chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Product preparation error, Underdose
Clinical narrative: It was found that a box of 10 MENVEO vaccines were not reconstituted correctly so the patient only received half of the dose. Once discovered corporation was contacted, the manufacturer, and the patient was offered re-vaccination of the vaccine to provide complete immunity. The vaccine is Meningococcal conjugate MENVEO MCV40, manufactured by GlaxoSmithKline (GSK).
Age: 51.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Arthralgia, Chills, Heart rate increased, Hypoaesthesia, Nodule
Clinical narrative: 05/04/17 Increased heart rate 90-100 beats per minute. 05/10-05/16/2017 Pain to legs, hips and joints. 05/12/2017 Nodules appeared to base of skull. 05/14/2017 Began MOTRIN use. 05/16-05/17/2017 Fever and chills. Temp. not documented per report of client. 05/18/2017 "rash all over" when asked specifically stated, "arms, chest and legs." Left leg and arm numbness on and off. Client reports went to ER via ambulance. Client reported all of this effects on 05/19/2017 via phone call to the Coordinating Nurse at the Health Department. Reported she told her PCP Dr. and he instructed her to call the health department. Reports she never had vaccines as a child due to her parent's religious beliefs. Vaccines needed to attend nursing school.
Age: 51.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Pain in extremity, Pyrexia, Rash generalised
Clinical narrative: 05/04/17 Increased heart rate 90-100 beats per minute. 05/10-05/16/2017 Pain to legs, hips and joints. 05/12/2017 Nodules appeared to base of skull. 05/14/2017 Began MOTRIN use. 05/16-05/17/2017 Fever and chills. Temp. not documented per report of client. 05/18/2017 "rash all over" when asked specifically stated, "arms, chest and legs." Left leg and arm numbness on and off. Client reports went to ER via ambulance. Client reported all of this effects on 05/19/2017 via phone call to the Coordinating Nurse at the Health Department. Reported she told her PCP Dr. and he instructed her to call the health department. Reports she never had vaccines as a child due to her parent's religious beliefs. Vaccines needed to attend nursing school.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: It was found that a box of 10 MENVEO vaccines were not reconstituted correctly so the patient only received half of the dose. Once discovered office was contacted, the manufacturer, and the patient was offered re-vaccination of the vaccine to provide complete immunity. The vaccine is Meningococcal conjugate MENVEO MCV40, manufactured by GlaxoSmithKline (GSK
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Altered state of consciousness, Heart rate increased, Injection site pain, Pain
Clinical narrative: Body aches and soreness in arm where shot was given. Next day she had fast heartbeat and felt like she was going pass out. Her body hurt too.
Age: 12.0
Sex: F
Vaccine: HPV9, MEN
Symptoms: Product preparation error, Underdose
Clinical narrative: It was found that a box of 10 MENVEO vaccines were not reconstituted correctly so the patient only received half of the dose. Once discovered corporation was contacted, the manufacturer, and the patient was offered re-vaccination of the vaccine to provide complete immunity. The vaccine is Meningococcal conjugate MENVEO MCV40, manufactured by GlaxoSmithKline (GSK).
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Diarrhoea, Dyspnoea, Pneumonia
Clinical narrative: Diarrhea and shortness of breath which was reported approximately 17 days after the injection. She stated PREVNAR caused her pneumonia (PREVNAR is a killed vaccine) and that the eggs in the product also caused the reaction (PREVNAR does not contain eggs).
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: It was found that a box of 10 MENVEO vaccines were not reconstituted correctly so the patient only received half of the dose. Once discovered office was contacted, the manufacturer, and the patient was offered re-vaccination of the vaccine to provide complete immunity. The vaccine is Meningococcal conjugate MENVEO MCV40, manufactured by GlaxoSmithKline (GSK
Age: 74.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Soreness, Redness, swelling at injection site. Fever, headache, body aches.
Age: 74.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Soreness, Redness, swelling at injection site. Fever, headache, body aches.
Age: 12.0
Sex: F
Vaccine: HEP, MEN, TDAP, VARCEL
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: It was found that a box of 10 MENVEO were not reconstituted correctly so the patient only received half of the dose. Once discovered HCA was contacted, the manufacturer, and the patient was offered re-vaccination of the vaccine to provide complete immunity. The vaccine is Meningococcal conjugate MENVEO MCV40, manufactured by GlaxoSmithKline (GSK).
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Mobility decreased, Nuclear magnetic resonance imaging
Clinical narrative: Pain in shoulder where vaccine was administered, unable to have full ROM of arm.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Product preparation error
Clinical narrative: It was found that a box of 10 MENVEO vaccines were not reconstituted correctly so the patient only received half of the dose. Once discovered office was contacted, the manufacturer, and the patient was offered re-vaccination of the vaccine to provide complete immunity. The vaccine is Meningococcal conjugate MENVEO MCV40, manufactured by GlaxoSmithKline (GSK
Age: 11.0
Sex: M
Vaccine: HPV4, MEN, TDAP
Symptoms: Product preparation error, Underdose
Clinical narrative: It was found that a box of 10 MENVEO vaccines were not reconstituted correctly so the patient only received half of the dose. Once discovered corporation was contacted, the manufacturer, and the patient was offered re-vaccination of the vaccine to provide complete immunity. The vaccine is Meningococcal conjugate MENVEO MCV40, manufactured by GlaxoSmithKline (GSK).
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Pain, Pyrexia
Clinical narrative: Patient sent message that he received a Tdap vaccine 5/17/17 at his routine physicial exam. He developed "mild fever, body aches, and on 5/19/17 a little bit of redness on back, chest, and arms". No change as of 5/22/17.
Age: 49.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Pain in extremity, Skin discolouration, X-ray normal
Clinical narrative: Developed left foot pain and purplish skin discoloration (resembling purpura fulminans) over middle three toes and midfoot, also had concurrent severe headache.
Age: 11.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Product preparation error
Clinical narrative: It was found that a box of 10 MENVEO vaccines were not reconstituted correctly so the patient only received half of the dose. Once discovered agency was contacted, the manufacturer, and the patient was offered re-vaccination of the vaccine to provide complete immunity. The vaccine is Meningococcal conjugate MENVEO MCV40, manufactured by GlaxoSmithKline (GSK).
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Flushing, Skin warm, Vomiting
Clinical narrative: Flush, vomiting, warm 30 minutes after injection. Sent out for evolution by physician at clinic at 3:20PM 5/20/17.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse, concerning a patient of an unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On an unknown date, the patient was vaccinated with an unspecified dose of PROQUAD lot number: M002053 with expiration date of 11-JUL-2017 (dose, dose number, anatomical location and route of administration were not provided) for prophylaxis, reconstituted with an sterile diluent (DILUENT MRK) (indication, formulation, strength, dose, route of administration, lot number and expiration date were not provided).  On the same date, the patient was also vaccinated with an unspecified dose of VARIVAX lot number: L049532 with expiration date of 08-DEC-2017 (dose, anatomical location and route of administration were not provided) for prophylaxis, reconstituted with an sterile diluent (DILUENT MRK) (indication, formulation, strength, dose, route of administration, lot number and expiration date were not provided). No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Pain in extremity
Clinical narrative: Information was received on 10-MAY-2017 from a physician via a company representative who was reporting on a female patient of unknown age. No medical history or concomitant medications were reported. The physician reported that on an unknown date, the female patient received her third dose of GARDASIL9 (lot, expiration, dose and injection site not reported) for prevention of HPV. It was reported that the patient experienced "arm pain"  which began 1 1/2 months after receiving the third dose of vaccine (date not reported). The outcome was not reported. The causality was not specified. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a physician referring to a patient of unknown gender and age. There was no information provided about the patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies. On an unspecified date (reported as 05-NOV-2017), the patient received an injectable dose of VARIVAX for prophylaxis (expiration date reported as 05-NOV-2017) (strength, dose, frequency, route of administration, anatomical location and lot # were not reported). On an unspecified date, the patient experienced "hdhd" (adverse event). Additionally, it was reported that a product quality complain (PQC) was involved. At the time of reporting, the therapy with VARIVAX continued. The outcome for the adverse event and the relationship between the adverse event and VARIVAX were not reported. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Musculoskeletal stiffness
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 45 year old female patient. The patient did not have pertinent medical history, drug reactions or allergies; and she was not taking any concomitant therapies. On 02-JUL-2008, the patient received the first dose of injectable RECOMBIVAX HB for vaccination (strength, dose, frequency, route of administration, anatomical location, lot # and expiration date were not reported). On approximately 03-JUL-2008 (reported as "the next day"), the patient developed a "stiff" neck (neck stiffness). On approximately 10-JUL-2008, the patient recovered from neck stiffness (onset date on 03-JUL-2008); no treatment was given for the event. On 12-AUG-2008, the patient received the second dose of injectable RECOMBIVAX HB for vaccination (strength, dose, frequency, route of administration, anatomical location, lot # and expiration date were not reported). On approximately 13-AUG-2008 (reported as "the next day"), again the patient developed a "stiff" neck (neck stiffness). On approximately 13-SEP-2008 (reported as "one month"), the patient recovered from neck stiffness (onset date on 13-AUG-2008). It was reported that, on an unspecified date in 2008, a nurse recommended the patient "to put heat on it and to not receive any more doses of RECOMBIVAX HB". Additionally, it was reported that there were not diagnostic laboratories or studies performed. The relationship between the therapy with RECOMBIVAX HB and the events of neck stiffness (onset date on 03-JUL-2008) and neck stiffness (onset date on 13-AUG-2008) was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. There was no information provided about the patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies. On an unspecified date in 2014, the patient received the first dose of GARDASIL for human papillomavirus (HPV) vaccine series (formulation, strength, dose, frequency, route of administration, anatomical location, lot # and expiration date were not reported). On 16-MAY-2017, the patient received a dose of injectable GARDASIL 9, reported as the second dose in the HPV vaccine series (lot # N002720 with expiration date on 12-MAY-2019) (strength, dose, frequency, route of administration, anatomical location and indication were not reported). There were no adverse effects reported. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation, Pyrexia
Clinical narrative: Fever, on site inflammation.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth, Pain
Clinical narrative: 3 inch round, erythematous, edematous, warm and tender area around injection site. Faint, lacy rash down whole arm. Pain w/movement of upper arm. Tx: NSAIDS, diphenhydramine, ice.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Pain in extremity, Rash
Clinical narrative: 3 inch round, erythematous, edematous, warm and tender area around injection site. Faint, lacy rash down whole arm. Pain w/movement of upper arm. Tx: NSAIDS, diphenhydramine, ice.
Age: 81.0
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Back pain, Blood glucose increased, Confusional state, Cough
Clinical narrative: 4/18/2017 - routine check up at doctor. Received shot for PREVNAR 13 Pneumococcal. 4/20/2017 - developed fever of 102 degrees, had aches and pain in back and leg. Had no energy, had to be lifted out of bed and/or chairs, tried to exert himself and could not due to exhaustion. No appetite and appeared to live in a fog (difficulty comprehending and showed signs of confusion) for approximately 2 1/2 weeks. Had difficulty sleeping and persistent cough. Also noticed rash appeared on his back and right shoulder blade. Glucose level is monitored daily and went to 177. 5/5/2017 - went to doctor due to not feeling well. Still running low-grade fever and persistent cough. Doctor ordered blood workup. No medicine given. 5/11/2017 - went back to doctor due to still not feeling well. Doctor wrote prescription for antibiotics. 5/13/2017 - glucose level back to 99 (which is normal). 5/16/2017 - fever normal, cough was diminished, he also appeared to be alert, and his normal self.
Age: 81.0
Sex: M
Vaccine: PNC13
Symptoms: Decreased appetite, Fatigue, Feeling abnormal, Insomnia, Loss of personal independence in daily activities
Clinical narrative: 4/18/2017 - routine check up at doctor. Received shot for PREVNAR 13 Pneumococcal. 4/20/2017 - developed fever of 102 degrees, had aches and pain in back and leg. Had no energy, had to be lifted out of bed and/or chairs, tried to exert himself and could not due to exhaustion. No appetite and appeared to live in a fog (difficulty comprehending and showed signs of confusion) for approximately 2 1/2 weeks. Had difficulty sleeping and persistent cough. Also noticed rash appeared on his back and right shoulder blade. Glucose level is monitored daily and went to 177. 5/5/2017 - went to doctor due to not feeling well. Still running low-grade fever and persistent cough. Doctor ordered blood workup. No medicine given. 5/11/2017 - went back to doctor due to still not feeling well. Doctor wrote prescription for antibiotics. 5/13/2017 - glucose level back to 99 (which is normal). 5/16/2017 - fever normal, cough was diminished, he also appeared to be alert, and his normal self.
Age: 81.0
Sex: M
Vaccine: PNC13
Symptoms: Malaise, Pain in extremity, Pyrexia, Rash
Clinical narrative: 4/18/2017 - routine check up at doctor. Received shot for PREVNAR 13 Pneumococcal. 4/20/2017 - developed fever of 102 degrees, had aches and pain in back and leg. Had no energy, had to be lifted out of bed and/or chairs, tried to exert himself and could not due to exhaustion. No appetite and appeared to live in a fog (difficulty comprehending and showed signs of confusion) for approximately 2 1/2 weeks. Had difficulty sleeping and persistent cough. Also noticed rash appeared on his back and right shoulder blade. Glucose level is monitored daily and went to 177. 5/5/2017 - went to doctor due to not feeling well. Still running low-grade fever and persistent cough. Doctor ordered blood workup. No medicine given. 5/11/2017 - went back to doctor due to still not feeling well. Doctor wrote prescription for antibiotics. 5/13/2017 - glucose level back to 99 (which is normal). 5/16/2017 - fever normal, cough was diminished, he also appeared to be alert, and his normal self.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Endotracheal intubation, Haemoglobin normal, Intensive care, Partial seizures, Seizure
Clinical narrative: Previous focal seizures progressed to generalized within few hours of vaccines requiring intubation. ICU care.
Age: 0.75
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Decreased appetite, Lethargy, Pyrexia, Rash
Clinical narrative: Fever 102, rash, lethargic, decreased appetite.
Age: 0.75
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Diet refusal, Lethargy, Pyrexia, Rash generalised
Clinical narrative: Fever 102, rash, lethargic, decreased appetite.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: B/L thighs with redness at injection sites.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Nausea, Peripheral swelling
Clinical narrative: Swelling in arm, nausea, headache.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local reaction, Pain, Peripheral swelling
Clinical narrative: Local reaction; red arm, swollen, 6/10 pain.
Age: 62.0
Sex: M
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Administered pediatric Hepatitis B.
Age: 20.0
Sex: F
Vaccine: HEPAB
Symptoms: Contusion, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Patient called clinic on 5/22/17 to report left hand swelling, shooting pain from left arm in to left palm between thumb and pointer finger which began the evening of 5/19/17. Pt. states within 7 hours after vaccination of TWINRIX she also developed a bruise on her left palm which continues to be bruised and painful. Pt. taking 500 mg of ADVIL daily.
Age: 1.08
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site reaction, Rash, Rash erythematous
Clinical narrative: 1425 Mother brought child back to clinic - she noted a rash on the child about 1400. We noted a raised pinpoint red rash on trunk, back and upper arms. Redness noted where adhesive from BAND AID was once removed. No swelling or difficulty breathing noted. Advised mother to take her to her PCP 5-9-17. Called mother, she took her to PCP was given BENADRYL x 48 hrs. She is doing better.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema multiforme, Pruritus
Clinical narrative: Developed erythema multiforme type rash and itching the evening vaccine was given. Rash continued to spread over next 3 days to present on extremities, face, neck and chest.
Age: 0.83
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia, Rash
Clinical narrative: Parents present to clinic with child on 5/8/17 around 1pm. Report child started to have high fever early last week and later a rash that started on Friday 5/5/17. Child no longer with fever today, rash still present. Parents wanted to ask if symptoms are related to vaccine from 4/17/17.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Dysgeusia, Feeling jittery, Throat tightness
Clinical narrative: Pt. was given a ZOSTAVAX at 10:26 a.m. and began C/O bad taste in her mouth and throat tight. C/O internal jittery and chest tightness.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blister, Erythema, Injection site erythema, Injection site vesicles, Pyrexia
Clinical narrative: 04/25/17 fever 101 degrees. Two erythematous - like vesicles; one at injection site R thigh, one on face (L cheek).
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Culture, Full blood count, Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Erythema and swelling in right thigh x2, one measuring 15.5 x 11.5cm, 2nd  9.5 x 10.5cm without bullae in center cellulitis suspected and cephalexin prescribed, CBC and blood culture also done.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Postictal state, Seizure
Clinical narrative: 4/29/17 patient presented to clinic postictal seizure event.
Age: 59.0
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Underdose
Clinical narrative: A pediatric dose was given instead of an adult dose.
Age: 59.0
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, MNQ
Symptoms: Underdose
Clinical narrative: A pediatric dose of Hep B was administered rather than an adult dose.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Dyskinesia, Loss of consciousness, Syncope
Clinical narrative: Patient developed syncope and fainted shortly after Tdap (BOOSTRIX) was administered. While unconscious, patient also developed brief jerky movements and recovered shortly thereafter. Patient was observed for > 20 min post reaction and subsequently felt okay to leave.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: It was found that a box of 10 MENVEO vaccines were not reconstituted correctly so the patient only received half of the dose. Once discovered office was contacted, the manufacturer, and the patient was offered re-vaccination of the vaccine to provide complete immunity. The vaccine is Meningococcal conjugate MENVEO MCV40, manufactured by GlaxoSmithKline (GSK
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 10-MAY-2017 from a physician. The physician reported that on an unspecified date, an unspecified patient may have received a dose of one of several improperly stored lots, but she is not sure which one of the lots  the unspecified patient received. The vaccines involved were ROTATEQ lot L038534, expires 18-AUG-2017,  L039638, expires 23-AUG-2017 or L046319, expires 28-SEP-2017. The temperature was reported to be 26 degrees F for 14 hours via data logger. No adverse effects were reported. No other information was reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Anaphylactic shock
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were unknown by the reporter. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX 19400 plaque forming units (PFU), as prophylaxis (Dose, route, lot # and expiration date were not reported). On an unknown date, the patient experienced anaphylactic shock after receiving ZOSTAVAX. It was unknown if treatment was given for the event or if lab diagnostics studies were performed to the patient. The outcome of anaphylactic shock was unknown. The reporter did not provide the causality between the events and ZOSTAVAX. Upon internal review, anaphylactic shock was determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to multiple unspecified patients of unknown age and gender. The concurrent conditions and medical history of the patients were not reported. On unknown dates,  the patients were vaccinated with an improperly stored dose of RECOMBIVAX with lot number  N002913 and expiration date of 23-FEB-2019 (strength, dose and route of administration were unknown) for prophylaxis. The vaccine was stored from 47 Fahrenheit degrees (°F) to 77°F for 18 minutes and reconstituted with properly stored sterile diluent with lot number reported as N007550 and expiration date of 03-MAY-2018. There was no previous temperature excursion. However, the temperature excursions were detected by a data logger. No adverse effects were reported. This is one of several cases received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA010583: US-009507513-1705USA010584:
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Malaise, Nausea, Skin warm
Clinical narrative: This is a spontaneous report from a contactable pharmacist communicated to a sales representative. A 7-decade-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date to an unspecified date at 0.5 ml, single for pneumococcal pneumonia immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced severe redness and heat of the arm that the product was injected into, felt a sick, nauseas feeling on an unspecified date with outcome of unknown.
Sex: F
Vaccine: MENB
Symptoms: Urticaria
Clinical narrative: This is a spontaneous report from a contactable physician received via a sales representative. An approximately 19-year-old female patient received the second single dose of TRUMENBA on an unspecified date for immunisation. No other vaccinations were administered at that time.  The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced urticaria all over her body on an unspecified date after vaccination, with unknown outcome. The physician advised them to administer diphenhydramine (BENADRYL) for treatment. No follow-up attempts possible. No further information expected.
Age: 17.0
Sex: F
Vaccine: MEN
Symptoms: Product preparation error
Clinical narrative: It was found that a box of 10 MENVEO vaccines were not reconstituted correctly so the patient only received half of the dose. Once discovered agency was contacted, the manufacturer, and the patient was offered re-vaccination of the vaccine to provide complete immunity. The vaccine is Meningococcal conjugate MENVEO MCV40, manufactured by GlaxoSmithKline (GSK).
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Feeling hot, Nausea, Pain in extremity, Skin mass
Clinical narrative: Sore arm, bump under skin, nausea, vomiting, had chills and felt hot.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: Sore arm, bump under skin, nausea, vomiting, had chills and felt hot.
Age: 17.0
Sex: F
Vaccine: DTAP, HEPA, HPVX, MEN, HEPA, HPV9, MNQ
Symptoms: Bone marrow oedema, Injection site oedema, Mobility decreased, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Shoulder pain - more than from an injection. Trouble moving her arm. Follow up with MD who ordered blood work and MRI and an antibiotic - referral to ortho who ordered PT - as of May 22, 2017 no resolution of pain.
Age: 17.0
Sex: F
Vaccine: DTAP, HEPA, HPVX, MEN, HEPA, HPV9, MNQ
Symptoms: Injection site pain, Injection site swelling, Joint range of motion decreased, Nuclear magnetic resonance imaging, Oedema
Clinical narrative: Shoulder pain - more than from an injection. Trouble moving her arm. Follow up with MD who ordered blood work and MRI and an antibiotic - referral to ortho who ordered PT - as of May 22, 2017 no resolution of pain.
Age: 17.0
Sex: F
Vaccine: DTAP, HEPA, HPVX, MEN, HEPA, HPV9, MNQ
Symptoms: X-ray
Clinical narrative: Shoulder pain - more than from an injection. Trouble moving her arm. Follow up with MD who ordered blood work and MRI and an antibiotic - referral to ortho who ordered PT - as of May 22, 2017 no resolution of pain.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Urticaria
Clinical narrative: Morning of May 19, saw hives in fairly solid  firm raised area approx. 3"x 2" across side of arm, mid way between injection site and elbow. Area was warm to touch, itchy, red. Increased in size by next day. Started to go away by May 21. Greatly decreased by May 22.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Induration, Skin warm, Swelling
Clinical narrative: MOTHER CALLED REPORTED REDNESS, SWELLING, HARD, HOT TO THE TOUCH. CLIENT WAS TAKEN TO PCP RECOMMENDED TYLENOL, BENADRYL.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Excoriation, Rash papular
Clinical narrative: ERYTHEMATOUS PAPULAR RASH WITH EXCORIATION ON THE LEFT UPPER AND LOWER LIMB.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Abdominal pain, Fatigue, Headache, Seizure
Clinical narrative: After the first GARDASIL injection patient became very tired, severe headaches and abdominal pain. After second dose seizures began. After third dose seizures more frequently.
Age: 19.0
Sex: F
Vaccine: HPVX
Symptoms: Vitiligo
Clinical narrative: Vitiligo skin started loosing pigment first under arms then vagina then eyes and face and around mouth then fingers and hands and wrists and arms.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Pt experiencing extreme arm pain after shot given.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: The patient experienced an injection site reaction to a ZOSTAVAX vaccination shortly after receiving the injection. The symptoms included pain, swelling, redness, and warmth at the site of injection which lasted for approximately four days. The patient also had a headache that lasted for four days after the injection. The patient took Ibuprofen intermittently to relieve pain. The symptoms resolved after approximately four days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: The patient experienced an injection site reaction to a ZOSTAVAX vaccination shortly after receiving the injection. The symptoms included pain, swelling, redness, and warmth at the site of injection which lasted for approximately four days. The patient also had a headache that lasted for four days after the injection. The patient took Ibuprofen intermittently to relieve pain. The symptoms resolved after approximately four days.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient experienced swelling, redness, and pain at and around the site of injection (from shoulders to elbows). Swelling has improved after 2 days with ibuprofen and diphenhydramine.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Blood culture, C-reactive protein, Differential white blood cell count, Feeling abnormal, Full blood count
Clinical narrative: Pt presented with fussiness and fever. Pt. temperature in office was 101.5. No other symptoms noted. Pt admitted to hospital due to age.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Pyrexia, Urine analysis
Clinical narrative: Pt presented with fussiness and fever. Pt. temperature in office was 101.5. No other symptoms noted. Pt admitted to hospital due to age.
Age: 23.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Type III immune complex mediated reaction
Clinical narrative: Arthus reaction- pain, erythema, swelling 5cmX7cm at injection site, now present for 4 days.
Age: 20.0
Sex: M
Vaccine: HEPAB
Symptoms: Loss of consciousness, Syncope
Clinical narrative: After 10 min patient exhibited signs of syncope with loss of consciousness. Patient assisted in getting to floor and raised legs. Ambulance was called and vitals were good.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Raised red patch, pain at site, itching, warm to touch.
Sex: F
Vaccine: HEPA, HPV9, VARCEL
Symptoms: Altered state of consciousness, Confusional state, Disorientation, Dizziness, Loss of consciousness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 641301) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 15 year old female patient. The patient's concomitant therapies, concurrent illness, medical history, prior vaccinations and other medications were not reported. On 23-JUN-2016, the patient was vaccinated with first dose of GARDASIL 9 lot # L016429, lot expiration date 09-AUG-2017 (dose and frequency were not reported) via intramuscular route, in the right arm and second dose of VARIVAX lot # L025208, lot expiration date 07-JUL-2017 (dose and frequency were not reported) via subcutaneous route, in the left arm for prophylaxis. Other suspect therapy which was given on the same day included HAVRIX (dose number: 2, intramuscularly in the left arm, lot# A4M5L; dose and expiration date unknown) for prophylaxis. On 23-JUN-2016, the patient become lightheaded and lost consciousness while sitting on the exam table. The patient had some shaking before she lost her consciousness. She had altered level of consciousness for 3-4 min. She was awake and oriented, but confused as she did not remember what happened. The outcome of altered state of consciousness, tremor, loss of consciousness, dizziness and confusional state were reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HEPA, HPV9, VARCEL
Symptoms: Tremor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 641301) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 15 year old female patient. The patient's concomitant therapies, concurrent illness, medical history, prior vaccinations and other medications were not reported. On 23-JUN-2016, the patient was vaccinated with first dose of GARDASIL 9 lot # L016429, lot expiration date 09-AUG-2017 (dose and frequency were not reported) via intramuscular route, in the right arm and second dose of VARIVAX lot # L025208, lot expiration date 07-JUL-2017 (dose and frequency were not reported) via subcutaneous route, in the left arm for prophylaxis. Other suspect therapy which was given on the same day included HAVRIX (dose number: 2, intramuscularly in the left arm, lot# A4M5L; dose and expiration date unknown) for prophylaxis. On 23-JUN-2016, the patient become lightheaded and lost consciousness while sitting on the exam table. The patient had some shaking before she lost her consciousness. She had altered level of consciousness for 3-4 min. She was awake and oriented, but confused as she did not remember what happened. The outcome of altered state of consciousness, tremor, loss of consciousness, dizziness and confusional state were reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Abdominal pain, Diarrhoea, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 641751) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 11 year old female patient. Information on the patient's other medications, lab data and prior vaccinations were not reported. Information on the patient's concurrent illnesse and medical history were reported as none. On 29-JUN-2016, the patient was vaccinated with GARDASIL 9 lot # M009116, dose 1, intramuscularly in the left arm for prophylaxis (dosage and expiration date unspecified). On the same day the patient was also vaccinated with ADACEL lot/batch # U5906AA, dose 1, intramuscularly in the right arm and MENACTRA lot/batch # U525AA, dose 1, intramuscularly in the left arm for prophylaxis (dosage and expiration date unspecified). On 29-JUN-2016, the patient had vomiting, diarrhea with severe abdominal pain. The outcome of abdominal pain, vomiting and diarrhoea were reported as recovered. The causality assessment for the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HEPA, HPV9, MENB, MNQ
Symptoms: Chest discomfort, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 641800) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 17 year old male patient. Information on the patient's other medications and prior vaccinations were not reported. Information on the patient's concurrent illnesses and medical history were reported as none. On 05-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # M005714, dose 1, intramuscularly in the right arm for prophylaxis (dosage unspecified). On the same day the patient was also vaccinated with included MENACTRA lot/batch # US244AA, dose 1, intramuscularly in the right arm, TRUMENBA lot/batch # M37314, dose 1, intramuscularly in the left arm and HAVRIX lot/batch # 24275, dose 1, intramuscularly in the left arm for prophylaxis (dosage and expiry date unspecified). On 05-JUL-2016, after vaccination with MEN B and HEP A patient had syncope episode. Patient was assisted to lying position and was applied ice on to the back of the neck. Patient informed that he was feeling better and then he was given with MCV4 and HPV vaccines. After vaccination patient complained of chest tightness. Patient's blood pressure and heart rate were 140/90 and 94 respectively. Patient remained lying for 10 minutes and was assisted to seated position. Patient was observed for additional 10 minutes. Patient stated that he was feeling better. The outcome of chest discomfort and syncope was reported as recovered. The causality assessment for the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 641856) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 11 year old male patient. Information on the patient's lab data and prior vaccinations were not reported. Information on the patient's concurrent illnesses, medical history and other medications were reported as none. On 28-JUN-2016, the patient was vaccinated with the first dose of GARDASIL 9 using needle and syringe (route not specified further) for prophylaxis (dosage, site, lot and expiry date unspecified). On 29-JUN-2016, after 12 hours of the vaccination patient had severe vomiting. Patient's parent informed that it was not a serious effect but also not listed in the CDC's website, as a side effect for GARDASIL vaccination. It was also mentioned that it might be a coincidence, but the patient was not ill prior the vaccination and seemed fine the next day. The outcome of vomiting was reported as recovered. The causality assessment for the event vomiting with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MENB
Symptoms: Chills, Lethargy, Pain, Pyrexia, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 641980) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 12 year old male patient. Information on the patient's other medications and prior vaccinations were not reported. Information on the patient's concurrent illnesses and medical history were reported as none. On 21-JUN-2016, the patient was vaccinated with GARDASIL 9 lot # M003659, dose 1, via unknown route, in the left arm for prophylaxis (dosage unspecified). On the same day the patient was also vaccinated with TRUMENBA, lot/batch # M37316, dose 1, via unknown route, in the right arm for prophylaxis (dosage and expiry date unspecified). On the same day, 3 hour after the vaccination patient had fever more than 103 degrees Fahrenheit with chills, vomiting, body aches and lethargy. The outcome of chills, vomiting, fever, pain and lethargy was reported as recovered. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, Feeding disorder, Headache, Hypersensitivity, Loss of personal independence in daily activities
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 15 year old female patient. The patient's medical history included IBS (Irritable bowel syndrome) and anxiety. The patient other medications included Zoloft 50 mg and dicyclomine 150 mg 3x day (3 tid). The patient had no current illnesses and the patient's prior vaccinations was not reported. On 09-JUL-2016, the patient was vaccinated with third dose of GARDASIL 9, route of administration: needle and syringe (not specified) in the left arm (dose, frequency, lot and lot expiration date unknown) for prophylaxis. The patient's lab data include: allergic reaction to the vaccine. On 10-JUL-2016, the patient woke at 4:30 am and was not able to move with major severe muscle aches, fatigue, headache, nausea, fever, she couldn't even put her own shoes and had feeding disorder and hypersensitivity. The patient was given Benadryl at onset and used ibuprofen for fever, Gatorade because could not eat. On an unknown date the patient had emergency room (ER) visit. The outcome of activities of daily living impaired, pyrexia, nausea, myalgia, mobility decreased, hypersensitivity, headache, feeding disorder and fatigue was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 15 year old female patient. The patient's medical history included IBS (Irritable bowel syndrome) and anxiety. The patient other medications included Zoloft 50 mg and dicyclomine 150 mg 3x day (3 tid). The patient had no current illnesses and the patient's prior vaccinations was not reported. On 09-JUL-2016, the patient was vaccinated with third dose of GARDASIL 9, route of administration: needle and syringe (not specified) in the left arm (dose, frequency, lot and lot expiration date unknown) for prophylaxis. The patient's lab data include: allergic reaction to the vaccine. On 10-JUL-2016, the patient woke at 4:30 am and was not able to move with major severe muscle aches, fatigue, headache, nausea, fever, she couldn't even put her own shoes and had feeding disorder and hypersensitivity. The patient was given Benadryl at onset and used ibuprofen for fever, Gatorade because could not eat. On an unknown date the patient had emergency room (ER) visit. The outcome of activities of daily living impaired, pyrexia, nausea, myalgia, mobility decreased, hypersensitivity, headache, feeding disorder and fatigue was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Fall, Laceration, Suture insertion, Syncope
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 14 year old male patient. The patient medical history included seasonal allergies. The patient had no current illnesses and the patient's other medications and prior vaccinations were not reported. On 05-JUL-2016, with first dose of GARDASIL 9, lot # M009116, intramuscularly in the right arm (dose, frequency and lot expiration date unknown) for prophylaxis and same day the patient fainted after receiving injection, fell and sustained laceration to chin and received six sutures in the clinic. The outcome of fall, syncope, suture insertion and laceration was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Abdominal pain, Dehydration, Pyrexia, Vomiting
Clinical narrative: This spontaneous report as received from a regulatory authority refers to an 11 year old male patient. The patient had no current illnesses, other medications, medical history and the patient's prior vaccinations was not reported. On 05-JUL-2016, with first third dose of GARDASIL 9, lot # M004116, intramuscularly in the left arm (dose, frequency and lot expiration date unknown) for prophylaxis. And the same day patient develop fever with body temperature of 102.5, had abdominal pain and vomiting for 3 days and the patient returned to office for worsening of abdominal pain, dehydration and sent to emergency department (ED) for IVF (intraventricular failure) and ruled out appendicitis. The outcome of abdominal pain, pyrexia and dehydration was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Fall, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 643260). This spontaneous report refers to a 12 year old female patient. The patient's medical history included asthma and nasal allergies. The patient had no concurrent illnesses. Information on the patient's prior vaccinations and other medications were not reported. On 06-JUL-2016, the patient was vaccinated with GARDASIL 9 batch# M01117, dose 1, intradermal route in the left arm for prophylaxis (dosage unspecified). On the same day, the patient fainted after receiving vaccination. The patient's mother was with her. The patient fell on floor, lying with her back and head down. The patient stated that, she has no pain in the back of head or neck and was able to state her name, date and place where she was at. There was no change in the patient's level of consciousness. There was no complaints of dizziness or vomiting. No bump, swelling, or bruising noted on back of head and neck. The patient was assisted to room and vital signs were checked. The patient was stable/asymptomatic when leaving the office with no complaints of dizziness, nausea or vomiting. The patient on exam neurologically intact. The patient was evaluated by PAC. The outcome of syncope and fall was reported as recovered. The causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.