheduled to work on 11/1/17, her doctor advised her not to work on 11/2 & 11/3. She did return to work her regular FTE status on 11/6/17. Request that pt follow up with this nurse in 1-2 weeks after completing prednisone to report how she is feeling.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of personal independence in daily activities
Clinical narrative: Reports she received flu vaccine on 10/20/17 in right arm at office. She reports she did not receive a copy of the flu vaccine consent form. Pt reports she looks away when she receives vaccines, but did turn her head while the needle was still in her arm and "felt it was very high up on the shoulder". She reports within 2-3 hours her shoulder became very sore, to the point where she didn't have "any mobility" in her shoulder. She was able to move her arm at the elbow. She reports the pain was so severe her husband had to help her get undressed. She reports she has this pain up until starting prednisone on 11/1/17. The provider is treating her with prednisone through 11/8/17 for inflammation. She has noticed a decrease in pain since starting the prednisone. She reports she is doing in home PT exercises for the next couple of weeks. Spoke to pt, she reports she was not scheduled to work on 11/1/17, her doctor advised her not to work on 11/2 & 11/3. She did return to work her regular FTE status on 11/6/17. Request that pt follow up with this nurse in 1-2 weeks after completing prednisone to report how she is feeling.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Insomnia, Pain
Clinical narrative: Two days after receiving shot I started to feel a lot of pain where I received the shot. The pain radiates around and under the area as well as up to shoulder. I have trouble moving arm up and certain ways without pain. I also feel a burning sensation off and on in the area. Have trouble sleeping because of pain. I have never had any issues with my arm and I did not do anything in that time period for it to cause the pain.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Blood creatine phosphokinase, Chromaturia, Decreased appetite, Diarrhoea, Headache
Clinical narrative: Flu like symptoms including HA, muscle aches, diarrhea, loss of appetite starting suddenly 2-3 hrs after vaccine, continuing x 2 days then resolved. Also describes violent muscle "shaking" and rust colored urine during this same period.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza like illness, Metabolic function test, Myalgia, Urine analysis
Clinical narrative: Flu like symptoms including HA, muscle aches, diarrhea, loss of appetite starting suddenly 2-3 hrs after vaccine, continuing x 2 days then resolved. Also describes violent muscle "shaking" and rust colored urine during this same period.
Age: 38.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site pain, Peripheral swelling, Skin warm
Clinical narrative: 24 hours after receiving the vaccine the left arm began to swell and was hot to touch. There was burning sensation at the site.
Age: 18.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Paraesthesia, Throat tightness
Clinical narrative: Tingling in face, arms, and hands. Was given BENADRYL at the Student health center. Later that evening around 7 pm she went to the Medical Center ER because she felt dizzy and her throat was closing up.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Mobility decreased, Muscle spasms, Myalgia, X-ray
Clinical narrative: PATIENT DESCRIBED THAT SHE HAD CRAMP IN HER ARM. SHE HAD MUSCLE PAIN. SHE CANNOT MOVE HER ARM SO EASILY. SHE ALSO FEELING LESS STRENGTH ON HER SAME ARM. DR RECOMMEND FOR XRAY AND REFERRED TO PHYSICAL THERAPIST. SHE IS GETTING PHYSICAL THERAPY SESSIONS SINCE 10/09/17 TILL NOW. SHE HAS SOME SESSIONS SET UP THIS MONTH AND WILL FIND OUT LATER AFTER DONE THIS PHYSICAL THERAPY SESSION. SHE IS SEEING SOME IMPROVEMENT AFTER PHYSICAL THERAPY SESSIONS.
Age: 39.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Chest X-ray normal, Induration, Laboratory test normal, Lymphangitis
Clinical narrative: Cellulitis, induration and lymphangitis left upper extremity. Ultrasound negative for abscess. Treated with IV ANCEF while inpatient, transitioned to outpatient ceftriaxone IV and then transitioned to oral KEFLEX.
Age: 39.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Respiratory viral panel, Ultrasound scan abnormal, Ultrasound scan normal, Viral test negative, White blood cell count increased
Clinical narrative: Cellulitis, induration and lymphangitis left upper extremity. Ultrasound negative for abscess. Treated with IV ANCEF while inpatient, transitioned to outpatient ceftriaxone IV and then transitioned to oral KEFLEX.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Swelling, redness, pain and warm to touch on vaccine site, rash like.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV, VARZOS
Symptoms: Injection site erythema, Injection site pain, Nausea, Pharyngeal oedema, Pyrexia
Clinical narrative: Patient developed a reaction two hours after receiving ZOSTAVAX, FLUZONE HD and PNEUMOVAX 23. She had no reaction to the ZOSTAVAX but her right arm where she received the flu and pneumonia shots had a fist sized red, tender area around the injection site. She also reported fever, nausea, and her throat was swollen.
Age: 19.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Low grade fever and injection site pain 8 hours after injection. Fever 102.9F by 24 hours with repeated vomiting. Fever 103.9F 30 hours post vaccine. Left deltoid red, swollen hot to touch by 48 hours post vaccine with severe pain area measuring 3 inches by 4 inches. Redness spread to entire upper arm outer aspect by 36 hours.
Age: 19.0
Sex: M
Vaccine: PPV
Symptoms: Vaccination site cellulitis, Vomiting
Clinical narrative: Low grade fever and injection site pain 8 hours after injection. Fever 102.9F by 24 hours with repeated vomiting. Fever 103.9F 30 hours post vaccine. Left deltoid red, swollen hot to touch by 48 hours post vaccine with severe pain area measuring 3 inches by 4 inches. Redness spread to entire upper arm outer aspect by 36 hours.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, heat and pain at injection site. Developed into cellulitis that reached elbow and required antibiotics.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: L arm from shoulder to elbow became red, hot, swollen, very painful X 2 to 4 days. She also felt nauseated, headaches, lightheaded X 2 to 3 days.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Nausea
Clinical narrative: L arm from shoulder to elbow became red, hot, swollen, very painful X 2 to 4 days. She also felt nauseated, headaches, lightheaded X 2 to 3 days.
Sex: M
Vaccine: MENB
Symptoms: Facial asymmetry, Gait inability, Guillain-Barre syndrome, Muscular weakness, Paraesthesia
Clinical narrative: This is a spontaneous report from a contactable nurse Practitioner via a Company representative. A 17-year-old other ethnic group male patient received TRUMENBA (Lot # R47584, Expiry Date 31Jul2018, NDC # 00005-0100-10) intramuscular at 0.5 mg, single on 24Jul2017 for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient went to the ER a couple of times because his hands and feet were tingling. His smile was asymmetrical so they thought it was bell's palsy but it wasn't. He had weakness in lower extremities, and then couldn't walk. He was eventually diagnosed with Guillain-Barre syndrome. He was hospitalized once, but caller was not provided with the dates. States the patient is going through rehab now. He was improving. He was walking and was even able to run now. Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Age: 40.0
Sex: F
Vaccine: HEPAB
Symptoms: Burning sensation, Fatigue, Malaise, Pyrexia, Tremor
Clinical narrative: Arm burned, felt very tired, shaky, sick, fever.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Blood glucose, Dizziness, Rash, Rash macular
Clinical narrative: Broke out in blotchy rash on the chest, neck area, dizziness, occurred two hours after vaccination.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza A virus test positive, Pyrexia
Clinical narrative: Patient developed fever on 11-5-17 and tested positive for Flu on 11-6-17 per lab respiratory panel testing.
Age: 7.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Erythema, Pharyngeal erythema, Pruritus, Rash, Urticaria
Clinical narrative: On 11-6-17, patient developed redness and hives around 1500. Grandmother gave her Benadryl and they went away. Patient came to clinic on 11-7-17 with redness and hives again around 1430. Bilateral cheeks, temporal region, and forehead were red, with small welts present, especially on cheeks, bilaterally. Reports itching. Temp 99.3. SpO2 100% - denies any other complaints or concerns - no trouble breathing, no oral swelling, no abdominal pain, no nausea / vomiting / diarrhea, no sense of "impending doom."  Throat noted to be slightly red. No other abnormalities noted. Benadryl given (25mg) and rash went away within 10-15minutes. CDC and GlaxoSmith Kline were called and notified.  VAERS form filled out. Left with grandmother - instructed that if they return to seek emergency medical attention - She verbalized understanding. Will consider allergy testing if they persist. No testing done at this time.
Age: 7.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pharyngeal erythema, Urticaria
Clinical narrative: On 11-6-17, patient developed redness and hives around 1500. Grandmother gave her Benadryl and they went away. Patient came to clinic on 11-7-17 with redness and hives again around 1430. Bilateral cheeks, temporal region, and forehead were red, with small welts present, especially on cheeks, bilaterally. Reports itching. Temp 99.3. SpO2 100% - denies any other complaints or concerns - no trouble breathing, no oral swelling, no abdominal pain, no nausea / vomiting / diarrhea, no sense of "impending doom."  Throat noted to be slightly red. No other abnormalities noted. Benadryl given (25mg) and rash went away within 10-15minutes. CDC and GlaxoSmith Kline were called and notified.  VAERS form filled out. Left with grandmother - instructed that if they return to seek emergency medical attention - She verbalized understanding. Will consider allergy testing if they persist. No testing done at this time.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain upper, Chills, Cough, Headache, Influenza virus test negative
Clinical narrative: Fever started 11-4-17, cough, chills, H/a, stomach ache.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Fever started 11-4-17, cough, chills, H/a, stomach ache.
Age: 32.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Inflammation, Skin warm
Clinical narrative: Redness, inflammation, hot to touch. Reported to clinic on 3rd day on Nov 7th.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Discomfort, Drug administered at inappropriate site, Joint crepitation, Joint lock
Clinical narrative: Left shoulder joint pain, popping, catching, and discomfort. As per SIRVA information the shot was administered too high and too far back on shoulder near the joint instead of further down on the arm in the deltoid muscle as has been administered in the past.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Musculoskeletal discomfort
Clinical narrative: Left shoulder joint pain, popping, catching, and discomfort. As per SIRVA information the shot was administered too high and too far back on shoulder near the joint instead of further down on the arm in the deltoid muscle as has been administered in the past.
Age: 70.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: Red, hot, swollen upper right arm. Pt states he does not feel well.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Myalgia, Pyrexia
Clinical narrative: Light headed, fever, muscle aches, chills.
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Musculoskeletal pain, Sleep disorder
Clinical narrative: Pt experienced shoulder pain 2 days after getting vaccine that is still unresolved. Pt describes not being able to sleep on that shoulder.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: The patient got the vaccine around 4 pm on 11/6/17 and she went home. When she wake up next morning, she notice the arm where she got injection is seem red and swollen so she go to the pharmacy. Patient is advised to go to the clinic to see the doctor, in a mean times she is going to buy pain relief OTC and BENADRYL OTC.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling, Swelling
Clinical narrative: Patient reported to the pharmacy today with complaint about having swelling in her right thumb and right side which started the next day after she received the vaccine. Patient reported that it is better now.