chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional (nurse) refers to a patient of unknown age and gender. On 02-JAN-2015 the patient was vaccinated with improperly stored VAQTA (lot  K008252, expiration date: 24-OCT-2015), .5 ml, doses (unspecified in series) intramuscular. No adverse effects were reported. Outcome of the event was not reported. Reporter considered the event to be not related to VAQTA. This is one of several reports received from the same source (MARRS # 1501USA003826, MARRS # 1501USA004956, MARRS # 1501USA004958, MARRS # 1501USA004959 and 1501USA004960. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored RECOMBIVAX HB (lot#, expiration date, dose, frequency and route were unknown). No adverse effects was reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On 13-JAN-2015 (reported as "yesterday"), the patient was vaccinated with an expired dose of ZOSTAVAX injection (lot # J011882 with expiry date: 04-JAN-2015; strength, dose and route of administration unspecified). No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Antibody test negative, No therapeutic response
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. On an unspecified dates the patient was vaccinated with 2 doses of VARIVAX (Merck), (doses, route, lot numbers and expiration dates not reported). On an unknown date the patient had titers drawn that had shown failure to seroconvert (negative titers). At the time of the report the outcome of failure to seroconvert (negative titers) was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with her first dose of GARDASIL, (dose, route, lot number and expiration date not reported). Then, approximately in 2008 (reported as "about 7 years ago") the patient received her second dose of GARDASIL, (dose, route, lot number and expiration date not reported). On 14-JAN-2015 (reported as currently), the patient was at pharmacist's office to receive her third dose of GARDASIL, (dose, route, lot number and expiration date not reported). No adverse effect reported. 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 registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date those patients were vaccinated with a dose of improperly stored PEDVAXHIB (dose, units, route of administration and lot number were not reported). No adverse effects were noted. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to unspecified number of patients of unspecified age and gender. The patients' medical history, concurrent conditions, drug reactions and allergies were not reported. On an unknown dates, the patients were vaccinated with doses of GARDASIL (dose, route of administration, anatomical location, lot# and exp.date were not reported) that were improperly stored. No adverse effects were reported. The outcome of the event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to unspecified number of patients of unspecified age and gender. The patients' medical history, concurrent conditions, drug reactions and allergies were not reported. On an unknown dates, the patients were vaccinated with doses of PEDVAXHIB (dose, route of administration, anatomical location, lot# and exp.date were not reported) that were improperly stored. No adverse effects were reported. The outcome of the event was unkonwn. This is one of several reports received from the same source. 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 nurse refers to an unspecified number of patients of unknown age and gender. In November 2014, the patients were vaccinated with improperly stored RECOMBIVAX HB 2.5 microgram/0.5ml (dose, lot number, 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 certified medical assistant refers to an unspecified number of patients of unknown age and gender. The case was originally opened on 06-OCT-2014 to evaluate improperly stored vaccines. On an unknown date (also reported as since the first call) those patients were possibly vaccinated with an improperly stored doses of ROTATEQ (therapy route defaulted to oral, dose, units, lot number were not reported). No adverse effects reported. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 77 year old male patient. Pharmacist reported that on 14-JAN-2015, the patient was inadvertently given with GARDASIL (lot #, dose and route not reported). No adverse effect reported. There was no additional information to report. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information had been received from a physician via market research program regarding a patient who had been vaccinated with ZOSTAVAX. Physician reported, "I had a patient that got shingles from the shingles vaccine". Adverse event onset date was "about 6-7 years ago" (specific date not provided). Outcome of shingles was reported as recovered/resolved with sequelae. Physician reported patient recovered six weeks after becoming symptomatic. It was reported that shingles did not reappear after restarting suspect therapy. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Peripheral swelling, Skin warm
Clinical narrative: Information had been received from a healthcare worker who reported that a 57 year old female with allergies to sulfa drugs and naproxen received a dose of PNEUMOVAX 23 (lot# K007826, expiration date 03-FEB-2016) in an unspecified arm on 01-DEC-2014. Concomitant medications included CALTRATE, unspecified multivitamins, fluticasone, vitamin D3, simvastatin, omeprazole, REGLAN, atenolol, VALIUM, ginger root, metformin and unspecified probiotics. Later that same day (01-DEC-2014), the patient reported that she had a swollen arm that was hot to the touch and described difficulty lifting the affected arm. Patient called into the physician's office on 02-DEC-2014 to report her symptoms but was not seen in the office. Patient was treated with BENADRYL and an unspecified topical ointment. There are two more AE reports involving this same PNEUMOVAX 23 lot; Lot# K007826 exp. 03-FEB-2016 (See SR#'s 1-12956467246 and 1-12956447580). A lot check has been requested with results to be reported to the physician. No further information provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist who reported that on 20-NOV-2014 a patient received an expired dose of RECOMBIVAX HB (lot# J014312, expiration date 07-SEP-2014). No known adverse effects. All of the data listed here was reconfirmed by the pharmacist. No further information provided. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Condition aggravated, Incorrect route of drug administration, Rash, Scab
Clinical narrative: Information received on 06DEC2014 from a customer who submitted the following question on MerckVaccines.com. "I received the ZOSTAVAX vaccine last week at my physician's office. I know it is a sub-Q vaccine but the medical assistant gave it to me IM. I tried to stop her but she just kept going. Will I get as good immunity if the route was wrong? Should I get it again?" Follow-up information was received 08DEC2014 from a 65 year old female patient who is also a nurse. The patient called to report that she received a dose of ZOSTAVAX on 03DEC2014 via intramuscular route rather than the recommended subcutaneous route. The patient reported that she has a pre-existing condition of atrial fibrillation (Afib) and she only occasionally experiences it. The patient reported that she experienced afib on 04DEC2014, a day after receiving ZOSTAVAX. Also, on 04DEC2014, the patient noticed a small "pox (rash)", a liquid-filled lesion on the back of her neck which was very painful. The patient reported that only one lesion was noticed and she popped the liquid-filled lesion herself and put "aspirin-water mixture" on the lesion and now it is crusted over. The patient reported that she put aspirin tablet in the water, dissolved it and made a paste and put that on her lesion. The patient (also nurse) did not want VZVIP packet, however she did say she could be contacted for follow-up. Concomitant medication included metformin, lisinopril and SYNTHROID. The patient reported drug allergies to codeine and penicillin. No hospitalization or life-threatening or significant disability occurred. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin lesion
Clinical narrative: Information received on 06DEC2014 from a customer who submitted the following question on MerckVaccines.com. "I received the ZOSTAVAX vaccine last week at my physician's office. I know it is a sub-Q vaccine but the medical assistant gave it to me IM. I tried to stop her but she just kept going. Will I get as good immunity if the route was wrong? Should I get it again?" Follow-up information was received 08DEC2014 from a 65 year old female patient who is also a nurse. The patient called to report that she received a dose of ZOSTAVAX on 03DEC2014 via intramuscular route rather than the recommended subcutaneous route. The patient reported that she has a pre-existing condition of atrial fibrillation (Afib) and she only occasionally experiences it. The patient reported that she experienced afib on 04DEC2014, a day after receiving ZOSTAVAX. Also, on 04DEC2014, the patient noticed a small "pox (rash)", a liquid-filled lesion on the back of her neck which was very painful. The patient reported that only one lesion was noticed and she popped the liquid-filled lesion herself and put "aspirin-water mixture" on the lesion and now it is crusted over. The patient reported that she put aspirin tablet in the water, dissolved it and made a paste and put that on her lesion. The patient (also nurse) did not want VZVIP packet, however she did say she could be contacted for follow-up. Concomitant medication included metformin, lisinopril and SYNTHROID. The patient reported drug allergies to codeine and penicillin. No hospitalization or life-threatening or significant disability occurred. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning a female patient (age unknown). Medical history and concomitant medications were not reported. On 05-NOV-2014, the patient received a dose of ZOSTAVAX (lot number K008885/expiration 20-SEP-2015) 0.65 ml subcutaneously. The female reported to the pharmacist that she received the ZOSTAVAX approximately 45 minutes after it was reconstituted. The ZOSTAVAX was exposed to 75 degrees F for 45 minutes (worst case). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse who reported that a dialysis patient inadvertently received a dose of PNEUMOVAX 23 on 08-DEC-2014 which expired in August 2014. This was supported. In addition the patient had previously received a dose of PNEUMOVAX 23 on an unspecified date last year. The nurse declined to report this adverse experience, therefore information is minimal. No adverse effects reported. No further information provided. Additional information is not expected.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Neck pain, Pruritus, Rash
Clinical narrative: Pt received ANTHRAX 0.5mL in (L) Deltoid on 10 Jan 15. Pt c/o rash, itchiness, and soreness to neck. One hour after shot. Worsening symptoms since. Denies SOB or chest pain.
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nursing assistant concerning a female of unknown age. No medical history or concomitant medications were reported. It was reported that on 05-DEC-2014 an expired dose of M-M-R II was administered to the patient. No adverse effects were reported. No additional information was provided. Additional information has been requested.
Age: 0.15
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Injection site swelling, Irritability
Clinical narrative: Red and swollen. Fussy. Right leg.
Age: 0.38
Sex: M
Vaccine: HIBV
Symptoms: Injection site erythema, Injection site swelling, Irritability
Clinical narrative: Right leg red and swollen. Fussy.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Malaise
Clinical narrative: Information was received on 08DEC2014 from a female reporter regarding her female friend (the consumer/patient). The woman reported that her friend developed shingles after becoming sick after an unspecified period of time after she (the patient), had received ZOSTAVAX on an unspecified date. The patient did not wish to provided information. No further information was provided. Additional information is not expected.
Age: 8.0
Sex: M
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Dtap vaccine administered child over recommended age. No adverse effects.
Age: 7.0
Sex: F
Vaccine: DTAP, HEP, IPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Pt given DTaP, age 7. No adverse side effects.
Sex: F
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received from a nurse via a company representative. No medical history or concomitant medications were reported. The nurse reported that an expired dose of GARDASIL (lot number: 0420AE, expires 01-DEC-2014) was inadvertently administered to a female patient (age not reported) on 02-DEC-2014 (dose and location not specified). No adverse effects reported. No other information was provided. Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Tdap was given instead of DTaP.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to at least 5 patients of unknown age and gender. On an unknown dates, since the end of 2012, the patients were vaccinated with unspecified doses of GARDASIL, intramuscular, (lot number and expiration dates not reported). which were improperly exposed to temperatures below 32F for unspecified lengths of time. No known adverse effects. Additional information has been requested.
Age: 1.09
Sex: M
Vaccine: MMR
Symptoms: Blood acid phosphatase normal, Differential white blood cell count normal, Full blood count normal, Generalised tonic-clonic seizure, Influenza virus test negative
Clinical narrative: Tonic-clonic seizure - lasted about 5 min. Felt warm to dad. Did not take temp.
Age: 1.09
Sex: M
Vaccine: MMR
Symptoms: Skin warm
Clinical narrative: Tonic-clonic seizure - lasted about 5 min. Felt warm to dad. Did not take temp.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional (nurse) refers to a patient of unknown age and gender. On 29-DEC-2014 the patient was vaccinated with improperly stored GARDASIL (lot # K005083, expiration date: 04-NOV-2016), .5 ml, doses (unspecified in series) intramuscular. No adverse effects were reported. Outcome of the event was not reported. Reporter considered the event to be not related to GARDASIL. This is one of several reports received from the same source (MARRS # 1501USA003826, MARRS #1501USA004956, MARRS # 1501USA004957, MARRS # 1501USA004958 and 1501USA004960). Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Erythema, Hypotension, Local swelling, Nausea
Clinical narrative: Redness diffuse, itching diffuse, throat, neck swelling, dizziness, hypotension, nausea.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pharyngeal oedema, Pruritus
Clinical narrative: Redness diffuse, itching diffuse, throat, neck swelling, dizziness, hypotension, nausea.
Sex: U
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site vesicles
Clinical narrative: This spontaneous report as received from a pharmacist via a company employee refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, dose and route were unknown). There were "bubbling" at the injection site immediately after vaccination. No treatment was given for the adverse event. The outcome of the event was unknown. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt reports redness and some slight swelling at injection site. The redness is 3" x 3" starting subsiding on Thurs.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Information has been received from a nurse concerning a patient (age and gender not specified). On 08DEC2014 the patient was vaccinated with M-M-R II, .5 ml, subcutaneous. The expiration date of the vaccine was 27JUL2014 (Reported Lot number J008882). The outcome of expired vaccine administered was unknown. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: 3 inch wide red rash nearby injection site.
Sex: U
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients of unknown ages and genders. On an unknown date reported at long ago the patients were vaccinated with GARDASIL (lot #, expiration date, dose and route were not reported). On an unknown date post administration of GARDASIL the patients experienced either felt or became lightheaded. It was unknown if the patients sought medical attention. The outcome of there were a hand full unspecified patients who either felt or became lightheaded was unknown. The registered nurse also reported that the over past 5 years the practice has not had any patients who have had any effects post administration of GARDASIL. Additional information is not expected because the registered nurse did not want to participate in adverse event6 report, as she stated it was long ago and she did not remember anything and she did not have time to participate.
Age: 51.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Pain, Pyrexia
Clinical narrative: 3-4 days after vaccine subjective fever, migrating arthralgias, pains above and below joints that are intermitant.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse. The nurse reported that one improperly stored dose of PNEUMOVAX 23 (lot number and expiration date not provided) was administered to a patient (age and gender not reported). No adverse effects were reported. No other information was provided. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received on 08DEC2014 from a physician regarding a patient (gender not reported). The physician reported the patient received two dose of PNEUMOVAX23 on unspecified dates, before age 65 year (see MARRS # 1501USA005342). This statement was unable to be further clarified. Physician additionally stated he knew of other unspecified physicians who routinely vaccinated their unspecified patients over 65 years with PNEUMOVAX23 every 5 years. regardless of their situation. No adverse effect reported. No additional information provided. Physician needed to disconnect call before AE collection was initiated, therefore all fields are NA. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site joint pain, Injection site pain, Injection site warmth
Clinical narrative: Case number PHHY2014US016102 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 509633) website on 03 Feb 2014: This report refers to a 65-yearold female patient. her medical history included pain and no drug reactions or allergies. her vaccination history included administration of first dose of PNEUMOVAX (other manufacturer and batch number: unknown) at the age of 60 years, on an undetermined date in 2008 following which she experienced redness at injection site. Her current condition included blood cholesterol increased. This polymedicated patient was vaccinated with FLUVIRIN (batch number: unknown) on an unspecified date in 2013 and PNEUMOVAX (batch number: J006242 and expiry date: 03 Aug 2014) intramuscularly on 06 Oct 2013. On 06 Oct 2013, she felt injection site was warm and she had pain at the injection site. On 07 Oct 2013, the pain went up to the elbow. On 08 Oct 2013, the pain was in the middle of her arm. She took TYLENOL for two days and it did not help. At the time of the report, outcome was reported as not recovered. No laboratory tests were performed. She sought medical attention by calling the pharmacist. Final outcome of the event was reported as condition unchanged as on 25 Oct 2013. No further information about seriousness and causality was reported.
Age: 35.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site bruising, Injection site erythema, Injection site warmth, Nodule
Clinical narrative: Case number PHHY2014US013932, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 513533) web site on 03 Feb 2014. This report refers to a 35-year-old male patient. His medical history included hypertension, seasonal allergies and asthma. On the 20 Oct 2013, he was vaccinated with FLUVIRIN (batch number: 13382P) intramuscularly in the right arm and with PNEUMOVAX (batch number: J004332) intramuscularly in the left arm. On 21 Oct 2013, he had a softball size swollen area with a knot in the center on his left arm, site was warm to the touch, had red streaks and bruising. He could not move his left arm at all for 3 days and had left arm soreness lasting for 7 days. He took bedfast for 72 hours. The patient had fever of not less than 103 degrees F for 72 hours after injection. It was reported that his fever persisted with acetaminophen treatment. The final outcome of the events reported as recovered. The seriousness and causality of the events were not reported.
Age: 35.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Case number PHHY2014US013932, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 513533) web site on 03 Feb 2014. This report refers to a 35-year-old male patient. His medical history included hypertension, seasonal allergies and asthma. On the 20 Oct 2013, he was vaccinated with FLUVIRIN (batch number: 13382P) intramuscularly in the right arm and with PNEUMOVAX (batch number: J004332) intramuscularly in the left arm. On 21 Oct 2013, he had a softball size swollen area with a knot in the center on his left arm, site was warm to the touch, had red streaks and bruising. He could not move his left arm at all for 3 days and had left arm soreness lasting for 7 days. He took bedfast for 72 hours. The patient had fever of not less than 103 degrees F for 72 hours after injection. It was reported that his fever persisted with acetaminophen treatment. The final outcome of the events reported as recovered. The seriousness and causality of the events were not reported.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain
Clinical narrative: Case number PHHY2014US013917 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 514050) on 03 Feb 2014. This report refers to a 23-years-old male patient. His medical history history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly in the left arm on 01 Nov 2013. On 01 Nov 2013, he had lower back pain. The back pain was severe and almost debilitating. He almost fell due to the pain while bending down. He did not lift anything heavy during the day and did not recall hurting back in any other way. The pain became better since date of injection and onset. It was reported that even after 2 weeks later the injection, his lower back still hurt though it was not as severe as before. The event outcome was reported as condition unchanged. The seriousness and causality of the event were not reported.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Case number PHHY2014US014107 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 514069) on 03 Feb 2014. This report refers to 47-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1308601) in the left arm on 24 Oct 2013. On the same day after vaccination, she had experienced pain shooting down arm to wrist, over her collar bone and up her neck. She went to emergency room. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Injected limb mobility decreased, Nausea, Pain in extremity
Clinical narrative: Case number PHHY2014US013948 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 514083) on 03 Feb 2014. This report refers to a 72-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1309301) intramuscularly in the left arm and PNEUMOVAX (other manufacturer, batch number: H022280) intramuscularly in the right arm on 19 Nov 2013. On 19 Nov 2013, four hours after vaccination, her right arm in which she received PNEUMOVAX hurt so bad and she could not life the arm. She was also nauseous and dizzy. Her left arm in which she received FLUVIRIN did not hurt. She stated that after vaccination, she did some yard work and thought that could have been the cause of her arm pain. The event outcome was reported as complete recovery. The seriousness and causality of the event were not reported.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2014US013996 is an initial spontaneous report received from a consumer via the vaccine adverse event reporting system (VAERS reference number: 514094) on 03 Feb 2014. This report refers to a 23-years-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 13394P) intramuscularly in the left arm on 30 Sep 2013. On 30 Sep 2013, he reported that the area where the shot was given turned to red and swollen and it felt hot to touch. The events lasted for about 4 days. The event outcome was reported as complete recovery. The seriousness and causality of the event were not reported.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Swelling
Clinical narrative: Case number PHHY2014US014015 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 514122) website on 03 Feb 2014. This case refers to a 30 year old female patient. Her concurrent conditions included intractable nausea and vomiting. On 26 Oct 2013, she was vaccinated with FLUVIRIN (batch number: 13393P) intramuscularly into her right arm and with PNEUMOVAX (other manufacturer, batch number: J001180) intramuscularly into her left arm in the second shift. On an unspecified date, she complained of pain in her deltoid and had swelling. No redness or heat was reported. The patient completely recovered from the events. The causality and seriousness of the events were not reported.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis, Pyrexia
Clinical narrative: Case number PHHY2014US016177 is an initial spontaneous report received from the vaccine event reporting system (VAERS reference number: 514207) on 03 Feb 2014. This report refers to 26-years-old female patient. Her medical history included Graves' disease and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: not reported) on an unknown date. It was reported that on an unknown date after vaccination, she experienced diaphoresis and low grade fever. The outcome, seriousness and causality of the events were not reported.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Rash
Clinical narrative: Case number PHHY2014US013928, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 514249) website on 03 Feb 2014. This report refers to a 57-year-old female patient. Past medical history included manu unspecified allergies, diabetes and hypotonia. This polymedicated patient was vaccinated with FLUVIRIN (batch number: 1309801) intramuscularly into the left arm on 19 Nov 2013. On the same day after vaccination, she experienced chills and rash. The final outcome of the events was reported as condition unchanged. The seriousness and causality of the events was not reported.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Burning sensation, Injection site erythema, Injection site induration, Pruritus
Clinical narrative: Case number PHHY2014US013976 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (reference number:514261) website on 03 Feb 2014. This report refers to a 32 year old female patient. Her current condition included allergy to latex and her concomitant medication was not reported. She had no illness at the time of vaccination. She was vaccinated with FLUVIRIN (batch number: 13392P) intramuscularly into left arm on 18 Nov 2013. It was reported that the vaccine was administered without wearing gloves due to latex allergy. On 20 Nov 2013, she complained about redness and hardness at site. She also had back pain. She felt as if her arm on fire and itching. She took BENADRYL tablets and felt better when followed up at 06:00 pm. The outcome of the events reported as complete recovery. The causality and seriousness of the events were not reported.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Immediate post-injection reaction, Induration, Swelling
Clinical narrative: Case number PHHY2014US014021, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 514357) website on 03 Feb 2014. This report refers to 29-year-old male patient. His medical history included asthma and his concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1310101) intramuscularly in the left arm on 13 Nov 2013. Immediately after withdrawal of needle, a large, dark, raised bruise appeared roughly 1/4 inch peak. After several minutes, the size decreased but it still remained raised and hard to touch. The event outcome was completely recovered. The seriousness and causality was not reported.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Feeling hot, Hyperhidrosis, Malaise
Clinical narrative: Case number PHHY2014US014105, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 514387) web site on 03 Feb 2014. This report refers to 65-year-old male patient. His medical history was not reported and his concomitant medications included omeprazole. He was vaccinated with FLUVIRIN (batch number: 13421P) and PNEUMOVAX (batch number: J004196) intramuscularly in the left arm on 19 Nov 2013. On the same day after vaccination, he experienced body aches, sweats, chills, feeling hot, localized erythema (left pectoral) and general malaise. He went to the clinic on 22 Nov 2013 and was prescribed TYLENOL and ibuprofen, take rest or monitor symptoms. All his vital signs were stable. The event outcome reported as was completely recovered. The seriousness and causality of the events were not reported.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain
Clinical narrative: Case number PHHY2014US014105, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 514387) web site on 03 Feb 2014. This report refers to 65-year-old male patient. His medical history was not reported and his concomitant medications included omeprazole. He was vaccinated with FLUVIRIN (batch number: 13421P) and PNEUMOVAX (batch number: J004196) intramuscularly in the left arm on 19 Nov 2013. On the same day after vaccination, he experienced body aches, sweats, chills, feeling hot, localized erythema (left pectoral) and general malaise. He went to the clinic on 22 Nov 2013 and was prescribed TYLENOL and ibuprofen, take rest or monitor symptoms. All his vital signs were stable. The event outcome reported as was completely recovered. The seriousness and causality of the events were not reported.
Sex: U
Vaccine: FLU3, PPV
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Case PHHY2014US013968 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 514406) website on 03 Feb 2014. This report refers to patient of unknown demographics. The patient's medical history was not reported. Concomitant medications included hydrochlorothiazide, amlodipine and simvastatin. The patient was vaccinated with FLUVIRIN (batch number: 1309701) intramuscularly into arm on 29 Oct 2013. On the same day, the patient was also vaccinated with PNEUMOVAX (batch number: J004332) intramuscularly on arm. On 31 Oct 2013, two days after vaccination, the patient experienced rash and some swelling at injection site. The patient presented herself to emergency room hospital. Outcome of the events was reported as recovered. Seriousness and causality of the events was not reported.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: Case number PHHY2014US014577 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 514500) website on 03 Feb 2014. This report refers to a 71-year-old female patient. Her medical history included allergy to Penicillin. Her vaccination history included administration of FLUVIRIN (batch number: unknown) the previous year in Sep 2012, but no reaction was reported following this administration and she went to work. This polymedicated patient was vaccinated with FLUVIRIN (batch number: 1309701) intramuscularly in to the left arm on 01 Nov 2013. On 21 Nov 2013, she developed itching on left arm that later spread to her entire body. Sometime later she also noticed hives. She took BENADRYL 50mg orally to treat the condition. This led to improvement in hives. Final outcome of the events was reported as complete recovery. No further information about seriousness and causality was reported.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Rash erythematous, Rash macular, Vomiting
Clinical narrative: Case number PHHY2014US014578 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 514577) web site on 03 Feb 2014. This report refers to a 42-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1309701) intramuscularly in to the left arm along with PNEUMOVAX (other manufacturer, batch number: H009826) intramuscularly in to the left arm on 01 Nov 2013. Approximately five hours after receiving the vaccines, she vomited for eight hours and developed fever for 24 hours. She also experienced red blotchy rash on arm from injection site to elbow. Final outcome of the events was reported as complete recovery. No further information about seriousness and causality was reported.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Case number PHHY2014US014506 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 514638) on 03 Feb 2014. This report refers to 66-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 13452P) intramuscularly in the left arm on 16 Nov 2013. On the same day after vaccination, she reported the minor pain day of shot which became progressively worse over the few days and pain was sharp and radiates upwards. She was visited to emergency room or doctor visit. The outcome of the event was reported as condition unchanged as of 25 Nov 2013. The seriousness and causality of the event were not reported. No additional information was available.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site scab
Clinical narrative: Case number PHHY2014US014503, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 514785) website on 03 Feb 2014. This report refers to a 71-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number 1308601) intramuscularly in the left arm on 01 Oct 2013. She came to pharmacy a month and half after vaccination and said that, her arm is still itchy site of administration and scratching so much as she had scabs (onset date was not reported). The final outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported. No additional information was available.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Case number PHHY2014US014520, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 514844) website on 03 Feb 2014, with the following internal review of the data received on 03 Feb 2014. This report refers to a 33-year-old female patient. Her medical history included unspecified autoimmune disease and concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 13394P) intramuscularly in the left arm on 26 Nov 2013. On the same day after vaccination, she experienced hives on chest and arms and complained of pruritus. The final outcome of the events was reported as completely recovery as of 27 Nov 2013. The seriousness and causality of the events were not reported. No additional information was available. Following internal review of the data received on 03 Feb 2014: The events hives and pruritus kept as separate diagnosis.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Headache, Lumbar puncture normal, Pyrexia
Clinical narrative: Case number PHHY2014US014674, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 514971) website on 03 Feb 2014. This report refers to a 48-year-old female patient. Her medical history included hypertension, diabetes type 2, hyperlipidemia, psoriasis and restless leg syndrome. Concomitant drugs included LIODERM, NORCO, PRINZIDE, LIPITOR and REQUIP. She was vaccinated with FLUVIRIN (batch number: 1308901), PNEUMOVAX (other manufacturer, batch number: J004747) in the right arm and ADACEL (other manufacturer, batch number: U4586AA) in the left arm, intramuscularly on 19 Nov 2013. On 20 Nov 2013, she experienced fever and headache. She visited the emergency room and underwent lumbar puncture spinal tap which showed negative result. The final outcome of the events reported as recovered. The seriousness and causality of the events were not reported.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Case number PHHY2014US014686, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 514982) web site on 03 Feb 2014. This report refers to a 78-year-old female patient. On 23 Nov 2013, she was vaccinated with FLUVIRIN (batch number: 1308201) in the left arm and with PNEUMOVAX (other manufacturer, batch number: H022280) in the right arm, intramuscularly. On 24 Nov 2013, she experienced soreness and pain at injection site. On 26 Nov 2013, she had red rash at injection site. She applied ice at the site and took Aspirin and ALEVE. It was reported that her pain was getting better and her rash was dissipating. The outcome of the event injection site redness reported as not recovered as of 27 Nov 2013. The seriousness and causality of the events were not reported.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Case number PHHY2014US014584 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 515020) on 03 Feb 2014. This report refers to 48-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 13435P) intramuscularly in the right upper arm on 06 Nov 2013. On an unspecified date in Nov2013, she had pain in her arm. She stated that the flu shot was administered in the middle of her upper arm (bicep/tricep area). The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Vaccination site pain
Clinical narrative: Case number PHHY2014US014587 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 515025) on 03 Feb 2014. This report refers to a 43-years-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 13443P) intramuscularly in the left arm on 28 Oct 2013. On 29 Oct 2013, he had pain close to vaccination site and it continued for a month. It was reported that he had reduced range of motion of the vaccinated limb and there was tenderness in the site when palpated. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site joint movement impairment, Injection site pain
Clinical narrative: Case number PHHY2014US014606 is an initial spontaneous report received from a consumer via the vaccine adverse event reporting system (VAERS reference number: 515135) on 03 Feb 2014. This report refers to a 54-years-old female patient. She did not have any medical history. Her concomitant medications were hydroxyzine, acyclovir, PROZAC and Levothyroid. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly in the left arm on 12 Nov 2013. On the same day her actual shot was little painful. The pain increased since the shot and she was experiencing substantial pain and loss of mobility in her left shoulder 17 days later. It was reported that the center of pain was vaccination site. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Inflammation, Pain in extremity
Clinical narrative: Case number PHHY2014US014621 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 515150) web site on 03 Feb 2014. This report refers to a 65-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1309201) and PNEUMOVAX (other manufacturer, batch number: J004747); both vaccines administered intramuscularly in the left arm on 16 Oct 2013. On 17 Oct 2013, his arm was red, sore and inflamed all over from upper shoulder to elbow. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Case number PHHY2014US014525 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 515194) website on 03 Feb 2014. This report refers to a 52-year-old female patient. Her medical history was not reported. Concomitant medication included ESTRACE. She was vaccinated with FLUVIRIN (batch number: 13375P) intramuscularly into left arm on 17 Nov 2013. On the same day, post vaccination, she experienced possible adverse reaction with FLUVIRIN. She describes the pain in the arm where she received the vaccination along the deltoid muscle where the shot was given. She states that the pain was severe and she had trouble lifting her arm. The pain has since subsided, but was not completely eliminated. Final outcome of the events was condition unchanged as of 01 Dec 2013. Seriousness and causality of the events was not reported.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: Case number PHHY2014US014527 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 515201) website on 03 Feb 2014. This report refers to a 23-year-old female patient. Her medical history and concomitant medications was not reported. She was vaccinated with FLUVIRIN (batch number: 13471P) into the left arm on 19 Nov 2013. Two days after vaccination, she experienced numbness radiating down arm (including fingers). Outcome of the events was condition unchanged as of 29 Nov 2013. Seriousness and causality of the events was not reported.