chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and unknown gender. Concurrent conditions, pertinent medical history, drug reactions or allergies were not reported. On an unspecified dates the patients were vaccinated with exposed to 44F doses of (Oka/Merck) VARIVAX lot # K016129, expiration date 23-SEP-2016 (dose, dose number, route and anatomical location were unspecified). Concomitant therapies were not reported. No adverse effects reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to an infant of unknown gender of 10 days old at the time of the report. Concurrent conditions and medical history was not reported. On an unknown date, the patient was administer4ed a dose of (Oka/Merck) VARIVAX (subcutaneous injection)(dose not reported) which underwent supported temperature excursions. Concomitant therapy was not reported. No adverse effects and no PQC involved. This case is related to MARR#1505USA009906, MARR#1505USA013645,MARR#1505USA013646. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Anxiety, Chest X-ray normal, Chest pain, Dyspnoea, Gastrointestinal disorder
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age with no pertinent medical history, concurrent conditions or allergies. On 13-APR-2015, the patient was vaccinated with a dose of GARDASIL (administration route, lot number and expiration date were not provided). Concomitant therapies included ALLEGRA. On an unknown date, 2 days after onset of therapy the patient experienced difficulty breathing, chest pain, unspecified "GI complaints", reflux and anxiety. The reporting physician stated that the patient had an abnormal pulmonary function test that showed he had restrictive pulmonary disease, however the physician mentioned the patient did not put forth a good effort with this test due to anxiety. The physician also mentioned the patient had a normal chest X-ray. The patient was seen in the physician's office and was given PREVACID and albuterol as treatment. The outcome of events was reported as not recovered. The reporter did not provide a causality assessment for the events. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Gastrooesophageal reflux disease, Pulmonary function test abnormal, Restrictive pulmonary disease
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age with no pertinent medical history, concurrent conditions or allergies. On 13-APR-2015, the patient was vaccinated with a dose of GARDASIL (administration route, lot number and expiration date were not provided). Concomitant therapies included ALLEGRA. On an unknown date, 2 days after onset of therapy the patient experienced difficulty breathing, chest pain, unspecified "GI complaints", reflux and anxiety. The reporting physician stated that the patient had an abnormal pulmonary function test that showed he had restrictive pulmonary disease, however the physician mentioned the patient did not put forth a good effort with this test due to anxiety. The physician also mentioned the patient had a normal chest X-ray. The patient was seen in the physician's office and was given PREVACID and albuterol as treatment. The outcome of events was reported as not recovered. The reporter did not provide a causality assessment for the events. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to an infant of unknown gender of 8 days old at the time of the report. Concurrent conditions and medical history was not reported. On an unknown date, the patient was administer4ed a dose of (Oka/Merck) VARIVAX (subcutaneous injection) (dose not reported) which underwent supported temperature excursions. Concomitant therapy was not reported. No adverse effects and no PQC involved. This case is cross referenced to MARR#1505USA009906, MARR#1505USA013644, MARR#1505US013646. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to an infant of 13 days old at the time of the report of unknown age. Concurrent conditions and medical history was not reported. On an unknown date, the patient was administered a dose of (Oka/Merck) VARIVAX, subcutaneous injection (dose not reported) which underwent supported temperature excursions. Concomitant therapy was not reported. No adverse effects and no PQC involved. This case is cross referenced to MARR#1505USA013644, MARR#1505USA013645, MARR#1505USA013646. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to an infant of unknown gender of 7 days old at the time of the report. Concurrent medications and medical history was not reported. On an unknown date, the patient was administered a dose of (Oka/Merck) VARIVAX subcutaneous injection (dose not reported) which underwent supported temperature excursions. Concomitant therapy was not reported. No adverse effects and no PQC involved. This case is cross referenced to MARR1505USA009906, MARR#1505USA013644, MARR#1505USA013645. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified patient of unknown age and gender. Information regarding the patient's medical history or concurrent conditions was not provided. On an unspecified date in July 2013, the patient was vaccinated with the first dose of GARDASIL (indication, dose, route of administration and lot number were not provided). Concomitant therapy was not reported. In March 2015, the patient was vaccinated with the second dose of GARDASIL (indication, dose, route of administration and lot number not provided) outside of the recommended dosing schedule; no adverse events were reported. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Chest discomfort
Clinical narrative: I had a shingles injection this afternoon. I experienced chest tightness / pain that went to the back.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to one unspecified patient of unknown age. Medical history, concurrent conditions and concomitant medications were not reported. On 07-MAY-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (dose, frequency and route of administration were not provided). No adverse events were reported. The outcome of events was unknown. No product quality complaint (PQC) was involved. No further information was provided. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema multiforme, Injection site erythema, Injection site oedema, Injection site pain, Rash
Clinical narrative: Patient received PREVNAR 13 injection on 5/16/14. When patient presented for follow-up appointment on 6/11/14, she reported injection site reaction (erythema, mild edema, and pain) that followed the administration of the vaccine. No systemic symptoms were reported. Skin rash, rash and erythema Multiform.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On 22-MAY-2015 the patient was inadvertently vaccinated with GARDASIL (lot # 0636AE, 0.5 ml, intramuscularly (IM)) that had expired on 09-JAN-2015. No adverse effects were reported. Additional information is not expected as the physician is not allowed to be contacted.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender with no pertinent medical history, drug allergies or reactions reported. On 16-OCT-2013, the patient was vaccinated with the first dose of GARDASIL lot # H021608, expiration date: 13-AUG-2015, 0.5 ml, intramuscular. On 14-MAY-2015, the patient was vaccinated with the second dose of GARDASIL lot # K010574, expiration date: 08-APR-2017, 0.5 ml, intramuscular. Concomitant therapy was not reported. It was reported that the patient received GARDASIL outside of prescribing information. No adverse effects were noted. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Insomnia, Joint stiffness, Joint swelling, Mobility decreased, Muscle spasms
Clinical narrative: 5/26/2015 patient called and reported the following: Received Tdap Friday afternoon 5/22/2015 because she had and injury, a lesion the size of a quarter on her left upper scalp sustained on her horse trailer. Friday evening at 11:00 pm. She had severe muscle spasms throughout her body and was unable to settle down and go to sleep. She took Baclofen to help with the muscle spasms. The muscle spasms gradually decreased and she was able to sleep. She noted to muscle problems in the morning. In the morning (Saturday 5/23/2015) she went to work in the barn to help exercise the arm where she had received the vaccine. She started to have difficulty using her left leg. She noticed swelling in the upper posterior of her knee (around popliteal area). The swelling became more pronounced as the day progressed and she had a large stiff and swollen area behind the left knee. She has had problems with her right knee in the past with swelling and pain in the knee joint area due to arthritis. I encouraged her to see her health care provider to determine what the swelling behind the left knee could be and to also report the muscle spasm pain. Her physician is in a different community but she felt that she might be able to schedule an appt with her orthopedic office more quickly.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to one unspecified patient of unknown age. Medical history, concurrent conditions and concomitant medications were not reported. On 07-MAY-2015, the patient was vaccinated with an improperly stored dose of VAQTA (dose, frequency and route of administration were not provided). No adverse events were reported. The outcome of events was unknown. No product quality complaint (PQC) was involved. No further information was provided. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Erythema, induration (L) upper arm, hyperemic.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician via field representative referring to an 83 year old female patient. Information about medical history and drug reactions or allergies was not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (1 shot, lot number, dose and route were unknown). Concomitant medications were unspecified. After receiving ZOSTAVAX, on an unknown date, the patient developed a case of the shingles. The patient sought medical attention via office visit. The outcome and causality of the event was unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: JEV1, RAB, JEV1, RAB
Symptoms: Blood test normal, Swelling, Tenderness, Thyroiditis
Clinical narrative: Case number PHHY2015US063894, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 566728) website on 12 May 2015. This report refers to a 15 year old female patient. Medical history was not reported. Concurrent conditions included penicillins and amoxicillin allergy, acne, depression and anxiety. Concomitant medications included RETIN A and minocycline. She was vaccinated with RABAVERT (batch number: 556011A) intramuscularly in right arm and IXIARO (other manufacturer, batch number: JEV13037E) intramuscularly in left arm on 09 Jan 2015. On 13 Jan 2015, she developed tenderness and swelling along cervical and supraclavicular lymph node. On 14 Jan 2015, pediatrician diagnosed inflammatory thyroiditis. All blood work results were within normal limits. No specific treatment was required. On 28 Jan 2015, she recovered from thyroiditis. Final outcome of all the events was complete recovery. Events were reported as non-serious. Seriousness assessment of inflammatory thyroiditis was upgraded (medically significant) based on the information available in the source document. Causality was not reported.
Age: 15.0
Sex: F
Vaccine: JEV1, RAB, JEV1, RAB
Symptoms: Blood test normal, Lymph node pain, Lymphadenopathy, Thyroiditis
Clinical narrative: Case number PHHY2015US063894, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 566728) website on 12 May 2015. This report refers to a 15 year old female patient. Medical history was not reported. Concurrent conditions included penicillins and amoxicillin allergy, acne, depression and anxiety. Concomitant medications included RETIN A and minocycline. She was vaccinated with RABAVERT (batch number: 556011A) intramuscularly in right arm and IXIARO (other manufacturer, batch number: JEV13037E) intramuscularly in left arm on 09 Jan 2015. On 13 Jan 2015, she developed tenderness and swelling along cervical and supraclavicular lymph node. On 14 Jan 2015, pediatrician diagnosed inflammatory thyroiditis. All blood work results were within normal limits. No specific treatment was required. On 28 Jan 2015, she recovered from thyroiditis. Final outcome of all the events was complete recovery. Events were reported as non-serious. Seriousness assessment of inflammatory thyroiditis was upgraded (medically significant) based on the information available in the source document. Causality was not reported.
Age: 16.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Immediate post-injection reaction, Loss of consciousness, Tooth fracture
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a male patient of unknown age. No information regarding the patient's pertinent medical history and concomitant medications was provided. On an unknown date, the patient was vaccinated with GARDASIL, (dose, route of administration, injection site, lot number and expiration date were not reported) and immediately afterwards, "he passed out, face first on the floor and cracked a bunch of teeth out". There was no product quality complaint involved. The outcome of the events was unknown. The relatedness between the event and GARDASIL was not reported. Follow up information has been received on 22-MAY-2015 from a licensed practical nurse concerning a 16 year old male patient. He had a history of short stature and required growth hormone injections. It was reported that at the time of vaccination the patient did not have any illnesses. On 28-JAN-2015 at 3:38 pm, the patient was vaccinated at the private doctor's office/hospital with the first dose of GARDASIL, intramuscular, lot number K009482. It was reported, that two minutes after receiving GARDASIL (on 28-JAN-2015 at 3:40 pm) the patient struggled to stand up from sitting position. The nurse reported that the patient had fallen forward as he had been passing out. His face hit the concrete floor and as a result three of the patient's upper teeth were fractured. No lower teeth were lost. The patient went to doctor of dental surgery (DDS). The reporting nurse stated that the patient recovered completely (on an unspecified date in 2015). The nurse considered the events to be medically significant as the patient required medical or surgical intervention. Additional information is not expected as all information has been obtained. Patient's details, suspect details, event details and narrative were updated.
Age: 16.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Face injury, Fall, Immediate post-injection reaction, Loss of consciousness, Tooth fracture
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a male patient of unknown age. No information regarding the patient's pertinent medical history and concomitant medications was provided. On an unknown date, the patient was vaccinated with GARDASIL, (dose, route of administration, injection site, lot number and expiration date were not reported) and immediately afterwards, "he passed out, face first on the floor and cracked a bunch of teeth out". There was no product quality complaint involved. The outcome of the events was unknown. The relatedness between the event and GARDASIL was not reported. Follow up information has been received on 22-MAY-2015 from a licensed practical nurse concerning a 16 year old male patient. He had a history of short stature and required growth hormone injections. It was reported that at the time of vaccination the patient did not have any illnesses. On 28-JAN-2015 at 3:38 pm, the patient was vaccinated at the private doctor's office/hospital with the first dose of GARDASIL, intramuscular, lot number K009482. It was reported, that two minutes after receiving GARDASIL (on 28-JAN-2015 at 3:40 pm) the patient struggled to stand up from sitting position. The nurse reported that the patient had fallen forward as he had been passing out. His face hit the concrete floor and as a result three of the patient's upper teeth were fractured. No lower teeth were lost. The patient went to doctor of dental surgery (DDS). The reporting nurse stated that the patient recovered completely (on an unspecified date in 2015). The nurse considered the events to be medically significant as the patient required medical or surgical intervention. Additional information is not expected as all information has been obtained. Patient's details, suspect details, event details and narrative were updated.
Age: 16.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Tooth loss
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a male patient of unknown age. No information regarding the patient's pertinent medical history and concomitant medications was provided. On an unknown date, the patient was vaccinated with GARDASIL, (dose, route of administration, injection site, lot number and expiration date were not reported) and immediately afterwards, "he passed out, face first on the floor and cracked a bunch of teeth out". There was no product quality complaint involved. The outcome of the events was unknown. The relatedness between the event and GARDASIL was not reported. Follow up information has been received on 22-MAY-2015 from a licensed practical nurse concerning a 16 year old male patient. He had a history of short stature and required growth hormone injections. It was reported that at the time of vaccination the patient did not have any illnesses. On 28-JAN-2015 at 3:38 pm, the patient was vaccinated at the private doctor's office/hospital with the first dose of GARDASIL, intramuscular, lot number K009482. It was reported, that two minutes after receiving GARDASIL (on 28-JAN-2015 at 3:40 pm) the patient struggled to stand up from sitting position. The nurse reported that the patient had fallen forward as he had been passing out. His face hit the concrete floor and as a result three of the patient's upper teeth were fractured. No lower teeth were lost. The patient went to doctor of dental surgery (DDS). The reporting nurse stated that the patient recovered completely (on an unspecified date in 2015). The nurse considered the events to be medically significant as the patient required medical or surgical intervention. Additional information is not expected as all information has been obtained. Patient's details, suspect details, event details and narrative were updated.
Age: 29.0
Sex: M
Vaccine: FLU3, JEV1, RAB
Symptoms: Pain, Pain in extremity, Pain in jaw, Paraesthesia, Peripheral swelling
Clinical narrative: Pain and tingling of rt arm, swelling of rt arm and hand, pain on right side of the body, rt sided jaw pain within a few hours of vaccine administration.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, warmth and tenderness at injection site. Rxed TYLENOL prn pain and application of ice.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, DTAPIPV, MMR
Symptoms: Amino acid level, Anaphylactic shock, Apparent life threatening event, Blood electrolytes
Clinical narrative: Information has been received from a physician and a medical assistant referring to a 4 year old female patient with bladder exstrophy which was diagnosed in 2011 and latex allergy. On unspecified dates, the patient had multiple surgeries for the bladder exstrophy. On 11-MAY-2012, the patient received the first dose of M-M-R II 0.5 ML, (lot# and expire date were not reported), subcutaneously. On 21-MAY-2015 the patient received the second dose of M-M-R II 0.5 ml, (lot# was reported as 1002242, expire date was reported as 21-JAN-2017) subcutaneously as well as a dose of KINRIX. Other concomitant therapy included BACTRIM for daily prophylactical use. Within 10 to 20 minutes the patient went into anaphylactic shock. The patient was administered a dose of epinephrine in the office as well as given oxygen. Paramedics arrived to the office and took the patient to hospital and the patient was admitted. On the same day at the hospital, the patient was administered a second dose of epinephrine as well as given BENADRYL and SOLU-MEDROL and CLARITIN. Electrolytes and a tryptophan level lab test were done but results of the labs were unspecified. On 21-MAY-2015, the patient was recovered. In the afternoon of 22-MAY-2015 the patient was discharged from the hospital. At the time of reporting, the causality was not reported. The physician stated that the anaphylactic shock the patient experienced was life threatening. Upon internal review, anaphylactic shock was determined to be medically significant event. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, DTAPIPV, MMR
Symptoms: Anaphylactic shock, Immediate post-injection reaction
Clinical narrative: Information has been received from a physician and a medical assistant referring to a 4 year old female patient with bladder exstrophy which was diagnosed in 2011 and latex allergy. On unspecified dates, the patient had multiple surgeries for the bladder exstrophy. On 11-MAY-2012, the patient received the first dose of M-M-R II 0.5 ML, (lot# and expire date were not reported), subcutaneously. On 21-MAY-2015 the patient received the second dose of M-M-R II 0.5 ml, (lot# was reported as 1002242, expire date was reported as 21-JAN-2017) subcutaneously as well as a dose of KINRIX. Other concomitant therapy included BACTRIM for daily prophylactical use. Within 10 to 20 minutes the patient went into anaphylactic shock. The patient was administered a dose of epinephrine in the office as well as given oxygen. Paramedics arrived to the office and took the patient to hospital and the patient was admitted. On the same day at the hospital, the patient was administered a second dose of epinephrine as well as given BENADRYL and SOLU-MEDROL and CLARITIN. Electrolytes and a tryptophan level lab test were done but results of the labs were unspecified. On 21-MAY-2015, the patient was recovered. In the afternoon of 22-MAY-2015 the patient was discharged from the hospital. At the time of reporting, the causality was not reported. The physician stated that the anaphylactic shock the patient experienced was life threatening. Upon internal review, anaphylactic shock was determined to be medically significant event. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, DTAPIPV, MMR
Symptoms: Amino acid level, Anaphylactic shock, Apparent life threatening event, Blood electrolytes
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of anaphylactic shock in a 4-year-old female patient who received KINRIX (batch number NS74P, expiry date 20th March 2017). Concomitant products included MMR vaccine. On 21st May 2015, the patient received KINRIX (unknown) .5 ml. On 21st May 2015, immediately after receiving KINRIX, the patient experienced anaphylactic shock (serious criteria GSK medically significant). On 21st May 2015, the outcome of the anaphylactic shock was recovered/resolved. It was unknown if the reporter considered the anaphylactic shock to be related to KINRIX. Additional information received: A nurse was advised by an allergist to give KINRIX and an MMR (Merck) vaccine at the same time on 21st May 2015. The patient experienced anaphylactic shock immediately after the vaccination. Patient was rushed to Emergency Room. Patient was discharged on 21st May 2015.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, DTAPIPV, MMR
Symptoms: Anaphylactic shock, Immediate post-injection reaction
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of anaphylactic shock in a 4-year-old female patient who received KINRIX (batch number NS74P, expiry date 20th March 2017). Concomitant products included MMR vaccine. On 21st May 2015, the patient received KINRIX (unknown) .5 ml. On 21st May 2015, immediately after receiving KINRIX, the patient experienced anaphylactic shock (serious criteria GSK medically significant). On 21st May 2015, the outcome of the anaphylactic shock was recovered/resolved. It was unknown if the reporter considered the anaphylactic shock to be related to KINRIX. Additional information received: A nurse was advised by an allergist to give KINRIX and an MMR (Merck) vaccine at the same time on 21st May 2015. The patient experienced anaphylactic shock immediately after the vaccination. Patient was rushed to Emergency Room. Patient was discharged on 21st May 2015.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood test, Computerised tomogram, Dehydration, Ear infection, Lethargy
Clinical narrative: Ear infection, vertigo, nausea, vomiting, fever, lethargy, weight loss, severe dehydration. Over the course of three weeks, symptoms increased in intensity and frequency. After several trips to the doctor, several prescriptions to ease the symptoms, and the ER, I was admitted to the hospital for a four day stay on December 20th, 2007.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Nausea, Nuclear magnetic resonance imaging, Pyrexia, Vertigo, Vomiting
Clinical narrative: Ear infection, vertigo, nausea, vomiting, fever, lethargy, weight loss, severe dehydration. Over the course of three weeks, symptoms increased in intensity and frequency. After several trips to the doctor, several prescriptions to ease the symptoms, and the ER, I was admitted to the hospital for a four day stay on December 20th, 2007.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Weight decreased
Clinical narrative: Ear infection, vertigo, nausea, vomiting, fever, lethargy, weight loss, severe dehydration. Over the course of three weeks, symptoms increased in intensity and frequency. After several trips to the doctor, several prescriptions to ease the symptoms, and the ER, I was admitted to the hospital for a four day stay on December 20th, 2007.
Age: 8.0
Sex: F
Vaccine: DTAP, HEP, HEPA, IPV, MMR, VARCEL
Symptoms: Seizure, Tic
Clinical narrative: Seizures, tics.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Musculoskeletal pain, Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: Soreness in arm/shoulder, some stiffness, progressively getting worse through the day and evening. Severe pain by morning with the slightest movement. Unable to move arm for 2 plus days. Doctor advised Advil. As of 05/26/2015 shoulder still sensitive with certain movements.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Dysphagia, Dyspnoea, Eye swelling, Lip swelling
Clinical narrative: Developed swelling of eyes, then lips; on way to hospital developed difficulty swallowing, breathing.  Per Mom arrived at ER approximately 4:45 p.m. received IV Steroids, other medications and sent home with P.O. steroids x 5 days.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of an unknown age and gender. The patients medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with a doses of improperly stored RECOMBIVAX HB (dose, frequency, route of administration, lot # and expiration dates unknown). No adverse effects were reported. It was unspecified if the patients sought medical attention. Follow up information has been received on 29-APR-2015 from a healthcare worker. It was reported that more unspecified patients (unspecified number) received doses of improperly stored RECOMBIVAX HB (dose, frequency, route of administration, lot # and expiration dates unknown). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested. General details and analysis were updated.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a clinical medical assistant refers to an unspecified patients of unknown age and gender. There was no medical history, drug reactions/allergies and concomitant medication provided. On 20-MAY-2015, the unspecified patients were vaccinated with an improperly stored doses of GARDASIL (dose, route, lot # and expiration date were not reported). There was no adverse effect reported. This is one of several reports 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 clinical medical assistant refers to an unspecified patients of unknown age and gender. There was no medical history, drug reactions/allergies and concomitant medication provided. On 20-MAY-2015, the unspecified patients were vaccinated with an improperly stored doses of RECOMBIVAX HB (dose, route, lot #, therapy type and expiration date were not reported). There was no adverse effect reported. This is one of several reports receivd from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Ophthalmic herpes zoster, Pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. In November 2014, the patient was vaccinated with a dose of ZOSTAVAX (lot# and dose were not reported). On 01-MAY-2015 (reported as "three weeks ago") the patient went to unidentified physician that she developed shingles that affected her eye area "with lesions along with pain, discomfort, at which point unidentified physician prescribed NEURONTIN and also prescribed acetaminophen, PERCOCET for pain. The outcome of the event was not reported. Relatedness between therapy and adverse event was not provided. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site warmth, Local reaction
Clinical narrative: (L) arm at site of ZOSTAVAX - 7x11 cm indurated, erythematous, warm. Local reaction vs. cellulitis -> amoxicillin/clavulanic acid.
Age: 1.58
Sex: M
Vaccine: HEPA
Symptoms: Generalised tonic-clonic seizure, Lethargy
Clinical narrative: 6 hrs after HepA vaccine (2nd dose) had 15-20 sec. of tonic/clonic seizure activity. No fever. Lethargic for about 15 min then came back to normal. Normal exam in office 4 hrs. later. No history of seizures.
Age: 1.02
Sex: M
Vaccine: MMR
Symptoms: Measles, Pyrexia, Rash, Rash maculo-papular
Clinical narrative: Measles like illness 11 days after MMR vaccine: (+) fever Tmax 102 F. (+) maculo-papular rash face/trunk/extremities. (+) LAD. Rx: Observe. Fever continue with TYLENOL/MOTRIN.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Eye movement disorder, Loss of consciousness, Musculoskeletal stiffness, Opisthotonus, Seizure
Clinical narrative: Seizure post immunizations (within 2-3 mins.) entire body stiffens and contracted along with arching of his back and neck. His wrist also bended, eyes rolled back, he lost consciousness. He was assisted to the carpeted floor. He began to slowly regain consciousness. Event lasted less than 5 seconds with no injuries.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a 63 year old female nurse, who was also the patient, via company representative. Medical history, concurrent conditions and concomitant medications were not provided. In approximately 2010 (about 5 years ago), the patient was vaccinated with ZOSTAVAX (dose, frequency, and route of administration were not provided), for prevention of shingles. On 09-MAY-2015 (currently), the patient had an active case of shingles. No treatment was given for the adverse event. Patient sought medical attention (office visit on unspecified date). The outcome of shingles was not recovered. Causality was not provided. No product quality (PQC) was involved. No further adverse event information was provided. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cold type haemolytic anaemia, Haemoglobin decreased, Laboratory test, Malaise
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 60 year old elderly female patient. On 07-JAN-2015 the patient was vaccinated with ZOSTAVAX (dose strength, route unspecified) and later the patient started to feel unwell on an unspecified date following ZOSTAVAX administration. Physician reported that the patient had unspecified lab work drawn, on an unspecified date, due to this, which showed that the patient's hemoglobin was low. The patient was then sent for additional unspecified testing on unspecified dates. The physician reported that following receipt of all testing results, the patient was diagnosed with cold agglutinin hemolysis on an unspecified date in 2015. The patient was treated with folic acid for the event reported. The outcome of cold agglutinin hemolysis is unknown. The patient sought medical attention. No product quality complaint was involved. Additional information has been requested.
Age: 1.24
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Eyelid oedema, Pruritus, Rash, Urticaria
Clinical narrative: Woke up about 9:00 pm with widespread hives, even in her ears, face, chest, legs, eyes were swollen shut, and she was very itchy. Mom gave Benadryl q6 hours and the rash started going away and swelling went down. Mom reported to office the following morning, 12/10/2013. Mom was advised to continue to monitor and go to Emergency Dept if patient has any difficulty breathing, facial or oral swelling, or difficulty swallowing. Mom stated at another visit after this event, 07/08/2014, that patient experienced shortness of breath at the time the hives were present as well.
Age: 36.0
Sex: M
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a 36 year old adult male patient. No information about medical history, concurrent conditions was reported for the patient. On 18-MAR-2015 the patient was vaccinated with pediatric dose of RECOMBIVAX HB (2.5/1.5), 0.5 ml, intramuscularly instead of an adult dose. No adverse effects were reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
Age: 1.28
Sex: M
Vaccine: MMR
Symptoms: Dyspnoea, Urticaria, Wheezing
Clinical narrative: This spontaneous report as received from a physician refers to a 15 month old male patient. The patient's current conditions included asthma. Drug reactions/allergies were none. On 20-JUN-2011, the patient was vaccinated with M-M-R II, 0.5 ml, subcutaneously. Concomitant therapies included albuterol and PULMICORT. On 20-JUN-2011, the patient developed hives on an unspecified location of his body, wheezing, and difficulty breathing "within an hour or so after receiving MMR II". No lab diagnostic studies were performed. The patient's parent sought medical attention and called physician's office on 20-JUN-2011 and was instructed to give BENADRYL as treatment for the events. The patient recovered from the events on 20-JUN-2011. The causality assessment was not provided. There was no product quality complaint involved. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: This spontaneous report as received from a physician refers to an 18 year old female patient. The patient's current conditions and medical history was not reported. On an unknown date the patient was vaccinated with GARDASIL injection 3 dose series (unknown strength and route). On an unknown date, the patient "had an abnormal pap smear after receiving the 3 dose GARDASIL series". The patient sought medical attention and made a office visit. The outcome of the event was reported as recovered. The causality assessment was not provided. There was no product quality complaint involved. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Diarrhoea, Pyrexia, Rash, Vomiting
Clinical narrative: This spontaneous report as received from a physician refers to a 2 year old child female patient. No information about medical history concurrent conditions was reported for the patient. On 27-APR-2015 the patient was vaccinated with first dose in the series of M-M-R II (dose, strength, route unspecified). No concomitant therapy was reported. On 29-APR-2015, the patient experienced fever, diarrhea and vomiting. On 07-MAY-2015 the patient experienced rash. The outcome of fever, rash, vomiting and diarrhea was reported as not recovered/not resolved. There was no intervention done to prevent serious criteria. No product quality complaint was involved. Additional information has been requested.
Age: 88.0
Sex: M
Vaccine: PNC13
Symptoms: Guillain-Barre syndrome
Clinical narrative: Pt had to go into ER 1 day after the vaccine and claimed to be diagnosed of GBS (Guillain Barre Syndrome).
Sex: F
Vaccine: MMR
Symptoms: Cellulitis, Incorrect route of drug administration
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. ON 18-MAY-2015 the patient was vaccinated intradermally, with a dose of M-M-R II (lot #, strength, dose and frequency were not reported). On the same day, the patient experienced little cellulitis (location not reported). The patient sought medical attention - visited office. The outcome of cellulitis was reported as recovering/resolving. The relatedness between vaccination with M-M-R II and cellulitis was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a physician referring to a female patient of unknown age. On unknown dates the patient was vaccinated with the first and second doses of GARDASIL (lot#, expiration date, dose and route were unknown). The physician was intended to administer the patient a dose of GARDASIL 9 to complete the series on 19-MAY-2015. No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event, Biopsy, Laboratory test, Smear cervix
Clinical narrative: This spontaneous report as received from a patient's mother, refers to a female patient of unknown age. The patient's concurrent conditions and medical history were not reported. On an unknown date (reported as 'when she was younger'), the patient was vaccinated with a dose of GARDASIL (dose, route, lot# and expiration date were not provided). It was reported, that since an unknown date, the patient was having unspecified problems and has needed biopsies, unspecified laboratory tests and pap smears. The outcome of unspecified problems was not reported. The relatedness between the event and GARDASIL was not provided. Additional information is not expected, because there are no reporter's contact details.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Fever. Nausea. Headache. Body aches. Chills.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Chest discomfort, Echocardiogram normal, Electrocardiogram ST segment elevation, Hyperhidrosis, Musculoskeletal discomfort
Clinical narrative: Acute onset of chest pressure radiating to left shoulder, 10 days after smallpox vaccination, associated with diaphoresis and slight improvement with leaning forward. Pain resolved with Motrin and Colchicine. Discharged on 1 week on Motrin and 3 months of Colchicine.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Pain, Troponin I increased
Clinical narrative: Acute onset of chest pressure radiating to left shoulder, 10 days after smallpox vaccination, associated with diaphoresis and slight improvement with leaning forward. Pain resolved with Motrin and Colchicine. Discharged on 1 week on Motrin and 3 months of Colchicine.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Chest discomfort, Discomfort, Echocardiogram normal, Electrocardiogram ST segment elevation, Hyperhidrosis
Clinical narrative: Acute onset of chest pressure radiating to left shoulder, 10 days after smallpox vaccination, associated with diaphoresis and slight improvement with leaning forward. Pain resolved with Motrin and Colchicine. Discharged on 1 week on Motrin and 3 months of Colchicine.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Musculoskeletal discomfort, Pain, Troponin I increased
Clinical narrative: Acute onset of chest pressure radiating to left shoulder, 10 days after smallpox vaccination, associated with diaphoresis and slight improvement with leaning forward. Pain resolved with Motrin and Colchicine. Discharged on 1 week on Motrin and 3 months of Colchicine.
Age: 18.0
Sex: M
Vaccine: HEP, HPV4, MNQ
Symptoms: Confusional state, Drooling, Eye movement disorder, Muscle twitching, Postictal state
Clinical narrative: Pt slumped forward from an upright, seated position (head in lap). Pt was observed drooling. Pt then sat upright with head and upper body twitching and shaking. Pt's eyes were rolled back in her head. Pt then came out of event and stared confusedly at provider. Pt appeared to be post ictal. Entire event lasted 10-15 seconds.
Age: 18.0
Sex: M
Vaccine: HEP, HPV4, MNQ
Symptoms: Posture abnormal, Staring, Tremor
Clinical narrative: Pt slumped forward from an upright, seated position (head in lap). Pt was observed drooling. Pt then sat upright with head and upper body twitching and shaking. Pt's eyes were rolled back in her head. Pt then came out of event and stared confusedly at provider. Pt appeared to be post ictal. Entire event lasted 10-15 seconds.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Decreased appetite, Injection site erythema, Skin warm
Clinical narrative: Developed right arm redness the size of 50 cent piece (according to mom) approx. 3 hours after vaccination. She gave TYLENOL at that time, again that night and the morning of 5/19/15. Was warm to touch. No hardness noted when nurse asked mother. On 5/21/15 mom says redness remains same size around injection site. She has slight appetite decrease, otherwise well.
Age: 35.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Hypoaesthesia, Muscle spasms, Musculoskeletal pain, Pain in extremity, Paraesthesia
Clinical narrative: Pt stated that she developed pain to the left arm and points to the Left shoulder blade area. She tnen had a muscle spasm to the left arm on the following Monday.  She also developed numbness and tingling in left neck, shoulder and elbow.  Her pain worsened in the left shoulder blade area and not at the injection site.  No fever or chills.
Age: 67.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: Fever 102F, aches, extremely painful left deltoid muscle that inhibited movement. No redness or swelling noted.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Injection site reaction - pt had redness and swelling beginning approximately 48 hrs after administration; swelling was larger than golf ball size and spread down back of arm. Pt. saw Dr. and received corticosteroid tx.
Age: 22.0
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: None - pt wanted meningococcal was given MMRII - no reaction.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: PREVNAR given 5/13/2015. On 5/15/15 she c/o redness at injection site (R) Deltoid). On 5/19/15 she returned to office with c/o (R) upper arm redness, warmth and tenderness.
Age: 1.95
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site swelling
Clinical narrative: Grapefruit sized swelling, erythema, edema pain to right leg.
Age: 94.0
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pruritus
Clinical narrative: Redness, swelling and pain at left deltoid site (site of injection).  Noted on 5/16/15 symptoms progressed with growing area of redness, new onset of pruritis on arm 5/19/15; then 5/22/15 rash to same area.  PREVNAR (not a choice on next page), Manufacturer: Wyeth Pharmaceuticals (Subsidiary of Pfizer; Lot #L62072    NDC: 0005-1971-01
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age and gender. Current conditions and medical history were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored ROTATEQ suspension 2 (unknown dose and strength; route defaulted to oral) (incorrect product storage). Concomitant medications were not reported. No adverse effect was reported. The outcome of the events was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unknown number of patients of unknown age and gender. The patient's current conditions and medical history were not reported. Since unspecified dates in October 2014, the patients were vaccinated with doses of improperly stored COMVAX (unknown strength and route) (incorrect product storage). Concomitant medications were not reported. No adverse effect was reported. The outcome of the events was unknown. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Pain, Pain in extremity, Skin warm
Clinical narrative: Patient received vaccine at 8:00am 5/13/15. Patient iced the arm and took ibuprofen both 5/13/15 and 5/14/15. Patient woke up 4am 5/15/15 with shooting pain down her left arm. Patient seen at EHS with induration of 10mm, warm, and red.