chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Blood test, Erythema, Infection, Injection site erythema, Malaise
Clinical narrative: This spontaneous report was received from a 66 year old female patient reporting on herself. The patient has no pertinent medical history and no known drug reactions/allergies. It was reported that on 20-OCT-2015 the patient was vaccinated with a "blooster" of PNEUMOVAX 23 (dose and route were not provided), Lot # reported as K010464, exp date on 23-MAR-2016, left arm. Concomitantly, the patient received on the same date a flu shot in her right arm (therapy unspecific). Other concomitant therapy includes omeprazole (manufacturer unknown). On the same day, the patient reported that her left arm began to hurt. On the next date, the patient reported she could not lift her arm above her waistline. On 22-OCT-2015 patient stated that she was now able to lift her arm, but there was redness at the injection site that traveled throughout the same day to her left elbow, and then to her left forearm. On 23-OCT-2015, she went to an unspecified physician who informed her she had an infection. The same unspecified physician prescribed cefadroxil 500 mg to be taken 2 times a day for 10 days. The patient reported that the redness was getting worse, and she was not feeling well, so she went to an unspecified hospital on 25-OCT-2015. At the unspecified hospital (at which she was not admitted), she was instructed to stop taking the prescribed cefadroxil. The hospital took unspecified blood tests and she was told that her body "was not fighting the infection". An unspecified healthcare provider at the hospital prescribed amoxicillin and clavulanate, 875mg, twice a day for a week and SULFATRIM DS, 100mg, 2 times a day for a week and administered an unspecified dose of IV ZOSYN. The patient also reported that she started taking acidophilus for her stomach, on 25-OCT-2015. At the time of the report, the patient had not recovered from injection site infection, infection not responding, and feeling unwell. The relatedness between the events and suspect therapy was not provided. Lot # K010464 was not valid for PNEUMOVAX 23. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLU4, FLU4, FLU4
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 58-year-old female patient who received FLUARIX QUADRIVALENT. On 9th September 2015, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 10th September 2015, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced injected limb mobility decreased and injection site pain. On an unknown date, the patient experienced wrong injection technique. On an unknown date, the outcome of the injected limb mobility decreased and injection site pain were not recovered/not resolved and the outcome of the wrong injection technique was unknown. The reporter considered the injected limb mobility decreased and injection site pain to be unrelated to FLUARIX QUADRIVALENT. Additional details provided were as follows: This case was not previously reported to anyone. This case was reported by the patient himself. On 9th September 2015, following day after vaccination, the patient started to experience small amount of pain in her left shoulder where the vaccine was injected. The patient reported that, she has limited range of motion (injected limb mobility decreased) to her left upper extremity and has a hard time clothing herself. The pain has progressed over the past 2 months which often brings her to tears due to severity. The patient reportedly has a condition called SIRVA (Shoulder Injury related to Vaccine). The patient stated that she believes that the issues are not related to the flu vaccine, but does believe that it is due to the way the injection was given stating that it was given too high. This led to the wrong injection technique. The patient stated that she had recorded the lot number and expiration date but did not have the information at the time of call. She did not wish to provide the majority of the report information stating that she did not want to get the pharmacy in trouble and her doctor did not know about the incident.
Age: 58.0
Sex: F
Vaccine: FLU4, FLU4, FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 58-year-old female patient who received FLUARIX QUADRIVALENT. On 9th September 2015, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 10th September 2015, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced injected limb mobility decreased and injection site pain. On an unknown date, the patient experienced wrong injection technique. On an unknown date, the outcome of the injected limb mobility decreased and injection site pain were not recovered/not resolved and the outcome of the wrong injection technique was unknown. The reporter considered the injected limb mobility decreased and injection site pain to be unrelated to FLUARIX QUADRIVALENT. Additional details provided were as follows: This case was not previously reported to anyone. This case was reported by the patient himself. On 9th September 2015, following day after vaccination, the patient started to experience small amount of pain in her left shoulder where the vaccine was injected. The patient reported that, she has limited range of motion (injected limb mobility decreased) to her left upper extremity and has a hard time clothing herself. The pain has progressed over the past 2 months which often brings her to tears due to severity. The patient reportedly has a condition called SIRVA (Shoulder Injury related to Vaccine). The patient stated that she believes that the issues are not related to the flu vaccine, but does believe that it is due to the way the injection was given stating that it was given too high. This led to the wrong injection technique. The patient stated that she had recorded the lot number and expiration date but did not have the information at the time of call. She did not wish to provide the majority of the report information stating that she did not want to get the pharmacy in trouble and her doctor did not know about the incident.
Age: 58.0
Sex: F
Vaccine: FLU4, FLU4, FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Wrong technique in product usage process
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 58-year-old female patient who received FLUARIX QUADRIVALENT. On 9th September 2015, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 10th September 2015, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced injected limb mobility decreased and injection site pain. On an unknown date, the patient experienced wrong injection technique. On an unknown date, the outcome of the injected limb mobility decreased and injection site pain were not recovered/not resolved and the outcome of the wrong injection technique was unknown. The reporter considered the injected limb mobility decreased and injection site pain to be unrelated to FLUARIX QUADRIVALENT. Additional details provided were as follows: This case was not previously reported to anyone. This case was reported by the patient himself. On 9th September 2015, following day after vaccination, the patient started to experience small amount of pain in her left shoulder where the vaccine was injected. The patient reported that, she has limited range of motion (injected limb mobility decreased) to her left upper extremity and has a hard time clothing herself. The pain has progressed over the past 2 months which often brings her to tears due to severity. The patient reportedly has a condition called SIRVA (Shoulder Injury related to Vaccine). The patient stated that she believes that the issues are not related to the flu vaccine, but does believe that it is due to the way the injection was given stating that it was given too high. This led to the wrong injection technique. The patient stated that she had recorded the lot number and expiration date but did not have the information at the time of call. She did not wish to provide the majority of the report information stating that she did not want to get the pharmacy in trouble and her doctor did not know about the incident.
Age: 61.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS, VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Got shingles ZOSTAVAX 19400UNT arm got swollen and red.
Age: 61.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Got shingles ZOSTAVAX 19400UNT arm got swollen and red.
Age: 61.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS, VARZOS
Symptoms: Erythema, Herpes zoster, Peripheral swelling
Clinical narrative: Got shingles ZOSTAVAX 19400UNT arm got swollen and red.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Erythema, Injection site erythema, Injection site swelling, Irritability, Pain in extremity
Clinical narrative: Approx. 4 cm raised red welt with inoculation site mark in the middle. Child complained of pain down her arm, was very fussy, crying, slight fever that night (102 F). Children's Advil did not appear to relieve her symptoms. The site is still red and swollen two days later.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Pyrexia, Urticaria
Clinical narrative: Approx. 4 cm raised red welt with inoculation site mark in the middle. Child complained of pain down her arm, was very fussy, crying, slight fever that night (102 F). Children's Advil did not appear to relieve her symptoms. The site is still red and swollen two days later.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Facial paresis, VIIth nerve paralysis
Clinical narrative: Patient developed a left seventh nerve palsy. Patient received vaccine in the morning and starting feeling weakness in facial muscles by that afternoon.
Sex: F
Vaccine: HPV4
Symptoms: Multiple sclerosis
Clinical narrative: Information has been received from a physician via a company representative referring to a female patient in her 20's. On an unknown date the patient was vaccinated with a dose of GARDASIL (dose and lot# were not reported). On an unknown date the patient experienced multiple sclerosis. The patient sought medical attention by seeing the physician. The outcome of multiple sclerosis was unknown. Causality was not reported. Upon reporter's assessment and internal review, the event of multiple sclerosis was considered to be medically significant. Additional information is not expected because the physician would not like to be contacted.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site bruising, Lethargy
Clinical narrative: Profound and persistent lethargy & joint aches, still going on 11/05/2015. Bruising below injection site (down towards triceps, also starting 2 days after injection, still visible today.
Age: 54.0
Sex: M
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: On the day after vaccination, rather severe hive on the entire back only. Dr. prescribed prednisone 20mg tabs on 11-2-15.
Age: 82.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient presented with red, swollen and itching area where vaccine was administered.
Age: 21.0
Sex: M
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Pt had a syncope about 3 to 4 minutes after getting a flu shot (AFLURIA). Paramedics arrived shortly after. Monitor basic vitals and was evaluated to be well so pt didn't have to acquire further treatment.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were not reported. On unknown dates since July 2015, the patients were inadvertently vaccinated with improperly stored doses of ROTATEQ orally (dose and lot number were not provided). No adverse reactions were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Pallor
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a 14 year old female patient. The patient's medical history, a drug reactions/allergies and concomitant medications were not reported. The patient was not pregnant. On 02-OCT-2015 at approximately 6:00pm, the patient was vaccinated with dose 2 of GARDASIL, 0.5 ml, intramuscularly. On 02-OCT-2015 (fourteen minutes after administration), the patient became pale and light headed. The physician had the patient lay down on an exam table and a cool cloth was placed on her forehead. Patient's pulse was normal but her lips were pale. The patient was alert. The patient had not eaten all day prior to her appointment. The patient was given water and a lollipop at the office. After 10 minutes the patient felt much better and recovered at the office. The physician then had a discussion with the patient about the importance of eating 3 meals a day and staying hydrated throughout the day. The outcome of the events was recovered. Causality assessment was not provided. The patient sought medical attention. No product quality complaint (PQC) was involved. No further information provided. 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 refers to an unknown number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patient were inadvertently vaccinated with improperly stored VAQTA (strength, dose, frequency, and route of administration not reported). No adverse effects reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unknown number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were inadvertently vaccinated with improperly stored PNEUMOVAX 23, (strength, dose, frequency, and route of administration not reported). No adverse effects reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HIBV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 12 month old female. No relevant medical history or con current conditions were reported. On 03-AUG-2015 the patient was vaccinated with improperly stored LIQUID PEDVAXHIB (lot # J013944, expiration date 13-AUG-2016; dose and route not reported), and improperly stored (Oka/Merck) VARIVAX (lot#L001330, expiration date 13-JAN-2017; dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unknown number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were inadvertently vaccinated with improperly stored (Oka/Merck) VARIVAX, (strength, dose, frequency, and route of administration not reported). No adverse effects reported. No product quality complaint (PQC) was involved. No further information 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 healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with an improperly stored doses of ROTATEQ (lot # L008054, exp. date: 30-NOV-2016) (route and dose were not reported). No adverse effects were reported. The outcome of the patient's event was not reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a healthcare worker refers to four patients of unknown age and gender. On an unknown date in 2015 (also reported as in the months of September 2015 and October 2015), the patients were vaccinated with PNEUMOVAX 23 (route, dose and frequency not reported, the patients received lot # 1022795 and one patient received lot # 1002310). On an unknown date in 2015 (also reported as two days after vaccination), the patients called the physician's office to report severe pain, swelling and redness at the injection site. The outcome of the events was unknown. The relatedness between the events and PNEUNOVAX 233 was not reported. This is one of several reports from the same source. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 30 year old female patient. The patient's concurrent conditions and medical history were not reported. On 28-OCT-2015, the patient was vaccinated with an expired dose of PROQUAD (Merck), subcutaneously, lot # K005885, expiration date: 24-OCT-2015, (dose and frequency were not reported) in the left upper arm. Co-suspect therapies or concomitant medications were not provided. The pharmacist reported that the patient just got it and felt fine. It was unknown if there was any relevant laboratory data. At the time of the report it was unknown if the patient would receive another PROQUAD (Merck) injection. No adverse symptoms reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX injection, 4 doses of lot # K021936; expiration Date: 10-NOV-2016 and 2 doses of lot # L018001; expiration Date: 19-MAY-2017 (strength and route unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the two reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3
Symptoms: Expired product administered
Clinical narrative: Expired vaccine given to pt.
Age: 73.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Injection site erythema, Injection site mass, Muscle tightness, Trigger finger
Clinical narrative: Redness and lumps on left arm that moved down pass elbow. Tendons tightening and development of Trigger Finger.
Age: 73.0
Sex: M
Vaccine: MNQ
Symptoms: Upper extremity mass
Clinical narrative: Redness and lumps on left arm that moved down pass elbow. Tendons tightening and development of Trigger Finger.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Inflammation, Pain, Paraesthesia, Rash, Secretion discharge
Clinical narrative: 10/30/15 TINGLING AND PRICKLING PAIN STARTED. 11/1/15 RASH APPEARED IN BAND LIKE SHAPES ON THE RIGHT SIDE OF BODY.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain
Clinical narrative: Sore shoulder.  Ongoing for a couple of weeks (as of 11/5/15) but not sure of specific date when it began.
Age: 55.0
Sex: M
Vaccine: FLUX
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Progressively worsening shoulder pain (lower deltoid) radiating out to shoulder blade and down to wrist.  Lateral elevation limited, use limited. I got a shot in the other arm last year and the same thing happened.  I thought it was bursitis. Lasted about 8 months.
Age: 31.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Immunology test, Skin lesion
Clinical narrative: Indicated that within a hour after receiving vaccines 11/2/2015 she developed raised red lesions on arm. Fever to 103. She did not present to medical facility until 11/4/15. Verbalized history of large localized reaction with other vaccines.
Age: 49.0
Sex: F
Vaccine: FLUC3
Symptoms: Arthralgia, Dysphagia, Pain in extremity, Pharyngeal oedema, Pruritus
Clinical narrative: Developed throat swelling with difficulty swallowing.  She went home and took a Benadryl 25 mg at 5:30.  She continued to feel itchy and throat tightness but no wheezing.  She began to have pain of her hand and feet.  She went to bed and awakened at 3 AM and  took 50 mg Benadryl and went back to sleep for 4 hours. She awakened at 7 AM and felt extremity pain, pruritis, and burning of her throat but could swallow. No respiratory symptoms. She took a Benadryl capsule, she thinks 25 mg. Now she has pain of her hands and feet joints with burning of the joints. Plan: Prednisone 20 mg bid x 3 days then 20 mg qd x 3 days. OTC ibuprofen or naproxen for pain (no history of ASA allergy).
Age: 49.0
Sex: F
Vaccine: FLUC3
Symptoms: Throat irritation, Throat tightness
Clinical narrative: Developed throat swelling with difficulty swallowing.  She went home and took a Benadryl 25 mg at 5:30.  She continued to feel itchy and throat tightness but no wheezing.  She began to have pain of her hand and feet.  She went to bed and awakened at 3 AM and  took 50 mg Benadryl and went back to sleep for 4 hours. She awakened at 7 AM and felt extremity pain, pruritis, and burning of her throat but could swallow. No respiratory symptoms. She took a Benadryl capsule, she thinks 25 mg. Now she has pain of her hands and feet joints with burning of the joints. Plan: Prednisone 20 mg bid x 3 days then 20 mg qd x 3 days. OTC ibuprofen or naproxen for pain (no history of ASA allergy).
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: About 45 min following flu shot, client noted arm numbness and tingling in fingers in that arm. Client then stated she was dx with Lymes Disease and wonders if it had an adverse reaction due to illness.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Throat irritation
Clinical narrative: Case number PHEH2015US022086, is an initial spontaneous report from a consumer received on 27 Oct 2015. This report refers to a 56 years old female patient. Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 26 Oct 2015. Shortly after vaccination she had a itching in the back of her throat and 2 to 3 hours later she had an asthma attack. She treated itchy throat with BENADRYL and had 2 to 3 cups of coffee and then had asthma attack treated with rescue inhaler. Events recovered on the same day (26 Oct 2015). Seriousness and causality of the events were not reported. Seriousness assessment of asthma attack was upgraded based on information in the source document.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unknown number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were inadvertently vaccinated with improperly stored GARDASIL 9, (strength, dose, frequency, and route of administration not reported). No adverse effects reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a physician via two company representative refers to two patients of unknown age and unknown age. The patients pertinent medical history was unspecified. On an unknown date, the two patients were vaccinated with ZOSTAVAX (dose and frequency were unknown). Concomitant medications were unspecified. On an unknown date, the two patients a shingles like rash (rash vesicular) few days after the vaccination. The outcome of the event was unknown. The relatedness of the events with ZOSTAVAX was not provided. Additional information is not expected as the reporter contact details were not provided.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unspecified number of patients of unknown age and gender. It was reported that 48 doses of improperly stored (Oka/Merck) VARIVAX (lot# was reported as L020001, expiration date 02-JUN-2017, Lot# L021210, expiration date 10-JUN-2017, number of doses administered for each lot was not specified, dose, route and frequency were unknown). No adverse events were reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patient. The patient had no history of drug allergies/reactions. The patient's concurrent conditions and medical history were none. The patient was vaccinated with first dose of PNEUMOVAX 23 in February 2015 (unknown lot #). On 30-OCT-2015, the patient was vaccinated with second dose of PNEUMOVAX 23 lot # K009105 and expiry date of 21-JAN-2015 intramuscularly. On 31-OCT-2015, following the administration of the second dose of PNEUMOVAX 23, the patient experienced a fever, body aches, chills, redness, and swelling that localized at the injection site. No lab diagnostic procedures were performed. The patient sought medical attention and called primary care physician. The outcome of fever, body aches, chills was resolving as it was reported that the patient's fever, body aches, and chills have gotten better. The outcome of redness, and swelling that localized at the injection site was unknown. Causality assessment was not provided. There was no product quality complaint 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 registered nurse refers to an unknown number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were inadvertently vaccinated with improperly stored PEDVAXHIB, (strength, dose, frequency, and route of administration not reported). No adverse effects reported. No product quality complaint (PQC) was involved. No further information 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 was received from a registered nurse refers to an unknown number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were inadvertently vaccinated with improperly stored, Oral ROTATEQ, (strength, dose, frequency, and route of administration not reported). No adverse effects reported. No product quality complaint (PQC) was involved. No further information provided. This is one of 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 as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were not reported. On unknown dates since July 2015, the patients were inadvertently vaccinated with improperly stored doses of GARDASIL 9 (dose, route and lot number were not provided). No adverse reactions were reported. This is one of several reports received from the same source. Additionl information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The patient's medical history, current conditions and concomitant medications were not reported. On unknown dates since July 2015, the patients were inadvertently vaccinated with improperly stored doses of M-M-R II (dose, route and lot number were not provided). No adverse reactions were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with the improperly stored doses of PROQUAD (Merck) injection (lot # L008354 with expiry date: 11-SEP-2016; lot # L010142 with expiry date: 24-SEP-2016; lot # L023112 with expiry date: 24-DEC-2016; strength, dose, site and route of administration were unspecified). No concomitant medications were reported. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown age and gender. Pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of oral, ROTATEQ, lot # K020182 and expiration date 25-JUN-2016, (dose was not provided). Concomitant medication was not reported. No adverse effects reported. This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 03-NOV-2015, the patient was vaccinated with the improperly stored dose of (Oka/Merck) VARIVAX (lot # L019130, expiration date 27-MAY-2017; dose and route of administration were not reported). No adverse reactions were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown age and gender. Pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of MMR II, lot # K005109 and expiration date 04-APR-2016, (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effects reported. This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an adult patient of unknown gender. On 03-NOV-2015, the patient was vaccinated with two doses of pediatric/adolescent formulation of RECOMBIVAX HB 5mcg/0.5ml, lot # H012250, expiration date 06-FEB-2015, intramuscularly to get the appropriate dosage for an adult, however, these two doses of RECOMBIVAX HB were both expired. This was the first dose in the RECOMBIVAX HB series this patient has been administered. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unknown number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were inadvertently vaccinated with improperly stored PROQUAD (Merck), (strength, dose, frequency, and route of administration not reported). No adverse effects reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unknown number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were inadvertently vaccinated with improperly stored MMR II, (strength, dose, frequency, and route of administration not reported). No adverse effects reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unknown number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant medication were not reported. On an unknown dates, the patients were inadvertently vaccinated with improperly stored RECOMBIVAX HB (strength, dose, frequency, and route of administration not reported). No adverse effects reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 4 month old female patient. No relevant medical history or concurrent conditions were reported. On 13-JUL-2015 the patient was vaccinated with improperly stored PEDVAXHIB (lot # K004541, expiration date 04-DEC-2016; Dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.18
Sex: M
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Informatino has been received from a medical assistant referring to a 9 week old male patient. No relevant medical history or concurrent conditions were reported. On 07-AUG-2015 the patient was vaccinated with improperly stored PEDVAXHIB (lot # K002935, expiration date 11-DEC-2016; dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with fourth dose of GARDASIL (unknown route, strength and dose) or GARDASIL 9 (unknown strength and route). The healthcare worker was unsure if the product was GARDASIL 9 or GARDASIL. No adverse affects were reported. There was no product quality compliant involved. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a medical assistant referring to a 4 year old female patient. No relevant medical history or concurrent conditions were reported. On 24-AUG-2015 the patient was vaccinated with VARIVAX (Merck) (lot # L001330, expiration date 13-JAN-2017; dose and route not reported) which had been exposed to temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a medical assistant referring to a 4 year old female patient. No relevant medical history or concurrent conditions were reported. On 14-AUG-2015 the patient was vaccinated with VARIVAX (Merck) lot # L001330, expiration date 13-JAN-2017; dose and route not reported) which had been exposed to temperature excursion. This is one of several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: Information has been received from a female patient of unknown age referring to herself. Concurent condition and medical history were not reported. On an unknown date the patient was vaccinated with GARDASIL 9 (strength, dose, route, lot# and expiration date were unknown) injection in the buttocks (Drug administered at inappropriate site). No adverse event was reported. Additional information is not expected because the reporter details were not provided.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Malaise, Pain
Clinical narrative: This spontaneous report as received from a physician via field representative refers to a 65 year old male patient. Pertinent medical history and drug reactions/allergies were unknown. On 23-OCT-2015 (FRIDAY), the patient was vaccinated with ZOSTAVAX, subcutaneous. Approximately on 24-OCT-2015 (reported as "over the weekend"), the patient felt very sweaty, and had body aches. The patient stated he just generally did not feel well over the course of the weekend. Outcome of the events was unknown. The patient did not seek medical attention. No product complaint was involved. Additional information has been vaccinated.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fall, Head injury, Laceration, Syncope
Clinical narrative: This spontaneous report was received from a nurse practitioner, via a company representative, referring to a 14 year old female patient. Information about concurrent conditions was not reported. The patient did not have pertinent medical history nor drug reactions/allergies.  On 13-OCT-2015 the patient was vaccinated with the first dose of GARDASIL, (dose, route of administration, lot # and expiration date were not provided). The patient was not taking any concomitant medication. On 13-OCT-2015, 15 min after the vaccination with GARDASIL, the patient experienced dizziness, tonic clonic movements, "fainted" and hit her head. The reporter also stated that the fall resulted in a two inch laceration on the patient's head. The treatment consisted in having the patient under observation and lay the patient in a supine position until the dizziness subsided. Laboratory diagnostics were not performed. The outcome of dizziness was reported as recovered, on 13-OCT-2015. The outcome of tonic clonic movements, syncope, head injury, fall and laceration was unknown. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Tonic clonic movements
Clinical narrative: This spontaneous report was received from a nurse practitioner, via a company representative, referring to a 14 year old female patient. Information about concurrent conditions was not reported. The patient did not have pertinent medical history nor drug reactions/allergies.  On 13-OCT-2015 the patient was vaccinated with the first dose of GARDASIL, (dose, route of administration, lot # and expiration date were not provided). The patient was not taking any concomitant medication. On 13-OCT-2015, 15 min after the vaccination with GARDASIL, the patient experienced dizziness, tonic clonic movements, "fainted" and hit her head. The reporter also stated that the fall resulted in a two inch laceration on the patient's head. The treatment consisted in having the patient under observation and lay the patient in a supine position until the dizziness subsided. Laboratory diagnostics were not performed. The outcome of dizziness was reported as recovered, on 13-OCT-2015. The outcome of tonic clonic movements, syncope, head injury, fall and laceration was unknown. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Received influenza vaccine on 10/14/15. Started feeling pins and needles sensation systemically starting from legs and throughout extremities and face the morning of 10/24/15. Symptoms have not improved or resolved.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site mass, Papule
Clinical narrative: Baseball sized lump (deltoid) 2 mm scattered papules heavily on trunk, arms and leg few on face.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site reaction, Joint swelling, Skin tightness
Clinical narrative: Redness, swelling and tightening of the Lt deltoid.  No pain per patient.
Age: 41.0
Sex: F
Vaccine: FLUN4
Symptoms: Epistaxis
Clinical narrative: Bloody nose one hour after administration of Flumist.  Begin while patient was moving medical totes.  Patient stated totes were not heavy.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: Pt was given wrong dose of flu vaccine. Should have been given regular flu vaccine and was given peds dose.
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Extra dose administered, Paraesthesia, Pruritus, Vaccination error
Clinical narrative: Patient was given FluZone intradermal vaccine, first dose did not fully penetrate the skin and a large amount of vaccine was visible dripping down his arm. Therefore a 2nd dose was given and this dose entered the intradermal space creating a wheal. Within 10 min patient reports left facial itching and tingling as well as feeling light-headed. He presented to his PCM clinic. A physician examined him and noted no redness or swelling of either the face or site of vaccine administration. Patient voiced concern about a possible "vaccine overdose". He was reassured and released home.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: A ping-pong size knot, with soreness & redness, at the injection site. The knot is still evident 11/5/2015 10:30 AM.
Age: 11.0
Sex: M
Vaccine: FLU4, FLUX, FLU4, FLU4
Symptoms: Limb discomfort, Musculoskeletal discomfort
Clinical narrative: Arm discomfort and the developed into shoulder region.
Age: 11.0
Sex: M
Vaccine: FLU4, FLUX, FLU4, FLU4
Symptoms: C-reactive protein increased, Flank pain, Joint range of motion decreased, Musculoskeletal pain, Myositis
Clinical narrative: Arm discomfort and the developed into shoulder region.
Age: 11.0
Sex: M
Vaccine: FLU4, FLUX, FLU4, FLU4
Symptoms: Nausea, Neck pain, Nuclear magnetic resonance imaging abnormal, Pyrexia, Type III immune complex mediated reaction
Clinical narrative: Arm discomfort and the developed into shoulder region.
Age: 11.0
Sex: M
Vaccine: FLU4, FLUX, FLU4, FLU4
Symptoms: Vomiting, White blood cell count increased
Clinical narrative: Arm discomfort and the developed into shoulder region.
Age: 11.0
Sex: M
Vaccine: FLU4, FLUX, FLU4, FLU4
Symptoms: Back pain, C-reactive protein increased, Chest pain, Endoscopy gastrointestinal abnormal, Gastrointestinal haemorrhage
Clinical narrative: Arm discomfort and the developed into shoulder region.
Age: 11.0
Sex: M
Vaccine: FLU4, FLUX, FLU4, FLU4
Symptoms: Gastrointestinal viral infection, Haemoglobin decreased, Hallucination, Injection site rash, Mobility decreased
Clinical narrative: Arm discomfort and the developed into shoulder region.
Age: 11.0
Sex: M
Vaccine: FLU4, FLUX, FLU4, FLU4
Symptoms: Musculoskeletal pain, Myositis, Nausea, Nuclear magnetic resonance imaging abnormal, Pain in extremity
Clinical narrative: Arm discomfort and the developed into shoulder region.
Age: 11.0
Sex: M
Vaccine: FLU4, FLUX, FLU4, FLU4
Symptoms: Pyrexia, Rash, Red blood cell sedimentation rate increased, Tenderness, Transfusion
Clinical narrative: Arm discomfort and the developed into shoulder region.
Age: 11.0
Sex: M
Vaccine: FLU4, FLUX, FLU4, FLU4
Symptoms: Type IV hypersensitivity reaction, White blood cell count increased
Clinical narrative: Arm discomfort and the developed into shoulder region.
Age: 11.0
Sex: M
Vaccine: FLU4, FLUX, FLU4, FLU4
Symptoms: Endoscopy, Gastrointestinal haemorrhage, Mobility decreased, Myositis, Transfusion
Clinical narrative: Arm discomfort and the developed into shoulder region.
Age: 11.0
Sex: M
Vaccine: FLU4, FLUX, FLU4, FLU4
Symptoms: Type IV hypersensitivity reaction
Clinical narrative: Arm discomfort and the developed into shoulder region.
Age: 11.0
Sex: M
Vaccine: FLU4, FLUX, FLU4, FLU4
Symptoms: Limb discomfort, Musculoskeletal discomfort
Clinical narrative: After flu shot given 10/30, three days later developed high fevers for the next three days up to 104, along with nausea, vomiting, severe pain of shoulder, left flank, neck.
Age: 11.0
Sex: M
Vaccine: FLU4, FLUX, FLU4, FLU4
Symptoms: C-reactive protein increased, Flank pain, Joint range of motion decreased, Musculoskeletal pain, Myositis
Clinical narrative: After flu shot given 10/30, three days later developed high fevers for the next three days up to 104, along with nausea, vomiting, severe pain of shoulder, left flank, neck.
Age: 11.0
Sex: M
Vaccine: FLU4, FLUX, FLU4, FLU4
Symptoms: Nausea, Neck pain, Nuclear magnetic resonance imaging abnormal, Pyrexia, Type III immune complex mediated reaction
Clinical narrative: After flu shot given 10/30, three days later developed high fevers for the next three days up to 104, along with nausea, vomiting, severe pain of shoulder, left flank, neck.
Age: 11.0
Sex: M
Vaccine: FLU4, FLUX, FLU4, FLU4
Symptoms: Vomiting, White blood cell count increased
Clinical narrative: After flu shot given 10/30, three days later developed high fevers for the next three days up to 104, along with nausea, vomiting, severe pain of shoulder, left flank, neck.
Age: 11.0
Sex: M
Vaccine: FLU4, FLUX, FLU4, FLU4
Symptoms: Back pain, C-reactive protein increased, Chest pain, Endoscopy gastrointestinal abnormal, Gastrointestinal haemorrhage
Clinical narrative: After flu shot given 10/30, three days later developed high fevers for the next three days up to 104, along with nausea, vomiting, severe pain of shoulder, left flank, neck.
Age: 11.0
Sex: M
Vaccine: FLU4, FLUX, FLU4, FLU4
Symptoms: Gastrointestinal viral infection, Haemoglobin decreased, Hallucination, Injection site rash, Mobility decreased
Clinical narrative: After flu shot given 10/30, three days later developed high fevers for the next three days up to 104, along with nausea, vomiting, severe pain of shoulder, left flank, neck.