chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.28
Sex: F
Vaccine: DTAP
Symptoms: Injection site urticaria, Pyrexia, Urticaria
Clinical narrative: Hives over entire body including legs and arms that ebbed and flowed for the next 5 days after first onset. Fever of 102° and higher. No other vaccination was administered to patient that day. The vaccine was Daptacel.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site vesicles
Clinical narrative: Blister at the injection site.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site rash, Nausea, Pain, Vomiting
Clinical narrative: Information has been received from a healthcare worker referring to a 67 year old female patient. On 22-APR-2015 the patient was vaccinated with ZOSTAVAX lot # K023623 for prevention of shingles (dose, route and application site were not reported). Concomitant therapies included omeprazole (manufacturer unknown) and levothyroxine sodium (manufacturer unknown). On 23-APR-2015 the patient called the pharmacy to reported that she began to experienced nausea, headache, whole body aches, injection site rash and vomiting on 23-APR-2015 the day after receiving ZOSTAVAX. The patient visited an unspecified urgent care clinic on an unspecified date due to the symptoms and was given a prescription for unspecified antibiotics. The outcome of events was reported as ont recovered. The causality between ZOSTAVAX and the events was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. Patient medical history and current condition was not reported. On 15-APR-2015 the patient was vaccinated with ROTATEQ oral liquid (unknown dose and Lot number) orally for prophylaxis which underwent supported temperature excursions. Reporter stated that since 8-APR-2015, the doses of ROTATEQ underwent supported temperature excursions. No adverse effects reported. The outcome of the event was unknown. This is one of the 5 reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse (R.N.) referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were vaccinated with GARDASIL (lot # K004205, expiration date 12-JAN-2017, lot# K005881, 14-JAN-2017; dose and route not reported) that had been improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. Patient medical history and current condition was not reported. On 16-APR-2015 the patient was vaccinated with ROTATEQ oral liquid (unknown dose and Lot number) orally which underwent supported temperature excursions. Reporter stated that since 8-APR-2015, the doses of ROTATEQ underwent supported temperature excursions. No adverse effects reported. The outcome of the event was unknown. This is one of the 5 reports received from the same reporter. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Pain, Pharyngeal erythema, Pruritus
Clinical narrative: Swollen, itchy, red, burn and stinging, warm to touch. Back of throat-> uvula red also red.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Swelling
Clinical narrative: Swollen, itchy, red, burn and stinging, warm to touch. Back of throat-> uvula red also red.
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Nodule, Skin warm
Clinical narrative: Knot to Lt arm-erythematous, warm to touch; approximately 1 1/2 inches.
Age: 79.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Blister, Crying, Erythema, Rash
Clinical narrative: Administered ZOSTAVAX and PREVNAR vaccines after pre-screening pt for appropriateness and if any contraindication present. Pt developed rash consisting of blisters, redness, weeping lesions on legs first, then arms, then trunk. Pt presented to MD office Thurs 5/14 and was prescribed prednisone, Amoxil, and clobetasol cream. As of 5/14 7pm rash is resolving per pt.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse (R.N.) referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were vaccinated with PNEUMOVAX 23 single dose vials (lot # K007826, expiration date 03-FEB-2016; dose and route not reported) that had been improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. Patient medical history and current condition was not reported. On 10-APR-2015 the patient was vaccinated with GARDASIL (unknown dose and lot number) via intramuscular route which underwent supported temperature excursions. Reporter stated that since 8-APR-2015, the doses of GARDASIL underwent supported temperature excursions. No adverse effects reported. The outcome of the event was unknown. This is one of the 5 reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. Patient medical history and current condition was not reported. On 13-APR-2015 the patient was vaccinated with GARDASIL (unknown dose and lot number) via intramuscular route which underwent supported temperature excursions. Reporter stated that since 8-APR-2015, the doses of GARDASIL underwent supported temperature excursions. No adverse effects reported. The outcome of the event was unknown. This is one of the 5 reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. Patient medical history and current condition was not reported. On 08-APR-2015 the patient was vaccinated with GARDASIL (unknown dose and lot number) via intramuscular route which underwent supported temperature excursions. Reporter stated that since 8-APR-2015, the doses of GARDASIL underwent supported temperature excursions. No adverse effects reported. The outcome of the event was unknown. This is one of the 5 reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse (R.N.) referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were vaccinated with MMR II (rHA) (K002036, expiration date 10-FEB-2016; lot# K005431, expiration date 15-APR-2016; lot# K009957, expiration date 17-JUL-2016; dose and route were not reported) that had been improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse (R.N.) referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were vaccinated with ROTATEQ (lot # K001450, expiration date 18-OCT-2015; lot# K006805, expiration date 24-MAR-2016; lot# K010221, 12-MAY-2016; lot# K0103323, 10-MAY-2016; lot# K023535, 22-MAY-2016; dose was not reported) which had been improperly stored. No adverse effects were reported. This one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PNC13, PPV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a health care professional refers to unspecified number of patients. This is a market research program. The reporter stated that in his/her hospital they decided to administer PNEMOVAX 23 (dose, route, lot number and expiration date were not provided) with PREVNAR 13 to at least some adult patients because PREVNAR 13 protected them against 13 strains which are not in PNEUMOVAX 23. Patient's outcomes were unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Injection site pain, Injection site paraesthesia, Pain in extremity
Clinical narrative: Information has been received from an unknown age female consumer referring to himself. Information regarding concurrent condition and medical history was not reported. On 12-FEB-2015 the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot# not reported). Concomitant therapy was not reported. On an unknown date in 2015, after receiving ZOSTAVAX, the patient experienced numbness, tingling and pain at the injection site, to the tip of her fingers. The patient visited physician office. The outcome of the events was reported as not recovered. Additional information is not expected because no demographics were provided for the patient or physician.
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Information has been received from an unknown age female consumer referring to himself. Information regarding concurrent condition and medical history was not reported. On 12-FEB-2015 the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot# not reported). Concomitant therapy was not reported. On an unknown date in 2015, after receiving ZOSTAVAX, the patient experienced numbness, tingling and pain at the injection site, to the tip of her fingers. The patient visited physician office. The outcome of the events was reported as not recovered. Additional information is not expected because no demographics were provided for the patient or physician.
Sex: U
Vaccine: MMR
Symptoms: No adverse event
Clinical narrative: This spontaneous report as received from person from practice via company representative refers to 3 patients of unknown ages and genders who on unknown dates were vaccinated with a dose of MMR II (dose, lot #, expiration date and route were not provided). On unknown dates the patients developed reactions (not specified) to unspecified lot of MMR II (vaccination complication). At the time of the report, the outcome of vaccination complication was not reported. This is one of several reports from the same source. Additional information is not expected. There was no consumer information to contact for follow-up.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On 06-MAY-2015 the patient was vaccinated with a dose of improperly stored (Merck) VARIVAX (dose 0.5 ml, lot# and expire date not reported) subcutaneously. No adverse experiences were reported. Additional information has been requested.
Sex: M
Vaccine: CHOL, TYP
Symptoms: Cellulitis, Culture negative, Ocular hyperaemia, Pyrexia
Clinical narrative: This case was found during archiving activities and has not previously been entered into the global safety database. The case was processed using procedural documents and current labeling documents. This spontaneous report was received from a physician, via a company representative and concerns a male subject of unspecified age: US9104. The subject's weight, height and medical history were not reported. The subject received typhoid vaccine oral ty21a (capsule, hard, oral, batch 115382A) on 12-MAY-1991 as a prophylactic vaccination. Non-company suspect drugs included: cholera vaccine (injection) as a prophylactic vaccination. Concomitant medications were not reported. On 16-MAY-1991, 07:00, the subject experienced cellulitis, high fever and red eyes. He was hospitalised for 1 day. Cultures (not specified) were taken on an unspecified date, and the results were negative. Action taken with typhoid vaccine oral ty21a and cholera vaccine was unknown. The subject had recovered from cellulitis, high fever and red eyes on an unspecified date. This report was serious (hospitalization).  This follow-up information was found during archiving activities and has not previously been entered into the global safety database. The case was processed using procedural documents and current labelling documents. Additional information was received from a physician on 30-JUN-1991. Additional reference (regulatory authory #1-0014) number added. On 16-MAY-1991, 4 days after initiation of vaccination the subject experienced cellulitis, high fever and red eyes.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Cellulitis, Injection site cellulitis
Clinical narrative: Case number PHHY2013US071181, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 478703) website on 03 Jul 2013, with a follow up received from the QA department (239504) on 08 Jul 2013, with the follow-up information received from Quality Assurance Department (reference number: 239504) on 22 Jul 2013. This report refers to a 63-year-old female patient. Her medical history and concomitant medications was not reported. On 16 Nov 2012, she was vaccinated with FLUVIRIN (batch number: not reported), ZOSTAVAX (batch number: not reported) at unspecified sites. She was also vaccinated with PNEUMOVAX (batch number: 1706AA, expiry date: 03 Oct 2013) subcutaneously on the same day. On 18 Nov 2012, she developed cellulitis around the injection site of PNEUMOVAX that spread to her waist. She visited the emergency room. She was prescribed an antibiotic. The event outcome was condition unchanged as of 28 Nov 2012. The seriousness and causality were not reported. Seriousness assessment of injection site cellulitis was upgraded based on the NVS-IME list. QA department stated that, as no batch number was provided, this batch review was performed based on a general review of the quality requirements for FLUVIRIN and the Annual Product Review for the FLUVIRIN 2012, it was concluded that FLUVIRIN manufacturing process was operated at a good level of overall control and the supporting systems are effective in supporting the compliant production, testing and supply processes for FLUVIRIN vaccine. From this conclusion there was no reason or explanation to account for the reported adverse event. Non-significant follow up received from the QA department on 08 Jul 2013: Updated QA reference number. Follow-up information received from Quality Assurance Department (reference number: 239504) on 22 Jul 2013: Updated FLUVIRIN annual product review report.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Vaccination site cellulitis
Clinical narrative: Case number PHHY2013US140283 is an initial spontaneous report received from a pharmacist via vaccine adverse event reporting system (VAERS reference number: 504389) on 03 Dec 2013, with the follow-up information received from Quality Assurance Department (reference number: 269177) on 17 Dec 2013. This report refers to a 66 years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: not reported) in the left arm and PNEUMOVAX 23 (other manufacturer, batch number: J004747, expiry date: 20 Jul 2014) subcutaneously in the tricep muscle of the left arm on 16 Sep 2013. On an unknown date in Sep 2013, after vaccination with PNEUMOVAX, she experienced vaccination site reaction. It was reported that she was diagnosed with cellulitis. It was not reported whether it was her first dose of PNEUMOVAX 23. She sought medical attention and was contacted by physician. She was treated with unspecified antibiotics. The outcome was reported as condition unchanged. The seriousness and causality of the event was not reported. Seriousness assessment of vaccination site cellulitis was upgraded based on the NVS-IME list. QA department stated that, as no batch number was provided, this batch review was performed based on a general review of the quality requirements for FLUVIRIN and the Annual Product Review for the FLUVIRIN 2012, it was concluded that FLUVIRIN manufacturing process was operated at a good level of overall control and the supporting systems are effective in supporting the compliant production, testing and supply processes for FLUVIRIN vaccine. From this conclusion there was no reason or explanation to account for the reported adverse event. Follow-up information received from Quality Assurance Department (reference number: 269177) on 17 Dec 2013: Updated FLUVIRIN annual product review report.
Age: 64.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Electromyogram, Injection site pain, X-ray limb normal
Clinical narrative: Mildly sore arm, progressively worsening to loss of range of motion, extreme pain. 3/10/15- diagnosed with capsular adhesions/shoulder and bicep deformity. Surgery scheduled 6/10/15.
Age: 64.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Electromyogram normal, Joint range of motion decreased, Limb deformity, Pain in extremity, Periarthritis
Clinical narrative: Mildly sore arm, progressively worsening to loss of range of motion, extreme pain. 3/10/15- diagnosed with capsular adhesions/shoulder and bicep deformity. Surgery scheduled 6/10/15.
Age: 64.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Peripheral swelling, X-ray limb normal
Clinical narrative: Mildly sore arm, progressively worsening to loss of range of motion, extreme pain. 3/10/15- diagnosed with capsular adhesions/shoulder and bicep deformity. Surgery scheduled 6/10/15.
Age: 32.0
Sex: F
Vaccine: PNC, PNC13
Symptoms: Erythema, Skin warm
Clinical narrative: 6" diameter red patch around injection site, heat, swelling, tenderness. Got worse over a four day period before dissipating. After 7 days light pink remains with a 3" bruise forming. IBU 800, BENADRYL, tx with ice.
Age: 32.0
Sex: F
Vaccine: PNC, PNC13
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 6" diameter red patch around injection site, heat, swelling, tenderness. Got worse over a four day period before dissipating. After 7 days light pink remains with a 3" bruise forming. IBU 800, BENADRYL, tx with ice.
Age: 1.33
Sex: F
Vaccine: MMR
Symptoms: Balance disorder, Cerebellar ataxia, Coordination abnormal, Cough, Measles post vaccine
Clinical narrative: Rash, low grade fever, runny nose, cough... Dx of mild measles due to MMR vaccine. 2 weeks later developed sudden loss of balance, coordination issues. Brought back in to doctor's office. Dx with Cerebellar Ataxia due to measles.
Age: 1.33
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash, Rhinorrhoea
Clinical narrative: Rash, low grade fever, runny nose, cough... Dx of mild measles due to MMR vaccine. 2 weeks later developed sudden loss of balance, coordination issues. Brought back in to doctor's office. Dx with Cerebellar Ataxia due to measles.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Head injury, Syncope, Vomiting
Clinical narrative: Information has been received from a healthcare worker (office manager) via a field representative concerning a 15 year old male patient. The patient's medical history and concurrent condition were not provided. On 11-MAY-2015, the patient was vaccinated with his first dose of GARDASIL 9, intramuscularly as vaccination (lot#, expiration date and dose not provided). Concomitant therapy was not provided. On 11-MAY-2015, after receipt of GARDASIL 9, the patient "fainted, hit his head" and when he "came to, he vomited". The patient was treated "conservatively" in the office then sent home. Therapy with GARDASIL 9 was also reported as continued. The outcome of the events was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were unspecified by the reporter. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, route of administration, lot # and expiration date unknown). On an unknown date, the patient was diagnosed with shingles. The patient sought medical attention - she visited the physician's office on an unknown date. The outcome of the adverse event was unknown. The relatedness between the adverse event and the vaccination with ZOSTAVAX was not reported. Additional information has been requested - as the information was not reported clearly.
Sex: U
Vaccine: RV5
Symptoms: Gastrointestinal pain
Clinical narrative: Information has been received from a physician concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On an unknown date, the patient was vaccinated with a dose of ROTATEQ, orally (lot#, expiration date and dose not provided). It was unspecified how many doses of ROTATEQ the patient had received. The patient experienced several intetinal cramping after the administration of ROTATEQ. The physician described severe intestinal cramping as the patient was doubled over with head on knees. The outcome of severe intestinal cramps was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 12-MAY-2015 the patient was vaccinated with a dose of improperly stored ROTATEQ (dose, route and lot number were not reported). No symptoms were reported. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Pain, Pain in extremity
Clinical narrative: The first adverse event was a sharp pain in my left shoulder as I reached to turn off a lamp. Over time, the pain became more frequent with certain ranges of motion. Then the range of motion in my left shoulder decreased immensely. I currently experience 24/7 chronic pain in my left shoulder, arm, and wrist, as well as limited range of motion. I received PT three times a week.
Age: 50.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: X-ray
Clinical narrative: The first adverse event was a sharp pain in my left shoulder as I reached to turn off a lamp. Over time, the pain became more frequent with certain ranges of motion. Then the range of motion in my left shoulder decreased immensely. I currently experience 24/7 chronic pain in my left shoulder, arm, and wrist, as well as limited range of motion. I received PT three times a week.
Age: 50.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Arthralgia, Injection site joint movement impairment, Injection site pain, Joint range of motion decreased, Pain in extremity
Clinical narrative: The first adverse event was a sharp pain in my left shoulder as I reached to turn off a lamp. Over time, the pain became more frequent with certain ranges of motion. Then the range of motion in my left shoulder decreased immensely. I currently experience 24/7 chronic pain in my left shoulder, arm, and wrist, as well as limited range of motion. I received PT three times a week.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients of unknown age and gender. Information regarding concomitant medications, concurrent conditions and medical history was not reported. On unspecified dates in April 2015, reported as since 03-APR-2015, unspecified patients were vaccinated with PROQUAD (dose, frequency, lot number, expiration date were not reported). The PROQUAD was exposed to temperatures outside of the recommended range. There were no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: (L) arm was red, swollen, indurated bl. and very tender, no fever. It's a local reaction to DTAP.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Pallor, Presyncope
Clinical narrative: Immediately after completion of immunization the patient had an episode of near syncope. Was left in supine position with elevaton of lower extremities. Was conscious, mild pallor B/P 91/51 pulse 67. Stayed 15 min. Then placed on sitting position for 10 min. Drank water. Stood and walked for 5 min no dizziness, discharged home.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 66 year old male patient. Concurrent conditions or pertinent medical history were not reported and the patient had no allergies or reactions to drugs. On 05-MAY-2015, the patient was vaccinated with a dose of ZOSTAVAX (lot # K023624 - Expiration date: 19-FEB-2016), 0.65 ml, subcutaneously. Concomitant therapies were not reported. On 05-MAY-2015, the patient experienced injection site erythema and injection site swelling after the administration of ZOSTAVAX. The pharmacist stated that the male patient did not experience a rash. The patient did not received treatment for the adverse events. On 08-MAY-2015, the patient sought for medical attention with the pharmacist to report the reaction. At the time of the report, the outcome of infusion site erythema and injection site swelling was reported as not recovered; and the causality between ZOSTAVAX and injection site erythema and injection site swelling was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to unspecified number of patients of unknown age and gender. Information regarding concomitant medications, concurrent condition and medical history was not reported. On an unspecified dates in April 2015, reported as since 03-APR-2015 unspecified patients were vaccinated with ZOSTAVAX (dose, frequency, lot number, expiration date were not reported). The ZOSTAVAX was exposed to temperatures outside of the recommended range. There were no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin burning sensation, Sunburn
Clinical narrative: Information has been received from a 58 year old male patient with diabetes mellitus referring to himself. The patient was diagnosed with shingles in approximately 2010 (reported as "over 5 years ago"). In approximately March 2015 (reported as "about two months ago"), the patient was vaccinated with a dose of ZOSTAVAX (lot number, dose and route were unknown). Concomitant therapies included metformin and losartan potassium (manufacture unknown). Recently on an unknown date in 2015, the patient was mowing the grass and he experienced sunburn, that felt just as bad or worse than the shingles he had 5 years ago. He was not sure if it was the shingles again. His skin was burning and felt like it was on fire from the waist up. The patient did not experience a rash or redness. He sought unspecified medical attention. Penicillin and levofloxacin were given for the events. The outcome and causality of the events was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site warmth, Pain in extremity
Clinical narrative: Pain left arm.  Redness and warmth that spread down the posterior triceps area on posterior arm.  Size was about 5 inches by 4 inches.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Culture, Pertussis
Clinical narrative: PT was diagnosed with whooping cough.
Age: 54.0
Sex: F
Vaccine: TTOX
Symptoms: Dyspnoea, Malaise, Pyrexia, Throat tightness, Urticaria
Clinical narrative: Severe hives all over my body. Shortness of breath, throat tight, fever. I went to the doctor 3 times, I'm still very sick, taking 4 different medicines.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of (Merck) VARIVAX (subcutaneous, lot# reported as L001330, expiration date: 13-JAN-2017, 0.5ml). The vaccine product was administered post temperature excursion (incorrect product storage). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Chronic fatigue syndrome, Migraine, Nausea
Clinical narrative: A spontaneous report was received from a 15 year old female patient who on 30-AUG-2010 received her first dose of GARDASIL (route and lot number not provided). The patient was taking "all kinds of medication" concomitantly. She has an allergy to "Zomec". The patient reported that she developed cancer after her first dose of GARDASIL. In late September 2011, she received her second dose of GARDASIL and in October 2012 she received the third dose. Since then (exact onset date not specified), she had anxiety, chronic migraines, fatigue syndrome and nausea. The patient sought unspecified medical attention. The outcome of the events were unknown. The patient stated she was seeking to proceed with legal action. Upon internal review, cancer was considered medically significant. Additional information is not expected as the patient provided no contact information and disconnected the call.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood heavy metal increased, Blood mercury abnormal, Chelation therapy, Dizziness
Clinical narrative: Saw Dr in Oct for vaccine. Called clinic talk to nurse, Nov or Dec. Saw Dr Feb '15. Immediately - not feeling well; stayed awake during night, due to flu vaccine; had flu vaccine, late day 10/28/14. Next morning, had pneumonia vaccination: my concern; too much for my body due to flu shot?? Answer "No" not too much; days and weeks to follow: I became stumbly (like running into door facings); feeling faint at most times; very faint HR and heartbeat. Would soak in tub of hot water to revive. Unable to drive or go places. Extremely weak. This went on into Feb '15/March 15. Chelation to remove until adverse reaction to chelation also.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Gait disturbance, Heart rate abnormal, Immediate post-injection reaction, Impaired driving ability, Insomnia
Clinical narrative: Saw Dr in Oct for vaccine. Called clinic talk to nurse, Nov or Dec. Saw Dr Feb '15. Immediately - not feeling well; stayed awake during night, due to flu vaccine; had flu vaccine, late day 10/28/14. Next morning, had pneumonia vaccination: my concern; too much for my body due to flu shot?? Answer "No" not too much; days and weeks to follow: I became stumbly (like running into door facings); feeling faint at most times; very faint HR and heartbeat. Would soak in tub of hot water to revive. Unable to drive or go places. Extremely weak. This went on into Feb '15/March 15. Chelation to remove until adverse reaction to chelation also.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise
Clinical narrative: Saw Dr in Oct for vaccine. Called clinic talk to nurse, Nov or Dec. Saw Dr Feb '15. Immediately - not feeling well; stayed awake during night, due to flu vaccine; had flu vaccine, late day 10/28/14. Next morning, had pneumonia vaccination: my concern; too much for my body due to flu shot?? Answer "No" not too much; days and weeks to follow: I became stumbly (like running into door facings); feeling faint at most times; very faint HR and heartbeat. Would soak in tub of hot water to revive. Unable to drive or go places. Extremely weak. This went on into Feb '15/March 15. Chelation to remove until adverse reaction to chelation also.
Age: 42.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Induration, Injection site vesicles, Pruritus generalised
Clinical narrative: Per pt: recieved varicella vaccine at empoyee health - blistering at vaccine site" provider; After varicella vaccine on 5/1/15 she developed an indurated area with vesicles. She is also itching all over at times. She will be working per diem but has not started employement yet.
Age: 63.0
Sex: F
Vaccine: TYP
Symptoms: Vertigo
Clinical narrative: States experienced a few minutes of vertigo while hiking a day after taking the first dose, then again a few hours after taking the second dose and a few more times over the next couple of days. Pt states she is still experiencing periodic vertigo and has left a message for her doctor.
Age: 31.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous prospective pregnancy report as received from a registered nurse refers to a 31 year old pregnant female patient. The patient was 33 weeks and 6 days pregnant and did not have drug reactions/alleriges. Pertinent medical history was not provided. Concomitant medications included unspecified prenatal vitamin. On 04-MAY-2015, the patient was inadvertently vaccinated with a dose of GARDASIL (route intramuscular, lot # K006191, dose an expiration date were not reported) when she was indicated (unspecified) TDAP vaccination. There was no adverse experience reported. The patient did not receive any treatment and there was no lab diagnostics and studies were performed. The last menstrual period (LMP) was on an approximately 09-SEP-2014 (calculated on subtracting 33 weeks and 6 days of pregnancy from date 04-MAY-2015). Estimated due date (EDD) was on 16-JUN-2015. The patient's and pregnancy outcome were unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to mulitple unspecified patients of unknown age/gender. The patients' concurrent or historical conditions were not provided. Concomitant therapies were not reported. On an unknown date the patients were vaccinated with improperly stored GARDASIL (dose, lot number, route and frequency were not reported). No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of (Merck) VARIVAX (subcutaneous, lot# reported as K016132, expiration date: 24-SEP-2016, 0.5ml). The vaccine product was administered post temperature excursion (incorrect product storage). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Dyspnoea, Hyperhidrosis, Hyperventilation, Tachycardia
Clinical narrative: Patient c/o diff breathing, started to hyperventilate. Pt was to exam rm v.s. taken strong peripheral pulses became sweatey tachycardia, VS taken 138/80, 100% O2sat. Pt was coherent responding to questions. Nurse remained with pt. He had eaten since AM, provided fruit and liq. B/P 120/80 P 80. Pt states feels better increased HOB, observed pt with father at 6pm. Pt was alert and oriented entire time here in the office.
Age: 81.0
Sex: M
Vaccine: PNC13
Symptoms: Bronchitis, Cough, Headache, Productive cough, Respiratory tract congestion
Clinical narrative: Four day after vaccine-coughing-congestion excess phlegm, headache. This lasted a week-went to Dr. diagnosed with acute bronchitis. Treatment-antibiotic and promethazine DM (cough syrup).
Age: 65.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Pt has had pain and numbness in left arm into fingers ever since he received the flu shot in Oct. 2014.
Age: 71.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Pain in extremity, X-ray
Clinical narrative: Got flu shot, my arm got so bad I could not use it, called doctor went for exam, was given pain pills, arm kept getting worse, called the doctor again, was sent for a xray. Still hurts.
Age: 14.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: Bruising and swelling at injection site.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Induration, Rash
Clinical narrative: Localized induration and erythema treated empirically with clinda for 1 days with resolution of rash. Place size was 3 cm of firmness.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients of unknown age and gender. Information regarding concomitant medications, concurrent conditions and medical history was not reported. On unspecified dates in April 2015, reported as since 03-APR-2015 and since 24-APR-2015, unspecified patients were vaccinated with (Merck) VARIVAX (dose, frequency, lot number, expiration date were not reported). The (Merck) VARIVAX was exposed to temperatures outside of the recommended range. There were no adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: FLU4, HEPA, PPV, TYP
Symptoms: Cellulitis, Local reaction
Clinical narrative: Pr developed local reaction with cellulitis Rt arm resolved after taking oral KEFLEX for 7 days.
Age: 38.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Injection site extravasation
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 38 year old female patient. None concurrent conditions, pertinent medical history, drug reaction or allergies were reported. On 08-MAY-2015 the patient was vaccinated with GARDASIL 0.5 ml, once, intramuscular, lot # K008621, expiration date 04-MAR-2017, (dose number and anatomical location were unspecified), which was considered an inappropriate schedule of drug administration, and experienced an injection site leaking as an unspecified amount of GARDASIL leaked out of the injection site onto the patient's skin. No treatment was given for the adverse event and no laboratory diagnostic studies were performed. The patient did not seek medical attention. The outcome of injection site leaking and inappropriate schedule of drug administration was unknown. The relatedness between injection site leaking and GARDASIL was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age. On an unknown date of 2014, reported as since 14-OCT-2014, the unknown number of patients were vaccinated with VAQTA (dose, route, lot # and expiration dates were not provided) that had been improperly stored. No concomitant medications were reported. No adverse effects reported. This is one of the several report received from the same reporter. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report has been received from a pharmacist concerning a female patient of 39 year old. The patient had no pertinent medical history or drug reactions/allergies. On approximately 21-APR-2015, (reported as "about two weeks ago"), the patient was vaccinated with (Merck) VARIVAX (lot # J008982, expiration date 19-JUL-2015), subcutaneous injection in right arm, (strength not reported), first dose, 0.5 ml. There was not concomitant medication reported. On an unknown date, in 2015, after (Merck) VARIVAX vaccination, the patient experienced injection site erythema and injection site warmth of her right arm. The patient sought medical attention, contacting the pharmacist. There was no treatment given for the injection site erythema and injection site warmth, in the patient's right arm. At the reporting time, the outcome of injection site erythema and injection site warmth was reported as not recovered. The pharmacist stated that she would inform the patient to contact her primary healthcare provider for follow up. Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Information has been received from a medical assistant referring to a 69 year old female patient with drug hypersensitivity for AUGMENTIN. The patient's medical history included myocardial infarction, osteoporosis, dyslipidaemia and diverticulum. On 22-APR-2015 the patient was vaccinated with PNEUMOVAX 23 lot # K019386, expired date 09-JUN-2016, intramuscular in the left deltoid as part of well-check visit (dose and dose number were not reported). Concomitant therapies included PLAVIX, ZESTRIL, metoprolol, CRESTOR, aspirin and NITROSTAT. On an unspecified date in April 2015, the patient developed left arm swelling. The patient called to the office on 23-APR-2015 to report the symptom, she visited the office on 24-APR-2015 in order that the physician could examine on her arm and was instructed to put moist compresses on her arm. No lab diagnostic studies performed. The outcome of event was unspecified by reporter. The causality between PNEUMOVAX 23 and the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age. On an unknown date in 2014, reported as since 14-OCT-2014, the unknown number of patients were vaccinated with GARDASIL (dose, route, lot# and expiration dates were not provided) that had been improperly stored. No concomitant medications were reported. No adverse effects reported. This is one of the several report received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age. On an unknown date of 2014, reported as since 14-OCT-2014, the unknown number of patients were vaccinated with RECOMBIVAX HB (dose, routte, lot# and expiration dates were not provided) for prophylaxis that had been improperly stored. No concomitant medications were reported. No adverse effects reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Extensive swelling of vaccinated limb, Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 65 year old female patient with blood cholesterol increased, hypertension, vitamin D deficiency and shellfish allergy. On 15-APR-2015 the patient was vaccinated with a dose of PNEUMOVAX 23, intramuscular, lot # L00318, expiration date 06-JUL-2015, (dose, dose number and anatomical location were unspecified). Concomitant therapies included pravastatin, amlodipine and vitamin D (unspecified). On 17-APR-2015, the patient experienced injection site cellulitis and she complained of "redness, swelling and warmth at the site of the injection" which radiated through her forearm. The nurse stated that the patient went to the office and was treated for cellulitis, and prescribed with an unspecified oral antibiotic. None laboratory diagnostic studies were performed. The outcome of the events was reported as recovered on 22-APR-2015. The relatedness between the adverse events and PNEMOVAX 23 was not reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Skin warm
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 65 year old female patient with blood cholesterol increased, hypertension, vitamin D deficiency and shellfish allergy. On 15-APR-2015 the patient was vaccinated with a dose of PNEUMOVAX 23, intramuscular, lot # L00318, expiration date 06-JUL-2015, (dose, dose number and anatomical location were unspecified). Concomitant therapies included pravastatin, amlodipine and vitamin D (unspecified). On 17-APR-2015, the patient experienced injection site cellulitis and she complained of "redness, swelling and warmth at the site of the injection" which radiated through her forearm. The nurse stated that the patient went to the office and was treated for cellulitis, and prescribed with an unspecified oral antibiotic. None laboratory diagnostic studies were performed. The outcome of the events was reported as recovered on 22-APR-2015. The relatedness between the adverse events and PNEMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown dates in 2015, the unspecified number of patients were vaccinated with doses of ROTATEQ, (strength, dose, frequency, route and anatomical location were not reported) (lot # K005397, expiration date 29-FEB-2016) for prophylaxis which were improperly exposed to 47 Fahrenheit temperature for 11 hours since an unspecified date in March 2015. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a 10 patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 02-MAR-2015, 09-MAR-2015, 10-MAR-2015, 17-MAR-2015 and 16-APR-2015, the 10 patients were vaccinated with doses of PROQUAD (Merck), (strength, dose, frequency, route and anatomical location were not reported) (lot # K020747, expiration date 30-APR-2014) which were improperly stored. No adverse events were reported. Additionally, it was reported that the temperature excursion for PROQUAD (Merck) was supported with in-house stability data. This is one of several reports received from the same reporter. Additional information has been requested.