chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: THE INJECTION SITE WAS RED AND LOOKED LIKE BRUISED. PT DENIES TAKING ANY BLOOD THINNERS OR ASA. AS OF NOW THE REDNESS IS ALMOST GONE BUT STILL TENDER.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Eye pain, Ocular discomfort, Pharyngeal oedema
Clinical narrative: Patient stated having trouble breathing throat swelling and pain/pressure behind her eyes.
Age: 43.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Chills, Muscular weakness, Nausea, Pyrexia, Tremor
Clinical narrative: 8 hrs after vaccine pt developed nausea, fever, chills, BLE upper weakness, tremors - saw urgent care 9-18-16, saw PCP 9-19-16 - worsened - 9/21 sought ED eval.
Age: 43.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Chills, Muscular weakness, Nausea, Pyrexia, Rhabdomyolysis
Clinical narrative: 8 hrs after vaccine pt developed nausea, fever, chills, BLE upper weakness, tremors - saw urgent care 9-18-16, saw PCP 9-19-16 - worsened - 9/21 sought ED eval.
Age: 43.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Tremor
Clinical narrative: 8 hrs after vaccine pt developed nausea, fever, chills, BLE upper weakness, tremors - saw urgent care 9-18-16, saw PCP 9-19-16 - worsened - 9/21 sought ED eval.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician regarding a patient of unknown age and gender. The patient's relevant medical history, drug history and concomitant medication information was unknown. On an unknown date, the patient was vaccinated with GARDASIL 9 lot/batch# 36301 with an expiry date in December 2017(dose, frequency and route were unknown). The administered vaccine underwent a temperature excursion and had been exposed to a temperature of 32.1 degree Fahrenheit for 7 hours. The patient did not experience any adverse events. It was unknown if any relevant tests were done. Lot number 36301 is an invalid lot number for GARDASIL 9. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant regarding 12 patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored VARIVAX lot # M008173/ expiration date-16-FEB-2018. No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information is not expected as reporter does not wants to get contacted.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician regarding a patient of unknown age and gender. The patient's relevant medical history, drug history and concomitant medication information was unknown. On an unknown date, the patient was vaccinated with GARDASIL 9 lot/batch# 36301 with expiry date December 2017(dose, frequency and route were unknown). The administered vaccine underwent a temperature excursion and had been exposed to a temperature of 32.1 degree Fahrenheit for 7 hours. The patient did not experience any adverse events. It was unknown if any relevant tests were done. Lot number 36301 is an invalid lot number for HPV vaccine. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacy technician concerning a multiple unspecified patients (unknown ages and genders). The patients pertinent medical history and concurrent conditions were not informed. It was reported that on multiple unspecified dates, the patients received improperly stored doses of ROTATEQ, lot # L048854, expiration date 31-AUG-2017, (dose was not provided), administered per oral route. Concomitant therapies were not informed. The temperature was 48 F and the time frame 12 hours 20 minutes. There was no a previous temperature excursion or call because of a data logger. No product quality complaint (PQC) was involved. Additional information has been requested. This is one of two reports from the same source (MARRS # 1609USA009557).
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot # K010465, expiration date 23-MAR-2016 (dose, dose number, route and anatomical location were not reported). Concomitant medications were not reported. The physician did not have any previous temperature excursions. No adverse symptoms were reported. A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # M006103, expiration date 01-AUG-2017 and/or lot # M004891 25-SEP-2017 (dose, dose number, route, and anatomical location were unspecified). The reporter stated that the vaccines were exposed to 5.5F during 10 minutes. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, and refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX, lot # M000757, expiration date 06-JAN-2018, and/or lot # M003440, expiration date 20-JAN-2018 (dose, dose number, route and anatomical location were unspecified). The reporter stated that the vaccines were exposed to 5.5F during 10 minutes. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of M-M-R II, lot # L035674, 0.5 ml, expiration date 17-SEP-2017, and/or lot # L034731, expiration date 09-SEP-2017, (dose, dose number, route, and anatomical location were unspecified). The reporter stated that the vaccines were exposed to 5.5F during 10 minutes. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Pyrexia, Vaccination site bruising
Clinical narrative: Patient came in on 09/08/16 and received a high dose influenza vaccination in accordance with the guidelines and due to the fact that the patient has received flu vaccination without any adverse reactions in the past. On 09/09/16 patient came to the pharmacy and her arm was bruised and red in the area where the vaccination was administered. Patient felt like she has a slight fever on 09/08/16 after receiving the vaccination but she took some acetaminophen and did not feel feverish since. No pain was reported. The patient was advised to continue with the acetaminophen if needed and diphenhydramine to see if it would help in case she was having an allergic reaction. She was also advised to see medical attention if the reaction got worse. Patient returned approximately 3 days later and reaction had significantly declined.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Terrible itch within 1-1/2 hrs from scalp to fee. (When I realized why) Broke out in bubbly rashes over face- scalp arms chest back leg still dealing w/eruptions here and there only a few. Felt under the weather that early evening. Have allergies. Used medicines and steroids to help w/it hive like rashes.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Musculoskeletal pain, Pain in extremity, Rash
Clinical narrative: Should/arm pain, rash above elbow.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Blood pressure increased, Rash
Clinical narrative: Blood Pressure elevated to 160/90, patient self check normal 120/80. Occurred 3 hours after immunization and slowly decrease after 2 hours. Also mild rash on left foot, same time frame. Resolved with Ibuprofen.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: An injection site (right arm). Red, swollen, itchy area. Appeared day after injection. No generalized symptoms. Symptoms receding at 3 days after injection. Comfort measures, diphenhydramine, APAP, Ibuprofen.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from two nurses via company representative and refers to a 4 year old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 06-SEP-2016, the patient was vaccinated with a dose of M-M-R II in her left leg (dose, route of administration, lot number and expiration date were not provided, albumin status could not be determined). It was not known if it was first or second dose of M-M-R II. On an unspecified date in September 2016, the patient experienced redness and unspecified swelling at the injection site at an unspecified time after vaccination. No Product Quality Complaint (PQC) was involved. The outcome of events was not reported. The relationship between events and M-M-R II was not reported. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Blister
Clinical narrative: Blister formed day after shot per patient report.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Mild reaction. 9X9cm, red circular, warm to touch. No pain, slight itching. Treatment is cold compress. Diphenhydramine prescribed for any itching.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Head discomfort, Muscle contracture, Screaming
Clinical narrative: 9/20/16 pt received MenB (BEXSERO) dose 2, within 2 hours came back to the office screaming that her "head was exploding" and that her "muscles were contracting". Gave her 800mg ibuprofen and 325mg TYLENOL and she turned around within 2 hrs. Very alarming appearance though.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Headache, Migraine, Neck pain
Clinical narrative: Pt came in 9/19/16 for second BEXSERO and stated she has had migraines since 2 wks after her first BEXSERO. She has never experienced migraines before. Second BEXSERO was given. She continues to have severe headaches and now has neck pain. She is scheduled to f/u w/neurology.
Age: 30.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Injection site nodule, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Right arm swollen, red, painful, knot noticed at injection site. Hot to touch, swelling noticed on entire arm and up to neck.
Age: 50.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Asthenia, Fatigue, Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: Yesterday her arm was very sore and swollen- she woke up 3 x during the night with pain. Arm feels hot, she feels tired and weak an has muscle aches. She has used ice and taken Ibuprofen.
Age: 50.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Skin warm
Clinical narrative: Yesterday her arm was very sore and swollen- she woke up 3 x during the night with pain. Arm feels hot, she feels tired and weak an has muscle aches. She has used ice and taken Ibuprofen.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Itching - redness - swelling - ALLEGRA - Ibuprofen 800 mg.
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a male pharmacist of unknown age referring to himself. The patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not reported. On an unspecified date, the patient received first injection of VARIVAX (lot#, expiry date and dosing details unknown). The patient was tested for VARIVAX "Immunoglobulin M (IGM) titers" on an unspecified date by an unspecified medical facility that reported "the levels were low" (no specifics given). The patient reported that he received a second injection of VARIVAX (lot#, expiry date and dosing details unknown) on an unknown date and was tested again for VARIVAX "Immunoglobulin M (IGM) titers" on an unknown date and reported the "the levels were again low". The outcome of antibody test negative was unknown. Causality assessment was not provided. There was no product quality complaint (PQC) involved. Additional information is not expected as the reporter denied consent to be contacted for further information.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an adult patient of unknown age and gender. The patient's concurrent  conditions and medical history were not reported. On 16-SEP-2016, the patient was vaccinated with an expired dose of M-M-R II lot # K010318, expiration date 22-JUL-2016 (dose, dose number, route and anatomical location were not reported). Concomitant medications were not reported. No adverse effects were reported. A Product Quality Complained was not involved. Additional information is not expected since the physician cannot be contacted.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis
Clinical narrative: Shoulder bursitis (R).
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left shoulder swelling, redness.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea
Clinical narrative: Pt experienced sudden severe nausea about approximately 2 hrs after receiving vaccine. Pt. is still experiencing it, but not as severe.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red, warm area at arm (upper).
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pain in extremity, Peripheral swelling, Ultrasound Doppler normal
Clinical narrative: Bruised, swollen arm and sore arm. Went to Dr to check her arm, Dr did a venous doppler to check for blood clot and no blood clot.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Swelling, itching, redness. TYLENOL prn, cold compress, cortisone cream.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus generalised, Urticaria
Clinical narrative: 1400 patient appeared to have generalized hives. More predominant to face and neck. Reported feeling itchiness to body. VS: B/P 140/82, temp 98.2, respiration easy non labored. Patient reports she suffers from unknown allergies and has a history of recurrent hives. Usually takes CLARITIN to manage it. Rash/hives spread to her abdomen and back. At 1410 BENADRYL 50 mg IM given to Left deltoid. At 1430 Redness subsided. Released with supervision of a friend. B/P 120/72. Alert and awake. Instructed to follow up with physician if allergy was to flare up with any respiratory issues to call 911. Follow up next day, patient reported to work.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Rash, Urticaria
Clinical narrative: 09:33 AM patient c/o hives and itchiness to her arms, face, lower back and legs. B/P 120/70, pulse 98, temp 96.4. Respirations easy non labored. Rash spreading rapidly at 09:35 AM - BENADRYL 50 mg IM to right deltoid administered. Continued to monitor and observe. At 10:05 AM redness, itching and hives subsided released with supervision of a friend. Alert and awake. Instructed to follow up with physician if allergy was to flare up with any respiratory issues to call 911. Follow up next day patient reported to work.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site irritation
Clinical narrative: Local irritation to injection site. Mild redness visible. BENADRYL gel applied topically. Redness diminished within 15 minutes. No further treatment required. Follow up the next day as per patient. No further reaction noted and reported to work.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site irritation
Clinical narrative: Local irritation to injection site. Mild redness visible no c/o itchiness. BENADRYL gel applied topically. Patient released at 2:10 with decreased redness. No further treatment required. Follow up next day rash had vanished within one hour post injection as per patient. She reported to work.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: Patient came to our pharmacy the day after receiving her flu shot stating that her left arm is red. The arm was warm to the touch but no different than her other arm. Patient also mentioned that her arm feels tender.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness and swelling from left shoulder to elbow and the area was itchy.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Tinnitus
Clinical narrative: Ringing in ears. Increased BP 178/49. Pharmacist gave me liquid BENADRYL. BP decreased throughout day. Ringing ceased.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Fatigue, Pyrexia
Clinical narrative: Patient developed symptoms a few hours after flu - high fever - ongoing for 2 days - diarrhea - fatigue.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Myalgia, Soft tissue swelling
Clinical narrative: Swollen tissue, redness, muscle pain.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Malaise, Pain in extremity, Skin warm
Clinical narrative: This spontaneous report was received from a 51 year old (reported as 51) female patient, who was reporting on herself. Her medical history and concurrent conditions were not reported. On 14-SEP-2016, the patient was vaccinated with PNEUMOVAX 23 lot # reported as L034335 with expiration date of 18-MAY-2017 (dose, frequency and route of administration were not reported). No concomitant medications were reported. On 15-SEP-2016 (reported as 24 hours later), the patient experienced redness, hot to touch, did not feel well and from shoulder to elbow it was hard in a spot and painful. Therefore, the patient received an unspecified treatment. No product quality complaints were involved. At the time of reporting, the outcome of the events was reported as recovering. Additionally, the relatedness between the events and the suspect therapy was not provided by the reporter. Additional information is not expected as no reporter contact details were provided.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain, Fatigue, Headache, Inappropriate affect, Pyrexia
Clinical narrative: Mom reports that fever started within 5 hours of flu shot. Inappropriate laughter in the night-fever 102 and "was out of it". In office visit, day after Flu shot, he reports abd. pain, and mild headache. Denies sore throat, denies vomit/diarrhea no cough, no rash. C/O being tired, taking sips of fluids.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient reported severe pain in arm where injection was given, pain reported to be in shoulder/upper arm.
Age: 63.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site pain
Clinical narrative: Patient's husband reported severe pain post-injection in shoulder/upper arm in arm where injection was given.
Age: 40.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Headache; injection site reaction (redness, swelling, pain). (R) arm/deltoid injection site (PNEUMOVAX).
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, PNC13, VARCEL
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: Patient given two doses of varicella by mistake (Varicella and PROQUAD given).
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy, Urticaria
Clinical narrative: Cervical lymph node swelling (L) side. Hives to neck and chest. Vaccine applied to (L) upper arm.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse referring to unspecified patients of unknown age and gender, the patients medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot number, expiration date, concentration, dose and frequency were not provided) route of administration was reported as unknown. Information regarding concomitant medications were not reported. Additional information has been requested.
Age: 1.58
Sex: M
Vaccine: HIBV, IPV
Symptoms: Abnormal behaviour, Aphasia
Clinical narrative: Go over labs, pt lost all words 3.5 weeks ago, gradually starting to use words and interact, per mom he would hide his face, not respond to them, his speech therapist is concerned. He stopped using sign language as well. Mom denies that he had any fever, diarrhea, GI symptoms, ate well, but stopped interacting with them, stopped smiling, stopped talking. Since Sunday 9/11 he began saying mama and daddy and a few other words and smiling again. Now has 7 words and 3 signs. He received his shot on Tuesday, August 18 and by Thursday he seemed off and then got worse and worse. Within a week he lost 27 spontaneous words and 22 signs that had been tracked by his speech therapist. This was very noticeable and happened in a three day period. The speech therapist was "freaked out". Suddenly he did not want to have anything to do with the parents or the therapist. He started looking away and standing in the corner for four minutes at a time. He did not want to sit. He stopped laughing and interacting. In the week prior to the follow up visit today he did not say words or signs except for mama or dada when he saw parents.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant regarding 9 patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored PROQUAD, lot no. M022399/expiration date-01-NOV-2017 (incorrect product storage). No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information is not expected as reporter does not wants to get contacted.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Diarrhoea, Vomiting
Clinical narrative: Stomach cramps and diarrhea with vomiting.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Chills, Ear congestion, Limb discomfort, Nausea
Clinical narrative: 8 hrs after vaccine came down with fever, chills, nausea, stuffed ears, heaviness in chest and arms. Person recovered enough to return to work on 919/16-did not seek medical treatment at that time. Still has fever/chills/recovering aches.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pyrexia
Clinical narrative: 8 hrs after vaccine came down with fever, chills, nausea, stuffed ears, heaviness in chest and arms. Person recovered enough to return to work on 919/16-did not seek medical treatment at that time. Still has fever/chills/recovering aches.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Mild aches joint pain, erythema, swelling at injection site - resolved.
Sex: M
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Dyspnoea, Headache, Loss of consciousness, Mobility decreased
Clinical narrative: This spontaneous report was received from a registered nurse who was notified by a field representative of a page referring to a male patient of unknown age. The patient's concurrent conditions or concomitant medications were not reported. It was reported that the patient was an active and healthy child. On an unspecified date, the patient got vaccinated with GARDASIL (dose number, dose, frequency, anatomical location, lot number and expiration date were not reported). It was reported that since receiving the vaccine, on an unspecified date, the patient could not go to school or play sports, some days he struggled to just get out of bed and that his life had changed. It was also reported that on a good day he has 5 seizures a day and that on a bad day he can have up to 30. He was in constant pain and had severe headaches. He also had issues where his throat closes up and he passes out because he could not breathe. His regular doctors and the hospital said they could not help the patient or did not know how to treat his vaccine injury. Therefore, the parents were seeking for homeopathic treatment. They did not have choice and felt that it was on the patient's best interest. However, that route was extremely expensive. The patient was from a one income family and had 4 siblings. He can not be left alone, and they have had to completely change his diet which causes the grocery bill to double, and they were beginning to receive the mounds of bills from his doctor and hospital visits. The outcome of the events was unknown. Upon internal review, can't go to school or play sports, struggles to just get out of bed. Live for his active child has changed was considered to be disabling and loss of consciousness and Seizures were considered to be medically significant events. Additional information is not expected as the reporter did not give consent for follow up.
Sex: M
Vaccine: HPV4
Symptoms: Pain, Seizure, Throat tightness
Clinical narrative: This spontaneous report was received from a registered nurse who was notified by a field representative of a page referring to a male patient of unknown age. The patient's concurrent conditions or concomitant medications were not reported. It was reported that the patient was an active and healthy child. On an unspecified date, the patient got vaccinated with GARDASIL (dose number, dose, frequency, anatomical location, lot number and expiration date were not reported). It was reported that since receiving the vaccine, on an unspecified date, the patient could not go to school or play sports, some days he struggled to just get out of bed and that his life had changed. It was also reported that on a good day he has 5 seizures a day and that on a bad day he can have up to 30. He was in constant pain and had severe headaches. He also had issues where his throat closes up and he passes out because he could not breathe. His regular doctors and the hospital said they could not help the patient or did not know how to treat his vaccine injury. Therefore, the parents were seeking for homeopathic treatment. They did not have choice and felt that it was on the patient's best interest. However, that route was extremely expensive. The patient was from a one income family and had 4 siblings. He can not be left alone, and they have had to completely change his diet which causes the grocery bill to double, and they were beginning to receive the mounds of bills from his doctor and hospital visits. The outcome of the events was unknown. Upon internal review, can't go to school or play sports, struggles to just get out of bed. Live for his active child has changed was considered to be disabling and loss of consciousness and Seizures were considered to be medically significant events. Additional information is not expected as the reporter did not give consent for follow up.
Sex: F
Vaccine: HPV4
Symptoms: Chronic respiratory disease, Dizziness, Headache, Nausea, Pain
Clinical narrative: This spontaneous report was received from a consumer (patient's mother) and refers to her daughter, a 22 year old female patient. The patient's medical history included type 1 diabetes mellitus. Concomitant medications included unspecified insulin and HUMALOG. The patient was received GARDASIL, 1st dose on 18-JUN-2008, 2nd dose on 13-AUG-2008 and 3rd dose on 18-DEC-2008 intramuscularly. At an unspecified time in 2008 after receiving GARDASIL (also reported as 18-JUN-2008), the patient experienced chronic respiratory disease, nausea, dizziness, pain, headache and numerous hospitalizations due to vomiting. The patient did not receive any treatment for the events. Several unspecified diagnostic tests were performed. The outcome of the events was reported as not recovered/not resolved. The causality of the events was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: This spontaneous report was received from a consumer (patient's mother) and refers to her daughter, a 22 year old female patient. The patient's medical history included type 1 diabetes mellitus. Concomitant medications included unspecified insulin and HUMALOG. The patient was received GARDASIL, 1st dose on 18-JUN-2008, 2nd dose on 13-AUG-2008 and 3rd dose on 18-DEC-2008 intramuscularly. At an unspecified time in 2008 after receiving GARDASIL (also reported as 18-JUN-2008), the patient experienced chronic respiratory disease, nausea, dizziness, pain, headache and numerous hospitalizations due to vomiting. The patient did not receive any treatment for the events. Several unspecified diagnostic tests were performed. The outcome of the events was reported as not recovered/not resolved. The causality of the events was unknown. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Migraine, Nausea, Nuclear magnetic resonance imaging normal, Peripheral swelling, Scan with contrast normal
Clinical narrative: 1st swelling Right Arm Deltoid area 2x normal size. 2nd week Intractable Migraines with Nausea and Vomiting requiring ER visit. Intractable Migraines have continued and treated with Imitrex,Tylenol# 3, and Motrin.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Vomiting
Clinical narrative: 1st swelling Right Arm Deltoid area 2x normal size. 2nd week Intractable Migraines with Nausea and Vomiting requiring ER visit. Intractable Migraines have continued and treated with Imitrex,Tylenol# 3, and Motrin.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Injection site swelling, Migraine, Nausea, Vomiting
Clinical narrative: 1st swelling Right Arm Deltoid area 2x normal size. 2nd week Intractable Migraines with Nausea and Vomiting requiring ER visit. Intractable Migraines have continued and treated with Imitrex,Tylenol# 3, and Motrin.
Age: 39.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site nodule, Injection site pruritus
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of induration in a 39-ear-old female patient who received FLUARIX TETRA (batch number 2994A, expiry date 30th JUNE 2017). On 17th SEPTEMBER 2016, the patient received FLUARIX TETRA. On 17th SEPTEMBER 2016, 5 hrs after  receiving FLUARIX TETRA, the patient experienced induration. On an unknown date, the outcome of the induration was not recovered/not resolved. It was unknown if the reporter considered the induration to be related to FLUARIX TETRA. Additional details were provided as follows: Hours after vaccination with FLUARIX Quadrivalent, the patient experienced induration.
Age: 39.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Induration
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of induration in a 39-ear-old female patient who received FLUARIX TETRA (batch number 2994A, expiry date 30th JUNE 2017). On 17th SEPTEMBER 2016, the patient received FLUARIX TETRA. On 17th SEPTEMBER 2016, 5 hrs after  receiving FLUARIX TETRA, the patient experienced induration. On an unknown date, the outcome of the induration was not recovered/not resolved. It was unknown if the reporter considered the induration to be related to FLUARIX TETRA. Additional details were provided as follows: Hours after vaccination with FLUARIX Quadrivalent, the patient experienced induration.
Age: 43.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: This case was reported by a consumer and described the occurrence of hives in a 43-year-old female patient who received FLULAVAL Quadrivalent (batch number 9N2X7, expiry date 30th APRIL 2017. On 20th SEPTEMBER 2016, the patient received FLULAVAL Quadrivalent, .5ml. On 20th SEPTEMBER 2016, less than a day after receiving FLULAVAL Quadrivalent, the patient experienced hives and injection site pain. On an unknown date, the outcome of the hives was recovering/resolving and the outcome of the injection site pain was not recovered/not resolved. The reporter considered the hives and injection site pain to be almost certainly related to FLULAVAL Quardrivalent. Additional details were provided as follows: This case was previously reported by a doctor. This case was reported by the patient, who was a medical representative. The patient received the vaccine in her left deltoid. At 18:30 hours, the patient experienced raised and itchy hives on inner upper arms and abdomen as well as a injection site pain after vaccination.
Age: 43.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site pain, Urticaria
Clinical narrative: This case was reported by a consumer and described the occurrence of hives in a 43-year-old female patient who received FLULAVAL Quadrivalent (batch number 9N2X7, expiry date 30th APRIL 2017. On 20th SEPTEMBER 2016, the patient received FLULAVAL Quadrivalent, .5ml. On 20th SEPTEMBER 2016, less than a day after receiving FLULAVAL Quadrivalent, the patient experienced hives and injection site pain. On an unknown date, the outcome of the hives was recovering/resolving and the outcome of the injection site pain was not recovered/not resolved. The reporter considered the hives and injection site pain to be almost certainly related to FLULAVAL Quardrivalent. Additional details were provided as follows: This case was previously reported by a doctor. This case was reported by the patient, who was a medical representative. The patient received the vaccine in her left deltoid. At 18:30 hours, the patient experienced raised and itchy hives on inner upper arms and abdomen as well as a injection site pain after vaccination.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Vaccination site induration, Vaccination site swelling
Clinical narrative: Patient was unable to lift his arm. He said the area of the vaccination was hard and swollen.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever = 104, patient was brought to ER.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Chills, Myalgia, Nausea
Clinical narrative: Chills, muscle aches, weakness, nausea.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Migraine, Myalgia, Pyrexia, Vomiting
Clinical narrative: Migraine headache, vomiting, low-grade fever, fatigue, muscle pain.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PPV, RVX
Symptoms: Emotional distress, Screaming
Clinical narrative: Inconsolable screaming that lasted over 4 hours. No amount of soothing helped calm he down. Baby Tylenol didn't work either.
Age: 17.0
Sex: F
Vaccine: HPV4, MENB, HPV4, MENB
Symptoms: Chills, Dizziness, Headache, Malaise, Myalgia
Clinical narrative: This is a spontaneous report from a contactable medical assistant via a Pfizer sales representative and from a contactable Consumer. A 17 year-old female patient of an unspecified ethnicity received TRUMENBA (Lot # M68769 Exp. 30Apr2017) via an unspecified route of administration at 0.5 ml single, and GARDASIL, both on 29Jul2016 for immunisation. The patient medical history and concomitant medications were note reported. On 29Jul2016 the patient experienced severe headache, dizziness, fever, chills, myalgias, and malaise. The patient was admitted to ER 45 min after immunization for severe headache, chills, myalgias, and malaise. While in ER the body temperature was 103 degrees. The events were treated with TORADOL, Prednisone, BENADRYL, TYLENOL. The outcome of the events was recovered. Follow-up (20Sep2016): This is a follow up spontaneous report from a contactable Consumer included: Lot Number and Expiration Date; vaccination date; events outcome; co-suspect medication; lab test; additional events Chills, Myalgias, Malaise; course of events; ER required; treatment.
Age: 17.0
Sex: F
Vaccine: HPV4, MENB, HPV4, MENB
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable medical assistant via a Pfizer sales representative and from a contactable Consumer. A 17 year-old female patient of an unspecified ethnicity received TRUMENBA (Lot # M68769 Exp. 30Apr2017) via an unspecified route of administration at 0.5 ml single, and GARDASIL, both on 29Jul2016 for immunisation. The patient medical history and concomitant medications were note reported. On 29Jul2016 the patient experienced severe headache, dizziness, fever, chills, myalgias, and malaise. The patient was admitted to ER 45 min after immunization for severe headache, chills, myalgias, and malaise. While in ER the body temperature was 103 degrees. The events were treated with TORADOL, Prednisone, BENADRYL, TYLENOL. The outcome of the events was recovered. Follow-up (20Sep2016): This is a follow up spontaneous report from a contactable Consumer included: Lot Number and Expiration Date; vaccination date; events outcome; co-suspect medication; lab test; additional events Chills, Myalgias, Malaise; course of events; ER required; treatment.
Age: 17.0
Sex: F
Vaccine: HPV4, MENB, HPV4, MENB
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable medical assistant via a Pfizer sales representative and from a contactable Consumer. A 17 year-old female patient of an unspecified ethnicity received TRUMENBA (Lot # M68769 Exp. 30Apr2017) via an unspecified route of administration at 0.5 ml single, and GARDASIL, both on 29Jul2016 for immunisation. The patient medical history and concomitant medications were note reported. On 29Jul2016 the patient experienced severe headache, dizziness, fever, chills, myalgias, and malaise. The patient was admitted to ER 45 min after immunization for severe headache, chills, myalgias, and malaise. While in ER the body temperature was 103 degrees. The events were treated with TORADOL, Prednisone, BENADRYL, TYLENOL. The outcome of the events was recovered. Follow-up (20Sep2016): This is a follow up spontaneous report from a contactable Consumer included: Lot Number and Expiration Date; vaccination date; events outcome; co-suspect medication; lab test; additional events Chills, Myalgias, Malaise; course of events; ER required; treatment.
Sex: M
Vaccine: PNC13
Symptoms: Hypoaesthesia
Clinical narrative: This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. A male patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration, on an unspecified date, as a single dose for immunization. The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced numbness after being vaccinated by his physician. After informing a physician patient could not feel his upper limbs on an unspecified date, the physician ignored the complaint and told patient that it would pass. The action taken with pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) was not applicable. The outcome of numbness was unknown.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Cardiac disorder, Memory impairment
Clinical narrative: This is a spontaneous report from a contactable consumer. An 82-year-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration at single dose on an unspecified date for immunisation. Medical history included cancer survivor. The patient's concomitant medications were not reported. The patient experienced heart problems and memory problems on an unspecified date with outcome of unknown.  But, the reporter did not specify these events as occurring prior to or after the patient received the vaccine.
Sex: M
Vaccine: PNC13
Symptoms: Malaise
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer who reported for her husband. A male patient of an unspecified age received a single dose of PREVNAR 13, on Mar2016 for immunisation.  The patient medical history and concomitant medications were not reported.  The patient was seriously ill since receiving the vaccine in Mar2016. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: MENB
Symptoms: Injection site erythema
Clinical narrative: This is a spontaneous report from a contactable nurse. A patient of unknown age, gender and race received TRUMENBA for immunization on unknown date at single dose via an unspecified route of administration. On unknown date the patient experienced redness at injection site. The outcome of the event was reported as not recovered.
Sex: F
Vaccine: MENB
Symptoms: Discomfort, Dyspnoea, Fatigue, Headache, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable consumer, reporting for his daughter. This female patient of an unspecified age, race and ethnicity received a single dose of TRUMENBA via an unspecified route of administration on 22Sep2016 for immunization. The patient medical history and concomitant medications were not reported. On 22Sep2016 the patient was feeling very heavy and she experienced sore at the injection site, on 23Sep2016 she was lethargic, very tired, she had headache and she could not breathe. Outcome of events was unknown.
Sex: F
Vaccine: MENB
Symptoms: Lethargy
Clinical narrative: This is a spontaneous report from a contactable consumer, reporting for his daughter. This female patient of an unspecified age, race and ethnicity received a single dose of TRUMENBA via an unspecified route of administration on 22Sep2016 for immunization. The patient medical history and concomitant medications were not reported. On 22Sep2016 the patient was feeling very heavy and she experienced sore at the injection site, on 23Sep2016 she was lethargic, very tired, she had headache and she could not breathe. Outcome of events was unknown.
Sex: U
Vaccine: IPV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Initial unsolicited report received from a physician on 19 September 2016. This case is linked to 2016SA173978 (same reporter). This case involves three patients of four years old of unknown gender who were vaccinated with a dose of IPOL (batch number: MI471M, expiration date: 09 September 2018, dose, dose series, form and frequency of administration were not reported), via intramuscularly on (between 13 September 2016 to 15 September 2016). The patient's illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects and medical conditions were unknown. The patient's did not receive any other vaccinations within 4 weeks of vaccinations. Concomitant medications were not reported. On September 2016 (unspecified date), same day following the vaccination patients were developed redness, warmth and induration at the injection sites. The lab data and corrective treatment was not reported. The outcome for the events was reported as unknown. List of documents held by sender: none.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Anaphylactic reaction, Dyspnoea, Urticaria
Clinical narrative: Initial unsolicited report received from a physician on 19-Sep-2016. This case involves a 71-year-old female patient who was vaccinated with a dose of Fluzone HD (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on 15-Sep-2016. The patient's illness at time of vaccination was reported as none and the pre-existing physician diagnosed allergies included sulfa, PCN, Macrobid allergy and birth defects, medical conditions (specify) were reported as Vicryl sutures, breast cancer mult skin cancers, chronic sinus infections. Concomitant medications were not reported. The patient had not received any vaccinations within 4 weeks of vaccination with Fluzone HD vaccine. On 16-Sep-2016 in the am, one day after the vaccination, patient started having difficulty in breathing and hives. The patient was diagnosed with an anaphylactic reaction. The patient was taken to emergency room. Laboratory investigations were reported as none. Patient's corrective treatment included breathing treatments, steroids and Benadryl IV and was discharged with a Medrol Dose pack. The patient was not recovered from events. Upon internal review the case was considered as serious because of important medical event anaphylactic reaction. List of documents held by sender: none. Sender's Comments: Anaphylactic reactions are listed post-vaccination with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Time to onset is compatible with the role of vaccine. patient have history of allergy to Penicillin, Sulfa drugs, Macrobid, Vicryl Sutures, also have history of Breast CA and chronic sinus infections. Complementary information regarding any drug or food intake during the period between vaccination and reaction as well as allergic testings to identify the culprit antigen, patient's history of reaction after previous vaccinations is needed for complete assessment of the case.