chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from an officer manager via a company representative refers an 18 year old male patient. There was no information about the patient's concurrent conditions, medical history, any known allergies or reactions or concomitant medications. On an unknown date, the patient was vaccinated with the third dose of GARDASIL 9 only 6 weeks after they received the 2nd dose (unspecified date) (drug use for unapproved schedule), intramuscularly, for prophylaxis (dose, lot number and expiration date were not reported). No adverse event was reported and there was not PQC reported. Additional information is not expected because there was no consent to contact physician.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a currently 17-year-old 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 VARIVAX lot # M037642 with an expiration date 01-SEP-2018 for prophylaxis (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of VARIVAX experienced the temperature excursion of 19 degrees Fahrenheit for 102 hours. There was previous temperature excursion of 9 degrees Fahrenheit for 15 minutes. A digital data logger was not involved.  This is one of several reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1704USA005658:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant and refers to a currently 16 years-old 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 VARIVAX lot # M037642 with an expiration date 01-SEP-2018 for prophylaxis (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of VARIVAX experienced the temperature excursion of 19 degrees Fahrenheit for 102 hours. There was previous temperature excursion of 9 degrees Fahrenheit for 15 minutes. A digital data logger was not involved.  This is one of several reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1704USA003591:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse (also reported as a medical assistant) 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 might have been vaccinated with improperly stored doses of PNEUMOVAX23 (dose, lot#, expiration date and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of  34.2 degrees Fahrenheit for 1 hour. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. Additional information is not expected, because there was no consent to contact the reporter.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect product storage, Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a licensed nurse practicioner concerning a 61 year old male patient. The patient's concurrent conditions and medical history, as well as concomitant medications were not reported. The reporter state that the ZOSTAVAX (Lot#: M041669) was received on 08-MAR-2017, and was stored in the refrigerator instead of the freezer and the vaccine was inactive. On 20-MAR-2017 at 10:38 am,  the patient was vaccinated with a improperly stored dose ZOSTAVAX lot # M041669, intramuscularly in the left arm for prophylaxis. No adverse event was reported. This is one of two reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA003760:
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site inflammation, Injection site warmth, Pyrexia
Clinical narrative: Fever of 103.1 F, chills, local inflammation and warmth at the site of injection. Cellulitis was discussed as a possible differential.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Extra dose administered
Clinical narrative: PROQUAD and KINRIX given on 4/10/2017 but was discovered that these were already administered on 05/23/2016.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13
Symptoms: Flushing, Urticaria, Vomiting
Clinical narrative: Child develop symptoms the following day after the vaccines were given. Child developed vomiting ×3, face was flushed and developed hives. Mother treated symptoms with Benadryl. Child was then seen in the emergency room at Hospital. He was asymptomatic on arrival to the hospital. He was treated with prednisolone and Pepcid.
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Blood test, Electroencephalogram, Generalised tonic-clonic seizure, Laboratory test, Lumbar puncture
Clinical narrative: Grand mal seizure lasting 45 minutes.  Went back to Dr. and she confirmed it was a seizure and said if it happens again to go to ER.
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Nuclear magnetic resonance imaging, Positron emission tomogram
Clinical narrative: Grand mal seizure lasting 45 minutes.  Went back to Dr. and she confirmed it was a seizure and said if it happens again to go to ER.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Contusion, Platelet count decreased
Clinical narrative: DAD STATES CHILD HAD IMMUNIZATIONS ON 4/13/17 AND WOKE 4/14/2017 WITH BRUISES ALL OVER, HE HAD RECEIVED THE MMR 1 MO PRIOR. NO OTHER SYMPTOMS.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient says since this morning she has had redness, swelling and pain down to her elbow from the injection.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Hypersensitivity, Impaired work ability, Malaise, Pain in extremity
Clinical narrative: Patient said their are was sore.  They did not feel well. They thgouht it was an allergic reaction to the injection.  They felt so ill they went home from work.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Back pain, Injection site pain, Injection site swelling, Pain, Pain in extremity
Clinical narrative: Patient develops sore arms/shoulders yesterday morning at 8:30 L>R. She thinks her shoulders were a little swollen last night. Patient felt a sharp pain in her back around 2 pm. "It didn't bother me that much, I just felt sore." At 5:30 pm she was at dance rehearsal and felt a sharp pain in her spine. Yesterday she developed sore neck pain, but she states this is not as bad as her spine. Full ROM in neck. Denies fevers, tingling and numbness in hands and legs, headache, sore throat. No change in voice.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Spinal pain
Clinical narrative: Patient develops sore arms/shoulders yesterday morning at 8:30 L>R. She thinks her shoulders were a little swollen last night. Patient felt a sharp pain in her back around 2 pm. "It didn't bother me that much, I just felt sore." At 5:30 pm she was at dance rehearsal and felt a sharp pain in her spine. Yesterday she developed sore neck pain, but she states this is not as bad as her spine. Full ROM in neck. Denies fevers, tingling and numbness in hands and legs, headache, sore throat. No change in voice.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pyrexia, Tenderness
Clinical narrative: This spontaneous report as received from a Registered Nurse via a company representative refers to a 75 year old female patient.  The patient's medical history, concomitant medication use and concurrent conditions were not reported. The patient was vaccinated with pneumococcal conjugate vaccine (PCB 13) one year ago (2016, exact date not specified). On 15-MAR-2017 the patient was vaccinated with PNEUMOVAX23, 1 DF, (route not specified), (lot # N003997, expiration date 20-OCT-2018) for prophylaxis. On 16-MAR-2017 the patient called the physician within one day of receiving PNEUMOVAX23 and complained of "arms that are red, painful to touch and feverish."  The patient called the physician's office to seek treatment and received an unspecified treatment for these complaints.  The patient's condition at the time of this reported was reported to be recovered. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to one unspecified patient (age and gender unknown). No information regarding the patient's concurrent conditions, medical history, drug reactions, allergies or concomitant therapies was provided. The reporter stated that, on an unspecified date, the patient was vaccinated with an improperly stored dose (incorrect product storage) of injectable VARIVAX (lot# L032391, expiration date 26-AUG-2017) (strength, dose, frequency, route of administration and anatomical location were not reported) for prophylaxis. The vaccine dose was exposed to a temperature excursion between -14 and -10 Celsius degrees for 2 hours; digital data logger was involved, but there was not previous temperature excursion. The reporter was not aware about any adverse events. There was no product quality complain (PQC) reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to multiple unspecified patients (age and gender unknown). No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on unspecified dates, the patients were vaccinated with improperly stored doses (incorrect product storage) of injectable PROQUAD (lot# L042818, expiration date 26-APR-2017; lot# M011664, expiration date 08-SEP-2017; and lot# M004889, expiration date 25-JUL-2017), subcutaneously for prophylaxis (strength, dose, frequency, albumin status and anatomical location were not reported). The vaccine doses were exposed to a temperature excursion of 19.4 Fahrenheit degrees in a time frame of 3 hours and 45 minutes; digital data logger was involved and previous temperature excursion was confirmed. No adverse effects were reported. Reportedly, the vaccine doses were reconstituted with properly stored diluent MRK (lot number and expiration date were unknown). There was no product quality complain (PQC) reported. This is one of three reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA002390: US-009507513-1704USA002389.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to multiple unspecified patients (age and gender unknown). No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on unspecified dates, the patients were vaccinated with improperly stored doses (incorrect product storage) of injectable VARIVAX (lot# L050956, expiration date 17-DEC-2017; and lot# M017290, expiration date 07-APR-2018), subcutaneously for prophylaxis (strength, dose, frequency, albumin status and anatomical location were not reported). The vaccine doses were exposed to a temperature excursion of 19.4 Fahrenheit degrees in a time frame of 3 hours and 45 minutes; digital data logger was involved and previous temperature excursion was confirmed. No adverse effects were reported. Reportedly, the vaccine doses were reconstituted with properly stored diluent MRK (lot number and expiration date were unknown). There was no product quality complain (PQC) reported. This is one of three reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA001051: US-009507513-1704USA002389:
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, concerning a patient of an unknown age and gender. The patient's medical history, concurrent conditions, drug reactions or allergies were not reported. On 03-APR-2017, the patient was inadvertently administered a dose of ZOSTAVAX lot # L044529 which expired on 09-FEB-2017 (strength, dose, route of administration or anatomical location were not provided), for prophylaxis. The vaccine was reconstituted in a properly stored sterile water diluent (manufacturer unknown). No adverse effects were reported. No further information was provided. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse and refers to a 5 year old patient of unknown age. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On 17-APR-2017, the patient was vaccinated with an unspecified expired dose of PROQUAD for prophylaxis (lot # L040413 with an expiration date of 13-APR-2017) (dosage, route and anatomical location were not reported). Other suspect and concomitant medications were not provided. No adverse effects were reported. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 8 month old male patient. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 01-DEC-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ dose 2, lot # L029617, orally, as prophylaxis (Strength, dose and expiration date were not reported), which experienced a temperature excursion (temperature and timeframe were no reported). It was not reported if there were previous temperature excursions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA006956: US-009507513-1704USA006957: US-009507513-1704USA006958: US-009507513-1701USA005974: US-009507513-1704USA007664: US-009507513-1704USA007665: US-009507513-1704USA007666: US-009507513-1704USA007667: US-009507513-1704USA007668: US-009507513-1704USA007669: US-009507513-1704USA007670: US-009507513-1704USA007671: US-009507513-1704USA007672: US-009507513-1704USA007673.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 12 weeks old male patient. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 06-DEC-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ dose 1, lot # L029617, orally, as prophylaxis (Strength, dose and expiration date were not reported), which experienced a temperature excursion (temperature and timeframe were no reported). It was not reported if there were previous temperature excursions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA006956: US-009507513-1704USA006957: US-009507513-1704USA006958: US-009507513-1701USA005974: US-009507513-1704USA007655: US-009507513-1704USA007664: US-009507513-1704USA007665: US-009507513-1704USA007667: US-009507513-1704USA007668: US-009507513-1704USA007669: US-009507513-1704USA007670: US-009507513-1704USA007671: US-009507513-1704USA007672: US-009507513-1704USA007673:
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal pain upper, Burning sensation, Diarrhoea, Erythema, Headache
Clinical narrative: This is a spontaneous report from a contactable consumer. A 59-year-old female patient received PREVNAR 13, via an unspecified route of administration on the left arm on 03Apr2017 at a single dose for immunization. Medical history included ongoing blood pressure high from 1993 and type II diabetes since 12Jan2007. Her doctor told her that because she had type II diabetes and would be 60 years in Nov2017, she needed to have this injection so that she would not get sick. Concomitant medication included ongoing losartan 100 mg daily (in the morning after breakfast with a glass of water) for blood pressure high ongoing for 5 years. In Apr2017, the patient reported having fever, diarrhea, headaches, and stomach aches. On 04Apr2017 when she woke up in the morning, she started having redness in her left arm, it was red, swollen, itchy and burning. On 05Apr2017, the patient was seen at doctor's office, and she showed the nurse her left arm. The nurse touched her arm and informed the patient that her arm would be okay, "it would go away tonight". The patient reported that it did not go away and each day the redness had increased with more burning and more itching. The patient did not receive treatment for the events. There was no laboratory data. The clinical outcome of the events, fever, diarrhea, headaches, and stomach aches, was unknown. The clinical outcome of the events, redness in her left arm, it was red, swollen, itchy and burning, was not recovered.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer. A 59-year-old female patient received PREVNAR 13, via an unspecified route of administration on the left arm on 03Apr2017 at a single dose for immunization. Medical history included ongoing blood pressure high from 1993 and type II diabetes since 12Jan2007. Her doctor told her that because she had type II diabetes and would be 60 years in Nov2017, she needed to have this injection so that she would not get sick. Concomitant medication included ongoing losartan 100 mg daily (in the morning after breakfast with a glass of water) for blood pressure high ongoing for 5 years. In Apr2017, the patient reported having fever, diarrhea, headaches, and stomach aches. On 04Apr2017 when she woke up in the morning, she started having redness in her left arm, it was red, swollen, itchy and burning. On 05Apr2017, the patient was seen at doctor's office, and she showed the nurse her left arm. The nurse touched her arm and informed the patient that her arm would be okay, "it would go away tonight". The patient reported that it did not go away and each day the redness had increased with more burning and more itching. The patient did not receive treatment for the events. There was no laboratory data. The clinical outcome of the events, fever, diarrhea, headaches, and stomach aches, was unknown. The clinical outcome of the events, redness in her left arm, it was red, swollen, itchy and burning, was not recovered.
Sex: F
Vaccine: MENB
Symptoms: Erythema
Clinical narrative: This is a spontaneous report from a contactable nurse via a company representative. This nurse reported for three patients, this is the first of three reports. A female patient of an unspecified age (in the age range right before 19) and ethnicity  received TRUMENBA, via an unspecified route of administration on en unspecified date in 2017 at 0.5 ml, single for Neisseria meningitidis Type B immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had a lot of redness  on an unspecified date with outcome of recovered.
Sex: F
Vaccine: MENB
Symptoms: Pain
Clinical narrative: This is a spontaneous report from a contactable nurse via a company representative. This nurse reported for three patients, this is the second of three reports. A female patient of an unspecified age (in the age range right before 19) and ethnicity received TRUMENBA, via an unspecified route of administration on en unspecified date in 2017 at 0.5 ml, single for Neisseria meningitidis Type B immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had a lot of soreness on an unspecified date with outcome of recovered.
Sex: F
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse via a company representative. This nurse reported for three patients, this is the third of three reports. A female patient of an unspecified age (in the age range right before 19) and ethnicity  received TRUMENBA , via an unspecified route of administration on en unspecified date in 2017 at 0.5 ml, single for Neisseria meningitidis Type B immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had fever on an unspecified date with outcome of recovered.
Age: 69.0
Sex: U
Vaccine: TDAP
Symptoms: Pain in jaw
Clinical narrative: Initial unsolicited report received from a pharmacist on 07-Apr-2017. This case involves a 69-year-old patient (gender not reported) who was vaccinated with a first dose of ADACEL (batch number U5292AA, expiry date: 14 April 2018, dose form, frequency and route of administration not reported) in the right deltoid on 04-Apr-2017. The illness at time of vaccination, birth defects and medical conditions were not reported. Pre existing physician diagnosed allergies included allergies to Sulfa drugs, penicillin and morphine. Any other vaccine within four weeks of vaccination was reported as unknown. Concomitant medications were not reported. On 05-Apr-2017, in the morning one day following the vaccination the patient developed jaw pain. It was unknown if pain was radiating from anywhere or if it's concentrated to a side. Patient was advised to seek medical attention either from her PCP or an emergency room. Relevant laboratory investigations were reported as none. Corrective treatment was not reported. The patient was not yet recovered from the event. List of documents held by the sender: None
Age: 21.0
Sex: M
Vaccine: TYP
Symptoms: Alcohol poisoning, Chills, Headache, Malaise, Oropharyngeal pain
Clinical narrative: Severe body aches and chills, severe headache, fever in excess of 104F, malaise, inebriation, severe sore throat.
Age: 21.0
Sex: M
Vaccine: TYP
Symptoms: Pain, Pyrexia
Clinical narrative: Severe body aches and chills, severe headache, fever in excess of 104F, malaise, inebriation, severe sore throat.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Local swelling, Lymphadenopathy, Pharyngeal erythema, Streptococcus test negative
Clinical narrative: When mom went in to get her out of bed, mom noted her neck was swollen.  The swelling remained about the same through the morning.  She had no distress and no fever. On exam about 1 pm, she had swollen submandibular glands about 2 in x 1 in on right and 1 in x 1 in on left.  Both were non-tender, non erythematous, patient looked well with no difficulty breathing.  Her posterior pharynx was mildly erythematous, her lungs were clear.h
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Musculoskeletal pain, Oedema peripheral, Pain in extremity, Peripheral swelling
Clinical narrative: Pain in shoulder/upper arm. Swelling/rash  on shoulder/upper arm. Swelling/redness in armpit.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Pain in shoulder/upper arm. Swelling/rash  on shoulder/upper arm. Swelling/redness in armpit.
Age: 0.25
Sex: F
Vaccine: DTAPH
Symptoms: Autopsy, Crying, Death, Immediate post-injection reaction, Initial insomnia
Clinical narrative: Screaming and crying starting immediately post-vac, including arched back and stiff limbs. Did not sleep until 0200 06/21/1994, found dead by mother 1000.
Age: 0.25
Sex: F
Vaccine: DTAPH
Symptoms: Musculoskeletal stiffness, Opisthotonus, Screaming, Sudden infant death syndrome
Clinical narrative: Screaming and crying starting immediately post-vac, including arched back and stiff limbs. Did not sleep until 0200 06/21/1994, found dead by mother 1000.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Haemoglobin decreased, Nausea, Pancytopenia, Platelet count decreased, Vomiting
Clinical narrative: Nausea, vomiting, pancytopenia requiring hospital admission on 4/13/17 Symptoms and pancytopenia resolved by 4/18/17.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: White blood cell count decreased
Clinical narrative: Nausea, vomiting, pancytopenia requiring hospital admission on 4/13/17 Symptoms and pancytopenia resolved by 4/18/17.
Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site vesicles
Clinical narrative: After administering vaccine with 1 inch needle, patient experienced a raised bump of fluid under the administration site. It appeared as if the fluid was subcutaneous. A 1 inch needle was appropriate for an intramuscular injection for this patient.
Age: 2.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Autism spectrum disorder, Confusional state, Exfoliative rash, Hair metal test abnormal, Hair texture abnormal
Clinical narrative: Fever, fell asleep; when awake had a confused look on face, unable to play with toys, unable to speak. Over the next week developed scaly red rash over face & arms. Hair started to stand on end, became coarse & wiry. Started screaming/howling like a wild animal. Full regression complete within 1 week of vaccination.
Age: 2.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Loss of personal independence in daily activities, Pyrexia, Rash, Rash erythematous, Regressive behaviour
Clinical narrative: Fever, fell asleep; when awake had a confused look on face, unable to play with toys, unable to speak. Over the next week developed scaly red rash over face & arms. Hair started to stand on end, became coarse & wiry. Started screaming/howling like a wild animal. Full regression complete within 1 week of vaccination.
Age: 2.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Screaming, Speech disorder
Clinical narrative: Fever, fell asleep; when awake had a confused look on face, unable to play with toys, unable to speak. Over the next week developed scaly red rash over face & arms. Hair started to stand on end, became coarse & wiry. Started screaming/howling like a wild animal. Full regression complete within 1 week of vaccination.
Age: 2.0
Sex: F
Vaccine: MEA
Symptoms: Attention deficit/hyperactivity disorder, Autism spectrum disorder, Extra dose administered, Measles antibody negative, Multiple allergies
Clinical narrative: Titers for Measles did not respond to adequate for entry into country with parents following father's assignment in another country. Was triple-immunized for Measles in order for titer response. Extreme (savant) Hyperlexia noted during 2-3 yrs old, multiple allergies developed during childhood.
Age: 2.0
Sex: F
Vaccine: MEA
Symptoms: Reading disorder
Clinical narrative: Titers for Measles did not respond to adequate for entry into country with parents following father's assignment in another country. Was triple-immunized for Measles in order for titer response. Extreme (savant) Hyperlexia noted during 2-3 yrs old, multiple allergies developed during childhood.
Age: 40.0
Sex: F
Vaccine: ANTH
Symptoms: Dizziness, Erythema, Hypersensitivity, Immediate post-injection reaction, Peripheral swelling
Clinical narrative: IMMEDIATELY AFTER INJECTION, WOOZY AND HAD TO SIT DOWN. LATER THAT EVENING ARM STARTED TO SWELL UP TO A POINT THAT THE SKIN WAS TO BURST AND HOT. HIVES, RED PATCHES, ITCHING SEVERE. STARTED TO CREEP UP TO CHEST. HAD TO GO TO THE ER AND THEY HAD TO TREAT ME.
Age: 40.0
Sex: F
Vaccine: ANTH
Symptoms: Pruritus, Skin warm, Urticaria
Clinical narrative: IMMEDIATELY AFTER INJECTION, WOOZY AND HAD TO SIT DOWN. LATER THAT EVENING ARM STARTED TO SWELL UP TO A POINT THAT THE SKIN WAS TO BURST AND HOT. HIVES, RED PATCHES, ITCHING SEVERE. STARTED TO CREEP UP TO CHEST. HAD TO GO TO THE ER AND THEY HAD TO TREAT ME.
Age: 31.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Large (3 inch diameter), red, warm-to-the-touch, sore spot at injection site appeared nearly 2 days after injection. Doctor treated with bactrim (antibiotic) and triamcinolone cream.
Age: 23.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Pruritus, Skin burning sensation, Urticaria
Clinical narrative: Broke out in raised hives all over upper and lower body/extremities during physical exercise after receiving 2nd or 3rd instance of the Anthrax vaccine. Skin was burning and extremely itchy. These conditions have persisted to this day. There is no family history of this condition. Now, anytime body temperature is elevated, hives and itching/burning ensues.
Age: 24.0
Sex: M
Vaccine: FLU3, FLU4
Symptoms: Albumin urine present, Anti-GAD antibody negative, Anti-insulin antibody decreased, Anti-islet cell antibody negative, Base excess negative
Clinical narrative: Patient diagnosed with T1DM in Feb 2017. Presented to local clinic, and subsequently, to ER on 20 Feb 2017, with a 4-week history of nocturia (6-7 times/night), polyuria, polydipsia, fatigue, and blurred vision. Patient reports weight loss of 12 pounds over previous 3 months. He also noted tingling in his feet for about 6 weeks prior to diagnosis. He was diagnosed with Diabetes and LANTUS was initiated, along with diet modification. On 27 Feb 2017, patient was evaluated by Dr., Endocrinology, who suspected patient has Type 1 DM and instructed him on titration of basal insulin, as well as adding pre-meal rapid acting insulin boluses. Patient tested antibody negative for GAD65 and Islet Cell antibodies, and his initial C-peptide level was 1.2 ng/mL. Patient denies a history of elevated glucose or blood pressure levels or history of hypertension prior to DM diagnosis. He exercised regularly and had a normal BMI (25) at time of diagnosis. Patient has no first degree family members with a history of diabetes, Type 1 or Type 2. He denies experiencing any congestion, cough, fever, sinus pain, or diarrhea in weeks-months prior to diagnosis.
Age: 24.0
Sex: M
Vaccine: FLU3, FLU4
Symptoms: Blood bicarbonate normal, Blood glucose increased, Blood ketone body absent, Blood lactic acid normal, Blood pH normal
Clinical narrative: Patient diagnosed with T1DM in Feb 2017. Presented to local clinic, and subsequently, to ER on 20 Feb 2017, with a 4-week history of nocturia (6-7 times/night), polyuria, polydipsia, fatigue, and blurred vision. Patient reports weight loss of 12 pounds over previous 3 months. He also noted tingling in his feet for about 6 weeks prior to diagnosis. He was diagnosed with Diabetes and LANTUS was initiated, along with diet modification. On 27 Feb 2017, patient was evaluated by Dr., Endocrinology, who suspected patient has Type 1 DM and instructed him on titration of basal insulin, as well as adding pre-meal rapid acting insulin boluses. Patient tested antibody negative for GAD65 and Islet Cell antibodies, and his initial C-peptide level was 1.2 ng/mL. Patient denies a history of elevated glucose or blood pressure levels or history of hypertension prior to DM diagnosis. He exercised regularly and had a normal BMI (25) at time of diagnosis. Patient has no first degree family members with a history of diabetes, Type 1 or Type 2. He denies experiencing any congestion, cough, fever, sinus pain, or diarrhea in weeks-months prior to diagnosis.
Age: 24.0
Sex: M
Vaccine: FLU3, FLU4
Symptoms: Carbon dioxide increased, Fatigue, Glucose urine present, Glycosylated haemoglobin increased, Haematocrit normal
Clinical narrative: Patient diagnosed with T1DM in Feb 2017. Presented to local clinic, and subsequently, to ER on 20 Feb 2017, with a 4-week history of nocturia (6-7 times/night), polyuria, polydipsia, fatigue, and blurred vision. Patient reports weight loss of 12 pounds over previous 3 months. He also noted tingling in his feet for about 6 weeks prior to diagnosis. He was diagnosed with Diabetes and LANTUS was initiated, along with diet modification. On 27 Feb 2017, patient was evaluated by Dr., Endocrinology, who suspected patient has Type 1 DM and instructed him on titration of basal insulin, as well as adding pre-meal rapid acting insulin boluses. Patient tested antibody negative for GAD65 and Islet Cell antibodies, and his initial C-peptide level was 1.2 ng/mL. Patient denies a history of elevated glucose or blood pressure levels or history of hypertension prior to DM diagnosis. He exercised regularly and had a normal BMI (25) at time of diagnosis. Patient has no first degree family members with a history of diabetes, Type 1 or Type 2. He denies experiencing any congestion, cough, fever, sinus pain, or diarrhea in weeks-months prior to diagnosis.
Age: 24.0
Sex: M
Vaccine: FLU3, FLU4
Symptoms: Haemoglobin normal, Insulin C-peptide normal, Nocturia, Paraesthesia, Platelet count normal
Clinical narrative: Patient diagnosed with T1DM in Feb 2017. Presented to local clinic, and subsequently, to ER on 20 Feb 2017, with a 4-week history of nocturia (6-7 times/night), polyuria, polydipsia, fatigue, and blurred vision. Patient reports weight loss of 12 pounds over previous 3 months. He also noted tingling in his feet for about 6 weeks prior to diagnosis. He was diagnosed with Diabetes and LANTUS was initiated, along with diet modification. On 27 Feb 2017, patient was evaluated by Dr., Endocrinology, who suspected patient has Type 1 DM and instructed him on titration of basal insulin, as well as adding pre-meal rapid acting insulin boluses. Patient tested antibody negative for GAD65 and Islet Cell antibodies, and his initial C-peptide level was 1.2 ng/mL. Patient denies a history of elevated glucose or blood pressure levels or history of hypertension prior to DM diagnosis. He exercised regularly and had a normal BMI (25) at time of diagnosis. Patient has no first degree family members with a history of diabetes, Type 1 or Type 2. He denies experiencing any congestion, cough, fever, sinus pain, or diarrhea in weeks-months prior to diagnosis.
Age: 24.0
Sex: M
Vaccine: FLU3, FLU4
Symptoms: Polydipsia, Polyuria, Type 1 diabetes mellitus, Urine ketone body present, Vision blurred
Clinical narrative: Patient diagnosed with T1DM in Feb 2017. Presented to local clinic, and subsequently, to ER on 20 Feb 2017, with a 4-week history of nocturia (6-7 times/night), polyuria, polydipsia, fatigue, and blurred vision. Patient reports weight loss of 12 pounds over previous 3 months. He also noted tingling in his feet for about 6 weeks prior to diagnosis. He was diagnosed with Diabetes and LANTUS was initiated, along with diet modification. On 27 Feb 2017, patient was evaluated by Dr., Endocrinology, who suspected patient has Type 1 DM and instructed him on titration of basal insulin, as well as adding pre-meal rapid acting insulin boluses. Patient tested antibody negative for GAD65 and Islet Cell antibodies, and his initial C-peptide level was 1.2 ng/mL. Patient denies a history of elevated glucose or blood pressure levels or history of hypertension prior to DM diagnosis. He exercised regularly and had a normal BMI (25) at time of diagnosis. Patient has no first degree family members with a history of diabetes, Type 1 or Type 2. He denies experiencing any congestion, cough, fever, sinus pain, or diarrhea in weeks-months prior to diagnosis.
Age: 24.0
Sex: M
Vaccine: FLU3, FLU4
Symptoms: Weight decreased, White blood cell count normal
Clinical narrative: Patient diagnosed with T1DM in Feb 2017. Presented to local clinic, and subsequently, to ER on 20 Feb 2017, with a 4-week history of nocturia (6-7 times/night), polyuria, polydipsia, fatigue, and blurred vision. Patient reports weight loss of 12 pounds over previous 3 months. He also noted tingling in his feet for about 6 weeks prior to diagnosis. He was diagnosed with Diabetes and LANTUS was initiated, along with diet modification. On 27 Feb 2017, patient was evaluated by Dr., Endocrinology, who suspected patient has Type 1 DM and instructed him on titration of basal insulin, as well as adding pre-meal rapid acting insulin boluses. Patient tested antibody negative for GAD65 and Islet Cell antibodies, and his initial C-peptide level was 1.2 ng/mL. Patient denies a history of elevated glucose or blood pressure levels or history of hypertension prior to DM diagnosis. He exercised regularly and had a normal BMI (25) at time of diagnosis. Patient has no first degree family members with a history of diabetes, Type 1 or Type 2. He denies experiencing any congestion, cough, fever, sinus pain, or diarrhea in weeks-months prior to diagnosis.
Age: 0.67
Sex: M
Vaccine: DTAPIPV, FLU4, HEP, PNC13
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: None.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: Burning and pain on injection site -> recommended NEOSPORIN.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: Urticarial rash continues - refer to Allergist.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Arthralgia, Headache, Rash
Clinical narrative: Skin rash, headache, joint pain.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: See additional page(s) for complete text.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema
Clinical narrative: Patient notice redness around site on left deltoid. Patient had concerns of cellulitis.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Bipolar disorder, Depressed mood, Irritability, Rash
Clinical narrative: Rash. Fussy, unhappy (bipolar).
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry skin, Injection site pruritus, Injection site reaction, Pyrexia, Rash
Clinical narrative: Injection site reaction 3 inches -dry skin itch - little prickly rash on face -fever like symptoms.
Age: 16.0
Sex: M
Vaccine: PPV
Symptoms: Induration, Pain, Skin warm, Swelling, Vomiting
Clinical narrative: Pain and swelling about 60 mins after vaccine admin, color and induration, and vomiting about 5 hrs after vaccine admin.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Pruritus, Swelling
Clinical narrative: Zoster vaccine administered right arm on 2/13/2017. Pt. called 2/14/2017 reporting itching, redness, and "golf ball" sized swelling. Advised to continue ice, BENADRYL, and start NSAIDS. On 2/15/2017 pt. called reporting worsening of cellulitis. Rx with KEFLEX by M.D.  pt. works with. On 2/17/2017 pt. called " full blown cellulitis". Rx with ROCEPHIN 2/16 and 2/17. Symptoms resolved approximately 3/15/17.
Age: 1.33
Sex: F
Vaccine: DTAP, MMRV, PNC13, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Mon has been contacted and patient was doing well. No signs of an adverse reaction.
Age: 79.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Redness and swelling from shoulder to elbow. Warm to the touch. Symptoms began 1 wk after vaccine and kept spreading. Patient seeking treatment with primary care physician.
Age: 11.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, MMRV
Symptoms: No adverse event, Underdose
Clinical narrative: Patient arrived to clinic w/ mom for well child check. Behind on vaccination schedule. Received PEDIARIX which is invalid dose for pt's age. No adverse signs/sxs from vaccine. Spoke with mom 4/17/17 and informed vaccine dose is insufficient for age, will need repeated.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Eye swelling, Sensation of foreign body
Clinical narrative: Patient received 1st GARDASIL vaccine and 2 hours later called clinic to report swollen eye and "little lump in throat" Pt took dose of BENADRYL at time of call which helped symptoms. She reported to ER for evaluation and started oral steroids.
Age: 1.25
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Parent was called, no adverse reaction noted.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Blood pressure orthostatic, Dizziness, Vertigo, Vomiting
Clinical narrative: In 24 hrs after administration of vaccines, she felt dizzy. Had to stop walking and sit down. Seen in clinic 4 days later continued dizziness while laying down. Vertigo sensation. Symptoms continue 7 days since administration will be following. She is vomiting a couple times and not dehydrated.
Age: 55.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site pain, Insomnia, Musculoskeletal pain, Rotator cuff syndrome, X-ray limb abnormal
Clinical narrative: On 10/20/2016 I got vaccine for Flu shot, and Pneumonia shot-it was painful and next day little sore and got worse, everyday. Keep me up all night. Toothache pain in shoulder with sharp pain all together. I went to hospitals for help.
Age: 22.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, warmth, swelling to site on (R) arm where vaccine administered. Temp 98.2. Diagnosed with cellulitis; given 7 day course of KEFLEX PO with resolution.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash
Clinical narrative: Patient called and described a red rash that developed around injection site. The rash was described as red, itchy, and hot. The rash was not severe and subsided quickly.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Mother states child developed Rash 48 hrs. after receiving vaccine. She carried child to Dr. for evaluation. Mother states Dr. told her it was not chicken pox. Mother gave child BENADRYL 1x. Brought child into Health Dept. 4-17-17 for Nurse to see child. Child has red cheeks with Lace-Like pattern rash over body from neck down. Mother states rash started on face and spread down body.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: Constant pain in left arm, trouble laying or sleeping on left arm; frequency increasing, getting worse; has trouble getting shirt on/off-limited mobility with that arm. Patient has not seen a doctor. Everything started after receiving vaccine per patient.
Sex: M
Vaccine: FLUN4, HEPA, HPV9
Symptoms: Abdominal pain upper, Dizziness, Head injury, 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 # 601621). This spontaneous report refers to a 15 year old male patient. Patient had no concurrent illnesses, medical history and other medications. On 01-OCT-2015, the patient was vaccinated with GARDASIL 9 lot # L013429, dose 1, intramuscularly in the left arm for prophylaxis. On the same day, the patient was also vaccinated with   (cold adapted ann arbor master strain) (FLUMIST) lot # FJ2099, dose 1, via intranasal route and HAVRIX lot # 294X9, dose 3, intramuscularly in the right arm for prophylaxis. On the same day at 10:40, the patient complained of stomach ache and felt dizzy after leaving the clinic. He stepped out of the elevator, fainted and hit his back of the head on floor. Episode lasted for less than 5 minutes and he was taken to emergency room (ER) for evaluation by emergency medical services (EMS). The outcome of the events was reported as recovered. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Pain of skin, Pruritus, 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 # 605976). This spontaneous report refers to a 20 year old female patient. Patient had no concurrent illnesses and information on patient's medical history and other medications were not reported. On 23-OCT-2015, the patient was vaccinated with GARDASIL 9 lot # K026246, dose 2, intramuscularly in the left arm for prophylaxis. On the same day, the patient experienced hives, itching, skin sore to touch. She was taking Zyrtec and was seen by primary care physician (PCP) and was put on steroids. The outcome of the events was reported as recovered. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Laboratory test normal, Nausea, 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 # 615010). This spontaneous report refers to a 22 year old female patient. Patient had no concurrent illnesses and information on the patient's medical history and other medications were not reported. On 14-DEC-2015, the patient was vaccinated with GARDASIL 9 lot # L007531, dose 1, intramuscularly in the right arm for prophylaxis. On the same day, the patient was also vaccinated with MENVEO lot # M15036, intramuscularly in the left arm for prophylaxis. On 14-DEC-2015, the patient experienced vomiting and nausea which required emergency room (ER) visit. Patient stated that all laboratory testing done was normal and she was sent home after ER visit. The outcome of the events was reported as recovered. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, 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 (VAERS # 616293) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 13 year old male patient. The patient's concomitant therapies, concurrent illness and medical history were not reported. On 21-DEC-2015 the patient was vaccinated with the third dose of GARDASIL 9 intramuscularly in the left arm, lot # L028083 (dose, frequency and lot expiration date were not reported) for prophylaxis. On 21-DEC-2015 the patient's left upper deltoid slightly warm to touch and mildly erythematous. Approximately 4cm X 3cm area the patient had hard knot at injection site, also had injection site induration. The patient had no swelling, streaks numbness, tingling, hives, trouble breathing or rest distress. The outcome of injection site erythema, injection site warmth, injection site nodule and injection site induration was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.