chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Tachycardia, Tremor
Clinical narrative: Initial report was received from a non-healthcare professional on 12 November 2013. A female patient (no details provided), with no reported personal and family medical history, and no reported concomitant therapy, had received her dose of MENACTRA (lot number, route and anatomical site of administration not reported) on an unspecified date. On an unspecified date post-vaccination, the patient experienced lightheadedness, seizure-like symptoms, confusion and rash. No further information was provided. The outcome was unknown. Documents held by sender: None. Follow-up information was received from a healthcare professional on 15 December 2013. The 15-year-old female patient had received first dose of MENACTRA batch number- U4657AA, intramuscularly in left arm on an unspecified date. The patient had no medical history, no illness at the time of vaccination, no other vaccination within 4 week of vaccination, no other medication and no other adverse event following prior vaccination. On an unspecified date, 3 minutes after vaccination the patient was not feeling quite well. Patient had increased in blood pressure was lightheaded, dizzy, and as thing progressed become clammy, noted to be tachycardic and hypertensive. The patient also developed rash on anterior chest, on forehead around the ear and on back. And patient complain of stiff leg and had difficulty in walking. She was crying and also had hyperreflexia, tingle sensation on hands, hyperreflexia of lower extremities, jerking/tremors of hands, arms, legs and allergic reaction. Patient's corrective treatment include 50 mg of BENADRYL, 125 mg of SOLU-MEDROL and 20 mg of PEPCID. Laboratory test include blood pressure 143/77, repeated 130/73, pulse was 122, temperature was 98.3, respiration was 16. On an unspecified date the patient had recovered from the event. Documents held by sender: None.
Age: 0.51
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 6 month old male patient. No relevant medical history or concurrent conditions were reported. On 22-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322. Additional information has been requested.
Age: 0.51
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 6 month old female patient. No relevant medical history or concurrent conditions were reported. On 16-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322. Additional information has been requested.
Age: 0.51
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 6 month old male patient. No relevant medical history or concurrent conditions were reported. On 08-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322. Additional information has been requested.
Age: 0.39
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 4 month old male patient. No relevant medical history or concurrent conditions were reported. On 12-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site paraesthesia, Migraine, Pain, Paraesthesia, Post-traumatic neck syndrome
Clinical narrative: Vaccine administered 08/04/15, moderate soreness for remainder of day; day 2 experienced noticeable painful tingling at insertion point, wrapping around to shoulder, down back of arm to pinky. Day 3 symptoms and pain worsened including "whiplash" feeling in neck accompanied by migraine type pain.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified patients of unknown age and gender. There was no information about concomitant medications, concurrent condition and medical history of patients reported. On an unknown date, improperly stored doses of RECOMBIVAX HB (dose, site, route of administration, lot# and expiry date were not reported) was administered to unspecified patients. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a 65 year old female referring to herself. Patient's relevant medical history and concurrent conditions were not reported. She was allergic to ibuprofen. On 27-JUL-2015 the patient was vaccinated with one intramuscular injection of PNEUMOVAX 23 (strength, dose, frequency, lot # unspecified). Concomitant therapies included PROLIA. Patient stated that she experienced a fever, chills, severe injection site pain, and a swollen arm on the same day she was vaccinated. Patient sought medical attention and called her physician on 28-JUL-2015 (reported as next day). She was advised to take TYLENOL and apply cold compresses where it hurts. No lab diagnostic studies were performed. Outcome of all the events were reported as not recovered. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient has not pertinent medical history and there were no drug allergies/drug reactions reported. ON 21-JUL-2015, the patient was vaccinated with (Oka/Merck) VARIVAX (lot number, expiration date, dose and strength were not reported) route default as  subcutaneous. No concomitant medication was reported. The reporter stated, that the patient was vaccinated with (Oka/Merck) VARIVAX, which has been subject to defrost cycling. No adverse event was reported. NO PQC involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified patients of unknown age and gender. There was no information about concomitant medications, concurrent condition and medical history of patients reported. On an unknown date, improperly stored doses of the GARDASIL, (dose, site, route of administration, lot# and expiry date were not reported) was administered to unspecified patients. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse regarding to 2 patients of unknown age and gender. There was no information about patient's concurrent condition and historical medication. On an unknown date, the patient was vaccinated with improperly stored ZOSTAVAX, Lot # L013546, expiration date 17-JUL-2016, (dose and strength were not reported). No concomitant medication was reported. No adverse event was reported. No PQC involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse's aide refers to an unspecified number of patients of unknown age and gender. No information on patients medical history or concurrent conditions was provided. On an unknown dates, the patient were vaccinated with improperly stored doses of GARDASIL injection (strength, dose, route of administration, lot# and expiration date were not reported). No information on patients concomitant medications was provided. No adverse effects were reported. This is one of several reports 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 as received from a nurse's aide refers to an unspecified patients of unknown age and gender. No information on patients medical history or concurrent conditions was provided. On an unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II injection (strength, dose, route of administration, lost # and expiration date were not reported). No information on patients concomitant medication was provided. No adverse effects were reported. This is one of several reports 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 as received from a nurse's aide refers to an unspecified number of patients of unknown age and gender. No information on patients medical history or concurrent conditions was provided. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX injection (strength, dose, route of administration, lot# and expiration date were not reported). No information on patients concomitant medications was provided. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 4 month old male patient. No relevant medical history or concurrent conditions were reported. On 01-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 8 weed old female patient. No relevant medical history or concurrent conditions were reported. On 11-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322. Additional information has been requested.
Age: 0.41
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 4 month old male patient. No relevant medical history or concurrent conditions were reported. On 02-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse  regarding to 2 patients of unknown age and gender. There was no information about patient's concurrent condition and historical medication. On 13-JUL-2015, the patient was vaccinated with improperly stored ZOSTAVAX (lot number, expiration date, dose and strength were not reported). No concomitant medication was reported. No adverse event was reported. No PQC involved. 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 licensed practical nurse regarding to 2 patients of unknown age and gender. There was no information about patient's concurrent condition and historical medication. On 08-JUL-2015, the patient was vaccinated with improperly stored VARIVAX (Lot number, expiration date, dose and strength were not reported). No concomitant medication was reported. No adverse event was reported. No PQC involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: VARCEL, VARZOS
Symptoms: Antibody test negative, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a 12 year old female patient. Pertinent medical history was none. There was no history of drug allergy or reactions. On 22-OCT-1988, the patient was vaccinated with first dose of (Oka/Merck) VARIVAX (unknown route, strength and dose) and on 11-MAR-2008, the patient received the 2nd dose of (Oka/Merck) VARIVAX (unknown route, strength and dose) (inappropriate schedule of drug administration). On 19-JUN-2015. The patient was seen in the office on 19-JUN-2015 and had titers drawn. The medical assistant stated, the titers showed low immunity on an unknown date in 2015. The patient was in the office today, 31-JUL-2015, in order to receive a "booster dose" of (Oka/Merck) VARIVAX due to the "low immunity"  however the patient was inadvertently administered a dose of ZOSTAVAX (lot # L006381 and exp. 25-MAY-2016) instead of "booster dose" of (Oka/Merck) VARIVAX. No treatment was received in response to the event. The outcome of the events was unknown. The causality assessment was not provided. There was no product quality complaint involved. Additional information has been requested.
Age: 0.51
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 6 month old female patient. No relevant medical history or concurrent conditions were reported. On 08-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original reports is MARRS#1507USA011322. Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 4 month old male patient. No relevant medical history or concurrent conditions were reported. On 08-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient (reporter's mother) of unknown age. The concurrent condition of the patient included diabetes mellitus. No medical history was reported. The reporter stated that her mother received an unspecified pneumococcal vaccination every year on unspecified dates. PNEUMOVAX23 (dose and route of administration not provided) could not be ruled out (inappropriate schedule of vaccine administration). No concomitant therapy was reported. No adverse effects were reported. The outcome of the events was unknown.  Product quality issue was not involved. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 3 month old female patient. No relevant medical history or concurrent conditions were reported. On 02-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with GARDASIL (dose, strength, route and lot# were not reported), which had been exposed to light. No adverse effects were reported. Additional information has been requested.
Age: 0.53
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 6 month old male patient. No relevant medical history or concurrent conditions were reported. On 02-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322. Additional information has been requested.
Age: 0.53
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 6 month old male patient. No relevant medical history or concurrent conditions were reported. On 22-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an 8 week old male patient. No relevant medical history or concurrent conditions were reported. On 30-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322. Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 4 month old male patient. No relevant medical history or concurrent conditions were reported. On 09-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322. Additional information has been requested.
Age: 0.45
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 5 month old male patient. No relevant medical history or concurrent conditions were reported. On 04-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to a patient of unknown age and gender. No relevant medical conditions were reported. In August 2014, a year ago, the patient was vaccinated with an initial dose of GARDASIL (strength, dose, route, lot# and expiration date not reported). There was no concomitant medication reported. On 03-AUG-2015, the patient was at the provider's office to receive a dose of GARDASIL 9 (inappropriate schedule of vaccine administration). The patient had not yet been administered the dose of GARDASIL 9 at time of call. No adverse effect was reported. Additional information is not expected since the reporter declined to participate in adverse event collection process.
Age: 0.33
Sex: F
Vaccine: RV5
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 11-JUN-2015, the patient inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322. Additional information has been requested.
Age: 0.18
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 9 week old female patient. No relevant medical history or concurrent conditions were reported. On 17-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is of several reports received from the same reporter. Original report is MARRS#1507USA011322. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 3 month old male patient. No relevant medical history or concurrent conditions were reported. On 05-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322. Additional information has been requested.
Age: 0.47
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 5 month old female patient. No relevant medical history or concurrent conditions were reported. On 18-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322. Additional information has been requested.
Age: 0.52
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 6 month old female patient. No relevant medical history or concurrent conditions were reported. On 29-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Inforrmation has been received from a medical assistant referring to an 8 week old male patient. No relevant medical history or concurrent conditions were reported. On 17-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322. Additional information has been requested.
Age: 0.39
Sex: F
Vaccine: RV5
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 22-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322. Additional information has been requested.
Age: 0.51
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 6 month old female patient. No relevant medical history or concurrent conditions were reported. On 06-JUL-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 6 month old female patient. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 3 month old male patient. No relevant medical history or concurrent conditions were reported. On 01-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322. Additional information has been requested.
Age: 0.27
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 3 month old female patient. No relevant medical history or concurrent conditions were reported. On 08-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTAEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Alopecia
Clinical narrative: Information has been received from a physician referring to a 16 years old female patient. Pertinent medica history and drug reactions/allergies were not reported. On 15-JUN-2015 the patient was vaccinated with a dose of GARDASIL 9, (dose and expiration date were not reported, lot # was reported as K010574) intramuscularly to prevent HPV. Concomitant drug was not reported. On 16-JUN-2015, 1 day after administration of GARDASIL 9, the patient started experienced hairloss. The patient sought medical attention by calling the physician's office. At the time of reporting, the patient did not recover. The causality was unknown. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 3 month old male patient. No relevant medical history or concurrent conditions were reported. On 04-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Site of injection has small rash, large area that's red, swollen, itchy, larger than the size of baseball, entire left back of left arm is red, swollen, warm.
Sex: M
Vaccine: BCG, OPV
Symptoms: Injection site abscess, Injection site erythema, Local reaction
Clinical narrative: Local reaction with abscess 0.75 x 1cm red, edematous area RUE without fever or supportive lymphadenitis present > 3months.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Swelling, Urticaria
Clinical narrative: Patient started with small bump last pm and woke up this morning with large welts on most of her body.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Blister, Erythema, Swelling
Clinical narrative: Varicella given 8/3/15-came in offive 8/6/15. Had redden area 2 1/2 circle with and center circle 1 1/2- which was raised-and slightly- blistering (very small))-No temp no other symptoms.
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 patients of unknown age and gender. There was no information about concomitant medications, concurrent condition and medical history of patients reported. On an unknown date, improperly stored doses of the ROTATEQ (dose, lot# and expiry date were not reported) was administered orally to unspecified patients. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Injection site joint pain, Injection site pain
Clinical narrative: Patient had extreme pain in shoulder joint immediately following vaccination x3 days. Patient stated pain was 8-9 and pain is burning. Went to walk-in clinic and received ibuprofen and injectable steroid.
Age: 5.0
Sex: M
Vaccine: DTP, IPV, MMR, VARCEL
Symptoms: Nasal congestion, Sneezing, Urticaria
Clinical narrative: Half an hour after receiving vaccines pt started sneezing, developed nasal congestion and hives. Mother returned to office. Child examined by MD-epinephrine 1:1000 0.15 given. Albuterol tx given. Symptoms resolved after 5 min.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. Since 25-JUN-2015 the patients were vaccinated with GARDASIL (dose and route of administration were not reported; lot # K008931 with exp. date: 04-JUL-2017, lot # K005881 with exp. date: 14-JAN-2017, lot # K006960 with exp. date: 19-FEB-2017, lot #K004205 with exp. date: 12-JAN-2017) which were exposed to temperatures outside of the recommended range. No adverse experiences have been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site rash, Myalgia, Pruritus
Clinical narrative: Rash and erythema surrounding injection site with warmth, itching and burnng. Mild headache and myalgias.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified patients of unknown age and gender. There was no information about concomitant medications, concurrent condition and medical history of patients reported. On an unknown date, improperly stored doss of GARDASIL 9 (dose, site, route of administration, lot# and expiry date were not reported) was administered to unspecified patients. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 88.0
Sex: F
Vaccine: PNC13
Symptoms: Dizziness, Injection site rash, Rash erythematous
Clinical narrative: Pt received vaccine 07/17. She did not notice any immediate reaction. She presented to ER on 07/26 c/o dizziness that began 07/25. At the ER she told them she recently had a vaccination and noticed a rash at the injection site on 07/22. Rash still present on 07/26 (mild, erythematous-LUE, 4x4 cm). Pt given prednisone and ANTIVERT and told to f/u with PCP, which she did on 07/31. Rash/symptoms resolved.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blood glucose normal, Blood pressure decreased, Incontinence, Pallor, Syncope
Clinical narrative: Patient has a episode of syncope with incontinence following her vaccines. Syncope occurred within 10 min after receiving her vaccines. She also experienced a blood pressure decrease and pallor. She gradually regained normal activity after taken to exam room for rest.
Age: 1.02
Sex: M
Vaccine: HIBV, PNC13, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Child developed swollen lower left side of thigh 2 days after vaccination.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: 2 welt like bumps at injection area, swelling warm to touch no pain. Taking TYL/Ibp.
Age: 0.33
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Crying, Full blood count normal, Sleep disorder
Clinical narrative: Severe crying for several days starting hours after Hib and PREVNAR. Hasn't slept for more than 1 hr at a time. Previously happy and easy.
Age: 71.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient presented to RPh with swollen, red bicep, warm to touch and was instructed to call provider (8-6-15) had office visit.
Age: 71.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Patient presented to RPh with swollen, red bicep, warm to touch and was instructed to call provider (8-6-15) had office visit.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Cellulitis, Peripheral swelling
Clinical narrative: (R) shoulder swollen-cellulitis. P: Locally ice. Ibuprofen 400mg Q 6 h.
Age: 41.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Body temperature increased, Impaired work ability, Lethargy, Pain
Clinical narrative: Temp to 103.1 x 2.5 days. Severe achiness. Lethargy. Unable to work.
Age: 47.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Wheezing
Clinical narrative: Pain & redness at injection site. Mild wheezing. Temp 99 degrees.
Age: 1.26
Sex: M
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site urticaria, Injection site warmth
Clinical narrative: Pt immediately after receiving vaccine developed large hive reaction redness along upper right arm 10 cm x 7 cm. Area slightly warm to touch. Non tender with palp. Moving arm fine. Lungs clear. BENADRYL given.
Age: 87.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Pt received vaccine on 7/30/15. Came back to store on 8/7/15 with red and swollen shoulder/arm. Shoulder was also hot to touch. Red area was quite large (at elbow level).
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a two patients of unknown age and gender. On 23-JUL-2015, those two patients were vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot # L007225, exp. date: 03-MAR-2017) (doses and routes were not reported). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Information has been received from a physician via field representative referring to an unspecified number of patients of unknown demographics. Relevant medical history, concurrent conditions and drug reactions/allergies of these patients were not provided. Since an unknown date these patients were vaccinated with GARDASIL (strength, dose, frequency unspecified). Concomitant medications were not provided. Reporting physician noticed that the patients passed out due to syncope on unspecified dates after vaccine administration. Outcome of the event, syncope was unknown. Reporting physician did not assess the causality of the event with respect to vaccination with GARDASIL. Additional information is not expected as the reporter did not wish further contact.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Contusion, Hypoaesthesia, Muscle twitching, Paraesthesia, Unresponsive to stimuli
Clinical narrative: Patient and family leaving exam/PE. I was called to the hallway and saw patient lying prone on the floor making twitching body motion, mildly  non responsive to her mother calling. I went to patient, held her arm firmly to feel her pulses and check breathing. At that time pt. suddenly regained consciousness and became responsive. Bruise noted under (L) eye-P.T.O. 911 called.  Assisted pt to exam bed in a colder room. O2 by nasal cannula started approximately 10L/min. As patient increased responsiveness and shared she hadn't eaten since morning offered to provide 8 oz apple juice and granola bar which pt ate on site. VSS. Numbness and tingling pt reported on the (L) side of face extending into her (L) hand resolved. Recheck of neuro and ROM and MM strength. Full return to baseline as previously documented in her well child exam. Pt. released to home under watch of her mother. S/sx of concern and where to call reviewed. Pt and mother state understanding. PV scheduled at 24, 48, 72 hrs follow up. Bruise was noted under the (L) eye and ice pack was provided to apply to minimize swelling.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to an unspecified number of patients of unknown age and gender. No pertinent medical history and drug reactions or allergies were reported. Approximately in 2015 (reported as "on unspecified dates between 27-JUL-2015 and 03-AUG-2015"), the patients were vaccinated with an unspecified number of improperly stored doses of GARDASIL (lot # K011562, expiration date 08-APR-2017) (dose, frequency, route of administration were not reported). Concomitant medications were not provided. No adverse effects were reported. 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 nurse's aide refers to an unspecified number of patients of unknown age and gender. No information on patients medical history or concurrent conditions was provided. On an unknown dates, the patient were vaccinated with improperly stored doses of ROTATEQ oral solution (strength, dose, lot# and expiration date were not reported). No information on patients concomitant medication was provided. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Limb injury
Clinical narrative: Information has been received from a pharmacist concerning a 62 year old female patient. There was no pertinent medical history reported. The patient has no drug reactions/allergies. On 20-JUL-2015, the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (subcutaneous, lot number was reported as 1012475 and expiration date was 10-JUL-2016). The pharmacist reported that the patient was seen by an unspecified physician and prescribed an unspecified steroid, after receiving ZOSTAVAX. The pharmacist stated that the reason the patient was prescribed an unspecified steroid was because she "thought" the patient "sustained" an unspecified foot injury but she was unsure if the foot injury occurred before or after receiving ZOSTAVAX (assuming foot injury occurred after receiving ZOSTAVAX. At the time of reporting, causality and outcome of the event were unknown. Additional information has been requested. Lot number: 1012475 is not valid for ZOSTAVAX.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 3 month old male patient. No relevant medical history or concurrent conditions were reported. On 10-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322. 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 a patients of unknown age and gender. Since 26-JUN-2015 the patient was vaccinated with MMR II (dose and route of administration were not reported; lot # K011188 with exp. date: 12-AUG-2016, lot # K000174 with exp. date: 01-AUG-2016, lot # K004948 with exp. date: 04-APR-2015) which were exposed to temperatures outside of the recommended range. No adverse experiences have been reported. 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 a patients of unknown age and gender. Since 26-JUN-2015 the patients were vaccinated with ROTATEQ (dose and route of administration were not reported; lot # K010221 with exp. date: 12-MAY-2016, lot # K023535 with exp. date: 22-MAY-2016, lot # K013868 with exp. date: 27-MAY-2016, lot # K004795 11-FEB-2016, lot #K006805 with exp. date: 24-MAR-2016, lot # K006458 with exp. date: 24-FEB-2016) which were exposed to temperatures outside of the recommended ranged. No adverse experiences have been reported. This if one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning a patient of unknown age and gender. There was no relevant medical history or drug reactions/allergies reported. On an unknown date, the patient was vaccinated with (Oka/Merck) VARIVAX (dose, route, lot number and expiration date were specified). On 28-JUL-2015 the patient was vaccinated with an expired dose of (Oka/Merck) VARIVAX (second dose, lot number was J007682 and expiration date was 13-JUN-2015, dose and route were unspecified). No adverse experience reported. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Headache, Pyrexia
Clinical narrative: Fever of 102.9, complaints of head hurting, stomach hurting, achy all over. Also swelling and redness at site of injection (upper right thigh).
Age: 5.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Abdominal pain upper, Headache, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Fever of 102.9, complaints of head hurting, stomach hurting, achy all over. Also swelling and redness at site of injection (upper right thigh).
Age: 5.0
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Pyrexia
Clinical narrative: Fever of 102.9, complaints of head hurting, stomach hurting, achy all over. Also swelling and redness at site of injection (upper right thigh).
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypersensitivity, Skin warm, Swelling, Tenderness
Clinical narrative: Severe redness and swelling. Warmth and sore to touch. Diagnosed with allergic reaction. Using Benadryl and hydrocortisone cream.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Attention deficit/hyperactivity disorder, Blood glucose increased, Depression, Diabetes mellitus, Disturbance in attention
Clinical narrative: Blood sugar 436, admitted into hospital 8/12/13, Diabetes, after release started noticing eye tics, depression, forgetfulness, hard time focusing and has since been diagnosed Type 2 diabetes, Juvenile Myoclonic Epilepsy, ADHD, Premenstrual Dysphoric Disorder, Sleep Apnea, and depression.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Juvenile myoclonic epilepsy, Memory impairment, Premenstrual dysphoric disorder, Sleep apnoea syndrome, Tic
Clinical narrative: Blood sugar 436, admitted into hospital 8/12/13, Diabetes, after release started noticing eye tics, depression, forgetfulness, hard time focusing and has since been diagnosed Type 2 diabetes, Juvenile Myoclonic Epilepsy, ADHD, Premenstrual Dysphoric Disorder, Sleep Apnea, and depression.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Type 2 diabetes mellitus
Clinical narrative: Blood sugar 436, admitted into hospital 8/12/13, Diabetes, after release started noticing eye tics, depression, forgetfulness, hard time focusing and has since been diagnosed Type 2 diabetes, Juvenile Myoclonic Epilepsy, ADHD, Premenstrual Dysphoric Disorder, Sleep Apnea, and depression.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Amnesia, Anxiety, Aphasia, Autonomic nervous system imbalance, Dizziness
Clinical narrative: Pain at injection site, head ache, nausea, fatigue, dizzy, black outs,  hot/cold, muscle twitching, leg and feet numbness, wakes up paralyzed and trembling with seizures and unable to call for help.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Feeling abnormal, Feeling of body temperature change, Headache, Hyperacusis
Clinical narrative: Pain at injection site, head ache, nausea, fatigue, dizzy, black outs,  hot/cold, muscle twitching, leg and feet numbness, wakes up paralyzed and trembling with seizures and unable to call for help.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Impaired gastric emptying, Injection site pain, Loss of consciousness, Muscle twitching
Clinical narrative: Pain at injection site, head ache, nausea, fatigue, dizzy, black outs,  hot/cold, muscle twitching, leg and feet numbness, wakes up paralyzed and trembling with seizures and unable to call for help.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Nervous system disorder, Paralysis, Partial seizures, Photophobia
Clinical narrative: Pain at injection site, head ache, nausea, fatigue, dizzy, black outs,  hot/cold, muscle twitching, leg and feet numbness, wakes up paralyzed and trembling with seizures and unable to call for help.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Postural orthostatic tachycardia syndrome, Seizure, Sleep disorder, Syncope, Tremor
Clinical narrative: Pain at injection site, head ache, nausea, fatigue, dizzy, black outs,  hot/cold, muscle twitching, leg and feet numbness, wakes up paralyzed and trembling with seizures and unable to call for help.