chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Disorganised speech, Headache, Injection site discomfort, Injection site pain, Mobility decreased
Clinical narrative: 3 immunizations on 11-12-15. Resulted in high fever and an emergency room visit on 11-14-15. Blood test results showed white cells in blood. PA and hospital report indicates it could be from the injections. Three (3) different vaccines administered, Thursday, November 12, 2015 about Noon-12:15 pm, by pharmacist. I reported this reaction by phone to my doctor (Monday, Nov. 16?), and also a pharmacist (19th) where the injections were given. All 3 injections were given in my left arm/shoulder because I have a torn rotator cuff on my right shoulder. The shingles vaccine was injected under the skin under my upper left arm and the other 2 injections were given in the top of my shoulder. As I expected, my left shoulder was tender to the touch, and very uncomfortable when leaning on it, similar to past immunizations. I report this because I had to go to the emergency room where white cells/bacteria were found in my blood. I was told there by the PA that it was probably introduced with the vaccine injections. On 11-12-15 I had a 10:00 a.m. appointment with Dr. at the local clinic, not for an illness, but for a routine, 6-month appointment, including a routine blood test. Everything was fine. I talked with Dr. about having the 3 immunizations that another clinic had recommended when I was there Sept. 22. Both Dr. and a pharmacist said it shouldn't be a problem to have all three vaccines at one time. She contacted the local pharmacy. I had no problems until about 10:50 p.m. that night. I felt intermittent chills, and after I was in bed, my body started sharking uncontrollably for what seemed like a long time, until I went to sleep. The next morning, Friday the 13th, my temperature was about 100 degrees, and it kept rising all day. I had a terrible headache, couldn't think clearly and was unable to get out of bed except to go to the bathroom. I did not eat all day, and when I drank a glass of skim milk, it curdled and came up. After I woke up Saturday, all morning my temperature varied from 102 degrees to over 103 degrees (103.7 degrees at one point). In mid-morning when my daughter phoned, she told me that I wasn't making any sense. When I didn't recognize my husband, he took me over to our local hospital to the emergency room. They did a variety of tests (blood test, urine, chest x-ray), and the PA said there were white cells in my blood, saying it was bacteria most likely.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Neutrophil count increased, Thinking abnormal, Tremor
Clinical narrative: 3 immunizations on 11-12-15. Resulted in high fever and an emergency room visit on 11-14-15. Blood test results showed white cells in blood. PA and hospital report indicates it could be from the injections. Three (3) different vaccines administered, Thursday, November 12, 2015 about Noon-12:15 pm, by pharmacist. I reported this reaction by phone to my doctor (Monday, Nov. 16?), and also a pharmacist (19th) where the injections were given. All 3 injections were given in my left arm/shoulder because I have a torn rotator cuff on my right shoulder. The shingles vaccine was injected under the skin under my upper left arm and the other 2 injections were given in the top of my shoulder. As I expected, my left shoulder was tender to the touch, and very uncomfortable when leaning on it, similar to past immunizations. I report this because I had to go to the emergency room where white cells/bacteria were found in my blood. I was told there by the PA that it was probably introduced with the vaccine injections. On 11-12-15 I had a 10:00 a.m. appointment with Dr. at the local clinic, not for an illness, but for a routine, 6-month appointment, including a routine blood test. Everything was fine. I talked with Dr. about having the 3 immunizations that another clinic had recommended when I was there Sept. 22. Both Dr. and a pharmacist said it shouldn't be a problem to have all three vaccines at one time. She contacted the local pharmacy. I had no problems until about 10:50 p.m. that night. I felt intermittent chills, and after I was in bed, my body started sharking uncontrollably for what seemed like a long time, until I went to sleep. The next morning, Friday the 13th, my temperature was about 100 degrees, and it kept rising all day. I had a terrible headache, couldn't think clearly and was unable to get out of bed except to go to the bathroom. I did not eat all day, and when I drank a glass of skim milk, it curdled and came up. After I woke up Saturday, all morning my temperature varied from 102 degrees to over 103 degrees (103.7 degrees at one point). In mid-morning when my daughter phoned, she told me that I wasn't making any sense. When I didn't recognize my husband, he took me over to our local hospital to the emergency room. They did a variety of tests (blood test, urine, chest x-ray), and the PA said there were white cells in my blood, saying it was bacteria most likely.
Age: 11.0
Sex: M
Vaccine: FLUN4, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Soreness, redness 3 cm x 7 cm, swelling at injection site, warm to touch-no fevers.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Staring
Clinical narrative: At the conclusion of giving the vaccines, baby lay quietly, did not cry, had blank look on face, eyes open. No cyanosis. Mother picked baby up, he came to alertness after approx. 1-2 minutes M.D. came in, baby was laid back down, was by then looking around. Became alert again, then cried.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Injection site urticaria, Rash macular
Clinical narrative: Hives/red splotches around the shoulder area and underarm of the arm vaccinated. Itchy and sore to the touch.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Persistent left upper arm pain 8/10. No mass, no warmth, no fever. Pain started day of injection. Not improving with time. Heating pad will help.
Age: 1.02
Sex: F
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Redness and hard lump a (L) VL.
Age: 0.3
Sex: F
Vaccine: RV1
Symptoms: Underdose, Vomiting
Clinical narrative: This case was received by a physician via call center representative and described the occurrence of vomiting in a 4-month-old female patient who received ROTARIX (batch number A41CB549A, expiry date 12th February 2017). On an unknown date, the patient received the 2nd dose of ROTARIX oral. On an unknown date, less than a day after receiving ROTARIX, the patient experienced vomiting and underdose. On an unknown date, the outcome of the vomiting and underdose were unknown. It was unknown if the reporter considered the vomiting to be related to ROTARIX lyophilized formulation. Additional details were provided as follows: This case was not previously reported to anyone. The patient vomited (regurgitated) her 2nd dose of ROTARIX, which led to an underdose.
Age: 1.63
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Pain
Clinical narrative: Soreness, redness below injection site.
Age: 17.0
Sex: F
Vaccine: ADEN_4_7, FLUX, MEN, RUB, TD, TYP
Symptoms: Acute respiratory distress syndrome, Cardiac disorder, Chest X-ray, Ear disorder, Full blood count
Clinical narrative: I had time to walk to designated area, sit down and then I was being dragged out by someone on each arm and taken to emergency room. I do not remember anything at all (3 days) until I woke up with one of my coworkers praying at the side of my bed. I have spoke to many Reps, private doctors and ENT's concerning this matter. I feel as if no one can answer my questions or they do not want to get involved. I have been looking for answers for several years. I am submitting this information to you: As I do not know that it ever has been. I was told they almost killed me by attending nurses. I feel it should be know to you. I have refused any other vaccinations since age 17. At my current age and health I feel I should receive common vaccinations but fear them. To ask at my current age 54 should I fear necessary vaccinations. To ask if this situation could be responsible for or contribute to my consistent sinus, ear, teeth and heart problems I have developed since then. Any information or guidance you may provide in this situation would be greatly appreciated.
Age: 17.0
Sex: F
Vaccine: ADEN_4_7, FLUX, MEN, RUB, TD, TYP
Symptoms: Intensive care, Loss of consciousness, Sinus disorder, Tooth disorder
Clinical narrative: I had time to walk to designated area, sit down and then I was being dragged out by someone on each arm and taken to emergency room. I do not remember anything at all (3 days) until I woke up with one of my coworkers praying at the side of my bed. I have spoke to many Reps, private doctors and ENT's concerning this matter. I feel as if no one can answer my questions or they do not want to get involved. I have been looking for answers for several years. I am submitting this information to you: As I do not know that it ever has been. I was told they almost killed me by attending nurses. I feel it should be know to you. I have refused any other vaccinations since age 17. At my current age and health I feel I should receive common vaccinations but fear them. To ask at my current age 54 should I fear necessary vaccinations. To ask if this situation could be responsible for or contribute to my consistent sinus, ear, teeth and heart problems I have developed since then. Any information or guidance you may provide in this situation would be greatly appreciated.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash vesicular
Clinical narrative: Pt presented 2 days after receiving ZOSTAVAX with blistered, red rash on lower left rash. Pt advised to cover rash and seek medical attention.
Age: 0.22
Sex: F
Vaccine: DTAP
Symptoms: Injection site abscess, Rash papular
Clinical narrative: Rash - started 2 days after injection. Papular rash w/o erythema at site of injection.
Sex: F
Vaccine: HPVX
Symptoms: Impaired quality of life, Paralysis
Clinical narrative: This spontaneous report as received from a patient's mother, via webpage, refers to a female patient of unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant medications was reported. On an unknown date, the patient was vaccinated with a dose of quadrivalent HPV vaccine (manufacturer unknown), (dose, route of administration, lot number and expiration date were not reported). It was reported that the patient's daughter lost three years of her life and was paralyzed for 6 months. The patient got well through a series of supplements and strict diet. The outcome of events was not reported. The reporter considered adverse events to be related to quadrivalent HPV vaccine (manufacturer unknown). Upon internal review, the event of paralysis was considered to be medically significant. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: 4 days after receiving shingles vaccine, shingles rash appeared - confirmed on ER visit 10/18/15. Treated with valacyclovir.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Discomfort, Muscular weakness, Pain in extremity
Clinical narrative: Soreness upper thighs, upper arms all over achiness and weakness in these areas. Severe discomfort.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUN4, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Per pt's mother. Reports that Wed morning 1/20/16 pt c/o pain to (R) thigh. Mom noticed pt's thigh was red, she sent pt to school and when he came home from school his thigh was more swollen and red.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site swelling, Injection site warmth, Macule, Skin discolouration
Clinical narrative: Pt. received HPV #2 on 8/31/15. Injection site became hot and swollen. Pt. returned 1/9/16 for HPV #3 and showed the MD a 6mm non tender pink macule with central thickening, 2mm yellow central discoloration as if a flat pustule. Plan: trial of warm compresses to attempt to get it to drain.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: 12/4/15 pt received vaccine. Patient states soreness in arm has not gone away. Very sore after sleeping hard to raise arm.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, X-ray
Clinical narrative: 12/4/15 pt received vaccine. Patient states soreness in arm has not gone away. Very sore after sleeping hard to raise arm.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 23-OCT-2015, the patient was vaccinated with improperly stored GARDASIL 9 (strength, dose and route of administration were not reported, lot # L007560, expiration date: 15-JUN-2017). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 44.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Injection site induration, Pyrexia
Clinical narrative: This spontaneous report was received from a 44 year old male patient (representative's husband) via a company representative. Concurrent conditions included diabetes mellitus and penicillin allergy. On 18-JAN-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot#, dose, frequency and route of administration were unspecified) because he was diabetic. Concomitant therapies included HYZAAR, VYTORIN, metformin and NORVASC. On 18-JAN-2016, the patient experienced injection site hardness not long after receiving PNEUMOVAX 23. Then, on 19-JAN-2016, the patient developed fever and weakness. The patient received treatment with ibuprofen. No product quality complaint was involved. It was stated that the patient did not seek for medical attention, that no intervention to prevent serious criteria was necessary, that the patient was not hospitalized and that the adverse event was not significant disability or incapacity or life threatening. At the time of the report, the outcome of injection site induration, asthenia and pyrexia was reported as not recovered. The relatedness of the adverse events with PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse and refers to an unspecified number of patients of unknown age and gender. Medical history and concomitant medications were unknown. Since 05-JAN-2016, an unspecified number of patients were vaccinated with doses of GARDASIL lot # K008931 Expiration date 04-MAR-2016 and Lot # K010215 expiration date 05-MAY-2017 (dose and route were not reported), which were exposed to temperatures outside of the recommended range. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Flushing, Headache, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a female patient in her 50s reporting on herself, via company representative. She had diabetes, asthma, clostridium difficile infection and pneumonia. She did not present drug reactions/allergies. On 12-JAN-2016, the patient was vaccinated with ZOSTAVAX PREFERIGERATED vial 19400 plaque-forming units (PFU), 1 shot (dose, route and lot number were not reported). No concomitant medications were reported. On 13-JAN-2016, 2 days after onset of therapy the patient experienced injection site swelling, hot and shooting pain. She also reported injection site tenderness, chilling, flush and headache. The patient sought medical attention and contacted a physician. The physician told the patient to take ibuprofen, BENADRYL and to place ice on the swelling area. At the time of report, the outcome of flushing and chilling was reported as recovered. For the rest of the adverse events, the outcome was recovering. The relatedness between the adverse events and the vaccination with ZOSTAVAX was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: This spontaneous report was received from a female patient in her 50s reporting on herself, via company representative. She had diabetes, asthma, clostridium difficile infection and pneumonia. She did not present drug reactions/allergies. On 12-JAN-2016, the patient was vaccinated with ZOSTAVAX PREFERIGERATED vial 19400 plaque-forming units (PFU), 1 shot (dose, route and lot number were not reported). No concomitant medications were reported. On 13-JAN-2016, 2 days after onset of therapy the patient experienced injection site swelling, hot and shooting pain. She also reported injection site tenderness, chilling, flush and headache. The patient sought medical attention and contacted a physician. The physician told the patient to take ibuprofen, BENADRYL and to place ice on the swelling area. At the time of report, the outcome of flushing and chilling was reported as recovered. For the rest of the adverse events, the outcome was recovering. The relatedness between the adverse events and the vaccination with ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of oral, ROTATEQ lot # K013868 with 27-MAY-2016 and lot # L008053 exp. 30-NOV-2016, (dose and route were not provided). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse and refers to an unspecified number of patients of unknown age and gender. Medical history and concomitant medications were unknown. Since 04-JAN-2016, an unspecified number of patients were vaccinated with doses of ROTATEQ, oral, lot # L004453 expiration date 27-MAY-2016 (dose was not reported), which were exposed to temperatures outside of the recommended range, were given to unspecified patients. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Anogenital warts, Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a 62 year old female patient reporting on herself. The patient's pertinent medical history included depression. Concomitant therapies included PAXIL and SEROQUEL. On approximately 09-OCT-2015 (reported as four or five weeks before the event occurred), while the patient was at the annual papanicolaou (pap) examination, the physician slipped in one dose GARDASIL (exact dose, route, lot # and expiration date were not reported) on her. The vaccine was administered in patient's arm. On 13-NOV-2015, the patient experienced an outbreak of perianal warts. The patient sought medical attention by visiting a physician. The event was treated with imiquimod ointment and some of the warts have been burned off. The patient stated that is was "a life altering event". The outcome of the outbreak of perianal warts was reported as not recovered/not resolved. The relatedness between the outbreak of perianal warts and GARDASIL was not reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Anogenital warts, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a 62 year old female patient reporting on herself. The patient's pertinent medical history included depression. Concomitant therapies included PAXIL and SEROQUEL. On approximately 09-OCT-2015 (reported as four or five weeks before the event occurred), while the patient was at the annual papanicolaou (pap) examination, the physician slipped in one dose GARDASIL (exact dose, route, lot # and expiration date were not reported) on her. The vaccine was administered in patient's arm. On 13-NOV-2015, the patient experienced an outbreak of perianal warts. The patient sought medical attention by visiting a physician. The event was treated with imiquimod ointment and some of the warts have been burned off. The patient stated that is was "a life altering event". The outcome of the outbreak of perianal warts was reported as not recovered/not resolved. The relatedness between the outbreak of perianal warts and GARDASIL was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 21-OCT-2015, the patient was vaccinated with improperly stored GARDASIL 9 (strength, dose and route of administration were not reported, lot # L007560, expiration date: 15-JUN-2017). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 22-OCT-2015, the patient was vaccinated with improperly stored GARDASIL 9 (strength, dose and route of administration were not reported, lot # L007560, expiration date: 15-JUN-2017). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # J012520 exp. 30-JAN-2016 (dose and route were not provided). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left upper arm red, warm and swollen.  Painful to touch.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Status asthmaticus
Clinical narrative: Pt admitted for observation on 1/16/16 for status asthmaticus.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 01-JUL-2014, later than recommendation dosing schedule the patient was vaccinated with PNEUMOVAX 23 lot # L033707, expiration date- 18-MAY-2017, dose 1 and on 13-JAN-2016, 2 dose (inappropriate schedule of drug administration). No adverse event was reported. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to an unspecified number of patients of unknown age and gender. Medical history and concomitant medications were unknown. Since 05-JAN-2016, an unspecified number of patients were vaccinated with doses of VAQTA lot # K018181 expiration date 04-JUN-2017 (route, dose and anatomical location were not reported), which were exposed to temperatures outside of the recommended range. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a pharmacist regarding an unspecified patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 11-AUG-2015, the patient was vaccinated with first dose of VAQTA (lot # L01405, expiry date 28-APR-2017) dose, route unknown. Then on 07-JAN-2016, the pharmacist administered the second dose of VAQTA (lot # L036878, expiry date 26-MAY-2017) to the same unspecified patient. It was reported that the second dose of VAQTA was administered one month earlier than recommended. Concomitant medications were not reported. Product quality complaint (PQC) was not filed. Additional information is not expected as reported did not wish to contact further.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL lot # K006960 exp. 19-FEB-2017, (route and dose were not provided). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. On 16-MAY-2014, the patient was vaccinated with her first dose of VAQTA (route, dose, lot # and expiration date were not provided). Then on 13-JAN-2016, the patient was in the office to receive her second dose (Inappropriate schedule of drug administration). No adverse symptoms were reported. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: Redness at the injection site and distally. There is also a knot at the injection site. (L) deltoid.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Finger swelling 1 day after MENACTRA and ball of foot hurts. No other symptoms.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare student referring to a patient of unknown age and gender. Patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was inadvertently administered an expired GARDASIL (strength, dose, frequently, route and lot number were not reported) the reporter mentioned it was unspecified GARDASIL. No concomitant medication were reported. No adverse effects noted and no product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified medical assistant and refers to an unspecified number of patients of unknown age and gender. Medical history and concomitant medications were unknown. It was reported that improperly stored doses of PEDVAXHIB Lot # K016965, expiry date 20-JUL-2017, (dose and route were not reported), were given to unspecified patients on unspecified dates, between 22-JUL-2015 and 31-DEC-2015. No adverse effects were reported. No product quality complaint (PQC) was involved. It was also reported that GARDASIL 9 and PNEUMOVAX 23 were included on the lost of questionable temperature stability vaccines, but no doses were administered. This is one of three reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: The initial spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 20-JAN-2016, the patient was vaccinated with an expired dose of ZOSTAVAX injection (lot # K011004 with expiration date 07-NOV-2015; dose and route were not provided). No adverse effects were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lot # K009506 exp. 22-SEP-2016, (dose and route were not provided). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, via a company representative, referring to a 65 year old male patient. The patient's medical history and concurrent condition were not reported. On 16-NOV-2014, the patient was vaccinated with a first dose of ZOSTAVAX (Lot#, expiration date and route of administration were not reported) both. No adverse experience was reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Child received an additional dose of Meningococcal Vaccine in error not knowing she had already received a dose in November 2015 at a Health Department.
Age: 14.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Fall, Gingival bleeding, Head injury
Clinical narrative: On 01/20/16, medical assisitant (MA) administered TDAP (Adacel) Lot#: U5214AA Exp: 12/04/17, Manuf: SP; and HPV9 (Gardasil) Lot#: L016429 Exp: 08/09/17 Manuf: Merck & Co vaccines. Per MA pt tolerated well immediately after administration. Pt's mother was present and stated the same. As stated by MA, she left the room door slightly open to be able to observe the pt, and mother was present with pt. Less than 4 minutes later we heard a loud scream, which was the pt's mother asking for help. MA was the first to respond, since she was near the room, and per MA she noted the pt was on the floor faced up, and called code blue.  All medical and nursing staff responded to code blue. Front desk called 911. Pt was conscious, A&O x 4, vitals WNL, and pt denied any pain. A bump on her forehead was noted and slight blood on her gums. Pt's mother stated she was looking at her phone, and from her peripheral vision she saw the pt falling down from exam table/bed. Pt's mother stated the pt fell face forward, and she turned her over. Pt's mother stated the pt gets nervous around blood and needles. She stated the pt has" fainted at school when learning about blood cells, and gets pale after receiving vaccines." Notified pt's mom to always alert anyone giving her vaccines or drawing her blood of this. About 8 min later the paramedics arrived and assessed pt. Per pt's mother, she was given the option to have the ambulance take pt to hospital, or stay and take pt to the ER within the pt's insurance network. Pt's mother stated she would stay and take the pt to ER herself. Paramedics left and pt was continuously assessed by Dr., and myself for about 45 min. Vitals were WNL, pt was A&O x 4, and still denied any pain 0/10. Pt was provided with water and cold compresses. At 4:06 pm Dr. okayed pt to go. Discharge instructions provided to pt's mother, by Dr.   Pt's mother verbalized understanding.
Age: 0.39
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Immune thrombocytopenic purpura, Petechiae, Platelet count decreased
Clinical narrative: Developed a petechial rash the evening after the administration of 4month vaccines.  The vaccines included a combination vaccine of DTAP, IPV, and HIB.  Also received PCV-13, Hep B, and oral rotavirus.  Parents did not seek medical attention for 2 weeks because the baby seemed well otherwise.  Presented to their PCP on 1/20/16 with the petechial rash.  Subsequently referred to my tertiary center for severe thrombocytopenia.  The clinical course is consistent with immune thrombocytopenia (ITP).  He was just diagnosed yesterday, and he will be observed closely in the coming days/weeks for any adverse effects of the ITP.
Age: 7.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Decreased appetite, Dizziness, Dyspnoea, Injection site inflammation, Injection site swelling
Clinical narrative: Fevers low grade initially then up to 103.8. Vomiting x 2 days. SOB, dizziness, lethargy/listless, anorexia, inflammation/swelling at site, no diarrhea.
Age: 7.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Lethargy, Listless, Pyrexia, Vomiting
Clinical narrative: Fevers low grade initially then up to 103.8. Vomiting x 2 days. SOB, dizziness, lethargy/listless, anorexia, inflammation/swelling at site, no diarrhea.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Abdominal pain, Decreased appetite, Dyskinesia, Enuresis, Genital pain
Clinical narrative: Pt developed fever to 105 degrees, anorexia and jerking (seizure like) movements of body for approx. 1 wk following vaccination. At 2 wks post vaccination he developed tics. (squinting and throat clearing) daytime enuresis and random complaints of pain in abdomen and genital area. Neurologist felt it was to pertussis portion of vaccine.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Pyrexia, Seizure like phenomena, Strabismus, Throat irritation, Tic
Clinical narrative: Pt developed fever to 105 degrees, anorexia and jerking (seizure like) movements of body for approx. 1 wk following vaccination. At 2 wks post vaccination he developed tics. (squinting and throat clearing) daytime enuresis and random complaints of pain in abdomen and genital area. Neurologist felt it was to pertussis portion of vaccine.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Blister, Buccal mucosal roughening, Local swelling, Mass, Pruritus generalised
Clinical narrative: Client reported itching that started on 01/15/16 at around 5PM. Per mom, client described the itching as all over his body. When scratched, his skin erupted in small blisters that did not ooze, but according to client looked like they could erupt if he continued scratching. Per mom, client refrained from scratching for this reason. Mom stated client was given Benadryl since the itching started and that seemed to help his symptoms. Client went to primary care provider on 01/20/15 and was told by physician he believed this to be a reaction to the vaccine administered and gave him prednisone to reduce itching and swelling. Physician recommended not continuing the HPV series. Mom stated she noticed today that client's face and neck are swollen, and that she can see this "swelling underneath his chin". Mom also disclosed that client had felt a "lump" under his collarbone after his first set of vaccines on 11/09/15, but his physician believed this lump to not be related to the immunizations. Mom stated client denies any shortness of breath, difficulty swallowing or speaking, tingling in the lips/mouth, or swelling of the tongue. Client did tell mom the "inside of his mouth feels rough."
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Rash, Swelling face
Clinical narrative: Client reported itching that started on 01/15/16 at around 5PM. Per mom, client described the itching as all over his body. When scratched, his skin erupted in small blisters that did not ooze, but according to client looked like they could erupt if he continued scratching. Per mom, client refrained from scratching for this reason. Mom stated client was given Benadryl since the itching started and that seemed to help his symptoms. Client went to primary care provider on 01/20/15 and was told by physician he believed this to be a reaction to the vaccine administered and gave him prednisone to reduce itching and swelling. Physician recommended not continuing the HPV series. Mom stated she noticed today that client's face and neck are swollen, and that she can see this "swelling underneath his chin". Mom also disclosed that client had felt a "lump" under his collarbone after his first set of vaccines on 11/09/15, but his physician believed this lump to not be related to the immunizations. Mom stated client denies any shortness of breath, difficulty swallowing or speaking, tingling in the lips/mouth, or swelling of the tongue. Client did tell mom the "inside of his mouth feels rough."
Age: 3.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Eye swelling, Skin disorder, Swelling face
Clinical narrative: Woke up from nap, noted swelling to face, eyes, "blemishes" to face. Mom gave Benadryl and will have child evaluated in ER.
Age: 51.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injected limb mobility decreased, Vaccination site pain
Clinical narrative: PAIN IN RIGHT ARM AT VACCINATION SITE. LIMITED RANGE OF MOTION-CANNOT LIFT ARM ABOVE SHOULDER-SORENESS LASTING GREATER THAN 3 WEEKS. TREATING WITH ALEVE (NAPROXEN) AROUND THE CLOCK.
Age: 51.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Arthroscopic surgery, Joint range of motion decreased, Rotator cuff syndrome, Vaccination site pain, X-ray limb abnormal
Clinical narrative: PAIN IN RIGHT ARM AT VACCINATION SITE. LIMITED RANGE OF MOTION-CANNOT LIFT ARM ABOVE SHOULDER-SORENESS LASTING GREATER THAN 3 WEEKS. TREATING WITH ALEVE (NAPROXEN) AROUND THE CLOCK.
Age: 30.0
Sex: F
Vaccine: HPV9, TYP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain in muscle exactly where the injection was.  When she holds her arm in a certain position she has extreme pain.  No redness, swelling, or weakness in arm.  She did have typical pain on injection, swelling and redness after injection that lasted about 1 week after shot but it improved.  This pain started about 2 weeks after initial shot.
Age: 18.0
Sex: M
Vaccine: ADEN_4_7, FLUN4, HEPAB, MEN, PPV, TDAP
Symptoms: Drug screen negative, Full blood count normal, Generalised tonic-clonic seizure, Metabolic function test normal, Urine analysis normal
Clinical narrative: Tonic Clonic Seizure.
Age: 1.02
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Erythema, Hypersensitivity, Skin lesion, Urticaria
Clinical narrative: After receiving vaccines, patient waited in an exam to observe any possible allergic reactions with her mother. Approximately 10 minutes after receiving the vaccines, the patient's mother reported red lesions on the child's forehead and trunk. The patient's provider was notified immediately. The provider diagnosed the lesions as urticaria caused by an allergic reaction to the vaccines. The provider prescribed PO Benadryl that was given to the patient immediately. Patient was observed by nursing staff in the clinic for 30 minutes and was evaluated by the provider prior to be allowed to leave. Patient's mother reported no further issues.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Very sore arm afternoon and night after shot. Arm was weak and extreme pain in shoulder when moving and lifting following morning.  Took Aleve for pain.  Did not get better.  Went to doctor on 12/8. Was prescribed diclofenac 75mg tablets.  Said to call back if not better after taking meds and would refer to physical therapist.  Pain returned just as severe after completed meds. Called for referral.  Had first appointment with physical therapist on 1/19/16.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain, Chills, Discomfort, Injected limb mobility decreased, Injection site swelling
Clinical narrative: Swelling at site, swelling involves upper arm and shoulder, arm mobility decreased to 30° or less, pain encompassing entire area, chills, abdominal cramps, swelling in arm becomes size of tennis ball, pain, swelling and discomfort begin to dissipate 24 hours after vaccination.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Swelling at site, swelling involves upper arm and shoulder, arm mobility decreased to 30° or less, pain encompassing entire area, chills, abdominal cramps, swelling in arm becomes size of tennis ball, pain, swelling and discomfort begin to dissipate 24 hours after vaccination.
Age: 41.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Patient noted that upon wake up next mornging she experience shoulder pain and was unable to move her arm.
Age: 41.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Mobility decreased
Clinical narrative: Patient noted that upon wake up next mornging she experience shoulder pain and was unable to move her arm.
Age: 14.0
Sex: F
Vaccine: FLU3, HEPA, HPV9, VARCEL
Symptoms: Chills, Dyspnoea, Speech disorder, Throat tightness
Clinical narrative: 14 y/o female was in Clinic for immunizations Wednesday evening at 8PM on 1/20/2016. She denied reactions to previous vaccine, heart and lungs sounds were normal, and she was afraid. Approximately 15 minutes after giving last of four vaccines (HPV, Varicella, Hepatitis A, Influenza and PPD). Patient started shivering, she was covered, provider asked mother to stay at her side, and provider checked on her approximately 4 times in the 15 minutes. Patient started complaining of shortness of breath and difficulty speaking. Provider then administered oxygen via nasal cannula at 4LPM. Symptoms improved somewhat but patient was still shivering and complaining of constriction in her throat. Provider asked medical assistant to call 911 at approximately 8:55 Pm. Fire paramedics arrived approximately 9:05pm, assessed patient, and they gave her Benadryl 50 mg, loaded patient on Gurney, transported to hospital.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Injection site erythema, Injection site pruritus, Injection site swelling, Pain
Clinical narrative: Upper arm swollen and tender from elbow to shoulder. Red swollen area around shot site, size of 50 cent piece. Itching at injection site, body ache, fatique, fever for a day. Symptoms lasting for 1 week. Used Benadryl for itching and ibuprofen for pain and aches. Called Dr. office and told to administer above products.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Peripheral swelling, Pyrexia, Tenderness
Clinical narrative: Upper arm swollen and tender from elbow to shoulder. Red swollen area around shot site, size of 50 cent piece. Itching at injection site, body ache, fatique, fever for a day. Symptoms lasting for 1 week. Used Benadryl for itching and ibuprofen for pain and aches. Called Dr. office and told to administer above products.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Significant pain at site of injection lasting approximately 2 days.
Age: 6.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site swelling, Injection site urticaria, Middle ear effusion, Peripheral swelling, Pyrexia
Clinical narrative: Noticed large amount of swelling at injection site in the morning following the vaccination.  By the afternoon the swelling was most of her arm.  By the evening it began to include hives around injection site.  Next day she began running a fever.  Followed up with the Dr.  They noted fluid behind the ear on effected side.
Age: 56.0
Sex: M
Vaccine: PNC13
Symptoms: Calcium ionised decreased, Hypocalcaemia, Muscle spasms
Clinical narrative: 6/2015 developed hypocalcemia (ionized calcium 0.76) with muscle spasm - admitted to hospital for IV calcium.
Sex: M
Vaccine: HEP
Symptoms: Neurological symptom, Wheelchair user
Clinical narrative: This case was reported in a literature article and described the occurrence of neurological symptom in a adult male patient who received Hepatitis B vaccine. On an unknown date, the patient received the 1st dose of Hepatitis B vaccine. On an unknown date, less than a week after receiving Hepatitis B vaccine, the patient experienced neurological symptom (serious criteria disability). On an unknown date, the outcome of the neurological symptom was unknown. The reporter considered the neurological symptom to be related to Hepatitis B vaccine. Additional information was provided: This case was reported in a literature article and it described the occurrence of unspecified neurological symptoms in a male patient of unspecified age who had received an unspecified Hepatitis B vaccine (manufacturer unknown). The patient had a Doctorate of Philosophy and worked in a medical school laboratory at the time of the event. He and his sister received the vaccine on the same day, but the author commented that she was fine. No further information on the patient's concurrent medical conditions, medical and family history or concomitant medication was provided. On an unspecified date, the patient received the first dose of an unspecified Hepatitis B vaccine. Dosage was unknown; administration route and site were not unspecified; batch number was not provided. On an unspecified date, within a week of the administration of the vaccine, the patient was experiencing unspecified neurological symptoms and required a wheelchair. No further clinical details or diagnosis were provided by the author. The event was considered as disabling as it required the use of a wheelchair. Treatment was unknown. Outcome was unspecified at the time of reporting. The author believed that the vaccine could have caused the event. The author concluded that "the controversy regarding vaccines will continue, with no resolution in the foreseeable future due to the divergence of views. Are vaccines a success story? Yes, they are as can be attested to with polio, smallpox, rubella diphtheria, measles and tetanus. How do we address the concerns mentioned earlier? One answer is to give one vaccine at a time, which would help identify which vaccine gives an adverse reaction. Added to this, waiting 90 days between live virus vaccines is prudent. Last, never give a vaccine to a child who has been ill in the last 2 weeks, or if there are signs of inflammation, such as active allergies, wheezing, or eczema". The article corresponding to this case is not available for submission due to copyright restrictions.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain
Clinical narrative: Pain in left shoulder and difficulty raising left arm. Pain is not at injection site but up near the collar bone.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Furuncle, Pain, Pruritus, Pyrexia, Rash generalised
Clinical narrative: Full body rash/boils and itching since Monday. He said chicken pox? Fever and body aches.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Irritability
Clinical narrative: At approx. 1700 vacc were administer (DTAP-Hob-IPV, Hep B, PCV13, Rotavirus) child was ongoing unconsolably for approx. 8-10 min. Provider was notified and provider assessed the pt.