chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Palpable 1-2 inch hardened lump in deltoid region of arm where vaccine was administered (left). Site is tender and painful. Noticed approximately 4 weeks following final dose in the 3-dose Gardasil-9 vaccination series.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain, Peripheral swelling, Swelling
Clinical narrative: Transient tenderness at injection site and swelling of shoulder, arm, and hand. Patient went to work immediately after receiving injection. Tenderness and swelling resolved overnite with ALEVE.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling, Swelling face
Clinical narrative: Patient indicated that about 3-4 hours after she was given the Zostavax immunization, she noticed swelling of her lip/face. Patient called the next morning to let the pharmacy know of the reaction. No medical treatment necessary as issue had resolved.
Age: 53.0
Sex: F
Vaccine: MMR, PPV
Symptoms: Pain
Clinical narrative: PATIENT HAD MORE PAIN THAN EXPECTED ESPECIALLY ON THURSDAY 4/7, 4/8 I CHECKED W/HER, SHE SAID GETTING BETTER BUT NOT 100%. I CHECKED AGAIN ON SATURDAY SHE SAID ALL GOOD-NO MORE PAIN.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness
Clinical narrative: Slight dizziness 30 minutes after vaccination otherwise fine, left work and still is experiencing dizziness as of 10:00 PM 4/12/16. No other symptoms.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Immediate post-injection reaction, Loss of consciousness
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of passed out in a 16-year-old female patient who received BEXSERO. Concurrent medical conditions included fear of needles (needle phobia). On an unknown date, the patient received BEXSERO. On an unknown date, immediately after receiving BEXSERO, the patient experienced passed out (serious criteria GSK medically significant). On an unknown date, the outcome of the passed out was recovered/resolved. It was unknown if the reporter considered the passed out to be related to BEXSERO. Additional details were provided as follows: This case was reported by a medical assistant (MA). The sales representative was unable to provide name of the primary reporter. Limited details were known for this report.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient rec'd flu vaccine on 3/11/16. At apt on 3/31/16 patient reported left arm pain since vaccination. Pt was instructed to use warm compress.
Age: 18.0
Sex: M
Vaccine: HEPA
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Peripheral swelling, White blood cell count
Clinical narrative: The next morning his arm was swollen. His mother called the office on 4/11/16. Nurse explained for her to take him to the doctor.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Pallor, Presyncope
Clinical narrative: Patient became pale and had near syncope 1 minute after vaccines were given. Cool wet paper towels were applied to her forehead, and she was fanned. She was given a cup of water and when she was feeling better, she was moved to the table to lay down, BP 78/40 -> 90/62 -> 100/70. She was monitored for 45 minutes and was asymptomatic prior to leaving office.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to unspecified patients of unknown demographics. On an unknown date the patients were vaccinated with improperly stored doses of ZOSTAVAX (dosing regimen unspecified). It was reported that an email was sent by the reporting physician after being informed by a colleague that a shipment of ZOSTAVAX came to the hospital unfrozen, at 4 degrees. The reporting physician knew that Merck made some lyophilized Varicella Zoster Virus (VZV) vaccines that were not stored frozen, but did not think they were available in the country. Her concern was that patients vaccinated with unfrozen zoster vaccine could develop insufficient VZV immunity. She indicated that she would try to learn more and contacted. Per the regulatory, only frozen formulation of ZOSTAVAX was marketed. Upon follow-up with the reporting physician she provided her contact of another physician and learned that the doses were received in the pharmacy and that the was quite sure that patients had been vaccinated with the shipment. Physician was not aware as to the number of doses administered. Was also not able to learn the time frame of the shipment or the dates of vaccination. Physician was not aware of any reports of adverse events but was concerned for the potential lack of efficacy for doses received at an improper temperature. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age. No information regarding the patient's medical history and concurrent conditions was provided. On unknown dates (reported as "previously"), the patient was vaccinated with 3 doses of ZOSTAVAX, injection, (dose, injection site, route of administration, lot number and expiration date were not reported). There were no concomitant medications reported. On an unknown date, the patient had failed to show titers for zoster. The outcome of the event was unknown at the time of the report. The relatedness between the event and ZOSTAVAX was not provided. 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 pharmacist refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 30-MAR-2016 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # K008927, expiry date 17-MAR-2016) (dosing regimen, frequency and route unknown). No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint reported. The action taken with the therapy with PNEUMOVAX 23 was unknown. The outcome of the events was unknown. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 4 year old male patient. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date (reported as at 12 months of age), the patient was vaccinated with the first dose of VARIVAX (Merck) (lot #, dose, route of administration and location were not reported) according to Center for Disease Control and Prevention (CDC) recommendation. On an unknown date (reported as an unspecified period of time after receiving first dose of VARIVAX (Merck), the patient developed shingles on an unspecified leg. The physician reported that the patient did resolved after an unspecified amount of time. The physician did not provide causality assessment between the event of shingles on an unspecified leg and therapy with VARIVAX (Merck). Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, MENB
Symptoms: Swelling face
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of facial swelling in a 16-year-old female patient who received BEXSERO (batch number L045711, expiry date 8th May 2017). Concomitant products included GARDASIL. On 27th February 2016, the patient received 1st dose of BEXSERO. In February 2016, 1 day after receiving BEXSERO, the patient experienced facial swelling. On 5th March 2016, the outcome of the facial swelling was recovered/resolved. It was unknown if the reporter considered the facial swelling to be related to BEXSERO. Additional details provided were as follows: The patient had received GARDASIL previously with no adverse reactions. The patient experienced face swelling which lasted for 1 week and which was described as severe, uncomfortable, and embarrassing. There were no other associated symptoms.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On an unknown dates (starting in January 2015), unspecified number of patients were administered an unspecified number of improperly stored doses of GARDASIL (dose, route of administration, injection site, lot# and expiration date were not reported). Administered doses of GARDASIL underwent temperature excursions at unspecified room temperature, for unknown time frames (since January 2015). Information about the previous temperature excursions was not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 0.75
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 9 month old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 05-APR-2016, the patient was vaccinated with PROQUAD lot # L050909, expiration date: 14-JUN-2017 (therapy type, dose and route of administration were not reported). Other suspect vaccine received on 05-APR-2016, included HAVRIX lot # 2PC5H, expiration date: 03-MAY-2018 (dose, route of administration and expiration date were not reported). There were no adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistance regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated improperly stored with RECOMBIVAX HB lot # L010595, expiration date 12-NOV-2016. No adverse event was reported. The outcome of the event was unknown. Temperature was 28 F, time frame 185 hours. Yes it was administered and no previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pruritus generalised
Clinical narrative: Felt itching on the body.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistance regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated improperly stored with GARDASIL 9 lot # L020015, expiration date-16-AUG-2017. No adverse event was reported. The outcome of the event was unknown. Temperature was 28 F, time frame 185 hours. Yes it was administered and no previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistance regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated improperly stored with ROTATEQ lot # K010325, expiration date-10-MAY-2016 and lot # L013203, expiration date- 28-JAN-2017. No adverse event was reported. The outcome of the event was unknown. Temperature was 28 F, time frame 185 hours. Yes it was administered and no previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistance regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated improperly stored with VARIVAX (Merck) lot # L0445426, expiration date-09-NOV-2017, lot no. L040423, expiration date- 15-OCT-2017. No adverse event was reported. The outcome of the event was unknown. Temperature and time frame was 30.2F for 48 hours and 42F for 48 hours. Cumulative excursion was 42F for 96 hours. Yes it was administered and no previous temperature excursion. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. Information on concurrent condition and medical history was not reported. On unspecified dates of 2005, the patient received two doses GARDASIL (dose, route and lot number not reported). The reporting nurse stated that the patient did not receive her second dose on time according to the recommended dosing schedule. The nurse practitioner stated she did not know if the patient ever received a third dose. No adverse symptoms reported. No further information provided. Additional information is not expected as the reporter did not have any further details to provide and did not with further contact.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 16 year old female patient. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 05-APR-2016, the patient was vaccinated with the second dose (of the three-dose regimen) of GARDASIL 9 injection, lot # L045711, dose reported as "1 shot" (strength, route and site of administration and expiration date were not reported). On 05-APR-2016, 7 to 8 minutes after receiving the dose of GARDASIL 9 (also reported as while on therapy with GARDASIL 9), the patient passed out. The patient did not seek medication attention. It was not reported if any lab diagnostic studies were performed. The patient was given water and had her blood pressure monitored. Product quality complaint was not involved. The patient fully recovered from the event on 05-APR-2016. The relatedness between the event and the therapy with GARDASIL 9 was not reported. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: FLU3, HEPA, IPV, TDAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a 17 year old patient of unknown gender. The patient's concurrent conditions and medical history were not provided. On 28-MAR-2016, the patient was accidentally vaccinated with an adult dose of VAQTA, 1 ml (lot number expiry date, anatomical site of injection and route were not reported). No adverse effects were reported and no product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: UNK
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. On unknown dates, the patients were vaccinated with improperly stored vaccines possibly including ROTATEQ (lot # K007243; exp. date: 13-DEC-2015) at 68.2 F for 2 hours with previous temperature excursion of 50.4 F for 1 hour and 30 minutes; VARIVAX (Merck) (lot#K005185; exp. date: 10-APR-2016) at 5.5 F for 22 minutes with no previous temperature excursion; VARIVAX (Merck) (lot# L001331; exp. date: 13-JAN-2017) at 5.5 for 22 minutes with no previous temperature excursion; PEDVAXHIB (lot # K008679; exp. date: 05-MAR-2017) at 68.2 F for 2 hours with previous temperature excursion of 50.4 F for 1 hour and 30 minutes; PNEUMOVAX 23 (lot # K008927; exp. date: 17-MAR-2016) at 68.2 F for 2 hours with previous temperature excursion on 50.4 F for 1 hour and 30 minutes and PEDVAXHIB (lot # K000331; exp. date: 23-OCT-2016) at 50.4 F for 1 hour and 30 minutes with no previous temperature excursion. Dose and route of administration were not provided for any of the reported vaccines. Concomitant medication was not reported. No symptoms were reported and no PQC was involved. The vaccines were not administered past the labeled expiry date, however the Medical assistant was not sure which vaccines were involved, therefore she reported the vaccines that were possibly involved. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: PNC13, TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at site.
Sex: U
Vaccine: VARZOS
Symptoms: No therapeutic response
Clinical narrative: This spontaneous report was received from a physician via publication/ACR TALK which was on the topic regarding biologics and vaccine, and no response to the vaccine regarding a patient/patients of unknown age and unknown gender. Information on the concurrent conditions and medical history was not reported. On an unknown date, the patient/patients was/were vaccinated with ZOSTAVAX (lot, expiry date, dose number, route and anatomical location were not specified) with the co-administration of RITUXAN (formulation, route, indication, dose and frequency were not specified) started on an unknown date. On an unknown date, it was reported that there was no response to the vaccine or no robust response to vaccine on co-administration of RITUXAN and ZOSTAVAX. Action taken with RITUXAN was unknown. Outcome of the event was unknown. The causality assessment was not provided by the reporter. The reporter also had also enquired regarding if there was information on patients immune response to vaccines while taking XELJANZ, including live and attenuated vaccines and how long to wait when administering ZOSTAVAX and XELJANZ. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: PPV, FLU4, PPV
Symptoms: Mobility decreased, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Rotator cuff syndrome
Clinical narrative: Pt received Influenza vaccine. Pt received PNEUMOVAX vaccine. Returned hours later unable to move.
Age: 56.0
Sex: F
Vaccine: PPV, FLU4, PPV
Symptoms: Mobility decreased
Clinical narrative: Pt received Influenza vaccine. Pt received PNEUMOVAX vaccine. Returned hours later unable to move.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL, VARCEL
Symptoms: Rash, Skin lesion
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a 12 month old female patient. The patient's medical history and concurrent conditions were not reported. On 14-MAR-2016, the patient was vaccinated with the first dose of (Merck) VARIVAX 0.5 ml, subcutaneous, (lot number L041206) (frequency, expiration date and concentration were not provided). Concomitant medications were not reported. No product quality complaint (PQC) was involved. On 16-MAR-2016, 2 days after receiving the vaccination the patient experienced varicella with 200 or more lesions throughout the patient's body. On an unknown date the patient sought medical attention by visiting the physician. The outcome of varicella was reported as not recovered. The primary reporter did not provide the causality between (Merck) VARIVAX and varicella. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL, VARCEL
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a 12 month old female patient. The patient's medical history and concurrent conditions were not reported. On 14-MAR-2016, the patient was vaccinated with the first dose of (Merck) VARIVAX 0.5 ml, subcutaneous, (lot number L041206) (frequency, expiration date and concentration were not provided). Concomitant medications were not reported. No product quality complaint (PQC) was involved. On 16-MAR-2016, 2 days after receiving the vaccination the patient experienced varicella with 200 or more lesions throughout the patient's body. On an unknown date the patient sought medical attention by visiting the physician. The outcome of varicella was reported as not recovered. The primary reporter did not provide the causality between (Merck) VARIVAX and varicella. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL, VARCEL
Symptoms: Varicella
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a 12 month old female patient. The patient's medical history and concurrent conditions were not reported. On 14-MAR-2016, the patient was vaccinated with the first dose of (Merck) VARIVAX 0.5 ml, subcutaneous, (lot number L041206) (frequency, expiration date and concentration were not provided). Concomitant medications were not reported. No product quality complaint (PQC) was involved. On 16-MAR-2016, 2 days after receiving the vaccination the patient experienced varicella with 200 or more lesions throughout the patient's body. On an unknown date the patient sought medical attention by visiting the physician. The outcome of varicella was reported as not recovered. The primary reporter did not provide the causality between (Merck) VARIVAX and varicella. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPVX, MENB, HPV4, MENB
Symptoms: Anaphylactic reaction, Dyspnoea
Clinical narrative: 12 minutes after administering HPV and meningococcal patient felt faint - lollipop given - with water. Started to cough - became pale. SOB examined immediately by Dr. - O2 by cannula applied. Epinephrine 0.3ml given IM - and nebulized with albuterol 2.5 mg - also given PO ORAPRED 40mg. Meds given at 10:15 am - BENADRYL 25mg given PO - monitored in office for 2 hours stable - discharge home.
Age: 13.0
Sex: F
Vaccine: HPVX, MENB, HPV4, MENB
Symptoms: Cough, Dizziness, Dyspnoea, Pallor
Clinical narrative: 12 minutes after administering HPV and meningococcal patient felt faint - lollipop given - with water. Started to cough - became pale. SOB examined immediately by Dr. - O2 by cannula applied. Epinephrine 0.3ml given IM - and nebulized with albuterol 2.5 mg - also given PO ORAPRED 40mg. Meds given at 10:15 am - BENADRYL 25mg given PO - monitored in office for 2 hours stable - discharge home.
Age: 11.0
Sex: F
Vaccine: FLU3, HEPA, HPVX, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Initial unsolicited report received from a Physician on 16 Feb 2015. A 11-year-old female patient, whose medical history and concomitant medications were none, had received a first dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (Adacel) (batch number U4965AA, expiry date 12-FEB-2017, Intramuscular route in the left deltoid) on 14 Feb 2015, received a dose of HEPATITIS A VACCINE (HEP A) (batch number unknown Intramuscular route on left deltoid) on 14 Feb 2015, received a dose of INFLUENZA VIRUS VACCINE POLYVALENT (Fluvirin) (batch number unknown Intramuscular route on left deltoid) on 14 Feb 2015, received a dose of HUMAN PAPILLOMA VIRUS VACCINE (HPV) (batch number unknown Intramuscular route on right deltoid on 14 Feb 2015 and received a dose of MENINGOCOCCAL A-C-Y-W135 (D CRM197 CONJ) VACCINE (Menveo) (batch number unknown Intramuscular route on right deltoid on 14 Feb 2015. Any other vaccinations before 4 weeks prior to Adacel vaccine were not reported. On 15 Feb 2015 the patient developed site reaction of redness, swelling, warmth on left deltoid and site reaction of redness, swelling on right deltoid. Laboratory investigations were none and she was prescribed with Bactrim and Ice packs. The outcome of the events was unknown. Patient required emergency room visit. Documents held by sender: none. Follow up information was received from a physician on 16 March 2015: It was reported that the patient was not visited the emergency room and event was occurred after 2 days. At the time of this report, outcome of the event was resolved on an unspecified date.
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Condition aggravated, Immobile, Laboratory test abnormal, Paralysis
Clinical narrative: This spontaneous report as received from a currently 29 years old female patient who was a certified medical assistant (C.M.A.) refers to herself via a field employee. The patient's concurrent conditions included Sjogren's syndrome and rheumatoid arthritis. On unknown dates, the patient was vaccinated with a first and a second dose of GARDASIL and on an unknown date in 2007, she was vaccinated with a third dose of GARDASIL (doses, routes of administration, lot # and expiration dates were not provided). The patient did not take any concomitant medications. On an unknown date (reported as "several months" after the patient received the third dose in the GARDASIL series), she felt paralyzed due to severe joint pain all over her body. The patient also felt  immobilized for an unspecified amount of time prior to receiving treatment with unspecified doses of methotrexate (manufacturer unknown), Sulfa and prednisone (manufacturer unknown) for an unspecified amount of time. On an unknown date, the patient had a follow up appointment with her physician where the physician ran some unspecified tests and gave a diagnosis of rheumatoid arthritis. The physician also told the patient that her rheumatoid arthritis was "dormant in her body" prior to receiving the GARDASIL series and the vaccine could have possibly triggered the rheumatoid arthritis. At the time of the report, the patient still had the rheumatoid arthritis, was on an unspecified dose of XELJANZ and was no longer on the treatment with methotrexate (manufacturer unknown), Sulfa and prednisone. The event of rheumatoid arthritis was considered to be disabling by the reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rheumatoid arthritis
Clinical narrative: This spontaneous report as received from a currently 29 years old female patient who was a certified medical assistant (C.M.A.) refers to herself via a field employee. The patient's concurrent conditions included Sjogren's syndrome and rheumatoid arthritis. On unknown dates, the patient was vaccinated with a first and a second dose of GARDASIL and on an unknown date in 2007, she was vaccinated with a third dose of GARDASIL (doses, routes of administration, lot # and expiration dates were not provided). The patient did not take any concomitant medications. On an unknown date (reported as "several months" after the patient received the third dose in the GARDASIL series), she felt paralyzed due to severe joint pain all over her body. The patient also felt  immobilized for an unspecified amount of time prior to receiving treatment with unspecified doses of methotrexate (manufacturer unknown), Sulfa and prednisone (manufacturer unknown) for an unspecified amount of time. On an unknown date, the patient had a follow up appointment with her physician where the physician ran some unspecified tests and gave a diagnosis of rheumatoid arthritis. The physician also told the patient that her rheumatoid arthritis was "dormant in her body" prior to receiving the GARDASIL series and the vaccine could have possibly triggered the rheumatoid arthritis. At the time of the report, the patient still had the rheumatoid arthritis, was on an unspecified dose of XELJANZ and was no longer on the treatment with methotrexate (manufacturer unknown), Sulfa and prednisone. The event of rheumatoid arthritis was considered to be disabling by the reporter. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Seizure
Clinical narrative: This spontaneous report was received from the patient's mother and refers to her son (unknown age). The patient's current conditions, medical history and concomitant medications were not reported. On 08-APR-2016, the patient was vaccinated with first dose of GARDASIL 9 intramuscularly. On 08-APR-2016, the patient experienced unspecified seizure moments after receiving his first dose of GARDASIL 9. Treatment was not given for adverse event (AE). The patient sought medical attention by contacting physician. Product quality complaint (PQC) was not involved. The outcome of the event was unknown. The reporter did not provide causal relationship between the event and suspect therapy. Upon internal review the event was considered as medically significant, serious. Additional information is not expected, as the reporter did not wish to be contacted further.
Age: 55.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Induration, Swelling
Clinical narrative: Local generalized hard, red, raised area noted following week approximately the size of a 50 cent piece.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Fatigue, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Fatigue, malaise, weakness, lethargy and fever 101.9 started to develop 8 hours after PCV13. Injection site became red warm and swollen and firm.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth, Lethargy, Malaise, Pyrexia
Clinical narrative: Fatigue, malaise, weakness, lethargy and fever 101.9 started to develop 8 hours after PCV13. Injection site became red warm and swollen and firm.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Dyspnoea, Nausea
Clinical narrative: Pt received 3rd HPV stayed at HD 15 min to 20 min after vaccine no problem. Got a call from school around 11 saying she had chills and then approx. 30 min to 45 min school called c/o SOB. Went to ER. But still complained of nausea.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Initial unsolicited report received from a non-healthcare professional (medical assistant) on 10 July 2015. That report is from a Partner and contact information in based upon the location of our trading partner. A female patient (age not reported), whose medical history was none and concomitant medication was not reported, had received a dose of ADACEL (batch number: U4971AA, expiration date: 14 February 2017, dose and dose number were not reported) intramuscularly in left deltoid on 2 July 2015. On an unspecified date post-vaccination, the patient experienced arm pain with limited range of motion. The patient did not have pre-existing physician diagnosed allergies, birth defects, medical conditions and illness at time of vaccination. The patient required ER/doctor visit. Laboratory investigation was not reported. The patient had received Ibuprofen as a corrective treatment, which was provided some relief of pain until the medication wears off. As of 10 July 2015, the patient was not recovered from event. List of documents held by sender: none.
Age: 72.0
Sex: F
Vaccine: HEP, HEPA, TDAP
Symptoms: Drug administered at inappropriate site, Sciatica
Clinical narrative: Initial unsolicited report received from a pharmacist on 10 July 2015. A female patient (age not reported), whose concomitant medication was not reported, had received a dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (Adacel) (batch number: U4875AA, expiration date, dose and dose number were not reported) intramuscularly in upper quadrant of Gluteal site on 25 June 2015 or 01 July 2015. Since Adacel was administered in the gluteal region, its an inappropriate site of vaccine administration for Adacel. The patient also received a dose of HEPATITIS A VACCINE (Hepatitis A) (batch number, expiration date, dose, dose number, route and site of administration were not reported) and also a dose of HEPATITIS B VACCINE (Hepatitis B) (batch number, expiration date, dose, dose number, route and site of administration were not reported) in arm on 25 June 2015 or 01 July 2015. The patient's medical history was reported as allergy to azithromycin and sulfa. On an unspecified date post-vaccination, the patient experienced sciatica pain. The patient required ER/doctor visit as the patient was seeing a chiropractor for the event. Laboratory investigation and corrective treatments were not reported. As of 10 July 2015, the patient had not recovered from the event. Follow-up information received from pharmacist on 18 August 2015. Patient's age was reported as 72 years. Patient was vaccinated on 25 June 2015 with Adacel (expiry date: 02 May 2016), Hepatitis A vaccine (manufacturer: Merck, batch number-L005558) and Hepatitis B vaccine (manufacturer: GSK, batch number- 3FZ74 and expiry date: 29 August 2015. The patient recovered from the event on an unspecified date. List of documents held by sender: none.
Age: 10.0
Sex: M
Vaccine: HEP, HEPA, IPV, MMR, TDAP, VARCEL
Symptoms: Dyspnoea, Pruritus generalised, Rash, Respiratory tract congestion, Sneezing
Clinical narrative: CONTINUOUS SNEEZE, SHORTNESS OF BREATH, CONGESTION, RASH, ITCHY ALL OVER BODY.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Irritability, Pyrexia
Clinical narrative: Fever 102.6, fussy.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Hypersensitivity, Pain, Pruritus, Skin warm
Clinical narrative: Pt reports she noted area itchy, red and warm day after injection. Area very painful.  Examination by provider notes this to be an allergic reaction.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Continuing pain at flu injection site; decreased range of motion of left arm. Unable to lift arm, move arm to back or extend arm.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 11-APR-2016, the patient was vaccinated with a dose of (Oka-Merck) PROQUAD lot # L030589, expiration date 10-FEB-2017 (dose and route of administration were not provided) that underwent a temperature excursion at 14 degrees Fahrenheit for 3 hours and 22 minutes. No adverse events reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # L039659 with expiration date: 15-MAR-2017; lot # L015460 with expiration date: 20-JUL-2017; exact dose and route of administration was not reported). No adverse effects were reported. The administered doses experienced a temperature excursion of 10 degrees Celsius for 1 hour and 16 minutes. The temperature excursion was detected by a data logger. There was no previous excursions. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified amount of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB injection, lot number L035878, expiration date 11-AUG-2018 (dose and route of administration were not reported. The vaccine was exposed to temperature of 57 Fahrenheit (F) for one hour. There was not previous excursion. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # L033343 with expiration date: 13-SEP-2017, lot # reported as L009545 with expiration date: 19-MAR-2017; exact dose and route of administration were not reported). No adverse effects were reported. The administered doses experienced a temperature excursion of 10 degree Celsius for 1 hour and 16 minutes. The temperature excursion was detected by a data logger. There was no previous excursions. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare provider refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 18-FEB-2016 the patient was vaccinated with improperly stored oral ROTATEQ vial, (lot # K010224, expiry date 13-MAY-2016) (dosing regimen, frequency and route unknown). No concomitant medications were reported. It was reported that the oral ROTATEQ experienced a temperature of 48 degree Fahrenheit for a 9 hours time fame. It was also reported that there was no previous temperature excursion. It was also reported that the healthcare provider did not call to report because of a data logger. It was also reported that the oral ROTATEQ that was improperly stored was administered. No adverse effects were reported. The action taken with the therapy with oral ROTATEQ was unknown. The outcome of the events was unknown. There was no product quality complaint reported. It was also reported that GARDASIL and GARDASIL 9 had appeared on the product list as temperature stability questions were asked, however no doses of the improperly stored GARDASIL and GARDASIL 9 were administered. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of oral ROTATEQ (lot # L013202, expiration date 27-JAN-2017, exact dose was not reported, orally). No adverse effects were reported. The administered doses experienced a temperature excursion of 10 degrees Celsius for 1 hour and 16 minutes. The temperature excursion was detected by a data logger. There was no previous excursions. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with PNEUMOVAX 23, lot number L035687, expiration date 16-FEB-2017 and lot number L038522, expiration date 11-AUG-2017 (route was not provided). Concomitant therapy information was not provided. On unknown dates, there was incorrect product storage as PNEUMOVAX 23 were administered to an unspecified number of unspecified patients following a temperature excursion that was originally reported on 21-MAr-2016. The temperature was 62 F for 2 hours and 12 minutes. No adverse event was reported. At the time of the report, the patients' status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MENB
Symptoms: Rash erythematous
Clinical narrative: This case was reported by a physician and described the occurrence of erythematous rash in unspecified number of patients who received BEXSERO. On an unknown date, the patients received BEXSERO at an unknown dose. On an unknown date, several days after receiving BEXSERO, the patients experienced erythematous rash. On an unknown date, the outcome of the erythematous rash was unknown. It was unknown if the reporter considered the erythematous rash to be related to BEXSERO. Additional details were provided as follows: The reported stated about several reports of bilateral erythematous rash presenting on both upper deltoids of an unspecified number of patients within days after vaccination with BEXSERO. This case has been linked to case US2016GSK019838.
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site rash, Rash
Clinical narrative: Information has been received from a registered nurse via a company representative concerning a female patient of unknown age with no drug reactions or allergies. The patient's concomitant medication and pertinent medical history were not reported. On an unknown date the patient was vaccinated with the first dose of GARDASIL 9 (dose, unit, route, lot # and exp. date not reported) and she didn't have any reaction. On an unknown date, the patient received her second dose of GARDASIL 9 (dose, unit, route, lot # and exp. date not reported) and developed a rash on her arm. Her rash was described as red and raised at the injection site to elbow. No lab diagnostics studies were performed. The patient did not seek medical attention, she called to nurse in her mother's office and sent picture of rash. The patient was treated with BENADRYL. Her redness had gotten better, but still had the bumps. Action taken with GARDASIL 9 was not applicable (also reported as therapy was not discontinued). The causal relationship between the event and GARDASIL 9 was not reported. Additional information is not expected we have no consent to contact the physician.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with LIQUID PEDVAXHIB, lot number L035878, expiration date 11-AUG-2017 (route was not provided). Concomitant therapy information was not provided. On unknown dates, there was incorrect product storage as LIQUID PEDVAXHIB were administered to an unspecified number of unspecified patients following a temperature excursion that was originally reported on 21-MAR-2016. The temperature was 62 F for 2 hours and 12 minutes. No adverse event was reported. At the time of the report, the patient's status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with MMR II lot number L027591, expiration date 23-JUL-2017 (route was not provided). Concomitant therapy information was provided. On unknown dates, there was incorrect product storage as MMR II were administered to an unspecified number of unspecified patients following a temperature excursion that was originally reported on 21-MAR-2016. The temperature was 62 F for 2 hours and 12 minutes. No adverse event was reported. At the time of the report, the patients' status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified amount of patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ oral liquid, orally lot # L037921, expiration date 31-MAY-2017 (dose was not reported). No adverse event were reported. The vaccine was exposed to temperature of 57 Fahrenheit (F) for one hour. There was no previous excursion. This is one of two reports from the same reporter. Additional information has been requested.
Age: 60.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a certified medical assistance regarding a 60 year old patient of unknown gender. There was no information about concurrent condition and historical medication. On 11-APR-2016, the patient was inadvertently administered a dose of (Oka/Merck) VARIVAX lot # L013825, expiration date 21-APR-2017 instead of being administered an intended dose of ZOSTAVAX. No adverse event was reported. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a patient's mother and refers to a her baby of an unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with a doses of ROTATEQ (orally, exact dose and lot # were not reported, expiration date 28-MAY-2016). On an unknown date, the patient experienced an unspecified problem. The outcome of the event was unknown. The relatedness between the event and oral ROTATEQ was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse (L.P.N.) refers to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. In approximately March 2016, the patients were orally vaccinated with improperly stored (reported as improperly exposed to 32.9 degrees Fahrenheit (F) for 1 hour on 24-MAR-2016) doses of oral ROTATEQ (lot # L013188, expiration date 02-NOV-2016, dose was not provided). No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurses (L.P.N.) refers to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. In approximately March 2016, the patients were vaccinated with improperly stored (reported as improperly exposed to 32.9 degrees Fahrenheit (F) for 1 hour on 24-MAR-2016) doses of GARDASIL (lot # K007828, expiration date 02-MAR-2017, dose and route of administration were not provided). No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.