chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Injection site erythema, Injection site infection, Injection site pain, Injection site swelling, Lymphadenopathy
Clinical narrative: Redness, swelling, tenderness at site of infection that extended from the shoulder to the elbow with swollen lymph nodes in the axilla and a mild fever.
Age: 56.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Pyrexia
Clinical narrative: Redness, swelling, tenderness at site of infection that extended from the shoulder to the elbow with swollen lymph nodes in the axilla and a mild fever.
Age: 32.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Paraesthesia
Clinical narrative: Injection site reaction the size of a quarter that progressed to the size of a softball with skin raised approximately 4 cm, tenderness, swelling, redness, and tingling to the fingers. Patient was treated with clindamycin and tylenol # 3, redness and swelling has significantly decreased. Tingling sensation in the arm is still present along with decreased range of movement.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Documented hypersensitivity to administered product, Eye inflammation, Injection site erythema, Ocular hyperaemia
Clinical narrative: Patient presents with red arm starting 2 inches below where she received the injection. She also had been using an eye drop "she forgot she was allergic to". So also presented with red inflamed eye. I think the fact that she used a medication she was allergic to and got the shot in the same day, may have made the reaction to the vaccine worse. She said she noticed her red arm on the 5th day. This was 3 days after she stopped the eye drop she was allergic to.
Age: 28.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: None known as of yet, first set was administered on 3/8/17 and then was stopped before the second set advising to get clearance from my OBGYN, who then advised that the facility should have not recommended it or administered it in the first place, at all.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Injection site pain, Injection site urticaria
Clinical narrative: Erythema (R) upper arm 5x7 cm with mild pain - at site of KINRIX. Then on 4/10/17 - developed hives x (L) arm lesion at site of PROQUAD. Local treatment only - cool compresses, BENADRYL if needed, etc.
Age: 6.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient's Mom reported on 3/29/17 9:00 pm. his left arm with redness and swelling. No pain, fever, rash or N and V. 3/30/17 arm better, less red and less swollen. Patient went to school. 3/31/17 she brought patient to HU states arm better today, less red and swollen. It is warm to the touch. Reviewed VIS on each vaccine given with patient's Mom. I asked if she had read her VIS that was given to her prior to patient getting his vaccinations on 03/29/17. She states she read parts of them, but not all. I read and showed to her on each VIS; DTaP, Mild problems (common) were redness or swelling, soreness or tenderness where shot was given. Also sometimes with the 4th or 5th dose of DTaP, swelling of the entire arm or leg in which shot was given, lasting 1-7 days. VIS; varicella, Mild problems were soreness or swelling where shot was given, fever and rash up to a month after vaccination. VIS; MMR, Mild problems were fever, mild rash, swelling of glands in the cheeks or neck. I told her she could give patient, TYLENOL following manufacturer's directions for his age and weight, available at any pharmacy, if needed. Also told her she could apply a clean, cool, wet washcloth over the sore area for comfort. I gave her names and phone numbers of walk in clinics in the area, if needed and told her to keep a watch on it today. If his arm dose start to get worse, to go to one of the walk in clinics or to the ER. She verbalized she understood and she stated she felt better about his arm and it was better than yesterday.
Age: 19.0
Sex: U
Vaccine: UNK
Symptoms: Headache, Injury, Peripheral swelling, Photophobia, Victim of crime
Clinical narrative: June 1967 - My arm swell after vaccine shots - I was sent to Hospital I was given one white tablet. I got severe headaches and my eye became very sensitive to light. I did not know anything about nerve damage at the time. The damage may have also came from another when he grab me by the neck and pulled me to the floor and tried to assault me. Their were witness from both watching. I have sent letters to newspapers asking my story be told in hope that one of the see it and contact me so I can get a legal statement from them. Nothing was done about my eyes until I received a injury in Judo class. My sparing partner threw me and I tired to throw him at the same time and I landed on the back of my head, neck and upper back. My sparing partner feel on my head, eyes and chest. I could not see and my room mate's told me I should go the hospital because I could get up in next morning and I may not be able to open my eyes. The doctor told me my eyes were highly sensitive to light and he ordered me too pairs of very dark sunglasses. I still have one pair of the in a box. One pair was stolen. To this day they have denied that my eyes became highly sensitive to light due to the injury to my eyes in the judo class. I had forgot about the problem I had after the vaccine shot. At the time I did not know that vaccine's could do that. I also got sick when they gave Flu shots in 1968-1969 they tried to make it look like it was in my mind.
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Seizure
Clinical narrative: Child received varicella vaccine on 1/12/17. 10 days later fever developed 102.0 and had seizure went to ER.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Rash
Clinical narrative: Patient had redness in the injection site. Patients mom noticed white bump on Friday 4-14-17. She also applied bandages to cover up the area.
Age: 58.0
Sex: M
Vaccine: VARCEL
Symptoms: Vaccination site swelling
Clinical narrative: 4/7/17: Pt. given varicella vaccine. 4/11/17 (R) arm swollen around vaccine site, denied pain. 4/14/17 (R) arm no swelling. Reported swelling post vaccine in camp. Vaccine unknown.
Age: 1.42
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site swelling, Pruritus generalised, Pyrexia
Clinical narrative: 3/16/17 - Patient started itching all over body, accompanied by fever, redness of skin at left thigh at injection site on exam - mild swelling and erythema (5 x 5 cm) at left thigh around the injection site (Lt. thigh).
Age: 59.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Erythema, Swelling
Clinical narrative: Swelling, redness 11 x 11 mm.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal discomfort, Amenorrhoea, Appetite disorder, Arthralgia, Blood follicle stimulating hormone
Clinical narrative: Patient presents 4/17/17 for missed periods (skipped 2-3 mos prior)was "regular". She also complains of fatigue, abdominal discomfort, appetite changes some wrist pain. Mother says onset was after her HPV vaccine. Screening labs pending. Thyroid, CBV, Celiac; Iron studies, hormones. Exam unremarkable.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Blood luteinising hormone, Blood prolactin, Fatigue, Full blood count, Laboratory test
Clinical narrative: Patient presents 4/17/17 for missed periods (skipped 2-3 mos prior)was "regular". She also complains of fatigue, abdominal discomfort, appetite changes some wrist pain. Mother says onset was after her HPV vaccine. Screening labs pending. Thyroid, CBV, Celiac; Iron studies, hormones. Exam unremarkable.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Metabolic function test, Oestradiol, Pregnancy test urine, Serum ferritin, Thyroid function test
Clinical narrative: Patient presents 4/17/17 for missed periods (skipped 2-3 mos prior)was "regular". She also complains of fatigue, abdominal discomfort, appetite changes some wrist pain. Mother says onset was after her HPV vaccine. Screening labs pending. Thyroid, CBV, Celiac; Iron studies, hormones. Exam unremarkable.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Urine analysis
Clinical narrative: Patient presents 4/17/17 for missed periods (skipped 2-3 mos prior)was "regular". She also complains of fatigue, abdominal discomfort, appetite changes some wrist pain. Mother says onset was after her HPV vaccine. Screening labs pending. Thyroid, CBV, Celiac; Iron studies, hormones. Exam unremarkable.
Age: 26.0
Sex: F
Vaccine: FLU4, VARCEL
Symptoms: Injection site rash, Vaccination site discolouration
Clinical narrative: Patient returned to clinic 11 days later and reported skin discoloration around vaccine administration site. Advised Pt to see a medical provider. Rash/discoloration is around site of Varicella administration (back of arm).
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster without complications.
Age: 86.0
Sex: M
Vaccine: PNC13
Symptoms: Chest discomfort, Chills, Constipation, Diarrhoea, Dizziness
Clinical narrative: PREVNAR 13 Plus: On 1-30-2017 Dr. told me to get pneumonia shot booster with med added, so I'd never have to get the shot again. Only pharmacist give the shots. After 3 places I ended up at pharmacy. Had a script. After a while, they finally gave me the shot. Pharmacist told me if I notice anything different call her please - so when I 1st started with severe chills, for 2 hrs. could not get warm. Got into bed that has heated mattress pad and still could not get warm. After 2 hrs. got severe hot flashes etc. Tried calling pharmacy, left on hold 2 times, upset so I closed, stayed in bed. This continued for 2 days and nites. Anyway in a.m. called pharmacy, they didn't know who gave me shot, so I talked with pharmacist, said she can help. Told her all (the headache, chest etc) she said the med had nothing to do with it. She was gonna research and call me right back. 2 days after she calls and said yes the chills are the problem. I was upset and told her, "You're too late, I found out, you were wrong, cause all I was going through are the side effects and warnings. I had everything listed on the paper plus more. Blurred vision. Sending copies of sheet, underlined all I had. Severe headaches, dizzy bad, and could not sleep. Was in severe pain, right arm, ribs all R side where shot given severely painful. 2 mos. severely ill. Cyclobenzaprine - This was given to me on 3/3/17 to help relieve the pains all over. Severe constipated 5 days and on 6th day had diarrhea real bad for 30 1/2 hrs. Again all side effects and warning sides I got all. On sheet from pharmacy called Dr. and said take it all 30 pills. I did check, I'll never listen to anyone on taking meds. I'll only take Warfarin.
Age: 86.0
Sex: M
Vaccine: PNC13
Symptoms: Emotional distress, Feeling cold, Headache, Hot flush, Insomnia
Clinical narrative: PREVNAR 13 Plus: On 1-30-2017 Dr. told me to get pneumonia shot booster with med added, so I'd never have to get the shot again. Only pharmacist give the shots. After 3 places I ended up at pharmacy. Had a script. After a while, they finally gave me the shot. Pharmacist told me if I notice anything different call her please - so when I 1st started with severe chills, for 2 hrs. could not get warm. Got into bed that has heated mattress pad and still could not get warm. After 2 hrs. got severe hot flashes etc. Tried calling pharmacy, left on hold 2 times, upset so I closed, stayed in bed. This continued for 2 days and nites. Anyway in a.m. called pharmacy, they didn't know who gave me shot, so I talked with pharmacist, said she can help. Told her all (the headache, chest etc) she said the med had nothing to do with it. She was gonna research and call me right back. 2 days after she calls and said yes the chills are the problem. I was upset and told her, "You're too late, I found out, you were wrong, cause all I was going through are the side effects and warnings. I had everything listed on the paper plus more. Blurred vision. Sending copies of sheet, underlined all I had. Severe headaches, dizzy bad, and could not sleep. Was in severe pain, right arm, ribs all R side where shot given severely painful. 2 mos. severely ill. Cyclobenzaprine - This was given to me on 3/3/17 to help relieve the pains all over. Severe constipated 5 days and on 6th day had diarrhea real bad for 30 1/2 hrs. Again all side effects and warning sides I got all. On sheet from pharmacy called Dr. and said take it all 30 pills. I did check, I'll never listen to anyone on taking meds. I'll only take Warfarin.
Age: 86.0
Sex: M
Vaccine: PNC13
Symptoms: Malaise, Musculoskeletal chest pain, Pain, Pain in extremity, Vision blurred
Clinical narrative: PREVNAR 13 Plus: On 1-30-2017 Dr. told me to get pneumonia shot booster with med added, so I'd never have to get the shot again. Only pharmacist give the shots. After 3 places I ended up at pharmacy. Had a script. After a while, they finally gave me the shot. Pharmacist told me if I notice anything different call her please - so when I 1st started with severe chills, for 2 hrs. could not get warm. Got into bed that has heated mattress pad and still could not get warm. After 2 hrs. got severe hot flashes etc. Tried calling pharmacy, left on hold 2 times, upset so I closed, stayed in bed. This continued for 2 days and nites. Anyway in a.m. called pharmacy, they didn't know who gave me shot, so I talked with pharmacist, said she can help. Told her all (the headache, chest etc) she said the med had nothing to do with it. She was gonna research and call me right back. 2 days after she calls and said yes the chills are the problem. I was upset and told her, "You're too late, I found out, you were wrong, cause all I was going through are the side effects and warnings. I had everything listed on the paper plus more. Blurred vision. Sending copies of sheet, underlined all I had. Severe headaches, dizzy bad, and could not sleep. Was in severe pain, right arm, ribs all R side where shot given severely painful. 2 mos. severely ill. Cyclobenzaprine - This was given to me on 3/3/17 to help relieve the pains all over. Severe constipated 5 days and on 6th day had diarrhea real bad for 30 1/2 hrs. Again all side effects and warning sides I got all. On sheet from pharmacy called Dr. and said take it all 30 pills. I did check, I'll never listen to anyone on taking meds. I'll only take Warfarin.
Age: 1.3
Sex: M
Vaccine: RVX
Symptoms: Rotavirus test positive
Clinical narrative: Positive Rotavirus A. Child had received a 3 dose series.
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Headache, Myalgia, Swelling
Clinical narrative: Headache for three days, swelling, redness in left arm, muscle pain.
Age: 55.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site haemorrhage, Rash
Clinical narrative: Bleeding for approximately one week post vaccine from vaccine site. Rash.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Injection site swelling, Myalgia, Pain
Clinical narrative: Left upper arm swollen, tender muscle from injection site down 1/3 of lateral arm (upper). Swelling well defined in muscle. No erythema. No skin changes. No fever. Pain with motion left arm. Onset of symptoms within a couple of hours post-injection. Treated with Prednisone 20 mg oral.
Sex: M
Vaccine: HPV9
Symptoms: Abdominal pain upper, Asthenia, Dizziness, Headache, Hypersensitivity
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 # 563584). This spontaneous report refers to a 11 year old male patient. Information on the patient's concurrent illnesses, medical history and other medications were not reported. On 26-JAN-2015, the patient was vaccinated with GARDASIL 9 dose 3 for prophylaxis (dosage, route, site of vaccination and lot# unspecified). The patient was vaccinated on a Monday and in the evening experienced stomach pain. On 27-JAN-2015, the patient experienced asthenia, swelling, rash generalised, nausea, hypersensitivity, headache, dizziness and abdominal pain upper, the patient's streptococcus test was negative and renal function test was normal. On Tuesday, the patient had called from school with headache, dizziness, stomach pains and was weak. The patient returned to school on Wednesday and felt light headache, sick in the stomach, dizzy and swelling then was sent home. On the same Wednesday night a rash had developed and the patient went to physician. The physician was informed that the patient had not been sick and had been perfectly well until vaccination. The physician ran some tests on the patient like streptococcus test and kidney disease test and the results came back negative. Tests were reported back to the physician on 03-FEB-2015. The patient had rashes and swelling all over his body, for that whole weekend. The physician then confirmed it was the GARDASIL 9 vaccine and that the patient may have short to long term of this rash with other possible side effects. The patient's parent/relative further stated that the patient still had recurring rashes (come and go) and was frightened of any other side effects. So far the patient had a couple of doctor visits and felt that if the patient gets any signs of other side effects, the patient should be taken to hospitals. The patient stated that he "doesn't ever want a shot again!". The outcome of all the events was unknown. The causality assessment for the events with respect to GARDASIL 9 was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Nausea, Rash generalised, Renal function test normal, Streptococcus test negative, Swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 563584). This spontaneous report refers to a 11 year old male patient. Information on the patient's concurrent illnesses, medical history and other medications were not reported. On 26-JAN-2015, the patient was vaccinated with GARDASIL 9 dose 3 for prophylaxis (dosage, route, site of vaccination and lot# unspecified). The patient was vaccinated on a Monday and in the evening experienced stomach pain. On 27-JAN-2015, the patient experienced asthenia, swelling, rash generalised, nausea, hypersensitivity, headache, dizziness and abdominal pain upper, the patient's streptococcus test was negative and renal function test was normal. On Tuesday, the patient had called from school with headache, dizziness, stomach pains and was weak. The patient returned to school on Wednesday and felt light headache, sick in the stomach, dizzy and swelling then was sent home. On the same Wednesday night a rash had developed and the patient went to physician. The physician was informed that the patient had not been sick and had been perfectly well until vaccination. The physician ran some tests on the patient like streptococcus test and kidney disease test and the results came back negative. Tests were reported back to the physician on 03-FEB-2015. The patient had rashes and swelling all over his body, for that whole weekend. The physician then confirmed it was the GARDASIL 9 vaccine and that the patient may have short to long term of this rash with other possible side effects. The patient's parent/relative further stated that the patient still had recurring rashes (come and go) and was frightened of any other side effects. So far the patient had a couple of doctor visits and felt that if the patient gets any signs of other side effects, the patient should be taken to hospitals. The patient stated that he "doesn't ever want a shot again!". The outcome of all the events was unknown. The causality assessment for the events with respect to GARDASIL 9 was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: 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 # 591678) on 04-APR-2017. This spontaneous report was received from a regulatory authority refers to a 11 year old female patient. The patient had no concurrent illness and pertinent medical history. The patient had a previous dose of Quadrivalent formulation. On 26-AUG-2015, the patient was vaccinated with the 2nd dose of GARDASIL 9, lot # L000610 (dose, frequency and expiration date were not provided) intramuscularly in the left arm for prophylaxis. On 26-AUG-2015, the patient had hives behind knees and elbows. The outcome of urticaria was unknown. The causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Cellulitis
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 # 592231). This spontaneous report refers to a 11 year old male patient. The patient's concurrent illnesses was reported as none. The patient's medical history was not reported. Other Medications included ADDERALL XR 25 24 hour one daily and ZOLOFT 25 mg one daily. On 28-AUG-2015 the patient was vaccinated with GARDASIL 9, lot # K026246, dose 1, intradermally in the left arm for prophylaxis. On the same day, the patient was vaccinated with MENVEO (lot# M14072, dose 1, intramuscularly in right arm) and ADACEL (lot# C4543AA, dose 1, intramuscularly in right arm). On 28-AUG-2015, the patient experienced cellulitis of right arm and put on antibiotics. The outcome of cellulitis is unknown. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HEP, HPV9, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Dyskinesia, Eye movement disorder, Loss of consciousness, Urinary incontinence, 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 # 594198). This spontaneous report refers to a 17 year old female patient. Patient had no concurrent illness as per parent and had no medical history as per screening questionnaire. Information on patient's other medications was not reported. On 08-SEP-2015, the patient was vaccinated with GARDASIL 9 lot # L000610, (dose: unknown) intramuscularly in the left arm; VARIVAX lot # L013395, (dose: unknown) subcutaneously in the right arm and M-M-R II (therapy type: rHA, lot # K021151) (dose: unknown) subcutaneously in the left arm for prophylaxis. On the same day patient was also vaccinated with BOOSTRIX lot # 2224P, (dose: unknown) intramuscularly in the right arm; ENGERIX-B lot # EY43T, (dose: unknown) intramuscularly in the left arm; MENACTRA lot # U5020CA (dose: unknown) intramuscularly in the right arm and IPOL lot # K16491, (dose: unknown) intramuscularly in the left arm for prophylaxis. On 08-SEP-2015, the patient passed out onto floor, her eyes rolled back into head, had jerking movements with arms, urinated and vomited. The outcome of the events was reported as recovered. The causality assessment for all the events with respect to the suspect therapies 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, TDAP
Symptoms: Blood test, Facial paralysis, Hypoaesthesia
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 # 601547). This spontaneous report refers to a 11 year old female patient. Patient had no concurrent illness. Information on the patient's medical history was not reported. On 28-SEP-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 BOOSTRIX lot # 2729X, dose 1, intramuscularly in the right arm and MENACTRA lot # U5178AA, dose 1, intramuscularly in the left arm for prophylaxis. In the morning of 30-SEP-2015, the patient's left side of the face felt numb. Parent took the child to emergency room (ER) that day and was diagnosed with Bell's palsy on left side of the face. Patient's mother felt that it was from one of the vaccines patient received two days prior. Lab tests: blood work was ordered. Other medication included: ER provider ordered prednisolone, twice a day (bid) for 7 days and acyclovir suspension, 5 times a day for 10 days. 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: FLUN4, HEPA, HPV9, MNQ, TDAP
Symptoms: Blood glucose normal, Haemoglobin normal, Loss of consciousness
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 # 601642). This spontaneous report refers to a 11 year old female patient. Information on the patient's concurrent illnesses, medical history and other medications were not reported. On 29-SEP-2015, the patient was vaccinated with GARDASIL 9 lot # L007560, dose 1, intramuscularly in the left arm and VAQTA lot # L022259, dose 1, intramuscularly in the left arm for prophylaxis. On the same day, the patient was also vaccinated with MENACTRA lot # U5172AA, dose 1, intramuscularly in the right arm; (cold adapted ann arbor master strain) FLUMIST lot # FJ2100, dose 1, via intranasal route and ADACEL lot # C4765AA, dose 1, intramuscularly in the right arm for prophylaxis. On 29-SEP-2015, after immunizations, patient was sitting in the chair and lost consciousness, her mom screamed for someone to help her. She ran over to patient's another nurse and cracked the ammonia. Patient was picked up and laid down in procedure room. Patient's blood pressure was checked and made her lay down for a while and was given water. Orthostatic blood pressures was completed to ensure she would not faint. Patient's blood glucose and hemoglobin was normal. Lab data included: blood glucose (BG): 123 and hemoglobin (Hgb): 13.1. Patient was monitored for 2 hours. The outcome of the events was reported as recovered. The causality assessment for all the events with respect to GARDASIL 9 and VAQTA was not provided by the reporter.  Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP, VARCEL
Symptoms: Hypotonia, Lethargy, 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 # 602761). This spontaneous report refers to a 12 year old male patient. The patient's concurrent illnesses was reported as none. The patient's medical history was not reported. On 15-OCT-2015 the patient was vaccinated with GARDASIL 9, lot # L016428, dose 1, intramuscularly in the left arm and VARIVAX, lot# L000456, dose 2, subcutaneously in the left arm for prophylaxis. On the same day, the patient was vaccinated with MENVEO (lot# M15032, dose 1, intramuscularly in right arm), BOOSTRIX (lot# 2224P, dose 1, intramuscularly in left arm) and FLUZONE (lot# U1444AA, dose 1, intramuscularly in right arm). On 15-OCT-2015, the patient experienced hypotonia, syncope and lethargy. Patient had an episode of syncope which lasted only a few seconds after administration of final vaccine HPV 9. Patient was alert and orientated. Patient had given juice and cool cloths. Patient laid down and retained color. Patient then began to become very lethargic for about 30 minutes. Patient responded to name and opened eyes. Patient body noted to be limp. After approximately 1 hour in office patient was still not completely functional. The outcome of hypotonia, syncope and lethargy was unknown. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: M
Vaccine: FLUN4, HPV9, MNQ, TDAP
Symptoms: 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 # 610140) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old male patient. The patient's concomitant therapies, concurrent illness and medical history were not reported.  On 11-NOV-2015 the patient was vaccinated with the second dose of GARDASIL 9 intramuscularly in the left arm, lot # L016428 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included MENVEO, BOOSTRIX and (cold adapted ann arbor master strain) FLUMIST. On 11-NOV-2015, at 14:15 the patient experienced hives (urticarial) on right arm down to wrist. The doctor prescribed BENADRYL 5 ml 125 mg oral, then the patient felt better from hives. The outcome of urticaria 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.
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Injection site pain, Injection site swelling, 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 ID-615247). This spontaneous report refers to a 12 year old male patient. The patient's medical history included pervasive developmental disorder, allergic rhinitis, allergy to AUGMENTIN, birch trees, dogs, elm, Kentucky blue grass, maple, oak and timothy grass. Other medications included LEXAPRO. On 07-DEC-2015 the patient was vaccinated with GARDASIL 9 lot # L013429, (unspecified dosage regimen) via intramuscular route in the left leg for prophylaxis. Other suspect therapies included ADACEL (unspecified dosage regimen, in the left leg), HAVRIX (unspecified dosage regimen, in the right leg), and MENACTRA (unspecified dosage regimen, in the left leg), given on the same day intramuscularly. On 08-DEC-2015, the patient experienced left thigh swelling, skin warm and pain in extremity when raised. The patient was treated with warm compresses. The outcome of pain in extremity, skin warm and peripheral swelling was reported as unknown. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: FLU3, HPV9, MNQ
Symptoms: Blood glucose decreased, Dizziness
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 # 615699) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 14 year old male patient. The patient's concomitant therapies, concurrent illness and medical history were not reported. On 09-OCT-2015 the patient was vaccinated with the first dose of GARDASIL 9 in the left arm, lot # L013429 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included MENACTRA and FLUARIX. On 09-OCT-2015 the patient felt dizzy (dizziness) when he sat down in lab and having blood work drawn. The patient's blood sugar was immediately withdrawn via finger stick and glucometer was 56 (blood glucose decreased). The outcome of blood glucose decreased and dizziness 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.
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Hyperhidrosis, Loss of consciousness, Nausea, Presyncope, 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 # 616489) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old female patient. The patient's concomitant therapies, concurrent illness and medical history were not reported. On 28-DEC-2015 the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # L016428 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included BOOSTRIX and MENACTRA. On 28-DEC-2015, the patient experienced hyperhidrosis, vomiting, presyncope, nausea and loss of consciousness. The outcome of hyperhidrosis, vomiting, presyncope, nausea and loss of consciousness 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.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV9
Symptoms: Fatigue, Injection site pain, Malaise, Nausea, Pyrexia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 616741). This spontaneous report refers to a 14 year old female patient. The patient had no concurrent illnesses. Information on the patient's medical history was not reported. The patient's other medications included FOCALIN XR (25 mg, daily). On 09-DEC-2015, the patient was vaccinated with GARDASIL 9 dose 1 via intramuscular route in the right arm for prophylaxis (dosage and lot # unspecified). On the same day, the patient was also vaccinated with FLUZONE dose 10 via intramuscular route in the arm site for prophylaxis (dosage and lot# unspecified). On 09-DEC-2015, the patient experienced fatigue, urticaria, pyrexia, nausea, malaise and injection site pain. Episodes of malaise, nausea and fatigue, initially occurred during the patient's dance class, after getting vaccine. These episodes occurred on a daily basis, mainly in the afternoon and the patient experienced soreness at injection site which lasted approximately for 1 week. The patient felt feverish with hive-like reaction 5 nights after vaccine. The patient was evaluated in the office on 15-DEC-2015 - nonfocal exam except for some tenderness at injection site, right deltoid muscle. Symptoms appeared to resolve several days after the office visit on 15-DEC-2015. The outcome of fatigue, urticaria, pyrexia, nausea, malaise and injection site pain was reported as recovered. The causality assessment for the events with respect to GARDASIL 9 was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV9
Symptoms: 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 # 616741). This spontaneous report refers to a 14 year old female patient. The patient had no concurrent illnesses. Information on the patient's medical history was not reported. The patient's other medications included FOCALIN XR (25 mg, daily). On 09-DEC-2015, the patient was vaccinated with GARDASIL 9 dose 1 via intramuscular route in the right arm for prophylaxis (dosage and lot # unspecified). On the same day, the patient was also vaccinated with FLUZONE dose 10 via intramuscular route in the arm site for prophylaxis (dosage and lot# unspecified). On 09-DEC-2015, the patient experienced fatigue, urticaria, pyrexia, nausea, malaise and injection site pain. Episodes of malaise, nausea and fatigue, initially occurred during the patient's dance class, after getting vaccine. These episodes occurred on a daily basis, mainly in the afternoon and the patient experienced soreness at injection site which lasted approximately for 1 week. The patient felt feverish with hive-like reaction 5 nights after vaccine. The patient was evaluated in the office on 15-DEC-2015 - nonfocal exam except for some tenderness at injection site, right deltoid muscle. Symptoms appeared to resolve several days after the office visit on 15-DEC-2015. The outcome of fatigue, urticaria, pyrexia, nausea, malaise and injection site pain was reported as recovered. The causality assessment for the events with respect to GARDASIL 9 was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: U
Vaccine: FLUN4, HPV9
Symptoms: Headache
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS ID-618307). This spontaneous report as received from a regulatory authority refers to a patient of unknown age and gender. The patient had no current illness. The patient's medical history included, ADHD (Attention deficit/hyperactivity disorder). Other medications included CONCERTA. On 28-SEP-2015 the patient was vaccinated with GARDASIL 9 lot # L004014 dose 1 (unspecified dosage regimen), via intramuscular route in the left arm for prophylaxis. Other suspect therapies included FLUMIST (INTRANASAL (COLD)) dose 2 (unspecified dosage regimen) given on the same day. After vaccinating, the patient experienced headache on the same day. She woke up for two nights complaining of severe headaches. The outcome of headache was reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: FLUN4, HPV9, MNQ
Symptoms: Burning sensation, Cellulitis, Erythema, Injection site erythema, Injection site swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS ID-619135).This spontaneous report refers to a 15 year old female patient. The patient had no current illness. The patient's medical history was not reported. Other medications included DEPO-PROVERA injections. On 18-NOV-2015 the patient was vaccinated with GARDASIL 9 lot # L011846 dose 1 (unspecified dosage regimen), via intramuscular route in the right arm for prophylaxis. Other suspect therapies included MENACTRA (dose 1, intramuscularly in the left arm) and FLUMIST dose 1, given on the same day. The patient's mother stated that the patient had large red bump on left arm where she had vaccination on 18-NOV-2015. The patient was taken to emergency room and was diagnosed with cellulitis. Antibiotics were given. The patients stated her left arm had burning sensation, itching and redness for one and half weeks after vaccination. Vaccine given in this arm was documented to be MENACTRA given in the left deltoid. There was access only to patient and mother reports. The outcome of cellulitis, burning sensation, pruritus, injection site swelling, injection site erythema and erythema was reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: FLUN4, HPV9, MNQ
Symptoms: Pruritus
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS ID-619135).This spontaneous report refers to a 15 year old female patient. The patient had no current illness. The patient's medical history was not reported. Other medications included DEPO-PROVERA injections. On 18-NOV-2015 the patient was vaccinated with GARDASIL 9 lot # L011846 dose 1 (unspecified dosage regimen), via intramuscular route in the right arm for prophylaxis. Other suspect therapies included MENACTRA (dose 1, intramuscularly in the left arm) and FLUMIST dose 1, given on the same day. The patient's mother stated that the patient had large red bump on left arm where she had vaccination on 18-NOV-2015. The patient was taken to emergency room and was diagnosed with cellulitis. Antibiotics were given. The patients stated her left arm had burning sensation, itching and redness for one and half weeks after vaccination. Vaccine given in this arm was documented to be MENACTRA given in the left deltoid. There was access only to patient and mother reports. The outcome of cellulitis, burning sensation, pruritus, injection site swelling, injection site erythema and erythema was reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Encephalitis, Laboratory test, Nervous system disorder
Clinical narrative: Diagnosed with meningoencephalitis and despite comprehensive medical care at Hospital attempt to uncover the etiology of his significant central nervous system dysfunction was unsuccessful. (as copied from discharge summary).
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PPV, VARCEL, HEPA, MMR, PNC13, VARCEL
Symptoms: Anaphylactic reaction, Ear swelling, Erythema, Eyelid oedema, Feeling hot
Clinical narrative: 4/5 Rash all over, swelling of eyes, lips and ears vomited x1. Given BENADRYL 3/4 tsp and taken to ER. Monitored in ER not further Tx. sent home Seen in office 4/7 and referred to allergist.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PPV, VARCEL, HEPA, MMR, PNC13, VARCEL
Symptoms: Lip discolouration, Lip swelling, Rash, Rash erythematous, Urticaria
Clinical narrative: 4/5 Rash all over, swelling of eyes, lips and ears vomited x1. Given BENADRYL 3/4 tsp and taken to ER. Monitored in ER not further Tx. sent home Seen in office 4/7 and referred to allergist.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PPV, VARCEL, HEPA, MMR, PNC13, VARCEL
Symptoms: Vomiting, Wheezing
Clinical narrative: 4/5 Rash all over, swelling of eyes, lips and ears vomited x1. Given BENADRYL 3/4 tsp and taken to ER. Monitored in ER not further Tx. sent home Seen in office 4/7 and referred to allergist.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PPV, VARCEL, HEPA, MMR, PNC13, VARCEL
Symptoms: Ear swelling, Eye swelling, Lip swelling, Rash generalised, Vomiting
Clinical narrative: 4/5 Rash all over, swelling of eyes, lips and ears vomited x1. Given BENADRYL 3/4 tsp and taken to ER. Monitored in ER not further Tx. sent home Seen in office 4/7 and referred to allergist.
Age: 22.0
Sex: F
Vaccine: RAB, TYP, RAB, TYP
Symptoms: Amnesia, Migraine, Reading disorder, Speech disorder, Thinking abnormal
Clinical narrative: Patient reports she received rabies and typhoid vaccinations on 4.11.2017.  Next day she began to have blurry/fuzzy vision.  Her head began to hurt she left her job.  She called a cab for a ride home, but when she tried to tell him her address, she could not remember.  She also could not remember her roommates name.  She went to the emergency department that evening.
Age: 22.0
Sex: F
Vaccine: RAB, TYP, RAB, TYP
Symptoms: Visual impairment
Clinical narrative: Patient reports she received rabies and typhoid vaccinations on 4.11.2017.  Next day she began to have blurry/fuzzy vision.  Her head began to hurt she left her job.  She called a cab for a ride home, but when she tried to tell him her address, she could not remember.  She also could not remember her roommates name.  She went to the emergency department that evening.
Age: 22.0
Sex: F
Vaccine: RAB, TYP, RAB, TYP
Symptoms: Headache, Memory impairment, Vision blurred
Clinical narrative: Patient reports she received rabies and typhoid vaccinations on 4.11.2017.  Next day she began to have blurry/fuzzy vision.  Her head began to hurt she left her job.  She called a cab for a ride home, but when she tried to tell him her address, she could not remember.  She also could not remember her roommates name.  She went to the emergency department that evening.
Sex: U
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. In February 2017 (reported as "one month ago"), the patient was vaccinated with a dose of GARDASIL 9 injection (dose, route of administration, anatomical location, lot # and expiry date were not specified) for prophylaxis. In February 2017, immediately after being administered the GARDASIL 9, the patient experienced redness and pain at the injection site. The patient sought medical attention and reported the symptoms of redness and pain at the injection site to his/her doctor on 22-MAR-2017. Product quality complaint (PQC) was not involved. The outcome of the events was reported as not recovered. The reporter did not provide the causality assessment between the events and GARDASIL 9. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to two unspecified patients of unknown demographics. The patients' pertinent medical histories, concomitant medications and drug reactions or allergies were not reported. On 10-MAR-2017, the patients were inadvertently administered an expired doses of ZOSTAVAX (19400 plaque-forming units, PFU) injection (lot # L027322 with expiration date at 21-OCT-2016; dose, route of administration and anatomical location were not reported) for prophylaxis. There was no adverse effect reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning to a female patient of unknown age. The patient's concurrent conditions, medical history, drug allergies/reactions, and concomitant therapies were not provided. On 23-MAR-2017 the patient was vaccinated with an expired dose of PNEUMOVAX23 lot # L012215, with expiration date of 13-JAN-2017 for prophylaxis (the route, dose, frequency, and strength were not provided). No adverse effects were reported. Additional information is not expected because there was no consent to contact physician.
Sex: F
Vaccine: HPV9
Symptoms: Myalgia
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 20-year-old female patient. The patient did not have pertinent medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On an unspecified date, the patient received de first and second dose of GARDASIL 9 for an unknown indication (dose, frequency, route of administration, lot number and expiration date were not reported). The patient did not present any side effects with those two doses. On 19-MAR-2017, the patient was vaccinated with the third dose of GARDASIL 9 (lot # M007764 expiration date 20-JAN-2018) intramuscular as prophylaxis (dose was not reported). A day after receiving the vaccine (on 20-MAR-2017), the patient experienced a leg muscle pain (myalgia).  Due to the event, the patient was instructed to take ibuprofen and acetaminophen (TYLENOL) as treatment; however, it was not known by the reporter whether or not the leg muscle pain was relieved by the medication. There were no lab diagnostics studies performed. On approximately 27-MAR-2017, the patient recovered from the event. At the time of the report, no further information was available. The causal relationship between the event and therapy was not reported. Additional information has been requested.
Age: 0.58
Sex: M
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a nurse concerning a 7 month old male patient. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On 31-MAR-2017, at the age of 7 months, the patient was vaccinated, with the first dose of ROTATEQ, intramuscularly (dose, strength, frequency, lot# and expiration date were not provided), for prophylaxis. No adverse reactions were reported. Additional information has been requested.