chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Inflammation, Pain, Swelling
Clinical narrative: Inflamed from shoulder to fingers. Swollen and painful. Required many doctors visits and shots.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Chills
Clinical narrative: Chills 2 hrs post vacc.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: Pain at injection site.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Hyperhidrosis, Immediate post-injection reaction
Clinical narrative: Diaphoresis and weakness immediately after receiving vaccine.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Headache, Presyncope
Clinical narrative: Near syncope, headache.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Nausea
Clinical narrative: Headache, nausea after 1432 shot.
Sex: F
Vaccine: MENB
Symptoms: Presyncope
Clinical narrative: Near syncope everything went black after vac.
Sex: U
Vaccine: MENB
Symptoms: Swelling
Clinical narrative: Swelling 10 min post injection.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Presyncope
Clinical narrative: Near syncope.
Age: 22.0
Sex: U
Vaccine: MENB
Symptoms: Presyncope
Clinical narrative: Near syncope.
Age: 20.0
Sex: M
Vaccine: MENB
Symptoms: Adverse drug reaction, Chills, Sluggishness
Clinical narrative: Rec'd vaccine - felt sluggish about 1 hour post vaccine, chills. Took a nap, then went to Health Center. Currently being tx for reaction to medication/BP.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Pain
Clinical narrative: She experienced pain level 9 out of 10. She took TYLENOL.
Age: 6.0
Sex: M
Vaccine: FLUX, VARCEL, FLUX, VARCEL
Symptoms: Headache, Migraine, Pain, Tonsillitis, Vomiting
Clinical narrative: My 6 year old received the flu shot and varicella vaccine after being repeatedly reminded by his public school that he had to have it to continue attending. Since receiving those vaccines (approx 7 weeks ago) he has been experiencing daily headaches, had 4 migraines causing vomiting and severe pain and contracted tonsillitis. Something is wrong with these vaccines when they make kids live in constant pain!
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Product quality issue
Clinical narrative: Nurse administering HPV vaccine noted that there was particulate matter in the syringe after drawing up the vaccine. The nurse discarded this syringe in the sharps container, but then used another vial from the same lot number. The new vial did not have any visual problems (no visible particulate matter), and the nurse injected this dose. Because particulate matter was noted in the first vial with the same lot number, the nurse should have used a different lot number.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Skin infection
Clinical narrative: After receiving ZOSTAVAX vaccine on 3/15/15, pt. developed swelling, tenderness, heat at site of injection. Pt. consulted with his MD, and MD diagnosed as skin infection and prescribed a course of antibiotics to treat.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No medical history and current conditions were reported. On an unknown date the patient was vaccinated with VAQTA (25/0.5) dose 1 (dose, lot number unknown) and the patient received a second dose of VAQTA 3 months after the initial dose of VAQTA. No adverse effects reported. No product quality complaint was involved. The outcome of the events was unknown. Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: (R) deltoid swelling with erythema without induration. Nontender palpation.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patient were vaccinated with improperly stored (Oka/Merck) VARIVAX (dose, route, lot number and expiration date were not reported). No co-suspect and concomitant therapies were reported. No adverse events reported. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Pain, Pyrexia, Tremor
Clinical narrative: The patient reported that about 12 hours after receiving PREVNAR (PCV13), she developed body aches, chills, fever, and "the shakes". These symptoms persist for 24-30 hours. Patient reported similar symptoms after her last tetanus shot.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Pt had a rash/hives itchiness.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Pt received ZOSTAVAX on 3/4/14 at pharmacy (R) arm. States 2-3 days later he developed shingles like rash. Presented to doctor's office today with scattered raised rash, shingles like covering entire (R) arm.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Big red spot at injection site Dr prescribed steroids and antibiotics.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt received vaccine on 3/9/15 - s/sx started occurring on 3/13/15 in (R) arm at injection site 5 x 5 cm area of redness. Erythema 8 x 10 cm and swelling at 3/16/15 appt for follow up.
Sex: U
Vaccine: MMR
Symptoms: Autism
Clinical narrative: This spontaneous report as received from a consumer refers to a child patient (also reported as friend of a friend's child) of unknown age. No information about medical history, concurrent conditions were reported for the patient. On an unknown date the patient was vaccinated with MMR II (dose strength, route unspecified). No concomitant therapy was reported. On an unknown date the patient experienced autism after receiving MMR II. The outcome of autism is unknown. No product quality complaint was involved. Additional information has been requested.
Age: 41.0
Sex: M
Vaccine: YF
Symptoms: Arthralgia, Diarrhoea, Dizziness, Headache, Hyperhidrosis
Clinical narrative: This 41 year old reported receipt of YF vaccine on Wed 3/11/2015. He was fine until Sat 3/14/2015 when he leaned over in car and felt nauseated, woozy-dizzy and onset of diffuse generalized headache as if "car sick". Later that day he developed a fever 100.3F (did check) with onset of watery brown diarrhea 2-3 times that day and vomited once about 6pm. He went to bed feeling achy with diffuse sweating. He awoke Sunday with generalized malaise, myalgia and arthralgia, headache easing and was able to take MOTRIN. He was able to hold down liquids and some bread sticks. This morning he reported to work feeling better but still achy, tired and not sure what he can/cannot eat. He researched online YF side effects and noted he was to report any n/v/d.
Age: 41.0
Sex: M
Vaccine: YF
Symptoms: Malaise, Motion sickness, Myalgia, Nausea, Pain
Clinical narrative: This 41 year old reported receipt of YF vaccine on Wed 3/11/2015. He was fine until Sat 3/14/2015 when he leaned over in car and felt nauseated, woozy-dizzy and onset of diffuse generalized headache as if "car sick". Later that day he developed a fever 100.3F (did check) with onset of watery brown diarrhea 2-3 times that day and vomited once about 6pm. He went to bed feeling achy with diffuse sweating. He awoke Sunday with generalized malaise, myalgia and arthralgia, headache easing and was able to take MOTRIN. He was able to hold down liquids and some bread sticks. This morning he reported to work feeling better but still achy, tired and not sure what he can/cannot eat. He researched online YF side effects and noted he was to report any n/v/d.
Age: 41.0
Sex: M
Vaccine: YF
Symptoms: Pyrexia, Vomiting
Clinical narrative: This 41 year old reported receipt of YF vaccine on Wed 3/11/2015. He was fine until Sat 3/14/2015 when he leaned over in car and felt nauseated, woozy-dizzy and onset of diffuse generalized headache as if "car sick". Later that day he developed a fever 100.3F (did check) with onset of watery brown diarrhea 2-3 times that day and vomited once about 6pm. He went to bed feeling achy with diffuse sweating. He awoke Sunday with generalized malaise, myalgia and arthralgia, headache easing and was able to take MOTRIN. He was able to hold down liquids and some bread sticks. This morning he reported to work feeling better but still achy, tired and not sure what he can/cannot eat. He researched online YF side effects and noted he was to report any n/v/d.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Information regarding concurrent conditions and medical history was not provided. On an unknown dates the patients were vaccinated with doses of M-M-R II that underwent a supported temperature excursion (dose, dose number, lot #, route and application sure were not reported). Concomitant therapy was not reported. No adverse experiences reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date an unspecified number of patients received improperly stored (Oka/Merck) VARIVAX (route, dose, frequency and lot # not reported). No adverse effects were reported. Additional information has been requested.
Age: 22.0
Sex: M
Vaccine: MENB
Symptoms: Blood alkaline phosphatase normal, Blood bilirubin unconjugated increased, Blood lactate dehydrogenase normal, Full blood count normal, Haptoglobin normal
Clinical narrative: Increased indirect bili 9; nl LFTs, nl haptoglobin, (-) sx except mild nausea after vaccine.  (-) pnh, (-) known dydbilirubinemias
Age: 22.0
Sex: M
Vaccine: MENB
Symptoms: Liver function test normal, Nausea
Clinical narrative: Increased indirect bili 9; nl LFTs, nl haptoglobin, (-) sx except mild nausea after vaccine.  (-) pnh, (-) known dydbilirubinemias
Sex: F
Vaccine: MENB
Symptoms: Myalgia, Nausea
Clinical narrative: Myalgia and nausea.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Pruritus, Skin warm
Clinical narrative: Pt states normal pain for about 4 days then started with itching and small red spot. Then redness spread and continued to itch and was warm to touch on day 5-6. Pt was treated with KEFLEX 500 for possible cellulitis said she is traveling.
Age: 20.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Injection site induration, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Patient became aware of firm, oval shaped lump in (R) arm subq fat. area upon awakening. The area increase 2 x's in size with increased warmth and tenderness. By mid afternoon sought care at walk-in clinic, and was referred to hospital. No tx.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: Erythematous skin reaction around site of injection on left arm.
Age: 40.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous prospective pregnancy report was received from a health professional refers to a 40 year old female patient. Patient's pertinent medical history and drug reactions were not reported. Patient was reported to be 34 weeks pregnant. The patient became pregnant with LMP of 08-JUL-2014 and EDD of 14-APR-2015. On 09-MAR-2015 the patient received a dose of GARDASIL (lot # K011492, expiry date: 22-JUN-2016), in error. Concomitant medications were not reported. The patient was prescribed to receive a Tdap vaccine on an unspecified date. The health professional stated that the error was not due to medication confusion, the error was human error. No adverse effect has been reported. No product quality complaint (PQC) was involved. Outcome of the event was unknown. Causality assessment was not provided. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive
Clinical narrative: This spontaneous report as received from a Physician assistant refers to a 24 year old female patient. Medical history, drug allergies and concurrent conditions were unspecified. On an unknown dates the patient was vaccinated with GARDASIL (also reported as manufacturer unkonwn and could not be ruled out) 1st and 2nd dose (strength, dose, route and lot number were unspecified) for an unknown indication when she was in high school. On an unspecified date, the patient was seen at the medical office and stated that she tested positive for an HPV type, but she did not know which one. No treatment was given. No product quality complaint (PQC) was involved. The outcome of event was unknown. Reporter causality assessment was not provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy reprot as received from a female patient of unknown age, refers to herself. On an unknown date, the patient was vaccinated with a dose of GARDASIL dose, route, lot# and expiration date were not reported. Later, on an unknown date, she found out that she was pregnant. The last menstrual period (LMP) and estimated delivery date (EDD) were not known. The pregnancy outcome was outcome pending. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to multiple individual patients of unknown demographics. No concurrent conditions or medical history were provided. On unknown dates, those patients were vaccinated with doses of ZOSTAVAX injection (strength, dose, route of administration, lot# and expiry date unspecified). No concomitant medications were reported. The pharmacist reported that an anonymous individual heard of a physician who had seen that multiple individual patients got the shingles after getting ZOSTAVAX. The outcome of shingles was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of unspecified patients of unknown age and gender. Information regarding concurrent conditions and medical history was not provided. On unknown dates the patients were vaccinated with doses of PROQUAD (Merck) that underwent a supported temperature excursion, (dose, dose number, lot #, route and application site were not reported) (incorrect product storage). Concomitant therapy was not reported. No adverse experiences reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of unspecified patients of unknown age and gender. Information regarding concurrent conditions and medical history was not provided. On unknown date the patients were vaccinated with (Oka/Merck) VARIVAX that underwent a supported temperature excursion (dose, dose number, lot #, route and application site were not reported). Concomitant therapy was not reported. No adverse experiences reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to 7 patients of unknown age and gender. On an unknown date the patents were vaccinated with PROQUAD (Merck), which was stored improperly. No adverse effects were reported. No product quality complaint was involved. The outcome of the events was unknown. No further information was provided. This case is linked to MARRS # 1503USA008748 with the same reporter link. 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 nurse refers to 7 patients of unknown age and gender. On an unknown date the patients were vaccinated with VARIVAX (Merck), which was stored improperly. No adverse effects were reported. No product quality complaint was involved. The outcome of the events was unknown. No further information was provided. This case is linked to MARRS # 1503USA008611 with the same reporter link. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a health care worker refers to 27 patients of unknown age and gender. On an unknown date the patients were vaccinated with (Oka/Merck) VARIVAX (dose, lot and route was unknown), which was improperly stored. No adverse effects were reported. The outcome of the events was unknown. This case is linked to MARRS# 1503USA008726 with the same reporter link. No further information was provided. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: Information has been received from a registered nurse referring to an approximately 19 year old female patient. The patient's medical history included eczema. On 22-MAY-1995, 29-JUN-1995 and 23-JAN-1997 the patient was vaccinated with the first, second and third dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (dose, route and lot# was not reported) for Hepatitis B respectively. Concomitant therapies included ELOCON. The nurse reported that the patient had negative titers for Hepatitis B at this time, approximately in 2015. She received a 0.5 mL dose of RECOMBIVAX HB (route and lot # not reported) on 17-FEB-2015 as the first dose in another Hepatitis B vaccination series for treatment for her negative Hepatitis B titers. The nurse stated that the patient was healthy, and the reason her titers were tested was for entry into nursing school. It was unknown if the patient sought medical attention or not. At the time of report, the status of patient was unknown. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a health care worker refers to 27 patients of unknown age and gender. On an unknown date the patients were vaccinated with PROQUAD (Merck) (dose, lot and route was unknown), which was improperly stored. No adverse effects were reported. The outcome of the events was unknown. This case is linked to MARRS# 1503USA007828 with the same reporter link. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a healthcare worker (certified medical assistant) referring to an adult patient of unknown age and gender. On an unknown date the patient started to vaccinate with M-M-R II (dose, frequency, route and lot# were not reported). So far the patient had received 3 doses of M-M-R II (extra dose administered). No adverse effects were reported. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a 12 month old patient of unknown gender. Patient's medical history, concurrent condition and concomitant therapy were not provided. On 13-MAR-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck), 0.5 ml (lot# and expiration date unspecified, frequency reported as once), subcutaneously (incorrect product storage). No adverse effect was reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Diarrhoea, Fatigue, Feeling hot, Headache
Clinical narrative: Information has been received from a 62 year old female patient concerning himself with drug reactions/allergies to KEFLEX. The patient had cyst behind left ear cut out by dermatologist on 25-FEB-2015. On 26-FEB-2015 the patient was vaccinated with a dose of ZOSTAVAX per injection (strength, dose and lot# were not reported). Concomitant therapies included WELLBUTRIN, XANAX, AMBIEN and SEROQUEL. The next day after the patient got the vaccine (on 27-FEB-2015) the patient had headache. The headache went away after the patient took headache medicine on unspecified date. The patient felt hot, feverish but she did not have a fever. She reported that the back of her neck was hot. The patient also felt weaker and weaker, sorer and sorer. The patient added that she also had diarrhea, and was in a "crummy mood". The patient got exhausted. The patient went to grocery store on last night (on approximately 05-MAR-2015) and asked a pharmacy to take her temperature but was told she needed to see her doctor. The patient also reported that the first pharmacy said ZOSTAVAX needed to be at room temperature but where she got ZOSTAVAX they took out of fridge and gave it to her. The patient wondered if that was caused what she was having. There was no lab diagnostics studies performed. The outcome of the events (except from headache) was not reported. The causality was not reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Mood altered, Pain, Pyrexia
Clinical narrative: Information has been received from a 62 year old female patient concerning himself with drug reactions/allergies to KEFLEX. The patient had cyst behind left ear cut out by dermatologist on 25-FEB-2015. On 26-FEB-2015 the patient was vaccinated with a dose of ZOSTAVAX per injection (strength, dose and lot# were not reported). Concomitant therapies included WELLBUTRIN, XANAX, AMBIEN and SEROQUEL. The next day after the patient got the vaccine (on 27-FEB-2015) the patient had headache. The headache went away after the patient took headache medicine on unspecified date. The patient felt hot, feverish but she did not have a fever. She reported that the back of her neck was hot. The patient also felt weaker and weaker, sorer and sorer. The patient added that she also had diarrhea, and was in a "crummy mood". The patient got exhausted. The patient went to grocery store on last night (on approximately 05-MAR-2015) and asked a pharmacy to take her temperature but was told she needed to see her doctor. The patient also reported that the first pharmacy said ZOSTAVAX needed to be at room temperature but where she got ZOSTAVAX they took out of fridge and gave it to her. The patient wondered if that was caused what she was having. There was no lab diagnostics studies performed. The outcome of the events (except from headache) was not reported. The causality was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a consumer regarding her daughter refers to a female patient of unknown age. No information about medical history, concurrent conditions were reported for the patient. On an unknown date in September 2013 the patient was vaccinated with first dose of GARDASIL (dose strength, route unspecified). The patient then received her second dose of the GARDASIL on an unknown date in September 2014 and third dose on 27-JAN-2015 (Inappropriate schedule of drug administration). The outcome of event reported is unkown. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a patient of unknown age and gender. No information about medical history, concurrent conditions were reported for the patient. On 13-MAR-2015 the patient was vaccinated with MMR II lot # H017435, 0.5 ml, subcutaneously that expired on 20-SEP-2014. The reporter stated that dose was supported by the patient. No adverse experience reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: On 3/13/15, mother reports RD has a red lump the size of a golf ball. Instructed to apply ice pack to site an give ibuprofen (pt allergic to TYLENOL). Also can give BENADRYL. If site worsens, go to nearest urgent care.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a patient of unknown age and gender. On 16-MAR-2015 the patient was vaccinated with ZOSTAVAX (lot # K003599, Expiry: 13-MAR-2015, 0.65 ml, subcutaneous) which was expired on 03-MAR-2015. No adverse effects reported. No product quality complaint was involved. The outcome of the events was unknown. No further information was provided. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 16Mar15 patient reported to work area to show reaction to injection site on left arm (deltoid area). Large/red/raised area noted (2.5 x 3.5). Patient reported rxn started approx Saturday (3/14/15) night after injections. BENADRYL taken. Patient instructed to report to local hospital for evaluation. Patient en route for evaluation. Updated MEDPROS "MR".
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Nausea, Pyrexia
Clinical narrative: Day after vaccination fever 99.1, nausea, dizziness, questionable vasovagal RXN.
Age: 18.0
Sex: U
Vaccine: UNK
Symptoms: Chills, Headache
Clinical narrative: Headache, chills.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Muscle tightness
Clinical narrative: This spontaneous report as received from the patient's grandfather refers to a 1 year old female patient with no allergies or drug reactions history. On 13-MAR-2015, the patient was vaccinated with a dose of MMR II, subcutaneous (dose, lot # and expiration date were not provided). On 13-MAR-2015, the patient experienced muscle tightness. At the time of the report the outcome of muscle tightness was reported as recovered. The patient subsequently experienced an underdose while she was vaccinated with (Oka/Merck) VARIVAX (MARRS 1503USA008473). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Headache, Myalgia, Nasal congestion
Clinical narrative: Dizzy, myalgias, H/A, stuffy nose resolved after 24 hrs. No flu shot.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Presyncope
Clinical narrative: Near syncope.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: Pain at injection site.
Age: 19.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Blood glucose decreased, Headache, Nausea, Vomiting
Clinical narrative: Nausea and vomited 10 min after injection B.S. 55 given 8 oz. Gatorade and pretzels. B.S. increased 115 and discharge. Vomited x2 after returning dorm room. Came to be seen after last episode vomit. Frontal HA. No fever. Felt weak slept for 2 hours in health center - felt better. 16 oz Gatorade feeling well.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Pyrexia
Clinical narrative: Fever, headache.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Decreased appetite, Pyrexia
Clinical narrative: Loss of appetite, fever 102.9.
Age: 20.0
Sex: M
Vaccine: UNK
Symptoms: Cough, Headache, Nausea, Pyrexia
Clinical narrative: H/A, nausea, fever, cough, temp 97.8. Supportive care.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Decreased appetite, Headache, Nausea
Clinical narrative: Headache, nausea, loss of appetite, chills.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Arm swelling, redness - rec cold compress.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: (L) arm swelling, redness, pain rec. cold compress and TYLENOL.
Age: 21.0
Sex: F
Vaccine: UNK
Symptoms: Rash macular
Clinical narrative: Macular rash abdomen and neck. (+) pruritic given BENADRYL 50mg Q 6 prn.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, erythema, pain at injection site.
Sex: U
Vaccine: HPV4
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 gender and age. Information about the patients' medical history and concurrent condition was not provided. On an unknown date, the patients were vaccinated with doses of GARDASIL injection (lot/batch#, expiration dates, dose, dose numbers and route of administration were not reported) that were improperly stored. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same source. 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 certified medical assistant refers to an unspecified number of patients of unknown gender and age. Information about the patient's medical history and concurrent condition was not provided. On an unknown date, the patients were vaccinated with doses of (Oka/Merck) VARIVAX (lot/batch#, expiration dates, dose, dose numbers and route of administration were not reported) that were improperly stored. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant 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 unknown date, the patients were vaccinated with doses od M-M-R II (lot/batch#, expiration dates, dose and dose numbers were not reported) that were improperly stored. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information has been requested.
Age: 1.45
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash, Rash vesicular
Clinical narrative: Within 5 minutes, developed herpetic non-blanching rash bilateral face. No other sx.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Visiting Nurse referring to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On unknown date the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (lot # K003405, expiration date: 06-MAR-2016). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Visiting Nurse referring to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 03-MAR-2015 the patient was vaccinated with one dose of VARIVAX (Merck) (lot # K002043, expiration date: 17-03-2015). This vaccine had been previously exposed to both supported excursion and defrosts cycling at various times. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: UNK
Symptoms: Visual impairment
Clinical narrative: Visual changes - seeing neurologist (-) optometrist appt.
Age: 27.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse referring to a 27 year old patient of unknown gender. On 11-MAR-2015 the patient was supposed to receive the second dose of VARIVAX (Merck) but instead received a dose of ZOSTAVAX (subcutaneous, lot# and dose were not reported). No symptoms were reported. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: (L) arm pain, erythema, swelling at injection site. Rec: cold compren and TYLENOL.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Blood glucose decreased, Presyncope
Clinical narrative: Near syncope/low glucose/post vacc.
Age: 21.0
Sex: F
Vaccine: UNK
Symptoms: Crying, Dizziness, Hyperventilation, Immediate post-injection reaction, Injection site pain
Clinical narrative: Pain at injection site immediately. Went to library - 12 in library felt shaky, crying, ht racing, lightheaded and hyperventilating upon arrival. Rested 1/2 hour - given Gatorade and felt better.
Age: 21.0
Sex: F
Vaccine: UNK
Symptoms: Nervousness, Palpitations
Clinical narrative: Pain at injection site immediately. Went to library - 12 in library felt shaky, crying, ht racing, lightheaded and hyperventilating upon arrival. Rested 1/2 hour - given Gatorade and felt better.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Nausea, Presyncope
Clinical narrative: Near syncope, nausea dizziness.
Age: 21.0
Sex: M
Vaccine: MENB
Symptoms: Feeling abnormal
Clinical narrative: Shot at 1215 throat/tongue fell funny.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling/redness/pain at injection site.
Age: 22.0
Sex: U
Vaccine: MENB
Symptoms: Loss of consciousness
Clinical narrative: ? LOC witness by friends.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age. On an unknown date the patient was in an unspecified pharmacy at an unspecified location and was vaccinated in armpit with a dose of ZOSTAVAX (lot# and dose not reported). No adverse experience was reported. 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 pharmacist refers to a patient of unknown demographics. The pertinent medical history and the concomitant medications were not reported. On 17-MAR-2015 (reported as today) the patient was vaccinated with ZOSTAVAX, (Lot# 003596), 0.65 ml, subcutaneously which was expired on 12-MAR-2015. It was reported that the dose was supported. No adverse event was reported. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to 5 patients of unknown age and gender. Information about current condition or medical history was not reported. On an unspecified date the 5 patients received improperly stored (Oka/Merck) VARIVAX (lot#, dose, route not reported). No adverse effects were 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 registered nurse referring to unspecified patients of unknown ages and genders. On 26-FEB-2015 the patients was vaccinated with doses of VARIVAX (Merck) (subcutaneous, lot#, expiration date, dose were not known), which underwent a supported temperature excursion. No adverse effects reported. It was unspecified if the patients sought for medical attention. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a health professional (healthcare worker) concerning unspecified number of patients. Healthcare worker reported that 7 doses of improperly stored VARIVAX (Merck) (0.5 ml, strength and lot# were not reported, subcutaneous) had been administered to patients. No adverse events were reported. Additional information is not expected because the reporter do not want to be contacted.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients. From 28-FEB-2015 to 11-MAR-2015, the multiple unspecified patients were vaccinated with 0.5ml dose of PROQUAD (Merck) which post supported temperature excursion(s) (lot# and expiration date not provided), subcutaneously. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a patient of unknown age and gender. On 11-MAR-2015, the patient received an unspecified dose of GARDASIL (0.5 ml, lot# were not reported) intramuscularly in the gluteal region (vaccine administered at inappropriate site). No adverse effects were reported. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Clonus, Pallor
Clinical narrative: This spontaneous report as received from a physician via company representative, refers to a 11 year old male patient without concurrent conditions or pertinent medical history. On 09-MAR-2015 the patient was vaccinated with the first dose of GARDASIL injection, lot # K006960, expiration date in February 2017. (Dosage and route were not reported). Concomitant therapies included Tdap (unspecified), tetanus toxoid (manufacturer unknown) administered on the same date. The physician informed that on 09-MAR-2015, the patient experienced a pallor, reported as "turned white" and had clonic movements. Also stated that the patient did not have a full syncope. The patient was told to lie down and was given water, after that he was able to walk out of the office 5 minutes after the events. It was unspecified if the patient will continue the therapy with GARDASIL. There were not laboratories diagnostic performed. The outcome of pallor was unknown while the outcome of tonic clonic movements was recovered on 09-MAR-2015. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Inflammation, Injection site erythema, Injection site inflammation, Skin warm
Clinical narrative: Redness and inflammation at site of injection and radiated to lower arm, warm to touch.
Age: 11.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Meningococcal given 3/16/2015, symptoms started 3/17/2015. Pt here today 3/18/15 c/o redness, warmth, indurated and nonfluctuant to (L) deltoid. Approx 12cm x 14cm.
Age: 11.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Cellulitis
Clinical narrative: Meningococcal given 3/16/2015, symptoms started 3/17/2015. Pt here today 3/18/15 c/o redness, warmth, indurated and nonfluctuant to (L) deltoid. Approx 12cm x 14cm.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis 9 cm x 6 cm surrounding vaccine sites on (L) thigh.
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: Pain, redness and itching.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Fever to 103 degrees, body aches, nausea started < 24 hours later. Pt seen 2 dy later. Advised to use TYLENOL, fluids, rest.
Age: 1.33
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Erythema, Local reaction, Skin warm
Clinical narrative: 2cm red, warm localized reaction.
Age: 65.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Painful, red, swelling at injection site (left deltoid) warm to touch - spreading down left arm. Placed on antibiotic instructed to return if no improvement or worsens. Instructed to come in Friday to see nurse for assessment.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Vaccine received 3/13/15. Sore on 3/13/15. On morning of 3/14/15 was red and swollen. Continued to spread daily - pain intensifying as swelling increases. On 3/18/15 has red roundish swollen area 3x4" and painful.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Dark pink, tenderness, slight induration 3.5 inches x 2.5 inches at site. Tx: Prednisone, ice/heat compresses.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Inflammation, Pain in extremity, Pyrexia
Clinical narrative: Case number PHHY2015US016401 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 549700) on 03 Feb 2015 and with follow up information received from the quality assurance department (QA reference number: 352865) on 19 Feb 2015, with the follow-up information received from Quality Assurance Department (reference number: 352865) on 18 Mar 2015. This report refers to a 59 years old female patient. She had no personal history of atypical moles or skin cancer including melanoma. Her medical history included glaucoma, migraines, knee pain, herpes zoster-involving ophthalmic nerve and thyroid cyst. Her current conditions were idiopathic leukocytoclastic vasculitis, mild intermittent asthma, hypertension, depression, high cholesterol, GERD (gastroesophageal reflux disease), nonalcoholic fatty liver, hyperparathyroidism unspecified and osteopenia. Her concomitant medications were NORCO, NORVASC, furosemide, potassium chloride, ondansetron, amoxicillin-clavulanate, Zolpidem tartrate, AVAPRO, famciclovir, clonidine, ALPHAGAN, COSOPT, LOTEMAX, TRAVATAN, calcium carbonate, Vitamin D, folic acid and methotrexate. She was vaccinated with FLUVIRIN (batch number: 1410801) and PNEUMOVAX (other manufacturer, batch number: J009833); both vaccines administered intramuscularly on 12 Oct 2014. On 13 Oct 2014, she experienced cellulitis, pain and inflammation of left arm and fever. She went to emergency room for treatment. The events outcome was unknown. The events were reported as non-serious, but the event cellulitis was upgraded as medically significant based on the information available in the NVS-IME list. The causality of the events was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1410801) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (QA reference number: 352865) on 19 Feb 2015: Updated QA reference number. Follow-up information received from the Quality Assurance Department (reference number: 352865) on 18 Mar 2015: Updated FLUVIRIN batch review report.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Infection, Pyrexia
Clinical narrative: Case number PHHY2015US017324, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 551297) website on 03 Feb 2015 and with follow up information received from the quality assurance department (QA reference number: 352579) on 18 Feb 2015, with the follow-up information received from Quality Assurance Department (reference number: 352579) on 17 Mar 2015. This report refers to a 69-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: 14584P) into the left arm along with PNEUMOVAX (batch number: K009876) into the left arm intramuscularly on 22 Oct 2014. On the same day after vaccination, the patient developed red ring of about 3-4 inches out, fever with a body temperature of 105. She went to a doctor and the doctor said that the patient was infected. It was reported that the patient remembers the vaccinator using gloves and swabbing. The final outcome of the events was recovered. The events were reported as non-serious. The event 'infected' was internally upgraded as medically significant based on the information available in the source document. The reporter considered the event to be suspected to PNEUMOVAX and causality for FLUVIRIN was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 14584P) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (QA reference number: 352579) on 18 Feb 2015: Updated QA reference number. Follow-up information received from the Quality Assurance Department (reference number: 352579) on 17 Mar 2015: Updated FLUVIRIN batch review report.
Age: 11.0
Sex: M
Vaccine: FLUN4, HPV4, MNQ
Symptoms: Cellulitis, Erythema, Induration, Injection site swelling, Rash
Clinical narrative: Case number PHHY2015US018594, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 551544) website on 03 Feb 2015 and with follow up information received from the quality assurance department (QA reference number: 352397) on 17 Feb 2015, with the follow-up information received from Quality Assurance Department (reference number: 352397) on 17 Mar 2015. This report refers to a 11-year-old male patient. It was reported that as per his mother the patient had no medical history and did not receive any concomitant medications. On 07 Oct 2014, he was vaccinated with MENVEO (batch number: M14021 and expiry date: Jul 2015) intramuscularly in the left arm along with FLUMIST QUADRIVALENT (other manufacturer, batch number: CH2063) intranasally and GARDASIL (other manufacturer, batch number: J010668) intramuscularly in the left arm. On the same date, after vaccination he experienced redness, rash, warm area which was hard to touch. His mother applied ice pack and gave BENADRYL prior to bed. On 08 Oct 2014, his mother noticed 3 inches of left arm swelling, above elbow to shoulder at site of injections. On 09 Oct 2014, his redness, hard to touch and warmth remained same, but his rash was spreading. The patient was taken to emergency care on the same date and he was diagnosed with cellulitis. He received KEFLEX and stated that if he did not recover in 2 days, he was recommended to be taken to the emergency room for intravenous antibiotics. The final outcome of the events was unknown. The events reported as non-serious. The causality of the events was not reported. Seriousness assessment of the events (cellulitis and its symptoms) was upgraded based on the available information in the source document. Based on the investigation performed, the QA department stated that, MENVEO (batch number: M14021) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (QA reference number: 352397) on 17 Feb 2015: Updated QA reference number. Follow-up information received from the Quality Assurance Department (reference number: 352397) on 17 Mar 2015: Updated MENVEO batch review report.