chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant and 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, the patient was vaccinated with an improperly stored dose of PEDVAXHIB lot # reported as N000238, expiration date 25-OCT-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 32 and 35 degrees Fahrenheit for 12 hours. A Digital Data Logger was involved. There were no previous temperature excursions reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated an improperly stored dose of PNEUMOVAX 23 injection, lot # M037533 with expiry date 17-MAY-2018 (exact dose and route of administration were not reported). The dose was exposed to the temperature of minus 1 degree Celsius or colder for one cycle (reported as 2 hours 15 minutes). There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Asthenia, Fatigue
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act referring to a 12-year-old female patient. The patient had no medical history or concurrent illnesses. On 11-OCT-2016, the patient was vaccinated with the second dose of GARDASIL 9 lot # M018810, intramuscularly in the left arm for prophylaxis and with the first dose of FLUZONE QUADRIVALENT lot # UI678AA, intramuscularly in the left arm for prophylaxis. On 28-OCT-2017, the patient experienced weakness, tiredness after taking the GARDASIL 9 shot. No lab data were available. On an unknown date, the patient recovered from asthenia and fatigue. The causality relationship between the adverse events and GARDASIL 9 was not provided. Additional information is not expected as no further information can be obtained from the local regulatory authority.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # M036156 with expiration date 23-FEB-2019, lot # M037248 with expiration date 21-FEB-2019, lot # M031574 with expiration date 11-NOV-2018 and lot # L048848 with expiration date 09-AUG-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 13.1 degrees Celsius for 7 hours and 50 minutes. A Digital Data Logger was involved. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA014902: US-009507513-1705USA007308: US-009507513-1705USA007306: US-009507513-1705USA007307: US-009507513-1705USA007303: US-009507513-1705USA007305.
Age: 64.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 64-year-old male patient received the first dose of PREVNAR 13 (Lot Number: R49358, NDC number: 00005197102, Expiry Date: Apr2018), on 08May2017 at 0,5ml single dose for immunization via intramuscular route in the right deltoid. The patient had no medical history or concomitant medications. On unknown date in May2017 the patient experienced redness, soreness, itchiness and warmness all at the injection site after administration of vaccine. The symptoms began within 24 hours of receiving the vaccine. The outcome of the events was reported as not recovered. No follow-up attempts are possible. No further information is expected.
Age: 0.17
Sex: F
Vaccine: DTPHEP, HIBV, PPV, RVX
Symptoms: Condition aggravated, Diarrhoea, Gastrooesophageal reflux disease, Injection site swelling, Pyrexia
Clinical narrative: Child had diarrhea for a period of approximately 1 month. Fever, swollen injection site, increased GERD symptoms and severity.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Periarthritis
Clinical narrative: This Spontaneous case, initially received on 05-May-2017 was reported by a other non-health professional and concerns a 60 years old adult female patient. Patient had an allergy to Penicillin, Sulfa, Clindamycin, Tetracycline.  Administration of Company suspect drug (s): On 10-Nov-2016 at 08:00 the patient was administered with FLUVIRIN, (dose: 0.5ml, batch number: 169305) via intramuscular route. Adverse reactions/events and outcomes: On 12-Nov-2016 the patient experienced continual pain in left arm and she was unable to lift arm without experiencing pain and was diagnosed with adhesive capsulitis on 22-Mar-2017. Action taken with influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived was not reported and outcome of the events was reported as not recovered. Reporter's Assessment: The other non-health professional did not provide any assessment between the events as and suspect vaccine. This case was serious (Disability, Medically significant).
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm
Clinical narrative: PT REPORTED REDNESS AND HEAT IN THE LOWER ARM JUST ABOVE ELBOW, SHE DIDN'T NOTICE ANY REDNESS, HEAT OR SWELLING AT THE INJECTION SITE. PT FEELS THE SYMPTOMS ARE CAUSED BY INJECTION. GAVE RECOMMENDATION FOR ICE AND NSAID, AS WELL A FOLLOW UP WITH DR.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Chills, Dizziness, Erythema, Pain in extremity
Clinical narrative: Fever, chills, severe swelling left arm with redness, pain, light-headed, dizzy, weak.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Fever, chills, severe swelling left arm with redness, pain, light-headed, dizzy, weak.
Age: 0.83
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: Lt leg large red knot area swollen and red - warm to touch. Rt leg - Very large area red, swollen, and hot to touch. Area is baseball sized. Pt was seen by APRN and given an RX for Cephalexin. Has F/U appt on 5/22/17.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Dizziness, Dyspnoea, Nausea, Oropharyngeal pain, Pyrexia
Clinical narrative: Feeling Nausea, Fever, light headedness. Went home from school early. Began to have swelling in chin and left forehead. On 5/16/2017 worsening throughout that day and 5/17/2017. Received tylenol 5/17/17 at 0930 from mother. Received 2 Benadryl at 1145 on 5/17/2017.  Came to our clinic on 5/17/2017 at 1215 and complained of feeling short of breath, soreness in her throat and worsening of the swelling on her face. Vitals 99.8 degrees fahrenheight. BP 90/60 and heart rate 106. Palor noted. Referred to ER immediately. Followed up with mother on 5/18/2017 who stated that the ER gave patient an oral cocktail of pepcid, benadryl and prednisone and sent home. Mother is attempting to schedule an appointment with PCP for follow up. Temperature on 5/18/2017 0930 100 degrees fahreneit. Tylenol administered by mother. Patient is resting at home.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Swelling face
Clinical narrative: Feeling Nausea, Fever, light headedness. Went home from school early. Began to have swelling in chin and left forehead. On 5/16/2017 worsening throughout that day and 5/17/2017. Received tylenol 5/17/17 at 0930 from mother. Received 2 Benadryl at 1145 on 5/17/2017.  Came to our clinic on 5/17/2017 at 1215 and complained of feeling short of breath, soreness in her throat and worsening of the swelling on her face. Vitals 99.8 degrees fahrenheight. BP 90/60 and heart rate 106. Palor noted. Referred to ER immediately. Followed up with mother on 5/18/2017 who stated that the ER gave patient an oral cocktail of pepcid, benadryl and prednisone and sent home. Mother is attempting to schedule an appointment with PCP for follow up. Temperature on 5/18/2017 0930 100 degrees fahreneit. Tylenol administered by mother. Patient is resting at home.
Age: 1.58
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC13
Symptoms: Drooling, Eye movement disorder, Incontinence, Irritability, Malaise
Clinical narrative: Parents reported intermittent fever since 05/16/2016. Mother took temporal temperature around 05:30pm and it was 101.9. Medicated with TYLENOL. Patient then had a seizure while laying on the couch with her mother. No prior history of seizures. Mother states patient began convulsing, eyes rolled back in her head, patient began drooling, and was incontinent. Episode lasted less than 1 minute, postictal for several minutes afterwards. Parents called 911 and child was transported to nearest ED via ambulance. Medics reported her temperature during transport as 104. Upon arrival to ED child was medicated with MOTRIN and then fell asleep for a 30 minute nap. Parents noted to ED provider upon waking child was fussy and appeared to not feel well, but otherwise acting like her normal self. Patient discharged from ED at 9:25 pm. Instructed to follow up with primary pediatrician.
Age: 1.58
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC13
Symptoms: Postictal state, Pyrexia, Seizure
Clinical narrative: Parents reported intermittent fever since 05/16/2016. Mother took temporal temperature around 05:30pm and it was 101.9. Medicated with TYLENOL. Patient then had a seizure while laying on the couch with her mother. No prior history of seizures. Mother states patient began convulsing, eyes rolled back in her head, patient began drooling, and was incontinent. Episode lasted less than 1 minute, postictal for several minutes afterwards. Parents called 911 and child was transported to nearest ED via ambulance. Medics reported her temperature during transport as 104. Upon arrival to ED child was medicated with MOTRIN and then fell asleep for a 30 minute nap. Parents noted to ED provider upon waking child was fussy and appeared to not feel well, but otherwise acting like her normal self. Patient discharged from ED at 9:25 pm. Instructed to follow up with primary pediatrician.
Age: 11.0
Sex: M
Vaccine: HPV9, MENB, MNQ, TDAP
Symptoms: Injection site pain, Nausea, Urticaria
Clinical narrative: A large wheal developed on each arm. Also c/o nausea as well as pain at injection sites.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Red rash on left arm around injectrion site. Office visit 5/18/2017 to get anti-inflammatory rx.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, DTAP, HIBV
Symptoms: Abasia, Decreased appetite, Dyspnoea, Pyrexia
Clinical narrative: Spiked a fever. Could not walk at all. Difficulty breathing. NO appetite.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, DTAP, HIBV
Symptoms: Abasia, Decreased appetite, Pyrexia, Somnolence
Clinical narrative: Spiked a fever. Could not walk at all. Difficulty breathing. NO appetite.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product packaging confusion
Clinical narrative: This spontaneous report was received from a office manager whom reported the shipment of PROQUAD, and sterile diluent (manufacturer unknown) which similar, and it could lead to confusion. It was also reported that the products were not administered, and no adverse effects were reported since there was not patient involved. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: PNC13, VARCEL
Symptoms: Varicella post vaccine, Varicella virus test positive
Clinical narrative: This information has been received from a Licensed Practical Nurse concerning a 2 year old female patient. The patient had no pertinent medical history, drug allergies, concurrent conditions or concomitant therapies. On an unknown date, the patient was vaccinated with VARIVAX with lot number reported as I017146 and expiration date on 13-MAY-2017 (dose, dose number, route of administration and anatomical location were not provided), administered for prophylaxis with its sterile diluent (manufacturer unknown) (lot number and expiration date were not provided). On 09-MAY-2017, the patient visited the office. The nurse reported that a culture was performed and the patient tested positive for Varicella. The patient had being treated with Acyclovir. At the time of the report, the patient had no recovered from varicella and the causal relationship between VARIVAX, its sterile diluent (manufacturer unknown) and the event was unknown. Additional information has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A patient of an unspecified age and ethnicity received a dose of PREVNAR 13, on unknown date at single dose for immunization. Relevant medical history and concomitant medication were not reported. On unknown date the patient experienced redness, warmness, soreness, and itchiness at the injection site after administration of vaccine. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Back pain, Blood test, Dizziness, Fatigue, Headache
Clinical narrative: Severe pain from shoulder to fingers. Body tremors, fatigue, headaches, back pain, dizziness, low BP 81/53. 3 ER visits and 2 doctor office no one can diagnose.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Hypotension, Pain in extremity, Tremor
Clinical narrative: Severe pain from shoulder to fingers. Body tremors, fatigue, headaches, back pain, dizziness, low BP 81/53. 3 ER visits and 2 doctor office no one can diagnose.
Age: 49.0
Sex: F
Vaccine: DTAP
Symptoms: Arthralgia, Joint swelling, Peripheral swelling, Pyrexia, White blood cell count normal
Clinical narrative: Fever, swollen left knee, then right elbow, then bilateral hands (migratory polyarthralgia). Went to ER and ruled out for septic arthritis. She received IV Fluids and Steroids. Patient improved after 5 days of oral steroids.
Age: 43.0
Sex: F
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No physical problems. Accidentally gave a pediatric and adult Hepatitis A.
Age: 44.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Injection site pain, Joint crepitation, Sleep disorder
Clinical narrative: Dull pain at injection site during the day, extreme pain while sleeping on my left side, enough to wake me up and keep me awake until the pain subsides (about 1 hour after moving to my right shoulder).  This happens nearly nightly, the symptoms have worsened over the past two months.  I also have minor popping/crackling sounds when rotating my arm.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Red, itchy rash on right torso. It has lasted over 3 months now.
Age: 1.17
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Administered subcutaneously. Eight minutes later, Mom noticed a hive below administration site. RN informed MD who stated to give 5mL BENADRYL PO. Ten minutes later RN checked on pt, hive no longer had a white head but was red and raised and slightly larger. No spreading. 30 mins after administration MD observed and gave OK to go home. Patient was checked on today 5/18. Mom reported at noon that she woke up and was "totally fine".
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Skin lesion
Clinical narrative: Redness at injection site, area of redness getting larger, not itchy, hot to the touch; reported to pharmacy, referred to Primary Care, lesion measured approx. 8cm X 4cm, no systemic symptoms.
Age: 18.0
Sex: M
Vaccine: MEN
Symptoms: Seizure, Syncope
Clinical narrative: Patient fainted, and started convulsing, dad held him and as I was about to give EPIPEN, dad said to hold off.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Erythema, Mobility decreased, Peripheral swelling, Skin warm
Clinical narrative: Patient states she experienced an increase in temperature all over her body. She states she could not move her arm up or down. Her arm looked red and swollen and is hot to the touch. I recommended for the patient to take some TYLENOL and BENADRYL and to also ice her arm.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: Patient reported vomiting and no other symptoms. Per patient, there were no visible injection site reactions.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site bruising, Peripheral swelling, Rash macular, Skin warm
Clinical narrative: Dime size bruise at injection site, muscle was hot to the touch, arm was swollen and blotchy. Pt was instructed to take BENADRYL and apply an ice pack 15 minutes at a time and to see medical attention of symptoms worsen.
Age: 1.33
Sex: F
Vaccine: HIBV, MMR, PPV, VARCEL
Symptoms: Crying, Irritability, Lethargy, Opisthotonus, Pain
Clinical narrative: Very high fever - 103.5 even with medication, extreme lethargy, fits of pain, rash that spread all over the body, screaming, back arching. This all lasted about six days. Then fussiness and incessant crying for about a month.
Age: 1.33
Sex: F
Vaccine: HIBV, MMR, PPV, VARCEL
Symptoms: Pyrexia, Rash generalised, Screaming, Streptococcus test negative
Clinical narrative: Very high fever - 103.5 even with medication, extreme lethargy, fits of pain, rash that spread all over the body, screaming, back arching. This all lasted about six days. Then fussiness and incessant crying for about a month.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site warmth, Pruritus, Urticaria
Clinical narrative: TDaP was administered 5/15/17 in office. With 24 hrs. patient reports local (Left upper arm) swelling and warmth. Hive of the arms and wide spread itching has worsened by now 48 hrs. No shortness of breath, swelling of face or mouth or lips or throat.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV, PNC13
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis to right thigh. Antibiotics prescribed sulfamethoxazole - trimethoprim 200-40 mg/5 ml 8 ml BID x 10 days.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling and redness at injection site. Hot to touch. Ice was applied and took MOTRIN. Area remains the same.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Swollen welt at site of injection. Hot to the touch.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Extensive swelling of vaccinated limb, Injection site swelling, Pyrexia
Clinical narrative: Received DTaP on 5/11/17 which resulted in extensive limb swelling of his entire right arm - also had fever 103. Pt seen 5/12, 5/13. 5/15 - swelling resolving.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Patient received Tdap on 3-30-17. On 5-15-17 patient called and reported redness and swelling at injection site. Was scheduled to be seen by provided on 5-17-17. Diagnosed with cellulitis at site on injection and prescribed cephalexin 500 mg 1 every 6 hr x 7 days.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Hypoaesthesia, Nausea, Paraesthesia, Vaccination site swelling, Vomiting
Clinical narrative: Per RN, patient told her she had 2 vaccines Wednesday, 5/10/17, HPV and MCV4, and Wed. evening her left arm swelled at the vaccine site, and her arm was a little numb and tingling. Her mother gave her ibuprofen and aceta. She reported nausea and vomiting on 5/12/17 and was advised to go to ED if worsens.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness and swelling at injection site. 7 cm x 10 m area. Warm to touch.
Age: 7.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Weight bearing difficulty
Clinical narrative: Lt. thigh pain. Swelling. Unable to bear weight.
Age: 85.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness 6m x 8m in area with soreness started approx 5 days after administration of PREVEAR 13 vaccine in Right Deltoid.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Body temperature increased, Irritability
Clinical narrative: Days after imms c/o fussiness Temp 101.5.
Age: 36.0
Sex: M
Vaccine: YF
Symptoms: Local reaction, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site urticaria
Clinical narrative: 10x7 cm area of erythema, induration tenderness, and urticaria at vaccine administration site. Pt afebrile - local reaction only.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Chills, Myalgia, Pyrexia, Tremor, Vomiting
Clinical narrative: High fever - 103; Vomiting; Shakes/chills; Myalgia.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Mild lacey rash on lower neck, chest, and upper abdomen. No other S/Sx. Positive constitution. No redness, pain, or rash around injection site or arm. Patient working in yard in high heat temperature - possible heat rash.
Age: 15.0
Sex: F
Vaccine: YF, YF
Symptoms: Dyspnoea
Clinical narrative: Client was given the yellow fever vaccine in a clinical office setting. She left the building and 40 minutes later her mother called to report that this minor had difficulty breathing. Traveled to E. Tx - Pepcid and BENADRYL via IV Albuterol breathing Tx. D/C to home.
Age: 15.0
Sex: F
Vaccine: YF, YF
Symptoms: Abnormal behaviour, Anaphylactic reaction, Dyspnoea, Eyelid oedema, Incoherent
Clinical narrative: Client was given the yellow fever vaccine in a clinical office setting. She left the building and 40 minutes later her mother called to report that this minor had difficulty breathing. Traveled to E. Tx - Pepcid and BENADRYL via IV Albuterol breathing Tx. D/C to home.
Age: 15.0
Sex: F
Vaccine: YF, YF
Symptoms: Lip swelling, Oxygen saturation decreased, Rhinorrhoea, Skin test negative, Urticaria
Clinical narrative: Client was given the yellow fever vaccine in a clinical office setting. She left the building and 40 minutes later her mother called to report that this minor had difficulty breathing. Traveled to E. Tx - Pepcid and BENADRYL via IV Albuterol breathing Tx. D/C to home.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema
Clinical narrative: Noticed area of erythema to side of neck and spotty erythema to cheek after administration of vaccines.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: I gave the vaccine to the patient after the patient dropped off a prescription from the doctor's office. The patient was totally fine after and before I gave the vaccine. But when he was trying to get up the chair and leave the immunization room he felt so dizzy but he didn't faint. He was able to talk, breath normal. I offered him water and juice. I checked his blood pressure three times until reached 97/64. Then he left the store.
Age: 92.0
Sex: U
Vaccine: PPV
Symptoms: Erythema, Injection site pruritus, Peripheral swelling, Skin warm
Clinical narrative: Vaccine give 05-11-2017 at 1:51 pm. Patient started itching at first at site of injection after 2 hours, then arm started to swell, red, and warm. Patient when to hospital around 4-5 pm of the same day. 05-12-17 - patient went back to hospital. 05-13-17 patient went to pharmacy to fill Rx for antibiotics given for swelling or possible cellulitis.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient chief complaints were localized swelling at the injection site, redness, pain, and itching.
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Paraesthesia, Swelling, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 617342) on 18-APR-2017. This spontaneous report refers to a 11 year old female patient. The patient's medical history included asthma and allergies to peanut, shellfish and tree nuts. Information about the patient's concurrent illnesses and other medications were not reported. On 30-DEC-2015, the patient was vaccinated with (GARDASIL 9) lot # L016429 (Expiration date : 09-AUG-2017), dose 1 (unspecified dosage), intramuscularly in the right arm for prophylaxis. On the same day, the patient was also vaccinated with MENACTRA lot # U5180AA, dose 1 (unspecified dosage), intramuscularly in the left arm for prophylaxis and ADACEL lot # U5292AA, dose 1 (unspecified dosage), intramuscularly in the left arm for prophylaxis. On 31-DEC-2015, 12 hours post vaccination, the patient experienced vomiting and 48 hours post vaccination (approximately on 01-JAN-2016), she had tingling in her fingers, feet (paraesthesia) and experienced mild swelling. The symptoms resolved the following day. The outcome of the events was reported as recovered. The causality assessment for the events with respect to GARDASIL 9 was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 618879) on 18-APR-2017. This spontaneous report was received from a regulatory authority which refers to a 11 year old male patient. The patient's medical history included amoxicillin allergy. The patient's concurrent illness included left eye irritation/conjunctivitis. The patient's other medication included Erythromycin. Information on the patient's prior vaccinations was not reported. On 11-JAN-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm, lot # L007560, expiration date: 15-JUN-2017 for prophylaxis. On the same day, the patient was also vaccinated with MENACTRA (dose number: 1, intramuscularly in the left arm, lot# U5058AC, manufacturer: Sanofi Pasteur, lot expiration date was not reported) for prophylaxis. On 12-JAN-2016, the patient's left arm was red, warm and swollen. On 13-JAN-2016, the provider ordered the patient to take Benadryl and had planned to recheck again the next day. The outcome for the events erythema, skin warm and peripheral swelling was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Antinuclear antibody, Blood folate, Blood iron, Blood lactate dehydrogenase, Blood thyroid stimulating hormone
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA #619202) and refers to a female patient of unknown age. The patient's medical history included abdominal pain and sees a GI MD (Gastroenterologist). Current illness was reported as none. Other medication included cyproheptadine. On an unknown date the patient was vaccinated with GARDASIL 9, lot#L020015, dose 1, intramuscularly in the left arm for prophylaxis (strength and dosing detail unknown). On an unknown date the patient experienced dizziness and tingling in legs for 4 days after receiving vaccination and the progressive symptoms included muscle weakness, fatigue resolution paresthesias continues with increased tiredness, proximal muscle weakness and headaches. The patient was seen at the Emergency Room by specialist doctors. On unknown dates the patient was referred to Neurology; and under went different lab tests, which included Lyme; Celiac; ANA (Antinuclear antibody); B12; CBC (Complete Blood Count); Metabolic panel; Ferritin; Folate; LDH (Lactate dehydrogenase); RA (Rheumatoid factor Antibodies); Sedimentation Rate; T4; TSH (Thyroid Stimulating Hormone); Reticulocyte count; Iron; TIBC (Total iron binding capacity); CRP (C-reactive protein) and the result of the lab tests were not provided. The outcome of the events were reported as not recovered/not resolved. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Sex: F
Vaccine: HPV9
Symptoms: C-reactive protein, Dizziness, Fatigue, Full blood count, Headache
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA #619202) and refers to a female patient of unknown age. The patient's medical history included abdominal pain and sees a GI MD (Gastroenterologist). Current illness was reported as none. Other medication included cyproheptadine. On an unknown date the patient was vaccinated with GARDASIL 9, lot#L020015, dose 1, intramuscularly in the left arm for prophylaxis (strength and dosing detail unknown). On an unknown date the patient experienced dizziness and tingling in legs for 4 days after receiving vaccination and the progressive symptoms included muscle weakness, fatigue resolution paresthesias continues with increased tiredness, proximal muscle weakness and headaches. The patient was seen at the Emergency Room by specialist doctors. On unknown dates the patient was referred to Neurology; and under went different lab tests, which included Lyme; Celiac; ANA (Antinuclear antibody); B12; CBC (Complete Blood Count); Metabolic panel; Ferritin; Folate; LDH (Lactate dehydrogenase); RA (Rheumatoid factor Antibodies); Sedimentation Rate; T4; TSH (Thyroid Stimulating Hormone); Reticulocyte count; Iron; TIBC (Total iron binding capacity); CRP (C-reactive protein) and the result of the lab tests were not provided. The outcome of the events were reported as not recovered/not resolved. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Sex: F
Vaccine: HPV9
Symptoms: Iron binding capacity total, Metabolic function test, Muscular weakness, Paraesthesia, Red blood cell sedimentation rate
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA #619202) and refers to a female patient of unknown age. The patient's medical history included abdominal pain and sees a GI MD (Gastroenterologist). Current illness was reported as none. Other medication included cyproheptadine. On an unknown date the patient was vaccinated with GARDASIL 9, lot#L020015, dose 1, intramuscularly in the left arm for prophylaxis (strength and dosing detail unknown). On an unknown date the patient experienced dizziness and tingling in legs for 4 days after receiving vaccination and the progressive symptoms included muscle weakness, fatigue resolution paresthesias continues with increased tiredness, proximal muscle weakness and headaches. The patient was seen at the Emergency Room by specialist doctors. On unknown dates the patient was referred to Neurology; and under went different lab tests, which included Lyme; Celiac; ANA (Antinuclear antibody); B12; CBC (Complete Blood Count); Metabolic panel; Ferritin; Folate; LDH (Lactate dehydrogenase); RA (Rheumatoid factor Antibodies); Sedimentation Rate; T4; TSH (Thyroid Stimulating Hormone); Reticulocyte count; Iron; TIBC (Total iron binding capacity); CRP (C-reactive protein) and the result of the lab tests were not provided. The outcome of the events were reported as not recovered/not resolved. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Sex: F
Vaccine: HPV9
Symptoms: Reticulocyte count, Rheumatoid factor, Serum ferritin, Thyroxine, Vitamin B12
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA #619202) and refers to a female patient of unknown age. The patient's medical history included abdominal pain and sees a GI MD (Gastroenterologist). Current illness was reported as none. Other medication included cyproheptadine. On an unknown date the patient was vaccinated with GARDASIL 9, lot#L020015, dose 1, intramuscularly in the left arm for prophylaxis (strength and dosing detail unknown). On an unknown date the patient experienced dizziness and tingling in legs for 4 days after receiving vaccination and the progressive symptoms included muscle weakness, fatigue resolution paresthesias continues with increased tiredness, proximal muscle weakness and headaches. The patient was seen at the Emergency Room by specialist doctors. On unknown dates the patient was referred to Neurology; and under went different lab tests, which included Lyme; Celiac; ANA (Antinuclear antibody); B12; CBC (Complete Blood Count); Metabolic panel; Ferritin; Folate; LDH (Lactate dehydrogenase); RA (Rheumatoid factor Antibodies); Sedimentation Rate; T4; TSH (Thyroid Stimulating Hormone); Reticulocyte count; Iron; TIBC (Total iron binding capacity); CRP (C-reactive protein) and the result of the lab tests were not provided. The outcome of the events were reported as not recovered/not resolved. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Sex: M
Vaccine: HPV9
Symptoms: Back pain, Headache, Pyrexia, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 619384). This spontaneous report refers to a 11 year old male patient. The patient had no current illnesses and medical history. Information on patient's other medications was not reported. On 15-JAN-2016, the patient was vaccinated with GARDASIL 9 (lot #, route and site not reported) for prophylaxis. On 16-JAN-2016, the patient experienced vomiting, fever, sore back and headache. The outcome of the events was reported as unknown. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Nausea, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 619987) on 18-APR-2017. This spontaneous report refers to a 25 year old female patient. The patient's concurrent illness included ear infection. The patient's historical drug included Vicodin and historical condition included mold. The patient's other medications was reported as none. On 29-DEC-2015, the patient was vaccinated with GARDASIL 9 lot # L014415 (Expiration date: 25-JUL-2017), dose 2 (unspecified dosage), intramuscularly in the left arm for prophylaxis. On 30-DEC-2015, the patient experienced nausea and a week later (approximately in JAN-2016), had an episode of fainting. The patient required an emergency room visit and no lab tests were done at the facility. The outcome of the events was reported as recovered. The causality assessment for the events with respect to GARDASIL 9 was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Hypotension, Vision blurred
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS ID-619988). This spontaneous report refers to a 11 year old male patient. The patient's current conditions, historical conditions and other medications were not reported. On 04-JAN-2016 the patient was vaccinated with GARDASIL 9 lot # L007560 dose 2 (unspecified dosage), intramuscularly in the left arm for prophylaxis. Three minutes after vaccination, the patient had hypotension and vision blurred. Blood pressure was 62/40 (units unspecified) on left arm and 70/46 (units unspecified) on the right arm. Heart rate was 33 (units unspecified) and respiratory rate was 18 (units unspecified). No additional medication was given. 10 minutes later, the patient returned to normal (according to the patient). He was observed for more than 45 minutes. The outcome of hypotension and vision blurred was reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 14.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Fall, Gingival bleeding, Head injury, Swelling face
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA #620212) and refers to a 14 year old female patient. Patient gets pale when she receives vaccines, and has fainted at school when she was learning about blood. The patient had no current illness. On 20-JAN-2016, an unspecified medical assistant administered the patient with GARDASIL 9 lot # L016429 dose 2, intramuscularly in the right arm for prophylaxis and ADACEL, intramuscularly in the left arm for prophylaxis. The medical assistant stated that the patient tolerated well immediately after vaccine administration. Patient's mother was present and stated the same. As stated by medical assistant, she left the room door slightly open to be able to observe the patient, and mother was present with patient. Less than 4 minutes later they heard a loud scream, which was the patient's mother asking for help. medical assistant was the first to respond, since she was near the room, and per medical assistant she noted the patient was on the floor faced up, and called code blue. All medical and nursing staff responded to code blue. Front desk called 911. Patient was conscious, A&O x 4 (Awake and Oriented to person, place, time and situation), vitals WNL (within normal limits), and patient denied any pain. A bump on her forehead was noted and slight blood on her gums. Patient's mother stated she was looking at her phone, and from her peripheral vision she saw the patient falling down from exam table/bed. patient's mother stated the patient fell face forward, and she turned her over. patient's mother stated the patient gets nervous around blood and needles. Patient's mother was notified to always alert anyone giving her vaccines or drawing her blood of this. About 8 min later the paramedics arrived and assessed patient. Per patient's mother, she was given the option to have the ambulance take patient to hospital, or stay and take patient to the Emergency Room within the patient's insurance network. patient's mother stated she would stay and take the patient to Emergency Room herself. Paramedics left and patient was continuously assessed by a doctor and medical assistant for about 45 min. Vitals were WNL (within normal limits), pt was A&O x 4 (Awake and Oriented to person, place, time and situation), and still denied any pain 0/10. Patient was provided with water and cold compresses. At 4:06 prn doctor permitted patient to go. Discharge instructions provided to patient's mother, by Doctor and patient's mother verbalized understanding. On 20-JAN-2016, 1 day after onset of therapy the patient experienced fall, head injury and gingival bleeding. The outcome of fall, head injury and gingival bleeding was unknown. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Blister, Buccal mucosal roughening, Local swelling, Mass, Pruritus generalised
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 620234) on 18-APR-2017. This spontaneous report as received from a regulatory authority refers to a 17 year old male patient. The patient's concomitant therapies, concurrent illness and pertinent medical history were not reported. On 20-JAN-2015 the patient went to primary care provider and was informed by physician that he believed this to be a reaction to the vaccine administered and gave him prednisone to reduce itching and swelling. Physician recommended not to continue the HPV series. Mom stated that patient's face and neck were swollen, and that she could see "swelling underneath his chin". Mom also disclosed that patient had felt a "lump" under his collarbone after his first set of vaccines on 09-NOV-2015, but patient's physician believed that lump was not related to the immunizations. Mom stated that patient denies any shortness of breath, difficulty swallowing or speaking, tingling in the lips/mouth, or swelling of the tongue. The patient informs mother that he felt rough inside his mouth. On 11-JAN-2016 the patient was vaccinated with the second dose of GARDASIL 9 intramuscularly in the left arm, lot # L027282 (dose, frequency and lot expiration date were not reported) for prophylaxis. On 15-JAN-2016 at around 5 PM, the patient reported itching all over the body. When scratched, the patient's skin erupted in small blisters that did not ooze, but according to patient looked like they could erupt if he continued scratching. The patient refrained from scratching for that reason. The mother stated that the patient was given Benadryl since the itching started and that seemed to help his symptoms. The patient required an emergency room visit. The outcome of blister, buccal mucosal roughening, local swelling, mass, pruritus generalized, rash and swelling face was reported as  unknown. The causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Swelling face
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 620234) on 18-APR-2017. This spontaneous report as received from a regulatory authority refers to a 17 year old male patient. The patient's concomitant therapies, concurrent illness and pertinent medical history were not reported. On 20-JAN-2015 the patient went to primary care provider and was informed by physician that he believed this to be a reaction to the vaccine administered and gave him prednisone to reduce itching and swelling. Physician recommended not to continue the HPV series. Mom stated that patient's face and neck were swollen, and that she could see "swelling underneath his chin". Mom also disclosed that patient had felt a "lump" under his collarbone after his first set of vaccines on 09-NOV-2015, but patient's physician believed that lump was not related to the immunizations. Mom stated that patient denies any shortness of breath, difficulty swallowing or speaking, tingling in the lips/mouth, or swelling of the tongue. The patient informs mother that he felt rough inside his mouth. On 11-JAN-2016 the patient was vaccinated with the second dose of GARDASIL 9 intramuscularly in the left arm, lot # L027282 (dose, frequency and lot expiration date were not reported) for prophylaxis. On 15-JAN-2016 at around 5 PM, the patient reported itching all over the body. When scratched, the patient's skin erupted in small blisters that did not ooze, but according to patient looked like they could erupt if he continued scratching. The patient refrained from scratching for that reason. The mother stated that the patient was given Benadryl since the itching started and that seemed to help his symptoms. The patient required an emergency room visit. The outcome of blister, buccal mucosal roughening, local swelling, mass, pruritus generalized, rash and swelling face was reported as  unknown. The causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, TYP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 620237) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 30 year old female patient. The patient had no concurrent illnesses and medical history. The patient's other medications, concomitant therapies and prior vaccinations were not reported. On 18-DEC-2015 the patient was vaccinated with first dose of GARDASIL 9 lot # L016429, lot expiration date 09-AUG-2017 (dose and frequency were not reported) via intramuscular route, in the left arm for prophylaxis. Other suspect therapy which was given on the same day included first dose of TYPHIM VI (intramuscularly in the right arm, lot# K04891; dose, frequency and expiration date were not reported). The patient had typical pain on injection, swelling and redness after injection that lasted about 1 week after the shot but it improved. On 06-JAN-2016, the patient had pain in the muscle exactly at the injection site. When she holds her arm in a certain position she had extreme pain. This pain started about 2 weeks after initial shot. There was no redness, swelling, or weakness in the arm. The patient visited the emergency room. The outcome of injection site erythema, injection site swelling and injection site pain was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Erythema, Injection site urticaria, Urticaria
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 620454). This spontaneous report refers to a 25 year old female patient. The patient's concurrent illnesses included common cold and medical history was reported as none. On 20-JAN-2016, the patient was vaccinated with GARDASIL 9 in the right arm (route, dose and lot# were not reported) for prophylaxis. On the day of vaccination, at first the patient had hives and they were raised and red. Slowly, they expanded in size and flattened, then faded away, mostly on the shot on arm of the patient. Patient was not taking chances on the second or third dose. Patient was dizzy for a little bit too, though this could just be overreaction. The outcome of dizziness, urticaria and erythema were reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.