chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: Haematocrit decreased, Haemoglobin decreased, Injection site pain, Injection site swelling, Lymphocyte percentage
Clinical narrative: 3 yo male with Sickle Cell disease vaccinated as per AAP recommendations with PPSV23 (1st dose). Injected intramuscularly to left thigh, tolerated will in office and sent home ambulating and in no distress after 10 minutes. Mother called around 2pm reporting that school called to inform her that child was having left thigh pain and swelling, otherwise well with no fever or respiratory distress.
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: Monocyte percentage, Neutrophil percentage, Platelet count increased, White blood cell count increased
Clinical narrative: 3 yo male with Sickle Cell disease vaccinated as per AAP recommendations with PPSV23 (1st dose). Injected intramuscularly to left thigh, tolerated will in office and sent home ambulating and in no distress after 10 minutes. Mother called around 2pm reporting that school called to inform her that child was having left thigh pain and swelling, otherwise well with no fever or respiratory distress.
Age: 84.0
Sex: M
Vaccine: FLUA3
Symptoms: Cough, Malaise, Throat irritation
Clinical narrative: Chesty cough, itchy throat, not feeling well.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Redness and swelling, below injection site 2 days post with continued soreness.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry skin, Exfoliative rash, Rash erythematous
Clinical narrative: Red, dry, scaly rash on left forearm - lasted approximately 3 days so far. No pain, itching, or swelling.
Age: 28.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Erythema, pain and warmth at site of injection - exaggerated, measured at 9 x 7.5 cm.
Age: 55.0
Sex: F
Vaccine: PNC13
Symptoms: Chest X-ray normal, Dyspnoea, Full blood count normal, Pain, Respiratory tract congestion
Clinical narrative: Body aches, congestion, wheezing, shortness of breath, runny nose.
Age: 55.0
Sex: F
Vaccine: PNC13
Symptoms: Rhinorrhoea, Wheezing
Clinical narrative: Body aches, congestion, wheezing, shortness of breath, runny nose.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus
Clinical narrative: Existing patient presented for flu shot. Has had flu shots in past with no problems. Flu shot FLUARIX QUAD given about 0930. Pt walked to transit center: noted increasing itching at injection site gave self an EPIPEN she carries secondary to allergy to insects and Sulfa. Called pharmacy at 10:30 and advised to stop back. Pt stopped in at 1500. Advised she was ok, but would take BENADRYL upon return home.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Anal incontinence, Irritability, Lethargy, Urinary incontinence
Clinical narrative: 3 to 4 hrs. after injection (Hep A). Pt. became very irritable, lethargic, lost bladder control and stooling. Pt. was afebrile during this time and when seen at office at 8/8/17.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Red raised arm about 3 inches in diameter with itching.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: Redness to left shoulders.
Age: 0.17
Sex: F
Vaccine: DTAP
Symptoms: Urticaria
Clinical narrative: Baby developed hives the night that she received first DTaP (DAPTACEL) which was the only vaccine she received that day. The hives lasted for 10 days.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP, MNQ
Symptoms: Blood creatine phosphokinase, Blood creatine phosphokinase MB, Burning sensation, Decreased appetite, Differential white blood cell count
Clinical narrative: Information was received on 14-JUL-2017 from a physician via a company representative regarding an 11 year old male patient with decreased appetite. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 10-JUL-2017 the patient was vaccinated with GARDASIL 9 (lot number and expiration unknown) dose 1, intramuscular in the left arm for prophylaxis. Other suspect therapies included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid administered in the left arm intramuscular and MENACTRA administered in the right arm intramuscular. After the vaccines were administered, the patient developed burning in his muscles and armpits. The patient's upper thighs hurt and were sensitive, as well as his legs and thighs became numb. The weekend before the patient was vaccinated, he had been anorexic which continued until Monday and Tuesday, exact dates unspecified. On 13-JUL-2017, the patient developed hurting lower than his thighs. The patient sought medical attention. The physician has prescribed ibuprofen and ordered tests for unspecified dates on 14-JUL-2017. Numerous unspecified tests ordered to include creatine kinase and blood work. A diagnosis cannot be determined until the physician has the results of the tests. The outcome of burning in his muscles and armpits, upper thighs hurt and were sensitive, his legs and thighs became numb and hurting lower than his thighs was reported as not recovered/not resolved. No further information was available. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP, MNQ
Symptoms: Full blood count, Hypoaesthesia, Metabolic function test, Pain in extremity, Sensory disturbance
Clinical narrative: Information was received on 14-JUL-2017 from a physician via a company representative regarding an 11 year old male patient with decreased appetite. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 10-JUL-2017 the patient was vaccinated with GARDASIL 9 (lot number and expiration unknown) dose 1, intramuscular in the left arm for prophylaxis. Other suspect therapies included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid administered in the left arm intramuscular and MENACTRA administered in the right arm intramuscular. After the vaccines were administered, the patient developed burning in his muscles and armpits. The patient's upper thighs hurt and were sensitive, as well as his legs and thighs became numb. The weekend before the patient was vaccinated, he had been anorexic which continued until Monday and Tuesday, exact dates unspecified. On 13-JUL-2017, the patient developed hurting lower than his thighs. The patient sought medical attention. The physician has prescribed ibuprofen and ordered tests for unspecified dates on 14-JUL-2017. Numerous unspecified tests ordered to include creatine kinase and blood work. A diagnosis cannot be determined until the physician has the results of the tests. The outcome of burning in his muscles and armpits, upper thighs hurt and were sensitive, his legs and thighs became numb and hurting lower than his thighs was reported as not recovered/not resolved. No further information was available. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP, MNQ
Symptoms: Burning sensation, Hyperaesthesia, Hypoaesthesia, Myalgia, Pain
Clinical narrative: Information was received on 14-JUL-2017 from a physician via a company representative regarding an 11 year old male patient with decreased appetite. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 10-JUL-2017 the patient was vaccinated with GARDASIL 9 (lot number and expiration unknown) dose 1, intramuscular in the left arm for prophylaxis. Other suspect therapies included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid administered in the left arm intramuscular and MENACTRA administered in the right arm intramuscular. After the vaccines were administered, the patient developed burning in his muscles and armpits. The patient's upper thighs hurt and were sensitive, as well as his legs and thighs became numb. The weekend before the patient was vaccinated, he had been anorexic which continued until Monday and Tuesday, exact dates unspecified. On 13-JUL-2017, the patient developed hurting lower than his thighs. The patient sought medical attention. The physician has prescribed ibuprofen and ordered tests for unspecified dates on 14-JUL-2017. Numerous unspecified tests ordered to include creatine kinase and blood work. A diagnosis cannot be determined until the physician has the results of the tests. The outcome of burning in his muscles and armpits, upper thighs hurt and were sensitive, his legs and thighs became numb and hurting lower than his thighs was reported as not recovered/not resolved. No further information was available. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP, MNQ
Symptoms: Hyperaesthesia, Hypoaesthesia, Myalgia, Pain in extremity
Clinical narrative: Information was received on 14-JUL-2017 from a physician via a company representative regarding an 11 year old male patient with decreased appetite. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 10-JUL-2017 the patient was vaccinated with GARDASIL 9 (lot number and expiration unknown) dose 1, intramuscular in the left arm for prophylaxis. Other suspect therapies included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid administered in the left arm intramuscular and MENACTRA administered in the right arm intramuscular. After the vaccines were administered, the patient developed burning in his muscles and armpits. The patient's upper thighs hurt and were sensitive, as well as his legs and thighs became numb. The weekend before the patient was vaccinated, he had been anorexic which continued until Monday and Tuesday, exact dates unspecified. On 13-JUL-2017, the patient developed hurting lower than his thighs. The patient sought medical attention. The physician has prescribed ibuprofen and ordered tests for unspecified dates on 14-JUL-2017. Numerous unspecified tests ordered to include creatine kinase and blood work. A diagnosis cannot be determined until the physician has the results of the tests. The outcome of burning in his muscles and armpits, upper thighs hurt and were sensitive, his legs and thighs became numb and hurting lower than his thighs was reported as not recovered/not resolved. No further information was available. Additional information has been requested.
Age: 0.75
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Irritability, Metabolic function test normal, Pyrexia, Rash, Somnolence
Clinical narrative: Fever up to 101.6 F the following day and continuing at around 99 or 100 degrees for 3 to 4 days. Questionable jaundice on 6/30/17. Child was taken to walk-in clinic on 6/30/17. Vitals and CMP values were normal. There was increased sleepiness the following day, then irritability, increased cruising for no reason for about 7 to 8 days. On day 3 or 4 a light rash appeared on the head and followed to neck and torso over 24 to 48 hrs then gradually disappeared. This lasted a total of about 3 days.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received on 14-JUL-2017 from a certified medical assistant (CMA) referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. The medical assistant reported that improperly stored doses of PROQUAD (Lot number M043309, expiration date 24-APR-2018 and Lot number N000678, expiration date 05-JUL-2018) were administered to multiple unspecified patients on multiple unspecified dates. (The doses, routes of administration and sites of administration were not reported.) The excursion information was reported as: The temperature was reported as 6 degrees Fahrenheit (F) to 14 degrees Fahrenheit (F) (9F).  Time frame was reported as 24 hours. There was no previous temperature excursion. The call was not because of a data logger. Product quality complaint was not involved. No adverse effects reported. No additional information was provided. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received on 14-JUL-2017 from a pharmacist refers to an elderly 72 year old female patient. The patient's medical history, concurrent conditions and concomitant therapy were not reported. On an unknown date, "2 or 3 months ago" the patient had received PNEUMOVAX 23 (Dose, route of administration, site of administration, Lot number and expiration date were not reported.) for prophylaxis.  The pharmacist reported that the patient, on 14-JUL-2017, received another dose of PNEUMOVAX 23 (Lot # N010106, expiration date 15-NOV-2018) (Dose, route of administration, and site of administration were not reported) for prophylaxis. No adverse effects reported. No further information was provided. Product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received on 14-JUL-2017 from a pharmacist referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapy were not reported. The pharmacist reported that improperly stored vaccines of RECOMBIVAX HB (Lot number N002202, expiration date 14-NOV-2019) were administered to multiple unspecified patients on multiple unspecified dates. (The doses, routes of administration and sites of administration were not reported.) The excursion information was reported as: The temperature was reported as 47 degrees Fahrenheit (F) to 77 degrees Fahrenheit (F). Time frame was reported as 23 hours and 50 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects reported. No additional information was provided. Product quality complaint was not involved. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Dyspnoea
Clinical narrative: This spontaneous report as received from a physician via a company representative concerning a 17 year old female patient. The patient did not have a significant medical history and was not taking and concomitant medication. On 13-JUL-2017 the patient was vaccinated with the first dose of GARDASIL 9, (route unknown) (lot # M037770, expiration date 01-JUN-2019) for prophylaxis. The patient returned to the physician's office on 17-JUL-2017 with complaints of difficulty breathing (onset date not specified). The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a licensed practical nurses referring to a patient of unknown age and gender. No concurrent condition, medical history and concomitant medication were reported. On 07-JUN-2017, the patient was vaccinated with GARDASIL (lot # M014929 and expiration date 27-MAY-2017) (strength, dose, route and frequency were not reported) for prophylaxis (Expired product administered). No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA002493.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not reported. On 17-JUL-2017, the patient was vaccinated with improperly stored ZOSTAVAX (lot # M042849, expiration date 18-JAN-2018, dose and route were not reported) for prophylaxis ,which was reconstituted with sterile diluent (MERCK STERILE DILUENT). The vaccine was exposed to temperature excursion of -13 degrees Celsius for 8 hours and the data logger was involved. There was no previous temperature excursion. Sterile diluent (MERCK STERILE DILUENT) was stored properly. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1708USA001487:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered Nurse (R.N) concerning multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of M-M-R II (rHA) (Lot # M029230; expiration date 08-JUN-2018), (Lot # M034856; expiration date 27-JUL-2018), (Lot # M042846; expiration date 21-OCT-2018), (Lot # M015931; expiration date 30-MAR-2018), (Lot # M029229; expiration date 08-JUN-2018), (Lot # M032157; expiration date 01-JUL-2018) for prophylaxis (dose and route not reported). It was also reported that the vaccine was reconstituted with properly stored diluent (Lot # unknown by reporter). The temperature was 9°C to 25°C for 210 hours and there was no previous temperature excursion. The call was made because of a data logger. adverse effects reported and there was no PQC involved. This is one of several cases from the same source.; Sender's Comments: US-009507513-1708USA003628: US-009507513-1708USA003629: US-009507513-1708USA003630: US-009507513-1708USA003632: US-009507513-1708USA003633: US-009507513-1708USA003634: US-009507513-1708USA003635: US-009507513-1708USA003627: US-009507513-1708USA003631:
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients whose age and gender were not reported. On an unknown date the patients were vaccinated with a dose of improperly stored ZOSTAVAX injection via parenteral route, lot # M037656, expiry date: 29-NOV-2017 for prophylaxis with a properly stored sterile water diluent whose lot number and expiration date were not reported. The ZOSTAVAX received by the patients were reported to be stored at temperature of -9 degree centigrade to 8 degree centigrade for a duration of three months. It was reported that there was no previous temperature excursion. The report was received because of data logger. No adverse effects were reported for the patients.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Immediate post-injection reaction, Rash
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 73 year old female patient. On 20-JUL-2017 the patient was vaccinated with PNEUMOVAX 23 lot # N010105 and (expiration date 15-NOV-2018), 0.5 ml, subcutaneously for prevention of pneumococcal disease. On 20-JUL-2017 (reported as immediately following the injection), the patient experienced headache.  On an unspecified date in July 2017 (reported as within a week of the injection), the patient experienced rash. The outcome of rash and headache was reported as recovering. There was no product quality complaint involved.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse practitioner concerning a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy information was not provided. On 31-JUL-2017, the patient was vaccinated with PROQUAD (lot # L042817, expiration date: 26-APR-2017, strength, dose, frequency and route were not reported) (expired drug administered) reconstituted with sterile diluent (lot # and expiration date were unknown) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored M-M-R II (lot # L049314, expiration date 03-DEC-2017, dose and route were unknown) reconstituted with sterile diluent for prophylaxis. Diluent was not involved in the temperature excursion. The temperature excursion was at 47.2 Fahrenheit for 45 minutes. Previous temperature excursion was at 47.8 Fahrenheit for 1 hour and 16 minutes. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1708USA003659: US-009507513-1708USA003660: US-009507513-1708USA003658.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 years old child of unknown gender. The patient's medical history, concurrent conditions, drug allergies and concomitant medications were not reported. On 01-AUG-2017 the patient received a concomitant administration of VARIVAX (lot # M038858, Expiry date: 14-SEP-2018) and PROQUAD (lot # N009773, Expiry date : 28-SEP-2018) reconstituted with STERILE WATER DILUENT (unknown lot, unknown expiration) (overdose). No adverse effects reported. The outcome of overdose was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not reported. On 17-JUL-2017, the patient was vaccinated with improperly stored ZOSTAVAX (lot # M042849, expiration date 18-JAN-2018, dose and route were not reported) for prophylaxis, which was reconstituted with sterile diluent (MERCK STERILE DILUENT). The vaccine was exposed to temperature excursion of -13 degrees Celsius for 8 hours and the data logger was involved. There was no previous temperature excursion. Sterile diluent (MERCK STERILE DILUENT) was stored properly. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006150:
Sex: F
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: This spontaneous report was received from a nurse via a company representative referring to a 11-12 year old female patient. On 15-JUL-2017, the patient was vaccinated with GARDASIL 9 for prophylaxis. On 15-JUL-2017, the patient experienced dizziness. After she felt fainted, she returned to the office, sat down and water was given her. The outcome of dizziness was reported as recovered/resolved.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age. On an unknown date, the patient was vaccinated with the third dose of GARDASIL 9 for prophylaxis, 18 days earlier than specified in the prescribing information. No adverse event.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a licensed practical nurses referring to a patient of unknown age and gender. No concurrent condition, medical history and concomitant medication were reported. On 05-JUL-2017, the patient was vaccinated with GARDASIL (lot # M014929 and expiration date 27-MAY-2017) (strength, dose, route and frequency were not reported) for prophylaxis (Expired product administered). No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006090.
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a physician refers to a 18 month old female patient. On 01-APR-2017 the patient was vaccinated with VARIVAX, .5 ml, subcutaneous for prophylaxis. On 2017 the patient experienced rash. The outcome of rash was reported as recovered/resolved.
Age: 66.0
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist concerning to a 66 year old patient of unknown gender. Patient's pertinent medical history, drug allergies/reactions and concomitant medication were reported as none. On 31-JUL-2017, the patient was vaccinated with PNEUMOVAX23 lot # M043424 (expiry date: 06-JUL-2018, dose, route and frequency not reported). The patient complained of "flu like symptoms, swelling and redness at the injection site". On 02-AUG-2017, the patient visited their primary care physician and was diagnosed with cellulitis, prescribed an unspecified antibiotic. It was not known at this time if the patient had recovered. The outcome of cellulitis was unknown. No further information to provide. The causal relationship between the event and PNEUMOVAX23 was not reported. Product quality complaint (PQC) was not involved. Upon internal review, the event cellulitis was determined as medically significant. This is one of the two patients report received from the same reporter (linked case#1708USA003434).
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 04-AUG-2017 the patient was vaccinated with an expired dose of GARDASIL 9 (lot # L044475, expiration date 17-MAY-2017, dose and route unknown) for prophylaxis (experienced expired product administered). GARDASIL 9 did not have any previous temperature excursions. No adverse symptoms were reported.
Age: 68.0
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist concerning to a 68 year old patient of unknown gender. Patient's pertinent medical history, drug allergies/reactions and concomitant medication were reported as none. On 31-JUL-2017, the patient was vaccinated with PNEUMOVAX 23 lot # M043424 (expiry date: 06-JUL-2018, dose, route and frequency not reported). The patient complained of "flu like symptoms, swelling and redness at the injection site". On 02-AUG-2017, the patient visited their primary care physician and was diagnosed with cellulitis, prescribed an unspecified antibiotic. It was not known at this time if the patient had recovered. The outcome of cellulitis was unknown. No further information to provide. The causal relationship between the event and PNEUMOVAX23 was not reported. Product quality complaint (PQC) was not involved. Upon internal review, the event cellulitis was determined as medically significant. This is one of the two patients report received from the same reporter (linked case#1708USA003034).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered medical assistant referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # M000761 with expiration date of 06-JAN-2018; strength, dose, route and anatomical location were not provided), for prophylaxis. Concomitant therapies included sterile diluent (manufacturer unknown).  It was also reported that the administered dose experienced a temperature excursion during 1 hour and 20 minutes at a temperature of 24.7 degrees Celsius on unspecified date. A data logger issue was involved. No previous temperature excursion and no adverse effects were reported.; Sender's Comments: US-009507513-1708USA003626:
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a other health professional refers to a 73 year old male patient. On 04-AUG-2017 the patient was vaccinated with PNEUMOVAX 23 lot # N010109 dose 1, .5 ml for prophylaxis. On AUG-2017 the patient experienced injection site erythema, injection site warmth and injection site swelling. The outcome of injection site erythema, injection site warmth and injection site swelling was reported as recovering/resolving.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash
Clinical narrative: This spontaneous report was received from an online news article (on 21-JUL-2017). The article refers to 18 unspecified patients (ages and genders not specified) who received ZOSTAVAX (Dates of vaccinations, doses, routes of administration, sites of administration, Lot numbers and expiration dates were not reported.) MARRS # 1708USA003597 refers to 16 of the 18 patients). Current conditions, medical history, allergies, and concomitant medications of the patients were not specified. The article stated the following: Eighteen patients have filed a liability lawsuit against Merck, alleging the company produced and sold an "unreasonably dangerous vaccine" that caused serious injuries after vaccination.  The plaintiffs were from 5 different states. Instead of preventing shingles, ZOSTAVAX caused the plaintiffs to "contract a persistent strain of herpes zoster," according to the suit, resulting in painful outbreaks, hospital visits and post-herpetic neuralgia in two cases." (Reference MARRS # 1708USA003624 for the 2 patients with post-herpetic neuralgia.) The treatment and outcome of the Instead of preventing shingles, ZOSTAVAX caused the plaintiffs to "contract a persistent strain of herpes zoster", resulting in painful outbreaks was not reported. Additional information is not expected as there were no contact details. Sender's Comments: GB-009507513-1703GBR007969: US-009507513-1708USA003624.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash
Clinical narrative: This spontaneous report was received on 21-JUL-2017. The article refers to 18 unspecified patients (ages and genders not specified) (Reference MARRS # 1708USA003597 for 16 of 18 patients) who received ZOSTAVAX (Dates of vaccinations, doses, routes of administration, sites of administration, Lot numbers and expiration dates were not reported.) Current conditions, medical history, allergies, and concomitant medications of the patients were not specified. The article stated the following:  Eighteen patients have filed a liability lawsuit against Merck, alleging the company produced and sold an "unreasonably dangerous vaccine" that caused serious injuries after vaccination. The plaintiffs were from 5 different places. Instead of preventing shingles, ZOSTAVAX caused the plaintiffs to "contract a persistent strain of herpes zoster," according to the suit, resulting in painful outbreaks, hospital visits and post-herpetic neuralgia in two cases (This MARRS # 1708USA003624  refers to 2 of the 18 patients.). The treatment and outcome of the Instead of preventing shingles, ZOSTAVAX caused the plaintiffs to "contract a persistent strain of herpes zoster", resulting in painful outbreaks and post-herpetic neuralgia was not reported. Additional information is not expected as there were no contact details.; Sender's Comments: GB-009507513-1703GBR007969: US-009507513-1708USA003597:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered medical assistant referring to a 7 patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot # M049122 with expiration date of 13-JUN-2018; strength, dose, route and anatomical location were not provided), for prophylaxis. Concomitant therapies included sterile diluent (manufacturer unknown). It was also reported that the administered doses experienced a temperature excursion during 1 hour and 20 minutes at a temperature of 24.7 degrees Celsius on unspecified dates. A data logger issue was involved. No previous temperature excursion and no adverse effects were reported. Sender's Comments: US-009507513-1708USA003540.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered Nurse (R.N) concerning multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of LIQUID PEDVAX HIB (Lot # M036058; expiration date 19-MAY-2018), (Lot # M034188; expiration date 20-MAY-2018), (Lot # N007750; expiration date 29-NOV-2019), (Lot # M047666; expiration date 17-JUL-2019), (Lot # N000235; expiration date 26-OCT-2019), for prophylaxis (dose and route not reported). It was also reported that the vaccine was reconstituted with properly stored diluent (Lot # unknown by reporter). The temperature was 9°C to 25°C for 210 hours and there was no previous temperature excursion. The call was made because of a data logger. Adverse effects reported and there was no PQC involved. This is one of several cases from the same source.; Sender's Comments:  US-009507513-1708USA003628: US-009507513-1708USA003629: US-009507513-1708USA003635: US-009507513-1708USA003631: US-009507513-1708USA003632: US-009507513-1708USA003633: US-009507513-1708USA003634: US-009507513-1708USA011937: US-009507513-1708USA003630:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered Nurse (R.N) concerning multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 (Lot # M042853; expiration date 17-JUL-2019), (Lot # N003703; expiration date 29-OCT-2019), (Lot # N004799; expiration date 15-NOV-2019) for prophylaxis (dose and route not reported). The temperature was 9°C to 25°C for 210 hours and there was no previous temperature excursion. The call was made because of a data logger. Adverse effects reported and there was no PQC involved. This is one of several cases from the same source. Sender's Comments: US-009507513-1708USA003629: US-009507513-1708USA011937: US-009507513-1708USA003635: US-009507513-1708USA003631: US-009507513-1708USA003632: US-009507513-1708USA003633: US-009507513-1708USA003634: US-009507513-1708USA003627: US-009507513-1708USA003630.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered Nurse (R.N) concerning multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (Lot # N010106; expiration date 15-NOV-2018) for prophylaxis (dose and route not reported). The temperature was 9°C to 25°C for 210 hours and there was no previous temperature excursion. The call was made because of a data logger. Adverse effects reported and there was no PQC involved. This is one of several cases from the same source.; Sender's Comments:  US-009507513-1708USA003628: US-009507513-1708USA011937: US-009507513-1708USA003635: US-009507513-1708USA003631: US-009507513-1708USA003632: US-009507513-1708USA003633: US-009507513-1708USA003634: US-009507513-1708USA003627:  US-009507513-1708USA003630:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered Nurse (R.N) concerning multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ per oral route (Lot # M041815; expiration date 28-JUN-2018), (Lot # M046008; expiration date 29-JUN-2018), (Lot # M035456; expiration date 01-MAY-2018), (Lot # M040268; expiration date 14-MAY-2018), (Lot # M044030; expiration date 13-JUN-2018) for prophylaxis (dose not reported).  The temperature was 9°C to 25°C for 210 hours and there was no previous temperature excursion. The call was made because of a data logger. Adverse effects reported and there was no PQC involved. This is one of several cases from the same source.; Sender's Comments: US-009507513-1708USA003628: US-009507513-1708USA003629: US-009507513-1708USA003635: US-009507513-1708USA003631: US-009507513-1708USA003632: US-009507513-1708USA003633: US-009507513-1708USA003634: US-009507513-1708USA003627: US-009507513-1708USA011937:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered Nurse (R.N) concerning multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA (Lot # N008823; expiration date 26-MAY-2018) for prophylaxis (dose and route not reported).  The temperature was 9°C to 25°C for 210 hours and there was no previous temperature excursion. The call was made because of a data logger. Adverse effects reported and there was no PQC involved. This is one of several cases from the same source.; Sender's Comments: US-009507513-1708USA003628: US-009507513-1708USA003629: US-009507513-1708USA003635: US-009507513-1708USA011937: US-009507513-1708USA003632: US-009507513-1708USA003633: US-009507513-1708USA003634: US-009507513-1708USA003627: US-009507513-1708USA003630:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to unspecified patients of unknown age and gender. The patients' current conditions, medical history and concomitant medications were not provided by the reporter. On an unknown date in 2017(reported as from 24-JUL-2017 to 07-AUG-2017), the patients were vaccinated with PNEUMOVAX 23 (strength, dose and route of administration were not reported) lot # M043424, expiration date 06-JUN-2018, for prophylaxis. The vaccine was exposed to a temperature of 47 degree fahrenheit to 77 degree Fahrenheit for 5 hours (incorrect product storage). There was no previous temperature excursion. Digital data logger was involved. There was no adverse effects.There was no product quality complaint (PQC) involved.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored GARDASIL 9 (Lot # M035486, expiration date 05-JUN-2019, dose and route were unknown) reconstituted with sterile diluent for prophylaxis. Diluent was not involved in the temperature excursion. The temperature excursion was at 47.2 Fahrenheit for 45 minutes. Previous temperature excursion was at 47.8 Fahrenheit for 1 hour and 16 minutes. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1708USA003659: US-009507513-1708USA003660: US-009507513-1708USA001211.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored PNEUMOVAX 23 (Lot # M040004, expiration date 20-MAY-2018, dose and route were unknown) for prophylaxis. The temperature excursion was at 47.2 Fahrenheit for 45 minutes. Previous temperature excursion was at 47.8 Fahrenheit for 1 hour and 16 minutes. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA001211: US-009507513-1708USA003660: US-009507513-1708USA003658:
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored VAQTA (Lot # N002921, expiration date 08-APR-2018, dose and route were unknown) for prophylaxis. The temperature excursion was at 47.2 Fahrenheit for 45 minutes. Previous temperature excursion was at 47.8 Fahrenheit for 1 hour and 16 minutes. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA003659: US-009507513-1708USA001211: US-009507513-1708USA003658:
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse, refers to a 19 year old female patient. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. On 11-JUL-2016, the patient was vaccinated with first dose of GARDASIL 9 and on 04-AUG-2017, she received her second vaccine dose (lot # M007728, expiry date 21-MAR-2018) for prophylaxis (inappropriate schedule of drug administration). No adverse effects were reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: This spontaneous report received from a physician assistant referred to a currently 60 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient who was adalimumab (HUMIRA) was administered ZOSTAVAX (lot: M035694, expiry date not reported) (Product use issue) with sterile diluent. No adverse effects reported.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding a 16 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 01-AUG-2017, the patient was vaccinated with an expired dose of GARDASIL lot # K010215 with expiration date 05-MAY-2017 (dose and route were not reported), for prophylaxis. No adverse effects was reported. The outcome of expired product administered and no adverse event was unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Vaccination site irritation, Vaccination site pain
Clinical narrative: This spontaneous report as received from a other health professional refers to a 61 year old male patient. On an unknown date the patient was vaccinated with ZOSTAVAX for prophylaxis. Other suspect therapies included sterile diluent(STERILE DILUENT). About 3 days after receiving ZOSTAVAX, the developed an area of "irritation" and "soreness" in the vaccinated arm (unspecified side) (vaccination site irritation and vaccination site pain). Also reported that, if anything touched or bumped [his] arm it was very sore. The outcome of vaccination site irritation and vaccination site pain is unknown. Causality was unknown. No Product Quality Complaint (PQC) was involved.
Age: 26.0
Sex: F
Vaccine: ANTH
Symptoms: Burning sensation, Hypoaesthesia, Paraesthesia, Peripheral coldness
Clinical narrative: Patient describes a burning sensation from elbow to wrist, numbness and tingling from elbow to shoulder and slight numbness/coldness in right hand.
Age: 0.75
Sex: M
Vaccine: HIBV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Injection site erythema starting was noticed the day after vaccination and is painful to the touch. It still hasn't gone away.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Pain, Skin warm, Swelling
Clinical narrative: Localized pain, heat to touch, swelling, dizziness.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. Since 27-JAN-2017, the patients were vaccinated with improperly stored doses of GARDASIL 9 for prophylaxis. There were no adverse events reported. Additional information has been requested.
Sex: U
Vaccine: HBHEPB
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of COMVAX lot # J013884 for prophylaxis. No adverse effects were reported. Data logger was involved. This is one of several reports received from the same reporter. Additional information is not expected.; Sender's Comments: US-009507513-1708USA000870: US-009507513-1708USA002370: US-009507513-1708USA002371: US-009507513-1708USA002372: US-009507513-1708USA002369:
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX lot # M035146 for prophylaxis. Concomitant therapies included sterile diluent(STERILE DILUENT). On an unknown date the patient experienced expired product administered and no adverse event. The outcome of expired product administered and no adverse event is unknown. The reporter considered expired product administered and no adverse event to be not related to ZOSTAVAX. Additional information has been requested.
Age: 1.25
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a 15-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 04-AUG-2017, the patient was vaccinated with improperly stored dose of M-M-R II injection (lot # M036544 (also reported as M023895), expiration date: 15-AUG-2018; dose and route of administration were not reported). The dose of the vaccine was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) (also reported as STERIL WATER DILUENT) injection. The reporter stated that the administered dose of M-M-R II was stored at temperature 10.2 degrees Celsius for 39 hours 45 minutes. Data logger was used to detect temperature excursions. There were no previous temperature excursions reported. No adverse effects were reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1708USA004009:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 07-AUG-2017, the patient received an improperly stored dose of PEDVAXHIB injection (lot # N003536 with expiration date at 02-NOV-2019; strength, exact dose, route of administration and anatomical location were not reported), for prophylaxis. The administered dose of vaccine was exposed to a temperature of 35.4 degrees Fahrenheit (F) for 12 minutes. There was no previous temperature excursion. Data logger was used to track the temperature. No symptoms were reported. No product quality complaint (PQC) was involved. This is one of several report received form the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA004004.