chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Injection site pain
Clinical narrative: This spontaneous report was received from a male patient concerning himself of unknown age (age reported as 76 (units unknown). On 28-APR-2014 the patient was vaccinated with ZOSTAVAX 1 time vaccine, in the left arm (route and dose unspecified). Concomitant therapies included LIPITOR. On 29-APR-2014, the patient experienced pain at site of insertion after getting ZOSTAVAX vaccine, in his left arm. On 02-MAY-2014 the patient started getting an intermittent pain in his back. He described this was painful to the touch, which has not gone away. There was no product quality complaint (PQC) involved. Patient sought no medical attention. The outcome of pain at site of insertion after getting ZOSTAVAX was unknown. The outcome of started getting an intermittent pain in his back was reported as not resolved. Causality assessment was not provided. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to a 12 year old female patient. On approximately 10-APR-2014, "3 weeks ago", the patient was vaccinated with GARDASIL (dose, lot # not reported). Concomitant therapies included DIPHTHERIA TOXOID (+) PERTUSSIS ACELLULAR VACCINE (UNSPECIFIED) (+) TE) and TUBERCULIN PURIFIED PROTEIN DERIVATIVE. On an unknown date in 2014, the patient experienced dizzy and was going to faint, but did not fall. The outcome is unknown. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Gait disturbance, Muscle tightness
Clinical narrative: This spontaneous report as received from a female patient of unknown age refers to herself. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot#, expiration date, route, dose and strength not reported). On an unspecified date after receiving PNEUMOVAX 23, the muscles in the patient's legs tightened and it was difficult for her to walk. The outcome of the events was unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 59.0
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an approximately 59 years old patient (gender unknown). On an unknown date in 2014, the patient was vaccinated with an expired ZOSTAVAX, vial, lot # J000432, expiry date 10-APR-2014, dose (unknown), and route of administration (unknown), for unknown indication. No concomitant medications were reported. No adverse effects have been observed or reported. No product quality complaint was involved. The outcome of events was unknown. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to an unspecified number of patients of unknown age. No concomitant medication, pertinent medical history, drug reactions or allergies were reported. In 2014 (exact date unspecified) the unspecified number of patients were administered for GARDASIL (lot #, expiration date, strength, dose and frequency were not reported) that were improperly stored. Doses of this vaccines were administered after 23-JAN-2014 until an unspecified date (date approximated: 2014). No adverse events were reported. This is several reports from the same source (MARRS # 1404USA014626, 1404USA015276). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to an unspecified number of patients of unknown age. No concomitant medication, pertinent medical history, drug reactions or allergies were reported. In 2014 (exact date unspecified) the unspecified number of patients were administer doses of ROTATEQ (lot #, expiration date, strength, dose and frequency were not reported) that were improperly stored. Doses of this vaccines were administered after 23-JAN-2014 until an unspecified date (date approximated: 2014). No adverse events were reported. This is several reports from the same source (MARRS # 1404USA014626, 1404USA015277). Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to an unspecified number of patients of unknown age. No concomitant medication, pertinent medical history, drug reactions or allergies were reported. In 2014 (exact date unspecified) the unspecified number of patients were administered doses of RECOMBIVAX HB 10 microgram/ml (lot #, expiration date, strength, dose and frequency were not reported) that were improperly stored. Doses of this vaccines were administered after 23-JAN-2014 until an unspecified date (date approximated: 2014). No adverse events were reported. This is several reports from the same source (MARRS # 1404USA015276, 1404USA15277). Additional information has been requested.
Age: 29.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a register nurse concerning a 29 year old patient of an unknown gender. Medical history and concurrent conditions were not reported. On 18-MAR-2014, the patient was vaccinated with MMR II (route was not reported) lot # 0480AE, expiration date 29-AUG-2015 (also reported as 20-SEP-2014), batch number H017436, albumin status rHA. Co-suspect and concomitant therapies were not reported. The register nurse reported that MMR II went through a unsupported temperature excursion; however 10 doses of MMR II were overlooked because they were stored in the fridge. These doses were administered to 10 patients, this case pertain to one of them. This case is linked to 1404USA001099, 1404USA001100, 1404USA001101, 1404USA011002, 1403USA010165, 1404USA014293, 1404USA014295, 1404USA014296, 1404USA014297, 1404USA014298, 1404USA014299, 1404USA01430 and 1404USA014301. Additional information has been requested.
Age: 51.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a register nurse concerning a 51 year old patient of an unknown gender. Medical history and concurrent conditions were not reported. On 16-FEB-2014, the patient was vaccinated with MMR II (route was not reported) lot # 0480AE, expiration date 29-AUG-2015 (also reported as 20-SEP-2014), batch number H017436, albumin status rHA. Co-suspect and concomitant therapies were not reported. The register nurse reported that MMR II went through a unsupported temperature excursion; however 10 doses of MMR II were overlooked because they were stored in the fridge. These doses were administered to 10 patients. This case pertain to one of them who received the first dose for travel purpose and had decided not to received a repeat dose of MMR II. This case is linked to 1404USA001099, 1404USA001100, 1404USA001101, 1404USA011002, 1403USA010165, 1404USA014293, 1404USA014294, 1404USA014295, 1404USA014297, 1404USA014298, 1404USA014299, 1404USA01430 and 1404USA014301. Additional information has been requested.
Age: 49.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a register nurse concerning a 49 year old patient of an unknown gender. Medical history and concurrent conditions were not reported. On 06-FEB-2014, the patient was vaccinated with M-M-R II (route was not reported) lot # 0480AE, expiration date 29-AUG-2015 (also reported as 20-SEP-2014), batch number H017436, albumin status RHA. Co-suspect and concomitant therapies were not reported. The register nurse reported that M-M-R II went through a supported temperature excursion; however 10 doses of M-M-R II were overlooked because they were stored in the fridge. These doses were administered to 10 patients. This case pertain to one of them who received the first dose for travel purpose and had decided not to received a repeat dose of M-M-R II. This case is linked to 1404USA001099, 1404USA001100, 1404USA001101, 1404USA001102, 1404USA010165, 1404USA014293, 1404USA014294, 1404USA014296, 1404USA014297, 1404USA014298, 1404USA014299, 1404USA01430 and 1404USA014301. Additional information has been requested.
Age: 29.0
Sex: M
Vaccine: MEN
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Presented to Clinic 3 days post vaccination with red swollen and painful injection site on left SQ arm, states pain is a 1-2 out of 10 when resting and a 3-4 out of 10 with movement, 3-4 out of 10 when touched. Sent to Hospital.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Pruritus
Clinical narrative: Blisters appeared on lower left ribcage. Extreme itching. Went to ER 12 hours later and after checking with pharmacy and oncall infectious disease specialist at the ER doc prescribed Valacyclovir(1000mg X 3)
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 84 year old female patient. No drug reactions or allergies were reported. On 21-APR-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose and route of administration not reported) lot # J004269, expiration date 12-JUL-2015. Concomitant therapies included calcitriol, losartan potassium (manufacturer unknown), LASIX and lovastatin (manufacturer unknown). On approximately 27-APR-2014 (about two days ago), the patient experienced rash around her tailbone (Coccyx) area and was diagnosed with shingles by the patient's physician on 29-APR-2014 (today). No lab diagnostics studies were performed. The patient was treated with acyclovir. The patient sought medical attention by visiting physician's office. The outcome of adverse event was reported as not recovered/not resolved. Relatedness between the adverse event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Vomiting
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 68 year old male patient with history of an unspecified reaction to unspecified "statins". On 18-MAR-2014 the patient was vaccinated with PNEUMOVAX23 lot # J009689, expiration date: 29-JAN-2014; dose 0.5 ml, intramuscular. No concomitant medications were reported. The patient called the medical assistant's facility on 31-MAR-2014 and stated that he experienced dizziness and vomiting on an unspecified date after 18-MAR-2014. Patient sought medical attention at un unspecified emergency room on an unspecified date. It was unspecified by medical assistant whether patient was hospitalized. The outcome of events is unknown. The relatedness between PNEUMOVAX23 and events was not reported. Additional information has been requested.
Age: 47.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a register nurse concerning a 47 year old patient of an unknown gender. Medical history and concurrent conditions were not reported. On 04-MAR-2014, the patient was vaccinated with M-M-R II (route was not reported) lot # 0480AE, expiration date 29-AUG-2015 (also reported as 20-SEP-2014), batch number H017436, albumin status rHA (recombinant human albumin. On 09-APR-2014, patient was vaccinated with M-M-R II (route was not reported) lot # J006954, expiration date 07-JUN-2015. Co-suspect and concomitant therapies were not reported. The register nurse reported that M-M-R II went through a unsupported temperature excursion; however 10 doses of M-M-R II were overlooked because they were stored in the fridge. These doses were administered to 10 patients. The clinic has contacted the patients and 3 out of 10 patients had received an additional dose of M-M-R II. This case is linked to 1404USA001099, 1404USA001100, 1404USA001101, 1404USA001102, 1403USA010165, 1404USA014293, 1404USA014294, 1404USA014295, 1404USA014296, 1404USA014298, 1404USA014299, 1404USA01430 and 1404USA014301. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Grip strength decreased
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 71 year old male patient. The patient's drug reactions or allergies were none. On 22-APR-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot # J011341, expiry date 13-DEC-2014) 0.65 ml, subcutaneous. Concomitant therapies included VOLTAREN EMULGEL, tramadol hydrochloride and LYRICA. Approximately on 25-APR-2014 (also reported as a week ago), the patient developed pain in joints of thumb, wrist and forefingers on his right side (disability). The patient was not able to grab things. It was reported that ZOSTAVAX was given on left side. There was no treatment rendered for the events. The outcome of the events were reported as not recovered. Causality of the event with suspect product was unknown. Product quality complaint was not reported. The patient sought medical attention (called pharmacy). Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a register nurse concerning a 36 year old patient of an unknown gender. Medical history and concurrent conditions were not reported. On 04-MAR-2014, the patient was vaccinated with M-M-R II (route was not reported) lot # J006954, expiration date 07-JUN-2015. Patient was schedule for revaccination (reported as next week, date unspecified). Co-suspect and concomitant therapies were not reported. The nurse reported that M-M-R II went through a unsupported temperature excursion; however 10 doses of M-M-R II were overlooked because they were stored in the fridge. These doses were administered to 10 patients, this case pertain to one of them. It was noted that the patient was scheduled for revaccination with M-M-R II nest week (date unspecified). This case is linked to 1404USA001099, 1404USA001100, 1404USA001102, 1403USA010165, 1404USA014293, 1404USA014294, 1404USA014295, 1404USA014296, 1404USA014297; 1404USA014299, 1404USA01430 and 1404USA014301. Additional information has been requested.
Age: 25.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a register nurse concerning a 25 year old patient of an unknown gender. Medical history and concurrent conditions were not reported. On 05-MAR-2014, the patient was vaccinated with M-M-R II (route was not reported) lot J006954, expiration date 07-JUN-2015. Co-suspect and concomitant therapies were not reported. The register nurse reported that M-M-R II went through a unsupported temperature excursion; however 10 doses of M-M-R II were overlooked because they were stored in the fridge. These doses were administered to 10 patients, this case pertain to one of them who had not received repeat dose to date. This case is linked to 1404USA001099, 1404USA001100, 1404USA001101, 1404USA001102, 1403USA010165, 1404USA014293, 1404USA014294, 1404USA014295, 1404USA014296, 1404USA014297, 1404USA014298, 1404USA01430 and 1404USA014301. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a register nurse concerning a 5 year old patient of an unknown gender. Medical history and concurrent conditions were not reported. On 05-MAR-2014, the patient was vaccinated with M-M-R II (route was not reported) lot # J006954, expiration date 07-JUN-2015. Co-suspect and concomitant therapies were not reported. The register nurse reported that M-M-R II went through a supported temperature excursion; however 10 doses of M-M-R II were overlooked because they were stored in the fridge. These doses were administered to 10 patients, this case pertain to one of them who had not received repeat dose to date. The case is liked to 1404USA001099, 1404USA001100,  1404USA001101, 1404USA001102, 1404USA010165, 1404USA014293, 1404USA014294, 1404USA014295, 1404USA014296, 1404USA014297, 1404USA014298, 1404USA014299 and 1404US14301.   Additional information has been requested.
Age: 1.07
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a register nurse concerning a 1 year old patient of an unknown gender. Medical history and concurrent conditions were not reported. On 05-MAR-2014, the patient was vaccinated with M-M-R II (route was not reported) lot # J006954, expiration date 07-JUN-2015. Co-suspect and concomitant therapies were not reported. The register nurse reported that M-M-R II went through a unsupported temperature excursion; however 10 doses of M-M-R II were overlooked because thet were stored in the fridge. These doses were administered to 10 patients. This case pertain to one of them who had not received repeat dose date. This case is linked to 1404USA001099, 1404USA001100, 1404USA001101, 1404USA001102, 1404USA014293, 1404USA014294, 1404USA014295, 1404USA014296, 1404USA014297, 1404USA014298, 1404USA014299, 1404USA01430 and 1403USA010165. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Herpes zoster, Rash vesicular
Clinical narrative: Dx'ed with herpes zoster 5/6/14.  Tx with Valtrex 1 gm TID 7 days. Pt was seen in ER previous to PCP visit due to chest pain where vesicular rash later errupted.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to unspecified number of patients with unspecified demographics. On an unknown date, unspecified patients received improperly stored RECOMBIVAX HB injection strength 2.5/0.5 (dose and frequency unspecified) that were exposed to 26.2 F for 5.5 hours. Concomitant therapy was unspecified. No adverse effects were reported. No product quality complaint was involved. The outcome of patients received improperly stored RECOMBIVAX HB injection that were exposed to 26.2 F for 5.5 hours was unknown. No further information was provided. This case is linked with MARRS # 1405USA003793 and MARRS # 1405USA003794 as same reporter cases. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health are worker refers to unspecified number of patients with unspecified demographics. On an unkown date, unspecified patients received improperly stored VAQTA (dose and frequency unspecified) that were exposed to 26.2 F for 5.5 hours. Concomitant therapy was unspecified. No adverse effects were reported. No product quality complaint was involved. The outcome of patients received improperly stored VAQTA that were exposed to 26.2 F for 5.5 hours was unknown. No further information was provided. This case is linked with MARRS # 1405USA003490 and MARRS # 1405USA003794 as same reporter cases. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to unspecified number of patients with unspecified demographics. On an unknown date, unspecified patients received improperly stored ROTATEQ (dose and frequency unspecified) that were exposed to 26.2 F for 5.5 hours. Concomitant therapy was unspecified. No adverse effects were reported. No product quality complaint was involved. The outcome of patients received improperly stored ROTATEQ that were exposed to 26.2 F for 5.5 hours was unknown. No further information was provided. This case is linked with cases MARRS # 1405USA003793 and MARRS # 1405USA003490 as same reporter cases. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This report was received from a nurse. The nurse reported that three patients were administered expired ROTATEQ. This spontaneous report refers to first patient (out of three patients who were administered expired ROTATEQ) of unspecified demographics. Patients medical history unspecified. On 02-APR-2014, the patient received expired ROTATEQ, (dose unspecified) (lot number H016249, expiry date 27-MAR-2014). Concomitant therapy was unspecified. No adverse effects reported. No product quality complaint was involved. The outcome of received the expired ROTATEQ on 02-APR-2014 was unknown. No further information was provided. This case is linked with MARRS # 1405USA002806 and MARRS # 1405USA002805 as same reporter cases. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This report was received from a nurse. The nurse reported that three patients were administered expired ROTATEQ vaccine. This spontaneous report refers to third patient (out of three patients who were administered expired ROTATEQ) of unspecified demographics. On 28-APR-2014, the patient received expired ROTATEQ, dose unspecified, (lot number H016249, expiry date 27-MAR-2014). Concomitant therapy was unspecified. No adverse effects reported. No product quality complaint was involved. The outcome of received the expired ROTATEQ on 28-APR-2014 was unknown. No further information was provided. This case is linked with MARRS 1405USA001811 and MARRS 1405USA002805 as same reporter cases. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This report was received from a nurse. The nurse reported that three patients were administered expired ROTATEQ vaccine. This spontaneous report refers to second patient (out of three patients who were administered expired ROTATEQ) of unspecified demographics. On 08-APR-2014, the patient was administered expired ROTATEQ, dose unspecified (lot number H016249, expiry date 27-MAR-2014). Concomitant therapy was unspecified. No adverse effects reported. No product quality complaint was involved. The outcome of received the expired ROTATEQ on 08-APR-2014 was unknown. No further information was provided. This case is linked with MARRS # 1405USA001811 and MARRS # 1405USA002806 as same reporter cases. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Throat tightness, Urticaria
Clinical narrative: Pt developed hives and a "stuffy throat" w/in 20 min of receiving vaccine. He was given BENADRYL, EPI and taken to ER.
Age: 0.85
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Large red patches over whole body, some with raised flesh colored centers.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Local reaction, Vomiting
Clinical narrative: Vomiting, localized reaction red/swollen hard area on upper left deltoid. Treatment at E.R. ORAPRED 15mg/5mL 60 mg P.O. BENADRYL 25 mg PEPCID 20 mg tab P.O.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Headache, Lip swelling, Pyrexia
Clinical narrative: Fever, headache, mild lip swelling.
Age: 2.0
Sex: F
Vaccine: TYP
Symptoms: Eye swelling, Swelling face
Clinical narrative: Swelling of eyes and face.
Age: 47.0
Sex: F
Vaccine: VARCEL
Symptoms: Palpitations, Vaccination complication
Clinical narrative: Patient states had racing heart and was unable to do anything. Concerned that she was having reaction to vaccine and went to Emergency Department for Treatment. Given Benadryl and discharged.
Age: 35.0
Sex: F
Vaccine: TYP
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Shortness of breath, chest tightness
Age: 32.0
Sex: F
Vaccine: HEPA, MMR, TDAP, TYP
Symptoms: Headache, Pyrexia, Rash generalised, Rash vesicular
Clinical narrative: Person who came with her for travel shot called, informed client had a fever (99F - 101F) with headache for 3 days: took VICODIN developed fine rash on almost all of body. After took NARCO 1/2 tabs and became rashes like chicken pox. Enc. to see P.M.D. She went to clinic/Dr ordered Vit A and claimed didn't sure. She feel better now 4/29/2014.
Age: 0.57
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Blood test, Choking, Electroencephalogram, Neurological examination, Pyrexia
Clinical narrative: Pt received 4 mo - izs. PDRX - (PEDIARIX) (DTAP, IVP, HEP B) - HIB - PREVNAR - Rotavirus. In eve. pt fever 100 F - stopped breathing almost like choking. Mom picked her up and blew on her face. Lasted a few seconds. No shaking of extremities.
Age: 0.57
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Respiratory arrest
Clinical narrative: Pt received 4 mo - izs. PDRX - (PEDIARIX) (DTAP, IVP, HEP B) - HIB - PREVNAR - Rotavirus. In eve. pt fever 100 F - stopped breathing almost like choking. Mom picked her up and blew on her face. Lasted a few seconds. No shaking of extremities.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Patient came back to pharmacy complaining of itching, burning, hot to touch area at site of injection. Told her to consult a physician. Looks like it may be cellulitis.
Age: 84.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 84 years old male patient who on 25-APR-2014, was vaccinated with ZOSTAVAX lot # J010447 Exp: 22-APR-2014, 0.65 ml, subcutaneous in the left arm. Pharmacist reported 2 patients were vaccinated with expired ZOSTAVAX. Both patients vaccinated on 25-APR-2014. No adverse effects reported. No further details provided. The outcome of vaccinated with expired ZOSTAVAX vaccine was unknown. Same reporter link MARRS 1405USA002220. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 80 years old female patient who on 25-APR-2014, was vaccinated with ZOSTAVAX lot # J010447 Exp: 22-APR-2014, 0.65 ml, subcutaneous in the left arm. Pharmacist reported 2 patients were vaccinated with expired ZOSTAVAX. Both patients vaccinated on 25-APR-2014. No adverse effects reported. No further details provided. The outcome of vaccinated with expired ZOSTAVAX vaccine was unknown. Same reporter link MARRS 1405USA003838. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPVX
Symptoms: Disorientation, Erythema, Fall, Fatigue, Gaze palsy
Clinical narrative: Fell out of chair, eyes rolled up, stopped breathing, body stiff, face red and disoriented when she came to. She is extremely tired.
Age: 17.0
Sex: F
Vaccine: HPVX
Symptoms: Musculoskeletal stiffness, Respiratory arrest
Clinical narrative: Fell out of chair, eyes rolled up, stopped breathing, body stiff, face red and disoriented when she came to. She is extremely tired.
Age: 30.0
Sex: M
Vaccine: HEP, MMR, MMR
Symptoms: Blood test, Fatigue, Headache, Rash
Clinical narrative: Patient had rash on his neck and face. Patient also reported fatigue and headaches.
Age: 30.0
Sex: M
Vaccine: HEP, MMR, MMR
Symptoms: Blood count, Measles post vaccine, Skin lesion
Clinical narrative: Patient had rash on his neck and face. Patient also reported fatigue and headaches.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Rash, Rash erythematous
Clinical narrative: Red patches on left arm, sore muscle. No treatment needed. Naproxen 1 tab BID as needed.
Age: 1.74
Sex: M
Vaccine: DTAP, HIBV, MMR, PPV
Symptoms: Abnormal behaviour, Aggression, Aphasia, Communication disorder, Unresponsive to stimuli
Clinical narrative: Behavior Changes. Significant lack of response, not remembering words and hard time communicating. Very Aggressive.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: (R) arm circumference increase in size swelling and rednesds. Cephalexin po prescribed for cellulitis.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Blood glucose increased, Chills, Dizziness, Feeling hot
Clinical narrative: Blood sugar slightly elevated on Wednesday AM and continued to rise through day and following day - Thursday. On Thursday AM - felt warm, then had chills. I also had several dizzy spells on Thursday.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: PATIENT HAS 2 INCH INDURATION FROM INJECTION SITE WITH EDEMA, REDNESS, WARMTH, AND TENDERNESS.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Injection site erythema, Injection site nodule, Pruritus, Rosacea
Clinical narrative: Nodule at injection site with redness. Itchiness and took Benadryl.  Rosacea also flared up.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Fatigue, Headache, Nausea, Swelling
Clinical narrative: Nausea/vomiting, swelling, redness, heat at site of vaccine. Headache. Fatigue.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Vaccination site warmth, Vomiting
Clinical narrative: Nausea/vomiting, swelling, redness, heat at site of vaccine. Headache. Fatigue.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Malaise
Clinical narrative: At approximately 11:00 AM on 05/06/2014, I noticed I felt tired and little sluggish; this increased as the day wore on. By late afternoon, I had a mild headache (None of the above symptoms would be worth reporting except...) By the time I got home at 9:30 PM on 05/06/2014, I was not feeling well and thought I might vomit. I immediately went to bed and despite chills was able to sleep for about an hour. At 10:30 PM on 05/06/2014, I was violently sick to my stomach. I also had chills and body pain. At 2:30 AM on 05/06/2014, I was again sick - this time with dry heaves as there was nothing left in my stomach. Chills and body pain continued. Throughout the day on 05/07/2014, I had water, crackers, and room temperature Coke. At 11:00 AM, I had intestinal distress and mild cramping. After sleeping the majority of the day, I felt better. As of 3:50 PM on 05/07/2014, the nausea passed but the body pain, stiffness and soreness remain. When my doctor's office called at 1:00 PM on 05/07/2014, I reported the reaction to the nurse practitioner that called.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms, Musculoskeletal stiffness, Nausea, Pain, Retching
Clinical narrative: At approximately 11:00 AM on 05/06/2014, I noticed I felt tired and little sluggish; this increased as the day wore on. By late afternoon, I had a mild headache (None of the above symptoms would be worth reporting except...) By the time I got home at 9:30 PM on 05/06/2014, I was not feeling well and thought I might vomit. I immediately went to bed and despite chills was able to sleep for about an hour. At 10:30 PM on 05/06/2014, I was violently sick to my stomach. I also had chills and body pain. At 2:30 AM on 05/06/2014, I was again sick - this time with dry heaves as there was nothing left in my stomach. Chills and body pain continued. Throughout the day on 05/07/2014, I had water, crackers, and room temperature Coke. At 11:00 AM, I had intestinal distress and mild cramping. After sleeping the majority of the day, I felt better. As of 3:50 PM on 05/07/2014, the nausea passed but the body pain, stiffness and soreness remain. When my doctor's office called at 1:00 PM on 05/07/2014, I reported the reaction to the nurse practitioner that called.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Sluggishness
Clinical narrative: At approximately 11:00 AM on 05/06/2014, I noticed I felt tired and little sluggish; this increased as the day wore on. By late afternoon, I had a mild headache (None of the above symptoms would be worth reporting except...) By the time I got home at 9:30 PM on 05/06/2014, I was not feeling well and thought I might vomit. I immediately went to bed and despite chills was able to sleep for about an hour. At 10:30 PM on 05/06/2014, I was violently sick to my stomach. I also had chills and body pain. At 2:30 AM on 05/06/2014, I was again sick - this time with dry heaves as there was nothing left in my stomach. Chills and body pain continued. Throughout the day on 05/07/2014, I had water, crackers, and room temperature Coke. At 11:00 AM, I had intestinal distress and mild cramping. After sleeping the majority of the day, I felt better. As of 3:50 PM on 05/07/2014, the nausea passed but the body pain, stiffness and soreness remain. When my doctor's office called at 1:00 PM on 05/07/2014, I reported the reaction to the nurse practitioner that called.
Age: 25.0
Sex: M
Vaccine: HPV4
Symptoms: Cough, Headache, Malaise, Muscle spasms, Muscle twitching
Clinical narrative: Cold-like symptoms including stuffy nose, itchy eyes, severe malaise, sneezing, light coughing, and headache. Also minor involuntary muscle twitches and light spasms in the arm where the vaccine was administered.
Age: 25.0
Sex: M
Vaccine: HPV4
Symptoms: Nasal congestion, Nasopharyngitis, Sneezing
Clinical narrative: Cold-like symptoms including stuffy nose, itchy eyes, severe malaise, sneezing, light coughing, and headache. Also minor involuntary muscle twitches and light spasms in the arm where the vaccine was administered.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Sore arm for 1 week. Unable to elevate arm above head.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Osteosarcoma, Pain in extremity, X-ray
Clinical narrative: 9-10-13 Patient received MENVEO on right arm. 2-23-14 Parent presented with patient with the complaint of right arm pain since Monday the 17th.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Hypoaesthesia, Immunoglobulin therapy, Laboratory test, Lumbar puncture
Clinical narrative: Numbness in hands and feet, progressed to weakness in arms and legs, inability to walk, gamma globulin treatment at hospital.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Muscular weakness
Clinical narrative: Numbness in hands and feet, progressed to weakness in arms and legs, inability to walk, gamma globulin treatment at hospital.
Age: 0.61
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Chest X-ray normal, Computerised tomogram head normal, Dyskinesia, Electroencephalogram normal, Full blood count normal
Clinical narrative: Abnormal movement of left arm and head x 3 days prior to admission 5/4/14 (straightening (L) arm and turning head (L), episodes lasting seconds) about 30 episodes. Admitted 5/6/14, EEG did not show epileptiform activity.
Age: 0.61
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Liver function test normal, Metabolic function test normal, Urine analysis normal
Clinical narrative: Abnormal movement of left arm and head x 3 days prior to admission 5/4/14 (straightening (L) arm and turning head (L), episodes lasting seconds) about 30 episodes. Admitted 5/6/14, EEG did not show epileptiform activity.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse refers to a patient of unknown age. On 04-MAY-2014, the patient was vaccinated with VARIVAX (dose and frequency were not reported) which was improperly stored at temperature of 8C for 54 hours. No adverse effects reported. No further information provided. Additional information has been requested.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Biopsy bone marrow normal, Biopsy skin abnormal, Blood test normal, Computerised tomogram normal, Endoscopy normal
Clinical narrative: Chief Concern: This patient contacted the Vaccine Healthcare Center to inquire about possible adverse events related to his receipt of the anthrax vaccine. He is a dentist. He contacted the VHC for a causality assessment as to whether receipt of the anthrax vaccine could be causally associated to his development of marginal B-cell lymphoma. History of present illness: The patient is a 40 year old male. He received 3 doses of the anthrax vaccine 2 weeks apart in July and Aug of 2000. He received the typhoid Vi vaccine with AVA #1. He states he does not remember any reaction or untoward symptoms after any of the doses. He believes he had all 3 doses in the triceps of the left arm. Records state he received influenza vaccine in the fall of 2001 and 2002 but no additional vaccines. One year after receiving anthrax #1-3. The papules were pruritic; they would come and go and would last about 7-14 days. There seemed to be no pattern to their reoccurrence. He initially ignored the outbreaks but ultimately did seek medical evaluation in 2000-03 and was told they were "hives". No treatment was prescribed but he occasionally took BENADRYL for the itching which did not relieve the symptoms. He then systematically eliminated detergents, soaps, starch, dry cleaning, alcohol, and certain foods including raw fish in the attempts to discover the etiology of the rash. None of these variables seemed to be related but the periodic outbreaks continued for the next 10 years. The papules became erythematous and continued to be self-limiting. In June 2011 he developed a granulomatous lesion on the left arm in the same place as the anthrax injections and his recurrent rash. The lesion was 10 x 30 mm, persistent, red, pruritic, but not accompanied by the usual rash on his back and chest. Through biopsy the lesion was diagnosed as marginal B-cell lymphoma. He was given topical steroids which had no effect followed by injectable steroids which resolved the lesion. He was seen by both dermatology and oncology specialties. Blood tests, marrow biopsy, endoscopy, CT and PET scans were all negative. In 2013 he had a recurrence of a larger lesion - about 1-2 inches in diameter - on the lower inside calf - which also was determined to be marginal B-cell lymphoma. Dermatology used injectable steroids which again resolved the lesion. Systemic symptoms he continues to develop the original pruritic erythematous papules approximately 1-2 x year managed by topical and injectable steroids. Low dose radiation may be considered. Past medical/surgical history: Reported: Past medical history no medical problems, no allergies, no asthma - no chronic medications, no smoking, no alcohol. Family history: Family medical history Mother- diabetes type 2, Father- ulcers resulting in gastric resection. PGF: colon cancer in his early 40. Children healthy. Marginal Zone B-cell lymphoma of mucosa associated lymphoid tissue extranodal.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Extranodal marginal zone B-cell lymphoma (MALT type), Granuloma, Injection site erythema, Injection site pruritus, Injection site reaction
Clinical narrative: Chief Concern: This patient contacted the Vaccine Healthcare Center to inquire about possible adverse events related to his receipt of the anthrax vaccine. He is a dentist. He contacted the VHC for a causality assessment as to whether receipt of the anthrax vaccine could be causally associated to his development of marginal B-cell lymphoma. History of present illness: The patient is a 40 year old male. He received 3 doses of the anthrax vaccine 2 weeks apart in July and Aug of 2000. He received the typhoid Vi vaccine with AVA #1. He states he does not remember any reaction or untoward symptoms after any of the doses. He believes he had all 3 doses in the triceps of the left arm. Records state he received influenza vaccine in the fall of 2001 and 2002 but no additional vaccines. One year after receiving anthrax #1-3. The papules were pruritic; they would come and go and would last about 7-14 days. There seemed to be no pattern to their reoccurrence. He initially ignored the outbreaks but ultimately did seek medical evaluation in 2000-03 and was told they were "hives". No treatment was prescribed but he occasionally took BENADRYL for the itching which did not relieve the symptoms. He then systematically eliminated detergents, soaps, starch, dry cleaning, alcohol, and certain foods including raw fish in the attempts to discover the etiology of the rash. None of these variables seemed to be related but the periodic outbreaks continued for the next 10 years. The papules became erythematous and continued to be self-limiting. In June 2011 he developed a granulomatous lesion on the left arm in the same place as the anthrax injections and his recurrent rash. The lesion was 10 x 30 mm, persistent, red, pruritic, but not accompanied by the usual rash on his back and chest. Through biopsy the lesion was diagnosed as marginal B-cell lymphoma. He was given topical steroids which had no effect followed by injectable steroids which resolved the lesion. He was seen by both dermatology and oncology specialties. Blood tests, marrow biopsy, endoscopy, CT and PET scans were all negative. In 2013 he had a recurrence of a larger lesion - about 1-2 inches in diameter - on the lower inside calf - which also was determined to be marginal B-cell lymphoma. Dermatology used injectable steroids which again resolved the lesion. Systemic symptoms he continues to develop the original pruritic erythematous papules approximately 1-2 x year managed by topical and injectable steroids. Low dose radiation may be considered. Past medical/surgical history: Reported: Past medical history no medical problems, no allergies, no asthma - no chronic medications, no smoking, no alcohol. Family history: Family medical history Mother- diabetes type 2, Father- ulcers resulting in gastric resection. PGF: colon cancer in his early 40. Children healthy. Marginal Zone B-cell lymphoma of mucosa associated lymphoid tissue extranodal.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Papule, Positron emission tomogram normal, Pruritus, Rash, Rash papular
Clinical narrative: Chief Concern: This patient contacted the Vaccine Healthcare Center to inquire about possible adverse events related to his receipt of the anthrax vaccine. He is a dentist. He contacted the VHC for a causality assessment as to whether receipt of the anthrax vaccine could be causally associated to his development of marginal B-cell lymphoma. History of present illness: The patient is a 40 year old male. He received 3 doses of the anthrax vaccine 2 weeks apart in July and Aug of 2000. He received the typhoid Vi vaccine with AVA #1. He states he does not remember any reaction or untoward symptoms after any of the doses. He believes he had all 3 doses in the triceps of the left arm. Records state he received influenza vaccine in the fall of 2001 and 2002 but no additional vaccines. One year after receiving anthrax #1-3. The papules were pruritic; they would come and go and would last about 7-14 days. There seemed to be no pattern to their reoccurrence. He initially ignored the outbreaks but ultimately did seek medical evaluation in 2000-03 and was told they were "hives". No treatment was prescribed but he occasionally took BENADRYL for the itching which did not relieve the symptoms. He then systematically eliminated detergents, soaps, starch, dry cleaning, alcohol, and certain foods including raw fish in the attempts to discover the etiology of the rash. None of these variables seemed to be related but the periodic outbreaks continued for the next 10 years. The papules became erythematous and continued to be self-limiting. In June 2011 he developed a granulomatous lesion on the left arm in the same place as the anthrax injections and his recurrent rash. The lesion was 10 x 30 mm, persistent, red, pruritic, but not accompanied by the usual rash on his back and chest. Through biopsy the lesion was diagnosed as marginal B-cell lymphoma. He was given topical steroids which had no effect followed by injectable steroids which resolved the lesion. He was seen by both dermatology and oncology specialties. Blood tests, marrow biopsy, endoscopy, CT and PET scans were all negative. In 2013 he had a recurrence of a larger lesion - about 1-2 inches in diameter - on the lower inside calf - which also was determined to be marginal B-cell lymphoma. Dermatology used injectable steroids which again resolved the lesion. Systemic symptoms he continues to develop the original pruritic erythematous papules approximately 1-2 x year managed by topical and injectable steroids. Low dose radiation may be considered. Past medical/surgical history: Reported: Past medical history no medical problems, no allergies, no asthma - no chronic medications, no smoking, no alcohol. Family history: Family medical history Mother- diabetes type 2, Father- ulcers resulting in gastric resection. PGF: colon cancer in his early 40. Children healthy. Marginal Zone B-cell lymphoma of mucosa associated lymphoid tissue extranodal.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Urticaria
Clinical narrative: Chief Concern: This patient contacted the Vaccine Healthcare Center to inquire about possible adverse events related to his receipt of the anthrax vaccine. He is a dentist. He contacted the VHC for a causality assessment as to whether receipt of the anthrax vaccine could be causally associated to his development of marginal B-cell lymphoma. History of present illness: The patient is a 40 year old male. He received 3 doses of the anthrax vaccine 2 weeks apart in July and Aug of 2000. He received the typhoid Vi vaccine with AVA #1. He states he does not remember any reaction or untoward symptoms after any of the doses. He believes he had all 3 doses in the triceps of the left arm. Records state he received influenza vaccine in the fall of 2001 and 2002 but no additional vaccines. One year after receiving anthrax #1-3. The papules were pruritic; they would come and go and would last about 7-14 days. There seemed to be no pattern to their reoccurrence. He initially ignored the outbreaks but ultimately did seek medical evaluation in 2000-03 and was told they were "hives". No treatment was prescribed but he occasionally took BENADRYL for the itching which did not relieve the symptoms. He then systematically eliminated detergents, soaps, starch, dry cleaning, alcohol, and certain foods including raw fish in the attempts to discover the etiology of the rash. None of these variables seemed to be related but the periodic outbreaks continued for the next 10 years. The papules became erythematous and continued to be self-limiting. In June 2011 he developed a granulomatous lesion on the left arm in the same place as the anthrax injections and his recurrent rash. The lesion was 10 x 30 mm, persistent, red, pruritic, but not accompanied by the usual rash on his back and chest. Through biopsy the lesion was diagnosed as marginal B-cell lymphoma. He was given topical steroids which had no effect followed by injectable steroids which resolved the lesion. He was seen by both dermatology and oncology specialties. Blood tests, marrow biopsy, endoscopy, CT and PET scans were all negative. In 2013 he had a recurrence of a larger lesion - about 1-2 inches in diameter - on the lower inside calf - which also was determined to be marginal B-cell lymphoma. Dermatology used injectable steroids which again resolved the lesion. Systemic symptoms he continues to develop the original pruritic erythematous papules approximately 1-2 x year managed by topical and injectable steroids. Low dose radiation may be considered. Past medical/surgical history: Reported: Past medical history no medical problems, no allergies, no asthma - no chronic medications, no smoking, no alcohol. Family history: Family medical history Mother- diabetes type 2, Father- ulcers resulting in gastric resection. PGF: colon cancer in his early 40. Children healthy. Marginal Zone B-cell lymphoma of mucosa associated lymphoid tissue extranodal.
Age: 0.8
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse refers to a 35 week old infant patient. On an unknown date, at 35 week the patient was inadvertently vaccinated with ROTATEQ dose 3, oral. No adverse effects reported. No further information was provided. Additional information has been requested.