chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.15
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Dyspnoea
Clinical narrative: Patient presented with difficulty breathing.
Age: 11.0
Sex: M
Vaccine: DTAP, MEN
Symptoms: Fatigue, Headache, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Fever, Headache, Nausea and Fatigue which resolved within 30 hours after treatment with ibuprofen and rest. Continued soreness and swelling at injection site over 48 hours out from Tdap vaccination.
Age: 11.0
Sex: M
Vaccine: DTAP, MEN
Symptoms: Pyrexia
Clinical narrative: Fever, Headache, Nausea and Fatigue which resolved within 30 hours after treatment with ibuprofen and rest. Continued soreness and swelling at injection site over 48 hours out from Tdap vaccination.
Age: 40.0
Sex: F
Vaccine: VARCEL
Symptoms: Lymphadenopathy, Pruritus, Rash
Clinical narrative: Patient received varicella injection and three and half weeks after injection the patient was still having symptoms at PCP visit of pruritus/rash/swelling of neck lymph nodes. The patient was given an injection of KENALOG, a MEDROL dose pack, BENADRYL, and antibiotics for treatment by the PCP. Symptoms have since resolved. Triamcinolone 40 mg once IM. Methylprednisolone 4 mg every day PO. Cephalexin 500 mg BID PO.
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Deafness unilateral, Feeling abnormal, Hyperhidrosis, Pallor, Tinnitus
Clinical narrative: Sitting in lobby. Noticed her lips were pale. SHe leaned into her mom c/o not feeling right. Pale. C/O not being able to feel anything. C/O not being able to hear in left ear. Moved extremities on command. Diaphoretic. Ammonia capsule broke. Immediate response. Did not lose consciousness. Had not eaten anything. Gave lollipop and water. Alert and oriented. BP 110/80. Within 2 minutes color in lips pink again. C/O ringing in ears. Ringing in ears last 2-3 minutes. Stable and allowed to go home after an additional 20 minute waiting period.
Age: 8.0
Sex: M
Vaccine: HEPA
Symptoms: Fatigue, Nausea, Pyrexia
Clinical narrative: #2 Hep A onset following AM 101.5 degrees, some nausea, fatigue. Fever later 103 degrees. Okay by 6/17 no c/o sore throat, etc to suggest viral syndrome.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates, the patients were vaccinated with doses of improperly stored PROQUAD (Merck), (dose, route of administration, injection site, lot number and expiration date were not reported). No adverse effects were reported. This is one of  several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 26-FEB-2015 the patient was received improperly stored (Oka/Merck) VARIVAX (lot # K007979, expiration date, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from healthcare worker, refers to unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. On unspecified dates, the unspecified number of patients received doses of VAQTA, injection (dose, lot#, expiration date, route of administration were not reported) that were improperly stored. No adverse experience was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.53
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Blood culture negative, CSF culture negative, Culture urine negative, Febrile convulsion, Pyrexia
Clinical narrative: Fever 104. Febrile seizure. Hospitalization x 1 day. Blood work, urine, CSF-all  neg. Prophylactic ceftriaxone.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 15-JAN-2015 the patient was received improperly stored VARIVAX (Merck) (lot # reported as R/R ON 6/15, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 11-MAY-2015 the patient was received improperly stored VARIVAX (Merck) (lot # K026385, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Apnoeic attack, Blood culture, Chest X-ray, Crying, Dyspnoea
Clinical narrative: 4 hrs after shots with crying inconsolably. Gasping for breath-parent reported apneic spell and shaking episodes she felt hot to touch and had body rash. Pt assessed at ER, tx with IV fluids, admit for obs.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Full blood count, Rash generalised, Skin warm, Tremor, Ultrasound abdomen
Clinical narrative: 4 hrs after shots with crying inconsolably. Gasping for breath-parent reported apneic spell and shaking episodes she felt hot to touch and had body rash. Pt assessed at ER, tx with IV fluids, admit for obs.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Urine analysis, Viral test
Clinical narrative: 4 hrs after shots with crying inconsolably. Gasping for breath-parent reported apneic spell and shaking episodes she felt hot to touch and had body rash. Pt assessed at ER, tx with IV fluids, admit for obs.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age. Medical history and drug allergy were not reported. On unknown dates the patients were vaccinated with improperly stored VARIVAX (Merck) (dose, route, lot# and expire date were not reported). Concomitant drug was not reported. No adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. On 29-APR-2015 the patient was vaccinated with VARIVAX (Merck) (lot # K016131 with expiration date: 23-SEP-2016, dose: 0.5 ml, administered subcutaneously) which had undergone supported excursion. No adverse effects were noted. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. On 08-APR-2015 the patient was vaccinated with VARIVAX (Merck) (lot # K016131 with expiration date: 23-SEP-2016, dose: 0.5 ml, administered subcutaneously) which had undergone supported excursion. No adverse effects were noted. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 18-MAR-2015 the patient was received improperly stored (Oka/Merck) VARIVAX (lot # K007979, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates, the patients were vaccinated with doses of improperly stored VARIVAX (Merck), (dose, route of administration, injection site, lot number and expiration date were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Dizziness, Nausea, Pain, Pain in extremity
Clinical narrative: Patient reports pain in the early morning and nausea when she woke this morning. She reports not being able to lift her arm without pain and feeling faint, dizzy and nauseous.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site cellulitis, Injection site erythema, Injection site infection, Injection site pain, Injection site swelling
Clinical narrative: Patient developed an infection at the injection site, accompanied by redness, swelling, pain, and cellulitis.  She was treated with Keflex starting within five days of developing the infection.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patients of unknown age and gender. The patients medical history and current conditions were not provided. On an unknown dates, the patients were vaccinated with a doses of PEDVAXHIB (doses and routes were not reported) lot # K002747, expiration date 09-DEC-2016, that were exposed to temperatures outside of the recommended range. The registered nurse was not aware of any adverse effects. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (Merck) (lot # K026385, expiry date 15-DEC-2015, 0.5 ml, subcutaneously). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to unspecified number of patients of unknown demographics. No concurrent condition, medical history or allergy/drug reactions were reported. The health professional reported that on an unspecified date, unspecified patients received doses of improperly stored GARDASIL injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. On 12-MAY-2015 the patient was vaccinated with (Oka/Merck) VARIVAX (lot # K016131 with expiration date: 23-SEP-2016, dose 0.5 ml, administered subcutaneously) which had undergone supported excursion. No adverse effects were noted. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX, (dose, route of administration, injection site, lot number and expiration date were not reported). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: Patient reported significant pain in arm during injection of Prevnar 13 vaccine.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored VAQTA (lot #, expiry date, dose and route of administration not reported). No adverse effects were reported. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: RAB
Symptoms: Muscle twitching, Paraesthesia
Clinical narrative: Post-exposure rabies series. Pt received Tdap 6/15/15, IG 6/16, Rabies #1 6/16, Rabies #2 6/19. Pt states bilat. calf muscle twitching with tingling 30 min after #2 dose intermittent. State epi contacted. Dose #3 given. Pt denies numbness/weakness bilat x4 ext.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 13-MAR-2015 the patient was received improperly stored (Oka/Merck) VARIVAX (lot # K007979, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 30-APR-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # L002419, expiration date 30-APR-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to unspecified number of patients of unknown demographics. No concurrent condition, medical history or allergy/drug reactions were reported. The health professional reported that on an unspecified date, unspecified patients received doses of improperly stored PNEUMOVAX 23 injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified number of patients of an unknown age and gender. The concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the unspecified number of patients received improperly stored VAQTA (Lot number, dose and route were not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patients of unknown age and gender. The patients medical history and concurrent conditions were not provided. On an unknown dates, the patients were vaccinated with a doses of PROQUAD (Merck) (doses and routes were not reported) lot # K020751, expiration date 30-APR-2016, that were exposed to temperatures outside of the recommended range. The registered nurse was not aware of any adverse effects. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored M-M-R II (lot #, expiry date, dose and route of administration not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL, (dose, route of administration, injection site, lot number and expiration date were not reported). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored PROQUAD (Merck), (dose, route of administration, injection site, lot number and expiration date were not reported). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Blister, Blister rupture, Erythema, Pruritus
Clinical narrative: Redness, pruritus, after 2 or 3 hours vesiculization (blisters dry up. >5 mm) rupture of vesicles.
Age: 52.0
Sex: F
Vaccine: MMR
Symptoms: Blood test, Computerised tomogram head normal, Electroencephalogram, Generalised tonic-clonic seizure, Nuclear magnetic resonance imaging brain
Clinical narrative: Grand Mal Seizure lasting 3 to 4 minutes. Ambulance ride to nearest hospital, given Ativan and received CT head scan, result negative.  Instructed to follow up with neurologist.
Age: 19.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Arthralgia, Blood test, Fatigue, Headache, Myalgia
Clinical narrative: Soon after vaccine was administered my daughter started having symptoms. It has been 6 days since the vaccine and she has high fever (over 103), muscle and joint pain, fatigue, edema and headache. We returned to facility on June 22nd and doctor ordered blood tests. Waiting on results.
Age: 19.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Oedema, Pyrexia
Clinical narrative: Soon after vaccine was administered my daughter started having symptoms. It has been 6 days since the vaccine and she has high fever (over 103), muscle and joint pain, fatigue, edema and headache. We returned to facility on June 22nd and doctor ordered blood tests. Waiting on results.
Age: 0.8
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 9.5 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 23-JUN-2015, the patient was in the office in order to get the third dose of ROTATEQ, oral, (dose, lot number and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. Since 01-APR-2015 (dates od specific vaccinations not reported), the patients were vaccinated orally for prophylaxis with doses of ROTATEQ (lot # K005394, expiry date 23-FEB-2016; lot # K013861, expiry date 18-MAY-2016), which were exposed to temperature outside of the recommended range since that day. The reporting nurse was not aware of any adverse effects at the time of this report. This is one of the several reports received from the same source. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Information has been received from a pharmacist concerning a 73 year old male patient. The patient had no drug reactions and allergies. On 15-MAY-2015 the patient was vaccinated with ZOSTAVAX (0.65 ml, once, subcutaneous). Concomitant therapies included unspecified medications. On 26-MAY-2015, the patient was given a prescription for MEDROL for a 6 day course for an unspecified reason. The reporter stated that the patient had not started MEDROL yet. The patient had sought medical attention by an unspecified way. The outcome of the event was unknown. Additional information is not expected as no consent to contact physician.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age. Medical history and drug allergy were not reported. On unknown dates the patients were vaccinated with improperly stored (Oka-Merck) PROQUAD (dose, route, lot# and expire date were not reported). Concomitant drug was not reported. No adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patients of unkonwn age and gender. The patients medical history and current conditions were not provided. On an unknown dates, the patients were vaccinated with a dose of RECOMBIVAX HB (doses and routes were not reported) lot # J009051, expiration date 26-MAR-2016, that were exposed to temperatures outside of the recommended range. The registered nurse was not aware of any adverse effects. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 07-MAY-2015, the patient was vaccinated with a dose of improperly stored (Oka-Merck) PROQUAD, lot # L002419, expiration date 30-APR-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is note expected because the physician did not wish to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from the healthcare worker refers to an unspecified number of patients of unspecified age and gender. Medical history and concurrent conditions were not reported. On an unspecified dates, the patients were vaccinated with improperly stored VARIVAX (Merck) injection (lot number, dose, frequency and route of administration were not reported). No adverse events were experienced. The outcome of the reported events was unkonwn. No product quality complaint (PQC) was filed. No further information has been provided. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to unspecified number of patients of unknown demographics. No concurrent condition, medical history or allergy/drug reactions were reported. The health professional reported that on an unspecified date, unspecified patients received doses of improperly stored PEDVAXHIB injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. On 22-APR-2015 the patient was vaccinated with (Oka/Merck) VARIVAX (lot # K016131 with expiration date: 23-SEP-2016, dose: 0.5 ml, administered subcutaneously) which had undergone supported excursion. No adverse effects were noted. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot #, expiry date, dose and route of administration not reported). No adverse effects were reported. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Decreased appetite, Dizziness, Headache, Pyrexia, Tinnitus
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fever in a 56-year-old female patient who received ENGERIX B adult (batch number 92M2J, expiry date 3rd November 2017). On an unknown date, the patient received ENGERIX B adult 1 ml. On 8th June 2015, 6 hrs after receiving ENGERIX B adult, the patient experienced fever, felt faint, ringing in ears, decreased appetite, headache and dizziness. On an unknown date, the outcome of the fever, felt faint, ringing in ears, decreased appetite and dizziness were not recovered/not resolved and the outcome of the headache was unknown. The reporter considered the fever, felt faint, ringing in ears, decreased appetite, headache and dizziness to be possibly related to ENGERIX B adult. Additional information provided: the patient was checked for titers for hepatitis B. Patient titers was low so a booster shot of ENGERIX B was given on 08 June 2015. The reporter stated that the patient has no significant medical issues.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pain, Injection site reaction, Pyrexia, Rash erythematous
Clinical narrative: Erythematous rash 5x4 cm (1 cm below) injection place. Fever 103 degrees on day of injection and severe pain in injection site.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: PCV 13 immunization given on Tues 6/9/14. Swelling and redness started day after -on 6/10/14. Redness and swelling involved lateral side of (R) upper arm. Associated with pain and itching-worse on 6/13 and then gradually improved. Still itchy yet some redness on 6/16/15.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy skin normal, Pruritus generalised, Rash generalised, Skin reaction
Clinical narrative: Delayed reaction 4 weeks after injection (28 days) rash, intense itching over entire body went to 2 specialists Rx-ATARAX 50mg 3 x day.
Sex: U
Vaccine: TDAP
Symptoms: Consciousness fluctuating, Loss of consciousness
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of loss of consciousness in a patient who received BOOSTRIX (batch number 9NA32, expiry date 28th March 2017). On 11th June 2015, the patient received BOOSTRIX. On 11th June 2015, 10 min after receiving BOOSTRIX, the patient experienced loss of consciousness (serious criteria GSK medically significant). On an unknown date, the outcome of the loss of consciousness was unknown. It was unknown if the reporter considered the loss of consciousness to be related to BOOSTRIX. Additional information was provided as follows: BOOSTRIX was given to the patient and the patient experienced in and out of consciousness. The reporter had limited information.
Age: 82.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Sunburn
Clinical narrative: This is a spontaneous report from a contactable nurse. A 82-years-old male patient received PREVNAR 13 (Lot number: I31687, Exp date: 21Sep2016), intramuscular on 27May2015 at 0.5 ml single dose. Medical history included chronic obstructive pulmonary disease from an unknown date and unknown if ongoing. Concomitant medication included losartan potassium, tamsulosin hydrochloride, ADVAIR DISKUS, DALIRESP, SPIRIVA, VENTOLIN, azithromycin, ethambutol, omeprazole, albuterol, COQ-10, fish oil, MUCINEX and aspirin. The patient had a redness from his knees to around his back up to his shoulder. The patient was in the hospital for 48 hours and received methylprednisolone 4 mg and BENADRYL. During hospitalization the patient was not better and there was a bad sun burn except that the skin not broken.
Age: 1.98
Sex: F
Vaccine: HEPA
Symptoms: Lethargy, Rash erythematous, Seizure, Vaccine positive rechallenge
Clinical narrative: On 06/10/2015 at approximately 1655 HRS, a woman called who identified herself as the mother of patient.  The caller stated that her child was having a reaction to a vaccine she received on 06/08/2015. Looking at the ASIIS report, the patient had been given a second Hepatitis A vaccine only. The caller reported "red bumps," "seizures," and said the child "wanted to only lay down." I asked if this had happened after the previous Hepatitis A shot and the caller said, "Yes, and it was even worse." I instructed the caller to contact 911 and have the child evaluated immediately. The caller agreed to do so.
Age: 63.0
Sex: M
Vaccine: TTOX
Symptoms: Oral herpes
Clinical narrative: Within a few hours of my shingles vaccination I developed three cold sores on my upper lip.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Oedema, Pruritus, Rash, Rash erythematous
Clinical narrative: 4x6 pruritic area of redness, warm to the touch and mild edema. On 5/23/15 pt reports continued sx's of red and white patchy bumps (not fluid or pus filled) and pruritis. Since sx's have persisted for three months, advised f/u with PCP for further evaluation.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Skin warm
Clinical narrative: 4x6 pruritic area of redness, warm to the touch and mild edema. On 5/23/15 pt reports continued sx's of red and white patchy bumps (not fluid or pus filled) and pruritis. Since sx's have persisted for three months, advised f/u with PCP for further evaluation.
Age: 15.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Syncope
Clinical narrative: Post vaccine pt had syncope episode.
Age: 75.0
Sex: M
Vaccine: TTOX
Symptoms: Influenza like illness, Injection site pain
Clinical narrative: Flu-like reaction, pain around shot area. Took an Advil.
Age: 44.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Diarrhoea, Injection site erythema, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Pt states she began having diarrhea and nausea in the evening after vaccinations. Then the next day 6/23/15 she noticed the area was red, swollen and hot to the touch. She states she has been putting ice on the area and taking Motrin. The nausea is gone but still some diarrhea. She says the area looks much better today 6/24/15.
Age: 0.52
Sex: F
Vaccine: DPP, RV5
Symptoms: Abnormal faeces, Diarrhoea, Diet refusal, Faeces pale, Lethargy
Clinical narrative: Pt began vomiting profusely. She vomited every 10 minutes for 2 1/2 hours. Pediatrician was notified within the first hour that vomiting began due to the severity and frequency. Pt became lethargic and very clingy. Approximately 3 1/2 hours later patient had stopped vomiting and had began to appear more alert. From that time until Monday 6/20/15, Pt would refuse to eat, with total 24 hour intake of 12-16 ounces. Two days later, pt had liquid diarrhea for 24 hours that was very acidic smelling and yellow in color. Stool has firmed at this time yet still has yelllow/greyish tint in color. Pt is fully recovered at this time, however still only taking 20 ounces in 24 hours.
Age: 0.52
Sex: F
Vaccine: DPP, RV5
Symptoms: Vomiting
Clinical narrative: Pt began vomiting profusely. She vomited every 10 minutes for 2 1/2 hours. Pediatrician was notified within the first hour that vomiting began due to the severity and frequency. Pt became lethargic and very clingy. Approximately 3 1/2 hours later patient had stopped vomiting and had began to appear more alert. From that time until Monday 6/20/15, Pt would refuse to eat, with total 24 hour intake of 12-16 ounces. Two days later, pt had liquid diarrhea for 24 hours that was very acidic smelling and yellow in color. Stool has firmed at this time yet still has yelllow/greyish tint in color. Pt is fully recovered at this time, however still only taking 20 ounces in 24 hours.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Death, Resuscitation
Clinical narrative: Found down at babysitters, attempted recusitation, DOA in ER.
Age: 64.0
Sex: F
Vaccine: PNC13, TDAP, VARZOS
Symptoms: Arthralgia, Chills, Induration, Influenza like illness, Myalgia
Clinical narrative: Flu-like syndrome; sore throat, fever, chills, joint and muscle aches; local hard knot that was itchy and tender; discolored plaque formed over this; on 6/23, she developed multiple papules that turned urticarial; these occurred on face, arms, legs, buttocks, abdomen without angioedema or anaphylaxis.
Age: 64.0
Sex: F
Vaccine: PNC13, TDAP, VARZOS
Symptoms: Nodule, Oropharyngeal pain, Papule, Pruritus, Pyrexia
Clinical narrative: Flu-like syndrome; sore throat, fever, chills, joint and muscle aches; local hard knot that was itchy and tender; discolored plaque formed over this; on 6/23, she developed multiple papules that turned urticarial; these occurred on face, arms, legs, buttocks, abdomen without angioedema or anaphylaxis.
Age: 64.0
Sex: F
Vaccine: PNC13, TDAP, VARZOS
Symptoms: Skin discolouration, Skin plaque, Tenderness, Urticaria papular
Clinical narrative: Flu-like syndrome; sore throat, fever, chills, joint and muscle aches; local hard knot that was itchy and tender; discolored plaque formed over this; on 6/23, she developed multiple papules that turned urticarial; these occurred on face, arms, legs, buttocks, abdomen without angioedema or anaphylaxis.
Age: 75.0
Sex: F
Vaccine: RAB
Symptoms: Dizziness
Clinical narrative: CLIENT CALLED ON 6/24/15 AT 4:17PM AND INFORMED RABIES CLINIC NURSE THAT SHE HAD BEEN A LITTLE DIZZY SINCE AND HOUR AFTER RECEIVING RABIES POST EXPOSURE PROPHYLAXIS. THE CLIENT STATES IT IS NOT INTERFERING WITH HER DAILY ACTIVITIES AND SHE HAS TRIED TO KEEP BUSY BY DOING LAUNDRY, CLEANING, GOING TO WORK. INFORMED CLIENT THAT DIZZINESS IS A SIDE EFFECT OF THE RABIES VACCINE AND SHE SHOULD RELAX AT HOME AND NOT TRY TO PERFORM A LOT OF ACTIVITIES.
Age: 0.83
Sex: F
Vaccine: DTAPIPVHIB, HEP, PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: None reported at this time.
Age: 11.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Induration, Skin warm, Swelling
Clinical narrative: Started to swell, get warm and hard - per patients mother.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Outbreak of shingles, the same day she got vaccine.  She was treated at Urgent care center with Valtrex and improved.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Diarrhoea, Dizziness, Heart rate increased, Hypoaesthesia oral
Clinical narrative: Swelling of tongue and numbness, Hives and redness at site. Fast heartbeat, dizziness, and weakness and swelling of face. Next day diarrhea swelling of hands feet and legs still going on.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site urticaria, Peripheral swelling, Swelling face, Swollen tongue
Clinical narrative: Swelling of tongue and numbness, Hives and redness at site. Fast heartbeat, dizziness, and weakness and swelling of face. Next day diarrhea swelling of hands feet and legs still going on.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema
Clinical narrative: Swelling of tongue and numbness, Hives and redness at site. Fast heartbeat, dizziness, and weakness and swelling of face. Next day diarrhea swelling of hands feet and legs still going on.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pruritus
Clinical narrative: Noticed injection site was itchy. Looking at my arm noticed large red area (approx. 4 inch circumference with a center darker red area of about 1 1/2 - 2 inch circumference).
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Dry skin, Erythema, Pruritus
Clinical narrative: Red, Dry, Itchy skin spreading from deltoid to elbow.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Localized redness, swelling, heat and itching at vaccine site and generalized body aches without fever.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: HPV9 #1 was given. 6 hrs after administration, pt. developed hives all over her body, worse on torso. BENADRYL was given with some relief. Significantly better after 24 hrs, resolved after 48 hrs.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 27-JAN-2015, the patient was received improperly stored VARIVAX (lot # K005427, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Age: 8.0
Sex: M
Vaccine: MMRV
Symptoms: Asthenia, Pain, Pyrexia, Rash morbilliform
Clinical narrative: Fever, achy, decreased energy, rash (measle like rash) x 2 weeks after PROQUAD vaccine.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Seizure
Clinical narrative: Seizure-seen at ED. Following up with neurology.
Age: 17.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given 2 days after expiration date 6-23-15-spoke with mom. Daughter did not have any reactions.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Skin warm
Clinical narrative: Pt received PREVNAR 13 on 5/29/15. Developed cellulitis. Received KEFLEX on 6/8/15 for treatment. Pt had redness warm to the touch and line on this arm.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a Certified Medical Assistant (C.M.A.) referring to unspecified patients of unknown age and gender. Concurrent conditions and pertinent medical history were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ, (lot #, strength, route of administration and dose were not provided). No adverse experiences were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 16-FEB-2015 the patient was received improperly stored VARIVAX (lot # K005427, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 05-MAR-2015, the patient was received improperly stored VARIVAX (lot # K005427, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 01-APR-2015, the patient was received improperly stored VARIVAX (lot # K005427, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 09-MAR-2015, the patient was received improperly stored VARIVAX (lot # K007979, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 11-MAY-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # L002419, expiration date 30-APR-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a Certified Medical Assistant (C.M.A.) referring to unspecified patients of unknown age and gender. Concurrent conditions and pertinent medical history were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PEDVAXHIB, (lot #, strength, route of administration and dose were not provided). No adverse experiences were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 13-APR-2015, the patient was received improperly stored VARIVAX (lot # K007979, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 03-MAR-2015, the patient was received improperly stored VARIVAX (lot # K007979, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 29-APR-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # L002419, expiration date 30-APR-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative refers to a 75 year old female patient. On 06-JUN-2015 the patient was vaccinated with ZOSTAVAX (lot # L000449; expiry: March 2016) (dose, route, frequency unspecified). No concurrent medications were reported. Approximately in June 2015 patient developed pain, itching and redness at the injection site after receiving the vaccine. The outcome of pain, itching and redness at the injection site was unknown. Causality was not reported. Additional information has been requested.