chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: FLUX
Symptoms: X-ray
Clinical narrative: Initial unsolicited report received from a non- healthcare professional on 6 October 2015. This case involves a 61-year-old male patient who was vaccinated with a dose of INFLUENZA VACCINE (Influenza) (batch number U53388A, route, dose and site of administration was not reported) 3 October 2015 at 10:00 AM. Patient medical history and concomitant medications were not reported. On 3 October 2015 at 5:00 PM, seven hours following the vaccination, the patient experienced chills, body aches and muscle tightness and same day at 11:00 PM, 13 hours following vaccination the patient experienced severe sweating, body aches, muscle tightness, arm tingling and stomach pain or soreness. On 3 October 2015, same day the patient also experienced rash at injection site. The patient required emergency room or doctor visit. Lab data included blood work, urinalysis, x-ray and CAT scan of abdomen. Corrective treatments were not reported. The patient was recovered from the events. List of documents held by sender: none. Follow-up information received from non-healthcare professional in the United States on 01 December 2015. No further information available.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Feeling hot, Pain, Tremor
Clinical narrative: Initial unsolicited report received from a consumer on 06-Oct-2015. This case involves a 70 years old female patient who was vaccinated with a first dose of FLUZONE HD via intramuscular route (batch number, expiry date, site of administration were not reported) on 06-Oct-2015. The patient had no illness at time of vaccination. She was diabetic and had cardiac conditions. Concomitant medications were not reported. On 06-Oct-2015, in the evening, few hours post vaccination, the patient developed body aches, chills, felt hot (no temperature was taken) and her hands were shaking. The patient took two asprin as corrective treatment. Laboratory tests were not reported. The symptoms were resolving. The outcome was reported as unknown. Follow up information received from a consumer on 17 December 2015. No new information was provided. Follow-up information received from a consumer on 22 January 2016. It was reported that the patient had not recived any vaccine at my office and come for visist after vaccination. No new information received. List of documents held by sender: none.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Feeling abnormal, Hypoaesthesia, Paraesthesia
Clinical narrative: Initial unsolicited report received from a consumer on 2 October 2015. This case involves a 42-year-old female patient who was vaccinated with a dose of Flu vaccine (batch number, expiration date, dose, dose number, route and site of administration not reported) on 1 October 2015. The patient also received daily 14 mg of AUBAGIO (batch number: 4A66CSA, expiration date: 28 February 2017) for multiple sclerosis since 1 October 2015. The patient received Flu vaccine three hours after starting the AUBAGIO. The patient's other medical history and concomitant history was not reported. The patient had numbness in the arms, legs, face, breast, and pretty much everywhere prior to starting AUBAGIO. On 2 October 2015, one day following the vaccination, the patient began feeling weird, numbness, and tingling in places that she normally did not have the tingling. She had an odd sensation, like cold pins and needles feeling, in the lumbar area of the back. It was reported, the numbness, tingling, and feeling weird was not all bothersome, it was just there. The patient did not contact her doctor since it was not bothersome. The AUBAGIO was ongoing at time of this report. Laboratory investigation and corrective treatment were not reported. The patient had not recovered from events. Company causality was assessed as possible for AUBAGIO. List of documents held by sender: none.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: Body aches, fever of 100 to 101. Injection site red, hot and swollen.
Age: 20.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Syncope
Clinical narrative: Injections were given and patient walked to front office then had syncopal episode. Assisted to floor by another patient and no injury noted. Moved to patient room and vs checked. She says she feels better now and was able to stand and walk with no dizziness. Encouraged her to use caution when she gets injections or has blood drawn as she may pass out again. RN July 19, 2016 4:36 PM.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis bullous, Erythema, Pain
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a female patient of unknown age. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 21-JUL-2016, the patient was vaccinated with a dose of ZOSTAVAX 1 dose in the left arm, lot # reported as MO13377 (not valid for ZOSTAVAX) (route of administration and expiration date were not reported). On unspecified date in July 2016, the patient experienced a "bullous" reaction with mild redness and soreness. The patient sought medical attention. It was unknown whether the patient was given any treatment for the events or if any lab diagnostics studies were performed. The outcome of the events was not reported. The relatedness between the events and ZOSTAVAX was not provided. Upon internal review the event of bullous reaction was considered to be medically significant. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 15 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 31-AUG-2015, the patient was vaccinated with a dose of GARDASIL (lot # L010596; dose and route were not provided) that had experienced and excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 14-SEP-2015, the patient was vaccinated with a dose of GARDASIL (lot # K014191; dose and route were not provided) that had experienced an excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 14-SEP-2015, the patient was vaccinated with a dose of GARDASIL (lot # L010596; dose and route were not provided) that had experienced an excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 31-AUG-2015, the patient was vaccinated with a dose of GARDASIL (lot # L010596; dose and route were not provided) that had experienced an excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR, MMRV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This is a spontaneous report as received from a Registered Nurse. The nurse reported that unspecified patients were vaccinated on unspecified dates with improperly stored doses of M-M-R II lot number L026551, expiration 16-JUL-2017; VARIVAX lot # L042267, expiration 27-OCT-2017 (MARRS# 1607USA004854) and PROQUAD lot number L9465057 expiration 17-MAY-2017 (MARRS# 1607USA-011587). No adverse effect reported. No further information received. Lot number L9465057 is an invalid lot number for PROQUAD. This is one of several reports from same reporter. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 20-AUG-2-15, the patient was vaccinated with a dose of GARDASIL (lot # L010596; dose and route were not provided) that had experienced an excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 31-AUG-2015, the patient was vaccinated with a dose of GARDASIL (lot # K004204, expiration date 12-JAN-2017; dose and route were not provided) that had experienced an excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 24.0
Sex: M
Vaccine: RAB
Symptoms: Decreased appetite, HIV test negative, Hepatic function abnormal, Laboratory test normal, Mononucleosis heterophile test negative
Clinical narrative: Client wanted pre-exposure Rabies to work with Raccoons. Received first Rabies vaccines on 7/19/16 tolerated shot well. That night when she got home. She had a fever, around 100.3. took some Ibuprofen. Went to bed. Fever in am was up again, she didn't take it, up near 100.2. She took TYLENOL and MOTRIN x3 times that day. (She is an RN who works in UC). Thursday temp was 101 or even higher per client. She took antipyretics. Friday went to UC. They  gave her IV fluids. WBC was 2.3 and her hepatic labs values where weird (her words). She stopped taking any TYLENOL. She said she forgot to tell the HD she had Graves' Disease. She had some N/ and no appetite. She had a HIV, Mono spot and a few other tests. 7/26/16 She called  me and stated all lab tests came back normal. She was feeling better.
Age: 24.0
Sex: M
Vaccine: RAB
Symptoms: Nausea, Pyrexia, White blood cell count decreased
Clinical narrative: Client wanted pre-exposure Rabies to work with Raccoons. Received first Rabies vaccines on 7/19/16 tolerated shot well. That night when she got home. She had a fever, around 100.3. took some Ibuprofen. Went to bed. Fever in am was up again, she didn't take it, up near 100.2. She took TYLENOL and MOTRIN x3 times that day. (She is an RN who works in UC). Thursday temp was 101 or even higher per client. She took antipyretics. Friday went to UC. They  gave her IV fluids. WBC was 2.3 and her hepatic labs values where weird (her words). She stopped taking any TYLENOL. She said she forgot to tell the HD she had Graves' Disease. She had some N/ and no appetite. She had a HIV, Mono spot and a few other tests. 7/26/16 She called  me and stated all lab tests came back normal. She was feeling better.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV9, MNQ
Symptoms: Erythema, Fall, Head injury, Headache, Swelling face
Clinical narrative: Pt was in for immunizations today.  After receiving immunizations pt had syncopal episode and fell, striking his head on the floor.  Witnessed by two MAs. Vital signs assessed and ice pack placed on left forehead for redness and swelling.  Pt awake after 30 seconds and c/o headache. Moved to chair after 10 minutes. Examined by Dr. Assisted to car with mom, scheduled for follow up visit tomorrow with Dr.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV9, MNQ
Symptoms: Syncope
Clinical narrative: Pt was in for immunizations today.  After receiving immunizations pt had syncopal episode and fell, striking his head on the floor.  Witnessed by two MAs. Vital signs assessed and ice pack placed on left forehead for redness and swelling.  Pt awake after 30 seconds and c/o headache. Moved to chair after 10 minutes. Examined by Dr. Assisted to car with mom, scheduled for follow up visit tomorrow with Dr.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Face injury, Headache, Syncope, Unresponsive to stimuli
Clinical narrative: Patient was administered 3 vaccines. She was told that she might be woozy and to sit for a minute after she had the vaccines. Nurse administered vaccines then left the room. Patient sat for about 5 minutes and decided she was able to walk. So, we walked down the hall. As I was going to pay the bill, she collapsed behind me. A few nurses went to her and one sent for a doctor. She was face down. When I lifted her head, her eyes were open but unresponsive. She came to in about 1 or 2 minutes. She laid there for about another 2 minutes before the nurses helped her walk to the trauma room where they placed her on a bed and put a wet paper towel on her forehead. They also gave her a little bottle of water and some ibuprofen. We sat there for about 20 minutes when the doctor came to check on her. She examined her rib and asked if she had headaches. She told us that fainting is not uncommon after vaccines are given and that if patient felt dizzy the next day or anything happened to contact her. She also instructed to give her plenty of fluids. We left. She felt dizzy off and on with headaches off and on for the remainder of the day.
Age: 13.0
Sex: F
Vaccine: HPVX
Symptoms: Dizziness, Fatigue, Headache, Pain, Syncope
Clinical narrative: Headache, Fainting, Dizziness, Tiredness child was given ibuprofen. Pain continues.
Sex: U
Vaccine: MMR, MMRV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This is a spontaneous report as received from a Registered Nurse. The nurse reported that unspecified patients were vaccinated on unspecified dates with improperly stored doses of VARIVAX lot # L042267, expiration 27-OCT-2017; M-M-R II; lot number L026551, expiration 16-JUL-2017; and PROQUAD lot number L9465057 expiration 17-MAY-2017. No adverse effect reported. No further information received. Lot number L9465057 is an invalid lot number for PROQUAD. This is one of several reports from the same reporter. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 14-SEP-2015, the patient was vaccinated with a dose of GARDASIL (lot # L010596; dose and route were not provided) that had experienced an excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This is a spontaneous report as received from a Registered Nurse. The nurse reported that unspecified patients were vaccinated on unspecified dates with improperly stored doses of PROQUAD lot number L9465057 expiration 17-MAY-2017; M-M-R II lot number L026551, expiration 16-JUL-2017 (MARRS# 1607USA0115876); and VARIVAX lot # L042267, expiration 27-OCT-2017 (MARRS# 1607USA004854). No adverse effect reported. No further information received. Lot number L9465057 is an invalid lot number for PROQUAD. This is one of several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Eye swelling, Herpes zoster, Pain
Clinical narrative: This spontaneous report as received from a physician refers to his wife of unknown age. The physician reported that his wife had received a dose of ZOSTAVAX (lot# and expiration date not reported) "about 4 years ago". The physician stated the patient "had a spot near her eye, her eye was swollen, she had couple other spots on her head, and experienced pain {in an unspecified area of the body)" and diagnosed with herpes zoster "within the last year". The patient was treated with an unspecified antiviral medication. No additional information provided. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 16 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 31-AUG-2015, the patient was vaccinated with a dose of GARDASIL (lot # L010596, dose and route were not provided) that had experienced an excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 28-JUL-2016, the patient inadvertently received an unknown dose of expired PNEUMOVAX 23 injection, lot # L003188, expiration date: 06-JUL-2016, intramuscularly (exact dose and anatomical location were not provided). There were no adverse effects reported. Additional information has been requested.
Age: 50.0
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a adult male patient. The pharmacist reported that a patient who is currently 50 years old with renal failure (diagnosed prior to ever receiving PNEUMOVAX 23. The patient received two doses of PNEUMOVAX 23, each dose on separate date; first dose administered on 05-NOV-2014 and the second dose was administered on 10-JAN-2016. No adverse effects reported. No further information was provided. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MMR
Symptoms: Arthritis, Eye disorder, Eye swelling, Joint swelling
Clinical narrative: This spontaneous report as received from a consumer concerning her 11 year old daughter. The patient's historical drug included HUMIRA for knee swelling, but had not used since December 2015. She is allergic to amoxicillin. Concomitant medications were not reported. On 07-JUN-2016, the patient was vaccinated with M-M-R II via subcutaneous route (lot # lot L044058, expiry date and dose not reported). Subsequently, on 10-JUN-2016, the patient knees began to swell. On 28-JUN-2016, the patient developed swelling in her right and sought medical attention-went to physician's office. The physician stated the patient had arthritis in her eye and treated with prednisone drops. The outcome of the events was reported as recovering. The patient's physician believed that all of her symptoms are as results of the vaccine. The reporter did not assess the relatedness between the events and the vaccine. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Abortion induced, Exposure during pregnancy
Clinical narrative: Based on additional information received on 18 July 2016, this case initially considered as non-serious was upgraded to serious due to event pregnancy terminated. Initial unsolicited pregnancy report received from a nurse on 08 June 2016. This case involves an 18-year-old female patient who was vaccinated with a second dose of MENACTRA (batch number: U5259AA, expiry date: 13 May 2017, dose not reported) intramuscularly in left deltoid on 07 June 2016. It was unknown, if the patient was pregnant at the time of vaccination. Pregnancy information (LMP was unknown, estimated delivery date, pregnancy trimester) was not reported. The patient's medical history and concomitant medications were not reported. By the time of reporting, the patient was not seen by obstetrician HCP. At the time of this report, the patient had not experienced any adverse events. Pregnancy outcome was not reported. Documents held by sender: none. Follow-up information received from a nurse on 18 July 2016. On an unknown date, the pregnancy was terminated. Upon internal review, the company decided to consider the event serious due to important medical event: pregnancy terminated. The outcome of pregnancy terminated was unknown. Sender's Comments: Patient was administered MENACTRA vaccine at that time she was unaware of pregnancy, usually vaccine are not given during pregnancy, and later patient has terminated the pregnancy. Details regarding the gestational age, cause for termination and any anomaly in previous baby are needed to further assess the case. MENACTRA vaccine is not absolutely contraindicated in pregnancy. Based on available information role of vaccine is unlikely.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown age and gender. Information on their concurrent conditions and medical history were not reported. On an unknown date the patients were vaccinated with improperly stored PROQUAD lot # L024122, expiry date 30-DEC-2016 (dose number, dose units, route and anatomical location were not reported). Concomitant medications were not reported. There was no Product Quality Complaint (PQC) involved. This case is linked to MARS # 1607USA012830 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to an unspecified number of "young adult" patents of unknown age and gender. No information about the patients' medical history and concurrent conditions was reported. On an unknown date, patients received hepatitis B vaccine (manufacturer unknown) (strength, dose, frequency, route of administration, lot # and expiration date were not provided). No concomitant therapy was reported. On an unknown date, patients were found to have not seroconverted following the administration of hepatitis B vaccines (manufacturer unknown). The outcome of reported event was unknown. Product quality complaint was not involved. The relatedness between the lack of seroconversion and received hepatitis B vaccine (manufacturer unknown) was not reported. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: HEPA, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (medical assistant) refers to a patient of an unknown age and gender. Information regarding the patient's pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On 25-JUL-2016, the patient was vaccinated with the second dose of MMR II (lot # K008625, expiration date: 16-JUN-2016, dose, route of administration and frequency were not reported), that was expired. No adverse effects were reported. There was no product quality complaint. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Aphasia, Inappropriate schedule of drug administration, Memory impairment
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with GARDASIL (dose1, 1 dose, route reported as vaccine and lot# unknown) as recommended by the CDC (Centers for Disease Control). On an unknown date, the patient was diagnosed with "TOTS" (Tip-of-the-Tongue Syndrome) and did not complete series of GARDASIL. She only received the first dose. On an unknown date, therapy with GARDASIL was discontinued. The outcome of the events were considered as unknown. Causality assessment was not provided. There was no product quality complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: HPV4, HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a office manager refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb. vaccine (GARDASIL) (lot number, expiration date, dose, route of administration and frequency were not reported). On an unknown date, a year later, the patient was vaccinated with hpv pl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot number, expiration date, dose, route of administration and frequency were not reported). No adverse effects were reported. There was no product quality complaint. Additional information his not expected because the reporter did not consent to contact with the patient's physician.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site infection, Tinea infection
Clinical narrative: Information has been received from a consumer referring to her 27 year old female patient. The patient had no pertinent medical history and drug reactions or allergies. There was no concomitant medication. On an unspecified date in March or April of 2016, the patient was vaccinated with VARIVAX (subcutaneous; dose was unknown) for prevention of varicella. The patient presented with redness at the injection site on the next day or two after the VARIVAX injection. The area turned into a red splotch and was still present as the date of this report. The patient visited an unspecified physician on 15-JUL-2016. The physician diagnosed her with ringworm as a result of the VARIVAX injection. An unspecified treatment was given for the event. No lab test was performed. Additional information is not expected as the reporter refused to provided HCP's contact details.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On an unknown date in 2011, the patient received the first dose in the series of three of GARDASIL (strength, dosing details, anatomical location, lot# and expiration date were unknown). On 06-JUL-2016, the patient was vaccinated with second dose in the series GARDASIL 9 (strength, dosing details, anatomical location, lot# and expiration date were unknown). No adverse effects were reported. The outcome of the events were unknown. No product quality complaint was involved. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pustule
Clinical narrative: This spontaneous report was received from a 63 year old female patient and refers to herself. The patient's medical history included cervical cancer (recovered). The patient's concurrent conditions included codeine drug reaction/allergy. On 08-JUL-2016 (reported as 10 days ago), the patient was vaccinated with ZOSTAVAX (1 time injection, route of administration was reported as injection, dose, lot# and expiration date were not provided) as shingles prevention. Concomitant therapies included lisinopril (manufacturer unknown) and EFFEXOR. On 15-JUL-2016, the patient began to have liquid filled pustules around the injection site on her arm. The patient sought medical attention. There were no lab diagnostics studies performed. An unspecified treatment was given for the adverse event. The outcome of the event was reported as not recovered/not resolved. The relatedness between the event and ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an immunization official referring to multiple unspecified patients of unknown ages and genders. The patients' medical histories and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with improperly stored doses VARIVAX (lot# M004326, expiration date 25-JAN-2018; lot# M005973, expiration date 02-FEB-2018; lot# M002064, expiration date 12-JAN-2018; lot# M004330, expiration date 26-JAN-2018; lot# M008171, expiration date: 16-FEB-2018; lot# M000995, expiration date 07-JAN-2018, route not reported). Concomitant therapies were not reported. The vaccines were improperly stored in 3.1 degrees Celsius for 1 hour. Previous temperature excursions included -13.1 degrees Celsius for 7 hours and -4 degrees Celsius for 14 hours. Cumulative time out of range (including present excursion) was 7 hours in unlimited range and 15 hours in refrigerated range. The vaccines were back in range. Data logger was involved. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple patients of unknown age and gender. On unknown dates the patients were inadvertently vaccinated with doses of improperly stored RECOMBIVAX HB (lot # L048849, expiration date 04-FEB-2018, route unknown). No adverse effects were reported. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site reaction, Joint swelling, Lymphadenopathy, Peripheral swelling
Clinical narrative: Friday night arm became bright red and swollen from shoulder to elbow. Took BENADRYL. Saturday arm was the same. Sunday swelling worse, also had swollen lymph nodes in her supraclavicular region as well as axilla. Monday developed red itchy rash of the injection site, scalp, palms, face, chest and legs. Swollen ankles.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Friday night arm became bright red and swollen from shoulder to elbow. Took BENADRYL. Saturday arm was the same. Sunday swelling worse, also had swollen lymph nodes in her supraclavicular region as well as axilla. Monday developed red itchy rash of the injection site, scalp, palms, face, chest and legs. Swollen ankles.
Age: 1.29
Sex: F
Vaccine: DTAP, FLU4, HIBV, PNC13
Symptoms: Pyrexia, Seizure
Clinical narrative: The patient developed fever and convulsions and was given Diazepam.
Age: 0.46
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Blood culture negative, CSF test normal, Culture urine negative, Diarrhoea, Fontanelle bulging
Clinical narrative: High fever 103.4, vomiting, diarrhea; presented to clinic with bulging fontanelle and fever 102 resolved with Tylenol and ice packs. full eval normal including CSF, blood culture and urine culture. pt's bulging fontanelle improved the next day as well as the fever.
Age: 0.46
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pyrexia, Vomiting
Clinical narrative: High fever 103.4, vomiting, diarrhea; presented to clinic with bulging fontanelle and fever 102 resolved with Tylenol and ice packs. full eval normal including CSF, blood culture and urine culture. pt's bulging fontanelle improved the next day as well as the fever.
Age: 78.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site reaction, Myalgia
Clinical narrative: Site reaction: erythema, myalgia.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. The reporter stated that a patient was administered the first dose in the series of three GARDASIL 9, intramuscularly, on 05-MAY-2016, and the second dose of GARDASIL 9 was administered earlier than the recommended two month interval on 01-JUL-2016. The primary reporter confirmed that the third dose of GARDASIL 9 was not administered. No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report as received from a female patient of unknown age regarding herself. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dosing details,lot# and expiry were not reported). The patient wanted to know how long the side effects last from ZOSTAVAX. She did not elaborate on what side effects she experienced. The outcome of the event was unknown. The reporter did not provided the causality between the event and the suspect therapy. There were no product quality complaints (PQC) involved. Additional information  has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Vaccination site haemorrhage
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's medical history was not reported. On 01-JUL-2016, the patient was inadvertently vaccinated by the intramuscular route with a dose of ZOSTAVAX lot # reported as M009773, expiration date reported as 17-MAY-2017 (dose and site of vaccination were not reported). In approximately July 2016, the patient a lot of bleeding at the vaccination site. The outcome of vaccination site haemorrhage was unknown. The relatedness between vaccination site haermorrhage and ZOSTAVAX. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report has been received from a physician via a company representative and refers to a 16 or 17 year old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date in June 2016 (reported as within the "last 4 weeks"), the patient was vaccinated with GARDASIL 9, 1 injection (frequency, route of administration, lot # and expiration date were not reported) and after being administered the patient fainted. No treatment was provided for the event. The subject did not seek medical attention. No product quality complaint was reported. The outcome of the event was not reported. The relatedness between the event and GARDASIL 9 was not reported. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: This spontaneous report as received from a pharmacist refers to his wife, a 56 year old female patient. The patient has no known allergies and medical history included polycystic ovaries, unspecified sinus issues and gastrointestinal stromal tumor. On 04-JUL-2016, the patient was vaccinated with ZOSTAVAX, subcutaneous (lot number not reported). Concomitant therapies included GLEEVEC, unspecified decongestant, and metformin. On 05-JUL-2016, the patient experienced a "bumpy, raised rash that is painfully, itchy." Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 14-JUL-2015, the patient was vaccinated with an improperly stored dose of M-M-R II lot # J005706, expiration date 15-AUG-2015 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 51 degrees Fahrenheit for 15 hours. There were no previous excursions reported. Data logger: unspecified. Lot number J005706 is an invalid lot number for M-M-R II. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent to contact healthcare worker.
Sex: U
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a consumer via a social webpage, refers to several 'young' patients of unknown age and gender. No medical history or concurrent conditions of the patients were reported. On an unknown date, the patients were vaccinated with GARDASIL for an unknown indication. The reporter stated having 'read stories of these young patients who had been injured by GARDASIL' (injury and adverse event). The outcome of the events was not known. Causality was considered to be related since the reporter stated, 'patients were injured by GARDASIL'. This is one of the two reports from the same source (linked to MARRS number 1607FRA011670). Additional information has been requested
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a non-medical healthcare worker refers to a patient of an unknown gender and age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (dose, lot#, expiration date and route and administration were not reported). On an unknown date, 5 weeks after the first dose of GARDASIL, the patient was inadvertently vaccinated with the second GARDASIL. There were no adverse effects reported. Product quality complaint (PQC) was not involved. Additional information is not expected as there was not consent for further contact.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to an 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 unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # L033690, expiration date 14-JUN-2018; lot # L038502, expiration date 16-AUG-2018; lot # M010440, expiration date 09-DEC-2018, lot # reported as M001811, expiration date 04-NOV-2018 (dose 0.5 ml, route of administration was not reported). None of the patients reported adverse effects. Administered doses of the vaccine experienced a temperature excursion of 32.4 degrees Fahrenheit for 3 hours and 30 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to three patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On 21-JUL-2015, the patients were vaccinated with an improperly stored doses of M-M-R II lot # J005706, expiration date 15-AUG-2015 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 51 degrees Fahrenheit for 15 hours. There were no previous excursions reported. Data logger: unspecified. Lot number J005706 is an invalid lot number for M-M-R II. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent to contact healthcare worker.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to an 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 unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # L035508, expiration date 12-MAY-2017; lot # M004508, expiration date 29-JUN-2017; lot # M014318, expiration date 30-SEP-2017, lot # reported as M019706, expiration date 24-OCT-2017 (dose was not reported, orally). None of the patients reported adverse effects. Administered doses of the vaccine experienced a temperature excursion of 32.4 degrees Fahrenheit for 3 hours and 30 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Therapeutic response unexpected
Clinical narrative: This report was received from an unspecified reporter via a Market Research. The reporter stated, that '20 years of lab studies in mice, and human observational data, suggested that the PNEUMOVAX 23 might be protective against heart attack and stroke'. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to two patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On 15-JUL-2015, the patients were vaccinated with improperly stored doses of M-M-R II lot # J005706, expiration date 15-AUG-2015 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 51 degrees Fahrenheit for 15 hours. There were no previous excursions reported. Data logger: unspecified. Lot number J005706 is an invalid lot number for M-M-R. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent to contact healthcare worker.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to an 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 unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # L025738, expiration date 14-AUG-2017; lot # L039660, expiration date 04-FEB-2018; lot # L045117, expiration date 06-OCT-2018, lot # M000442, expiration date 31-MAR-2018 (dose and route of administration were not reported). None of the patients reported adverse effects. Administered doses of vaccine experienced a temperature excursion of 32.4 degrees Fahrenheit for 3 hours 30 minutes. 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 physician and refers to an unspecified number of patients of unknown age and gender. There was information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lot # M021124, expiration date 02-FEB-2018; lot # M022531, expiration date 23-FEB-2018 (dose and route of administration were not reported). None of the patients reported adverse effects. Administered doses of the vaccine experienced a temperature excursion of 32.4 degrees Fahrenheit for 3 hours 30 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding to a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 29-JUN-2016, the patient was vaccinated with GARDASIL dose 3, lot # m014929/ expiration date-27-MAY-2017, 23 weeks after 2nd dose that is on 20-JAN-2016. No concomitant medication was reported. No adverse event was reported. The outcome of event was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to an 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 unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L043214, expiration date 30-AUG-2017; lot # M003659, expiration date 20-SEP-2017; lot # M009116, expiration date 13-JUN-2018 (dose and route of administration were not reported). None of the patients reported adverse effects. Administered doses of vaccine experienced the temperature excursion of 32.4 degrees Fahrenheit for 3 hours 30 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On 17-JUL-2015, the patients were vaccinated with improperly stored doses of M-M-R II lot # J005706, expiration date 15-AUG-2015 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of 51 degrees Fahrenheit for 15 hours. There were no previous excursions reported. Data logger: unspecified. Lot number J005706 is an invalid lot number for M-M-R II. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent to contact healthcare worker.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash, Lethargy, Pain, Skin warm
Clinical narrative: 24 hours after injection pt lethargic, w/rash at inj site. Rash increased in size to about size of three 1/2 dollars. No itching, and warmth and sore persisting 48 hours later. Advised ice and BENADRYL.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Headache
Clinical narrative: About 5 min. after receiving HPV9 vaccine, patient reported dizziness. Nurse applied cold compress to patient's forehead and had pt sit with head between knees. After 5 min, patient sat up and drank 6oz. orange juice and 4 oz. water. Patient then reported headache and continued dizziness. Nurse placed mat on floor and patient lay down. Patient fully recovered in 10 min.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Dyskinesia, Syncope
Clinical narrative: Tdap given to child in (R) deltoid and tolerated well. The HPV was then administered in the (R) deltoid also with appropriate spacing. As soon as the needle was withdrawn, the child fainted and had a slight jerking movement. Within 30-45 seconds was beginning to be fully aroused, but took 45-60 minutes to feel strong enough to be discharged from health dept. Sent to PCP.