chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Hypoaesthesia, Hypotension, Immediate post-injection reaction, Migraine, Mydriasis
Clinical narrative: Immediately after the injection his face went numb, couldnt speak clearly, almost passed out, blood pressure skyrocketed, pupils dilated, and he was dizzy. Now, 6 days later he STILL has migraines, stabbing stomach pains, low blood pressure, nausea, and dizziness, and he can barely stay awake. He has not been able to return to school since the vaccine because of how bad the effects are.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Nausea, Somnolence, Speech disorder
Clinical narrative: Immediately after the injection his face went numb, couldnt speak clearly, almost passed out, blood pressure skyrocketed, pupils dilated, and he was dizzy. Now, 6 days later he STILL has migraines, stabbing stomach pains, low blood pressure, nausea, and dizziness, and he can barely stay awake. He has not been able to return to school since the vaccine because of how bad the effects are.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Impaired healing, Neck pain, Rash vesicular
Clinical narrative: Following injection with ZOSTAVAX I developed a pain and swelling on one side just under my skull and down my neck, and other side same spot had 2 shingles-like blisters that are taking a very long time to heal.
Age: 19.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a physician refers to a 19 year old male patient. Concurrent conditions, medical history and allergies were not reported. The reporter indicated that the patient was scheduled to receive M-M-R II and VARIVAX (Merck) but instead, on 27-FEB-2015, the patient was concomitantly vaccinated with a dose of PROQUAD (Merck), 0.5 ml, subcutaneous, (frequency, route, anatomical location, lot number and expiration date were not reported) and a dose of VARIVAX (Merck), (strength, dose, frequency, route, anatomical location, lot number and expiration date were not reported). No adverse effects were noted. It was reported that the patient did not seek medical attention. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left upper arm swelling, tenderness, redness, started evening after receiving PREVNAR vaccine earlier that day. Seen 3-6-15 and 3-9-15 in office, tx with antihistamines, NSAID then abx.
Age: 59.0
Sex: M
Vaccine: HEPAB
Symptoms: Hepatitis A antibody negative, Inappropriate schedule of drug administration, No therapeutic response, Underdose
Clinical narrative: This case was reported by a pharmacist and described the occurrence of therapy non-responder in a 63-year-old male patient who received TWINRIX. Co-suspect product included Hepatitis B vaccine. Previously administered products included TWINRIX (dose 1). On 28th February 2011, the patient received TWINRIX 1 ml. In October 2010, the patient received Hepatitis B vaccine. In October 2010, an unknown time after receiving TWINRIX and Hepatitis B vaccine, the patient experienced underdose. On 28th February 2011, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder, drug dose administration interval too long and underdose were unknown. It was unknown if the reporter considered the therapy non-responder to be related to TWINRIX and Hepatitis B vaccine. It was unknown if the reporter considered the drug dose administration interval too long underdose to be related to Hepatitis B vaccine. Additional information: Patient received TWINRIX on 28 August 2010 and 28 February 2011 with a dose of Hepatitis B in October 2010. Patient is now saying that he does not have Hepatitis A antibodies. Pharmacist has not seen the labs. Also the patient's 2nd dose of TWINRIX was delayed longer than one month. Also the patient had interchange of monovalent hepatitis B with TWINRIX.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Muscle twitching, Myalgia, Pain in extremity, Peripheral coldness
Clinical narrative: This case was reported by a consumer and described the occurrence of rash in a 49-year-old female patient who received ENGERIX B adult (batch number EA3Z2, expiry date 18th February 2017). The patient's past medical history included intervertebral disc protrusion. Concurrent medical conditions included viral titer (titer did not show coverage for hep b), thyroid disorder, blood pressure, multiple allergies, automobile accident (still has lingering pain) and drug allergy (allergic to bacitracin, neomycin and neosporin). Concomitant products included felodipine, garlic, nasal saline, SYNTHROID, triamterene, VERAMYST and vitamin c. On 16th January 2015 09:00, the patient received the 1st dose of ENGERIX B adult. On 16th January 2015, 1 hr after ENGERIX B adult, the patient experienced rash. On 17th January 2015, the patient experienced foot pain, cold feet, muscle twitching and joint pain. The pain was treated with prednisone. On an unknown date, the outcome of the rash was recovered/resolved and the outcome of the foot pain, cold feet, muscle twitching and joint pain were recovering/resolving. It was unknown if the reporter considered the rash, foot pain, cold feet, muscle twitching and joint pain to be related to ENGERIX B adult. Additional information received: Patient reports she developed a rash on face an hour after getting vaccine. Day after vaccine in the early morning, patient reports developing muscle twitching and muscle pain in lower extremities and joint pain in her legs and back. She also reports she had coldness in toes and pain underneath feet which went from left to right side. She describes that the muscle pain was different from the nerve pain she had in (historical) car accident. Patient went to ER on both 17Jan2014 and 19Jan2014, and her doctor on 19Jan2014. Her doctor gave her prednisone, TYLENOL #3 and MOBIC. She reports she did take prednisone, but not TYLENOL #3 or MOBIC. She reports going to an allergist at time of report, and has an appointment with a neurologist scheduled or 2pm day of report. At time of report, patient is still having muscle pain, twitching and coldness in toes and lower extremities that is improving but still exists.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: This case was reported by a consumer and described the occurrence of rash in a 49-year-old female patient who received ENGERIX B adult (batch number EA3Z2, expiry date 18th February 2017). The patient's past medical history included intervertebral disc protrusion. Concurrent medical conditions included viral titer (titer did not show coverage for hep b), thyroid disorder, blood pressure, multiple allergies, automobile accident (still has lingering pain) and drug allergy (allergic to bacitracin, neomycin and neosporin). Concomitant products included felodipine, garlic, nasal saline, SYNTHROID, triamterene, VERAMYST and vitamin c. On 16th January 2015 09:00, the patient received the 1st dose of ENGERIX B adult. On 16th January 2015, 1 hr after ENGERIX B adult, the patient experienced rash. On 17th January 2015, the patient experienced foot pain, cold feet, muscle twitching and joint pain. The pain was treated with prednisone. On an unknown date, the outcome of the rash was recovered/resolved and the outcome of the foot pain, cold feet, muscle twitching and joint pain were recovering/resolving. It was unknown if the reporter considered the rash, foot pain, cold feet, muscle twitching and joint pain to be related to ENGERIX B adult. Additional information received: Patient reports she developed a rash on face an hour after getting vaccine. Day after vaccine in the early morning, patient reports developing muscle twitching and muscle pain in lower extremities and joint pain in her legs and back. She also reports she had coldness in toes and pain underneath feet which went from left to right side. She describes that the muscle pain was different from the nerve pain she had in (historical) car accident. Patient went to ER on both 17Jan2014 and 19Jan2014, and her doctor on 19Jan2014. Her doctor gave her prednisone, TYLENOL #3 and MOBIC. She reports she did take prednisone, but not TYLENOL #3 or MOBIC. She reports going to an allergist at time of report, and has an appointment with a neurologist scheduled or 2pm day of report. At time of report, patient is still having muscle pain, twitching and coldness in toes and lower extremities that is improving but still exists.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning to 4 unspecified patients of unknown age and gender. No medical history or concurrent conditions were reported. On unknown date, the patients were vaccinated with a dose of improperly stored PNEUMOVAX (dose, route and lot number not provided). Co-suspect or concomitant therapies were not reported. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to a patient of unknown age and gender. The patient pertinent medical history and drug reactions or allergies were not provided. On an unknown date, the patient was inadvertently administered VARIVAX (Merck) (route, lot # and expiration date were not provided) when the patient was prescribed ZOSTAVAX. No adverse events were reported. It was unknown if the patient sought medical attention. At the time of the report, the patient status was unknown. 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 health care worker refers to an unspecified number of patients of unknown demographics. The patients concurrent conditions or medical history were not reported. On an unknown date, the reporter stated that the patients received a dose of an improperly stored VARIVAX (Merck) (dose, route, anatomical location, lot number and expiration date not reported). No adverse effects were reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Broke out with shingles 1/8/15 (L) scalp and (L) occipital area.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from certified medical assistant refers to unknown number of patients of unknown age and gender. Since 20-FEB-2015, the patients were vaccinated with a dose of VARIVAX (Merck) which was previously exposed to temperatures outside of the recommended range (dose, route of administration and lot # were not reported). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to patient of unknown age and gender. The patient's relevant medical history was not reported. On 11-NOV-2014, the patient was vaccinated with a dose of MMR II (therapy type, route, dose, frequency and lot # were not reported) which underwent an excursion. This is one of several reports received from the same source. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Within 24 hours of vaccines administration patient began to experience fever and chills and achiness. Went to clinic to dr and was prescribed TYLENOL or ADVIL and told to watch for signs of rash.
Age: 0.38
Sex: M
Vaccine: HIBV
Symptoms: Ear infection, Staphylococcal infection
Clinical narrative: This spontaneous report as received from a registered nurse refers to a currently 1 year old male patient. The patient had no pertinent medical history. On 11-APR-2014, the patient received the first dose of LIQUID PEDVAXHIB and a second dose on 31-JUL-2014 (lot #J010382 and expiry 28-MAY-2016; dose, route not provided). There were no concomitant medications. On an unspecified date in 2014 (reported as "since November 2014 or December 2014"), the patient experienced MRSA in one of his ear. The patient seek medical attention and saw a doctor. The patient was on unspecified antibiotics for a couple of months, which had been given as treatment. At the time of the report the patient was still fighting with the ear infection. Relatedness between the event and suspect vaccine was not specified. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. The pharmacist informed that on 26-FEB-2015 the patient was vaccinated with one dose of ZOSTAVAX 0.65 ml, subcutaneous, for prophylaxis (lot# and expiration date were not reported), that was improperly stored. No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from a mother's consumer refers to a female patient of unknown age. Medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with a dose of M-M-R !! (dose, route, lot number and expiry date were not reported). There was no concomitant medication provided. On an unknown date and for the past 5 days, the patient experienced pain her right thigh after receiving the M-M-R II. The outcome of pain in her right thigh was reported as not recovered at the time of the report. Relatedness between the therapy with M-M-R II and the pain in her right thigh was not reported. Additional information is not expected because no reporter details were provided.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. The patient's relevant medical history was not reported. On 13-NOV-2014, the patient was vaccinated with a dose of M-M-R II (therpay type, route, dose, frequency and lot # were not reported) which underwent an excursion. This is one of several reports received from the same source. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Cardiac disorder, Herpes zoster, Pain, Rash
Clinical narrative: This spontaneous report as received from the patient's wife refers to her 76 year old male husband with Diabetes Mellitus and hypertension without drug reactions and allergies. On unknown date in 2007 the patient was vaccinated with ZOSTAVAX when he first came out of seniors (dose, route of administraiton and lot # were not reported). It was reportd that the patient took a lot of concomitant medications. On 21-FEB-2015 the patient developed rash and went to an urgent care center on 27-FEB-2015 where he was treated for an unspecified herat condition. Patient was ordered generic VALTREX and a patch for pain. He was also diagnosed with singles on 27-FEB-2015 (also reported as 23-FEB-2015). It was also reported that the patient just returned from urgent care and continued in pain until start of treatment. The patient's wife consulted an unspecified pharmacist who advised contact the pharmaceutical compnay. The outcome of unspecified heart condition and shingles was reported as not recovered/not resolved. 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 health care worker refers to unspecified patients of unknown age and gender who on an unknown dates, since February 2015, had been vaccinated with improperly stored VARIVAX (Merck) (dose, route, lot # and expiration date were not provided). No adverse effects were noted. Additional information is not expected because the reporter refused additional contact.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Paraesthesia
Clinical narrative: About 3-4 days after getting vaccine the area around injection spot got red and larger than a quarter. Also patient had "weird" tingling sensation.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pain, Pain in extremity, Rash
Clinical narrative: About 3-4 days after getting vaccine the area around injection spot got red and larger than a quarter. Also patient had "weird" tingling sensation.
Age: 1.55
Sex: M
Vaccine: HEPA
Symptoms: Pyrexia
Clinical narrative: Fever temp 101.0
Age: 29.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a phyisican refers to a 29 year old male patient. Concurrent conditions and medical history was reported as none. The physician reported that the patient showed an immune response to hepatitis B titers which were drawn on unknown date of May 2011. The patient was firefighter and exposed to blood during the extraction of a person who was negative for the hepatitis B surface antigen on unknown date of October 2014. The physician reported that his patient's hepatitis B titers were drawn on 25-OCT-2014 following his blood exchange and the titers were negative. On 28-OCT-2014, prophylaxis dose of RECOMBIVAX HB (lot # J006511, expiry date: 28-JAN-2016) through intramuscular route was administered. Concomitant medications were not reported. The patient's titers drawn again on 12-DEC-2014, and they were positive and showed a quantative hepatitis B surface antibody of 52. On 10-FEB-2015 blood levels were drawn and IgM core antibodies to hepatitis B were positive and on 19-FEB-2015 his hepatitis "BE" antigens were negative. The physician stated that polymerase chain reaction (PCR ) testing has been conducted on unspecified date and the results were pending. The patient sought for the medical attention and had occupational health visit. The outcome of the reported event was considered as recovered on 12-DEC-2014 and the causality assessment was not provided. No product quality complaint (PQC) was filed. No further information has been provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. On unspecified dates doses of GARDASIL (dose, frequency, route and lot# were not reported), which were exposed to a temperature excursion, had been administered to unspecified patients. No adverse experience had been reported. This is one of several reports from same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. On unspecified dates, an unspecified number of patients were administered dose of VAQTA (dose, frequency, route and lot# were not reported), which were exposed to a temperature excursion. No adverse experience had been reported. This is one of several reports received from same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician via the company representative concerning a female patient of unknown age. The patient's concurrent conditions and medical history were not reported. On an unknown date the patient was inadvertently exposed to GARDASIL during pregnancy. Concomitant medications were not reported. No adverse effects were reported. The LMP and EDD were not known. The pregnancy outcome was pending. Additional information is not expected since the reporting physician did not wish to be contacted.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed pratical nurse referring to an unspecified number of patients of unknown age and gender. On unspecified dates, an unspecified number of patients were vaccinated with doses of RECOMBIVAX HB (dose, frequency, route and lot # were not reported), which were exposed to a temperature excursion. No adverse experience had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. On unspecified dates, doses of PEDVAXHIB (dose, frequency, route and lot# were not reported), which were exposed to a temperature excursion, had been administered to unspecified patients. No adverse experienced had been reported. This is one of several reports received from same reporter. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to two 17 year old patients of unknown gender. On 27-FEB-2015, the patients were accidentally vaccinated with a dose of ZOSTAVAX instead of VARIVAX (Merck). No adverse effect was reported. Additional information is not expected as there was no contact details available.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacist referring to a 62 year old male patient. Information about patient's medical history or drug reactions/allergies was not reported. On 25-FEB-2015 the patient was vaccinated with ZOSTAVAX (lot # K009810 with expiration date 10-OCT-2015, unspecified single dose, subcutaneous). The pharmacist reported that the patient had ZOSTAVAX reconstituted with sterile diluent (lot # reported as K011199). Concomitant therapies included COUMADIN and multiple unspecified prescription drugs. On 27-FEB-2015 the patient experienced injection site reactions (a red, bruised, hard lump, 6 to 8 inches in size, that was warm to touch and swelling of lower and upper arm) after receiving ZOSTAVAX. The patient saw a physician on an unspecified date. KEFLEX was given for the events. The pharmacist contacted patient and patient stated that injection site reaction was improving (recovering). The causality was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Contusion, Erythema, Induration, Mass, Peripheral swelling
Clinical narrative: Information has been received from a pharmacist referring to a 62 year old male patient. Information about patient's medical history or drug reactions/allergies was not reported. On 25-FEB-2015 the patient was vaccinated with ZOSTAVAX (lot # K009810 with expiration date 10-OCT-2015, unspecified single dose, subcutaneous). The pharmacist reported that the patient had ZOSTAVAX reconstituted with sterile diluent (lot # reported as K011199). Concomitant therapies included COUMADIN and multiple unspecified prescription drugs. On 27-FEB-2015 the patient experienced injection site reactions (a red, bruised, hard lump, 6 to 8 inches in size, that was warm to touch and swelling of lower and upper arm) after receiving ZOSTAVAX. The patient saw a physician on an unspecified date. KEFLEX was given for the events. The pharmacist contacted patient and patient stated that injection site reaction was improving (recovering). The causality was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Skin warm
Clinical narrative: Information has been received from a pharmacist referring to a 62 year old male patient. Information about patient's medical history or drug reactions/allergies was not reported. On 25-FEB-2015 the patient was vaccinated with ZOSTAVAX (lot # K009810 with expiration date 10-OCT-2015, unspecified single dose, subcutaneous). The pharmacist reported that the patient had ZOSTAVAX reconstituted with sterile diluent (lot # reported as K011199). Concomitant therapies included COUMADIN and multiple unspecified prescription drugs. On 27-FEB-2015 the patient experienced injection site reactions (a red, bruised, hard lump, 6 to 8 inches in size, that was warm to touch and swelling of lower and upper arm) after receiving ZOSTAVAX. The patient saw a physician on an unspecified date. KEFLEX was given for the events. The pharmacist contacted patient and patient stated that injection site reaction was improving (recovering). The causality was not 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: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. Patients' concurrent conditions, concomitant medication and medical history were not provided. On unknown dates the patients were vaccinated with doses of improperly stored VARIVAX (Merck) (0.5 ml, subcutaneous, dose number, lot# and expiry date were not provided). No adverse event was reported. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician via a field representative concerning a 74 year old male patient. on 13-AUG-2012 the patient was vaccinated with ZOSTAVAX lot # 0564AE expiration date unspecified, 1 dose/once, subcutaneously. Concomitant therapies included hydrochlorothiazide, TOTAPEN, metformin, latanoprost, aspirin (baby), fluticasone and "VATROPRALOL" (correct spelling unknown). On 12-FEB-2015 the patient developed shingles that had crossed two dermatomes. The physician also stated this case of shingles was not too painful for the patient. The patient visited the Doctor's office for medical attention. An unspecified antiviral medication was given to the patient. None lab diagnostics study was performed. The outcome of the event was reported as not recovered. The reporter did not assess the causality. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 12 month old patient of unknown gender. On 13-FEB-2015, the patient was inadvertently administered one dose of VARIVAX (Merck) injection, (strength, lot number, expiry date, and dose were not reported), and one dose of PROQUAD injection, (strength, lot number, expiry date, and dose were not reported), subcutaneously, which was accidental overdose. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. On 05-FEB-2015 the patient was vaccinated with VARIVAX (Merck) which underwent a supported temperature excursion, (lot# and dose not reported), subcutaneous. No adverse effects were reported. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Condition aggravated, Herpes zoster, Skin warm
Clinical narrative: Developed a herpes zoster rash/infection- rash, hot to the touch, visible blistering
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Local reaction
Clinical narrative: Large localized reaction left upper arm - itchy, redness does not appear to be infected. Large area 5x5.5 in. Small area 1.5x1.25 in.
Age: 0.3
Sex: U
Vaccine: MMR
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a 4 month old patient. Patient medical history and current condition was not reported. On 09-MAR-2015 the 4 month old patient was vaccinated with M-M-R II vaccine of dose 0.5 ml via subcutaneous route outside the prescribing information. No adverse effect was reported. The outcome of the event was unknown. Additional informatino has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist technician concerning three unspecified patients (demographics unknown). On an unknown date, the patients were vaccinated with doses of VARIVAX (Merck) (Lot # K010337, expiration date: 22-JUL-2016) that on an unspecified date were exposed to a temperature excursion. It was reported that the doses of VARIVAX (Merck) were exposed to temperatures of 60F for 1 hour, then less than 46F for 3 hours. No adverse experience had been reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Registered nurse refers to an unspecified number of patients of unknown demographics. On unknown dates, unspecified number of patients received ZOSTAVAX, 0.65 ml, (indication and lot numbers were not reported) subcutaneously that underwent a supported temperature excursion. No adverse experiences reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. The patient's relevant medical history was not reported. On 13-NOV-2014, the patient was vaccinated with a dose of M-M-R II (therapy type, route, dose, frequency and lot # were not reported) which underwent an excursion. This is one of several reports received from the same source. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia
Clinical narrative: Patient given MMR II on 2/10/15. Started with arthralgia on 2/19/15. 2/27/15 seen by MD with constant c/o arthralgias of knees, ankles, hands and elbow. Patient to take ADVIL and f/u in 1 week.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Blood glucose normal, Nausea, Vomiting
Clinical narrative: Observed for 20 min-she talking talking and laughing. Talk mother she needed to co to bathroom. Dr noticed 45 min after vaccine given BP/P/ R ok - nausea emesis abdominal cramping.
Age: 0.33
Sex: M
Vaccine: HIBV, IPV
Symptoms: Injection site reaction, Keloid scar
Clinical narrative: Keloid formation on right thigh
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Psychomotor hyperactivity
Clinical narrative: This spontaneous report as received from a male consumer refers to himself. Patient medical history and current condition was not reported. Approximately on 02-MAR-2015 (reported as a week ago on Monday) the patient was vaccinated with ZOSTAVAX one time vaccine injection. Other co-suspects were not reported. On an unknown date the patient experienced trouble sleeping, reported as he got 4 hours sleep the previous night and was hyper active. Product quality complaint was not reported. The outcome of the events was unknown. Causality assessment was not provided by the reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown gender and age. Information about the patients medical history and concurrent condition was not provided. On an unspecified dates since 16-JAN-2015, the patients were vaccinated with doses of ZOSTAVAX (dose, dose number, lot/batch# and expiration dates were not reported) that were improperly stored. Information about concomitant medications was not provided. No adverse effect was reported. No product quality complaint (PQC) was involved. The nurse called back for temperature stability information. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. The patient's relevant medical history was not reported. On 19-NOV-2014, the patient was vaccinated with a dose of M-M-R II (therapy type, route, dose, frequency and lot # were not reported) which underwent an excursion. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to an adult (reported as approximately 55 year old) female patient. The patient's medical history was not reported. In approximately June 2014 (reported as about nine months ago), the patient was vaccinated with a dose of ZOSTAVAX (dose, lot #, expiration date and route of administration were not reported) in the arm. No concomitant medication was reported. On an unknown date, after receiving ZOSTAVAX, the patient experienced a red, raised and warm area on her unspecified arm at the injection site. The patient did not seek medical attention. No treatment was given for the adverse events. The outcome of events was unknown. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 28.0
Sex: M
Vaccine: UNK
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever sore arm at injection sit.
Sex: F
Vaccine: UNK
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Soreness at injection site and lump after injection.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Hypoaesthesia, Pain
Clinical narrative: Pt developed shingles, pain, numbness in arm.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Grip strength decreased, Headache, Hypoaesthesia, Injection site erythema, Injection site pain
Clinical narrative: Pt developed shingles, pain, numbness in arm.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Musculoskeletal disorder, Pain in extremity, Paraesthesia, Tinnitus
Clinical narrative: Pt developed shingles, pain, numbness in arm.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Fatigue, Pain in extremity
Clinical narrative: Upper arm was red and painful like she had a sunburn. She had chills and felt "wiped out" for 2-3 days. She took TYLENOL as needed. By Friday. 1/30/15 she felt fine.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Eyelid oedema, Paraesthesia oral, Rash, Urticaria
Clinical narrative: 10/28 (Tuesday)= started, itching of the neck. Noted (L) eye slightly mid and lower lid was puffy/swollen. By the time I was driving home, itching was getting worst. Noted that my back and chest were also very itchy; (L) lower lid was getting more swollen. Turned back to the hosp. w/intention of going to ER. Checking my body, noted that my chest and back were covered w/welts, rashes and red areas. I decided to get/took BENADRYL orally when I went home (decided to go home instead of going to ER). BENADRYL took care of the welts and rashes. But after the oral BENADRYL wore of, noted that rashes/welts came back-> face, eye lids, body and extr (Before taking 1st dose of BENADRYL, on this 1st day, noted lips got tingly and (R) decrease eyelid was swollen. No difficulty w/breathing). This rashes/welts comes and goes. Finally saw dr on 10-20-14. Was told to take MEDROL Pack, continued BENADRYL po. Episode continued till Saturday 11-1-14.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Neuralgia
Clinical narrative: Shingles blisters continued routinely 4-6 wks. after injection. Along with added nerve pain in area of shingles (lower back and buttocks). Usually takes place after arising from overnight sleep early AM. NIXODERM ointment applied. 1 x day for a wk.
Age: 42.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Induration, Pain in extremity
Clinical narrative: (R) arm erythema, induration, pain. Treated with cephalexin, heat, ibuprofen.
Age: 1.73
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered on 2/11/15.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacy technician referring to multiple unspecified patients of unknown ages and genders. On unknown dates, the patients received doses of RECOMBIVAX HB (route, lot#, dose and frequency unknown) that were improperly stored. No adverse effects reported. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Dizziness, Rash, Swelling
Clinical narrative: Patient came to pharmacy and stated that after getting the vaccine she experienced dizziness, swelling and rash.
Age: 0.75
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: This case was reported by a physician via other manufacturer and described the occurrence of febrile seizure in a 9-month-old male patient who received PEDIARIX (batch number E4T94, expiry date unknown). Co-suspect products included PREVENAR 13 (batch number H06568, expiry date unknown) and ACT HIB (batch number U1047AA, expiry date unknown). Previously administered products included PREVENAR 13 with an associated reaction of no adverse event (1st dose was administered on 12 February 2014 and the 2nd on 06 June 2014), hepatitis B vaccine with an associated reaction of no adverse event and DAPTACEL with an associated reaction of no adverse event. Concurrent medical conditions included hypotonia and developmental delay. Concomitant products included lactulose. On 6h August 2014 12:53, the patient received the 1st dose of PEDIARIX (intramuscular), the 3rd dose of PREVENAR 13 (intramuscular) and the 3rd dose of ACT HIB (intramuscular). On 7th August 2014, 05:00, 1 days after receiving PEDIARIX, the patient experienced febrile seizure (serious criteria GSK medically significant). The patient was treated with TYLENOL and MOTRIN. On 7th August 2014, the outcome of the febrile seizure was recovered/resolved. It was unknown if the reporter considered the febrile seizure to be related to PEDIARIX. Additional information: The mother's patient reported that her son had 106 degree Fahrenheit but he had 101.6 degree Fahrenheit in the emergency room. The patient was not hospitalized. The duration of the seizures was 10 minutes. The reporter didn't consider the convulsions generalized and fever to be related to PREVENAR 13 but she was not sure.
Age: 0.75
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Pyrexia, Seizure
Clinical narrative: This case was reported by a physician via other manufacturer and described the occurrence of febrile seizure in a 9-month-old male patient who received PEDIARIX (batch number E4T94, expiry date unknown). Co-suspect products included PREVENAR 13 (batch number H06568, expiry date unknown) and ACT HIB (batch number U1047AA, expiry date unknown). Previously administered products included PREVENAR 13 with an associated reaction of no adverse event (1st dose was administered on 12 February 2014 and the 2nd on 06 June 2014), hepatitis B vaccine with an associated reaction of no adverse event and DAPTACEL with an associated reaction of no adverse event. Concurrent medical conditions included hypotonia and developmental delay. Concomitant products included lactulose. On 6h August 2014 12:53, the patient received the 1st dose of PEDIARIX (intramuscular), the 3rd dose of PREVENAR 13 (intramuscular) and the 3rd dose of ACT HIB (intramuscular). On 7th August 2014, 05:00, 1 days after receiving PEDIARIX, the patient experienced febrile seizure (serious criteria GSK medically significant). The patient was treated with TYLENOL and MOTRIN. On 7th August 2014, the outcome of the febrile seizure was recovered/resolved. It was unknown if the reporter considered the febrile seizure to be related to PEDIARIX. Additional information: The mother's patient reported that her son had 106 degree Fahrenheit but he had 101.6 degree Fahrenheit in the emergency room. The patient was not hospitalized. The duration of the seizures was 10 minutes. The reporter didn't consider the convulsions generalized and fever to be related to PREVENAR 13 but she was not sure.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site pain, Mobility decreased, Muscular weakness, Neck pain, Pain in extremity
Clinical narrative: Information has been received from a nurse referring to a 65 year old female patient. The patient had none pertinent medical history and drug reactions/allergies. Information regarding concurrent condition was not provided. The patient denied ever receiving PNEUMOVAX 23 previously. On 04-FEB-2015 the patient was vaccinated with the first dose of PNEUMOVAX 23 (lot # K009105, expiration date 21-JAN-2016, 0.5 ml, intramuscularly in the right deltoid). Concomitant therapies included FLUZONE in left deltoid on 04-FEB-2015. On 04-FEB-2015, several hours after she received the dose, the patient developed pain at the injection site. She reported that there was no swelling, bruising, or induration at the injection site. The patient felt "feverish" on the same day but she didn't take her temperature. Over the next few days, the patient took some TYLENOL and one VICODIN, but she did not experience relief form her pain. The patient sought medical attention on 10-FEB-2015 when she went to Emergency Department. She sought medical attention because her pain in her right shoulder was radiating up to her neck and she rated her right shoulder pain as the worst pain in her life with degree "20 out of 10". The patient was experiencing limited range of motion and weakness in her right arm (from an unspecified date in February 2015). In the emergency department, the patient was not identified anything other than tense muscles (from an unspecified date in February 2015). The was treated with diazepam and no pain medication was given. The patient was reported to have been "relatively calm," and she was reluctant to take medication. The patient was referred to orthopedist for physical therapy but the nurse reported that the patient had not followed up with the recommended orthopedist consult. The patient consulted the nurse on 27-FEB-2015, and the nurse noted a decreased grip in the patient's right hand (specified date unknown). The patient was guarding the right arm, and she was performing her activities of daily living with her left arm. The patient currently had not recovered full use of her right arm. The outcome of the events was not recovered. The causality between PNEUMOVAX 23 and all events were not provided. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: Information has been received from a nurse referring to a 65 year old female patient. The patient had none pertinent medical history and drug reactions/allergies. Information regarding concurrent condition was not provided. The patient denied ever receiving PNEUMOVAX 23 previously. On 04-FEB-2015 the patient was vaccinated with the first dose of PNEUMOVAX 23 (lot # K009105, expiration date 21-JAN-2016, 0.5 ml, intramuscularly in the right deltoid). Concomitant therapies included FLUZONE in left deltoid on 04-FEB-2015. On 04-FEB-2015, several hours after she received the dose, the patient developed pain at the injection site. She reported that there was no swelling, bruising, or induration at the injection site. The patient felt "feverish" on the same day but she didn't take her temperature. Over the next few days, the patient took some TYLENOL and one VICODIN, but she did not experience relief form her pain. The patient sought medical attention on 10-FEB-2015 when she went to Emergency Department. She sought medical attention because her pain in her right shoulder was radiating up to her neck and she rated her right shoulder pain as the worst pain in her life with degree "20 out of 10". The patient was experiencing limited range of motion and weakness in her right arm (from an unspecified date in February 2015). In the emergency department, the patient was not identified anything other than tense muscles (from an unspecified date in February 2015). The was treated with diazepam and no pain medication was given. The patient was reported to have been "relatively calm," and she was reluctant to take medication. The patient was referred to orthopedist for physical therapy but the nurse reported that the patient had not followed up with the recommended orthopedist consult. The patient consulted the nurse on 27-FEB-2015, and the nurse noted a decreased grip in the patient's right hand (specified date unknown). The patient was guarding the right arm, and she was performing her activities of daily living with her left arm. The patient currently had not recovered full use of her right arm. The outcome of the events was not recovered. The causality between PNEUMOVAX 23 and all events were not provided. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Grip strength decreased, Injected limb mobility decreased, Injection site pain, Muscle tightness, Muscular weakness
Clinical narrative: Information has been received from a nurse referring to a 65 year old female patient. The patient had none pertinent medical history and drug reactions/allergies. Information regarding concurrent condition was not provided. The patient denied ever receiving PNEUMOVAX 23 previously. On 04-FEB-2015 the patient was vaccinated with the first dose of PNEUMOVAX 23 (lot # K009105, expiration date 21-JAN-2016, 0.5 ml, intramuscularly in the right deltoid). Concomitant therapies included FLUZONE in left deltoid on 04-FEB-2015. On 04-FEB-2015, several hours after she received the dose, the patient developed pain at the injection site. She reported that there was no swelling, bruising, or induration at the injection site. The patient felt "feverish" on the same day but she didn't take her temperature. Over the next few days, the patient took some TYLENOL and one VICODIN, but she did not experience relief form her pain. The patient sought medical attention on 10-FEB-2015 when she went to Emergency Department. She sought medical attention because her pain in her right shoulder was radiating up to her neck and she rated her right shoulder pain as the worst pain in her life with degree "20 out of 10". The patient was experiencing limited range of motion and weakness in her right arm (from an unspecified date in February 2015). In the emergency department, the patient was not identified anything other than tense muscles (from an unspecified date in February 2015). The was treated with diazepam and no pain medication was given. The patient was reported to have been "relatively calm," and she was reluctant to take medication. The patient was referred to orthopedist for physical therapy but the nurse reported that the patient had not followed up with the recommended orthopedist consult. The patient consulted the nurse on 27-FEB-2015, and the nurse noted a decreased grip in the patient's right hand (specified date unknown). The patient was guarding the right arm, and she was performing her activities of daily living with her left arm. The patient currently had not recovered full use of her right arm. The outcome of the events was not recovered. The causality between PNEUMOVAX 23 and all events were not provided. Additional information has been requested.