chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Blood test, Erythema, Gait disturbance, Headache
Clinical narrative: This spontaneous report as received from an 81 year old female patient regarding herself. Concurrent conditions included hypertension and penicillin and sulfa allergy. The patient's medical history included lymphoma. On 03-FEB-2016 the patient was vaccinated with PNEUMOVAX 23 single dose once intramuscularly (lot# and expiry date were not reported). Concomitant therapies included COUMADIN and CARDIZEM. On 03-FEB-2016, the patient experienced redness around the injection site. The same evening she felt horrendous pain, and the redness spread down her arm to her elbow and she came down with a headache and her legs shook. The patient stated she was very weak and had trouble walking. The patient also stated that the redness had now traveled underneath her left arm and it was "bright red and felt hot". Lab test included routine blood work (results unspecified) from her oncologist. The patient sought medical attention which included a call to the pharmacist. The outcome of the events was reported as not recovered/not resolved. The reporter did not provide the causality between the events and the suspect therapy. There were no product quality complaints (PQC) involved. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Pain, Tremor
Clinical narrative: This spontaneous report as received from an 81 year old female patient regarding herself. Concurrent conditions included hypertension and penicillin and sulfa allergy. The patient's medical history included lymphoma. On 03-FEB-2016 the patient was vaccinated with PNEUMOVAX 23 single dose once intramuscularly (lot# and expiry date were not reported). Concomitant therapies included COUMADIN and CARDIZEM. On 03-FEB-2016, the patient experienced redness around the injection site. The same evening she felt horrendous pain, and the redness spread down her arm to her elbow and she came down with a headache and her legs shook. The patient stated she was very weak and had trouble walking. The patient also stated that the redness had now traveled underneath her left arm and it was "bright red and felt hot". Lab test included routine blood work (results unspecified) from her oncologist. The patient sought medical attention which included a call to the pharmacist. The outcome of the events was reported as not recovered/not resolved. The reporter did not provide the causality between the events and the suspect therapy. There were no product quality complaints (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date in 2016, the patient received expired dose of RECOMBIVAX HB second dose, lot # J012520, expiration date: 30-JAN-2016 (exact dose, interval, route of administration and anatomical location were not reported). There were no concomitant medications provided. There was no adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medication was reported. On an unspecified dates in 2016 (reported as "since 05-JAN-2016"), the patients were vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # reported as K015369, expiry date 26-MAR-2016 (dose, route of administration and anatomical location were not reported). Administered doses were exposed to the following conditions: temperature of 33 Fahrenheit degrees for 15 hours and 15 minutes. There was no previous temperature excursions. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. 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 healthcare worker (certified medical assistant) refers to patients of unknown age and gender. The patients medical history, concurrent conditions and concomitant medications were not specified. On unspecified dates, the patients were vaccinated with improperly stored VAQTA lot # L002717, expiry date 02-JUN-2017 (dose, strength, route, dose numbers, vaccination site unspecified). The previous temperature excursion for the lot # L002717 was reported at a temperature of 34 degrees F for 15 hours. No adverse effects were reported. Product quality complaint (PQC) was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: FLU3, HPV4, TDAP, FLU3, HPV4, TDAP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medication was reported. On an unspecified dates in 2016 (reported as "since 05-JAN-2016"), the patients were vaccinated with an improperly stored doses of GARDASIL lot # K008931, expiry date 04-MAR-2017 (dose, route of administration and anatomical location were not reported). Administered doses were exposed to the following conditions: temperature of 33 Fahrenheit degrees for 15 hours and 15 minutes. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: FLU3, HPV4, TDAP, FLU3, HPV4, TDAP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medication was reported. On an unspecified dates in 2016 (reported as "since 05-JAN-2016"), the patients were vaccinated with an improperly stored doses of GARDASIL lot # K008931, expiry date 04-MAR-2017 (dose, route of administration and anatomical location were not reported). Administered doses were exposed to the following conditions: temperature of 33 Fahrenheit degrees for 15 hours and 15 minutes. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of an unknown age. The patient's concurrent conditions included chronic obstructive pulmonary disease (COPD). There was no information regarding the patient's medical history reported. On 08-FEB-2016, the patient was vaccinated with ZOSTAVAX 0.65 ml, once, subcutaneously, lot# reported as L037727 and expiration date: 09-DEC-2016. Lot# L037727 is an invalid lot number for ZOSTAVAX. The patient's concomitant medications included VENTOLIN and SPIRIVA. On an unspecified date in February 2016 (reported as within "two days after receiving" ZOSTAVAX, the patient experienced exacerbated COPD symptoms. On an unspecified date, the patient sought medical attention from her physician and was prescribed prednisone (manufacturer unknown) 10 mg, daily for 30 days as a treatment for the "COPD symptoms". The outcome of the event was reported as not recovered at the time of the report. The causality assessment between the event and ZOSTAVAX was not provided. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Food allergy, Immediate post-injection reaction, Incorrect dose administered, Vomiting
Clinical narrative: This spontaneous report was received from a physician regarding a 6 month old male patient. There was no information about concurrent condition and historical medication. On 21-JAN-2016, the patient was vaccinated with a small drop of ROTATEQ lot # L008574, expiration date- 22-NOV-2016, orally (incorrect dose administered). No concomitant medication was reported. On 21-JAN-2016 (also reported as immediately after administration), the patient experienced vomiting reported as faint pink emesis. The physician reported that on an unknown date in January 2016, the patient was still having vomiting episodes with other foods, like bananas (food allergy). The physician stated this vomiting could be due to another unspecified issue with swallowing and not ROTATEQ. No treatment was given for the adverse events. The outcome of vomiting was reported to be not recovered and the outcome of vomiting episodes with other foods, like bananas (food allergy) was unknown. The reporter did not assess the relatedness of events to the suspect therapy ROTATEQ. Product quality complaint (PQC) was not filed. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Exposure during pregnancy, Injection site pain, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse regarding his wife, a female patient of unknown age. No concurrent conditions or medical history were provided. On approximately 26-JAN-2016 (reported as "about 2 weeks ago"), the patient was vaccinated with a dose of M-M-R II injection (lot# and expiry date, strength, dose, route and site of administration were unspecified). No concomitant medications were reported. On an unknown date in 2016, the patient experienced pain at the injection site and some lightheadedness following the administration of the vaccine but these symptoms went away within a couple of hours. The patient sought medical attention, she was seen by her unspecified physician on 08-FEB-2016, for an unspecified reason, where she was given an unspecified pregnancy test which resulted in a positive response. The patient became pregnant with unspecified last menstrual period (LMP) and estimated date of delivery (EDD), however, the nurse reported that the patient was due to start menstruation cycle on 01-FEB-2016 but did not and therefore might be a little over of a month pregnant. The pregnancy outcome was outcome pending and fetal outcome was unknown. The outcome of an unspecified adverse event was unknown. The outcome of injection site pain and dizziness was reported as recovered in 2016. The relatedness between the events and M-M-R II was not provided. Additional information has been requested.
Age: 0.58
Sex: F
Vaccine: DTAP, FLUX, HEP, HIBV, IPV, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1, DTAPIPVHIB, PNC13, RV1
Symptoms: Rash generalised
Clinical narrative: Observed rash all over body. Mother states this started day after vaccination. Was evaluated by the pediatrician and recommended treatment with BENADRYL, CLARITIN. Mother states the child is doing well 2/12/16.
Age: 64.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 3 inch by 4.5 inch area of erythema and swelling over (L) bicep. Area of erythema is tender to palpation.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 10-FEB-2016 the patient was vaccinated with a properly stored expired dose of M-M-R II (lot #K000738, expiry date 16-JAN-2016) intramuscularly. No concomitant medications were reported. No adverse effects were reported. The was no product quality complaint reported. The action taken with the therapy with M-M-R II was unknown. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Local reaction
Clinical narrative: Vaccines were given on 2/9/16. Patient seen on 2/12/16 for localized reaction on left deltoid area. Reddened area is 5 inch by 4 inch, reddened slightly edematous, non painful, skin is only slightly warm.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to an 81 year old female patient. The patient's concurrent conditions, medical history and allergies were not reported. In approximately 2012 (reported as about 3 or 4 years ago), the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, route, anatomical location, batch/lot number and expiration date were not reported). Other suspect and concomitant therapies were not reported. On an unspecified date in February 2016 (reported as "sometime this week"), the patient experienced rash on her forward trunk that appeared to be shingles. The patient sought medical attention from the reporting physician, on an unspecified date in February 2016, and she was treated with acyclovir. It was unspecified if laboratory diagnostic studies were performed. No product quality complaint (PQC) was involved. The outcome of rash on her forward trunk that appeared to be shingles was reported as recovering. The relatedness between the events and therapy with ZOSTAVAX was not reported. 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 pharmacist and refers to an unspecified number of patients of unknown age and gender. No medical history, concurrent conditions and drug reactions/allergies were reported for the patients. On unknown dates beginning since 11-JAN-2016, the unspecified patients were vaccinated with improperly stored doses of ZOSTAVAX lot # L031273 with expiration date 19-NOV-2016, (dose, frequency, route and anatomical site of administration were not reported), which were previously exposed to temperatures outside of the recommended range. No concomitant medications were reported. No adverse experiences had been reported. No product quality complaint was involved. This is one of two reports received from the same source (MARRS # 1602USA006564). Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Injection site erythema, Injection site warmth, Mobility decreased, Peripheral swelling
Clinical narrative: Left deltoid/upper arm with redness and tenderness about the size of a softball. No fever and no other treatment ordered. Dad calling and stating child got HPV and Hep A vaccines on Monday and his arm is swollen now. Dad wondering if they should be worried. Dad calls to report pt got vaccines 2 days ago. The area he got the shots is now red and warm to touch. The red area is about the size of a softball per father. Child is not able to raise arm normally. Appt recommended and dad agrees. Child is at school and father is hoping for something after school. Appt  made for 4pm today with Dr. Father will call back before apt time if area worsens at all.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with incorrectly stored doses of PROQUAD (Merck) (dose, frequency and route of administration were not reported, lot # L041627 with expiration date: 20-APR-2017, therapy type unknown). No concomitant therapies reported. No adverse effects reported. 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 refers to multiple unspecified patients of an unknown age. The patient's pertinent medical history and concomitant medications were not reported. On unspecified dates, multiple unspecified patients were vaccinated with improperly stored (at 30 F for cumulative total of 10 hours and 30 minutes) VARIVAX (Merck) (lot # L027787; expiry date: 21-JUL-2017). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On 04-FEB-2016, the patient was received improperly stored PEDVAXHIB lot # L030870, expiration date 10-JUN-2018, 0.5 ml, intramuscularly. No adverse effects were reported. Additional information has been requested.
Age: 0.35
Sex: M
Vaccine: DTAPIPV, PPV, RV1
Symptoms: Crying, Decreased appetite, Drug administered to patient of inappropriate age, Dyspnoea, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of crying in a 4-month-old male patient who received KINRIX. Concomitant products included Pneumococcal vaccine, Rotavirus vaccine and TYLENOL. On 1st February 2016, the patient received KINRIX (intramuscular) .5 ml. On 1st February 2016, less than a day after receiving KINRIX, the patient experienced crying, decreased appetite, difficulty breathing, fever, drowsiness and inappropriate age at vaccine administration. On an unknown date, the outcome of the crying, difficulty breathing and fever were recovered/resolved and the outcome of the decreased appetite and drowsiness were not recovered/not resolved and the outcome of the inappropriate age at vaccine administration was unknown. It was unknown if the reporter considered the crying, decreased appetite, difficulty breathing, fever and drowsiness to be related to KINRIX. Additional details were provided as follows: This case was previously reported to a doctor. The patient's birth weight was reported as 7.63 kg. The patient has 1 sibling. The patient's mother planned to follow up with the patient's physician on an unknown date.
Age: 0.35
Sex: M
Vaccine: DTAPIPV, PPV, RV1
Symptoms: Somnolence
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of crying in a 4-month-old male patient who received KINRIX. Concomitant products included Pneumococcal vaccine, Rotavirus vaccine and TYLENOL. On 1st February 2016, the patient received KINRIX (intramuscular) .5 ml. On 1st February 2016, less than a day after receiving KINRIX, the patient experienced crying, decreased appetite, difficulty breathing, fever, drowsiness and inappropriate age at vaccine administration. On an unknown date, the outcome of the crying, difficulty breathing and fever were recovered/resolved and the outcome of the decreased appetite and drowsiness were not recovered/not resolved and the outcome of the inappropriate age at vaccine administration was unknown. It was unknown if the reporter considered the crying, decreased appetite, difficulty breathing, fever and drowsiness to be related to KINRIX. Additional details were provided as follows: This case was previously reported to a doctor. The patient's birth weight was reported as 7.63 kg. The patient has 1 sibling. The patient's mother planned to follow up with the patient's physician on an unknown date.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 67 year old female patient. Her medical history, concurrent conditions and concomitant medications were not reported. On 06-FEB-2016, the patient was vaccinated with a dose of ZOSTAVAX (subcutaneously, lot # reported as 035506, expiration date 16-DEC-2016; dose was not reported). In February 2016, the patient experienced redness and a swollen knot about the size of a honey bun at the injection site. There was no pain around the injection site. The patient did not seek medical attention. The outcome of the adverse events was unknown. The relatedness between the adverse events and ZOSTAVAX was not reported. 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 pharmacist and refers to an unspecified number of patients of unknown age and gender. No medical history, concurrent conditions and drug reactions/allergies were reported for the patients. On unknown dates beginning since 11-JAN-2016, the unspecified patients were vaccinated with improperly stored doses of VARIVAX (Merck) lot # L005300 with expiration date 17-FEB-2017, (dose, frequency, route and anatomical site of administration were not reported), which were previously exposed to temperatures outside of the recommended range. No concomitant medications were reported. No adverse experiences had been reported. No product quality complaint was involved. This is one of two reports received from the same source (MARRS # 1602USA005288). Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a health professional or nurse refers to a 23 year old female patient. No medical history and concurrent conditions were reported. On an unknown date the patient was vaccinated with GARDASIL 9 (lot number and expiry date unknown) (dosing regimen and frequency unknown) intramuscularly. Concomitant therapies included LEXAPRO and MIRENA IUD. On 01-FEB-2016, the patient experienced injection site soreness. It was reported that the patient sought medical attention and no treatment was given for the event. There was no product quality complaint reported. It was reported that the therapy with GARDASIL 9 was continued. The outcome of injection site pain was reported as recovering. The relatedness of the events to the therapy with GARDASIL 9 was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a registered nurse via company representative referring to an unspecified number of patients of unknown age and gender. The patient's medical histories and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with an unspecified dose of GARDASIL (lot number, dose, expiration date and route were not provided). Concomitant medications were not reported. It was reported that "a lot of patients faint after receiving GARDASIL". The outcome of syncope was unknown. The primary reporter did not provide the causality between GARDASIL and syncope. This is one of two reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Abasia, Headache, Incomplete course of vaccination, Pain in extremity
Clinical narrative: This spontaneous report was received from a registered nurse via company representative referring to a female patient in her 20's. The patient's medical history and concurrent conditions were not provided. On an unknown date in 2015, the patient was vaccinated with the first dose of GARDASIL 0.5 ml, (lot number, expiration date and route were not provided). Concomitant medications were not reported. On an unknown date in 2015, the patient experienced pain in extremity, headache and abasia reported as "the worst pain in her thigh, she could not walk and she had the worst headache". Because of these adverse events, the patient decided to discontinue the series after the first dose and had not gotten another dose since. The outcome of abasia, headache and pain in extremity was reported as recovered after stopping therapy on unspecified date in 2015. No product quality complaint (PQC) was reported. The primary reporter did not provide the causality between GARDASIL and abasia, headache and pain in extremity. This is one of two reports from the same source. 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 healthcare worker (certified medical assistant) refers to patients of unknown age and gender. The patients medical history, concurrent conditions and concomitant medications were not specified. On unspecified dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 lot # L014458, expiry date 11-FEB-2017 (dose, strength, route, dose numbers, vaccination site unspecified). The previous temperature excursion was reported at a temperature of 34 degrees F for 15 hours. No adverse effects were reported. Product quality complaint (PQC) was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a consumer refers to herself: a 60 year old female. The patient's concurrent condition included: hyperthyroid, high blood pressure, high ITF 2, osteoporosis, high immunoglobulin E (IGE), unspecified allergies (also reported as the patient did not have drugs reactions and allergies). On 05-FEB-2016, the patient was vaccinated with ZOSTAVAX 0.65 ml single shot subcutaneous (site of administration lot number and expiration date were not reported). Concomitant therapies included methimazole (manufacturer unknown), propranolol hydrochloride (manufacturer unknown), diazepam (manufacturer unknown) and zolpidem. On 06-FEB-2016, she noticed injection site redness, swelling and pain. She sought medical attention at unspecified Urgent Care facility. She was diagnosed with cellulitis and prescribed KEFLEX. She has taken six doses of the antibiotics since 06-FEB-2016 and her reactions have not improved. The patient stated that at the time of the report, the injection site has redness, swelling, itching, pain, hard to the touch and is warm to the touch. The outcome of the events was reported as not recovered/not resolved. The relatedness between adverse events and ZOSTAVAX was not reported. Additional information is not expected as the patient did not wish to be contacted.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: This spontaneous report as received from a consumer refers to herself: a 60 year old female. The patient's concurrent condition included: hyperthyroid, high blood pressure, high ITF 2, osteoporosis, high immunoglobulin E (IGE), unspecified allergies (also reported as the patient did not have drugs reactions and allergies). On 05-FEB-2016, the patient was vaccinated with ZOSTAVAX 0.65 ml single shot subcutaneous (site of administration lot number and expiration date were not reported). Concomitant therapies included methimazole (manufacturer unknown), propranolol hydrochloride (manufacturer unknown), diazepam (manufacturer unknown) and zolpidem. On 06-FEB-2016, she noticed injection site redness, swelling and pain. She sought medical attention at unspecified Urgent Care facility. She was diagnosed with cellulitis and prescribed KEFLEX. She has taken six doses of the antibiotics since 06-FEB-2016 and her reactions have not improved. The patient stated that at the time of the report, the injection site has redness, swelling, itching, pain, hard to the touch and is warm to the touch. The outcome of the events was reported as not recovered/not resolved. The relatedness between adverse events and ZOSTAVAX was not reported. Additional information is not expected as the patient did not wish to be contacted.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 lot # L020015, expiry date 16-AUG-2017 (strength, dose, route and site of administration were not reported) in immunization series. No adverse effects were reported. This is one of several cases 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 medical assistant refers to a unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On an unspecified dates in 2016, starting on or after 14-JAN-2016, the patients were vaccinated with improperly stored doses of ROTATEQ, oral, lot # reported as L023866 and lot# L023866 and expiration date 24-MAR-2017, (dose was not reported). There were no concomitant medications provided. No adverse effect was reported. Excursion details were reported as follows: Temperature: 34F; Time frame: 25 hours. There was no previous temperature excursion and it was not because of data logger. There was no product quality issue involved. Lot number L023866 has been verified to be a valid lot number for ROTATEQ. Lot number L028366 is an invalid lot number for ROTATEQ. Additional information has been requested. It was determined that the Aware Date for the initial version should have been 08-FEB-2016 instead of 09-FEB-2016; therefore, MARRS # 1602USA005194 will be deleted from our database and replaced with MARRS #1602USA005200.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (certified medical assistant) refers to patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not specified. On unspecified dates, the patients were vaccinated with improperly stored GARDASIL 9 lot # L011846 with expiry date 16-JUN-2017, lot # L017407 with expiry date 15-AUG-2017, lot # L020200 with expiry date 16-AUG-2017 (dose, strength, route, dose numbers, vaccination site unspecified). The previous temperature excursion for lots (# L011846, L017407) was reported at a temperature of 34 degrees F for 15 hours. The first excursion for the new lot # L020200 was reported at a temperature of 34 degrees F for 24 hours. No adverse effects were reported. Product quality complaint (PQC) was not 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 referring to an unspecified number of patients with unknown demographics. Information about the patients' medical history, concurrent conditions and drug reactions/allergies was not reported. On 08-FEB-2016, the patients were vaccinated with improperly stored doses of VARIVAX (Merck), (dose, and route of administration were not provided), lot # L034372 with expiration date 08-SEP-2017, lot # L032395 with expiration date 26-AUG-2017, lot # reported as L039092 with expiration date 06-OCT-2017 and lot # reported as L037561 with expiration date 29-SEP-2017. Concomitant medication was not reported. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 26-JAN-2016, the patient received a dose of improperly stored GARDASIL injection (lot # K010215 with expiration date 05-MAY-2017; dose and route were not provided). No adverse effects were reported. The vaccination was exposed to temperature of 50.3F for 1 hour and 20 minutes. There was a previous temperature excursion of 48.9F for 2 hours. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 4 year old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On 03-FEB-2016, the patient was vaccinated with an expired dose of PROQUAD (Merck) (lot # K009470, expiration date 03-JAN-2016) 0.5 ml, subcutaneously, in the right thigh. No adverse effects were reported. No PQC (product quality complaint) was involved. Additional information is not expected as the reporter did not want to be contacted.
Age: 61.0
Sex: F
Vaccine: PPV, FLU4, PPV
Symptoms: Mobility decreased, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Rotator cuff syndrome
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 56 year old female patient. Her medical history was not provided. Her concurrent conditions included seasonal allergies, arthritis, diabetes, high cholesterol, unspecified thyroid problems, sleep apnea and hypertension. None drug reactions/allergies were reported. On 30-OCT-2015, the patient was vaccinated with the dose of PNEUMOVAX 23 (0.5 ml, intramuscularly; lot # and expiration date were not reported). Concomitant therapies included FLONASE, hydrocodone, ketorolac tromethamine, metformin, SOLU-MEDROL, VICTOZA, ZETIA and an unspecified medication reported as gabapentin. On an unknown date, the patient experienced severe pain in her shoulders that hurt to touch. She also could not move her arms. The patient sought medical attention - she returned to the office a few days later and she received the treatment with diphenhydramine hydrochloride and the symptoms seemed to subside. On an unknown date, the patient went to the orthopedist who stated that she likely had chronic shoulder pain and referred her to a pain specialist. The pain specialist performed a magnetic resonance imaging (MRI) on an unknown date and stated that the patient had torn tendons in her rotator cuff in her arms. It was also provided that the patient was suing the practice. The outcome of the adverse event was unknown. The relatedness between the adverse event and PNEUMOVAX 23 was not provided. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV, FLU4, PPV
Symptoms: Mobility decreased
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 56 year old female patient. Her medical history was not provided. Her concurrent conditions included seasonal allergies, arthritis, diabetes, high cholesterol, unspecified thyroid problems, sleep apnea and hypertension. None drug reactions/allergies were reported. On 30-OCT-2015, the patient was vaccinated with the dose of PNEUMOVAX 23 (0.5 ml, intramuscularly; lot # and expiration date were not reported). Concomitant therapies included FLONASE, hydrocodone, ketorolac tromethamine, metformin, SOLU-MEDROL, VICTOZA, ZETIA and an unspecified medication reported as gabapentin. On an unknown date, the patient experienced severe pain in her shoulders that hurt to touch. She also could not move her arms. The patient sought medical attention - she returned to the office a few days later and she received the treatment with diphenhydramine hydrochloride and the symptoms seemed to subside. On an unknown date, the patient went to the orthopedist who stated that she likely had chronic shoulder pain and referred her to a pain specialist. The pain specialist performed a magnetic resonance imaging (MRI) on an unknown date and stated that the patient had torn tendons in her rotator cuff in her arms. It was also provided that the patient was suing the practice. The outcome of the adverse event was unknown. The relatedness between the adverse event and PNEUMOVAX 23 was not provided. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Paraesthesia
Clinical narrative: Patient complains of not being able to elevate her arm and tingling in her fingers. I referred her to see the prescribing physician. Physician not sure if related to vaccine or if some other cause.
Age: 59.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Activities of daily living impaired, Injection site pain, Mobility decreased, Sleep disorder
Clinical narrative: Severe pain in area of injection. Limited mobility of arm. It has now been over 2 weeks and it seems to be getting worse. Cannot lift arm to remove pullover shirts. Have trouble sleeping as pain is persistent.
Age: 59.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Injected limb mobility decreased, Insomnia, Vaccination site pain
Clinical narrative: Severe pain in area of injection. Limited mobility of arm. It has now been over 2 weeks and it seems to be getting worse. Cannot lift arm to remove pullover shirts. Have trouble sleeping as pain is persistent.
Age: 61.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Injection site pain
Clinical narrative: Soreness at injection site and in deltoid muscle.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Asthenia, Contusion, Dizziness, Fatigue
Clinical narrative: I have aches in joints, bruising, tiredness, weakness, nausea, dizziness, headaches muscle pain, swelling and sleep problems.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Myalgia, Nausea, Sleep disorder, Swelling
Clinical narrative: I have aches in joints, bruising, tiredness, weakness, nausea, dizziness, headaches muscle pain, swelling and sleep problems.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Immediate post-injection reaction, Injection site pain, Nuclear magnetic resonance imaging normal
Clinical narrative: When I received a flu shot on 22 October 2015, the needle was inserted higher and the pain was more severe than any previous shot. The pain began immediately and has not stopped. I was seen by my primary care physician who ordered an MRI. The MRI showed no apparent structural damage to the area, but the pain persists. My doctor then ordered physical therapy, which I am currently undergoing.
Age: 64.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pyrexia, Upper extremity mass
Clinical narrative: Developed lump on right arm and fever.
Age: 26.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Abdominal pain upper, Constipation, Diarrhoea
Clinical narrative: Intense stomach cramping with alternating constipation and diarrhea. Got worse in the next few days. Reappeared several weeks later, causing a visit to ER.
Age: 0.88
Sex: F
Vaccine: HIBV
Symptoms: Hair colour changes, Injection site erythema, Injection site induration, Injection site nodule, Injection site pruritus
Clinical narrative: Around age 1, a hard, itchy nodule developed in left thigh at immunizations injection site; it is intensely itchy, can become red and swollen when itched or when she has a cold. The hair surrounding the spot is darker than the rest of her leg hair. Vaccination Granuloma induced by aluminum containing vaccines.
Age: 0.88
Sex: F
Vaccine: HIBV
Symptoms: Injection site reaction, Injection site swelling, Vaccination site granuloma
Clinical narrative: Around age 1, a hard, itchy nodule developed in left thigh at immunizations injection site; it is intensely itchy, can become red and swollen when itched or when she has a cold. The hair surrounding the spot is darker than the rest of her leg hair. Vaccination Granuloma induced by aluminum containing vaccines.
Age: 41.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site pain, Musculoskeletal pain, Pain in extremity, X-ray
Clinical narrative: 9/24/15: flu shot administered in the morning.  Stabbing, shooting extreme pain felt deep within my shoulder immediately at time of injection that traveled down my arm into my fingertips which tingled.  My fiance was in the office with me and he saw my reaction to this injection.  I have had flu shots before and while they are not pleasant I have never felt this type of pain with any past injection before. The arm pain continued to get worse.  I used heat thinking it was some sort of muscle soreness and I gave it some time to be sure it wasn't just the soreness associated with the injection site but this was deep within the shoulder, not like past injections where the injection site would be sore. 10/4/15: Notified my Doctor.  Advised to ice the area off and on and to let my Doctor know how it feels after 2 weeks. After the 2 weeks no improvement called my Doctor back.  Advised to do another round of ice for another 2 weeks.  Still no improvement advised to come into the office. 11/2/15: appt with Dr.  She checked it out and prescribed Diclofenac Sod Dr 75mg Tab.  Took as prescribed.  Some improvement while on this medication but soon after I had completed taking all medication the pain came back.  Notified Dr of this. 11/23/16: another round of Diclofenac Sod Dr 75mg Tab.  Same as before- some improvement while taking medication but soon after completing pain came back.  Notified Doctor of this-referred to Shoulder Specialist. 1/4/16: appt with shoulder specialist.  X Rays were taken and cortisone shot adminstered.  Immediate relief from the shot for 2 weeks.  On the 3rd week the pain came back. 1/25/16: follow up visit with shoulder specialist.  At the time of the follow up appt, pain was back.  I am getting married on 2/17/16 so at the time of this appt shoulder specialist said he did not want me to do anything until after the ceremony.  Prescribed Methylprednisolone 4mg DosePak to take if needed at time of wedding ceremony.  Shoulder specialist wants to see me soon after marriage and has mentioned Physical Therapy for future treatment.  Right now TBD.
Age: 41.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Immediate post-injection reaction, Injection site pain, Pain, Pain in extremity, Paraesthesia
Clinical narrative: 9/24/15: flu shot administered in the morning.  Stabbing, shooting extreme pain felt deep within my shoulder immediately at time of injection that traveled down my arm into my fingertips which tingled.  My fiance was in the office with me and he saw my reaction to this injection.  I have had flu shots before and while they are not pleasant I have never felt this type of pain with any past injection before. The arm pain continued to get worse.  I used heat thinking it was some sort of muscle soreness and I gave it some time to be sure it wasn't just the soreness associated with the injection site but this was deep within the shoulder, not like past injections where the injection site would be sore. 10/4/15: Notified my Doctor.  Advised to ice the area off and on and to let my Doctor know how it feels after 2 weeks. After the 2 weeks no improvement called my Doctor back.  Advised to do another round of ice for another 2 weeks.  Still no improvement advised to come into the office. 11/2/15: appt with Dr.  She checked it out and prescribed Diclofenac Sod Dr 75mg Tab.  Took as prescribed.  Some improvement while on this medication but soon after I had completed taking all medication the pain came back.  Notified Dr of this. 11/23/16: another round of Diclofenac Sod Dr 75mg Tab.  Same as before- some improvement while taking medication but soon after completing pain came back.  Notified Doctor of this-referred to Shoulder Specialist. 1/4/16: appt with shoulder specialist.  X Rays were taken and cortisone shot adminstered.  Immediate relief from the shot for 2 weeks.  On the 3rd week the pain came back. 1/25/16: follow up visit with shoulder specialist.  At the time of the follow up appt, pain was back.  I am getting married on 2/17/16 so at the time of this appt shoulder specialist said he did not want me to do anything until after the ceremony.  Prescribed Methylprednisolone 4mg DosePak to take if needed at time of wedding ceremony.  Shoulder specialist wants to see me soon after marriage and has mentioned Physical Therapy for future treatment.  Right now TBD.
Age: 41.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: X-ray limb
Clinical narrative: 9/24/15: flu shot administered in the morning.  Stabbing, shooting extreme pain felt deep within my shoulder immediately at time of injection that traveled down my arm into my fingertips which tingled.  My fiance was in the office with me and he saw my reaction to this injection.  I have had flu shots before and while they are not pleasant I have never felt this type of pain with any past injection before. The arm pain continued to get worse.  I used heat thinking it was some sort of muscle soreness and I gave it some time to be sure it wasn't just the soreness associated with the injection site but this was deep within the shoulder, not like past injections where the injection site would be sore. 10/4/15: Notified my Doctor.  Advised to ice the area off and on and to let my Doctor know how it feels after 2 weeks. After the 2 weeks no improvement called my Doctor back.  Advised to do another round of ice for another 2 weeks.  Still no improvement advised to come into the office. 11/2/15: appt with Dr.  She checked it out and prescribed Diclofenac Sod Dr 75mg Tab.  Took as prescribed.  Some improvement while on this medication but soon after I had completed taking all medication the pain came back.  Notified Dr of this. 11/23/16: another round of Diclofenac Sod Dr 75mg Tab.  Same as before- some improvement while taking medication but soon after completing pain came back.  Notified Doctor of this-referred to Shoulder Specialist. 1/4/16: appt with shoulder specialist.  X Rays were taken and cortisone shot adminstered.  Immediate relief from the shot for 2 weeks.  On the 3rd week the pain came back. 1/25/16: follow up visit with shoulder specialist.  At the time of the follow up appt, pain was back.  I am getting married on 2/17/16 so at the time of this appt shoulder specialist said he did not want me to do anything until after the ceremony.  Prescribed Methylprednisolone 4mg DosePak to take if needed at time of wedding ceremony.  Shoulder specialist wants to see me soon after marriage and has mentioned Physical Therapy for future treatment.  Right now TBD.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Cough, Disease susceptibility, Dyspnoea, Pyrexia, Rhinorrhoea
Clinical narrative: For 3+ months he has had non-stop cough, mucus, labored breathing, shortness of breath, wheezing, and on/off fevers.  He is becoming easily susceptible to catching the sicknesses around him which he has not had prior to the last vaccination he received.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Wheezing
Clinical narrative: For 3+ months he has had non-stop cough, mucus, labored breathing, shortness of breath, wheezing, and on/off fevers.  He is becoming easily susceptible to catching the sicknesses around him which he has not had prior to the last vaccination he received.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient came in after article in newspaper shared that the HIGH DOSE FLU vaccine caused persistent arm pain this year. She said he had arm pain since receiving the vaccine.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient's spouse came in after article in newspaper shared that the HIGH DOSE FLU vaccine caused persistent arm pain this year. She said he had arm pain since receiving the vaccine.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Pt noticed area of injection site warm and possibly swollen. Area is also pink and occasionally itchy. It has not improved since 2/9/16. Pt was advised to see physician.