chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: FLUN4, HEPA, HPV4, MNQ, TDAP, FLUN4, HEPA, HPV4, MNQ, TDAP
Symptoms: White blood cell count increased
Clinical narrative: Case number PHHY2014US012660 is an initial spontaneous report received from a consumer (patient's father) via the vaccine adverse event reporting system (VAERS reference number: 513651) on 03 Feb 2014 with follow-up information from the Quality Assurance Department (reference number: 279320) on 03 Mar 2014 and 06 Mar 2014. This report refers to an 11-year-old female patient. She did not have any allergies or chronic illness. She had a loose tooth for few days. Her concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M13014), HAVRIX (other manufacturer, batch number: 494G5) and GARDASIL (other manufacturer, batch number: J011272); all the three vaccines administered intramuscularly in the right arm on 25 Oct 2013. She also received FLUMIST (other manufacturer, batch number: BJ2154) via intranasal route and BOOSTRIX (other manufacturer, batch number: B5X7M) intramuscularly in the left arm on the same date. On 26 Oct 2013, she woke up in the morning and noticed bleeding from mouth before going to school. It was stated that the bleeding appeared more than usual. It was reported that over course of day in school, bruising and petechiae were noticed. She was taken to urgent care and her platelet count was reported as decreased to 2000 (units and normal values were not reported). She was transferred to hospital for admission and treatment. Her white blood cell count (WBC) was increased to 12.1 (units and normal values were not reported). Her hemoglobin (Hb) was 11.9 and hematocrit (Hct) was 35.1 (units and normal values were not reported for Hb and Hct). Her coagulation test, blood urea nitrogen (BUN), creatinine and liver enzymes were reported as normal (results were not reported). The outcome was reported as complete recovery. The seriousness and causality of the event were not reported. Based on the investigation performed by the QA department, it was confirmed that MENVEO batch number M13014, was manufactured in accordance with approved internal procedures and it is was in compliance with the requirements. Non-significant follow-up received from a Quality Assurance Department (reference number: 279320) on 06 Feb 2014: Updated QA reference number. Follow-up received from the Quality Assurance Department (reference number: 279320) on 06 Mar 2014: Updated batch review report.
Age: 16.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Cellulitis, Lymphadenitis, Pyrexia
Clinical narrative: Case number PHHY2014US012801, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 513798) website on 03 Feb 2014 and a follow-up information was received from Quality Assurance Department (reference number: 279242) on 06 Mar 2014. This report refers to a 16-year-old male patient. On an unknown date, he was vaccinated with MENVEO (batch number: M12102, Expiry date: Sep 2014) and BOOSTRIX (batch number: 932Z9) both intramuscularly in the left arm and FLUZONE (batch number: UH900AA) intramuscularly in the right arm. On an unknown date, after vaccination he experienced cellulitis and lymphadenitis of upper arm and fever. The final outcome of the events was reported as recovered. The seriousness and causality of the events were not reported. Batch review report (reference number: 279242) received from quality assurance department on 06 Mar 2014. Based on the batch review performed, it was concluded that concerned MENVEO was manufactured in accordance with approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Follow up received from Quality Assurance Department (reference number: 279242) on 06 Mar 2014: Updated batch review report and expiry date of vaccine.
Age: 22.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Extensive swelling of vaccinated limb
Clinical narrative: Case number PHHY2014US012736 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS, reference number: 514589) website on 03 Feb 2014 and a follow-up information was received from Quality Assurance Department (reference number: 279666) on 03 Mar 2014. This report refers to a 22 year old male patient. His medical history was not reported and his concomitant medication included ADDERALL. He was vaccinated with FLUVIRIN (batch number: 1309401, expiry date: 30 Apr 2014) intramuscularly and PNEUMOVAX (other manufacturer, batch number: H022280) subcutaneously both into right arm on 15 Oct 2013. On 18 Oct 2013, he experienced swollen arm on the same side of shot. He was also diagnosed with cellulitis. He was taken to emergency room for medical support. The outcome of the events was reported as complete recovery. The causality and seriousness of the events were not reported. Based on the investigation performed, QA department stated that, the FLUVIRIN (batch number: 1309401) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Non-significant follow-up received from Quality Assurance Department (reference number: 279666) on 07 Feb 2014: Updated QA reference number only. Follow-up received from Quality Assurance Department (reference number: 279666) on 03 Mar 2014: Updated batch review report.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Arteriogram carotid, Cerebrovascular accident, Disorientation, Echocardiogram, Hypoaesthesia
Clinical narrative: Case number PHHY2014US012764, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 514943) website on 03 Feb 2014, with the follow-up received from Quality Assurance Department (reference number: 279118) on 07 Mar 2014. This report refers to a 74-year-old male patient. His medical history included mantle cell lymphoma. He was vaccinated with FLUVIRIN (batch number: 1309301, expiry date: 30 Apr 2014) intramuscularly in the left arm on 22 Oct 2013. On the same date, 45 minutes after vaccination his right arm went limp and felt disoriented for a short time. Following these events, he also had numbness in right leg and went to ER. He underwent MRI with and without contrast, x-ray heart carotid arteries and transesophageal echocardiogram tests, and was diagnosed as having had a stroke. The final outcome of the events reported as not recovered. Case reported as serious (life-threatening). Based on the investigation performed, QA department stated that, the FLUVIRIN (batch number: 1309301) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 279118) on 07 Mar 2014: Updated batch review report.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Hypotonia, Nuclear magnetic resonance imaging, X-ray
Clinical narrative: Case number PHHY2014US012764, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 514943) website on 03 Feb 2014, with the follow-up received from Quality Assurance Department (reference number: 279118) on 07 Mar 2014. This report refers to a 74-year-old male patient. His medical history included mantle cell lymphoma. He was vaccinated with FLUVIRIN (batch number: 1309301, expiry date: 30 Apr 2014) intramuscularly in the left arm on 22 Oct 2013. On the same date, 45 minutes after vaccination his right arm went limp and felt disoriented for a short time. Following these events, he also had numbness in right leg and went to ER. He underwent MRI with and without contrast, x-ray heart carotid arteries and transesophageal echocardiogram tests, and was diagnosed as having had a stroke. The final outcome of the events reported as not recovered. Case reported as serious (life-threatening). Based on the investigation performed, QA department stated that, the FLUVIRIN (batch number: 1309301) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 279118) on 07 Mar 2014: Updated batch review report.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Case number PHHY2014US012741, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 515476) website on 03 Feb 2014 with a follow up report received from the quality assurance department (QA reference number: 278717) on 04 Mar 2014. This report refers to a 35-year-old male patient. His medical history and concomitant medication was reported. He was vaccinated with FLUVIRIN (batch number: 1309501, Expiry date: 30 Apr 2014) intramuscularly in the left arm on 21 Nov 2013. On 22 Nov 2013, he awoke with redness and warmth at injection site. On 23 Nov 2013, the area had grown and was hard, hot and painful. In the afternoon of 23 Nov 2013, he went to urgent care and was diagnosed with cellulitis. He was treated with ROCEPHIN 1 gm intramuscularly on each hip, along with oral AUGMENTIN 875 mg BID for 7 days which was started on 24 Nov 2013 morning. The final outcome of the events was reported as complete recovery on 25 Nov 2013 afternoon. The seriousness and causality of the events were not reported. No additional information was available. Based on the review performed, the product batch (batch number: 1309501) was manufactured in accordance with the approved internal procedures and in compliance with requirements. Follow up report was received from the quality assurance department (QA reference number: 278717) on 04 Mar 2014: The batch review report was updated.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site warmth
Clinical narrative: Case number PHHY2014US012741, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 515476) website on 03 Feb 2014 with a follow up report received from the quality assurance department (QA reference number: 278717) on 04 Mar 2014. This report refers to a 35-year-old male patient. His medical history and concomitant medication was reported. He was vaccinated with FLUVIRIN (batch number: 1309501, Expiry date: 30 Apr 2014) intramuscularly in the left arm on 21 Nov 2013. On 22 Nov 2013, he awoke with redness and warmth at injection site. On 23 Nov 2013, the area had grown and was hard, hot and painful. In the afternoon of 23 Nov 2013, he went to urgent care and was diagnosed with cellulitis. He was treated with ROCEPHIN 1 gm intramuscularly on each hip, along with oral AUGMENTIN 875 mg BID for 7 days which was started on 24 Nov 2013 morning. The final outcome of the events was reported as complete recovery on 25 Nov 2013 afternoon. The seriousness and causality of the events were not reported. No additional information was available. Based on the review performed, the product batch (batch number: 1309501) was manufactured in accordance with the approved internal procedures and in compliance with requirements. Follow up report was received from the quality assurance department (QA reference number: 278717) on 04 Mar 2014: The batch review report was updated.
Age: 56.0
Sex: M
Vaccine: DTAPIPV, PPV, VARZOS
Symptoms: Influenza like illness
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 51 year old male patient. On 17-DEC-2013 the patient was vaccinated with PNEUMOVAX 23 (subcutaneous, right arm, lot J011651, exp date 22-AUG-2014). Co-suspect therapies included ZOSTAVAX (subcutaneous, right arm, lot J011338 exp date 19-DEC-2014) and DTAP (intramuscular, right deltoid, lot J25EG) both given on 17-DEC-2013. On the same date the patient experienced flu like symptoms. The patient recovered on an unknown date in December 2013. The relatedness was not provided. This case is linked to 1312USA010905, 1403USA003215, 1403USA003217, 1403USA003218, 1403USA003219, 1403USA003220, 1403USA003221, 1403USA003222, 1403USA003223, 1403USA003224, 1403USA003225, 1403USA003226, 1403USA003227, 1403USA003228, 1403USA003229, 1403USA003230, 1403USA003231, 1403USA003232, 1403USA003233, 1403USA003234, 1403USA003235, 1403USA003236, 1403USA003237, 1403USA003238, 1403USA003239, 1403USA003240, 1403USA003241, 1403USA003242, 1403USA003243, 1403USA003244, 1403USA003245, 1403USA003246, 1403USA003247, 1403USA003248, 1403USA003249, 1403USA003250, 1403USA003251, 1403USA003252 and 1403USA003253. Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Information has been received from a physician concerning a 66 year-old female patient, who, on an unspecified date, was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not provided). It was reported that, on an unknown date, the patient developed a huge blister, redness and pain at the injection site. Two days after the vaccination, the patient was seen by the doctor, who prescribed her KEFLEX. Later, on an unspecified date, the patient saw the patient again and reported that "everything resolved". Relatedness between huge blister, redness and pain at the injection site and ZOSTAVAX was not mentioned. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Injection site abscess, Injection site pain
Clinical narrative: Information has been received from a physician concerning a 66 year-old female patient, who, on an unspecified date, was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not provided). It was reported that, on an unknown date, the patient developed a huge blister, redness and pain at the injection site. Two days after the vaccination, the patient was seen by the doctor, who prescribed her KEFLEX. Later, on an unspecified date, the patient saw the patient again and reported that "everything resolved". Relatedness between huge blister, redness and pain at the injection site and ZOSTAVAX was not mentioned. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chapped lips, Injection site erythema, Injection site swelling, Injection site warmth, Oral herpes
Clinical narrative: Vaccine site, left arm, swollen to size of golf ball, red ring around, and hot for about 2 weeks. I have never had a fever blister and started developing about day and 1/2 fever blister on lips and inside mouth and could not get rid of them for 4 months with ZOVIRAX pills for 10 days. Once and then another round of ZOVIRAX the FAMVIR and ZOVIRAX cream finally got rid of. I still have scars on lips from fever blisters.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Oral herpes, Scar, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Vaccine site, left arm, swollen to size of golf ball, red ring around, and hot for about 2 weeks. I have never had a fever blister and started developing about day and 1/2 fever blister on lips and inside mouth and could not get rid of them for 4 months with ZOVIRAX pills for 10 days. Once and then another round of ZOVIRAX the FAMVIR and ZOVIRAX cream finally got rid of. I still have scars on lips from fever blisters.
Age: 10.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain upper, Headache
Clinical narrative: My daughter was given the GARDASIL vaccine 08/12/2013 and on 10/21/2013. I was not told about any serious effects that have occurred to other people. My daughter has had headaches and aches/pains in her body since she received the second shot.
Age: 10.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Headache, Pain
Clinical narrative: My daughter was given the GARDASIL vaccine 08/12/2013 and on 10/21/2013. I was not told about any serious effects that have occurred to other people. My daughter has had headaches and aches/pains in her body since she received the second shot.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Headache, Loss of consciousness, Nausea, Urine analysis
Clinical narrative: This spontaneous report was received from a Nurse refers to a 11 year old female patient. On 27-FEB-2014 the patient was vaccinated with GARDASIL lot # H021346 (Expiry: 01-OCT-2015), 0.5 ml, intramuscular. On 28-FEB-2014, 2 days after onset of therapy the patient experienced everything went black and then she developed headache and nausea. The patient sought medical attention and visited the office. The patient was prescribed with TYLENOL and MOTRIN. On an unknown date, the patient had blood pressure checked and urine analysis completed but results were not specified. The nurse stated that prescription was rest fluid, check urine output closely. On an unknown date, the patient was feeling fine. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age with penicillin (manufacture unknown) allergy and codeine (manufacture unknown) allergy. On an unknown date, patient developed allergic reaction to codeine (manufacture unknown) and penicillin (unspecified) (manufacture unknown). On an unknown date, patient was vaccinated with first dose of PNEUMOVAX 23 (strength, dose unit, route, lot# and expiry date unknown). On 07-MAR-2014, the patient was vaccinated with booster dose of PNEUMOVAX 23 0.5 ml with lot number (J010395) and expiry date 16-FEB-2015 intramuscularly. On 07-MAR-2014, 5 hours later, patient experienced severe arm pain and called pharmacist for medical attention and she had no problems with the first dose of PNEUMOVAX 23. No laboratory tests were performed. the outcome of severe arm pain was reported as not recovered/not resolved. No further information was provided. This case # 1403USA004795 is linked to case # 1403USA005016 and 1403USA005017 via same patient link. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to a 23 year old patient of an unknown gender. On 06-MAR-2014, the patient was vaccinated with a dose of properly stored VARIVAX (Merck) (lot # 0418AE), 0.5 ml, subcutaneously that had expired on 27-FEB-2014. No adverse events were reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age with thyroid issues, migraines and dexamethasone (manufacturer unknown) allergy. On 21-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX, vial (dose and route unspecified) for shingles prevention. Concomitant therapies included levothyroxine sodium (manufacturer unknown), sumatriptan, naproxen sodium, TREXIMET and estrogens, PREMARIN. On an unspecified date the patient developed hives around her back and stomach. Patient saw an unspecified physician who prescribed an unspecified antihistamine on an unspecified date. Patient was fully recovered on an unspecified date. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 56 years old non pregnant female patient with no drug reactions, allergies and no pertinent medical history. On 26-FEB-2014 the patient was vaccinated subcutaneously with ZOSTAVAX (dose 0.65 ml, once, lot # reported as J011548, expiration date reported as 19-DEC-2014). There were no concomitant medications. The pharmacist reported that after a patient was administered ZOSTAVAX (in approximately February 2014) she developed a bump the size of her hand, that was hard and hot to the touch at the injection site. There were no lab diagnostics studies performed. There was no treatment given for the events. The outcome of the event was reported as not recovered. The patient sought medical attention by calling the pharmacist. The relatedness between the event and suspect vaccine was not reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain in extremity
Clinical narrative: This spontaneous report was received from a male physician of unknown age via company representative and referred to a physician himself. No pertinent medical history, drug reactions or allergies were reported. On an unknown date (reported as an awhile ago), the patient was vaccinated with ZOSTAVX (lot #, expiration date, strength, dose and frequency were not reported) via. No concomitant medications were reported.The reported stated that approximately on 30-JAN-2014 (reported as about 5 weeks ago), he got shingles and he had chronic pain in his leg. The pain in his leg was a level 10, except if he put topical medication on the leg, then the pain level was a 4. The outcome of events was unknown at the time of the report. The relatedness between ZOSTAVAX and events shingles and chronic pain in his leg was not reported. Additional information has been requested.
Age: 1.6
Sex: M
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a certified nurse practitioner refers to a 20 month old male child. On 03-MAR-2014 the patient was inadvertently vaccinated with PNEUMOVAX 23 instead of PREVNAR 13. Lot number, expiry date, route of administration and anatomical location of the vaccination were not reported. The outcome of the event and treatment information were not reported. No adverse effects were reported. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old male patient. The patient had no drug allergies or reactions. On 28-FEB-2014 the patient was vaccinated with ZOSTAVA lot # J011333, Expiry date: 13-DEC-2014 in the right deltoid region. Concomitant therapies included inhaled corticosteroids (unspecified). On 03-MAR-2014, (reported as on Monday) the patient developed redness and warmth at his injection site. The patient sought medical attention by consulting the pharmacist. The pharmacist reported that his injection site was not raised and there was no evidence of a vesicular rash. No treatment as rendered for the event. The patient was recovering from the event. The patient did not notify his physician. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age (reported as "in her 40's"). On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route of administration and Lot number not provided). No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of unspecified patients of unknown age and gender were administered doses of ROTATEQ (Lot# unspecified) dose, route, frequency and location unspecified that was stored outside the recommended temperature range as noted in the prescribing information. No adverse effects reported. This is one of several repots received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of unspecified patients of unknown age and gender were administered doses of GARDASIL (Lot# unspecified) dose, route, frequency and location unspecified that was stored outside the recommended temperature range as noted in the prescribing information. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of unspecified patients of unknown age and gender were administered doses of VAQTA (Lot# unspecified) dose, route, frequency and location unspecified that was stored outside the recommended temperature range as noted in the prescribing information. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site warmth, Night sweats
Clinical narrative: On 3/8/14 pt noticed a small red area on L upper arm. Area slowly became bigger over the next 2-3 days. Fever, chills and night sweats last night. Area L upper arm red, tender, warm to touch. Tx with Cephalexin 500mg, po 4 times 1 day x 10 days.
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: On 3/8/14 pt noticed a small red area on L upper arm. Area slowly became bigger over the next 2-3 days. Fever, chills and night sweats last night. Area L upper arm red, tender, warm to touch. Tx with Cephalexin 500mg, po 4 times 1 day x 10 days.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Irritability, Pyrexia, Rash morbilliform
Clinical narrative: Measles like rash with low grade fever and irritability.
Age: 1.23
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Gait disturbance, Pyrexia, Urticaria
Clinical narrative: Pt seen at clinic on 03/07/2014 for 15 mo WCC - given PENTACEL. The next day child developed fever and refused to walk. Also developed hives - was taken to ED - no tx. Attempted cath UA unsuccessful - told to RTC but came to clinic instead treated with BENADRYL.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site mass, Injection site urticaria, Rash papular
Clinical narrative: Lump on (R) upper arm with purpura and some raised wheals.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Lip swelling, Swelling face, Swollen tongue
Clinical narrative: After rotavirus ingestion, the patient had swelling of the face and lips and tongue.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Petechiae
Clinical narrative: Questionable petechiae developed on face and some on chest after vaccines were administered pt was given 10ml of prednisone 15mg/5ml as a precaution. Patient had no SOB and looked ok. Patient was observed for 15 min. and was released. Patient left happy no difficulties.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a patient, who on 07-MAR-2014 was vaccinated with an expired dose of VARIVAX (Merck) (dose not provided, lot # 0082AE, expiry date 03-JAN-2014). No adverse effects were reported. Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Pt came in office with rash on left side x 3-4 days. Itching too. Pt has been prescribed Valacyclovir and Hydrocortisone. No pain at this time.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Pruritus, Rash
Clinical narrative: Pt came in office with rash on left side x 3-4 days. Itching too. Pt has been prescribed Valacyclovir and Hydrocortisone. No pain at this time.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Seen Health Center on 2-25-2014 with fine rash face - upper chest and back. Given a MEDROL dose pak 24mg (taper) 2 weeks prior to 2-25-2014 - by Dr. - rash came on within 1-2 wks after Zoster vaccine. Still has rash and itching 3-10-14. Patient started on VALTREX 500mg 1 PO TID 3-10-2014 x 30days. Improving.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia
Clinical narrative: Shoulder joint pain.
Age: 0.39
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Dyskinesia, Electroencephalogram normal, Tremor
Clinical narrative: Leg jerks. Arm jerks. Whole body shake/tremor. Jerking and shaking events now occur every 6 to 8 days.
Age: 0.35
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC13, RV5
Symptoms: Abdominal pain, Condition aggravated, Drug intolerance, Eczema, Infantile spasms
Clinical narrative: 02/13/14-Seen for eczema flair and diagnosed with intolerance of Protopic. 02/18/14-Irritability reported by phone-? of side effect of Rotateq. 02/21/14-Seen for colic-like symptoms. 03/03/14-Seen for history of seizure like episodes; ref to neurologist. 03/04/14-Diagnosed by neurologist with infantile spasms.
Age: 0.35
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC13, RV5
Symptoms: Irritability, Seizure like phenomena
Clinical narrative: 02/13/14-Seen for eczema flair and diagnosed with intolerance of Protopic. 02/18/14-Irritability reported by phone-? of side effect of Rotateq. 02/21/14-Seen for colic-like symptoms. 03/03/14-Seen for history of seizure like episodes; ref to neurologist. 03/04/14-Diagnosed by neurologist with infantile spasms.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Swelling
Clinical narrative: Redness bruising swelling.
Age: 0.13
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Haematochezia, Intussusception, Milk allergy
Clinical narrative: Significant amount of bloody stool.  Went to hospital and was dx with Milk Protein Allergy.  PCP feels it was intussusception.
Age: 0.21
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Death
Clinical narrative: Deceased 1/11/14 - mom found at 5AM no previous signs.
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: CSF test normal, Computerised tomogram head normal, Ear infection, Endotracheal intubation, Febrile convulsion
Clinical narrative: Complex febrile seizure requiring multiple meds (Versed, Phenobarbital, Dilantin) and intubation for airway protection ( < 24 hrs.). Fever persisted to 3/2/14. On 3/5/14 (R) mild otitis seen (had 2 doses Ceftriaxone in hosp).
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Pyrexia, White blood cell count normal
Clinical narrative: Complex febrile seizure requiring multiple meds (Versed, Phenobarbital, Dilantin) and intubation for airway protection ( < 24 hrs.). Fever persisted to 3/2/14. On 3/5/14 (R) mild otitis seen (had 2 doses Ceftriaxone in hosp).
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Erythema, Rash, Rash pruritic
Clinical narrative: 2 days after injection, cheeks were bright red. 1 day later, arms, legs and torso broke out in rash that itched. BENADRYL every 4 hours to control itch.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Reddened area, left upper arm, measuring 2" x 2 1/2", area swollen and painful to touch. Patient reports temp of 100.2 on 2/27/14. Temp was 98.1 on 2/28/14.
Age: 61.0
Sex: F
Vaccine: FLU3, MMR, MNQ
Symptoms: Fatigue, Laboratory test, Lip ulceration, Tongue ulceration
Clinical narrative: 3-6-14 1155AM - Dr calls and says patient presents to their clinic complaining of fatigue and ulcers lower lip and tongue for "2-3 days". Doctor requested VIS info, on each vaccine. Says he doesn't think symptoms relate to vaccines, but will do additional testing/blood work and call if he finds any significant info. Says he will also hydrate client - no other information shared.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Paralysis
Clinical narrative: Numbness began late November 2013 - early December. Hospitalized 1/18/2014 with paralysis. Dx Guillain - Barre Syndrome. Released from hospital 2/28/14. To receive Home Health PT.
Age: 14.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Pt. given HPV and meningococcal vaccine (MENACTRA). Within a minute, (+) syncopal episode, fell of exam table, within 2 min awake and oriented x3, vitals stable, no distress.
Age: 12.0
Sex: M
Vaccine: MNQ, TYP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Large red swollen area at site of administration 15 cm x 11 cm.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Hyperhidrosis, Muscle twitching, Pallor
Clinical narrative: Moments after receiving #1 HPV and #1 Hep A child became twitchy, pale, diaphoretic. Episode lasted 2 min. VS stable, never lost consciousness.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site swelling
Clinical narrative: (R) arm (deltoid) swelling.
Age: 18.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse reaction, patient was given HAVRIX 1440 and should have been given HAVRIX 720 due to age.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pt. reports pain in her left shoulder since the date of the immunization.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Fall
Clinical narrative: Immuniz. given at 2:33 PM 3/6/13. Pt felt faint on her way out of the office but did not appear to lose consciousness - fell to floor. No injury. Was asked to wait 15 min after admin but Mom had declined due to other commitments.
Age: 68.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Atrial fibrillation, Cardiac failure congestive, Cough, General physical health deterioration, Influenza like illness
Clinical narrative: Got shingles vaccine shot on 1-10-13 - next day started w/ flu like  symptoms - then started a cough that would not stop - then went into A-Fib and had to be admitted to hospital and have went downhill from there. Looking this vaccine up on internet the info states that app. 1 1/2% of people taking this vaccine comes down with congestive heart failure. Nowhere on their info sheet (pharmacy) does this info appear. Congestive heart failure can be fatal and people should be warned about this before taking this vaccine. I would not have taken it if I had known this before taking it.
Age: 0.21
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash, Varicella virus test positive
Clinical narrative: Lab work (viral culture) (varicella) positive. Rash - OV 2/25/14.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Erythema, Headache, Nausea, Swelling
Clinical narrative: Pt had swelling and redness immediately after injection. Pt presented to ED 2 weeks later with dizziness, headaches, and nausea. Pt discharged home with azithromycin, meclizine, and oxymetazoline nasal spray. Meclizine 25 mg TID.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with GARDASIL (dose, route and lot# not provided). On an unknown date, the patient may have received a GARDASIL dose too early. No adverse effects were reported. Additional information is not expected.
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abortion spontaneous, Exposure during pregnancy, Influenza
Clinical narrative: Flu shot on 9/10/13. Caught flu and miscarried 9/23/13.
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abortion spontaneous, Abortion threatened, Bed rest, Chills, Chromosome analysis normal
Clinical narrative: Flu shot on 9/10/13. Caught flu and miscarried 9/23/13.
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dysuria, Exposure during pregnancy, Haemorrhage in pregnancy, Haemorrhage urinary tract, Pyrexia
Clinical narrative: Flu shot on 9/10/13. Caught flu and miscarried 9/23/13.
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Shortened cervix, Ultrasound antenatal screen abnormal, Urinary tract infection, Uterine contractions during pregnancy, Uterine spasm
Clinical narrative: Flu shot on 9/10/13. Caught flu and miscarried 9/23/13.
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Vomiting, White blood cell count increased
Clinical narrative: Flu shot on 9/10/13. Caught flu and miscarried 9/23/13.
Age: 18.0
Sex: F
Vaccine: ANTH
Symptoms: Anxiety, Depression, Haemorrhoids, Infertility female, Mental disorder
Clinical narrative: Fertility issues, tilted uterus, hemorrhoids, cysts on ovaries, mental health issues, anxiety, depression, suicide attempts, mental health issues for offspring.
Age: 18.0
Sex: F
Vaccine: ANTH
Symptoms: Ovarian cyst, Suicide attempt, Uterine malposition
Clinical narrative: Fertility issues, tilted uterus, hemorrhoids, cysts on ovaries, mental health issues, anxiety, depression, suicide attempts, mental health issues for offspring.
Age: 22.0
Sex: F
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Injection site erythema, Injection site inflammation, Injection site nodule
Clinical narrative: Chronic local pink/red inflamed nodule measuring about 2.5 cm x 2.0 cm at site of inoculation right upper arm over deltoid.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Condition aggravated, Fluid retention, Headache, Hypertension, Hypertensive crisis
Clinical narrative: Received flu shot 10/30/13. HTN crisis 11-12-13 and hospitalized x 3 days. Continued to have HTN, neck pain, headache, general malaise, edema, fluid retention. Had HTN crisis, HAs, neck pain in 2012 after flu shot given 10-7-12. Hosp x 2 wks with same effects. All or most of labs, invasive procedures WNLs. In 2012 effects wore off in 2 1/2 months. Still waiting for symptoms to subside. Will provide medical documentation or sign consent for authorization.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Laboratory test normal, Malaise, Neck pain, Oedema
Clinical narrative: Received flu shot 10/30/13. HTN crisis 11-12-13 and hospitalized x 3 days. Continued to have HTN, neck pain, headache, general malaise, edema, fluid retention. Had HTN crisis, HAs, neck pain in 2012 after flu shot given 10-7-12. Hosp x 2 wks with same effects. All or most of labs, invasive procedures WNLs. In 2012 effects wore off in 2 1/2 months. Still waiting for symptoms to subside. Will provide medical documentation or sign consent for authorization.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Headache, Hypertensive crisis, Neck pain
Clinical narrative: Received flu shot 10/30/13. HTN crisis 11-12-13 and hospitalized x 3 days. Continued to have HTN, neck pain, headache, general malaise, edema, fluid retention. Had HTN crisis, HAs, neck pain in 2012 after flu shot given 10-7-12. Hosp x 2 wks with same effects. All or most of labs, invasive procedures WNLs. In 2012 effects wore off in 2 1/2 months. Still waiting for symptoms to subside. Will provide medical documentation or sign consent for authorization.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Abnormal behaviour, Crying, Inappropriate affect, Laboratory test normal
Clinical narrative: Patient showed unusual behavior (laughing /crying) his wife took him to the ER 10:30P that night. Discharged same night wife said that all tests are normal.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pallor, Rash erythematous, Rash maculo-papular
Clinical narrative: Rash (widespread, red, blanching, maculopapular). No other symptoms. No specific treatment. Consistent with possible VARIVAX rash.
Age: 75.0
Sex: F
Vaccine: FLU3, UNK
Symptoms: Injection site pain, Local swelling, Pain
Clinical narrative: Patient came in on 12/1/13 and said she was still having extreme soreness to the touch and to lift her arm from a flu shot given on. Pt said when the (10/31/13) shot was given she felt a lot of pain and her arm swelled a lot.
Age: 75.0
Sex: F
Vaccine: FLU3, UNK
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Patient came in on 12/1/13 and said she was still having extreme soreness to the touch and to lift her arm from a flu shot given on. Pt said when the (10/31/13) shot was given she felt a lot of pain and her arm swelled a lot.
Age: 34.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Cellulitis, Chills, Injection site erythema, Musculoskeletal stiffness
Clinical narrative: Had redness at injection site. Developed rash, itching, cellulitis, joint pain, stiffness, fever and chills.
Age: 34.0
Sex: M
Vaccine: PPV
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: Had redness at injection site. Developed rash, itching, cellulitis, joint pain, stiffness, fever and chills.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Dysphonia, Increased upper airway secretion
Clinical narrative: Patient reported having increased production of phlegm in throat, resulting in the need to clear his throat "500 times per day" per patient. He states that he had/has a very hoarse voice and reports possible redness at back of throat. Saw his primary physician who then referred him to an ENT to be scoped. No diagnosis at this time. He takes Benadryl at night which seems to alleviate his symptoms. Air quality was listed as "unsafe" around that time. He may be experiencing severe allergy symptoms and states he is not sure whether or not any of this is related to the vaccine but wanted it reported.
Age: 13.0
Sex: M
Vaccine: FLU3, HEPA, HPV4, MNQ, HPV4
Symptoms: Injection site reaction, Rash macular
Clinical narrative: Child was at school and noticed red blotches on left upper arm which started during the day at school.  No other s/s were experienced.  Child told legal guardian about it when he got home from school that day and she called the health department and sent follow-up picture of arm via email.
Age: 13.0
Sex: M
Vaccine: FLU3, HEPA, HPV4, MNQ, HPV4
Symptoms: Local swelling, Rash macular
Clinical narrative: Child was at school and noticed red blotches on left upper arm which started during the day at school.  No other s/s were experienced.  Child told legal guardian about it when he got home from school that day and she called the health department and sent follow-up picture of arm via email.
Age: 53.0
Sex: F
Vaccine: FLU3, HEP, PPV, TDAP
Symptoms: Erythema, Local swelling, Pain in extremity
Clinical narrative: Patient had 2 vaccines in each arm, right arm was very painful throughout the evening, later became red and swollen.  She took ibuprofen for pain and alternated cold and heat on it.  Day three she called her physician who prescribed Tylenol 3 for pain.
Age: 1.03
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Immediate post-injection reaction, Induration, Injection site erythema, Injection site swelling, Skin warm
Clinical narrative: Immediate and localized erythema and swelling at and around injection sites. Warm and firm to touch. Dr. notified at time of incident.  Benadryl given, which resulted in reduced redness and swelling approximately 15 minutes later.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Musculoskeletal pain, Pain
Clinical narrative: Immediate shoulder pain when vaccination was injected.  Sought visit to the MD on 3/10/2014 when pain was still present and unable to lift left arm without significant pain.
Age: 14.0
Sex: F
Vaccine: YF
Symptoms: Fall
Clinical narrative: Patient in to receive Yellow Fever vaccination. Patient left clinic room with mother to go to check out. Patient was in check out for five minutes, when per patient hit and slid down the check out door. Elevated patient's feet on chair, and applied cold compress to the back of patient's neck while patient remained on floor. After ten minutes we then let patient sit up and drink some water for five minutes before she stood up. Patient left with mother without any more incidence.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Vaccination site pain
Clinical narrative: Patient seen by clinican at clinic on 3/6/14 reporting soreness to site since vaccine was administered. Pain improved initially then worsened. Hurts to lie on R side, pain is 3-5/10. Pain is not constant just with activity.
Age: 0.44
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Muscle twitching, Pyrexia
Clinical narrative: Fever, admitted to Hosp.- went up to 104 degrees- possible seizure(parent reported twitching), then to normal temperature.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient had localized redness & swelling to injection site, reported no pain, no itching, no fever, no additional symptoms. Patient came into school nurse office & stated had not noticed but someone in class pointed out redness.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pustule, Local swelling, Oedema peripheral
Clinical narrative: Swelling and edema on arm that spread down toward elbow. Sore at injections site with visible pustule present. Patient states started 2 hours post vaccination and has been present for 3 days.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Chest pain, Decreased appetite, Epistaxis, Headache
Clinical narrative: Back and chest pain left side. Shingles rash left side at 11:00 am 03/06/2014. Pain rash nausea headache blood from left nostril body ache over whole body loss of appetite.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Nausea, Pain, Rash
Clinical narrative: Back and chest pain left side. Shingles rash left side at 11:00 am 03/06/2014. Pain rash nausea headache blood from left nostril body ache over whole body loss of appetite.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Lymphadenopathy, Pyrexia, Rash, Rash erythematous, Rash pruritic
Clinical narrative: On 03/1/14 upon waking up at 9 AM child had fever of 99 degrees F. On 03/3/01 swollen glands in his neck accompanied the low grade fever. On 3/10/14 child's face broke out in a rash. By 3/11/14 child's entire face, neck and torso were covered in a raised, red, itchy, rash. Low grade fever was off and on. Still has swollen glands in his neck.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Myalgia, Pyrexia
Clinical narrative: Fever (tactile), myalgia and dizziness.
Age: 24.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Patient became pale and diaphoretic, weak and dizzy - 2 mins after administration of TDAP vaccine, symptoms resolved after 5 mins.
Sex: F
Vaccine: VARZOS
Symptoms: Anaphylactic reaction, Drug hypersensitivity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown date a couple of years ago the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose and route unspecified) and patient developed anaphylactic reaction due to neomycin allergy. The patient might have been hospitalized for this reaction, but it's unspecified whether she was admitted or stayed overnight. Patient sought medical attention. It was reported the event was improved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Death
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age. On 19-DEC-2013 the patient was vaccinated with ZOSTAVAX, subcutaneous. No details regarding the dosing regimen were provided. It was unknown if the patient received any co-suspected or concomitant medications. On 09-JAN-2014, the patient experienced patient deceased. No further details were provided. The action taken with ZOSTAVAX was unknown and a causality assessment was not provided. Additional information has been requested.
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered at inappropriate site, Injection site nerve damage, Injection site pain
Clinical narrative: Case number PHEH2014US004434, is an initial spontaneous report from a consumer received on 03 Mar 2014. This report refers to a female patient of unknown age. Past medical history and concomitant medications were not reported. She was vaccinated with FLUCELVAX (batch number: not reported) into the nerve in the left arm on an unknown date. On 16 Nov 2012, she developed intense pain in the left arm where the vaccine was administered. The final outcome of the event was condition unchanged at the time of reporting. The physician stated that it will be 6 months to 1 year before the patient heals. The seriousness and causality of the event were not reported.