chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers a 73 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions and concomitant medication were not reported. It was stated that the pharmacy received the ZOSTAVAX on 15-JUL-2016. On 26-SEP-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX 19400 plaque-forming unit (PFU) injection, subcutaneously, 0.65 ml, lot # M014310, expiry date 26-MAY-2017 (anatomical location was not specified) for prophylaxis. On 22-MAR-2017, the pharmacy was audited by The Board of Pharmacy. The freezer temperature where ZOSTAVAX was stored was registered by the pharmacy thermometer as 2 Fahrenheit degrees, however the auditor's thermometer registered the temperature as 9 Fahrenheit degrees which was considered as a temperature excursion. The Board of Pharmacy auditor determined that the pharmacy's freezer thermometer should have been calibrated. Seven of the 10 doses of ZOSTAVAX that had undergone the temperature excursion had been administered to 7 patients between July 2016 and January 2017 (also reported as "over an 11 months period"). The remaining 3 doses were sent back for disposal. There was no previous temperature excursion. No adverse effect were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all follow up information has been received.; Sender's Comments: US-009507513-1705USA006382: US-009507513-1705USA006383: US-009507513-1705USA006384: US-009507513-1705USA006385: US-009507513-1703USA010654: US-009507513-1705USA006381:
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Arthritis, Disability, Joint swelling, Loss of personal independence in daily activities
Clinical narrative: This spontaneous report was received from a 59-year-old female patient who reported on herself, via a company representative. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date, approximately in March 2017, (reported as about 2 months ago), the patient was vaccinated with ZOSTAVAX (dose, route of administration, anatomical location, lot# and expiration date were not reported) for prevention of shingles. On an unknown date in 2017, reported as shortly after receiving ZOSTAVAX, the patient experienced leg pain, joint swelling and was diagnosed with inflammatory arthritis. On an unknown date in 2017 (reported as "during the diagnosis work up"), the patent had rheumatoid factor test performed with negative result. It was reported that the patient experienced significant disability in that she was unable to exercise due to pain in her joints. An unspecified treatment was provided for the adverse event. No product quality complaint (PQC) was involved. The outcome of the adverse event was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected as the patient did not give consent to contact her physician.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Rheumatoid factor negative
Clinical narrative: This spontaneous report was received from a 59-year-old female patient who reported on herself, via a company representative. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date, approximately in March 2017, (reported as about 2 months ago), the patient was vaccinated with ZOSTAVAX (dose, route of administration, anatomical location, lot# and expiration date were not reported) for prevention of shingles. On an unknown date in 2017, reported as shortly after receiving ZOSTAVAX, the patient experienced leg pain, joint swelling and was diagnosed with inflammatory arthritis. On an unknown date in 2017 (reported as "during the diagnosis work up"), the patent had rheumatoid factor test performed with negative result. It was reported that the patient experienced significant disability in that she was unable to exercise due to pain in her joints. An unspecified treatment was provided for the adverse event. No product quality complaint (PQC) was involved. The outcome of the adverse event was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected as the patient did not give consent to contact her physician.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacy administrator via a company representative and refers to a 68-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. In approximately 2014 (reported as "about 3 years ago (unspecified date)"), the patient received ZOSTAVAX injection (dose, frequency, route of administration, lot # and expiration date were not reported) for prevention of shingles. Since receiving the ZOSTAVAX injection (approximately in 2014), the patient had recurrent episodes of shingles in his mouth. The patient sought medical attention. The patient was treated with lidocaine, and also received an unspecified "mouth wash" from the pharmacy. The outcome of the event and the causality assessment were not provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 15-MAY-2017, the patient was vaccinated with an expired dose of PNEUMOVAX23 lot # L029073, with expiration date 19-APR-2017, for prophylaxis (administration route was not reported). No adverse effects were reported. A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 14-MAY-2017, the patient was vaccinated with an expired dose of RECOMBIVAX HB lot # K026531, expiration date 15-APR-2017, for prophylaxis (route of administration was not reported). No adverse effects were reported. A product quality complaint was not involved. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Diet refusal, Feeling abnormal, Lethargy, Pyrexia
Clinical narrative: Refused food and water for 6 hours, lethargy, spacing out, fever for 24 hours.
Age: 1.08
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMRV, PNC13
Symptoms: Body temperature increased, Rash
Clinical narrative: Rash on clients chest and underarms and temp up to 100.6  Tylenol given 2 times and temp back to normal.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site induration, Injection site nodule, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Red itchy rash approximately 3 inches in diameter in a circle surrounding the raised, painful, hard knot site of the injection.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Rash erythematous, Rash pruritic, Vaccination complication
Clinical narrative: Red itchy rash approximately 3 inches in diameter in a circle surrounding the raised, painful, hard knot site of the injection.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Menstruation irregular
Clinical narrative: Irregular menstrual cycle, ranging from 28-95 days long.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Vaccine had expired the day before administration.
Age: 1.17
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Erythema, swelling, and induration at the site of injection.
Age: 1.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse, concerning a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patient was inadvertently vaccinated with ZOSTAVAX 19400 plaque-forming unit (PFU) with lot # M030139 and expiration date on 18-AUG-2017 (dose and anatomical location were not provided) in combination with the sterile diluent (manufacturer unknown) with lot # L001533 and expiration date on 24-OCT-2017 (strength and dose were not reported), for prophylaxis; instead of the intended dose of M-M-R II. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report has been received from a Licensed Practical Nurse 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 3 doses of GARDASIL after the age of 28 years. No adverse symptoms were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 13-APR-2017 the patient was intramuscularly vaccinated with expired dose of PNEUMOVAX23 (dose was not reported, lot # L029113 with expiration date: 27-MAR-2017). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered 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 VARIVAX lot # M042858, expiration date 21-OCT-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 15 to 46 degrees Fahrenheit (F) (35 (F)) for 10 hours. Digital data logger was not involved. There were no previous excursions reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On 03-MAY-2016, the patient was intramuscularly vaccinated with the first dose of PNEUMOVAX23 (dose was not reported) in pneumococcal prevention process. The second dose PNEUMOVAX23 was administered on 08-MAY-2017 (dose was unknown, lot# reported as N001007 expiration date: 19-SEP-2018). Concomitant medications were not reported. No adverse effects reported (also reported as "patient was fine"). 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 nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient might have received an improperly stored dose of PNEUMOVAX 23 (exact dose, route of administration, lot # and expiration date were not reported). The administered dose underwent a temperature excursion of -1 degrees Celsius for 24 hours. There were no previous excursion reported and a digital data logger was not involved. No adverse effect was reported. No product quality complaint was involved. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site mass, Injection site warmth
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. This spontaneous report refers to a 13 year old male patient. The patient had no pertinent medical history. No concomitant medications were reported. On 11-MAR-2016, the patient was vaccinated with the third dose of hpv GARDASIL 9, intramuscularly in the left arm, lot # reported as L036301 (expiry date was not reported) for prophylaxis. On 11-MAR-2016, the patient got lump under the skin which was warm to touch at injection site of left deltoid since administration date. The patient sought medical attention via emergency room visit. The outcome of the events was not recovered (also reported as per patient's mother lump seemed to be getting bigger). The relatedness between the events and GARDASIL 9 was not provided by the Agency.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified patient of unknown demographics. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 15-MAY-2017, the patient was vaccinated with an expired dose of GARDASIL injection (lot# K016966 with expiration date on 10-MAY-2017; dose, route of administration and anatomical location were not reported). No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Blood cholesterol abnormal, Nausea, Sleep disorder
Clinical narrative: The initial case (from a contactable consumer) was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 15Jun2015, this case now contains all required information to be considered valid. This is a spontaneous report from a non-clinical-study program from a contactable physician. A 51-year-old female patient received treatment with LYRICA 150 mg capsule oral from unspecified date to 01Jun2015 at 150mg twice daily, LIPITOR from unspecified date, VISTARIL 25mg capsule oral from 29May2015 at 25mg three times a day as needed for sleep, EFFEXOR XR 150 mg once daily, NEURONTIN 400 mg three times per day, and Prevnar. In the past the patient had an allergic reaction with LIPITOR and morphine. Additional medical history included headache and taking medication for sleep, rash, and cholesterol. Concomitant drugs included NEXIUM capsule delayed release oral 40 mg once daily as directed, BRINTELLIX tablet oral 10 mg once daily, atenolol 50 mg tablet oral at 50 mg once daily then at 1.5 tablet once a day, cyclobenzaprine tablet oral 10 mg twice a day as needed, MAXALT oral 5 mg tablet as needed (take one pill at onset of headache, repeat in 1 hour if needed), promethazine 12.5 mg tablet at 0.5 tablet oral three times a day as needed, simvastatin 40 mg tablet oral at 1 tablet every night for cholesterol, SYNTHROID oral 50 mcg once a day, VITAMIN B-12 250 mcg tablet, ZOFRAN oral 4 mg every eight hours as needed for nausea, CELEXA tablet oral 40 mg once a day discontinued on 29May2015, and FLEXERIL, atenolol, NYSTOP, BACTRIM, magnesium, promethazine, risperidone, simvastatin for cholesterol, trazodone, fluocinonide, cyclobenzaprine, MOBIC, NEXIUM, and Vitamin B-12. Drug allergies include Lipitor and morphine. On an unspecified date, while on pregabalin, hydroxyzine pamoate and atorvastatin sodium, the patient experienced nausea, sleep disorder and cholesterol level abnormal. Action taken with pregabalin, hydroxyzine pamoate and atorvastatin sodium was unknown. Outcome of the events was unknown. Follow-up (12AUG2015): Follow-up attempts completed. No further information expected. Follow-up (23Feb2016): New information reported from a Pfizer-sponsored program by a contactable physician includes: concomitant drugs data and new concomitant drug Flexeril. Follow-up attempts completed. No further information expected. Follow-up (12May2017): New information was received from a contactable physician reporting: additional concomitant therapy, medical history, and additional suspect medication of Lyrica, Lipitor, Prevnar, Vistaril, Neurontin, Effexor XR. Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Cough, Dyspnoea, Hypersensitivity, Malaise
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (the patient) reported that she was a 73-year-old female patient of an unspecified ethnicity that received PREVNAR 13, via an unspecified route of administration on Jan2017 at single dose for immunisation. The vaccine was administered by her primary care physician (PCP). Medical history included she a tumor in her lung removed in 2006. The patient's concomitant medications were not reported. On an unspecified date one week later vaccination, she experienced coughing, shortness of breath, allergy symptoms but much worse, very sick feeling and weakness. She visited PCP who gave her an inhalation therapy and was given several nebulizer treatments. Symptoms continued and went back to the lung specialist. The outcome for all the events was not recovered. No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Rash erythematous
Clinical narrative: Red rash on upper arm near injection site. Not itchy, not spreading as of 5-15-17. Pt advised to watch rash and seek medical attention if worsens or spreads.
Age: 1.58
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Incorrect route of drug administration, Injection site pain, Injection site swelling, Measles post vaccine, Pain
Clinical narrative: Patient started getting a nasty cold on 4/24/17.  Fever of 101 degrees started on 4/29/17.  Rash covering entire body, including eyeballs appeared on 5/1/17. Fever on and off over next 7 days. Rash started going away 8 days later.  Painful sores on buttocks, back, one arm and one leg are still present today on 5/17/17. Doctor confirmed on May 4th that he has the measles from the vaccine.  We were instructed to observe.  No medication was administered. We saw Dr on May 9th, rash was starting to go away.  She instructed we give another MMR vaccine.  I declined.  No medication was given and no follow up appointment was suggested.
Age: 1.58
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash generalised, Skin ulcer, Viral upper respiratory tract infection
Clinical narrative: Patient started getting a nasty cold on 4/24/17.  Fever of 101 degrees started on 4/29/17.  Rash covering entire body, including eyeballs appeared on 5/1/17. Fever on and off over next 7 days. Rash started going away 8 days later.  Painful sores on buttocks, back, one arm and one leg are still present today on 5/17/17. Doctor confirmed on May 4th that he has the measles from the vaccine.  We were instructed to observe.  No medication was administered. We saw Dr on May 9th, rash was starting to go away.  She instructed we give another MMR vaccine.  I declined.  No medication was given and no follow up appointment was suggested.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Abdominal X-ray, Intussusception, Ultrasound abdomen abnormal, X-ray abnormal
Clinical narrative: Intussusception.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Pain in extremity, Palmar erythema, Peripheral swelling, Pruritus
Clinical narrative: On the morning of May 9th 2017 I received the GARDASIL 9 vaccine for the first time. (Just to note, I had not done anything out of the ordinary from my daily routine). Later on that evening the palms of my hands became extremely red, itchy, and painful. Also my fingers had became a little bit swollen. My hands stayed like this throughout the following day as well. So in the evening of May 10th I took an antihistamine which seemed to help my symptoms get better.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: Negative reaction to a shingles vaccination.
Sex: U
Vaccine: HEPA, HIBV, HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received on 27-APR-2017 from a nurse and refers to unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. The nurse reported that several doses of improperly stored vaccines were administered to unspecified patients on unspecified dates. No adverse effects were reported. The vaccines were VAQTA (Lot number M039202, expiration date 11-MAR-2018), PEDVAXHIB (Lot number M036056, expiration date 18-MAY-2019), and GARDASIL 9 (Lot number M037770, expiration date 01-JUN-2019). The vaccines dose, site of administration and route of administration were not reported. These three vaccines were exposed to the following temperature of 32 degrees Fahrenheit (F) to 35 degrees Fahrenheit (lowest temperature was 35 degrees Fahrenheit) for a time frame of 72 hours. The call was not due to a data logger. There were no previous temperature excursions. No additional information available at the time of the report. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: Information had been received on 02-MAY-2017 from a pharmacist who reported that a patient (age and gender not reported) received ZOSTAVAX (date of vaccination, dose and lot#/expiration not reported) subcutaneous with sterile diluent "in the back of the arm, not the preferred area for injection". Pharmacist was not able to provide the lot#/expiration date for the properly stored sterile diluent used to reconstitute the vaccine. No adverse events reported. Pharmacist disconnected the call prior to most fields being asked therefore most fields are not applicable. No further information to report. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Impaired driving ability, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: Patient was told by vaccine administrator that his arm might be sore the following day. However extreme soreness started late afternoon and worse at night with chills. Soreness mostly in back of arm and lasted thru Friday. The arm soreness was so bad the day of the shot he could hardly turn the steering wheel on our rider mower.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Headache
Clinical narrative: Headache.
Age: 49.0
Sex: M
Vaccine: ANTH
Symptoms: Back pain, Lumbar radiculopathy, Multiple sclerosis, Polycythaemia, Thrombocytopenia
Clinical narrative: Questions onset of multiple sclerosis with receipt of 6 Anthrax vaccines, Hepatitis B and other vaccines prior to overseas travel. Questions genetics of MS with vaccines. Discussion with patient and review of medical records was limited to available electronic medical records (12/2005-2016) lists multiple health issues to include thrombocytopenia and erythrocytosis, lumbar radiculopathy, lumbago, Multiple Sclerosis (2005-6), BPM and more. I have no access to medical records prior to Dec 2005, specifically time periods prior to and after receipt of AVA and other vaccines in 1999-2000.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Patient developed redness and swelling around the injections site for 1 week. It was the size of a quarter then when away. About 1 week after that the area of redness returned. It had a red center and was hard to the touch in the middle. It was about the size of a quarter and was very red and itchy. This resolved in about 1 week.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Tic
Clinical narrative: Facial tick.
Age: 1.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Speech disorder developmental
Clinical narrative: Expressive speech delay.
Age: 69.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Pain
Clinical narrative: PT STATES SHE STILL HAS LINGERING SORENESS IN DELTOID AREA OF ARM SINCE VACCINATION. SHE REPORTS NO REDNESS OR SWELLING ASSOCIATED WITH THE PAIN. REFERRED TO PRIMARY CARE PHYSICIAN FOR FURTHER EVALUATION.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Injection site discharge, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Very  painful/swollen around injection site, clear drainage from site, and extreme itchiness.
Age: 76.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Erythema, Hypersensitivity, Pruritus, Skin swelling, Skin warm
Clinical narrative: Patient's arm became real red and warm. She didn't experience any itching until the evening of 5/16/17. The skin appears to be red and swollen and has spread over the last few days. It appears that she has had a minor allergic reaction becasue she has no other systemic symptoms.
Age: 76.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Erythema, Hypersensitivity, Peripheral swelling, Pruritus
Clinical narrative: Patient's arm became real red and warm. She didn't experience any itching until the evening of 5/16/17. The skin appears to be red and swollen and has spread over the last few days. It appears that she has had a minor allergic reaction becasue she has no other systemic symptoms.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Oedema, Pain, Skin reaction
Clinical narrative: Localized skin reaction - edema, erythema, pain developed one day following vaccination. Treatment: BENADRYL and TYLENOL as needed.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Redness, pain, warm to touch. Patient seen by PCP was told cold compression and Ibuprofen.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: Left upper arm with redness 1" x 2 1/4" area. Will do ZYRTEC BID and cool compresses.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Swelling
Clinical narrative: Redness of the skin and swelling.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Amnesia, Anxiety, Depression, Personality change
Clinical narrative: Anxiety, depression, memory loss, personality change.
Age: 1.5
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: None.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Swelling in right arm, redness and itchiness. Came in less then 24 hrs after vaccine administered.
Age: 1.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC13, VARCEL
Symptoms: Anaphylactic reaction, Swelling face, Urticaria
Clinical narrative: Patient had anaphylactic reaction to vaccines administered. 25 minutes after administration of 5 vaccines. MMR and Varicella were given. He had swelling of face, hives on face and neck, stomach.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report was received from a 58 year old female patient via social media regarding herself. No medical history and concurrent conditions were reported. On an unknown date (also reported as few years ago), the patient was vaccinated with varicella virus vaccine live (Oka/Merck)(Manufacturer unknown) (lot number and expiry date unknown)  for prophylaxis. No concomitant medications were reported. On an unknown date the patient developed chickenpox from someone with shingles who did not know she was contagious. This inspite of having chicken pox vaccine a few years ago. The outcome of chickenpox was unknown. The relatedness of the event with varicella virus vaccine live (Oka/Merck)(Manufacturer unknown) was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dysmenorrhoea, Gastroenteritis viral, Impaired gastric emptying, Vomiting
Clinical narrative: Information has been received from a consumer referring to her daughter of unknown age. Information about concurrent conditions, medical history and concomitant medication was not provided. On an unknown date, when the patient was 11 years old, the patient was vaccinated with serious of GARDASIL (lot#, dose, dose# and route unknown) for prophylaxis. It was reported that the vaccine paralyzed her stomach causing her to vomit after every bite of solid food. She lived with a stomach virus "24/7/365" and would for the rest of her life. The patient was now 17 years old and suffered in everyday with her menstrual cycle being a nightmare and excruciating. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information is not expected since there was no contact details provided. Sender's Comments: US-009507513-1605USA001123.
Age: 1.33
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Pyrexia, Rash
Clinical narrative: Rash and fever.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Blindness, Fall, Injected limb mobility decreased
Clinical narrative: 2 hours after receiving vaccines, patient fell to her knees while at work and everything went black but was still able to hear people talking. Difficulty elevating left arm. The darkness only lasted about 1 minute. Pt. was rushing that day to get to work. Sent to ER for further evaluation.
Age: 11.0
Sex: M
Vaccine: HPV9, MEN
Symptoms: Pruritus, Rash generalised
Clinical narrative: itchiness and rash all over body except face.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Fatigue, Headache, Injection site cellulitis, Mobility decreased
Clinical narrative: Cellulitis at injection site. Severe muscular pain. Unable to move arm. Throbbing headache/chills/fatigue.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Myalgia
Clinical narrative: Cellulitis at injection site. Severe muscular pain. Unable to move arm. Throbbing headache/chills/fatigue.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Swelling face, Urticaria, Viral test negative
Clinical narrative: Pt. got rash welts, swollen face.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Skin discolouration, Viral test negative
Clinical narrative: Pt. got rash welts, swollen face.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling of the entire anterior right thigh area around the site of the KINRIX IM injection that was administered on 05/15/2017.
Age: 1.08
Sex: M
Vaccine: HIBV, MMRV, PNC13
Symptoms: Diarrhoea, Discomfort, Erythema, Irritability, Lymphadenopathy
Clinical narrative: Fussiness, mother noticed swelling at the inguinal area 2 days back , first on one side and then became bilateral the next day. He has been afebrile. Also reported to have a loose stool. Appears uncomfortable; Marked enlargement of inguinal , cervical and submandibular LN Skin shows red macules - consistent with rose spot lesion , blanchable.
Age: 1.08
Sex: M
Vaccine: HIBV, MMRV, PNC13
Symptoms: Macule, Skin lesion, Swelling
Clinical narrative: Fussiness, mother noticed swelling at the inguinal area 2 days back , first on one side and then became bilateral the next day. He has been afebrile. Also reported to have a loose stool. Appears uncomfortable; Marked enlargement of inguinal , cervical and submandibular LN Skin shows red macules - consistent with rose spot lesion , blanchable.
Age: 21.0
Sex: F
Vaccine: TYP
Symptoms: Chills, Decreased appetite, Diarrhoea, Oropharyngeal pain, Pyrexia
Clinical narrative: Diarrhea (up to 7 loose/watery non-bloody BMs without mucus)x ~ 1 week, as of 5/17 improving. Loss of appetite ongoing since onset. Fever (up to ~103) & chills and head congestion started on 5/14/2017 and then sore throat.
Age: 21.0
Sex: F
Vaccine: TYP
Symptoms: Sinus congestion
Clinical narrative: Diarrhea (up to 7 loose/watery non-bloody BMs without mucus)x ~ 1 week, as of 5/17 improving. Loss of appetite ongoing since onset. Fever (up to ~103) & chills and head congestion started on 5/14/2017 and then sore throat.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Rash erythematous
Clinical narrative: Red rash on arm, not itching or spreading.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Seizure
Clinical narrative: Seizure.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling
Clinical narrative: Swelling at injection site.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient's left arm is extremely swollen between the area of his left shoulder to left elbow, it is also distinctly red.
Age: 4.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Red, bumpy, swollen around injection site.
Age: 73.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Asthenia, CSF protein increased, Fatigue, Hypoaesthesia, Paraesthesia
Clinical narrative: Started feeling, weakness, numbness and tingling in my feet, 2 days before I walked 5.5 miles, that after one mile I started feeling tired.
Age: 73.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Bladder catheterisation, Dysphagia, Guillain-Barre syndrome, Hypoaesthesia, Muscular weakness
Clinical narrative: Started feeling, weakness, numbness and tingling in my feet, 2 days before I walked 5.5 miles, that after one mile I started feeling tired.
Age: 73.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Paraesthesia, Urosepsis
Clinical narrative: Started feeling, weakness, numbness and tingling in my feet, 2 days before I walked 5.5 miles, that after one mile I started feeling tired.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Pruritus
Clinical narrative: 8cm erythema, edema and tenderness over Left mid-deltoid.  + Pruritic.  No anaphylaxis, no angioedema, no wheezing.
Age: 18.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 7:00 am on 5-17-17 injection site red, swollen, painful, measured site at 50 mm x 40 mm.
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash papular
Clinical narrative: Received vaccine on 5/2/17. Began breakout on 5/9/17 of papular rash.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash, Rash erythematous, Sinusitis
Clinical narrative: 5/16/17: 03:22 pm; phone call - Pt. called states that child has had fever since Friday 5/12/17. It has been as high as 104 a couple of times and 103-99 the rest of the time. It will go down with TYLENOL/MOTRIN, but then comes back up. She is wondering if this could be from his vaccines he got on 5/3/17. These symptoms are occurring on days 9-12 post vaccination. She took him to urgent care yesterday and he had a slight rash (little red dots) on his stomach and some behind his knees. He has a diagnosis of eczema, but he has never had it on his stomach. He was diagnosed with a sinus infection at Urgent Care on 5/15/17 and was given an antibiotic. He has had 2 doses so far and his rash (pink spots/pimples) is worse today. Mom states he has about 40-50 spots on his stomach, back, neck and a couple on his face. His fever today has only been 99. Nurse spoke with mom and recommended she take him back to urgent care to have the rash evaluated to make sure it is not a reaction to the new antibiotic.
Age: 4.0
Sex: U
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Right thigh redness and swelling, and tenderness upon palpation.
Age: 40.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Computerised tomogram, Dizziness, Face injury, Nausea, Pain in extremity
Clinical narrative: 11/1/17 at 12:15pm dizzy and nauseous 12:20pm Arm where shot was given very painful 12:30pm Got up to go to restroom-fainted-landed on tile floor. Broke left cheek in 3 pieces which now have titanium plates. 245pm was taken to ER via ambulance 11/8/17 Had surgery to put the plates in my face Still recovering.
Age: 40.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Surgery, Syncope
Clinical narrative: 11/1/17 at 12:15pm dizzy and nauseous 12:20pm Arm where shot was given very painful 12:30pm Got up to go to restroom-fainted-landed on tile floor. Broke left cheek in 3 pieces which now have titanium plates. 245pm was taken to ER via ambulance 11/8/17 Had surgery to put the plates in my face Still recovering.
Age: 40.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Dizziness, Facial bones fracture, Fall, Internal fixation of fracture, Nausea
Clinical narrative: 11/1/17 at 12:15pm dizzy and nauseous 12:20pm Arm where shot was given very painful 12:30pm Got up to go to restroom-fainted-landed on tile floor. Broke left cheek in 3 pieces which now have titanium plates. 245pm was taken to ER via ambulance 11/8/17 Had surgery to put the plates in my face Still recovering.
Age: 40.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Pain in extremity, Syncope
Clinical narrative: 11/1/17 at 12:15pm dizzy and nauseous 12:20pm Arm where shot was given very painful 12:30pm Got up to go to restroom-fainted-landed on tile floor. Broke left cheek in 3 pieces which now have titanium plates. 245pm was taken to ER via ambulance 11/8/17 Had surgery to put the plates in my face Still recovering.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Peripheral swelling
Clinical narrative: Patient states she woke up w/a swollen arm and shoulder down to wrist.
Age: 42.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: And injection site pain, swelling.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: The vaccine was administered on 5/15/17. On 5/16/17 a small reaction developed. By 5/17/17, a red welt developed on the site of administration. The welt was approximately 6" x 2". Referred patient to PCP.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Dizziness, Feeling abnormal, Injection site rash, Injection site swelling, Myalgia
Clinical narrative: Slight rash and swelling at ZOSTA site. Some swelling at BOOSTRIX site, muscle pain (legs especially). Runny nose, felt faint and "funny in the head" (as described like she was having an "sick") felt sleepy. Symptoms would come and go (leave for a few hours and returning - lasted two weeks.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Rhinorrhoea, Somnolence
Clinical narrative: Slight rash and swelling at ZOSTA site. Some swelling at BOOSTRIX site, muscle pain (legs especially). Runny nose, felt faint and "funny in the head" (as described like she was having an "sick") felt sleepy. Symptoms would come and go (leave for a few hours and returning - lasted two weeks.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, HPV9
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: HPV9 was administered to patient outside the recommended age. Patient is only 6 months old. Vaccine was given by mistake.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Lymphocyte percentage increased, Neutrophil percentage decreased, Pyrexia, White blood cell count decreased
Clinical narrative: Vaccines given on 3/31/17. Fever began the following day and lasted 4 days. Tmax = 105 degrees. No other symptoms.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site reaction, Injection site warmth, Urticaria
Clinical narrative: Pt had a quarter size welt on his left thigh. Mom said noticed it 5-16-17 when he woke up. The area is warm to the touch.
Age: 50.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Nausea
Clinical narrative: Headache and nausea continuous since administration of PREVNAR 13.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient came in and her left arm was red, warm to touch from injection site down to her elbow. Marked her redness and swelling with a pen told her to watch if goes outside the area, call Dr. Take antihistamine ranitidine 150 mg x 3 days. Call pharmacy and that I will follow up.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: Pt. came in with 50 cent size red, raised welt on Lt. thigh, this was where the PROQUAD was given.
Age: 11.0
Sex: M
Vaccine: DTAP, MNQ
Symptoms: Wrong drug administered
Clinical narrative: Patient was given DTaP vaccination instead of TDaP vaccination.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Hypersensitivity, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: The morning after receiving the 23-valent pneumococcal vaccine, pt called PCP C/O pain, redness, and swelling in area of injection. He also noticed fever of 102 degrees. On arrival at PCP office, redness has spread down to arm with severe pain in shoulder proximal arm area with movement. Differential diagnosis included allergic reaction vs infectious cellulitis vs hematoma of muscular tissues. PCP prescribed loratadine and cotrimoxazole and instructed pt. to apply ice packs and keep arm at heart level. On follow up 4/28/17, pt. reported swelling had moved to bicep and elbow, pt. instructed to continue taking medications and call if not improved in 3 days- no further contact from pt.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Muscle haemorrhage, Pain, Pyrexia
Clinical narrative: The morning after receiving the 23-valent pneumococcal vaccine, pt called PCP C/O pain, redness, and swelling in area of injection. He also noticed fever of 102 degrees. On arrival at PCP office, redness has spread down to arm with severe pain in shoulder proximal arm area with movement. Differential diagnosis included allergic reaction vs infectious cellulitis vs hematoma of muscular tissues. PCP prescribed loratadine and cotrimoxazole and instructed pt. to apply ice packs and keep arm at heart level. On follow up 4/28/17, pt. reported swelling had moved to bicep and elbow, pt. instructed to continue taking medications and call if not improved in 3 days- no further contact from pt.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Nausea, Pyrexia
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 #617688) and refers to a 12 year old female patient. Patient's current illnesses, medical history, lab data and other medications were reported as none. On 28-DEC-2015 the patient was vaccinated with GARDASIL 9, lot # L025737, dose 2, intramuscular in the left arm for prophylaxis (strength and dosing detail unknown). On 29-DEC-2015, approximately 10 hours post vaccination the patient had body temperature approximately 102 (unit unknown) and felt nauseated with headache. The outcome of headache, pyrexia and nausea was reported as recovered/resolved. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Age: 19.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Gait disturbance, Muscle spasms, Nausea, Pyrexia
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 # 618168) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 19 year old male patient. The patient's medical history included irritable bowel syndrome (IBS) and autistic spectrum. Information on the patient's concurrent illnesses were reported as none. Patient's other medication included Citalopram 30 mg per day. Information on patient's prior vaccination and lab data were not reported. On 07-JAN-2016, the patient was vaccinated with the second dose of GARDASIL 9 by using needles and syringe (route not specified further) for prophylaxis (dosage, anatomical location, lot number and expiry date unspecified). On 08-JAN-2016, the patient had dizziness, fever, nausea, severe leg cramps. Patient still had trouble in walking. The outcome of dizziness, fever, nausea, muscle spasms and gait disturbance was reported as not recovered. The patient required emergency room visit. Causality assessment was not provided      Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Abdominal discomfort, Pain, 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 # 618390) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 15 year old male patient. Information on the patient's other medications and prior vaccinations were not reported. Information on patient's medical history, current illness and lab data were reported as none. On 16-NOV-2015, the patient was vaccinated with the first dose of GARDASIL 9 lot # L001312, via intramuscular route, in the right arm for prophylaxis (dosage and expiry date unspecified). Patient's mother stated that patient broke out in hives and had bad gastro intestinal upset and body aches started, the night after receiving the vaccination on 16-NOV-2015.. Patient took Benadryl and have improved. The outcome of abdominal discomfort, urticaria and pain was reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Headache, Nausea, Pyrexia
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 # 618932) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 13 year old male patient. Patient had no current illness and medical history. Information on the patient's lab data was reported as none. Information on patient's prior vaccination was not reported. Patient's other medication included MVI. On 13-JAN-2016, the patient was vaccinated with the second dose of GARDASIL 9 lot # L017407, via intramuscular route, in the right arm for prophylaxis (dosage and expiry date unspecified). On 14-JAN-2016, Patient's mother called the clinic and informed that the patient woke up with fever (100.1), nausea and a horrible headache. Patient took the first dose of GARDASIL 9 on 08-NOV-2015. Patient's mother also informed that patient complained of headache on the day after the injection. The outcome of headache, pyrexia and nausea was unknown. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Headache, Malaise, Pain, Pyrexia
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 # 620264) on 18-APR-2017. This spontaneous report was received from a regulatory authority concerning a 13 year old male patient. Information on current illnesses, pertinent medical history, concomitant medications, lab data and prior vaccinations were not reported. On 02-NOV-2015, the patient was vaccinated with GARDASIL 9 injection, dose number 2 (dose, lot number and expiration date unknown) via intramuscular route in the left arm for prophylaxis. On 03-NOV-2015, the patient had fever with body temperature of 100.8 with headache, body aches and malaise. Fever spiked to 102.8 by 02:00pm. He was given ibuprofen and fluids. On 04-NOV-2015 at 7:00 am, the patient's fever was 99.5 but he still felt unwell. On the same day at 7:00 pm, he had no fever and by 05-NOV-2015 at 7:00 am, he felt fine. The outcome of the events were reported as recovered/resolved. The Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.