chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: HEP, HEPA, MMR, TD
Symptoms: Chills, Headache, Muscle tightness, Nausea, Rash
Clinical narrative: Nausea, vomiting, headache, chills, leg muscle tightness bilaterally. No redness or swelling at point of injection. Reports rash on right leg.
Age: 61.0
Sex: F
Vaccine: HEP, HEPA, MMR, TD
Symptoms: Vomiting
Clinical narrative: Nausea, vomiting, headache, chills, leg muscle tightness bilaterally. No redness or swelling at point of injection. Reports rash on right leg.
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Dehydration, Feeling of body temperature change, Influenza
Clinical narrative: Patient stated that after receiving the Tdap injection, he went home and drank a couple beers, ate dinner, then went to bed around midnight. He stated that at 3:00 AM he awoke feeling weak, hot then cold, and dehydrated. He stated that he felt as if he had the flu without vomiting. He stated the symptoms lasted for approximately two days. He stated that he did not seek medical attention, but treated himself by drinking a large amount of water and refraining from alcohol intake.
Sex: U
Vaccine: MMR
Symptoms: Death
Clinical narrative: This spontaneous report was received from a physician via company representative regarding 100 unspecified patients. The physician reported an adverse event involving an unspecified measles vaccine. The physician stated that he had read an unspecified article in a locally published newsletter (name of the newsletter not provided). The article stated that there were hundred deaths caused by Measles, Mumps, and Rubella Virus Vaccine, (manufacturer unknown) (dose, strength, dose number, Lot no, vaccination site not specified). Concurrent conditions, medical history and concomitant medications were not provided. No further information was provided. The cause of death was not reported. Product quality complaint (PQC) was not reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema
Clinical narrative: This is a spontaneous report from a contactable nurse and pharmacist. The nurse reported same events for 4 patients with the same lot number of PREVNAR 13 given on the same date. This is the 3rd of 4 reports. A 65-year-old female patient of an unspecified ethnicity received PREVNAR 13 (lot # L62074, Expiry Date Nov2016) intramuscular at 0.5 ml, single in left deltoid on 19Jun2015. The patient did not receive other vaccines. The patient medical history was not reported. The reporter did not know of any illness at time of vaccination. The patient's concomitant medications were not reported. The reporter did not believe the patient was given any other vaccines within four weeks of this vaccination. On an unspecified date, in the last couple of weeks, clarified as within the month of reporting, the patient experienced cellulitis and redness. The patient called the office and returned for an office visit to see the doctor for the occurred events. The patient was not hospitalized for the event and had no pain or fever so no antibiotic was given. The patient received TYLENOL and ice for the events. The outcome of the events was unknown. Follow-up (23JUL2015): Follow-up attempts completed. No further information expected. Follow-up (10Aug2015): Additional information reported from the contactable pharmacist includes gender and age of the patient, date of vaccination and treatment received. Event Cellulitis added. Case upgraded to serious.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Electromyogram abnormal, Monoplegia, Muscular weakness, Musculoskeletal pain, Nerve conduction studies abnormal
Clinical narrative: This is a spontaneous report from a contactable physician reporting on behalf of himself. This 73-year-old male patient received PREVNAR 13, via an unspecified route of administration at single dose in left deltoid on 28Apr2015. Medical history included blood pressure high from 2005 and ongoing, tachycardia from 2013 and ongoing, atrial fibrillation from 2013 and ongoing, osteoporosis from 2005 and ongoing. Concomitant medication included irbesartan 300 mg daily for high blood pressure, metoprolol 25 mg twice a day for hypertension and tachycardia, XARELTO 10 mg daily to prevent stroke and for atrial fibrillation, terazosin 10mg daily, RYTHMOL for atrial fibrillation. On 22May2015, the patient developed severe pain in shoulder with outcome of recovered. Also in 2015 (unspecified date), he experienced left arm partial paralysis, acute brachial neuritis or Parsonage-Turners syndrome with outcome of not recovered and pain on an unspecified date with outcome of unknown. The events were described as follows: About 4-5 weeks later the vaccination he developed Acute Brachial Neuritis or Parsonage-Turners Syndrome. The patient also had severe shoulder pain starting on 22May2015, for 5 days; the pain subsided and his arm was left partially paralyzed. The patient has not regained full use of his arm yet. The patient underwent lab tests and procedures, which included MRI of the neck and shoulder on 24Jul2015, that did not show any other cause or pathology. Electromyogram on 31Jul2015, showed the partial paralysis and weakness of the deltoid muscle. Nerve Conduction test on 31Jul2015 showed that he had a deficit in the nerves to the deltoid muscle.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Neuralgic amyotrophy, Nuclear magnetic resonance imaging normal, Pain, Radiculitis brachial
Clinical narrative: This is a spontaneous report from a contactable physician reporting on behalf of himself. This 73-year-old male patient received PREVNAR 13, via an unspecified route of administration at single dose in left deltoid on 28Apr2015. Medical history included blood pressure high from 2005 and ongoing, tachycardia from 2013 and ongoing, atrial fibrillation from 2013 and ongoing, osteoporosis from 2005 and ongoing. Concomitant medication included irbesartan 300 mg daily for high blood pressure, metoprolol 25 mg twice a day for hypertension and tachycardia, XARELTO 10 mg daily to prevent stroke and for atrial fibrillation, terazosin 10mg daily, RYTHMOL for atrial fibrillation. On 22May2015, the patient developed severe pain in shoulder with outcome of recovered. Also in 2015 (unspecified date), he experienced left arm partial paralysis, acute brachial neuritis or Parsonage-Turners syndrome with outcome of not recovered and pain on an unspecified date with outcome of unknown. The events were described as follows: About 4-5 weeks later the vaccination he developed Acute Brachial Neuritis or Parsonage-Turners Syndrome. The patient also had severe shoulder pain starting on 22May2015, for 5 days; the pain subsided and his arm was left partially paralyzed. The patient has not regained full use of his arm yet. The patient underwent lab tests and procedures, which included MRI of the neck and shoulder on 24Jul2015, that did not show any other cause or pathology. Electromyogram on 31Jul2015, showed the partial paralysis and weakness of the deltoid muscle. Nerve Conduction test on 31Jul2015 showed that he had a deficit in the nerves to the deltoid muscle.
Sex: M
Vaccine: TDAP
Symptoms: Anaphylactic shock
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of anaphylactic shock in a adolescent male patient who received dTpa vaccine. In 1993, the patient received dTpa vaccine .5 ml. In 1993, an unknown time after receiving dTpa vaccine, the patient experienced anaphylactic shock (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the anaphylactic shock was recovered/resolved. It was unknown if the reporter considered the anaphylactic shock to be related to dTpa vaccine. Addition details were provided as follow: The reporter was the patient's wife. The patient went into anaphylactic shock in 1993 after receiving an unknown Tdap vaccine (unknown manufacturer). The patient was hospitalized.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Borrelia test negative, Immunology test normal, VIIth nerve paralysis
Clinical narrative: Approximately 24 hours after administration of vaccine, the patient developed symptoms consistent with a left sided Bell's Palsy.  This examiner did not see the patient on the day of vaccination but 5 days later when the patient presented to care.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ, VARCEL, HEP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, red, warmth at injection site.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ, VARCEL, HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Swelling, red, warmth at injection site.
Age: 62.0
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis, Chills, Inflammation, Local swelling, Pyrexia
Clinical narrative: Patient says she experienced low grade fever with chills with localized swelling and inflamamation lasting 72 hours.  Patient seen today (08/17/2015) by Dr.
Age: 43.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus
Clinical narrative: About 5 minutes after administration patient responded with itching. I gave her a 25mg Benadryl and watched her. At that time she called MD and MD told her to go to ER. She did not feel ambulance was necessary. She had no trouble breathing when she left. Vaccine was administered at approximately 11:40am and she left for ER at approximately 12p.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site warmth, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, swelling and warmth of injection site.
Age: 13.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Blood pressure decreased, Dizziness, Heart rate decreased, Hypotension, Lethargy
Clinical narrative: PT BEGAN TO FEEL LIGHTHEADED AND THEN PASSED OUT. LOC FOR 5-10 SECONDS. DROP IN BLOOD PRESSURE/PULSE 88/55 & 57 RESPECTIVELY.  PT REMAINED HYPOTENSIVE AND LETHARGIC >5 MINUTES SO EPINEPHRINE 0.3MG WAS ADMINISTERED IM.  PT REMAINED IN THE OFFICE UNDER CONTINUAL VITALS MONITORING FOR >35 MINUTES UNTIL HIS BP & PULSE RETURNED TO NORMAL AND HE WAS NO LONGER SYMPTOMATIC.
Age: 13.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Loss of consciousness
Clinical narrative: PT BEGAN TO FEEL LIGHTHEADED AND THEN PASSED OUT. LOC FOR 5-10 SECONDS. DROP IN BLOOD PRESSURE/PULSE 88/55 & 57 RESPECTIVELY.  PT REMAINED HYPOTENSIVE AND LETHARGIC >5 MINUTES SO EPINEPHRINE 0.3MG WAS ADMINISTERED IM.  PT REMAINED IN THE OFFICE UNDER CONTINUAL VITALS MONITORING FOR >35 MINUTES UNTIL HIS BP & PULSE RETURNED TO NORMAL AND HE WAS NO LONGER SYMPTOMATIC.
Age: 73.0
Sex: F
Vaccine: DT
Symptoms: No adverse event, Underdose
Clinical narrative: Patient was given dose of pediatric DT instead of adult. No adverse reaction noted.
Age: 82.0
Sex: F
Vaccine: VARCEL
Symptoms: Dizziness, Herpes zoster, Nausea, Pain in extremity, Rash vesicular
Clinical narrative: Right leg pain, blistering rash, nausea, dizziness, administering antiviral shingle medication.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Ocular hyperaemia, Sleep terror
Clinical narrative: Per Guardian had red eyes and night terror.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dizziness, Electrocardiogram, Electroencephalogram, Moaning
Clinical narrative: Light headed, moaning weakness, trembling, tachycardia.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Tachycardia, Tremor
Clinical narrative: Light headed, moaning weakness, trembling, tachycardia.
Age: 56.0
Sex: F
Vaccine: HEPAB
Symptoms: Dehydration, Diarrhoea, Vomiting
Clinical narrative: Vomiting, Diarrhea, Dehydration.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature decreased, Chills, Headache
Clinical narrative: 96.7 degree temp, chills, 146/100 bp, headache.
Age: 34.0
Sex: F
Vaccine: RAB
Symptoms: Dyspnoea, Erythema, Tachycardia, Throat tightness
Clinical narrative: Erythema to face, tachycardia, mild throat tightness and SOB
Age: 41.0
Sex: F
Vaccine: DTAP
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Left shoulder pain and reduced ROM due to pain after injection. On going for 1 month since injection.
Age: 76.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: No adverse events at this time.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, RV5
Symptoms: Crying, Immediate post-injection reaction, Injection site haemorrhage
Clinical narrative: MA administered Hep B in Right thigh and immediately saw bright red blood pulsate out of the injection site.  Bleeding stopped with pressure.  Patient was crying for longer than usual ~ 5 minutes after administration.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Swelling face, Urticaria
Clinical narrative: Swelling and "hives" on face. Mother tried oral Benadryl and Benadryl cream.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Infection
Clinical narrative: Pt called clinic 5 days after receiving imm to report infection symptoms. Pt seen in clinic that day for cellulitis, given bactrim. Pt called next day saying cellulitis was spreading. Advised to go to ER. Prescribed clindamycin in ER.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Headache
Clinical narrative: PATIENT CALLED ON 8/16/2015 AND TALKED TO PHARMACIST ON DUTY. SHE SAID SHE HAS A HEADACHE AND JOINT PAIN. PATIENT SAID SHE WILL CALL HER DR.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Cellulitis, Infection
Clinical narrative: Cellulitis at the site of infection. Patient was prescribed Levaquin 500mg for treatment.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pustule, Injection site swelling, Pyrexia
Clinical narrative: Fever 100.8 dg F, aching joints, swelling at injection site (right arm, dorsal), pox right arm ventral.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Injection site swelling, Injection site warmth, Pruritus, Urticaria
Clinical narrative: I received the vaccine ZOSTAVAX vial on August 3, 2015. On August 5, 2015, I suddenly developed acute urticaria: burning and itching hives on both legs. The injection site became swollen and hot, increasing to approximately the size of a large red tennis ball. My doctor advised me to go to ER after I had taken allergy medicine. After several hours of waiting in ER, the hives began to dissipate. I was given a prescription for steroids but I didn't feel the need to fill it. The injection site also became less aggravated and after several days of allergy medication, it has healed. I was advised to never take a shingles vaccine again.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to unspecified number of patients of unknown age and gender. No information about patients' pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On unspecified dates, the patients were administered doses of GARDASIL 9 lot# L001312, expiration date 24-FEB-2017 and lot# K026246, expiration date 28-JAN-2017 (dose and route of administration were not reported) which were exposed to temperatures outside of the recommended range. No adverse experience was reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a healthcare worker (also a certified medical assistant) referring to a patient of unknown age and gender. There was no medical history or drug reaction/allergies reported. The patient was administered a dose of MMR II on 30-SEP-2013 and a dose of another live vaccine (Oka/Merck) VARIVAX (dose and route were unspecified), on 03-OCT-2013. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On 20-MAR-2014, the patient was vaccinated with the first dose in the series of three of GARDASIL (lot#, expiration date, dose and route not reported). The second dose was vaccinated to the patient on 13-AUG-2015 (lot#, expiration date, dose and route not reported) (inappropriate schedule of drug administration). The reporter confirmed that the third dose of GARDASIL was not administered to the patient. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
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. No information about medical history, concurrent conditions was reported for the patient. On 13-AUG-2015 the patient was vaccinated with improperly stored (Merck) PROQUAD lot # L006388, expiration date 25-AUG-2016 (Dose strength, route unspecified). No adverse symptoms reported. No product quality complaint was involved. 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 physician refers to unspecified number of patients of unknown age and gender. No information regarding the patient's concurrent conditions and medical history were reported. On unspecified dates, the patient were vaccinated with doses of improperly stored ROTATEQ, oral (unknown strength and lot#). Concomitant medications were not reported. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a 19 year old male patient. Information about concurrent conditions, medical history and concomitant medication was not provided. On 27-MAY-2015 the patient was vaccinated with a pediatric dose of VAQTA (lot # K018181, dose, dose# and route not provided). No adverse experience has been reported. The outcome of the event was not provided. Additional information has been requested.
Age: 20.0
Sex: U
Vaccine: MMRV
Symptoms: Medication error, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 20 year old patient of unknown gender. Concurrent condition and medical history were not reported. On 22-JUL-2015 the patient was inadvertently vaccinated with a dose of (Merck) PROQUAD (lot # K025760, expiration date 08-JUN-2016, 0.5 ml) subcutaneously (Drug administered to patient of inappropriate age). No adverse experiences were reported. Therapy with PROQUAD was continued. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to unspecified number of patients of unknown age and gender. No information about patients' pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On unspecified dates, the patients were administered doses of PNEUMOVAX 23 lot # K010466, expiration date 23-MAR-2016 (dose and route of administration were not reported) which were exposed to temperatures outside of the recommended range. No adverse experience was reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: Information has been received from a pharmacist referring to her daughter, a 19 year old female patient. There was no medical history or drug reaction reported. On unknown dates, when the patient was a child, she was vaccinated with three doses of RECOMBIVAX HB (dosage, strength, route and lot # were not reported). There was no concomitant medication reported. In 2015 the patient underwent serological testing for hepatitis B. The titer results were negative for hepatitis B. It was unspecified whether the patient sought medical attention or not. At the time of reporting, the outcome was unknown. This is one of several reports received from the same reporter (MARRS# 1508USA003160). Additional information is not expected because the reporter didn't wish to contact.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to unspecified number of patients of unknown age and gender. No information about patients' pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies were provided. On unspecified dates, the patients were administered does of GARDASIL lot # K007828, expiration date 02-MAR-2017 and lot # K023432, expiration date 18-JUN-2016 (dose and route of administration were not reported) which were exposed to temperatures outside of the recommended range. No adverse experience was reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a pharmacist via company representative referring to an unspecified 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 the first doses of ZOSTAVAX (lot#, expiration date, dose and route not reported). The reporting pharmacist stated, on unknown dates, an unspecified physician might be providing a booster dose of ZOSTAVAX (lot#, expiration date, dose and route not reported) to these patients after 5 years of receiving the initial doses. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX lot # K003413, expiry date 06-MAR-2016 (dose and frequency not reported). No adverse experience reported. No product quality complaint (PQC) was involved. No further information provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: Information has been received from a pharmacist via a Public employee referring to an unknown age female patient with plaque psoriasis. The patient's medical history was not reported. On 24-JUN-2015 the patient was vaccinated with a dose of ZOSTAVAX vial form-STR (dose, frequency, route, lot # and expiration date were unknown) for shingles prevention. Concomitant therapies were not reported. On an unknown date in 2015 after the vaccination the patient's pre-existing condition of plaque psoriasis cleared up. Additional information is not expected as the reporter did not give consent to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to five patients of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. The health professional reported that on an unknown date, patients were vaccinated with improperly stored (Oka/Merck) VARIVAX injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaint (PQC) involved. The reporter's causality assessment was not provided. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unspecified patients of unknown age and gender. There was no medical history or concurrent condition reported. The nurse reported on unknown dates improperly stored (temperature excursion) VARIVAX (lot # L001330, expiration 13-JAN-2016; lot # L004655, expiration 11-FEB-2017) (dosage, and route were not reported) had been administered to unspecified patients. No concomitant medication was provided. Number of doses administered was unspecified. At the time of the report, no adverse effects was reported. This is one of several reports that received from the same source. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4, MEN
Symptoms: Blood test, Fatigue, Malaise
Clinical narrative: This spontaneous report was received from a physician refers to an approximately 16 year old male patient. No concurrent condition or medical history was reported. On 03-AUG-2015, the patient was vaccinated with GARDASIL (lot # K011562, dose 3, dose and route of administration not provided). Concomitant therapies included vaccination with meningococcal vaccine (unspecified). On 05-AUG-2015, the patient experienced fatigue and malaise. No treatment was given for the events. The patient called the physician's office on an unspecified date. The physician advised him to have unspecified blood work. The blood work was completed on 07-AUG-2015 but the results were unknown. The outcome of the events was reported as not recovered. The causality assessment was not reported. No product quality issue was involved. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: Information has been received from a female pharmacist of unknown age referring to herself. There was no medical history or drug reaction reported. On unknown dates, she was vaccinated with full three dose series of Hep B vaccine (manufacturer unknown) (dosage, strength, route and lot # were not reported) as an adult. There was no concomitant medication reported. On an unknown date the pharmacist had negative titers for hepatitis B. At the time of the report, the outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter didn't wish to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 12-AUG-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (dose and route were not reported, lot # L003774, expiration date 04-FEB-2017). There was no adverse effect 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 healthcare student (pharmacy student) refers to 22 patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unspecified dates between 01-APR-2015 and 28-MAY-2015, the 22 patients were vaccinated each with ZOSTAVAX (lot # L006379 expiry date of 25-MAY-2015 and also reported with expiry date of 24-MAY-2015 subcutaneous, which were improperly exposed to 8 Fahrenheit (F) for 28 days since an unspecified time. Concomitant medications were not reported. No known adverse effects were reported. There was no product quality complaint involved. 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 pharmacist refers to unspecified patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On unspecified dates, unspecified number of patients were vaccinated with improperly stored doses of ZOSTAVAX vial, 19,400 PFU (plaque-forming units), lot # L011534, exp. date: 03-JUL-2016; lot# K011002, exp. date: 11-JUL-2015 and lot# L003601, exp. date: 03-JUL-2016 (dose and route unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Chest pain, Decreased appetite, Ear pain, Inflammation
Clinical narrative: Client stated he received a Tdap vaccine on 6-1-15 at his PMD's office, and 2 days later he experienced weakness, loss of appetite, weight loss, soreness and redness that radiated from his (L) arm (site of injection) to (L) shoulder, (L) side lower neck, (L) side of chest, behind (L) ear.
Age: 79.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Neck pain, Weight decreased
Clinical narrative: Client stated he received a Tdap vaccine on 6-1-15 at his PMD's office, and 2 days later he experienced weakness, loss of appetite, weight loss, soreness and redness that radiated from his (L) arm (site of injection) to (L) shoulder, (L) side lower neck, (L) side of chest, behind (L) ear.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Allodynia, Anxiety, Arthralgia, Bone pain, Cellulitis
Clinical narrative: Flu-like symptoms muscle, joint pain, nausea/vomiting 2 days after vaccine. Aug. 4 - dx with cellulitis (antibiotics) swollen, tender, red arm/numbness adverse reaction to Tdap. Sept - dx with post vaccination syndrome allodynia, sore muscles, numbness/tingling extremities, headache, nausea, sore throat, vomiting, chronic sore joints/bones/nerve pain/anxiety, muscle spasms/twitches. Jan diagnosed with fibromyalgia.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Fibromyalgia, Headache, Hypoaesthesia, Influenza like illness
Clinical narrative: Flu-like symptoms muscle, joint pain, nausea/vomiting 2 days after vaccine. Aug. 4 - dx with cellulitis (antibiotics) swollen, tender, red arm/numbness adverse reaction to Tdap. Sept - dx with post vaccination syndrome allodynia, sore muscles, numbness/tingling extremities, headache, nausea, sore throat, vomiting, chronic sore joints/bones/nerve pain/anxiety, muscle spasms/twitches. Jan diagnosed with fibromyalgia.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Muscle spasms, Muscle twitching, Myalgia, Nausea, Neuralgia
Clinical narrative: Flu-like symptoms muscle, joint pain, nausea/vomiting 2 days after vaccine. Aug. 4 - dx with cellulitis (antibiotics) swollen, tender, red arm/numbness adverse reaction to Tdap. Sept - dx with post vaccination syndrome allodynia, sore muscles, numbness/tingling extremities, headache, nausea, sore throat, vomiting, chronic sore joints/bones/nerve pain/anxiety, muscle spasms/twitches. Jan diagnosed with fibromyalgia.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Oropharyngeal pain, Paraesthesia, Peripheral swelling, Post vaccination syndrome, Tenderness
Clinical narrative: Flu-like symptoms muscle, joint pain, nausea/vomiting 2 days after vaccine. Aug. 4 - dx with cellulitis (antibiotics) swollen, tender, red arm/numbness adverse reaction to Tdap. Sept - dx with post vaccination syndrome allodynia, sore muscles, numbness/tingling extremities, headache, nausea, sore throat, vomiting, chronic sore joints/bones/nerve pain/anxiety, muscle spasms/twitches. Jan diagnosed with fibromyalgia.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Flu-like symptoms muscle, joint pain, nausea/vomiting 2 days after vaccine. Aug. 4 - dx with cellulitis (antibiotics) swollen, tender, red arm/numbness adverse reaction to Tdap. Sept - dx with post vaccination syndrome allodynia, sore muscles, numbness/tingling extremities, headache, nausea, sore throat, vomiting, chronic sore joints/bones/nerve pain/anxiety, muscle spasms/twitches. Jan diagnosed with fibromyalgia.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: Patient returned to pharmacy 2 days after immunization and showed pharmacist a rash measuring 1/2 inch diameter in size that had developed around the injection site which itched occasionally. PCP aware according to patient. Patient using calamine lotion.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Patient complained of intermittent numbing, tingling down right side of face, neck, shoulder, arm and hands.  Lasts a minute at a time about 8 times a day. Started 1 week after vaccination. Still symptomatic 1 month later. Referred patient to PCP for possible other causative agents.
Age: 0.51
Sex: M
Vaccine: DTAP, HEP, PNC13
Symptoms: Vomiting
Clinical narrative: Started vomiting approx. 8 hrs. after receiving his immunization. Vomited 6-8 times that evening. Last vomited at 1am (8/11/15). No vomiting 8/11 or 8/12. Vomited 1 time morning of 8/13, Seen in clinic 8/13.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site induration, Injection site pruritus, Injection site reaction, Injection site warmth, Rash maculo-papular
Clinical narrative: Warmth, induration, pruritic maculopapular rash 3-5 cm diameter around site of injection. No fever or systemic symptoms.
Sex: U
Vaccine: HIBV
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. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses of PEDVAXHIB (lot # K015464 with expiration date 09-JUL-2017, lot # K026533 with expiration date 07-AUG-2017, lot # K025006 with expiration date 22-JUL-2017 and lot # L004740 with expiration date 16-NOV-2017; dose and route of administration were not reported). No adverse events have been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, HEPA, HPV4, MNQ, TDAP
Symptoms: Blood pressure decreased, Loss of consciousness, Syncope
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an 11 year old female patient. The patient's medical history included syncope, 5 or 6 years ago due to hypoglycemia and drug reaction/allergies were none. On 04-AUG-2015, the patient was vaccinated with GARDASIL (lot # L018286, expiration date 13-APR-2017 (dose and route were not reported). Concomitant medications were none. On 04-AUG-2015, the patient fainted or lost consciousness. The patient was repositioned in a supine position and her blood pressure was measured. Her blood pressure after she lost consciousness, was lower than it had been before she received the dose of GARDASIL. After an unspecified period of time, "a few minutes" the patient regained consciousness and the patient received some juice when she was able to sit upright. The patient received four additional other unspecified vaccinations after she was able to sit upright, and she did not experience any "light-headedness" or loss of consciousness after she received the other four unspecified vaccinations. The patient was released to home after this experience. The outcome of the events was reported as recovered on 04-AUG-2015. The relatedness of the events with the GARDASIL was not provided. This is one of several reports from the same source. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, HEPA, HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to an 11 year old female patient. The patient's medical history included syncope, 5 or 6 years ago due to hypoglycemia and drug reaction/allergies were none. On 04-AUG-2015, the patient was vaccinated with GARDASIL (lot # L018286, expiration date 13-APR-2017 (dose and route were not reported). Concomitant medications were none. On 04-AUG-2015, the patient fainted or lost consciousness. The patient was repositioned in a supine position and her blood pressure was measured. Her blood pressure after she lost consciousness, was lower than it had been before she received the dose of GARDASIL. After an unspecified period of time, "a few minutes" the patient regained consciousness and the patient received some juice when she was able to sit upright. The patient received four additional other unspecified vaccinations after she was able to sit upright, and she did not experience any "light-headedness" or loss of consciousness after she received the other four unspecified vaccinations. The patient was released to home after this experience. The outcome of the events was reported as recovered on 04-AUG-2015. The relatedness of the events with the GARDASIL was not provided. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of M-M-R II (dose, route, lot # and expiration date were not provided) which were exposed to temperatures of outside of the recommended range (incorrect product storage). No adverse effects had been reported. 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: This spontaneous report was received from a licensed practical nurse regarding an unspecified patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unspecified date since 02-JUN-2015, the patients were vaccinated with an improperly stored doses of (Oka/Merck) VARIVAX (dose and route were not reported, lot # K011800 with expiration date 21-AUG-2016 and lot #L002871 with expiration date 27-JAN-2015). 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: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a licensed practical nurse regarding an unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unspecified dates since 02-JUN-2015, the patients were vaccinated with an improperly stored doses of ZOSTAVAX (dose and route were not reported, lot # K018175, expiration date 10-JAN-2016). There were no adverse effects reported. Thi sis 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 registered nurse refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses of RECOMBIVAX HB (lot # J014655 with expiration date 16-APR-2016, lot # K006682 with expiration date 17-DEC-2016, lot # K018180 with expiration date 17-SEP-2016, lot # K009505 with expiration date 07-FEB-2016 (adult); dose and route of administration were not reported). No adverse events have been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
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. On 13-AUG-2015 the patient was inadvertently vaccinated with an expired dose of MMR II (dose, frequency were not reported, expiration date 11-JUL-2015) subcutaneously. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with doses of improperly stored GARDASIL 9 or GARDASIL (dose, route, lot# and expiration date were not reported). Concomitant drug was reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HIBV, HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to unspecified patients of unknown demographics. On an unknown date (also reported as since 09-APR-2015) the patients were vaccinated with LIQUID PEDVAXHIB lot # K015462; expiry: 10-JUL-2017 (dose, route, frequency unspecified). Other suspect therapies included GARDASIL (dose, route, frequency unspecified). It was reported that the vaccines which were exposed to temperature outside of the recommended range, have been administered to unspecified patients on unspecified dates since 09-APR-2015. No adverse effects have been reported. It was also reported that administrative worker, called back to evaluate the same doses, which were previously exposed to temperatures outside of the recommended range, and have been administered to patients. No additional information was provided. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a health professional (medical assistant) refers to a 17 year old patient (unknown gender). No concurrent conditions, medical history or allergy/drug reactions were reported. On 06-AUG-2015, the patient was inadvertently given a dose of ZOSTAVAX lot # L011533, exp. date: 03-JUL-2016 (strength and dose unspecified) via intramuscular administration instead of (Oka/Merck) VARIVAX. No concomitant medications were reported. No adverse effect was reported. The outcome of the event was unknown. There were no product quality complaint (PQC) involved. No further information was provided. 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 nurse via Center refers to a patient of unknown gender, between the age of 13 years and 18 years old. The patient's medical history and concurrent conditions were unknown. On 21-JUL-2015, the patient was vaccinated with an unknown dose of (Oka/Merck) VARIVAX (route was not reported, lot # K026386, expiry date 15-DEC-2016), which underwent temperature excursion of 8.9 degrees Celsius for 1 hour and 28 minutes on 07-JUL-2015. Concomitant medications were unknown. The patient did not experience any adverse events. 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 certified medical assistant concerning to an unspecified number of patients of unknown age and gender. Information regarding the patient's medical history, concurrent conditions or concomitant medication was not provided. Between 02-JUL-2015 and 04-AUG-2015, the patients were vaccinated with ROTATEQ lot # K007828 with expiration date of: 02-MAR-2017, (strength, dose and route of administration were unknown). That was improperly stored at a temperature of 32F during 6 hours. No adverse events of product quality complaints were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning to an unspecified number of patients of unknown age and gender. Information regarding the patient's medical history, concurrent conditions or concomitant medication was not provided. Between 02-JUL-2015 and 04-AUG-2014, the patients were vaccinated with M-M-R II lot # K002816 with expiration date of: 25-FEB-2016 and lot K006141 with expiration date of: 29-APR-2016 (strength, dose and route of administration were unknown). That was improperly stored at a temperature of 32F during 6 hours. No adverse events or product quality complaints were reported. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Breath sounds abnormal, Syncope, Vaccine positive rechallenge
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 19 years old female patient. The patient had a history of syncope after receiving a vaccinations. On an unknown date in approximately June 2015 (reported as "about one month ago"), the patient was vaccinated with the first dose of GARDASIL 1 injection, first dose of three dose series (dose, lot # and expiration date were not reported). Concomitant therapies administered during the same visit included TDap and MENACTRA. On an unknown date in approximately June 2015 (reported as "after the product was administered"), the patient experienced syncope. She also experienced a "bit of snorting respiration" but it was "not enough to qualify as a seizure or convulsion". The patient was revived with ammonia inhalant. The patient's father was with her and mentioned that this happened each time she got a vaccine and thinks it had to do with her level of anxiety about "receiving the shots". It was not specified if the patient plans to complete GARDASIL series. The outcome of the adverse events was reported as recovered (unspecified date). The causality between the adverse event and GARDASIL was not provided. Additional information is not expected as the reporter did not wish to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse via Poison and Drug Center refers to a patient of unknown gender, between the age of 19 years and 29 years old. The patient's medical history and concurrent conditions were unknown. ON 28-JUL-2015, the patient was vaccinated with an unknown dose of (Oka/Merck) VARIVAX (route was not reported, lot # K026386, expiry date 15-DEC-2016) which underwent temperature excursions as follows: 8.9 degrees celsius for 1 hour and 28 minutes on 07-JUL-2015 and 0.4 degrees Celsius for 1 hour and 25 minutes on 28-JUL-2015. Concomitant medications were unknown. The patient did not experience any adverse events. 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 certified medical assistant concerning to an unspecified number of patients of unknown age and gender. Information regarding the patient's medical history, concurrent conditions or concomitant medication was not provided. Between 02-JUL-2015 and 04-AUG-2015, the patients were vaccinated with GARDASIL lot # K007828 with expiration date of: 02-MAR-2017, (strength, dose and route of administration were unknown). That was improperly stored at a temperature of 32F during 6 hours. No adverse events or product quality complaints were reported. Additional information has been requested.