chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Severe swelling. Redness. Itching. Warm to touch.
Age: 1.56
Sex: F
Vaccine: VARCEL
Symptoms: Ultrasound scan, Vascular neoplasm
Clinical narrative: Soon after vaccine administration (about 1 hour) the child developed three (3) vascular tumors; two in the (L) axilla measuring 2 x 1 cm and 3.4 x 1.8 cm; and one on lower abdomen wall 1 x 1 cm. These tumors still remain.
Age: 26.0
Sex: M
Vaccine: HPV4
Symptoms: Blood pressure decreased, Dizziness, Headache
Clinical narrative: Rapid drop in blood pressure. Almost fainted. Ended up on floor of pharmacy with legs elevated. Symptoms cleared after 10 minutes.  Headache developed within 1 hour.  Pain went away with 400mg ibuprofen.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Swelling face, Urticaria
Clinical narrative: This spontaneous report as received from a physician refers to a 12 month old male patient with no pertinent medical history or drug reactions/allergies. On 27-JUN-2011 the patient was vaccinated with (oka/merck) VARIVAX (lot # 669098/1567Z, EXP date 11-NOV-2012, route not reported), MMR II (rHa, lot # 666684/0741Z, EXP date 19-MAY-2012, route not reported) and VAQTA (lot # 670282/0125AA, EXP date 06-DEC-2013 route not reported). Concomitant therapies included PREVNAR (lot # and route not reported, vaccinated on 27-JUN-2011). On 27-JUN-2011, one hour after the administration of vaccine, the patient experienced bad, widespread generalized hives further described as hives on face, arms and a little bit on chest. On an unknown date the patient experienced facial swelling. Patient sought medical attention. The patient was treated in the emergency room on 28-JUN-2011 with BENADRYL (route unspecified) and discharged on 28-JUN-2011. On 29-JUN-2011, patient was treated in another emergency room with BENADRYL administered intramuscularly and systemic steroids. Patient was discharged from this emergency room on 29-JUN-2011. Patient recovered on an unspecified date. The adverse event of bad, widespread generalized hives further described as hives on face, arms and a little bit on chest and facial swelling was reported as medically significant and life threatening. Additional information has been requested.
Sex: U
Vaccine: HBHEPB
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse (L.P.N) refers to a patient of unknown age. On 10-MAY-2013 the patient was vaccinated with COMVAX (lot # 1513AA, expiry date 06-MAY-2013) (intramuscular, 0.5 ml, strength not reported). It was reported that the patient was inadvertently administered COMVAX that had expired on 06-MAY-2013. No adverse effects were reported. It was unspecified whether the patient sought for medical attention. The outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacy technician and a healthcare worker refers to 4 patients of unknown age. The pharmacy technician mentioned that a medical assistant for a physician reported that on an unknown date the patients were vaccinated with PNEUMOVAX 23 lot # H014561 Exp 21-MAR-2014 (dose and route unknown). On an unknown date the 4 patients experienced "gross swelling" around the injection site. The patient sought unspecified medical attention. The outcome of the event was unknown. The healthcare worker requested a lot check for PNEUMOVAX 23 (lot # H014561 Exp 21-MAR-2014) due to patients having adverse experiences. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: This spontaneous report as received from a 70 year old female consumer refers to herself with unspecified blood pressure problem. The patient's medical history included two prior cases of shingles. On 09-MAY-2012 the patient was vaccinated with a dose of ZOSTAVAX (route and lot # not reported). Concomitant therapies included SPIRIVA and unspecified blood pressure medication. In July 2012, two months after receiving the ZOSTAVAX vaccine, she developed a third case of shingles on her "tailbone" area. Approximate time was two months later, after receiving the vaccine. She reports that the lesions are "bigger" than before. The outcome of shingles is unknown. The patient did not seek medical attention. No treatment was given for shingles. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age. The nurse was reporting that the patient received the first dose of GARDASIL (injection, strength, lot#, dose/frequency, route and duration were unspecified) on 27-JUL-2009 and the second dose (injection, strength, lot#, dose/frequency, route and duration were unspecified) on 13-MAY-2013. No adverse effect reported. The outcome was unknown. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Injection site reaction, Oedema peripheral, Pyrexia, Skin warm
Clinical narrative: Information has been received from a nurse practitioner concerning a 45-year-old female patient with asthma and hypertension and no known drug allergies, who on 09-MAY-2013 was vaccinated with a dose of PNEUMOVAX23, subcutaneously (dose and lot # not provided) in her left arm (also reported "for asthma"). Concomitant medication included diphtheria toxoid, pertussis acellular vaccine (unspecified) and an unspecified ACE inhibitor. It was reported that on 10-MAY-2013, the patient experienced injection site reaction. The patient reports that upon waking up on 10-MAY-2013, she felt feverish and noted the left arm in which PNEUMOVAX23 was administered, was red, swollen and hot to the touch. The patient did not seek medical advice at the time of the reaction, but reported she took some ibuprofen and by the next day (11-MAY-2013) was feeling better. No laboratory tests were performed. At the time of the report, the patient was recovering from being feverish and the injection site reaction. Relatedness for feeling feverish and for the symptoms of injection site reaction for PNEUMOVAX23 was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (lot # not reported) (strength and total daily dose not reported). It was reported that the patient received the dose of GARDASIL in a buttock. No adverse effect was reported. It was unspecified whether the patient sought for medical attention. The outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 17-APR-2013 the patient was vaccinated with the first dose of VAQTA (Lot # not reported) (Dose, route not reported). No other co suspects were reported. No concomitant therapy was reported. The registered nurse reported that the second dose of VAQTA was administered on 17-APR-2013. No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Electromyogram, Nonspecific reaction
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female patient in her 60's years old. On 24-OCT-2012 the patient was vaccinated with standard ZOSTAVAX (lot number not provided). On 03-NOV-2012, the patient experienced lumbar plexopathy after receiving ZOSTAVAX. Unspecified treatment was given for adverse event. EMG test was performed and results was not provided. The patient had sought medical attention via doctor's visit. The outcome of lumbar plexopathy was unknown. The causality was not provided. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event, Product packaging issue
Clinical narrative: This spontaneous report as received from a medical assitant refers to a patient of unknown age and unknown gender. On 10-MAY-2013 the patient was vaccinated with a dose of VARIVAX (Merck) lot # 666369/0226Z, expired date 28-JAN-2013 (dose, route not reported). No adverse effects reported. It was reported that potential mix expired VARIVAX vial with other VARIVAX vials in the same carton that were not expired. At the time of reporting, the patient's outcome was unknown. PQC was filed. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers an unknown number of patients of unknown age. The physician reported that the unknown number of patients might have received improperly stored PNEUMOVAX 23 from 21-JAN-2011 to present. No adverse event reported. This is one of several reports from the same reporter (Other MARRS# 1305USA009039, 1305USA010280, 1305USA010282, 1305USA010283). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers an unknown number of patients of unknown age. The physician reported that the unknown number of patients might have received improperly stored MMR II from 21-JAN-2011 to present. No adverse event reported. This is one of several reports from the same reporter (Other MARRS# 1305USA009039, 1305USA010280, 1305USA010281, 1305USA010282). 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 physician refers an unknown number of patients of unknown age. The physician reported that the unknown number of patients might have received improperly stored RECOMBIVAX HB from 21-JAN-2011 to present. No adverse event reported. This is one of several reports from the same reporter (Other MARRS# 1305USA009039, 1305USA010280, 1305USA010281, 1305USA010283). Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Severe swelling, redness, itching, warm to touch.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Severe swelling, redness, itching, warm to touch.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Severe swelling, redness, itching, warm to touch.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Severe swelling, redness, itching, warm to touch.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Incomplete course of vaccination, Intensive care, Meningitis
Clinical narrative: Initial report was received from a consumer on 10 May 2013. A 17-year-old female patient had received an intramuscular injection of MENACTRA (lot number, site and date of administration not reported) when she was between age 11 and 12. She never had a booster dose. The patient was currently in the hospital in ICU with meningitis. No amputations were done at this time. She has been in the hospital for about 3 weeks. Past medical history and relevant diagnosis tests were unknown. Outcome was not recovered. Documents held by sender: None.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Severe swelling, redness, itching, warm to touch.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Severe swelling, redness, itching, warm to touch.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 04-MAY-2013, the patient was vaccinated with ZOSTAVAX (lot # J000436, exp. 10-APR-2014) 0.65 ml/once, subcutaneous. The patient experienced "bad swelling, redness and warm to touch of upper arm after the patient received ZOSTAVAX, at the pharmacy. The patient sought medical attention by contacting physician and was treated with BENADRYL and ice topically. At the time of reporting, the outcome was unknown. The pharmacist explained adverse event was reported to VAERS. Pharmacist requested lot check for ZOSTAVAX (lot # J000436, exp. 10-APR-2014). This is one of the reports from the same reporter (1305USA008554, 1305USA009032 and 1305USA009034). Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 04-MAY-2013, the patient was vaccinated with ZOSTAVAX (lot # J000436, exp. 10-APR-2014) 0.65 ml/once, subcutaneous. The patient experienced "bad swelling, redness and warm to touch of upper arm after the patient received ZOSTAVAX, at the pharmacy. The patient sought medical attention by contacting physician and was treated with BENADRYL and ice topically. At the time of reporting, the outcome was unknown. The pharmacist explained adverse event was reported to VAERS. Pharmacist requested lot check for ZOSTAVAX (lot # J000436, exp. 10-APR-2014). This is one of the reports from the same reporter (1305USA008554, 1305USA009032 and 1305USA009034). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to 4 unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with M-M-R II that underwent an unsupported temperature excursion. No adverse effect reported. Lot number H074607 (expiration date 01-MAR-2014) is an invalid not number for M-M-R II. Additional information has been requested.
Age: 1.21
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Oedema peripheral, Tenderness
Clinical narrative: Redness, swollen and tenderness of left arm after administration of vaccines (MENACTRA, Tdap).
Age: 11.0
Sex: F
Vaccine: HPV2
Symptoms: Blood gases, Blood glucose, Cardiac monitoring, Computerised tomogram head, Dizziness
Clinical narrative: About 5:30 pm patient c/o headache. C/O mom found patient in tub asleep about 6 pm. Patient got out of tub was in moms room bent over to pick up cup. Patient could not grab a hold of cup. C/O dizziness, talking to mom incoherently. Took to ER local. Patient was real drowsy want to sleep. ER did - EKG, blood test, B/S, Blood gases CT scan drug testing U/A. ER couldn't find out the problem. Transfer by helicopter to hospital. Heart monitored overnight. Patient was fine the next morning.
Age: 11.0
Sex: F
Vaccine: HPV2
Symptoms: Drug screen, Electrocardiogram, Full blood count, Grip strength decreased, Headache
Clinical narrative: About 5:30 pm patient c/o headache. C/O mom found patient in tub asleep about 6 pm. Patient got out of tub was in moms room bent over to pick up cup. Patient could not grab a hold of cup. C/O dizziness, talking to mom incoherently. Took to ER local. Patient was real drowsy want to sleep. ER did - EKG, blood test, B/S, Blood gases CT scan drug testing U/A. ER couldn't find out the problem. Transfer by helicopter to hospital. Heart monitored overnight. Patient was fine the next morning.
Age: 11.0
Sex: F
Vaccine: HPV2
Symptoms: Incoherent, Metabolic function test, Somnolence
Clinical narrative: About 5:30 pm patient c/o headache. C/O mom found patient in tub asleep about 6 pm. Patient got out of tub was in moms room bent over to pick up cup. Patient could not grab a hold of cup. C/O dizziness, talking to mom incoherently. Took to ER local. Patient was real drowsy want to sleep. ER did - EKG, blood test, B/S, Blood gases CT scan drug testing U/A. ER couldn't find out the problem. Transfer by helicopter to hospital. Heart monitored overnight. Patient was fine the next morning.
Age: 52.0
Sex: M
Vaccine: MMR
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, Drug administered to patient of inappropriate age, Rash, Tenderness
Clinical narrative: This spontaneous report as received from a nurse, refers to a 52 year old male patient. Nurse states that a patient was tested for titers for measles, mumps and rubella (MMR) on 26-FEB-2013 for "work hiring purposes". Levels showed measles and mumps "immune" and rubella "less than 1". It was unknown whether patient has received MMR shots before. Nurse reports that a dose of M-M-R II (lot # H012572 exp date 25-JUN-2014), 0.5 ml, subcutaneous for non-immune titer on hire for employer, was administered to the patient on 06-MAR-2013. No other concomitant medications were reported. IgG and IgM levels were drawn on an unspecified date in 2013, after M-M-R II shot was administered, and results showed rubella went from "less than 1 to 175." On 20-MAR-2013, "Two weeks" after receiving M-M-R II, the patient developed an unspecified rash. The rash resolved on 22-MAR-2013 "within two days." The patient went for an office visit in mid April (approximately on 15-APR-2013) because he began experiencing "tenderness in underarm on left side as well as tenderness on his groin on right side." It is unknown whether the patient has recovered from tenderness. The patient sought unspecified medical attention. The nurse reported no treatment was given for adverse events. Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: MMR
Symptoms: Viral titre decreased
Clinical narrative: This spontaneous report as received from a nurse, refers to a 52 year old male patient. Nurse states that a patient was tested for titers for measles, mumps and rubella (MMR) on 26-FEB-2013 for "work hiring purposes". Levels showed measles and mumps "immune" and rubella "less than 1". It was unknown whether patient has received MMR shots before. Nurse reports that a dose of M-M-R II (lot # H012572 exp date 25-JUN-2014), 0.5 ml, subcutaneous for non-immune titer on hire for employer, was administered to the patient on 06-MAR-2013. No other concomitant medications were reported. IgG and IgM levels were drawn on an unspecified date in 2013, after M-M-R II shot was administered, and results showed rubella went from "less than 1 to 175." On 20-MAR-2013, "Two weeks" after receiving M-M-R II, the patient developed an unspecified rash. The rash resolved on 22-MAR-2013 "within two days." The patient went for an office visit in mid April (approximately on 15-APR-2013) because he began experiencing "tenderness in underarm on left side as well as tenderness on his groin on right side." It is unknown whether the patient has recovered from tenderness. The patient sought unspecified medical attention. The nurse reported no treatment was given for adverse events. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth, Local reaction
Clinical narrative: Localized reaction, redness, warmth, pain, induration around injection site. Appx 1 week later.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR
Symptoms: Erythema, Feeling hot
Clinical narrative: 4" x 3 1/2" area of warmth, erythema starting after vaccine 5/15/13. Patient seen in clinic 5/17/13 started on KEFLEX (250/5) give 80 TID x 10 days. Follow up appt to be scheduled.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV1, DTAPHEPBIP, PNC13, RV1
Symptoms: Death, Foaming at mouth, Immediate post-injection reaction, Mouth haemorrhage, Pallor
Clinical narrative: Immediately after the vaccines, the child looked pale and blood like foam came in the mouth. The child pooped too. The doctor came & stated after checking his mouth that he is normal and it is due to immunization.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV1, DTAPHEPBIP, PNC13, RV1
Symptoms: Death
Clinical narrative: Immediately after the vaccines, the child looked pale and blood like foam came in the mouth. The child pooped too. The doctor came & stated after checking his mouth that he is normal and it is due to immunization.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Antibody test, Contusion, Full blood count abnormal, Immunoglobulin therapy, Platelet count decreased
Clinical narrative: Pt states he started having small purple spots that evening, that progress the next day, to large bruises, Parents called office 18:00 05/10/13, Pt was seen at a local urgent care and started on po steroids, pt followed up with PCP 05/14/13, CBC shoed platellet count of 2,000, pt was seen in local ER, repeat plt count was less than 5,000. Pt was admitted to the hospital and is currently under the care of a hematologist, he recieved  IVIG and po steroids to this point. Pt is currently still hospitalized.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Pt states he started having small purple spots that evening, that progress the next day, to large bruises, Parents called office 18:00 05/10/13, Pt was seen at a local urgent care and started on po steroids, pt followed up with PCP 05/14/13, CBC shoed platellet count of 2,000, pt was seen in local ER, repeat plt count was less than 5,000. Pt was admitted to the hospital and is currently under the care of a hematologist, he recieved  IVIG and po steroids to this point. Pt is currently still hospitalized.
Age: 0.17
Sex: M
Vaccine: DTPIHI, HIBV, RVX
Symptoms: Crying, Oedema peripheral, Rash
Clinical narrative: Prolonged crying, developed rash on chest/stomach, and stared blankly when he was not crying. I called the nurse line and they said he would be fine and did not need to go to the hospital. His legs were swollen, and it took him almost 2 weeks to recover. The symptoms began after a few hours of receiving the shots.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Pallor, Staring, Syncope, Unresponsive to stimuli
Clinical narrative: Child collapsed to ground, eyes open, unresponsive for approximately 10-20 seconds, eyes with absent stare and then closed. Child head and shoulders cradled and  child regained consciousness; then appeared pale but able to talk and answer questions appropriately.
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Nausea, Pain in extremity, Paraesthesia
Clinical narrative: Woke up and felt like she was going to vomit. Severe pain in arm and tingling in fingers. She felt hot. Was told to take ibuprofen by Dr.
Age: 28.0
Sex: F
Vaccine: SMALL
Symptoms: Urticaria
Clinical narrative: Uriticaria L face, around L upper arm chest and back.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Vaccine administered 5/4/13 R deltoid 8:45pm. Complaint of moderate pain at injection site on 5/5/13 6:25AM. Tylenol and cold packs utilized. 5/5/13 9:22pm complaint of R upper arm redness and warm to touch. Temp 99.4. MD notified. Keflex 500mg po QID x 7 days. Elevate arm. 5/6/13 Redness improved. Feeling better. 5/7/13 Continues to improve. 5/8/13 Nearly resolved. 5/9/13 Resolved.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Pt reported rash on upper arm, 6-8" long, which lasted for approximately 4 weeks.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Pyrexia
Clinical narrative: Mom states child immediately upon leaving clinic developed redness at site which progressively became worse. Child developed fever and pain and itching at site. Child seen by local urgent care and primary care physician.
Age: 0.76
Sex: F
Vaccine: HEP, HEP
Symptoms: Crying, Hypersensitivity, Rash erythematous, Rash generalised
Clinical narrative: 9 month old had red, raised rash behind head, behind neck, on back, behind arms and cried when crawling. Rash got increasingly worse until Benadryl was given 5/17/13 at 9:30am, then symptoms lessened. Indicative of systemic reaction.
Age: 0.76
Sex: F
Vaccine: HEP, HEP
Symptoms: Crying, Pain, Rash
Clinical narrative: 9 month old had red, raised rash behind head, behind neck, on back, behind arms and cried when crawling. Rash got increasingly worse until Benadryl was given 5/17/13 at 9:30am, then symptoms lessened. Indicative of systemic reaction.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Woke up next morning with erythema, swelling and itching near injection site.Returned to clinic 5/16/13, was seen by practitioner. Advised ice, Zyrtec and if needed Benadryl. Pt did not return for follow-up visit 5/17, reported area decreasing in size and less red.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, VARCEL, VARCEL
Symptoms: Erythema, Injection site pruritus, Skin warm, Somnolence
Clinical narrative: 7mm Raised, red, very warm to the touch, injection site that itches, increased sleepiness.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, VARCEL, VARCEL
Symptoms: Fatigue, Hypersomnia, Induration, Injection site erythema, Injection site pruritus
Clinical narrative: 7mm Raised, red, very warm to the touch, injection site that itches, increased sleepiness.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, VARCEL, VARCEL
Symptoms: Injection site vesicles, Injection site warmth, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: 7mm Raised, red, very warm to the touch, injection site that itches, increased sleepiness.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, VARCEL, VARCEL
Symptoms: Upper extremity mass
Clinical narrative: 7mm Raised, red, very warm to the touch, injection site that itches, increased sleepiness.
Age: 0.3
Sex: M
Vaccine: TDAP
Symptoms: Irritability, Pyrexia, Wrong drug administered
Clinical narrative: Patient inadvertently received Tdap instead of DTaP. Within 12 hours mom said fever went to 106 and fussiness. Temp decreased to 103 after mom gave cold water. At time of exam temp 101.6 no antipyretic had been administered.
Age: 18.0
Sex: M
Vaccine: TDAP
Symptoms: Incorrect dose administered
Clinical narrative: Multiple doses administered for single dose series. One dose of Tdap in recommended. No treatment need at time of visit.
Age: 1.05
Sex: F
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Urticaria
Clinical narrative: Hives the evening of imm. cleared w/BENADRYL. Hives came back 5/16/13.
Age: 11.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site swelling, Swelling
Clinical narrative: (R) arm red - swelling 2 days post vaccine, Rt arm red and warm extending from injection site. Treated with KEFLEX 500mg, cool compress.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender with no pertinent medical condition reported. On an unknown date (reported as when the patient was 19 years old) the patient was vaccinated with the first two doses of GARDASIL (lot number and expiration date not reported) (dose and route not reported). No other suspect therapies or concomitant medications were reported. The pharmacist reported that the patient received the first two doses of GARDASIL when the patient was 19 years old. The patient was now 25 years od and was in the office to get the third dose. No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a other health professional refers to a female patient of unknown age. On 04-MAY-2013 the patient was vaccinated with PNEUMOVAX 23 (Lot # not provided) (dose and route not reported). No other co suspects were reported. No concomitant therapy was reported. On 08-MAY-2013, 4 days after the administration of PNEUMOVAX 23, the patient suffered swelling to the arm, at the injection site. The patient sought medical attention (saw the doctor). The outcome of the patient suffered swelling to the arm, at the injection site was unknown. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker, also referred to as a C.M.A., also referred to as physician, refers to a female patient of unknown age. On 23-AUG-2012 the patient was vaccinated with RECOMBIVAX HB dose 1, 0.5 ml, intramuscular. Lot number, expiry date and indication were not reported. On 15-APR-2013 the patient was vaccinated with RECOMBIVAX HB dose 2, 0.5 ml, intramuscular, Lot number, expiry date and indication were not reported. On 14-MAY-2012 the patient was scheduled for a vaccination with RECOMBIVAX HB dose 3, 0.5 ml, intramuscular. Lot number, expiry date and indication were not reported. The patient experienced no adverse event. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Local reaction
Clinical narrative: Local reaction to immunization, no fever. (L) arm with erythema meaning 10 x 10 cm central induration of approx 4 x 4 cm, mother instructed cool compresses. 25 mg of BENADRYL given at clinic.
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, VARCEL
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Red, hive type rash to face, itching no resp. distress no S.O.B.
Age: 43.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Feeling hot, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Severe redness, heat, tenderness at site of injection and extending to (R) clavicle, supraclavicular lymph node swelling and tenderness.
Age: 43.0
Sex: M
Vaccine: TDAP
Symptoms: Lymph node pain, Lymphadenopathy, Tenderness
Clinical narrative: Severe redness, heat, tenderness at site of injection and extending to (R) clavicle, supraclavicular lymph node swelling and tenderness.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Cellulitis
Clinical narrative: Cellulitis - treated with Cefdinir.
Age: 18.0
Sex: F
Vaccine: FLU3, HEPA, HPV4, VARCEL
Symptoms: Erythema, Injection site reaction, Pain in extremity, Pruritus, Swelling
Clinical narrative: Patient developed itchyness, redness, swelling, and pain to left arm subcutaneous. Area measured approximatly 2.5inches width and 2.5inches in lenght around site of injection.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Daughter has had a red, itchy rash behind ears, face, neck, arms and legs.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC
Symptoms: Pyrexia
Clinical narrative: High fever over 104 for over 24 hours, gave Tylenol to bring down fever.
Age: 62.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, stomach cramps.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Blood creatine phosphokinase, Full blood count, Human chorionic gonadotropin, Injection site urticaria, Metabolic function test
Clinical narrative: Hives at site of vax, full feeling in throat.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Throat tightness, Urine analysis
Clinical narrative: Hives at site of vax, full feeling in throat.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Headache, Myalgia, Pain, Pyrexia
Clinical narrative: Swelling, redness, streaks of red throughout upper arm, extreme muscle pain, fever, body aches, headache.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Swelling, redness, streaks of red throughout upper arm, extreme muscle pain, fever, body aches, headache.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Arthralgia, Burning sensation, Condition aggravated, Dizziness
Clinical narrative: This case was reported by a healthcare professional (nurse and subject) and described the occurrence of headache in a 58-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included morning stiffness. Historic vaccination included seasonal influenza vaccine (non-gsk); Novartis; intramuscular; left deltoid given on 19 October 2011. Concurrent medications included RESTASIS, Vitamin D, Vitamin C and BIOTIN. On 18 January 2013 at 08:30 the subject received a dose of FLULAVAL (.5 ml, intramuscular, right arm). On 18 January 2013, immediately after vaccination with FLULAVAL, the subject experienced headache, stiff neck, muscle pain, eye lightening (described as "light going in and out of eyes"), neck burning, neck contraction, limited movement of neck, dizziness, and yellow vision. Within months after vaccination with FLULAVAL, the subject experienced chronic pain, hand pain, fatigue, arthralgia, weakness in thigh and decreased exercise endurance. The subject stated that since receiving the vaccination, she had "chronic pain that does not subside and her whole life is now different." Since receiving FLULAVAL, the subject stated that her morning stiffness did not "go away after exercising" and she had "trouble getting out of bed because the stiffness in her neck, back, and limbs are now chronic, occur every day and do not dissipate after exercising." She reported "pain in her left had that is ridiculous." She reported feeling "fatigued all the time and has myalgia and arthralgia that is listed in the FLULAVAL prescribing information." The subject described that she felt "like her muscles and tendons were too short so they pull. Her hands and feet hurt all the time and her thighs feel too weak." The subject stated that the contractions in her neck prevented her from moving freely. The reported ongoing muscle aches and pain. She reported that her "exercise endurance has been reduced (she has trouble doing lunges at work)." The healthcare professional considered the events were disabling. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with FLULAVAL. The subject stated that she was "certain that FLULAVAL caused all of these" events.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Exercise tolerance decreased, Fatigue, Headache, Immediate post-injection reaction, Mobility decreased
Clinical narrative: This case was reported by a healthcare professional (nurse and subject) and described the occurrence of headache in a 58-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included morning stiffness. Historic vaccination included seasonal influenza vaccine (non-gsk); Novartis; intramuscular; left deltoid given on 19 October 2011. Concurrent medications included RESTASIS, Vitamin D, Vitamin C and BIOTIN. On 18 January 2013 at 08:30 the subject received a dose of FLULAVAL (.5 ml, intramuscular, right arm). On 18 January 2013, immediately after vaccination with FLULAVAL, the subject experienced headache, stiff neck, muscle pain, eye lightening (described as "light going in and out of eyes"), neck burning, neck contraction, limited movement of neck, dizziness, and yellow vision. Within months after vaccination with FLULAVAL, the subject experienced chronic pain, hand pain, fatigue, arthralgia, weakness in thigh and decreased exercise endurance. The subject stated that since receiving the vaccination, she had "chronic pain that does not subside and her whole life is now different." Since receiving FLULAVAL, the subject stated that her morning stiffness did not "go away after exercising" and she had "trouble getting out of bed because the stiffness in her neck, back, and limbs are now chronic, occur every day and do not dissipate after exercising." She reported "pain in her left had that is ridiculous." She reported feeling "fatigued all the time and has myalgia and arthralgia that is listed in the FLULAVAL prescribing information." The subject described that she felt "like her muscles and tendons were too short so they pull. Her hands and feet hurt all the time and her thighs feel too weak." The subject stated that the contractions in her neck prevented her from moving freely. The reported ongoing muscle aches and pain. She reported that her "exercise endurance has been reduced (she has trouble doing lunges at work)." The healthcare professional considered the events were disabling. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with FLULAVAL. The subject stated that she was "certain that FLULAVAL caused all of these" events.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle contractions involuntary, Muscular weakness, Musculoskeletal stiffness, Myalgia, Pain
Clinical narrative: This case was reported by a healthcare professional (nurse and subject) and described the occurrence of headache in a 58-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included morning stiffness. Historic vaccination included seasonal influenza vaccine (non-gsk); Novartis; intramuscular; left deltoid given on 19 October 2011. Concurrent medications included RESTASIS, Vitamin D, Vitamin C and BIOTIN. On 18 January 2013 at 08:30 the subject received a dose of FLULAVAL (.5 ml, intramuscular, right arm). On 18 January 2013, immediately after vaccination with FLULAVAL, the subject experienced headache, stiff neck, muscle pain, eye lightening (described as "light going in and out of eyes"), neck burning, neck contraction, limited movement of neck, dizziness, and yellow vision. Within months after vaccination with FLULAVAL, the subject experienced chronic pain, hand pain, fatigue, arthralgia, weakness in thigh and decreased exercise endurance. The subject stated that since receiving the vaccination, she had "chronic pain that does not subside and her whole life is now different." Since receiving FLULAVAL, the subject stated that her morning stiffness did not "go away after exercising" and she had "trouble getting out of bed because the stiffness in her neck, back, and limbs are now chronic, occur every day and do not dissipate after exercising." She reported "pain in her left had that is ridiculous." She reported feeling "fatigued all the time and has myalgia and arthralgia that is listed in the FLULAVAL prescribing information." The subject described that she felt "like her muscles and tendons were too short so they pull. Her hands and feet hurt all the time and her thighs feel too weak." The subject stated that the contractions in her neck prevented her from moving freely. The reported ongoing muscle aches and pain. She reported that her "exercise endurance has been reduced (she has trouble doing lunges at work)." The healthcare professional considered the events were disabling. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with FLULAVAL. The subject stated that she was "certain that FLULAVAL caused all of these" events.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Photopsia, Xanthopsia
Clinical narrative: This case was reported by a healthcare professional (nurse and subject) and described the occurrence of headache in a 58-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included morning stiffness. Historic vaccination included seasonal influenza vaccine (non-gsk); Novartis; intramuscular; left deltoid given on 19 October 2011. Concurrent medications included RESTASIS, Vitamin D, Vitamin C and BIOTIN. On 18 January 2013 at 08:30 the subject received a dose of FLULAVAL (.5 ml, intramuscular, right arm). On 18 January 2013, immediately after vaccination with FLULAVAL, the subject experienced headache, stiff neck, muscle pain, eye lightening (described as "light going in and out of eyes"), neck burning, neck contraction, limited movement of neck, dizziness, and yellow vision. Within months after vaccination with FLULAVAL, the subject experienced chronic pain, hand pain, fatigue, arthralgia, weakness in thigh and decreased exercise endurance. The subject stated that since receiving the vaccination, she had "chronic pain that does not subside and her whole life is now different." Since receiving FLULAVAL, the subject stated that her morning stiffness did not "go away after exercising" and she had "trouble getting out of bed because the stiffness in her neck, back, and limbs are now chronic, occur every day and do not dissipate after exercising." She reported "pain in her left had that is ridiculous." She reported feeling "fatigued all the time and has myalgia and arthralgia that is listed in the FLULAVAL prescribing information." The subject described that she felt "like her muscles and tendons were too short so they pull. Her hands and feet hurt all the time and her thighs feel too weak." The subject stated that the contractions in her neck prevented her from moving freely. The reported ongoing muscle aches and pain. She reported that her "exercise endurance has been reduced (she has trouble doing lunges at work)." The healthcare professional considered the events were disabling. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with FLULAVAL. The subject stated that she was "certain that FLULAVAL caused all of these" events.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Localized redness and swelling to left thigh at site of Varicella vaccine, clustering of vesicular lesions noted. Slightly painful and warm to touch. Supportive treatment as needed.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Skin reaction
Clinical narrative: Localized redness and swelling to left thigh at site of Varicella vaccine, clustering of vesicular lesions noted. Slightly painful and warm to touch. Supportive treatment as needed.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypotension, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Patient was given PNEUMOVAX vaccine in (R) deltoid patient called 3 days later stating (R) arm was red, swollen and hot, painful. Came into office was hypotensive sent to ER - was kept 2 days in hospital.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site urticaria, Injection site warmth, Oedema peripheral, Skin warm
Clinical narrative: Patient was vaccinated with ZOSTAVAX on 5/14/13. Patient stated "the day after I got my shot my arm started turning red, swelling, and getting hot to touch." A 9.5 cm x 7 cm red whelp noted on left upper arm and warm to touch. Patient instructed to apply cool compresses to local reaction/affected area.
Age: 25.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Nausea, Oedema peripheral, Pyrexia, Urticaria
Clinical narrative: Fever 103.0, hives, nausea, swelling Rt-upper arm to fingers.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Received HBV2 DTAP1 HIB1 PCV1 ROTARIX1. Developed fever, had febrile seizure within 12 hrs.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Injection site pain, Rash vesicular
Clinical narrative: Next day after vaccination patient reported weakness and shooting pain through arm where injection given. Today presents with vesicular rash on injected arm - photo taken.
Age: 0.16
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Crying, Feeding disorder of infancy or early childhood, Irritability
Clinical narrative: Inconsolable crying X > 6 hours, decreased feeding. No fever, no vomiting. (+) Acetaminophen given - baby seemed more comfortable, sleeping, decreased fussiness.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Papule, Rash pruritic
Clinical narrative: Patient has a pruritic rash, discrete papules with a erythematous base on both arms, thighs, upper chest, upper back 4-5 days after vaccine was given (on 5-13-2013).
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt. presented to pediatric fast track clinic on 5/17/13 with mother reporting c/o left arm redness, warmth and swelling that started after vaccines given on 5/15/13. Pt. started on oral KEFLEX and scheduled to follow-up in 3 days.
Age: 11.0
Sex: M
Vaccine: HEP, HPV4
Symptoms: Presyncope, Syncope
Clinical narrative: This spontaneous report was received from a nurse regarding an 11 year old male patient with no pertinent medical history reported. On an unknown date the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (dose and route were not specified). The nurse stated that the patient may also had received a dose of an Hepatitis B vaccine (manufacturer unspecified) at the same office visit. The nurse reported that the patient experienced a vasovagal reaction, and fainted after receiving his first dose of GARDASIL. The patient recovered and then fainted a second time while still in the physician's office. It was reported that the patient is now fully recovered. No treatment information was reported. The reporting nurse did not assess the causality between GARDASIL, and Hepatitis B vaccine (manufacturer unknown) and vasovagal reaction and faint. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown ages. On an unknown date, patients were vaccinated with ZOSTAVAX, (lot number, dose and expiration date were not reported) subcutaneous. The pharmacist reported that when he used a 25 gauge 5/8 inch needle (manufacturer of needle unspecified) to administer ZOSTAVAX, the patients (name of specific patients were unspecified) complained that the ZOSTAVAX vaccination hurts. The pharmacist reported that if he used a 31 Gauge 8 mm insulin syringe (manufacturer unspecified to administer ZOSTAVAX the patient's were happy and did not complain of pain. No other information to report. On an unspecified date the patients recovered from the event. Additional information is not expected.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer refers to herself a 52 year old female patient with morphine allergy. The patient's medical history included breast cancer. In July or August 2012 (exact date unspecified) the patient was vaccinated with ZOSTAVAX (dose and not number were not reported) in the right arm for shingles vaccination. The reporter stated the patient was not taken any concomitant medications. On 13-MAY-2013 the patient was diagnosed with shingles, after receiving the ZOSTAVAX. The patient was treated with valcyclovir hydrochloride (1 tablet/3 times a day), and cephalexin (1 tablet/ twice a day). The outcome of shingles was reported as not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a child patient of unknown age. On 13-MAY-2013, the patient was vaccinated with an expired dose of M-M-R II (Lot # 670623/0664AA, expiration date 04-MAY-2013). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Erythema, Induration, Oedema peripheral
Clinical narrative: This spontaneous report as received from a physician assistant refers to a patient of unknown age. In April 2013, "within the last month", the patient was vaccinated with a dose of PNEUMOVAX23 (route and lot # not reported). The physician's assistant reported that on an unknown date, the patient experienced red, hard and swollen arm. The outcome of red, hard and swollen arm was unknown. The patient sought unspecified medical attention. Additional information is not expected.