chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, patients were vaccinated with improperly stored VARIVAX, Lot # M000760, expiry date 06-JAN-2018 and Lot # M009768, expiry date 23-FEB-2018, subcutaneous, (dose and frequency not reported). No adverse effects were reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored PROQUAD lot# M004892, expiry date: 25-JUL-2017 (dosing details, expiry date were not reported). It was reported that the vaccines were exposed to the temperature of 24.3F during at time frame of 8 hours and 30 minutes. No previous temperature excursion was reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date the patients were vaccinated with improperly stored ZOSTAVAX, lot# L046295 with expiry date: 17-FEB-2017 (dosing details, expiry date were not reported). It was reported that the vaccines were exposed to the temperature of 24.3 F during a time frame of 8 hours and 30 minutes. No previous temperature excursion was reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Redness along injection site, cellulitis appearance.
Age: 62.0
Sex: U
Vaccine: HEPA
Symptoms: Abdominal pain, Chills, Decreased appetite, Lymphadenopathy, Nephrolithiasis
Clinical narrative: Severe swelling of right lymph node on right jaw, fever, chills, anorexia, abdominal pain, rash, suspecting serum sickness like syndrome. Ultrasound was performed, showed kidney stones.
Age: 62.0
Sex: U
Vaccine: HEPA
Symptoms: Pyrexia, Rash, Serum sickness-like reaction, Ultrasound kidney abnormal
Clinical narrative: Severe swelling of right lymph node on right jaw, fever, chills, anorexia, abdominal pain, rash, suspecting serum sickness like syndrome. Ultrasound was performed, showed kidney stones.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Grandmother states that she noticed on 08/02/2016 that patient had swelling and redness to left upper arm. Child states there is no pain unless it is touched. Redness noted from three finger breadths below acromion process down to the elbow. Distal pulses noted +2. ROM WNL.
Age: 42.0
Sex: M
Vaccine: RAB, TTOX
Symptoms: Anxiety, Blood pressure increased, Injection site pain, Nausea, Stress
Clinical narrative: This case was reported by a consumer via patient support programs and described the occurrence of injection site pain in a 42-year-old male patient who received RABAVERT. Co-suspect product included Tetanus NVS. Concurrent medical conditions included anxiety disorder, animal bite, low back pain (due to anxiousness) and multiple allergies. Concomitant products included Aspirin (Baby)) and immunoglobulins nos. On 12th July 2016, the patient received the 1st dose of RABAVERT and Tetanus vaccine. On 12th July 2016, less than a day after receiving RABAVERT and Tetanus vaccine, the patient experienced injection site pain and increased blood pressure. In July 2016, the patient experienced queasy and stress. On an unknown date, the outcome of the injection site pain and queasy were recovering/resolving and the outcome of the increased blood pressure was recovered/resolved and the outcome of the stress was unknown. The reporter considered the injection site pain to be related to RABAVERT and Tetanus vaccine. The reporter considered the queasy and increased blood pressure to be unrelated to RABAVERT and Tetanus vaccine. It was unknown if the reporter considered the stress to be related to RABAVERT and Tetanus vaccine. Additional information was provided as follows: This case was received from the healthcare provider via the vaccine patient assistance program. On Sunday, the patient was exposed to a bat that landed on his back but did not bite him. The patient received his 1st rabies vaccine in his right arm, which was sore, a tetanus vaccine in left arm which was also sore, 3 injections in left buttock area, 2 in right buttock area and another in his right thigh. The patient was not sure what all the shots were but thought that he may have got another vaccine shot in his right thigh and possibly the other shots were the immune globulin. On 12 July 2016, less than a day after receiving RABAVERT, the patient experienced injection site soreness and increased blood pressure. In July 2016, less than a week after receiving RABAVERT, the patient experienced queasiness in stomach and stress, but believed that it was just his anxiety. The patient's blood test was found to be 150/95 in the emergency room but his normal was 130/80. The patient also reported that he had lower back soreness generally and it was not worse since the vaccinations, however he felt that it was due to his anxiousness. The case did not include any product complaint.
Age: 17.0
Sex: M
Vaccine: HPV4, MENB, MNQ
Symptoms: Urticaria
Clinical narrative: Hives to bilateral lower extremities on set 8-3-16 0900; mom gave oral BENADRYL at 0930; referred to PCP.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Syncope
Clinical narrative: Client became dizzy after rec. vaccines; syncopal episode. She was out for less than 1 minute, father and nurse caught her and lowered to the floor. Can follow commands and verbalize needs.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: Bells Palsy.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Asthenia, Headache, Hyperhidrosis, Malaise
Clinical narrative: On 7/25/16 received TRUMENBA vaccine, 24 hours later developed vomiting, weakness, HA, sweats, generalized malaise and joint pain.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Vomiting
Clinical narrative: On 7/25/16 received TRUMENBA vaccine, 24 hours later developed vomiting, weakness, HA, sweats, generalized malaise and joint pain.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Pain upon injection, feeling of illness for the next 24 hours, swelling and redness at application site, patient applied heat and vinegar.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Urticaria
Clinical narrative: The patient stated that she had her ZOSTAVAX injection on Tue Aug 2nd. Today when she woke she noticed she has a 5 inch welt in the location of the injection. Recommended patient call her dr.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Fever Headaches Body Aches.
Age: 44.0
Sex: F
Vaccine: MNQ
Symptoms: Lip swelling, Pruritus, Urticaria
Clinical narrative: Awoke with itching of right side of back, welts noted.  Also reports upper lip swelling.  Patient called 911, EMTs evaluated, advised showering & Benadryl.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: PATIENT DIAGNOSED WITH SHINGLES ON 8/3/16. TOLD TECHNICIAN SHE STARTED GET SYMPTOMS A FEW DAYS EARLIER BUT WAITED TO SEE DOCTOR. DOCTOR PRESCRIBED VALACYCLOVIR FOR HER.
Sex: U
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. The patient was vaccinated with VARIVAX on an unknown date 4 days prior to the patient's 1 year birthday, which is outside of the prescribing information recommendation. No adverse event reported. Additional information is not expected as the reporter did not wish to be contacted.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown demographics. Age at vaccination was not reported. The patient's pertinent medical history and drug history or allergies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot # M001745 and expiry date 07-APR-2016) intramuscular (dosage information was not reported). On an unknown date, the nurse reported that, a patient was administered a ZOSTAVAX intramuscularly instead of subcutaneously. No adverse effects were reported. No product quality complaint was reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to 5 patients of unspecified age and gender. The patients' concurrent conditions and medical history were not provided. On 09-JUN-2016, the patients were vaccinated with a dose GARDASIL 9 via subcutaneous route (batch# reported as 1040164, expiry date: 20-FEB-2018). Concomitant medications were not mentioned. No adverse events were reported. Product quality complaint was not filed. Follow up information has been received on 23-JUN-2016. Lot number 1040164 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast). Follow up information was received on 01-AUG-2016 from the Registered Nurse, who clarified that another health care provider administered GARDASIL 9 subcutaneously with a one inch needle in deltoid region. Each of the five unspecified patients had the injection site evaluated post injection. The primacy reporter stated that she was relatively certain that the GARDASIL 9 vaccine was injected into muscle, despite improper administration technique. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in 2015, the patient received the first dose of GARDASIL 9 (exact dose, route of administration, lot # and expiration date were not provided). On 15-APR-2016, the patient received the second dose of GARDASIL 9 lot # L038503, expiration date: 18-DEC-2017 (exact dose and route of administration were not provided) and on 02-AUG-2016, the third dose of GARDASIL 9 (exact dose, route of administration, lot # and expiration date were not provided). There were no adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. The medical assistant reported that a patient received two doses of GARDASIL (each dose administered on a separate unspecified date) in "2013". The medical assistant stated that the patient received a third dose "to complete the HPV series"  today, 01-AUG-2016, in which GARDASIL 9 was administered to the patient. No adverse effect reported. The outcome of the events was unknown. No further information was provided. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: F
Vaccine: MENB
Symptoms: Erythema, Injection site erythema, Injection site irritation, Injection site mass, Injection site pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in an adult female patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. In July 2016, less than a week after receiving BEXSERO, the patient experienced injection site pain, injection site erythema, injection site irritation and injection site lump. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site irritation and injection site lump were unknown. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site irritation and injection site lump to be related to BEXSERO. Additional details were provided as follows: This case was reported by a registered nurse via an email to the sales representative, who called to report it to the Medical Information. The age at vaccination was not reported. The reporter stated that, an employee in the store where reporter's clinic was located received the BEXSERO vaccine three weeks ago from reporting date (not by their office). After a week, the patient came to ask about injection site pain, localized tenderness and erythema after BEXSERO vaccination, which reporter suggested should resolve. At the time of reporting, the reporter walked to the patient and the patient stated that she still had a lump under the skin in the injection site. The reporter did not assess it, but wondered what he might say, whether injection site irritation more of an issue with BEXSERO and when should the patient return to the provider who gave her the injection.
Sex: F
Vaccine: MENB
Symptoms: Tenderness
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in an adult female patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. In July 2016, less than a week after receiving BEXSERO, the patient experienced injection site pain, injection site erythema, injection site irritation and injection site lump. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site irritation and injection site lump were unknown. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site irritation and injection site lump to be related to BEXSERO. Additional details were provided as follows: This case was reported by a registered nurse via an email to the sales representative, who called to report it to the Medical Information. The age at vaccination was not reported. The reporter stated that, an employee in the store where reporter's clinic was located received the BEXSERO vaccine three weeks ago from reporting date (not by their office). After a week, the patient came to ask about injection site pain, localized tenderness and erythema after BEXSERO vaccination, which reporter suggested should resolve. At the time of reporting, the reporter walked to the patient and the patient stated that she still had a lump under the skin in the injection site. The reporter did not assess it, but wondered what he might say, whether injection site irritation more of an issue with BEXSERO and when should the patient return to the provider who gave her the injection.
Age: 0.35
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Irritability, Pyrexia, Rash, Rash generalised
Clinical narrative: 2-3 hours after vaccines were given she broke out in a rash. She also had a fever and very fussy. She came in the office today for her rash that has spread all over her body. Treat with TYLENOL and watch closely.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Dizziness, Erythema, Feeling abnormal, Local reaction
Clinical narrative: Vaccine admin 8/1/16 BEXSERO # 2 dose. Patient reports dizziness and "felt bad", chills on 8/2/16. Seen in office on 8/3/16 with local reaction of erythema, tenderness, generalized symptoms resolved by the time seen.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Tenderness
Clinical narrative: Vaccine admin 8/1/16 BEXSERO # 2 dose. Patient reports dizziness and "felt bad", chills on 8/2/16. Seen in office on 8/3/16 with local reaction of erythema, tenderness, generalized symptoms resolved by the time seen.
Age: 26.0
Sex: F
Vaccine: DTAP, RAB
Symptoms: Anxiety, Chest discomfort, Heart rate increased, Nausea, Palpitations
Clinical narrative: Palpitations, chest tightness, anxiety, nausea, elevated heart rate - symptoms worsened after vaccine number 3.
Sex: F
Vaccine: MENB
Symptoms: Dyspnoea
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of shortness of breath in a adolescent female patient who received BEXSERO. On 27th July 2016, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On 27th July 2016, several hours after receiving BEXSERO, the patient experienced shortness of breath (serious criteria hospitalization and other: serious as per reporter). On 28th July 2016, the outcome of the shortness of breath was recovered/resolved. The reporter considered the shortness of breath to be possibly related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The physician indicated that the patient received vaccination and a few hours later was admitted to hospital at night due to shortness of breath and trouble while breathing. On 28th July 2016, the patient was released from the hospital. It was unknown if the patient would receive the second vaccination in the series. The sales representative put in a request to the Medical Science Liaison (MSL), but he would advise her that this report had already been completed.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Pt rec'd vaccine late a.m. In middle of night it became painful to lay on (L) side. The next a.m. there was a hard painful lump where imm. was administered. It was also hard and hot. No fever/chills. Erythema induration and warmth 11x17 cm three days later. Cephalexin 500mg QID rx'd #28. Pt afebrile at time of appt 3 days later.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: C/O tender erythematous swelling over injection site for 2 days. Treatment: 1. Take BENADRYL 25 mg 1 po q 6 hrs prn.
Age: 17.0
Sex: M
Vaccine: HEP, HPV4, IPV, MMR, TDAP, VARCEL
Symptoms: Cough, Pharyngeal oedema, Swollen tongue, Urticaria
Clinical narrative: Pt received Tdap, IPV, Hepatitis B, Varicella, MMR, HPV QV 7/28/16. Within minutes pt started coughing, broken out in hives and c/o his throat and tongue swelling. Pt given 5 mg of Epi at 1:01 pm IM and 50 mg BENADRYL IM. O2 face mask. Hives none, throat and tongue decreased swelling.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Dizziness, Erythema, Fatigue, Feeling hot
Clinical narrative: Client reported that she develop reaction from the TDAP she received 7/26/2016. She had pain on the (L) arm, tenderness, redness and some swelling. Also had pain on her rib cage, extreme tiredness, chills, nausea, dizziness. Yesterday felt extremely hot and body aches.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal chest pain, Nausea, Pain, Pain in extremity, Swelling
Clinical narrative: Client reported that she develop reaction from the TDAP she received 7/26/2016. She had pain on the (L) arm, tenderness, redness and some swelling. Also had pain on her rib cage, extreme tiredness, chills, nausea, dizziness. Yesterday felt extremely hot and body aches.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Tenderness
Clinical narrative: Client reported that she develop reaction from the TDAP she received 7/26/2016. She had pain on the (L) arm, tenderness, redness and some swelling. Also had pain on her rib cage, extreme tiredness, chills, nausea, dizziness. Yesterday felt extremely hot and body aches.
Age: 4.0
Sex: F
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Injection site hypoaesthesia, Injection site pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 19-year-old female patient who received BEXSERO (batch number 151501, expiry date 31st December 2016). On 20th July 2016, the patient received the 1st dose of BEXSERO .5 ml. On 21st July 2016, 1 days after receiving BEXSERO, the patient experienced injection site pain and injection site numbness. On an unknown date, the outcome of the injection site pain and injection site numbness were not recovered/not resolved. It was unknown if the reporter considered the injection site pain and injection site numbness to be related to BEXSERO. Additional details were provided as follows: The reporter stated that, the patient experienced arm pain and numbness which were localized, after administration of BEXSERO on unknown arm. There was no redness at the injection site. At the time of reporting, the pain and numbness were getting worse.
Sex: M
Vaccine: FLU3
Symptoms: Headache, Muscle twitching
Clinical narrative: Initial unsolicited report received from a consumer on 14 October 2015. This case involves a male patient (age not reported) who was vaccinated with a dose of FLUZONE (lot number, route and site of administration, dose in series were not reported) on 13 October 2015 at 13:00 hours. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions and concomitant medications were not reported. Patient denies of any illness at the time of vaccination. On 13 October 2015, few hours after vaccination, the patient experienced twitching in the evening. Then woke up with severe headache "this am". The patient's Laboratory data was not reported. The patient's corrective treatment was not reported. The outcome of the event was unknown. List of documents held by sender: none.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion
Clinical narrative: Initial unsolicited report received from a pharmacist on 14 October 2015. This case involves a 71-year-old female patient who was vaccinated with a dose of FLUZONE HD (batch number: UI475AA, expiration date: 11 May 2016, dose, dose number and site of administration were not reported) intramuscularly on 9 October 2015. The patient's medical history and concomitant medication were not reported. On 9 October 2015, same day following the vaccination the patient had developed bruise at her wrist. Laboratory investigation and corrective treatment were not reported. The outcome of the event was unknown. List of documents held by sender: none.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Blood glucose fluctuation
Clinical narrative: Initial unsolicited report received from a consumer on 29 October 2015. This case involves a (age unknown) female patient who was vaccinated with a [route and dose series not reported] dose of FLU VACCINE (batch number, expiry date and site of administration were not reported) on an unspecified date. Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as diabetes and celiac disease. It was reported that, patient had received several flu vaccines over the past years. Concomitant medications were not reported. On an unspecified date, "1 to 2 weeks" following the vaccination patient experienced erratic blood sugars. Lab data and corrective treatment were not reported. The outcome of event was recovered. Follow up information received from physician on 30 November 2015. This case involves 09-years-old patient who was vaccinated with 0.5 ml dose of Flu vaccine (batch number: UI496AB, expiry date: 30-Jun-2016) in left deltoid on 29 October 2015. The batch number provided corresponds to the product INFLUENZA QUADRIVAL A-B VACCINE. Concomitant medications included HUMALOG insulin pump. List of documents held by sender: none.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Prenatal screening test
Clinical narrative: This spontaneous prospective pregnancy report was received from an office manager refers to a currently 19 year old female patient. The patient had no pertinent medical history or drug reactions/allergies. On 13-APR-2016, she was vaccinated with GARDASIL 9 (lot # L027282, expiration date 21-SEP-2017) dose 3. It was unknown when the patient received first and second doses. Concomitant therapies included prenatal vitamins. At the time of the report, she was about 5 week's pregnant. Her last menstrual period was approximately on 28-JUN-2016 and estimated due date is 04-APR-2017. The outcome of pregnancy was pending. On an unknown date, she had an unspecified prenatal work done. She was doing fine. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: Pt was behind in DTAP #5. Pt is 12yrs old and should of gotten TDAP instead. Pt is fine. The school is not wanting to let Pt. in do to he did not get a TDAP.
Age: 6.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a 6 year old patient. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 27-JUL-2016, the patient was inadvertently administered a dose of GARDASIL 9 instead of VAQTA.  No product confusion occurred. No adverse effect reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Condition aggravated, Guttate psoriasis
Clinical narrative: Information has been received from a pharmacist, who is also the patient's mother, concerning to her daughter, a 17 years old female patient. The patient's concurrent conditions included Guttate psoriasis. No medical history and drug reactions/allergies were ported. On 19-JAN-2016, 26-FEB-2016 and on an unspecified date in June 2016, the patient was vaccinated with the first dose, second dose, and third dose, respectively of GARDASIL 9, (concentration, route, anatomical location, lot number, and expiration date were not provided). Other suspect and concomitant therapies were not provided. On an unspecified date in July 2016, the patient experienced a "flare up" of her Guttate psoriasis. No product quality complaint was involved. At the time of reporting, the patient was not recovered of the "flare up" of her Guttate psoriasis. The relatedness between the Guttate psoriasis and GARDASIL 9 was not reported. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Fall, Feeling hot, Hyperhidrosis, Pallor
Clinical narrative: The patient stated that she felt light-headed then fell to a seated position when she tried to walk away. She was hot, sweaty, pale, and visibly shaking. She vomited once.
Age: 22.0
Sex: F
Vaccine: MNQ
Symptoms: Tremor, Vomiting
Clinical narrative: The patient stated that she felt light-headed then fell to a seated position when she tried to walk away. She was hot, sweaty, pale, and visibly shaking. She vomited once.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Decreased appetite, Irritability, Skin warm, Somnolence
Clinical narrative: About an hour after receiving vaccinations patient got uncharacteristically fussy and drowsy. He fell asleep for about five to ten minutes. For the remainder of the day he had a loss in appetite, fussiness, hot to the touch despite lack of fever, and slept for over 10 hours.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Injection site mass, Injection site pain, Injection site rash
Clinical narrative: Large lump underneath skin where vaccine was administered. Large rash where vaccine was administered. Sore arm where vaccine was administered.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Presyncope, Tremor
Clinical narrative: Patient moved from exam table to chair post vaccine administration.  While sitting in chair, patient began shaking for approximately "2 seconds" as reported by administering LPN and patient's mother. Patient experienced near syncopal episode for approximately 20 minutes post administration. Patient assisted to supine position and provided with ice packs and water. LPN remained with patient until she was well enough to walk safely.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Feeling cold, Headache, Injection site pain, Lethargy, Musculoskeletal pain
Clinical narrative: Initial unsolicited report received from a consumer on 16 October 2015. This case involves a 51-years-old male patient who was vaccinated with a dose of FLUZONE QIV (batch number, expiry date, dose, dose in series were not reported) intramuscularly in right deltoid on 09 October 2015. The patient's illness at time of vaccination reported as no, pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) reported as allergic to dust mites and lactose. Any other vaccinations within 4 weeks of vaccinations were not reported. Concomitant medications were not reported. On 09 October 2015, same day following the vaccination, the patient had developed right shoulder pain. On 09 October 2015, few hours following the vaccination (in the evening), the patient had experienced body aches, myalgia, headache, lethargy, fever, night sweats. On an unknown date, following the vaccination (in the morning), the patient had experienced cold. Relevant diagnostic tests/laboratory data was reported as none and corrective treatment was not reported. The patient was not recovered from the events. The patient's symptoms persisted on and off for 01 week. List of documents held by sender: none.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Myalgia, Night sweats, Pain, Pyrexia
Clinical narrative: Initial unsolicited report received from a consumer on 16 October 2015. This case involves a 51-years-old male patient who was vaccinated with a dose of FLUZONE QIV (batch number, expiry date, dose, dose in series were not reported) intramuscularly in right deltoid on 09 October 2015. The patient's illness at time of vaccination reported as no, pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) reported as allergic to dust mites and lactose. Any other vaccinations within 4 weeks of vaccinations were not reported. Concomitant medications were not reported. On 09 October 2015, same day following the vaccination, the patient had developed right shoulder pain. On 09 October 2015, few hours following the vaccination (in the evening), the patient had experienced body aches, myalgia, headache, lethargy, fever, night sweats. On an unknown date, following the vaccination (in the morning), the patient had experienced cold. Relevant diagnostic tests/laboratory data was reported as none and corrective treatment was not reported. The patient was not recovered from the events. The patient's symptoms persisted on and off for 01 week. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Neuritis, Vertigo
Clinical narrative: Initial unsolicited report received from a pharmacist on 26 October 2015. This case involves a patient (age and gender was not reported) who was vaccinated with a dose of FLUZONE (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unknown date. Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. Concomitant medications were not reported. On an unspecified date, three to four days after the vaccination, the patient experienced vestibular neuritis with symptom of vertigo. Patient required emergency room and doctor visit. Lab data and corrective treatments were not reported. The patient was recovering (reported as unknown) from the events as it was reported that symptom of vertigo that had lessened but was still constant now at 4 weeks past vaccination. List of documents held by sender: none.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Flushing, Urticaria
Clinical narrative: Initial unsolicited report received from a healthcare professional  on 28 October 2015. This case involves 80-years-old female patient who was vaccinated with first dose of FLUZONE HD (batch number: UI453AA, expiry date: 30 April 2016, dose, route and site of administration were not reported) on an unknown date. Illness at time of vaccination reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as no known allergy (NKA) and cancer. Concomitant medications were not reported. On an unknown date, few seconds (immediately/within minutes) following the vaccination, the patient had developed flushing, hives and shortness of breath. The patient required ER/doctor visit. Relevant diagnostic tests/laboratory data was none. The patient was treated with Benedryl and Steroids IV. It was reported that the patient was still on IV Chemotherapy that day. On an unknown date, the patient was recovered within a half an hour (after vaccination). Upon medical review, the case was considered as serious due to important medical event: shortness of breath, flushing, hives. List of documents held by sender: none. Follow-up information received from a healthcare professional on 15 December 2015. The patient was vaccinated with a dose of FLUZONE HD, intramascularly on 1 October 2015 at 10.14 am. On 1 October 2015 at 10.15 am, one minute following the vaccination the patient had developed flushing, hives and shortness of breath. It was reported that the patient gets vaccinated with a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE annually. The patient required doctor visit in outpatient clinic. On 10 October 2015 the patient got recovered.; Sender's Comments: Follow up information received on 15 December 2015 changes the medical assessment as follows: Shortness of breath, hives and flushing are listed with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Time to onset seems compatible with a role of the vaccination. To be noted, patient had a medical history of MDS (Myelodysplastic Syndrome) which could be an alternative explanation for the presentation of dyspnea and other symptoms. Based on available information, the role of vaccine cannot be assessed as it is confounded by underlying conditions.
Age: 26.0
Sex: F
Vaccine: HPVX
Symptoms: Arthralgia, Erythema, Eye pain, Fatigue, Influenza like illness
Clinical narrative: Pain, redness and mild swelling in the arm. Eye & joints pain, mild fever, feel sleepy, tired and bit sick (flu-like symptoms).
Age: 26.0
Sex: F
Vaccine: HPVX
Symptoms: Malaise, Pain in extremity, Peripheral swelling, Pyrexia, Somnolence
Clinical narrative: Pain, redness and mild swelling in the arm. Eye & joints pain, mild fever, feel sleepy, tired and bit sick (flu-like symptoms).
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Diet refusal, Injection site reaction, Local reaction
Clinical narrative: Patient refused to eat for 12 hours after vaccines. Localized reaction at the site of the PENTACEL vaccine in the lower extremity. Patient was improved within 24 hours.
Age: 17.0
Sex: M
Vaccine: MEN
Symptoms: Computerised tomogram head abnormal, Concussion, Laceration, Loss of consciousness, Suture insertion
Clinical narrative: When exiting the exam room after receiving immunizations, the patient passed out and landed face first on the tile floor. Patient sustained laceration to forehead and jaw.
Age: 0.33
Sex: F
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: Used sterile water diluent instead of sodium chloride diluent with HIB vaccine.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Abdominal pain upper, Chest pain, Heart rate increased, Nausea, Pyrexia
Clinical narrative: Pt reports 3 hours after injection given - 102 degree fever, rapid heart rate, nausea, stomach & chest pain. Resolving as of evening of 8/3 when reported.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Pruritus generalised, Rash
Clinical narrative: Rash, itchiness all over body.
Age: 13.0
Sex: F
Vaccine: HPV4, HEPA, HPV9
Symptoms: Decreased interest, Depression, Disturbance in attention, Dizziness, Fatigue
Clinical narrative: Dizziness that has not gone away for two months. Chronic fatigue, depression, sleeps constantly, always feels sick to stomach, lost 15 lbs so far, lack of interest, change in personality. Exhaustion after small tasks. Unable to concentrate.
Age: 13.0
Sex: F
Vaccine: HPV4, HEPA, HPV9
Symptoms: Hypersomnia, Malaise, Personality change, Weight decreased
Clinical narrative: Dizziness that has not gone away for two months. Chronic fatigue, depression, sleeps constantly, always feels sick to stomach, lost 15 lbs so far, lack of interest, change in personality. Exhaustion after small tasks. Unable to concentrate.
Age: 13.0
Sex: F
Vaccine: HPV4, HEPA, HPV9
Symptoms: Decreased interest, Dizziness, Fatigue, Hypersensitivity, Hypersomnia
Clinical narrative: Dizziness that has not gone away for two months. Chronic fatigue, depression, sleeps constantly, always feels sick to stomach, lost 15 lbs so far, lack of interest, change in personality. Exhaustion after small tasks. Unable to concentrate.
Age: 13.0
Sex: F
Vaccine: HPV4, HEPA, HPV9
Symptoms: Incomplete course of vaccination
Clinical narrative: Dizziness that has not gone away for two months. Chronic fatigue, depression, sleeps constantly, always feels sick to stomach, lost 15 lbs so far, lack of interest, change in personality. Exhaustion after small tasks. Unable to concentrate.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Cataplexy, Electroencephalogram, Electroencephalogram abnormal, Hypersomnia, Immediate post-injection reaction
Clinical narrative: Almost immediately upon receiving the GARDASIL vaccine, our daughter began sleeping constantly. By 12/2014, she began collapsing with any strong emotions. She was diagnosed with narcolepsy with cataplexy. She had ZERO symptoms prior to this vaccine.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Narcolepsy, Syncope
Clinical narrative: Almost immediately upon receiving the GARDASIL vaccine, our daughter began sleeping constantly. By 12/2014, she began collapsing with any strong emotions. She was diagnosed with narcolepsy with cataplexy. She had ZERO symptoms prior to this vaccine.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Arnold-Chiari malformation, Blood potassium decreased, Computerised tomogram, Dizziness, Epilepsy
Clinical narrative: In September 2015, patient took the HPV virus vaccination and the changes began. Please read the story and Pray for patient!  Patient is my granddaughter and her Mother feels it is now time for everyone to see and know what has been happening to her daughter - patient has now had 5 of these episodes since February 2016 and has been to family doctors, hospitals, ER's, Neurologist, NeuroSurgeons, had MRI's, Cat Scans, Brain Wave test, etc with no conclusive answer. At first the doctors said she could possibly be faking, then it's epilepsy, then it's migraines, now it's Chiari Malformation. The doctors cleared patient to do anything she felt like doing with adult supervision. So, on Sunday July 31, 2016 she was running in a track meet with her Mom, coaches, medical staff, etc in attendance, when one of these episodes happened. Up until this time the doctors had not been able to see what was happening to patient when one of the episodes came on - her coach told her Mom on Sunday get this on video!! I have patient - take the videos!!!! Patient was taken to the ER and they found nothing wrong except her potassium was low but should not have caused anything like what you see on this video!! All her vitals were NORMAL - no heat exhaustion, no heat stroke, Nothing!!! Videos have been sent to her doctors and we are waiting on appointments to become available!!  Her mother has done hours of investigation into all aspects of possible causes and truly believes that patient is having a reaction to taking the HPV virus vaccination. That is the only answer left!!! Now she waits and watches for any sign from patient that it is happening again!! Please pray for patient and her family!!!
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Laboratory test, Migraine, Nuclear magnetic resonance imaging
Clinical narrative: In September 2015, patient took the HPV virus vaccination and the changes began. Please read the story and Pray for patient!  Patient is my granddaughter and her Mother feels it is now time for everyone to see and know what has been happening to her daughter - patient has now had 5 of these episodes since February 2016 and has been to family doctors, hospitals, ER's, Neurologist, NeuroSurgeons, had MRI's, Cat Scans, Brain Wave test, etc with no conclusive answer. At first the doctors said she could possibly be faking, then it's epilepsy, then it's migraines, now it's Chiari Malformation. The doctors cleared patient to do anything she felt like doing with adult supervision. So, on Sunday July 31, 2016 she was running in a track meet with her Mom, coaches, medical staff, etc in attendance, when one of these episodes happened. Up until this time the doctors had not been able to see what was happening to patient when one of the episodes came on - her coach told her Mom on Sunday get this on video!! I have patient - take the videos!!!! Patient was taken to the ER and they found nothing wrong except her potassium was low but should not have caused anything like what you see on this video!! All her vitals were NORMAL - no heat exhaustion, no heat stroke, Nothing!!! Videos have been sent to her doctors and we are waiting on appointments to become available!!  Her mother has done hours of investigation into all aspects of possible causes and truly believes that patient is having a reaction to taking the HPV virus vaccination. That is the only answer left!!! Now she waits and watches for any sign from patient that it is happening again!! Please pray for patient and her family!!!
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia, Vomiting
Clinical narrative: Redness, swelling and warm to touch at injection site. Low grade fever developed during the day and vomiting at night.
Age: 43.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, heat to touch, spreading from injection site down to elbow, covered entire upper arm.
Age: 14.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event
Clinical narrative: No adverse event present after vaccination.
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA, IPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth, Local reaction
Clinical narrative: Large local reaction to left thigh of injection (DTAP site)  - red, warm, and painful. Pt went to ER and noted to be 8 cm in diameter. Told to do cold compresses and Motrin. Returned next day to ER and 10 cm in diameter and given Augmentin and oral steroids with Benadryl. I asked her to hold off on giving Augmentin another 24 hrs as likely local reaction.
Age: 13.0
Sex: F
Vaccine: HPVX
Symptoms: Erythema, Local reaction, Local swelling, Skin warm
Clinical narrative: Localized reaction with swelling erythema and warmth to palpation, no anaphylaxis or urticaria, no vomiting, no syncope, no petechiae.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Rash, Skin exfoliation
Clinical narrative: Flat, sl. scaly rash on trunk first noted 8/2 pm; not painful/itchy, not worsening; otherwise feeling fine.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Mass, Peripheral swelling, Pruritus
Clinical narrative: Phone call 8/4/16, in the morning from Mom who reports patients arm is red, has a "half dollar size" lump, swollen and very itchy. Nurse advised to give BENADRYL, MOTRIN and apply ice to arm.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: (L) arm itch, painful, swelling noticed and red in color. Advised BENADRYL, TYLENOL and to ice area.
Age: 62.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Cough, Dyspnoea, Fatigue
Clinical narrative: One day after I had the Pneumonia vaccine, started coughing all night and had short of breath, when going up the stairs I was feeling tired and it got worse so the 6th day after I had the vaccine (I had it on June 22nd 2016) went to doctor and she prescribed: FLOVENT 110mcg inhalation, PROAIR 8.5GM inhalation, on July 1st prescribed antibiotics: Azithromycin, Benzonatate.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Area around immunization site was red and swollen.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Musculoskeletal stiffness, Myalgia
Clinical narrative: Was told I should get the GARDASIL vaccine by a dermatologist because I had warts on my finger....first shot was fine back in December 2015. After the second shot at about a month after....I started getting serious pain in the injection arm, the pain only got worse through night time. Soon after it felt like a water pocket or swollen ball was in my arm. I went back to the doctor who gave it to me, they looked and could see and feel the swelling of my muscle and told me that it couldn't be from the shot....(I knew it was, but since they did not seem to find it serious I just left) now it was time for my third and last shot a few months later, this was middle of June 2016. I received it, all was well for a few weeks. Now on July 25th I woke up and my arm was so sore I could barely move it. Today is the 26th and I am in more pain then the second shot swelling ever gave me. I do not see a lump or swelling yet, but I feel it. I can not lift my arm past my chest area. It is stiff and the muscle hurts very badly. I have contacted my doctor again and am currently waiting on a response. I just feel I need to report this as it is something my doctor was not familiar with seeing. Again, at night it is the worst! Can not lay on it or be touched at all, it is about 6 inches around the shot area so the pain is in my shoulder down about half way on my upper arm. I hope this can be resolved and maybe have an answer for what it doing onto  my body a month after this vaccine. NOTE: I would have really loved to speak with someone with the GARDASIL company, but they DO NOT HAVE A PHONE NUMBER ANYWHERE...only the FDA.