chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. There was no information provided about the patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies. On 04-APR-2017, the patient inadvertently received an expired dose of injectable VARIVAX for prophylaxis (lot # K021483 with expiration date on 03-NOV-2016) (strength, dose, frequency, route of administration and anatomical location were not provided). Additional information is not expected because the reporter did not consent for further follow up.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information was received from a registered nurse concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The nurse reported that on 17-APR-2017, the patient was inadvertently given a dose of ZOSTAVAX 19400 PFU (lot # M039453, expiration date 19-DEC-2017; route of administration unknown), reconstituted with sterile diluent-MSD (lot number unknown) instead of VARIVAX (unspecified lot number and expiration date) for an unspecified reason. No adverse effect reported. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Erythema, Mobility decreased, Skin warm, Swelling
Clinical narrative: This is a spontaneous report from a contactable consumer via Pfizer sales representative. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date to at single dose for immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced Severe redness, puffiness and heat from shoulder to elbow for several days along with limitation of arm movement on an unspecified date with outcome of unknown. No follow-up attempts are possible. No further information is expected.
Age: 10.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Abdominal pain upper, Back pain, Headache, Laboratory test, Menorrhagia
Clinical narrative: Headache day of vaccine and rash. Pain in her back, stomach, pelvis. Periods lasting weeks at a time and heavy. Back pain is constant.
Age: 10.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Pelvic pain, Rash
Clinical narrative: Headache day of vaccine and rash. Pain in her back, stomach, pelvis. Periods lasting weeks at a time and heavy. Back pain is constant.
Age: 10.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Abdominal pain, Imaging procedure, Laboratory test, Pelvic pain, Spinal pain
Clinical narrative: Headache day of vaccine and rash. Pain in her back, stomach, pelvis. Periods lasting weeks at a time and heavy. Back pain is constant.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Agitation, Emotional disorder, Injection site joint pain, Injection site pain, Irritability
Clinical narrative: Parent called to report that patient had adverse reaction to fifth dose of DTaP administered in March.  She states for 2-2-1/2 days patient was complaining of leg pain not just at the site of the vaccine but also in his ankle and knee on the same leg.  There is no redness or swelling or palpable lump that mother could appreciate.  Additionally he was very clingy, requested mother to carry him around, seemed more emotional and agitated than his normal self.  This lasted for about 2 days as well.  He has since returned to his normal self with no behavioral or other changes beyond the 2 days after the vaccine.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Local reaction, Pruritus, Tenderness
Clinical narrative: Pt reports induration that is red aprox 8x4cm,  tender and itchy x 2 days now, the redness appears to be spreading, it used to be smaller. No fever, chills, feels fine otherwise. No Resp. symptoms. Advised its local rxn to the shot, can do benadryl or claritin daily, ibuprofen 400mg tid prn take with food, ice application may be helfpful as well. s/s infection discussed.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Seizure
Clinical narrative: Initially complained to supervisor of severe headache, Supervisor to her to go ho home. On 2/10/17 went to ER for headaches. Then on 2/14/17 taken by ambulance to ER for seizures and released Feb 25. 2017.
Age: 0.08
Sex: M
Vaccine: HIBV
Symptoms: Eczema, Injection site swelling, Irritability, Pyrexia, Urticaria
Clinical narrative: Fever, swelling an injection site, irritable, severe eczema, hives.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Eczema, Injection site swelling, Irritability, Pyrexia, Urticaria
Clinical narrative: Fever, swelling at injection site, irritability, severe eczema breakout as well as hives all over his body.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt reports inj. site was raised red and tender to touch. Pt called to report symptoms to provider on 4/27/17 and was told to ice, use Benadryl and mark site and if any problems with SOB or throat tightening she was to go to Urgent Care.  If not improved on 4/28/17 she was to contact provider to be seen.
Age: 5.0
Sex: F
Vaccine: UNK
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report was received from the patient's mother and refers to a five and half year old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was administered M-M-R II (dose, anatomical location, route of administration, lot #, therapy type, and expiration date were not reported) or an unspecified polio vaccine by an unspecified nurse. The physician's office informed the patient's mother that the chart was incorrectly marked as the patient had received an unspecified polio vaccine. The patient's mother was unsure if her daughter received the M-M-R II or the unspecified polio vaccine. No product quality complaint was identified. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Pruritus
Clinical narrative: This spontaneous report has been received from a 81-year-old female patient reporting on herself. The patient did not have any relevant medical not drug reactions/allergies. The concomitant therapies included an unspecified high blood pressure medication. On 11-SEP-2016, the patient was vaccinated with ZOSTAVAX (strength, dose, frequency, lot number, and expiration date were not reported) intravenously (IV) for shingles prevention. Other suspect therapy included sterile diluent (DILUENT MRK). On approximately 25-SEP-2016 (reported as "two weeks after receiving ZOSTAVAX"), the patient developed itching on her back and shoulders. The patient spoke with a couple of doctors on unspecified dates and she was given treatment for itching on her back and shoulders. There were no laboratory diagnostic tests performed. At the time of this report, the patient had not recovered from itching on her back and shoulders. The causality assessment between itching on her back and shoulders and ZOSTAVAX was unknown. Additional information is not expected as no contact consent was provided.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with the improperly stored doses of RECOMBIVAX HB (dose, route, lot # and expiration date were not reported) for prophylaxis. The vaccines were reconstituted whit a properly stored sterile diluent (DILUENT MRK) (lot # and expiration date were not reported). There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 9 degrees Celsius for 56 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA015115: US-009507513-1704USA015114: US-009507513-1704USA010748: US-009507513-1704USA015113:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with the improperly stored doses of ROTATEQ (dose, lot # and expiration date were not reported) orally for prophylaxis. The vaccines were reconstituted whit a properly stored sterile diluent (DILUENT MRK) (lot # and expiration date were not reported). There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 9 degrees Celsius for 56 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA015115: US-009507513-1704USA015114: US-009507513-1704USA015112: US-009507513-1704USA010748:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with the improperly stored doses of VAQTA (dose, route, lot # and expiration date were not reported) for prophylaxis. The vaccines were reconstituted whit a properly stored sterile diluent (MRK) (lot # and expiration date were not reported). There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 9 degrees Celsius for 56 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA015115: US-009507513-1704USA010748: US-009507513-1704USA015112: US-009507513-1704USA015113.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with the improperly stored doses of M-M-R II (dose, route, lot # and expiration date were not reported) for prophylaxis. The vaccines were reconstituted whit a properly stored sterile diluent (DILUENT MRK) (lot # and expiration date were not reported). There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 9 degrees Celsius for 56 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA010748: US-009507513-1704USA015114: US-009507513-1704USA015112: US-009507513-1704USA015113:
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Cough
Clinical narrative: Initial unsolicited report received from a pharmacist on 24-Apr-2017. This case involves 53-year-old female patient, who was vaccinated with a dose of ADACEL) intramuscularly (Batch number: U5489AA, expiration date, dose in series were not reported) in left deltoid on 17-Apr-2017. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as allergic to sulfa and diabetes. Patient's concomitant medication were not reported. On 17-Apr-2017, same day following the vaccination, the patient developed an occasional dry, hacking cough. No laboratory investigation was performed and corrective treatments was not reported. The patient did not recover from event. List of documents held by sender: none.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Child was at school and teacher noticed some swelling around his injection site. Child then was taking to Urgent care by parents. Their they gave him benadryl. From the time the patient left the hospital the symptoms had worsen. Patient right leg from injection site down to his lower leg about an inch or two past his patella was swollen and warm to touch.
Age: 64.0
Sex: F
Vaccine: DTAP
Symptoms: Head discomfort, Injection site pain, Insomnia, Mobility decreased, Muscular weakness
Clinical narrative: Severe and constant pain to upper rt shoulder, arm radiating to back of neck. Distal arm and hand feels slightly weak. Not a headache but a heaviness.. Unable to sleep on rt side, excruciating pain when turning. Unable to raise or abduct arm. Generalized body aches. Used hot packs and Motrin with little effect. Pain continues.
Age: 64.0
Sex: F
Vaccine: DTAP
Symptoms: Neck pain, Pain
Clinical narrative: Severe and constant pain to upper rt shoulder, arm radiating to back of neck. Distal arm and hand feels slightly weak. Not a headache but a heaviness.. Unable to sleep on rt side, excruciating pain when turning. Unable to raise or abduct arm. Generalized body aches. Used hot packs and Motrin with little effect. Pain continues.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Injection site vesicles
Clinical narrative: Patient had headache and dizziness. Patient reported blisters present on injection site.
Age: 3.0
Sex: M
Vaccine: FLU4, HEPA, HIBV, MMR
Symptoms: Fatigue, Pyrexia
Clinical narrative: C/O FATIGUE AND FEVER 38 DEGREES CELSIUS; RECURRENT FEVER X 48 HOURS AFTER INITIAL ONSET IN PM.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain, Dyskinesia, Hypoaesthesia, Insomnia, Paraesthesia
Clinical narrative: Belly pain, involuntary leg movements, tingling and numbness in legs, insomnia.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Eye pain, Eye swelling, Feeling hot, Rash
Clinical narrative: After receiving the 2nd MMR vaccine, my daughter woke up 5 days later with an extremely swollen face and eyes. Her whole face was red and hot and she kept saying her eyes were hurting. We called our dr. who said to start benedryl. We also started cortisone cream the following day for her rash on her face and upper chest. Still working through it but  much better (3 days after rash began).
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Swelling face
Clinical narrative: After receiving the 2nd MMR vaccine, my daughter woke up 5 days later with an extremely swollen face and eyes. Her whole face was red and hot and she kept saying her eyes were hurting. We called our dr. who said to start benedryl. We also started cortisone cream the following day for her rash on her face and upper chest. Still working through it but  much better (3 days after rash began).
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Peripheral swelling, Swelling
Clinical narrative: Patient recieved ppsv 23 and said she had swelling of arm and chest and pain.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Influenza like illness, Myalgia, Rash
Clinical narrative: Rash on IMZ arm, a few penny sized bumps,  flu-like symptoms coming on, slight muscle aches/pain.
Age: 27.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Urticaria
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of hives in a patient who received RABAVERT. On an unknown date, the patient received the 3rd dose of RABAVERT. On an unknown date, unknown after receiving RABAVERT, the patient experienced hives. On an unknown date, the outcome of the hives was unknown. It was unknown if the reporter considered the hives to be related to RABAVERT. Additional details were provided as follows: The patient received RABAVERT as a pre exposure schedule. The health care professional had no product or patient information and stated that she would call back to give the information.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Participant of the vaccine Trumenba is vaccinated on 4/27/17 10:30am in left deltoid area. Mother returns to immunization clinic on 4/28/17 10:00am because today at 8:00am the child was taken to urgent care for redness on left deltoid area, in area where vaccination was administered on 4/27/17. She handed the CBC and I saw the arm red and swollen, mother states that the labs were ok and that it could be a cellulitis. The Dr at the urgent care states it could be cellulitis and prescribed Acetaminophen 1g PO. They bring child to the clinic, I checked the arm and it was red in left deltoid area and warm to touch, cold ice compress was given and PANADOL 1g PO.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Angioedema, Injection site reaction, Injection site swelling, Local swelling
Clinical narrative: Angioedema of (L) upper arm at site of injection swelling extended into (L) lateral cervical area.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Irritability, Pyrexia, Rash
Clinical narrative: Mild leg rash. Low grade fever/crankiness.
Age: 80.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness/sore on 4/20/17, swelling, warm to touch. Now using warm compress 2-3 times a day with TYLENOL and BENADRYL 25 mg every 8 hours. All on Left Deltoid.
Age: 80.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling, Pain in extremity, Vaccination complication
Clinical narrative: Redness/sore on 4/20/17, swelling, warm to touch. Now using warm compress 2-3 times a day with TYLENOL and BENADRYL 25 mg every 8 hours. All on Left Deltoid.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Left arm with several inch diameter; itchy erythematous, indurated area at site of TDaP and MENACTRA vaccines. BENADRYL and icepack helped. Improved within a day or two.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5
Symptoms: Incorrect route of drug administration
Clinical narrative: Flu shot given subcutaneous and not IM.
Age: 73.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt received Hepatitis A vaccine. Upon removal of needle Pt's Right deltoid area became swollen and red. Pt was seen by Dr. and RN, LPN. Pt was given TYLENOL 325mg x 2 and 25 mg BENADRYL IM Left deltoid. Ice applied.
Age: 1.58
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Rash maculo-papular
Clinical narrative: Approximately 12 hrs after PROQUAD, developed slightly raised maculopapular rash, first facial then diffuse, although spread widely. No other symptoms.
Age: 43.0
Sex: M
Vaccine: ANTH
Symptoms: Headache, Pain
Clinical narrative: Started to have a headache approximately 2 hours after vaccination progressed the next day to severe headache, body aches, took TYLENOL OTC for headache and body aches.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Mild erythema and edema from the injection site to 2 inches above the elbow.
Age: 50.0
Sex: M
Vaccine: TYP, YF
Symptoms: Dizziness, Feeling abnormal, Neurological symptom, Tremor
Clinical narrative: Pt. developed neurologic symptoms, including (R) hand tremor and dizziness/"spaciness" which was episodic.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diet refusal, Emotional distress
Clinical narrative: Patient became inconsolable and would not nurse. Event lasted approx. 2 hrs. Gave 1.25 ml infants TYLENOL in office.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Inflammation
Clinical narrative: Red and inflamed arm. Went to ER for further eval.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Laboratory test, Pyrexia, Vaccination complication
Clinical narrative: Mom called clinic 4-27-17 and stated pt had 102 F fever. Had not given TYLENOL. Couns to give TYLENOL and if doesn't improve to see a doctor. Called mom back 4-28-17: mom stated fever went up to 104 F and took to ER. Labs done and MD stated fever was from vaccines most likely. Was able to get the fever down in the ER.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Bruising, pain lasting almost 1 week at the site, Pt's pain gone on follow up on 4/27/17. Follow up with Doctor 4/29/17, Pt is doing well.
Age: 6.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling 108mm x 103mm, hot, no pain. Right deltoid improving some yesterday.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Body temperature increased, Ear discomfort, Eye movement disorder, Febrile convulsion, Irritability
Clinical narrative: Pt. was given the MMR on 4-19-17. He presented to our office on 4-24-17 with temp of 100, ear pulling, runny nose and fussy. He was Dx with a virus. Went to ER on 4-25 due to temp of 102 and an episode of eyes rolling into back of head and altered mental status. Dx with febrile seizure.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Mental status changes, Rhinorrhoea, Viral infection
Clinical narrative: Pt. was given the MMR on 4-19-17. He presented to our office on 4-24-17 with temp of 100, ear pulling, runny nose and fussy. He was Dx with a virus. Went to ER on 4-25 due to temp of 102 and an episode of eyes rolling into back of head and altered mental status. Dx with febrile seizure.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Pt presented to clinic today 72 post vaccine. CPX admin on 4-25-17. Reports red raised area at site of vaccine admin. Approx 2.5 inch in diam with minimal redness. No treatment required.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: Redness, itchiness, urticaria- around injection site. Patient has been self medicating w/ BENADRYL, Hydrocortisone.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site reaction, Injection site warmth, Urticaria
Clinical narrative: Patients left leg was hot to the touch and has a welt.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Night sweats, Pain, Pyrexia
Clinical narrative: Redness at site of injection, fever, night sweats, pain.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13
Symptoms: Computerised tomogram normal, Cyanosis, Electroencephalogram, Foaming at mouth, Petit mal epilepsy
Clinical narrative: Turned blue, convulsions, lasted 3-5 minutes, foaming at mouth and nose. taken to hospital via ambulance. Night prior (looking back, after the fact) patient had what may have been an absence seizure.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13
Symptoms: Seizure
Clinical narrative: Turned blue, convulsions, lasted 3-5 minutes, foaming at mouth and nose. taken to hospital via ambulance. Night prior (looking back, after the fact) patient had what may have been an absence seizure.
Age: 52.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Induration, Pain, Pyrexia, Swelling, Tremor
Clinical narrative: Pain, swelling, hard traveling towards elbow, under arm and inside armpit with body shakes, fever, whole body pain.
Age: 52.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Pain, Pyrexia, Swelling, Tremor
Clinical narrative: Pain, swelling, hard traveling towards elbow, under arm and inside armpit with body shakes, fever, whole body pain.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: PATIENT HAS PAIN AT INJECTION SITE. Still hurts 30 days later.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Autism spectrum disorder, Decreased eye contact, Irritability, Learning disability, Metal poisoning
Clinical narrative: Aluminum nano particle poisoning starting with Hep B shot on 04/19/2013 (Day 2 of birth) culminating with MMR vaccine on 04/18/2014 CUMULATIVE aluminum injected directly into blood through vaccines is close to 2 milligrams. Apart from that my child got over 20 times safe limits of ethyl mercury, polysorbate80, bovine serum, foreign pig DNA, LACTOSE. Lost eye contact, irritable, learning disabled Diagnosed with AUTISM. My child is non-verbal and needs lifelong care. Vaccines damaged my child. Doctors did not give us any help and attributed everything to AUTISM and only recommended therapies. My child suffered Aluminum and mercury poisoning due to giving too many vaccines too soon.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Toxic encephalopathy
Clinical narrative: Aluminum nano particle poisoning starting with Hep B shot on 04/19/2013 (Day 2 of birth) culminating with MMR vaccine on 04/18/2014 CUMULATIVE aluminum injected directly into blood through vaccines is close to 2 milligrams. Apart from that my child got over 20 times safe limits of ethyl mercury, polysorbate80, bovine serum, foreign pig DNA, LACTOSE. Lost eye contact, irritable, learning disabled Diagnosed with AUTISM. My child is non-verbal and needs lifelong care. Vaccines damaged my child. Doctors did not give us any help and attributed everything to AUTISM and only recommended therapies. My child suffered Aluminum and mercury poisoning due to giving too many vaccines too soon.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Itchiness, Swelling, Erythema given Medrol Dose Pak, and advised to seek medical attention if worsened.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Exposure during pregnancy, Nausea, Posture abnormal, Skin warm
Clinical narrative: Patient was given Tdap vaccine. Advised to wait. In waiting area, reception noticed pt was slumped over the table. Pt was approached, taken by wheelchair to the exam room. She was coherent, however, dizziness and nausea noted. Pt resting on table, feeling warm, given cold compresses, checking BP, pulse and oxygen levels. Vitals stable except mild tachycardia into 110s.  Given cold water, emesis basin.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Tachycardia
Clinical narrative: Patient was given Tdap vaccine. Advised to wait. In waiting area, reception noticed pt was slumped over the table. Pt was approached, taken by wheelchair to the exam room. She was coherent, however, dizziness and nausea noted. Pt resting on table, feeling warm, given cold compresses, checking BP, pulse and oxygen levels. Vitals stable except mild tachycardia into 110s.  Given cold water, emesis basin.
Age: 66.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Asthenia, Dizziness
Clinical narrative: 20 minutes after recieved Fluzone HD and Zostavax patient complained of feeling light headed and weak. Patient refused 911 service. She sat at the store for 20 minutes while a pharmacist monitor her symptoms and then she left with her husband.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Injection site pain, Rotator cuff syndrome, X-ray limb normal
Clinical narrative: Developed constant left deltoid/shoulder pain. Seen by PCP. Was diagnosed with bursitis. Ice and TYLENOL prn were suggested and referred to orthopedic. Seen by dr orthopedic specialist. Diagnosed with rotator cuff tendonitis. He suggested ice 4x/day and TYLENOL prn without improvement in symptoms. Completed physical therapy as ordered without improvement in symptoms. Orthopedic provider suggests steroid injection, I am reluctant to this treatment because there is a risk of a tear to the rotator cuff related to the steroid injection.
Age: 61.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Pt. reported that her arm is sore with swollen about 2.5 to 3.0" diameter. She came to pharmacy at 4:00 PM.
Age: 61.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Fatigue, Injected limb mobility decreased, Injection site bruising, Injection site erythema, Injection site induration
Clinical narrative: Pt. reported that her arm is sore with swollen about 2.5 to 3.0" diameter. She came to pharmacy at 4:00 PM.
Age: 61.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site mass, Injection site swelling, Loss of personal independence in daily activities, Pain, Pain in extremity
Clinical narrative: Pt. reported that her arm is sore with swollen about 2.5 to 3.0" diameter. She came to pharmacy at 4:00 PM.
Age: 61.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pyrexia
Clinical narrative: Pt. reported that her arm is sore with swollen about 2.5 to 3.0" diameter. She came to pharmacy at 4:00 PM.
Age: 61.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Antinuclear antibody, Arthralgia, Decreased appetite, Headache, Rheumatoid factor
Clinical narrative: 14 days after MMR and Hep B given Pt. developed generalized severe arthralgia's, headache decrease appetite with weight loss. Arthralgia's lasting .2 wks.
Age: 61.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Weight decreased
Clinical narrative: 14 days after MMR and Hep B given Pt. developed generalized severe arthralgia's, headache decrease appetite with weight loss. Arthralgia's lasting .2 wks.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dyspnoea, Headache, Hepatic failure, Pain
Clinical narrative: Liver failure, rashes, seizures, pain, headaches, weak. Shortness of breath.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Seizure
Clinical narrative: Liver failure, rashes, seizures, pain, headaches, weak. Shortness of breath.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: My husband and I received the TDAP vaccination on the same date 10/25/2014. The following date my had an adverse reaction where my arm was swollen and ached for several weeks.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site reaction, Injection site warmth, Rash erythematous, Rash pruritic
Clinical narrative: Patient stated that she developed a red, itchy rash, that felt warm (feverish) at the injection site and the surrounding left deltoid starting a couple days after the injection.  Vaccine administered on 4/22 and patient presented on 4/30.
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: Neck pain, Pyrexia, Rash generalised
Clinical narrative: Fever and sore neck for 2 days, then a mild rash break out all over her body.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: HIVES AND ALLERGIC REACTION.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Computerised tomogram normal, Electroencephalogram normal, Generalised tonic-clonic seizure, Laboratory test normal
Clinical narrative: Grand mal seizure, or clonic-tonic seizure, First seizure.  Second clonic-tonic seizure occurred on 4/25/2017. Medication prescribed for seizures.
Age: 0.17
Sex: M
Vaccine: 6VAX-F, RVX, UNK
Symptoms: Crying, Diet refusal, Pyrexia, Vomiting
Clinical narrative: Began vomiting in large amounts in the morning on the day after immunizations. He vomited after every feeding all of his milk. Then in the evening around 5:30 he started crying uncontrollably and we couldn't console him. He had a fever and cried for hours and refused to eat. The fever has spiked up a few times since then and we can always tell he has a fever because of the way he cries uncontrollably. As of 04/30/2017 his fever is back tonight.
Age: 4.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Aplastic anaemia, Biopsy bone marrow abnormal, Injection site pain, Transfusion
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (564197) under the Freedom of Information Act, concerning a 4 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 22-FEB-2016, the patient was vaccinated with the third dose of GARDASIL 9 lot # L045711 via intramuscular, in the left arm, as prophylaxis (Strength and dose were not reported). On 22-FEB-2016, the patient became pale and fainted. The outcome of pallor and syncope was reported as recovered on an unspecified date in 2017. The causality between the events and GARDASIL 9 was not provided. Additional information is not expected as no follow up information can be obtained from the agency.
Age: 4.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Pallor, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (564197) under the Freedom of Information Act, concerning a 4 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 22-FEB-2016, the patient was vaccinated with the third dose of GARDASIL 9 lot # L045711 via intramuscular, in the left arm, as prophylaxis (Strength and dose were not reported). On 22-FEB-2016, the patient became pale and fainted. The outcome of pallor and syncope was reported as recovered on an unspecified date in 2017. The causality between the events and GARDASIL 9 was not provided. Additional information is not expected as no follow up information can be obtained from the agency.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, HPV9, MNQ, TDAP
Symptoms: Rash, Rash erythematous, Skin warm
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 11-year-old female patient who received BOOSTRIX. Co-suspect products included GARDASIL 9 and MENACTRA. Concurrent medical conditions included food allergy (many food allergies) and drug allergy (some drug allergies). On 1st March 2017, the patient received BOOSTRIX, GARDASIL 9 and MENACTRA. On 1st March 2017, unknown after receiving BOOSTRIX, the patient experienced labeled drug-drug interaction medication error. On 7th March 2017, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved and the outcome of the labeled drug-drug interaction medication error was unknown. It was unknown if the reporter considered the rash to be related to BOOSTRIX. Additional details were reported as follows: This case was reported by the pharmacist for her daughter. The patient received BOOSTRIX and MENACTRA vaccines together, which led to labeled drug-drug interaction medication error. On 7th March 2017, the patient developed a rash on hand. On 10th March 2017, a rash was also developed on her chin. The reporter did not know if the rash was related to the vaccinations. The batch number of the BOOSTRIX vaccine was unknown. It was unknown if the reporter considered the rash to be related to GARDASIL 9 and MENACTRA as well.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, HPV9, MNQ, TDAP
Symptoms: Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 11-year-old female patient who received BOOSTRIX. Co-suspect products included GARDASIL 9 and MENACTRA. Concurrent medical conditions included food allergy (many food allergies) and drug allergy (some drug allergies). On 1st March 2017, the patient received BOOSTRIX, GARDASIL 9 and MENACTRA. On 1st March 2017, unknown after receiving BOOSTRIX, the patient experienced labeled drug-drug interaction medication error. On 7th March 2017, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved and the outcome of the labeled drug-drug interaction medication error was unknown. It was unknown if the reporter considered the rash to be related to BOOSTRIX. Additional details were reported as follows: This case was reported by the pharmacist for her daughter. The patient received BOOSTRIX and MENACTRA vaccines together, which led to labeled drug-drug interaction medication error. On 7th March 2017, the patient developed a rash on hand. On 10th March 2017, a rash was also developed on her chin. The reporter did not know if the rash was related to the vaccinations. The batch number of the BOOSTRIX vaccine was unknown. It was unknown if the reporter considered the rash to be related to GARDASIL 9 and MENACTRA as well.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, HPV9, MNQ, TDAP
Symptoms: Labelled drug-drug interaction medication error, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 11-year-old female patient who received BOOSTRIX. Co-suspect products included GARDASIL 9 and MENACTRA. Concurrent medical conditions included food allergy (many food allergies) and drug allergy (some drug allergies). On 1st March 2017, the patient received BOOSTRIX, GARDASIL 9 and MENACTRA. On 1st March 2017, unknown after receiving BOOSTRIX, the patient experienced labeled drug-drug interaction medication error. On 7th March 2017, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved and the outcome of the labeled drug-drug interaction medication error was unknown. It was unknown if the reporter considered the rash to be related to BOOSTRIX. Additional details were reported as follows: This case was reported by the pharmacist for her daughter. The patient received BOOSTRIX and MENACTRA vaccines together, which led to labeled drug-drug interaction medication error. On 7th March 2017, the patient developed a rash on hand. On 10th March 2017, a rash was also developed on her chin. The reporter did not know if the rash was related to the vaccinations. The batch number of the BOOSTRIX vaccine was unknown. It was unknown if the reporter considered the rash to be related to GARDASIL 9 and MENACTRA as well.
Age: 61.0
Sex: F
Vaccine: VARZOS, TDAP, VARZOS
Symptoms: Urticaria
Clinical narrative: Lip swelling, difficulty speaking secondarily; chest itching that night with progression the next morning with itching everywhere without rash but then when woke up states had hives scattered across all body surfaces -including face and lips. Did not have tongue swelling or trouble swallowing/breathing. Within days had full resolution of all symptoms.  Treatment was symptomatic with Benadryl only with good relief of itching and eventual resolution of hives and itching.
Age: 61.0
Sex: F
Vaccine: VARZOS, TDAP, VARZOS
Symptoms: Lip swelling, Pruritus generalised, Speech disorder, Urticaria
Clinical narrative: Lip swelling, difficulty speaking secondarily; chest itching that night with progression the next morning with itching everywhere without rash but then when woke up states had hives scattered across all body surfaces -including face and lips. Did not have tongue swelling or trouble swallowing/breathing. Within days had full resolution of all symptoms.  Treatment was symptomatic with Benadryl only with good relief of itching and eventual resolution of hives and itching.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site inflammation, Injection site rash
Clinical narrative: "A rash at the injection site two days later"; Information has been received from a pharmacist referring to a 54 year old female patient. The patient had no medical history, concomitant medication, drug reactions or allergies. On 15-APR-2017, the patient received a dose of ZOSTAVAX, subcutaneous for prophylaxis with Lot # M039452 and expiration date of 19-DEC-2017 (anatomical location and dosage were not provided). On 17-APR-2017, the patient developed a rash at the injection site. Furthermore, it was reported that the patient did not received treatment for the event. At the time of reporting, the patient had not recoverd from the rash at the injection site. Additionally, the reporter did not provided causal relationship between the event and vaccination with ZOSTAVAX. There was not product quality complaint involved. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash
Clinical narrative: "A rash at the injection site two days later"; Information has been received from a pharmacist referring to a 54 year old female patient. The patient had no medical history, concomitant medication, drug reactions or allergies. On 15-APR-2017, the patient received a dose of ZOSTAVAX, subcutaneous for prophylaxis with Lot # M039452 and expiration date of 19-DEC-2017 (anatomical location and dosage were not provided). On 17-APR-2017, the patient developed a rash at the injection site. Furthermore, it was reported that the patient did not received treatment for the event. At the time of reporting, the patient had not recoverd from the rash at the injection site. Additionally, the reporter did not provided causal relationship between the event and vaccination with ZOSTAVAX. There was not product quality complaint involved. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Patient received live vaccines while pregnant. (MMR, Varicella, also HPV).
Age: 16.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: Patient received live vaccines while pregnant. (MMR, Varicella, also HPV).
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Cerebral haemorrhage, Cerebrovascular accident, Computerised tomogram, Dizziness
Clinical narrative: Severe headache, dizziness, weakness, nausea started 8 minutes after shot, diagnosed with stroke with brain bleed in ER.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Headache, Laboratory test, Nausea, Nuclear magnetic resonance imaging
Clinical narrative: Severe headache, dizziness, weakness, nausea started 8 minutes after shot, diagnosed with stroke with brain bleed in ER.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Pain in extremity
Clinical narrative: Soreness in L arm for 3weeks.
Age: 11.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Haematocrit decreased, Haemoglobin normal, Pain, Peripheral swelling
Clinical narrative: Mother reported, swelling, redness and pain a few hours after injection on 4/24/2017. Pt. then started with fever on 4/25/2017. Pt's affected arm that was injected/swollen x2 size of the arm with severe tenderness. Pt was hospitalized for management.
Age: 11.0
Sex: M
Vaccine: PPV
Symptoms: Platelet count normal, Pyrexia, Swelling, Tenderness, White blood cell count increased
Clinical narrative: Mother reported, swelling, redness and pain a few hours after injection on 4/24/2017. Pt. then started with fever on 4/25/2017. Pt's affected arm that was injected/swollen x2 size of the arm with severe tenderness. Pt was hospitalized for management.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Skin discolouration, Swelling
Clinical narrative: Pain, redness/black and blueness, soreness, bump.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Herpes zoster, Polymerase chain reaction, Varicella virus test negative
Clinical narrative: This spontaneous report was received from a physician and a registered nurse referring to a 10 year old male patient. The patient's medical history included a non-accidental head trauma as baby. The patient's concurrent conditions included Attention-deficit/hyperactivity disorder (ADHD). The patient historical drugs included MMR. The patient never had chickenpox, herpes zoster or allergies. The patient's concomitant therapies included VYVANSE and INTUNIV. On 24-JAN-2008, the patient received a dose of injectable VARIVAX 0.5 mL, subcutaneously in his left thigh for prophylaxis (lot number reported as 1559U with expiration date on 27-SEP-2009) (strength and frequency were not reported) and sterile diluent (lot number reported as 1455U with expiration date in April 2010). On 24-JAN-2011, the patient received a dose of injectable PROQUAD 0.5 mL, subcutaneously in his left thigh for prophylaxis (lot number reported as 0649Z with expiration date on 29-OCT-2011) (strength and frequency were not reported) and sterile diluent (lot number reported as E009807 with expiration date in January 2012). No rash was detected at the site of vaccination injection following the vaccination. The reporter stated that, on 31-MAR-2017 (also reported as on 14-MAR-2017 by the register nurse), the patient visited the physician's office and shingles were detected on left side of the patient's back (also reported as "left side T2 posterior lateral" and "upper back"), next to his armpit level in a "4 by 4 cm" patch. Moreover, it was stated that, on an unspecified date, the patient was placed on acyclovir antiviral therapy 400mg/5cm (1 3/4 top, four times a day (qid) for 5 days) as treatment for the event. It was reported that the patient was afebrile and he did not have any other systemic symptoms. On 31-MAR-2017, a sample of a swab of an unroofed shingle vesicle was collected for further examination. On 03-APR-2017, the specimen arrived to the laboratory. It was reported that, on 04-APR-2017, the patient was "getting better" concerning the event of shingles. It was reported that, the specimen provided for polymerase chain reaction (PCR) analysis was an adequate specimen, no varicella zoster virus (VZV) deoxyribonucleic acid (DNA) was amplified but beta-globulin was amplified. On 12-APR-2017, the results were negative for VZV and did not detect the presence of varicella zoster virus. The relationship between the event of shingles and the therapy with VARIVAX and PROQUAD were not provided. Additional information is not expected as all correspondence was received.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician and a licensed practical nurse and refers to a male patient of an unknown age. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 22-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9 injection (route and site of administration, dose, lot number and expiration date were not reported). He received the second and the third dose of GARDASIL 9) injection (route and site of administration, dose, lot number and expiration date were not reported) on 13-JAN-2017 and 30-MAR-2017, respectively. No adverse effect was reported. No additional information was provided. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning two unspecified patients of unknown age and gender. The patients's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported.     On unknown dates, the patients were vaccinated with an improperly stored dose of GARDASIL 9 lot # M005714, expiration date: 03-OCT-2017 (Strength, dose, frequency and route were not reported) as prophylaxis, which experienced a temperature excursion of 9 Celsius degrees for 20 hours. Previous temperature excursions were reported as from 02-OCT-2016 to 04-OCT-2016 of 9 Celsius degrees for 43 hours 30 minutes. From 25-OCT-2016 to 26-OCT-2016 of 9 Celsius degrees for 23 hours and 30 minutes. On 28-OCT-2016 of 9 Celsius degrees for 48 hours. From 23-DEC-2016 to 24-DEC-2016 of 9 Celsius degrees for 20 hours. Data logger was not involved. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA015304: