chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Cough, Insomnia, Malaise, Nausea
Clinical narrative: experienced malaise; experienced; he could not sleep; chills; nausea; episodes of coughing; This case was reported by a consumer and described the occurrence of malaise in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th February 2020, the patient received the 1st dose of Shingrix. On 19th February 2020, 1 days after receiving Shingrix, the patient experienced malaise, fever, insomnia, chills, nausea and cough. On an unknown date, the outcome of the malaise, insomnia, chills, nausea and cough were unknown and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the malaise, fever, insomnia, chills, nausea and cough to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix on 18th February 2020 around 9 AM and began to experience fever and malaise.  The patient could not sleep, continuing to experience fever, chills, nausea, and episodes of coughing. The fever subsiding but he continued to have some malaise. The patient went to the GSK Website for Shingrix, and said that he ticked the boxes for listed adverse event but did not experience other events besides those that were listed.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: experienced malaise; experienced; he could not sleep; chills; nausea; episodes of coughing; This case was reported by a consumer and described the occurrence of malaise in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th February 2020, the patient received the 1st dose of Shingrix. On 19th February 2020, 1 days after receiving Shingrix, the patient experienced malaise, fever, insomnia, chills, nausea and cough. On an unknown date, the outcome of the malaise, insomnia, chills, nausea and cough were unknown and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the malaise, fever, insomnia, chills, nausea and cough to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix on 18th February 2020 around 9 AM and began to experience fever and malaise.  The patient could not sleep, continuing to experience fever, chills, nausea, and episodes of coughing. The fever subsiding but he continued to have some malaise. The patient went to the GSK Website for Shingrix, and said that he ticked the boxes for listed adverse event but did not experience other events besides those that were listed.
Age: 26.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Dizziness, Nausea
Clinical narrative: Pt came into the clinic very nervous about getting immunizations to travel. After immunizations were given patient stated that she felt fine when questioned. Patient was taken to front desk for check out. While checking out the patient reported feeling dizzy. Patient was directed back to Immunization clinic. Nurse assessed patient and had her prop her legs in the chair. Cool compress was placed on back of patients neck and well as under her chin. Patient was able to talk to nurse through out ordeal. Patient did report that she could hear but it was difficult to hear what nurse was saying at first. BP checked at 1:45 pm 79/53. Patient c/o nausea but never vomit. Patient was given a  Coke w/ peanut butter crackers and she was able to tolerate that. BP checked @ 1:50pm 79/56 P-54. Patient continue to talk to nurses about up coming trip. BP checked @ 1:57 pm 93/70 P-57. Patient stated that she felt better and felt more like herself. BP checked @2:05 pm 97/73 P-63. Nurse had patient take feet out of chair and for patient to remain seated for a few mins. Patient stated again that she was feeling better. Denies dizziness. Patient was advised to wait in lobby an additional 15 mins before she was able to leave facility.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse reaction: vaccine was administered by error prior to patient turning 16.
Age: 66.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Chills, Headache, Injection site swelling, Myalgia
Clinical narrative: swollen injection site,muscle pain,headache, shivering,
Sex: F
Vaccine: HEP
Symptoms: Antibody test negative
Clinical narrative: titers drawn on an unknown date indicated insufficient antibodies; This spontaneous report was received from a female patient of unknown age, who is also a physical therapist and was reporting on herself. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions or allergies or medical history provided.   On an unknown date the patient was vaccinated with hepatitis b vaccine (manufacturer unknown) 10mcg/1.0 ml, intramuscularly (dose, frequency, lot #, expiration date and thimerosal status were not reported) for prophylaxis. It is unknown if the patient received one or more doses of the vaccine. On an unknown date, titers drawn indicated insufficient antibodies. On an unknown date, the patient received an additional dose of hepatitis b vaccine (manufacturer unknown) to boost her immunity. Current antibody levels were not known.  The causality assessment of the event was not provided.
Sex: U
Vaccine: HEPA, HIBV, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; a patient was administered an improperly stored dose of either VAQTA, PEDVAXHIB, or GARDASIL9; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.       On 16-DEC-2019, the patient was vaccinated with an improperly stored dose either of hepatitis a vaccine, inactivated (VAQTA) VIAL (lot # S010727, expiration date 26-JUL-2020; strength and route were not reported), haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # S006471, expiration date 22-JAN-2022; strength and route were not reported) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # 1621926, expiration date 28-NOV-2021; strength and route were not reported) for prophylaxis (product storage error). The administered dose of the vaccine was stored with the temperature of 34.9 degrees Fahrenheit for 7 minutes and 48.2 degrees Fahrenheit for 5 hours. Data logger was involved. There was no previous temperature excursion. No additional adverse effects were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.;  devicelotnumber: 1621926; expirationdate: 28-NOV-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: No information about availability; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Pneumonia
Clinical narrative: pneumonia; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a 62-year-old patient of an unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was prescribed zoster vaccine live (ZOSTAVAX) vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 03-APR-2015, the patient was administered zoster vaccine live (ZOSTAVAX) (dose, anatomical location, route of administration, lot # and expiry date were not provided) at pharmacy by a pharmacist. The patient suffered the following injuries and was diagnosed on the following dates as a result of the zoster vaccine live (ZOSTAVAX) vaccine: pneumonia and was diagnosed on 09-JUN-2015. The outcome of the event was not provided. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of pneumonia was considered to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient(pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. On or about 28-AUG-2012, pt was inoculated with zoster vaccine live(ZOSTAVAX) (dose, route of administration, anatomical location, lot#, expiration date were unknown), as prescribed and/or administered by a healthcare provider for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to zoster vaccine live(ZOSTAVAX) inoculation, pt was treated by a health care provider at Emergency Department for shingles. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Age: 15.0
Sex: M
Vaccine: HEP, HPV9
Symptoms: Abnormal behaviour, Alanine aminotransferase normal, Anion gap, Aspartate aminotransferase normal, Base excess increased
Clinical narrative: Client's mother came into Clinic to bring another child for immunizations on 03/02/2020. At that time she told me of reaction son had from last immunizations on 12/13/2019. According to ER report, Client presented to ER with difficulty breathing. He had received his third set of vaccinations around 08:45 on December 13, 2019. He went to school and said that his hands felt heavy and appeared yellow. (In report from mother she stated blue and purple).  At about noon he developed a diffuse headache. He left school about 245 PM. He had mild shortness of breath through the day. He did not feel well, had no appetite and slept. Did not interact with others as usual. While walking home from Aunt's home he started complaining shortness of breath. He laid down and it seemed to get worse so they brought him to the emergency department. Of note, mother states that the first time he had immunizations they were 6 different shots and he had some slight shortness of breath afterwards. The patient also states that he had a slight headache with that as well. The second time was on September 20 that he had immunizations, and the shortness of breath was worse as was the headache. Systolic blood pressure at the time of intake was 150.
Age: 15.0
Sex: M
Vaccine: HEP, HPV9
Symptoms: Basophil count normal, Basophil percentage, Blood albumin normal, Blood alkaline phosphatase normal, Blood bicarbonate normal
Clinical narrative: Client's mother came into Clinic to bring another child for immunizations on 03/02/2020. At that time she told me of reaction son had from last immunizations on 12/13/2019. According to ER report, Client presented to ER with difficulty breathing. He had received his third set of vaccinations around 08:45 on December 13, 2019. He went to school and said that his hands felt heavy and appeared yellow. (In report from mother she stated blue and purple).  At about noon he developed a diffuse headache. He left school about 245 PM. He had mild shortness of breath through the day. He did not feel well, had no appetite and slept. Did not interact with others as usual. While walking home from Aunt's home he started complaining shortness of breath. He laid down and it seemed to get worse so they brought him to the emergency department. Of note, mother states that the first time he had immunizations they were 6 different shots and he had some slight shortness of breath afterwards. The patient also states that he had a slight headache with that as well. The second time was on September 20 that he had immunizations, and the shortness of breath was worse as was the headache. Systolic blood pressure at the time of intake was 150.
Age: 15.0
Sex: M
Vaccine: HEP, HPV9
Symptoms: Blood bilirubin normal, Blood calcium normal, Blood chloride normal, Blood creatinine, Blood glucose normal
Clinical narrative: Client's mother came into Clinic to bring another child for immunizations on 03/02/2020. At that time she told me of reaction son had from last immunizations on 12/13/2019. According to ER report, Client presented to ER with difficulty breathing. He had received his third set of vaccinations around 08:45 on December 13, 2019. He went to school and said that his hands felt heavy and appeared yellow. (In report from mother she stated blue and purple).  At about noon he developed a diffuse headache. He left school about 245 PM. He had mild shortness of breath through the day. He did not feel well, had no appetite and slept. Did not interact with others as usual. While walking home from Aunt's home he started complaining shortness of breath. He laid down and it seemed to get worse so they brought him to the emergency department. Of note, mother states that the first time he had immunizations they were 6 different shots and he had some slight shortness of breath afterwards. The patient also states that he had a slight headache with that as well. The second time was on September 20 that he had immunizations, and the shortness of breath was worse as was the headache. Systolic blood pressure at the time of intake was 150.
Age: 15.0
Sex: M
Vaccine: HEP, HPV9
Symptoms: Blood pH normal, Blood potassium normal, Blood sodium normal, Blood urea normal, Carbon dioxide decreased
Clinical narrative: Client's mother came into Clinic to bring another child for immunizations on 03/02/2020. At that time she told me of reaction son had from last immunizations on 12/13/2019. According to ER report, Client presented to ER with difficulty breathing. He had received his third set of vaccinations around 08:45 on December 13, 2019. He went to school and said that his hands felt heavy and appeared yellow. (In report from mother she stated blue and purple).  At about noon he developed a diffuse headache. He left school about 245 PM. He had mild shortness of breath through the day. He did not feel well, had no appetite and slept. Did not interact with others as usual. While walking home from Aunt's home he started complaining shortness of breath. He laid down and it seemed to get worse so they brought him to the emergency department. Of note, mother states that the first time he had immunizations they were 6 different shots and he had some slight shortness of breath afterwards. The patient also states that he had a slight headache with that as well. The second time was on September 20 that he had immunizations, and the shortness of breath was worse as was the headache. Systolic blood pressure at the time of intake was 150.
Age: 15.0
Sex: M
Vaccine: HEP, HPV9
Symptoms: Chest X-ray normal, Decreased appetite, Drug screen negative, Dyspnoea, Electrocardiogram normal
Clinical narrative: Client's mother came into Clinic to bring another child for immunizations on 03/02/2020. At that time she told me of reaction son had from last immunizations on 12/13/2019. According to ER report, Client presented to ER with difficulty breathing. He had received his third set of vaccinations around 08:45 on December 13, 2019. He went to school and said that his hands felt heavy and appeared yellow. (In report from mother she stated blue and purple).  At about noon he developed a diffuse headache. He left school about 245 PM. He had mild shortness of breath through the day. He did not feel well, had no appetite and slept. Did not interact with others as usual. While walking home from Aunt's home he started complaining shortness of breath. He laid down and it seemed to get worse so they brought him to the emergency department. Of note, mother states that the first time he had immunizations they were 6 different shots and he had some slight shortness of breath afterwards. The patient also states that he had a slight headache with that as well. The second time was on September 20 that he had immunizations, and the shortness of breath was worse as was the headache. Systolic blood pressure at the time of intake was 150.
Age: 15.0
Sex: M
Vaccine: HEP, HPV9
Symptoms: Eosinophil count normal, Eosinophil percentage, Fibrin D dimer, Fraction of inspired oxygen, Haematocrit increased
Clinical narrative: Client's mother came into Clinic to bring another child for immunizations on 03/02/2020. At that time she told me of reaction son had from last immunizations on 12/13/2019. According to ER report, Client presented to ER with difficulty breathing. He had received his third set of vaccinations around 08:45 on December 13, 2019. He went to school and said that his hands felt heavy and appeared yellow. (In report from mother she stated blue and purple).  At about noon he developed a diffuse headache. He left school about 245 PM. He had mild shortness of breath through the day. He did not feel well, had no appetite and slept. Did not interact with others as usual. While walking home from Aunt's home he started complaining shortness of breath. He laid down and it seemed to get worse so they brought him to the emergency department. Of note, mother states that the first time he had immunizations they were 6 different shots and he had some slight shortness of breath afterwards. The patient also states that he had a slight headache with that as well. The second time was on September 20 that he had immunizations, and the shortness of breath was worse as was the headache. Systolic blood pressure at the time of intake was 150.
Age: 15.0
Sex: M
Vaccine: HEP, HPV9
Symptoms: Haemoglobin increased, Headache, Limb discomfort, Lymphocyte count increased, Lymphocyte percentage
Clinical narrative: Client's mother came into Clinic to bring another child for immunizations on 03/02/2020. At that time she told me of reaction son had from last immunizations on 12/13/2019. According to ER report, Client presented to ER with difficulty breathing. He had received his third set of vaccinations around 08:45 on December 13, 2019. He went to school and said that his hands felt heavy and appeared yellow. (In report from mother she stated blue and purple).  At about noon he developed a diffuse headache. He left school about 245 PM. He had mild shortness of breath through the day. He did not feel well, had no appetite and slept. Did not interact with others as usual. While walking home from Aunt's home he started complaining shortness of breath. He laid down and it seemed to get worse so they brought him to the emergency department. Of note, mother states that the first time he had immunizations they were 6 different shots and he had some slight shortness of breath afterwards. The patient also states that he had a slight headache with that as well. The second time was on September 20 that he had immunizations, and the shortness of breath was worse as was the headache. Systolic blood pressure at the time of intake was 150.
Age: 15.0
Sex: M
Vaccine: HEP, HPV9
Symptoms: Malaise, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume decreased
Clinical narrative: Client's mother came into Clinic to bring another child for immunizations on 03/02/2020. At that time she told me of reaction son had from last immunizations on 12/13/2019. According to ER report, Client presented to ER with difficulty breathing. He had received his third set of vaccinations around 08:45 on December 13, 2019. He went to school and said that his hands felt heavy and appeared yellow. (In report from mother she stated blue and purple).  At about noon he developed a diffuse headache. He left school about 245 PM. He had mild shortness of breath through the day. He did not feel well, had no appetite and slept. Did not interact with others as usual. While walking home from Aunt's home he started complaining shortness of breath. He laid down and it seemed to get worse so they brought him to the emergency department. Of note, mother states that the first time he had immunizations they were 6 different shots and he had some slight shortness of breath afterwards. The patient also states that he had a slight headache with that as well. The second time was on September 20 that he had immunizations, and the shortness of breath was worse as was the headache. Systolic blood pressure at the time of intake was 150.
Age: 15.0
Sex: M
Vaccine: HEP, HPV9
Symptoms: Monocyte count normal, Monocyte percentage, Neutrophil count normal, PCO2 increased, Platelet count normal
Clinical narrative: Client's mother came into Clinic to bring another child for immunizations on 03/02/2020. At that time she told me of reaction son had from last immunizations on 12/13/2019. According to ER report, Client presented to ER with difficulty breathing. He had received his third set of vaccinations around 08:45 on December 13, 2019. He went to school and said that his hands felt heavy and appeared yellow. (In report from mother she stated blue and purple).  At about noon he developed a diffuse headache. He left school about 245 PM. He had mild shortness of breath through the day. He did not feel well, had no appetite and slept. Did not interact with others as usual. While walking home from Aunt's home he started complaining shortness of breath. He laid down and it seemed to get worse so they brought him to the emergency department. Of note, mother states that the first time he had immunizations they were 6 different shots and he had some slight shortness of breath afterwards. The patient also states that he had a slight headache with that as well. The second time was on September 20 that he had immunizations, and the shortness of breath was worse as was the headache. Systolic blood pressure at the time of intake was 150.
Age: 15.0
Sex: M
Vaccine: HEP, HPV9
Symptoms: Protein total normal, Red blood cell count normal, Red cell distribution width normal, Somnolence, Troponin I
Clinical narrative: Client's mother came into Clinic to bring another child for immunizations on 03/02/2020. At that time she told me of reaction son had from last immunizations on 12/13/2019. According to ER report, Client presented to ER with difficulty breathing. He had received his third set of vaccinations around 08:45 on December 13, 2019. He went to school and said that his hands felt heavy and appeared yellow. (In report from mother she stated blue and purple).  At about noon he developed a diffuse headache. He left school about 245 PM. He had mild shortness of breath through the day. He did not feel well, had no appetite and slept. Did not interact with others as usual. While walking home from Aunt's home he started complaining shortness of breath. He laid down and it seemed to get worse so they brought him to the emergency department. Of note, mother states that the first time he had immunizations they were 6 different shots and he had some slight shortness of breath afterwards. The patient also states that he had a slight headache with that as well. The second time was on September 20 that he had immunizations, and the shortness of breath was worse as was the headache. Systolic blood pressure at the time of intake was 150.
Age: 15.0
Sex: M
Vaccine: HEP, HPV9
Symptoms: Urine analysis normal, White blood cell count normal, Yellow skin
Clinical narrative: Client's mother came into Clinic to bring another child for immunizations on 03/02/2020. At that time she told me of reaction son had from last immunizations on 12/13/2019. According to ER report, Client presented to ER with difficulty breathing. He had received his third set of vaccinations around 08:45 on December 13, 2019. He went to school and said that his hands felt heavy and appeared yellow. (In report from mother she stated blue and purple).  At about noon he developed a diffuse headache. He left school about 245 PM. He had mild shortness of breath through the day. He did not feel well, had no appetite and slept. Did not interact with others as usual. While walking home from Aunt's home he started complaining shortness of breath. He laid down and it seemed to get worse so they brought him to the emergency department. Of note, mother states that the first time he had immunizations they were 6 different shots and he had some slight shortness of breath afterwards. The patient also states that he had a slight headache with that as well. The second time was on September 20 that he had immunizations, and the shortness of breath was worse as was the headache. Systolic blood pressure at the time of intake was 150.
Age: 1.0
Sex: F
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Injection site bruising, Injection site erythema, Injection site rash, Vomiting
Clinical narrative: On July 6th 2018 at 9:00pm fever began and lasted until July 8th. Fever spiked as high as 103.9 degrees. Vomited at 1am on July 7th. On July 9th, a red, bumpy rash developed at the injection site - upper right thigh.  Rash lasted a few days, and then bruised over. Called Dr. on July 9th to explain symptoms. Emailed a photo of the rash. Doctor called back and said is was a reaction to Varicella shot and said there was no need to come into the office for a visit.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Drug hypersensitivity, Injection site bruising, Injection site discolouration, Injection site erythema, Injection site rash
Clinical narrative: Patient was seen in office by PCP on 03.03.20 where Kinrix and Proquad immunizations were administered to the left thigh. Father stated during return visit on 03.10.20 he noticed the immunization site was warm to touch approx. 4-6 hours after 03.03.20 visit along with discoloration including redness and bruising. on 03.04.20 the pt was taken to the ED for allergic reaction to antibiotic prescribed at the same visit along with swelling progression to immunization site. ED note stated  "There is an approximately 3 cm in diameter erythematic and warm, slightly elevated rash to the left lateral thigh. No pitting edema present."  Pt was examined during return follow up visit by PCP on 03.10.20 where it was noted the swelling had completely dissipated, only leaving a slight purple-blue hue at injection site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Patient was seen in office by PCP on 03.03.20 where Kinrix and Proquad immunizations were administered to the left thigh. Father stated during return visit on 03.10.20 he noticed the immunization site was warm to touch approx. 4-6 hours after 03.03.20 visit along with discoloration including redness and bruising. on 03.04.20 the pt was taken to the ED for allergic reaction to antibiotic prescribed at the same visit along with swelling progression to immunization site. ED note stated  "There is an approximately 3 cm in diameter erythematic and warm, slightly elevated rash to the left lateral thigh. No pitting edema present."  Pt was examined during return follow up visit by PCP on 03.10.20 where it was noted the swelling had completely dissipated, only leaving a slight purple-blue hue at injection site.
Age: 56.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Pain, Pain in extremity, Ultrasound scan
Clinical narrative: From provider's note on 3/9/20: Prolonged muscle pain after Shingrix injection. Patient reports that her harm was sore right after getting the vaccination and it has never completely gone away. She denies ever having a hot, red, or swollen area at the injection site. She was a little achy but it only lasted about 24 hours. Since that time the left upper arm has been tender, not really tender to touch but tender with mobility. If she raises her arm such as when driving, she will get an aching sensation in that muscle that makes her have to lower her arm. She reports when it is really bothering her it can be a 4/10 on a pain scale. She has not been able to palpate any lumps and palpating the area occasionally creates some mild discomfort but not all the time. It truly is with movement and using that arm where she gets most of her symptoms. She has never had any arm or shoulder pain before. She has no pain radiating to her forearm. She has full mobility to her shoulder, elbow, and wrist.
Sex: U
Vaccine: HEPA, HIBV, HPV9, UNK, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported.; on 01/06/2020 a patient was administered an improperly stored dose of either VAQTA, PEDVAX HIB, or GARDASTL9; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about patient's pertinent concurrent conditions, medical history, concomitant medications, previous drug reactions or allergies were not provided.  On 06-JAN-2020, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) pre-filled syringe (lot # S010727, expiration date 26-JUL-2020); haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # S006471, expiration date 22-JAN-2022) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe (lot # 1621926, expiration date 28-NOV-2021) for prophylaxis (for all vaccines concentration, number of administered dose, route and anatomical location of vaccination were not reported) (product storage error). No adverse effects were reported for the patient. The medical assistant could not confirm which vaccine was administered to the patient.  Involved vaccines experienced temperature excursion of 34.9 degrees Fahrenheit (F) for 7 minutes and 48.2 F for 5 hours. There was no previous temperature excursion. Digital data logger was involved.
Age: 11.0
Sex: M
Vaccine: DTAP, MNQ
Symptoms: Cough, Oropharyngeal pain, Pain, Pruritus, Swelling
Clinical narrative: significant swelling, pain, itching in left arm. cough same day sore throat next day
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Injection site pain, Myalgia
Clinical narrative: Shivering, fever, headache, muscle and joint pain plus the usual injection site pain.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Shivering, fever, headache, muscle and joint pain plus the usual injection site pain.
Sex: F
Vaccine: TYP
Symptoms: Early onset familial Alzheimer's disease
Clinical narrative: Patient has early onset Alzheimer's and during home visit found a suspect bag in patient's home counter.  Patient lives on her own but receives periodic home visits twice a week. Patient specified that she had no recollection of where bag originated and it was there since yesterday.  Patient left the bag alone since was not sure what it was about and did not want to touch it; patient had emptied the contents on sink. Reporter has no knowledge that patient requires a Typhoid vaccine.  The bag on the counter was white with green labeling. It had information about a Typhoid vaccine. Inside there were gloves, cotton balls with blood, one syringe with capped needle and another empty syringe wrapper with no needle and a used alcohol pad. There was a white plastic container with a lidlid was open--and reporter assumes items were in that container.  There were also clear fluid filled sheets of paper, and what could be bubble wrap or insulator.  There were no details on the bag as to the vaccine administrator. Reporter took photos of bag and contents and will submit them as follow-up; she then disposed items since did not want to leave it at patient's home.   Reporter not sure if patient received the vaccine.  Patient has no symptoms seemed perfectly fine during visit.  Patient takes daily walks with dog and could have picked up bag on the waybut that would be out of norm.  Please contact reporter if you have additional questions about incident or patient.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Gait inability, Mobility decreased, Peripheral swelling
Clinical narrative: patient called and reported that arm was significantly swollen (more than would be expected with a vaccine) and that should could not move her arm.  Said pain was spreading to her back and was becoming so severe that should could not move her arm or walk. Advised patient to follow up with primary care physician to seek their treatment recommendation.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Left arm pain starting the day of the receiving the pneumonia vaccine. Pain at the site, that shoots down the arm. No weakness, numbness, or change in color of the arm, no bleeding, underlying mass, or swelling. Tylenol and low dose benzo was given in the ED, sling applied for comfort. Possible underlying nerve irritation or periosteal inflammation per ED doctors note.
Age: 44.0
Sex: M
Vaccine: ANTH, ANTH, ANTH, ANTH, ANTH, FLU4, HEP, HEP, HEPA, HEPAB
Symptoms: Blindness, Deafness, Myalgia
Clinical narrative: AS I CAME BACK, LOSS OF HEARING, EYESIGHT AND MUSCLE HURT.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Pyrexia, Skin warm
Clinical narrative: Chills fever, and hot to touch
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given a high dose flu vaccine, she is not 65. Patient is 42 and should have been given the standard flu injection.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abdominal pain, Emotional distress, Irritability
Clinical narrative: Infant had extreme fussiness and abdominal pain 2 hours after infant go dose of vaccines for 4 hours. She wanted to stay curled in the fetal position with knees to chest and mother couldn't straighten her out. She was completely inconsolable during that time. Mother gave her Tylenol initially and then finally laid a warm compress on her abdomen and this relaxed her. She never had any blood in her stool. She hasn't had this problem again. She was not reevaluated that day.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: Injection site pain, fatigue, headache, aching in muscles and joints
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired vaccine administered; The patient experienced no symptoms; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.  On 19-JAN-2016, the patient was vaccinated with an expired dose of  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) subcutaneously for prophylaxis, lot # J016233 and expiration date 19-DEC-2015 (dose, strength and frequency were not reported).  It was reported that the patient experienced no symptoms.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided; Nurse reported the patient was administered an improperly stored dose of ROTATEQ; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, or drug reactions/allergies.     On 26-FEB-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) vial (product storage error), by oral route (lot # 1660151, has been verified to be a valid lot number; expiration date 17-SEP-2020) as prophylaxis (dosage schedule and strength were not reported).   The administered dose of the vaccine experienced a temperature excursion below 36 Fahrenheit degrees  to 35.2 Fahrenheit degrees for 10 minutes and below 36 Fahrenheit degrees to 35 Fahrenheit degrees  for 1 hour and 20 minutes as recorded by a data logger. There was no previous temperature excursion. There was no adverse effect reported.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Transient ischaemic attack
Clinical narrative: transient ischemic attack; Information has been received from a lawyer concerning a case in litigation and refers to a a 60-year-old patient of an unknown gender. No information about the patient's medical history, concurrent conditions and concomitant medications was provided. On 13-AUG-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) injection (dose, route of administration, lot # and expi8ry date were not specified), prescribed by a healthcare provider and administered by a physician for a long-term prevention of shingles and zoster-related conditions. As a result of zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered from transient ischemic attack diagnosed on 27-AUG-2015. The outcome of the event was unknown.   Upon internal review, the event of transient ischemic attack was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal pain, Back pain, Burning sensation, Herpes zoster, Radicular pain
Clinical narrative: thoracic radicular pain around right flank to right abdomen; abdominal pain; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 61-year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or about 17-APR-2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided), as prescribed by a healthcare provided for the long-term prevention of shingles and/or zoster-related conditions. The patient suffered right sided abdominal pain and burning, intermittent radiating pain to the back and was diagnosed with shingles on 13-AUG-2013. The patient also suffered thoracic radicular pain around right flank to right abdomen area and was diagnosed on 26-SEP-2013. The outcome of the events was unknown. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Mobility decreased
Clinical narrative: difficult to move the arm up and down; swelling at the injection site; This spontaneous report as received from a medical assistant refers to a 69-year-old male patient. This report concerns 1 patient and 1 combination product. The patient's concurrent conditions included diabetes, hypertension and latex allergy. His concomitant therapies included lisinopril (manufacturer unknown), metformin and insulin human (HUMULIN). No information about the patient's past medical history was provided. On 03-MAR-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscularly, lot # S029542, expiration date 10-JUN-2021 (dose was not reported) for prophylaxis. On 04-MAR-2020, the patient experienced swelling at the injection site and difficulty to move the arm up and down. The patient sought for medical attention by scheduling appointment with a physician. The outcome of the events was reported as not recovered/not resolved. The relatedness between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S029542; expirationdate: 10-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date in 2008, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, anatomical location, route of administration, lot # and expiry date were not provided), as prescribed and/or administered by the healthcare provider at physician's office for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by the healthcare provider for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was considered to be not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. In 2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided), as prescribed and/or administered by a pharmacist for the long-term prevention of shingles and/or zoster-related conditions. Subsequently, the patient was treated by healthcare provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient suffered and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the shingles was unknown. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: No additional adverse effects; A thin female patient was administered GARDASIL 9 in her buttock; This spontaneous report as received from a medical assistant via a company representative refers to a 23-year-old female patient. This case concerns 1 patient and 1 combination product. The patient was thin. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 04-MAR-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R002344, expiration date 16-NOV-2020 in her buttock instead of her arm or thigh(dose and route of administration were not reported) for prophylaxis. There was no adverse event reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R002344; expirationdate: 16-NOV-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Dizziness, Palpitations
Clinical narrative: Patient reports that about 1.5 hours after Tdap injection on 3/6/20 she had the following symptoms: dizziness, racing heart and weakness which lasted about 10 minutes. Reports she had not experienced theses symptoms again but wanted it noted in her chart for future reference.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash, Rash pruritic
Clinical narrative: Patient says has itchy rash  on face with blisters by eye lash.  Still has as of yesterday 3/09/2020
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Trigeminal neuralgia
Clinical narrative: right trigeminal neuralgia; Information has been received from a lawyer concerning a case in litigation and refers to a 63-year-old patient of an unknown gender. No information about the patient's medical history, concurrent conditions and concomitant medications was provided. On 11-NOV-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) injection (dose, route of administration, vaccination site, lot # and expiry date were not specified), prescribed by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. As a result of zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered right trigeminal neuralgia diagnosed on 22-OCT-2014. The outcome of the event was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Deafness neurosensory, Tinnitus
Clinical narrative: diagnosed with symmetric high-frequency sensorineural hearing loss; tinnitus in both ears; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 27-JUL-2016, the patient was administered zoster vaccine live (ZOSTAVAX) (dose, route, lot # and expiration date not provided) by a pharmacist, at a pharmacy, as recommended for long-term prevention of shingles and zoster-related conditions. O an unspecified date, the patient suffered the following injuries and was diagnosed as a result of the zoster vaccine live (ZOSTAVAX) vaccine with: tinnitus in both ears and was diagnosed with symmetric high-frequency sensorineural hearing loss. The outcome of the events was unknown. Causality assessment between the events and the suspect vaccine was related.  Upon internal review symmetric high-frequency sensorineural hearing loss was considered to be medically significant event.