chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a 19 year old female patient. No relevant medical history of the patient was reported. The patient received the first two doses of GARDASIL over the summer (reported as received the full GARDASIL series over the summer). The reporter was not able to provide the dates of the administration of the first two doses of GARDASIL at the time of the report and it was reported that they were administered at another facility. On 22-SEP-2014, the patient was vaccinated with the third dose of GARDASIL 120 Y (lot number, expiration date, route of administration and site of administration were not reported). There were no concomitant medications reported. On 22-SEP-2014, a PAP smear was also performed and the patient had a positive human papilloma virus (HPV) detection on her PAP smear. The cells in the PAP smear were normal and the type of HPV was not specified at the time of the report. The patient did not report any discomfort or any other adverse effects at the time of the report. There was no product quality complaint (PQC) involved. The outcome of positive HPV detection was unknown. The action taken with GARDASIL was not applicable. The causality of the event was unknown. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a currently 69 years old female patient. The patient's medical history included shingles. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). The patient reported that she has already had shingles but everyone said that ZOSTAVAX would keep it from recurring. it didn't. On an unknown date, the patient developed shingles. It was also reported that, after the shot the pharmacist told her ZOSTAVAX should only make shingles less severe. The patient was disappointed. The outcome of shingles was unknown. The relatedness between the shingles and the vaccination with ZOSTAVAX was unknown. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: This spontaneous report as received from a currently 69 years old female patient. The patient's medical history included shingles. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). The patient reported that she has already had shingles but everyone said that ZOSTAVAX would keep it from recurring. it didn't. On an unknown date, the patient developed shingles. It was also reported that, after the shot the pharmacist told her ZOSTAVAX should only make shingles less severe. The patient was disappointed. The outcome of shingles was unknown. The relatedness between the shingles and the vaccination with ZOSTAVAX was unknown. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 55 year old female patient with hypertension. Drug Reactions/Allergies were reported as none. On 02-OCT-2014, the patient was vaccinated with ZOSTAVAX vial, 0.65 milliliter, subcutaneous in the right arm. Patient was taking unspecified oral medications for hypertension concomitantly. On an unknown date approximately in October 2014, the patient experienced redness, swelling and bruised area on her right arm, at the injection site after receiving ZOSTAVAX. Lab diagnostic studies were not performed. No treatment was given. The outcome of redness, swelling and bruised area  on her right arm was reported as not recovered. Patient sought medical attention and came back to pharmacy. Product quality complaint was not reported. 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 nurse practitioner refers to a multiple unspecified patients of unknown age and genders. Patients' medical histories, concurrent conditions and drug reactions or allergies were not reported. On an unknown date, the patients were administered intramuscularly doses of GARDASIL (dose: 0.5 ml, frequencies and lot # were not reported) which underwent multiple, unspecified temperature excursions. The stability of the administered doses have not been evaluated for stability at this time due to lack of information. Product quality complaint (PQC) was not involved. No adverse experiences were reported. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 12 month old female patient with sensitive skin. There were no drug reactions/allergies. On 09-OCT-2014 the patient was vaccinated with (Oka/Merck) VARIVAX (dose not reported, lot # reported as K005186, expired date: 10-APR-2016). Other suspect therapies included M-M-R II (dose not reported, lot # reported as J013131, expired date: 17-OCT-2016). Concomitant therapies included Vitamin D (unspecified). On 09-OCT-2014, 1 day onset of therapy the patient experienced hives below the injection sites of both vaccines. There was no treatment given for the event. There was no lab diagnostics studies performed. The outcome of hives below the injection sites of both vaccines was reported as recovering/resolving. The patient was still in the physician's office when the reaction occurred. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 24 year old female patient. Medical history and current conditions were not reported. On an unknown date, the patient who was supposed to received (Oka/Merck) VARIVAX was inadvertently given ZOSTAVAX Vial 19400 PFU via an unknown route (dose was  not reported). Concomitant medications were not reported. No adverse effect was reported. Product quality complaint was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 18-SEP-2014 the patient was vaccinated with expired second dose of RECOMBIVAX HB, injection 5/0.5 mcrg/ml, lot # 0293AE, expired date 01-SEP-2014 (dose, frequency and route unknown). The RECOMBIVAX HB did not have any previous temperature excursions. No adverse symptoms reported. RECOMBIVAX HB was supported with post-expiry data. Additional information has been requested.
Age: 0.6
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, Irritability, Pyrexia
Clinical narrative: this spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Unknown number of improperly stored ROTATEQ (dose, route, lot # not reported) were administered to patients. No adverse effects were reported.  This is one of several reports from the same source.  Follow up information was received from the nurse on 26-SEP-2014. A six month old patient had experienced a low grade fever and crankiness after receipt of the vaccine. The outcome of the events was unknown. There was one cycle that reached -40 centigrade, with the balance of the excursions of 0 centigrade. The total excursion timeframe was less than 300 hours. ROTATEQ excursion support. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 25-SEP-2014 the patient was vaccinated with an improperly stored dose of PROQUAD (lot#, strength, dosage, frequency and route). This is one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 18-SEP-2014 the patient was vaccinated with an expired dose of RECOMBIVAX HB INJ 10/1.0 micro-G/ml (reported as "MCRG/ML"), lot # J014312, expiration date: 07-SEP-2014, 1.0 ml, intramuscularly. No adverse event were reported. Additional information has been reported.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, RV5
Symptoms: Breath holding, Crying, Cyanosis, Erythema, Hypotonia
Clinical narrative: ROTATEQ administered first. PEDIARIX then given IM in left thigh. Infant cried, held breath, got red in face, mother noted lips got blue. Infant was staring then went limp and began breathing again. This occurred immediately after administration. Infant was back at baseline within one minute.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, RV5
Symptoms: Immediate post-injection reaction, Staring
Clinical narrative: ROTATEQ administered first. PEDIARIX then given IM in left thigh. Infant cried, held breath, got red in face, mother noted lips got blue. Infant was staring then went limp and began breathing again. This occurred immediately after administration. Infant was back at baseline within one minute.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Local swelling, Pruritus, Skin reaction
Clinical narrative: Gave ZOSTAVAX. Pt's arm became red and swollen. Marked 2 spots with Sharpie marker. Redness went outside marks w/in minutes. Gave 25 mg liquid BENADRYL. Pt seemed to be better w/in 20 min. Pt complained of itching.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: Injection site reaction - red, swollen, hot to touch. Tenderness, itchiness. Pain in arm. Received on 10-3-14 and symptoms began on 10-4-14. Still present 10-6-14. Knot at site of injection.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Injection site reaction - red, swollen, hot to touch. Tenderness, itchiness. Pain in arm. Received on 10-3-14 and symptoms began on 10-4-14. Still present 10-6-14. Knot at site of injection.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Hypersensitivity, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Received DTaP shot in left upper arm and 2 days later has severe allergic reaction with erythema induration and swelling. Started at injection site on deltoid and extends from acromion of shoulder to 13 cm distal and completely around upper left arm. Treated w/ Prednisolone 15mg/5ml.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Injection site rash, Local swelling, Pain, Tenderness
Clinical narrative: Swollen arm, inflamed, rash spreading around injection site. Pain when touched (injection administered on 9/30/14).
Age: 33.0
Sex: F
Vaccine: HEP, HEPA, TDAP, VARCEL
Symptoms: Skin reaction
Clinical narrative: Moderate local skin reaction peaking within 2 days of administration. May have been related to non-IM administration of an "IM" vaccine.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Grip strength decreased, Injection site erythema, Injection site swelling, Injection site warmth, Local swelling
Clinical narrative: Left arm - swelling around shot sight - swelling in hand couldn;t make a fist - red and hot around injection. Lips and hand tingles. Relieved with antihistamine. Scary side effects for person.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: Left arm - swelling around shot sight - swelling in hand couldn;t make a fist - red and hot around injection. Lips and hand tingles. Relieved with antihistamine. Scary side effects for person.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Patient developed Varicella virus (chicken pox).
Age: 6.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, C-reactive protein normal, Differential white blood cell count normal, Full blood count normal, Mobility decreased
Clinical narrative: Patient woke up on 7/20/2014 with pain in right hip bone impairing mobility. It increased over the morning in severity until we had to go to emergency room. Dr said it was possible temporary arthritis in her hip joint a side effect from MMR vaccine. 2 days later she developed a rash looking like measles.
Age: 6.0
Sex: F
Vaccine: MMR
Symptoms: Monarthritis, Rash morbilliform, X-ray of pelvis and hip normal
Clinical narrative: Patient woke up on 7/20/2014 with pain in right hip bone impairing mobility. It increased over the morning in severity until we had to go to emergency room. Dr said it was possible temporary arthritis in her hip joint a side effect from MMR vaccine. 2 days later she developed a rash looking like measles.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Sl. red, swollen deltoid where received PENTACEL. Sl. warm to touch, no fever, eating and sleeping well.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, light swelling, itching at injection site. Small bruising.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Decreased appetite, Dizziness, Fatigue, Headache, Laboratory test normal
Clinical narrative: 3-4 hours after onset of vaccines, she dev. (L) arm pain, stiffness. Followed by pain into neck, headaches, several body aches, poor appetite, fatigue, dizziness.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Musculoskeletal stiffness, Neck pain, Pain, Pain in extremity
Clinical narrative: 3-4 hours after onset of vaccines, she dev. (L) arm pain, stiffness. Followed by pain into neck, headaches, several body aches, poor appetite, fatigue, dizziness.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Headache, Neck pain, Pain, Pain in extremity
Clinical narrative: 3-4 hours after onset of vaccines, she dev. (L) arm pain, stiffness. Followed by pain into neck, headaches, several body aches, poor appetite, fatigue, dizziness.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Chills, Malaise, Mobility decreased, Pyrexia
Clinical narrative: Pt woke up AM not move arm, headache, burning fever took TYLENOL et alternate with MOTRIN worse by noon malaise, chills, fever, shaking by 700 still high fever. Healthcare professional considered going hospital w/ fever. Broken 50 hours from getting shot.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Tremor
Clinical narrative: Pt woke up AM not move arm, headache, burning fever took TYLENOL et alternate with MOTRIN worse by noon malaise, chills, fever, shaking by 700 still high fever. Healthcare professional considered going hospital w/ fever. Broken 50 hours from getting shot.
Age: 0.49
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Erythema and swelling on (L) thigh.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Erythema, Local reaction, Skin warm, Swelling
Clinical narrative: After receiving the Hib vaccine in the (L) thigh, pt developed a local Rx the size around as big as a baseball, red, swelling and warm to touch. Instructed pt mom to apply cool rag to site and give TYLENOL.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug intolerance, Erythema, Local swelling, Skin warm, Tenderness
Clinical narrative: 8cm x 4cm erythematous, warm, tender, swelling. Ice. Pt can't tolerate NSAIDs. KEFLEX ordered.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Mass
Clinical narrative: Lump size of a quarter in leg - right. No facial swelling, difficulty breathing or swallowing. No fever or redness at site. Warm compress applied. TYLENOL for pain.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased
Clinical narrative: Could not move right arm, or lift it after administration of ZOSTAVAX. Went to physical therapy, received cortisone injections, still has problems.
Age: 63.0
Sex: M
Vaccine: PPV, TDAP, VARZOS
Symptoms: Cold sweat, Delirium, Feeling cold, Injection site reaction
Clinical narrative: Localized reaction at injection site, cold sweats, chills, delirium - 4 days, referred to physician.
Age: 0.15
Sex: U
Vaccine: DTAP, HIBV
Symptoms: Crying, Diet refusal, Irritability
Clinical narrative: Pt cried and was very fussy for 8 hrs after DTAP and HIB given on 7/28/14. Did not eat for 8 hrs (nurse) per mom.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Haematochezia, Occult blood positive
Clinical narrative: Vaccines given on 9/30/14. Nine days later began with bloody stool. 10/13/14 still with bloody stool. No fever. Is breastfeeding and mother does not eat dairy. Soft breastfeeding stools - not water loss.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Injection site induration, Injection site pain
Clinical narrative: 10/9/14 Pt crying after received PENTACEL in (R) thigh. 10/10/14 (R) thigh with mild induration from injection site, extending along distal area of induration. Seems tender. No redness.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Dizziness, Fatigue, Feeling hot, Heart rate increased
Clinical narrative: About 15 minutes after immunization, pt had a warm sensation rush over her. Had to stop reading, mild light headed, increased heart rate. Remained at pharmacy for about 50 minutes. Had some water, walked around pharmacy without incident. Pt felt OK and left. Pt went home to eat, noticed her feet appeared blotchy and previous symptoms returned. Contacted MD. Pt advised to go to ER. ER gave BENADRYL IV. Listed as acute allergic reaction. Oral antihistamines. As of 10/13/14, pt feeling much better than last week, but still tired/cold symptoms/scratchy throat/pain and itchy on left hip/buttock.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Musculoskeletal pain, Nasopharyngitis, Pruritus, Rash macular
Clinical narrative: About 15 minutes after immunization, pt had a warm sensation rush over her. Had to stop reading, mild light headed, increased heart rate. Remained at pharmacy for about 50 minutes. Had some water, walked around pharmacy without incident. Pt felt OK and left. Pt went home to eat, noticed her feet appeared blotchy and previous symptoms returned. Contacted MD. Pt advised to go to ER. ER gave BENADRYL IV. Listed as acute allergic reaction. Oral antihistamines. As of 10/13/14, pt feeling much better than last week, but still tired/cold symptoms/scratchy throat/pain and itchy on left hip/buttock.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Throat irritation
Clinical narrative: About 15 minutes after immunization, pt had a warm sensation rush over her. Had to stop reading, mild light headed, increased heart rate. Remained at pharmacy for about 50 minutes. Had some water, walked around pharmacy without incident. Pt felt OK and left. Pt went home to eat, noticed her feet appeared blotchy and previous symptoms returned. Contacted MD. Pt advised to go to ER. ER gave BENADRYL IV. Listed as acute allergic reaction. Oral antihistamines. As of 10/13/14, pt feeling much better than last week, but still tired/cold symptoms/scratchy throat/pain and itchy on left hip/buttock.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, IPV, MMR
Symptoms: Expired drug administered, Nausea
Clinical narrative: This case was reported by a pharmacist and described the occurrence of nausea in a 4-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline), MMR (non-GSK) and poliomyelitis vaccine inactivated (non-GSK). The subject's medical history included fever post vaccination following unknown previous vaccine. Concurrent medical conditions included asthma. Concurrent medications included albuterol. On 2 June 2014, the subject received 3rd and expired dose of KINRIX (.5 ml, unknown route of administration), unspecified dose of MMR (Non-GSK) (unknown route of administration), unspecified dose of Poliomyelitis vaccine inactivated (Non-GSK) (unknown route of administration). On 2 June 2014, 2 days after vaccination with KINRIX, MMR (Non-GSK) and Poliomyelitis vaccine inactivated (Non-GSK), the subject experienced nausea. At the time of reporting, the outcome of the event was unspecified. Follow-up information received on 29 July 2014 by a pharmacist: Asthma began in February 2012. Around this date, the subject started the treatment with Albuterol. As KINRIX was expired, an additional dose would be given in August. Nausea was resolved on 05 June 2014.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Product quality issue
Clinical narrative: This case was reported by a nurse and by a vaccines responsible physician and described the occurrence of injection site redness in a 4-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included PROQUAD (Merck; unknown route and injection site) given on 28 March 2014. On 28 March 2014, the subject received unspecified dose of KINRIX (.5 ml, left thigh instead of upper arm, unknown route). On 31 March 2014, 3 days after vaccination with KINRIX, the subject experienced injection site redness which led to a maladministration. Several doses of the caps of the vaccine were loose in the box; the doses of KINRIX with the loose tops were discarded but the remaining doses in the box were used for this subject. The reporter was unsure if the other doses used were safe to have used. The subject came and was seen by the doctor but no additional interventions or meds were ordered for him. At the time of reporting, the outcome of the event was unspecified. This case is one of the two cases reported by the same reporter linked to A1067553A. This case was associated to a product complaint. Conclusion regarding the complaint, received on 17 April 2014: According to the thorough investigation performed at the different production steps, and the observation of the returned samples, GlaxoSmithKline Biologicals considers this complaint as unsubstantiated. Follow-up information received on 29 April 2014: At the time of reporting, the outcome of the event was improved.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Drug administered at inappropriate site, Injection site erythema, Product quality issue
Clinical narrative: This case was reported by a nurse and by a vaccines responsible physician and described the occurrence of injection site redness in a 4-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included PROQUAD (Merck; unknown route and injection site) given on 28 March 2014. On 28 March 2014, the subject received the last dose of KINRIX (.5 ml, left thigh instead of upper arm, unknown route). On 31 March 2014, 3 days after vaccination with KINRIX, the subject experienced injection site redness which led to a maladministration (vaccine administered at inappropriate site). Several doses of the caps of the vaccine were loose in the box; the doses of KINRIX with the loose tops were discarded but the remaining doses in the box were used for this subject. The reporter was unsure if the other doses used were safe to have used. The subject's grandmother will continue to watch it and will call back to bring him if needed. At the time of reporting, the outcome of the event was unspecified. This case is one of the two cases reported by the same reporter linked to A1067555A. This case was associated to a product complaint. Conclusion regarding the complaint, received on 17 April 2014: According to the thorough investigation performed at the different production steps, and the observation of the returned samples, GlaxoSmithKline Biologicals considers this complaint as unsubstantiated.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site reaction
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site reaction in a 5-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). The subject had no medical history and no concomitant medication. On 17 March 2014 the subject received 1st dose of KINRIX (other, right thigh). Less than one week after vaccination with KINRIX, the subject experienced injection site reaction. No other event was reported. The subject was taken to an express care facility for treatment. At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event was probably related to vaccination with KINRIX.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered at inappropriate site, Injection site rash
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of injection site rash in a 4-year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included MMR vaccine (non-gsk); Merck; unknown; unknown given on an unspecified date; VARIVAX (non-gsk); Merck; unknown; unknown given on an unspecified date. In March 2014, the subject received 1st dose of KINRIX (route unknown, left thigh, batch number not provided). KINRIX was given on an inappropriate site, preferred site is deltoid. Less than one month after vaccination with KINRIX, the subject experienced injection rash. After 3 days, the events was resolved. The physician considered the event was possibly related to vaccination with KINRIX.
Age: 8.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, Injection site rash
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site rash in a 8-year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline). On 11 January 2014 at 14:30 the subject received a dose of KINRIX (unknown, right arm) as the 5th dose in the series. On 11 January 2014, at the time of vaccination with KINRIX, the subject experienced inappropriate age at vaccine administration. On 12 January 2014, 1 day after vaccination with KINRIX, the subject experienced injection site rash. Immunization serious was not delayed or discontinued. KINRIX is approved for use in children 4 through 6 years of age. On 14 January 2014 the injection site rash was noted to have improved. The healthcare professional considered the events were probably related to vaccination with KINRIX.
Age: 0.46
Sex: M
Vaccine: DTAPIPV, RVX
Symptoms: Diarrhoea, Drug administered at inappropriate site, Hypersomnia, Injection site warmth, Irritability
Clinical narrative: This case was reported by a consumer (subject's mother) and described the occurrence of fever in a 5-month-old male subject who was vaccinated with KINRIX (GlaxoSmithKline), Rotavirus vaccine. A physician or other health care professional has not verified this report. On 10 December 2013 at 17:50 the subject received 2nd dose of KINRIX (unknown, left thigh) and an unspecified dose of possible Rotavirus vaccine (oral). On 10 December 2013, at the time of vaccination with KINRIX, the subject experienced vaccine administered at inappropriate site and wrong vaccine administered. The subject received KINRIX in the left thigh. The mother of the subject reported that her 5-month old son was given KINRIX accidentally by one of the nurses in the office. The office provided very limited information in terms of what dose was given and the lot number. KINRIX is indicated for use in 4 through 6 years of age with the preferred vaccination site of deltoid muscle of the upper arm. On 10 December 2013 at 19:00, approximately one hour and 10 minutes after vaccination with KINRIX and possible Rotavirus vaccine, the subject experienced fussy. At 19:30 on 10 December 2013, one and half hours after vaccination with KINRIX and possible Rotavirus vaccine, the subject experienced fever. The mother stated that her son received a 4 month oral vaccine the same day but she was not sure of the name of the vaccine [possibly rotavirus vaccine, unknown manufacturer]. The subject experienced both local and systemic reaction. The injection site was very warm to the touch, his stool has been very loose, he developed a fever about an hour and half after the administration. The subject has been very fussy and he has been sleeping a lot; he usually awakens at least three times during the night and last night (10 December 2013) he did not [sleep for longer]. The mother considered the events life threatening. It was noted that she consulted a healthcare professional. At the time of reporting the fever had resolved. The events of sleeps for longer, fussy, warmness to touch at injection site and loose stools were unresolved.
Age: 0.46
Sex: M
Vaccine: DTAPIPV, RVX
Symptoms: Pyrexia, Wrong drug administered
Clinical narrative: This case was reported by a consumer (subject's mother) and described the occurrence of fever in a 5-month-old male subject who was vaccinated with KINRIX (GlaxoSmithKline), Rotavirus vaccine. A physician or other health care professional has not verified this report. On 10 December 2013 at 17:50 the subject received 2nd dose of KINRIX (unknown, left thigh) and an unspecified dose of possible Rotavirus vaccine (oral). On 10 December 2013, at the time of vaccination with KINRIX, the subject experienced vaccine administered at inappropriate site and wrong vaccine administered. The subject received KINRIX in the left thigh. The mother of the subject reported that her 5-month old son was given KINRIX accidentally by one of the nurses in the office. The office provided very limited information in terms of what dose was given and the lot number. KINRIX is indicated for use in 4 through 6 years of age with the preferred vaccination site of deltoid muscle of the upper arm. On 10 December 2013 at 19:00, approximately one hour and 10 minutes after vaccination with KINRIX and possible Rotavirus vaccine, the subject experienced fussy. At 19:30 on 10 December 2013, one and half hours after vaccination with KINRIX and possible Rotavirus vaccine, the subject experienced fever. The mother stated that her son received a 4 month oral vaccine the same day but she was not sure of the name of the vaccine [possibly rotavirus vaccine, unknown manufacturer]. The subject experienced both local and systemic reaction. The injection site was very warm to the touch, his stool has been very loose, he developed a fever about an hour and half after the administration. The subject has been very fussy and he has been sleeping a lot; he usually awakens at least three times during the night and last night (10 December 2013) he did not [sleep for longer]. The mother considered the events life threatening. It was noted that she consulted a healthcare professional. At the time of reporting the fever had resolved. The events of sleeps for longer, fussy, warmness to touch at injection site and loose stools were unresolved.
Age: 0.1
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, Urticaria
Clinical narrative: This case was reported by a physician and described the occurrence of hives in an infant male subject who was vaccinated with KINRIX, (GlaxoSmithKline). On an unspecified date in July 2013 the subject received unspecified dose of KINRIX (unknown) and experienced inappropriate age at vaccine administration. In July 2013, a couple of hours after vaccination with KINRIX, the subject experienced hives. The hives resolved three days after administration with KINRIX. At the time of reporting limited information was provided. KINRIX is indicated in children 4 through 6 years of age.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Expired drug administered, Injection site pain, Injection site reaction, Mobility decreased
Clinical narrative: This case was reported by a consumer (patient) and described the occurrence of arm pain at injection site in a 61-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medications included High blood pressure pill, Vitamin, Biotin and TYLENOL. On 14 October 2013 at 18:40 the subject received 1st dose of BOOSTRIX (unknown details, left arm) and experienced expired vaccine used. The BOOSTRIX expired on 14 October 2013. On the morning of 15 October 2013, 1 day after vaccination with BOOSTRIX, the subject experienced arm pain at injection site, muscle tightness under injection site, and injection site muscle reaction (described as "muscle stiffness and weakness" at the injection site). Within months of vaccination with BOOSTRIX, the subject experienced injection site reaction (difficulty in moving arm). Per the consumer, "this reaction has worsened in time." The consumer reported that she "has had left arm pain which involves muscle stiffness, muscle tightness, and muscle weakness." She also described "it as being unable to reach over her head to turn off the alarm clock in the morning." At the time of reporting, it was the consumer's opinion that the events were disabling. The consumer sought medical attention from the doctor's office. At the time of reporting the events were worse.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Muscle tightness, Musculoskeletal stiffness
Clinical narrative: This case was reported by a consumer (patient) and described the occurrence of arm pain at injection site in a 61-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medications included High blood pressure pill, Vitamin, Biotin and TYLENOL. On 14 October 2013 at 18:40 the subject received 1st dose of BOOSTRIX (unknown details, left arm) and experienced expired vaccine used. The BOOSTRIX expired on 14 October 2013. On the morning of 15 October 2013, 1 day after vaccination with BOOSTRIX, the subject experienced arm pain at injection site, muscle tightness under injection site, and injection site muscle reaction (described as "muscle stiffness and weakness" at the injection site). Within months of vaccination with BOOSTRIX, the subject experienced injection site reaction (difficulty in moving arm). Per the consumer, "this reaction has worsened in time." The consumer reported that she "has had left arm pain which involves muscle stiffness, muscle tightness, and muscle weakness." She also described "it as being unable to reach over her head to turn off the alarm clock in the morning." At the time of reporting, it was the consumer's opinion that the events were disabling. The consumer sought medical attention from the doctor's office. At the time of reporting the events were worse.
Age: 0.4
Sex: F
Vaccine: DTAPIPV, HIBV, PNC13, RV1
Symptoms: Dermatitis diaper, Lethargy
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of lethargy in a 5-month-old female subject who was vaccinated with KINRIX (GlaxoSmithKline), HIB, PREVENAR and ROTARIX. The subject had no relevant medical history and the previous vaccination went uncomplicated. On 6 May 2014, the subject received unspecified dose of KINRIX (.5 ml, unknown route and injection site; lot number not provided) which led to an inappropriate age at vaccine administration as KINRIX was recommended for children aged 4-6 years. On the same day the following vaccines were also administered: unspecified dose of HIB vaccine (unknown route, injection site and batch number), unspecified dose of PREVENAR (unknown route, injection site and batch number) and unspecified dose of ROTARIX (oral; lot number not provided). On 6 May 2014, less than one day after vaccination with Hib vaccine, KINRIX, PREVENAR and ROTARIX, the subject experienced lethargy. In May 2014, the subject visited the physician due to diaper rash. The doctor informed the subject's mother that the indication for KINRIX was for 4-6 years. At the time of reporting the outcome of the lethargy resolved and the outcome of diaper rash was unspecified.
Age: 1.52
Sex: M
Vaccine: DTAPIPV, PNC13, VARCEL
Symptoms: Drug administered to patient of inappropriate age, Injection site swelling, Injection site warmth, Wrong drug administered
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 18-month-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included PREVNAR 13 (non-GSK manufacturer) given on 11 March 2014; varicella virus vaccine (manufacturer unspecified) given on 11 March 2014. On 11 March 2014 the subject received 4th dose of KINRIX (0.5 ml, intramuscular, left thigh) which led to a maladministration (inappropriate age at vaccine administration and wrong vaccine administered). On 12 March 2014, 1 day after vaccination with KINRIX, the subject experienced swelling injection site and warmness to touch at injection site. At the time of reporting the outcome of the events was unspecified.
Sex: U
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a nurse and described the occurrence of injection site redness in subjects of unspecified age and gender who were vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of KINRIX (unknown route, arm and batch number). At an unspecified time after vaccination with KINRIX, the subjects experienced redness and swelling, both at the injection site. The nurse mentioned to the field representative she had noticed these adverse events more lately. The representative stated it was more than one subjects and the nurse did not state how many subject have these adverse events. These subjects did not receive any other vaccines in the same arm on the same day. At the time of reporting, the events were resolved. The nurse considered the events were probably related to vaccination with KINRIX.
Sex: U
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of swelling injection site in a subject of unspecified age and gender who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of KINRIX (unknown route, injection site and batch number). 1 day after vaccination with KINRIX, the subject experienced swelling and redness at the injection site. At the time of reporting the outcome of the events was unspecified.
Age: 2.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administration error, Injection site reaction, Rash erythematous
Clinical narrative: This case was reported by a consumer and described the occurrence of red bump at injection site in a 4-year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included seasonal allergy. On 5 August 2014, at 10:15 AM, the subject received unspecified dose of KINRIX (unknown, left leg) which led to a maladministration (vaccine administered at inappropriate site). On 6 August 2012, at 7:30 AM, 1 day after vaccination with KINRIX, the subject experienced red bump at injection site. The reporter's daughter woke up she had a large red bump the size of a quarter on the injection site. The subject's mother put cream/ointment on the bump and it seems to be getting smaller in size and not as red. The subject's mother called the doctor office this morning, and they told her it was normal and just to put it on ice and give ibuprofen. At the time of reporting, the red bump at injection site was improved.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. No pertinent medical history was reported. On 04-JUN-2012, the patient was vaccinated with first dose of GARDASIL, 0.5 ml, intramuscular and the second dose on 10-JUL-2014. No adverse effects was reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: This spontaneous report as received from a physician refers to 2 other unspecified patients with unknown age and gender. On an unknown date, the patients were vaccinated with GARDASIL (route, frequency, lot number not provided). The patients felt faint within 15 minutes of receiving GARDASIL. The patients recovered on an unspecified date. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: DTAPIPV
Symptoms: Injection site swelling, Product quality issue
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a child subject of unspecified gender who was vaccinated with KINRIX (GlaxoSmithKline). In July 2014, the subject received an unspecified dose of KINRIX (unknown route and injection site, batch number not provided). In July 2014, less than 2 weeks after vaccination with KINRIX, the subject experienced swelling injection site. This case was associated to a product complaint. At the time of reporting, the outcome of the event was unspecified. The healthcare professional considered the event was probably related to vaccination with KINRIX. The reporter reported 2 other cases of swelling injection site after vaccination with KINRIX (cases A1083480A and A1083482A). These cases were associated to a product complaint since the reporter said that these cases happened in a relatively short period of time so she was afraid they were related to a specific lot of the vaccine. Follow-up information received on 11 August 2014: A safety statement was requested, an evaluation was performed and the conclusion shows that: "The review of the currently available safety data for batch number 94F5K and family does not highlight a safety issue. It is unlikely that the reported events are related to a manufacturing problem. No investigation required." GlaxoSmithKline Biologicals considers this product complaint as unsubstantiated.
Sex: U
Vaccine: DTAPIPV
Symptoms: Injection site swelling, Product quality issue
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a child subject of unspecified gender who was vaccinated with KINRIX, (GlaxoSmithKline). In July 2014, the subject received an unspecified dose of KINRIX (unknown route and injection site, batch number not provided). In July 2014, less than 2 weeks after vaccination with KINRIX, the subject experienced swelling injection site. This case was associated to a product complaint. The subject was treated with BENADRYL. At the time of reporting, the outcome of the event was unspecified. The healthcare professional considered the event was probably related to vaccination with KINRIX. The reporter reported 2 other cases of swelling injection site after vaccination with KINRIX (cases A1083480A and A1083483A). These cases were associated to a product complaint since the reporter said that these cases happened in a relatively short period of time so she was afraid they were related to a specific lot of the vaccine. Follow-up information received on 11 August 2014: A safety statement was requested, an evaluation was performed and the conclusion shows that: "The review of the currently available safety data for batch number 94F5K and family does not highlight a safety issue. It is unlikely that the reported events are related to a manufacturing problem. No investigation required."  GlaxoSmithKline Biologicals considers this product complaint as unsubstantiated.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician refers to a 16 year old female patient. On an unknown date, the patient was vaccinated with the second dose of GARDASIL (route, frequency, lot number not provided). The patient fainted for a few seconds after receiving second injection of GARDASIL series. As treatment, office called 911 services, patient remained in office and was not transported to hospital. Patient completely recovered without any injury. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a patient of unknown age and gender. On 08-OCT-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # not reported) that had expired on 22-AUG-2014. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site warmth, Skin burning sensation
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a female patient of unknown age. On 06-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). The pharmacist reported that on an unspecified date in October 2014 afterwards vaccination, the patient experienced fine rash at the injection site which was hot to the touch and a burning sensation in the inside of her rash. The injection site was very pink and was about the size of a silver dollar. At the time of the report, the patient's outcome was unknown. 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 nurse concerning an unspecified number of patients, of an unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with a dose of GARDASIL (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. Doses of GARDASIL were exposed to a supported temperature excursion, that was evaluated on 10-JAN-2014 (SRN 1-10059041254) were administered to unspecified patients on unspecified dates. No adverse effect has been reported. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Adenoidectomy
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient's current conditions or medical history were not reported. On an unknown date, reported as in the past, the patient was vaccinated with a dose of VARIVAX (Merck) injection (dose, frequency, route, anatomical location, lot number and expiration date not reported). On an unknown date, the pharmacist reported that the patient will have his adenoids taken out (the reason was not reported). Outcome of the event was unknown at the time of the report. Additional information is not expected as the reporter did not have additional information to report.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's medical history included shingles twice "in her 70's". On 01-APR-2013 the patient was vaccinated with ZOSTAVAX, 0.65 ml (route and lot number were not reported). Concomitant medications were not reported. On an unknown date the patient experienced the shingles three times. The outcome of the patient had shingles three times was reported as recovered/resolved on an unspecified date. The relationship between ZOSTAVAX and shingles was not reported. Patient sought unspecified medical attention. Additional information is not expected.