chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Patient states that her flu shot was painful upon administration and that her pain level over past 2 weeks has been a 7 out of 10 on pain scale. She states her doctor's office suggested ALEVE OTC and to make an appointment if pain persists. Patient also states that her left arm (flu-shot arm) has sharp pain shoots down to elbow and she cannot lift if more than half way and cannot unhook her bra. She never expressed this amount of pain at administration or previously.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema peripheral, Rash
Clinical narrative: Within half hour of receiving vaccine I developed rash as well as my arm swelling. I took some BENADRYL - swelling went down & arm was normal by next day.
Age: 66.0
Sex: U
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Patient reports muscle aches for 2 weeks after flu shot.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral
Clinical narrative: Severe swelling of right arm.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Pt received IM injection of FLUZONE on 11/12/12. On 11/?/12 pt reported a red 1/2 inch circle on arm, was warm to touch and sore.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Fall, Feeling hot, Insomnia, Pain, Pyrexia
Clinical narrative: 2 hours after receiving vaccine - pt started feeling warm and achy all over - fever of 101.9 degrees F couldn't sleep all night. Patient took MOTRIN & drank ginger ale. She fell in the house. She saw her doctor 6 days and fell in the office. She's feeling better now.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Heart rate increased
Clinical narrative: Patient complained about increase in heart rate. I called paramedics. (911). Vital signs were normal.
Age: 52.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Aphonia, Pain, Pyrexia
Clinical narrative: High fever and much pain, lost of voice: voice has only partially returned...
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Pruritus, Rhinorrhoea, Swelling face
Clinical narrative: 2 hrs after vax admin her face began to swell & itch. Also difficulty sleeping a few days. Also clear runny nose. No neuro or resp sxs. Has similar reaction to flu vax yearly; no reaction to other vax. Still itchy face 4 days later.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: (L) arm red/swollen/painful. Lump at site of KINRIX. Fever 103 degrees.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site vesicles, Oedema peripheral, Pain in extremity
Clinical narrative: Swelling & soreness of (R) arm starting evening after vaccination, resolved to minimal soreness by 11/9. Blister type presentation around injection site, filled w/ clear fluid - referred to physician no redness.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pruritus, Ocular hyperaemia
Clinical narrative: Complained of itchy bloodshot eyes 2 hours after vaccine administration. Had symptoms throughout evening. Next morning, symptoms were resolved.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Abnormal behaviour, Diarrhoea, Feeling of body temperature change, Malaise, Pain in extremity
Clinical narrative: 3 hours later, became "violently ill", "bones ached", arm very sore/ diarrhea/ vomiting on 11-6-2012 until 2pm 11-7-2012. Also reported "hot & cold "feeling.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: 3 hours later, became "violently ill", "bones ached", arm very sore/ diarrhea/ vomiting on 11-6-2012 until 2pm 11-7-2012. Also reported "hot & cold "feeling.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Musculoskeletal pain, Neck pain
Clinical narrative: Pain began in shoulders of both arms and spread to neck, back and shoulder blades. NSAIDs helped a little, but condition very painful.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Condition aggravated, Migraine, Rash
Clinical narrative: 11/13/12 Migraine lasting approx 9 hours after receiving flu vaccine using 2 step method. 11/14/12 Describes 4 asthma attacks through night requiring inhaler and rash around neck.
Sex: F
Vaccine: FLU3
Symptoms: Muscle spasms, Vomiting
Clinical narrative: Vomiting, spasm.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: Pt started 11/7/12 with small quarter-sized lump at injection site-arm itched some with mild redness noted per pt.
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Pain, redness, and swelling in left arm lasting 4 days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Pain, Rash erythematous, Rash generalised, Rash vesicular
Clinical narrative: Rash on tiny red vesicles from sacrum to (L) buttock down to (L) calf & (L) foot. Very painful, numbness in (L) foot. Toes still painful to touch, & numbness in toes.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Rash on tiny red vesicles from sacrum to (L) buttock down to (L) calf & (L) foot. Very painful, numbness in (L) foot. Toes still painful to touch, & numbness in toes.
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Injected limb mobility decreased, Oedema peripheral, Pain
Clinical narrative: Pain in lower front armpit. When raising arm lower edge of scapula tender. A little swollen in front. Place where shot given doesn't hurt moving arm front to back make breast side of arm hurt.
Age: 79.0
Sex: F
Vaccine: UNK
Symptoms: Syncope
Clinical narrative: Syncope episode past 3 years within 3 days of receiving shot.
Age: 1.13
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash maculo-papular
Clinical narrative: Began 11/4/12 - 3-4 maculopapular lesions on nape of neck. Multiple maculopapular lesions scattered on chest. Excoriated maculopapules present on legs.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Adverse event
Clinical narrative: Pt. got vaccine on 10/31 but did not notice rash or redness until 11/6. Pt. saw Dr and Dr said pt. had rxn but wouldn't give pt. a steroid because pt. can't take steroids. Dr recommended pt. watch site and as of 11/14 its almost gone.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Pt. got vaccine on 10/31 but did not notice rash or redness until 11/6. Pt. saw Dr and Dr said pt. had rxn but wouldn't give pt. a steroid because pt. can't take steroids. Dr recommended pt. watch site and as of 11/14 its almost gone.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. The patient was vaccinated with the second dose of GARDASIL (lot number not provided) on 01-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. The patient received the first dose of GARDASIL many years ago and the second dose on 01-NOV-2012. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Hypotonia, Mobility decreased
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a female patient of unknown age who was not pregnant. The patient was vaccinated with first dose of GARDASIL (lot number, dose, route, site not reported) on an unknown date and the second dose on 08-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. The patient could not move her arm and felt "flaccid" after receiving the second dose of GARDASIL on 08-NOV-2012. The patient had a mild reaction when she received the first dose in the past (date unspecified). The patient saw a nurse practitioner for medical attention. No treatment was given. No laboratory studies were performed. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant. It was reported that an unknown number of patients might have received GARDASIL (lot# unspecified) that had been improperly stored. The exact number and identities of the patients were not known at the time of the report. No adverse effects reported. The outcome of the event was unknown. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Dysaesthesia, Muscle twitching
Clinical narrative: Pt received Tdap vaccine 11/1/12. Approx 1 week later developed muscle twitching in arms, thighs, face and disethesias (cold sensations).
Age: 1.3
Sex: U
Vaccine: MMR, MMRV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 15 months old patient of unknown gender. On 12-NOV-2012, the patient was vaccinated with dose 1 M-M-R II (dose, route and lot # not reported). Secondary suspect therapy included on 12-NOV-2012, dose 1 PROQUAD (Merck) (dose, route and lot # not reported). No concomitant medications were reported. The nurse stated that there was no adverse symptoms. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV2
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a physician, via a sales representative, and described the occurrence of swelling injection site in a 22-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline).  On 20 August 2012 in the "pm", the subject received 3rd dose of CERVARIX .5 ml, unknown route, right arm). On 20 August 2012 in the "pm", less than one day after vaccination with CERVARIX, the subject experienced swelling injection site and injection site redness. The swelling at vaccination site was "the size of a golf ball". At the time of reporting the outcome of the events was unspecified. Follow-up information was received on 18 September 2012 via healthcare professional who provided no additional information.
Age: 25.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pyrexia
Clinical narrative: Pt has pneumonia vaccine on 10/19/12. Pt went to ED on 10/21/12 after redness/swelling of arm and fever of 103.2.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Asthma, Chest X-ray, Wheezing
Clinical narrative: Pt came in with fly to have imm. administered with no c/o Imm. given with no problems. Fly. left prior to 20 mins but returned stating pt having asthma attack. Pt. wheezing with retractions noted. BP 110/70. Referred ER ASAP.
Age: 18.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Vaccination complication
Clinical narrative: Pain, swelling, redness, tender to touch to the (L) upper dorsal arm at 9:15 am.
Age: 1.14
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Injection site induration, Injection site swelling, Injection site warmth, Somnolence
Clinical narrative: Quarter size, hard, swollen area on upper left thigh states temperature to area is same to surrounding skin-warm. States no change in behavior noted other than increased drowsiness.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash, Skin warm
Clinical narrative: 1 inch x 3 inch raised, painful, heated. Treated with NSAIDS. Resolved in 1 weeks.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Back disorder, Burning sensation, Vaccination complication
Clinical narrative: Pt came in today (11/6/12) and explained she thinks she got a rxn from shingles vaccine. She received vaccine on 8/29/12 and for 6 weeks after her back was reg & "Burned up". Went to md office (for another problem) and asked about rxn but md did not do anything.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Malaise, Pain, Pyrexia
Clinical narrative: I started to feel headachy, feverish & over all malaise within 2 hors of vaccine. By 7pm my temp increased to 102 degrees - for more than 24 hrs - body aching terribly for 48 hrs+. Temp 100.2 at 50 hour post vaccine time despite analgesic.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient received ZOSTAVAX 10-16-12, called today, described rash on trunk, advised pt to call MD. MD called me to confirm shingles and prescribed VALTREX 1gm.
Age: 1.04
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Right leg PCV-13 & HIB red and sore, swollen.
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: This spontaneous report was phoned in by a sales representative (US12-052962) reported by a pharmacist refers to a patient of unknown age and gender. The patient's relevant medical history is unknown. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX. Route and dose were not reported. No other co-suspects were reported. No concomitant medications were reported. On an unknown date after vaccination of ZOSTAVAX, the patient reported a rash and pruritus. No treatment information was reported. It is unknown if there is any relevant laboratory data. As of 29-OCT-2012 it is unknown if the patient will have another ZOSTAVAX. The patient recovered from the rash and pruritus after three days. The relatedness for pruritus and rash is unknown for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to a patient of unknown gender and age. The patient was vaccinated with ZOSTAVAX (lot #0748AA, exp: 18-AUG-2012) on 06-NOV-2012. This day, the patient received an expired dose of ZOSTAVAX. No treatment information was reported. The patient outcome was unknown. No adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On 22-OCT-2012, the patient was vaccinated with a dose of VARIVAX(Merck)(lot number unspecified) instead of ZOSTAVAX due to human error. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. The outcome of the patient was unknown. It was unknown if the patient had sought medical attention. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to an 11 years old patient. The patient was vaccinated SC, with a dose of 0.65 ml ZOSTAVAX instead of VARIVAX(Merck) on 06-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. The patient's mom had called physician's office. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a medical assistant refers to an approximately 67 year old male patient with drug allergy to erythromycin and no pertinent medical history. The patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not provided) on an unknown date. No other co-suspects were reported. There were no concomitant medications. On unknown date the patient developed shingles 18 months later. The patient had sought medical attention via office visit. The treatment with VALTREX, prednisone and TOPICORT were given for the shingles. There were no laboratory diagnostics studies performed. The outcome of shingles was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with dose 1 VAQTA on 20-FEB-2009. And the patient was received the second dose and third dose of VAQTA on 31-MAR-2010 and 02-NOV-2012, respectively. No other co-suspects were reported. No concomitant medications were reported. No adverse symptoms were reported. It was unknown if the patient sought medical attention. At the time of report, the patient's status was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a other healthcare worker refers to a patient of unknown age and gender who on 02-NOV-2012, was vaccinated with a dose of VARIVAX (Merck) (dose and lot number not reported) instead of ZOSTAVAX (Merck) due to human error. No other co-suspects were reported. No concomitant medications were reported. No treatment information was reported. No adverse effect reported. At the time of the report, the patient outcome for adverse events was unknown. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered
Clinical narrative: Information has been received from a pharmacist (reference # NK 5489) concerning a 61 years old female patient who on 23-OCT-2012, was given one injection of ZOSTAVAX (dose and route not reported) (lot # 670617/0618AA) which expired on 26-JUL-2012. The patient had no relevant medical history or relevant concomitant medications. The patient's relevant past drug history was unknown. It was unknown if there was any relevant laboratory data. As of 30-OCT-2012, the patient had not been revaccinated and the outcome of her getting the expired ZOSTAVAX was unknown. This is one of several reports received from the same source (related MARRS # 1211USA00230). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with a dose of PNEUMOVAX23 (dose, route and lot number not provided) which had expired in "August 2012" on 10-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unspecified if the patient had sought medical attention. The pharmacist stated that a decision had already been made to revaccinate the patient. Additional information has been requested.
Age: 92.0
Sex: F
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 92 years old female patient. Within the last couple of weeks, on approximately November 2012, the patient received subcutaneously a 0.5 mL dose of VARIVAX (Merck) (0.5-VARIVAX dosing instructions) (lot# not provided) instead of ZOSTAVAX (Merck) as she was scheduled for. No treatment at the time of the report was received. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report as received from a registered pharmacist via a company representative refers to an unknown number of patients of unknown age and gender. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX23 (lot # not reported) dose and route not reported. No concomitant medications were reported. The representative reported that pharmacist told her that there had been a couple of reactions with vaccinations of PNEUMOVAX23. The representative had no information about the reactions with PNEUMOVAX23 at the time of the call. The outcome of the event was unknown at the time of this report. No other information to report. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, No adverse event, Pregnancy test
Clinical narrative: This spontaneous prospective pregnancy report as received from a licensed practical nurse refers to a 24 years old female patient. The patient's history of previous pregnancies and live births was not known. The reporter stated that the patient had hepatitis B series(manufacture unknown) when she was young, but a titer was drawn and she did not seroconvert. Nurse stated the client was in nursing school, so she was given a dose of RECOMBIVAX HB on 21-AUG-2012, and now maybe pregnant. No adverse effects were reported. Other suspect therapies included Hepatitis B vaccine (manufacture unknown). No concomitant medications were reported. The patient was awaiting results of pregnancy test. The outcome was unknown. Additional information is not expected.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 50 years old female patient with allergy to nuts and fish. The patient's medical history included shingles. The patient was vaccinated with a dose of ZOSTAVAX (dose, route not provided, lot number reported as H013024, expiry date: 09-OCT-2013) on 06-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. On 07-NOV-2012 the patient developed rash, warmth and redness in the surrounding area of the injection site. The patient had not sought medical attention. The treatment with BENADRYL was given for the adverse events. The outcome of rash, warmth and redness in the surrounding area of the injection site was unknown. Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash pruritic
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 years old female patient with asthma, diabetes and chronic obstructive pulmonary disease (COPD). On 26-OCT-2012, the patient was vaccinated subcutaneously in the left arm with a dose of 0.65 ml of ZOSTAVAX (lot# reported as H013017, expiry 09-OCT-2013). Patient received unspecified concomitant medications. On 02-Nov-2012, the patient called the pharmacy and stated that she has itchy rash at injection site. No treatment was given. The patient sought medical attention (called the pharmacy on 02-NOV-2012). The outcome of itchy rash at injection site was reported as not recovered. The pharmacist stated he would have the patient follow-up with her health provider if needed. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Myalgia, Paraesthesia, Varicella
Clinical narrative: This spontaneous report was received from a female consumer of unknown age reporting  on herself with osteoarthritis. The patient was vaccinated subcutaneously with a dose of ZOSTAVAX (lot # and dose not reported) on 26-OCT-2012. Other suspect therapies included a dose of Influenza Virus Vaccine (manufacturer unknown) (lot #, dose and route not reported) on 20-OCT-2012. No concomitant medications were reported. The consumer reported that when she received her ZOSTAVAX injection on 26-OCT-2012, "by the time she had walked to the parking lot," she had the sensation that she was being electrocuted. She reports that the sensation lasted for about 4-5 minutes. She reported that as soon as she got home she called the pharmacist who gave her the vaccination. The pharmacist (unspecified by reporter) told her to see her physician (unspecified by reporter), and she stated her physician drew unspecified blood samples (results not provided). Consumer had a medical history of osteoarthritis, but reported she had unusual pain in her arm muscles, in areas that she had not had experienced pain before. Consumer reported that 2 days after receiving her ZOSTAVAX vaccination (on 28-OCT-2012), she had an outbreak of chickenpox. No treatment information was reported. The event of had the sensation that she was being electrocuted resolved within 5 minutes and the outcome of had unusual pain in her arm muscles and outbreak of chickenpox was reported as recovering. The relatedness for the reported events was not provided for ZOSTAVAX and Influenza Virus Vaccine (manufacturer unknown). Additional information is not expected.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Antibody test negative, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a physician refers to a 60 years old patient(gender unspecified). The patient had a negative history of chicken pox and negative varicella time. On 02-NOV-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot # and route not reported) instead of VARIVAX due to a human error. No concomitant medications were reported. No adverse effect was reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX on 11-NOV-2012  that had expired on 01-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. No treatment information was reported. The outcome of expired vaccine used is unknown. Expired vaccine used is not related to ZOSTAVAX. Additional information has been requested.
Age: 0.3
Sex: F
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse (L.P.N) refers to a 4-month-old female patient. On 21-AUG-2012 the patient was vaccinated with dose 1 of ROTATEQ (lot # not reported) orally. No concomitant medications were reported. On 31-OCT-2012 patient received dose 2 of ROTATEQ (lot # 0884AA, expiration date 14-OCT-2012) orally. No adverse experience has been observed or reported. No additional information currently available. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist via field representative concerning a mid to late 70's years old female patient with unspecified pertinent medical history or drug reactions/allergies. On an unspecified date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number were not reported). No other co-suspects were reported. No concomitant medications were reported. In 2012, couple weeks ago, the patient who was immunized with ZOSTAVAX, got shingles. No treatment information was reported. The patient's outcome was unknown. The relatedness for shingles was unknown. Additional information is not expected.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with an expired dose of lot # (671142/1268AA; exp date 05-NOV-2012) of ZOSTAVAX (dose and route not reported) on 11-NOV-2012. No adverse symptoms were reported. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: This pharmacist reports that a 66 year old male patient was given PNEUMOVAX 23 injection, in the right arm on 28Oct2012. The patient's relevant medical history, concomitant medications are unknown and his past drug history includes, he may have gotten the PNEUMOVAX before but does not remember. On 29Oct2012 the patient came into the pharmacy to show the pharmacist that his right arm was swollen. It is unknown if there is any relevant laboratory data. As of 29Oct2012 it is unknown if the patient will have another PNEUMOVAX and his right arm is swollen today.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dysgeusia, Erythema, Eye irritation, Eye pain
Clinical narrative: 10:45 AM began to feel flushed, slightly disoriented, slight metallic taste in nose and mouth and eyes began to burn/sting. 10:50 AM was given IM Benadryl 50 mg in right gluteal per our emergency protocol.  Auscultated lungs which found to have inspiratory wheezing in the RUL, LUL, and RML.  States feels slight tightness in chest.  Face is reddened in appearance, slight generalized urticaria noted on cheeks.  11:15  BP 140/90, P 88, and RR 22 and pt. anxious.  Declines 911 to be called at this time.  11:24 am  BP 138/90, P 78, RR 16.  Wheezed noted only in the RUL, other wheezes have dissipated.  States "feeling better".  11:26 am All wheezes have dissipated.  Employee states, "My lungs feel open like I have had a breathing treatment."  Face is no longer reddened.  She denies tightness in chest.  She declined to follow up at Instant Care Facility.  She returned to work and declined going home for the day.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Urticaria, Wheezing
Clinical narrative: 10:45 AM began to feel flushed, slightly disoriented, slight metallic taste in nose and mouth and eyes began to burn/sting. 10:50 AM was given IM Benadryl 50 mg in right gluteal per our emergency protocol.  Auscultated lungs which found to have inspiratory wheezing in the RUL, LUL, and RML.  States feels slight tightness in chest.  Face is reddened in appearance, slight generalized urticaria noted on cheeks.  11:15  BP 140/90, P 88, and RR 22 and pt. anxious.  Declines 911 to be called at this time.  11:24 am  BP 138/90, P 78, RR 16.  Wheezed noted only in the RUL, other wheezes have dissipated.  States "feeling better".  11:26 am All wheezes have dissipated.  Employee states, "My lungs feel open like I have had a breathing treatment."  Face is no longer reddened.  She denies tightness in chest.  She declined to follow up at Instant Care Facility.  She returned to work and declined going home for the day.
Sex: F
Vaccine: PPV, TDAP, PPV
Symptoms: Oedema peripheral, Pain in extremity, Rash
Clinical narrative: This report was received and was assigned manufacturer report number 30121090179-0001. A female patient with an unspecified age, pertinent medical history or drug reactions / allergies. On an unspecified date, the patient was vaccinated with a dose of PNEUMOVAX23. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced an adverse reaction due to PNEUMOVAX23. No treatment information was reported. The patient's outcome was unknown. This was originally reported by the patient. Additional information has been requested.
Sex: F
Vaccine: PPV, TDAP, PPV
Symptoms: Vaccination complication
Clinical narrative: This report was received and was assigned manufacturer report number 30121090179-0001. A female patient with an unspecified age, pertinent medical history or drug reactions / allergies. On an unspecified date, the patient was vaccinated with a dose of PNEUMOVAX23. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced an adverse reaction due to PNEUMOVAX23. No treatment information was reported. The patient's outcome was unknown. This was originally reported by the patient. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Chills, Dizziness, Erythema, Fasciitis
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site arm cellulitis in a 61-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included allergy to REMICADE, depression, high cholesterol, hypertension and LIPITOR allergy. Concurrent vaccination included pneumococcal vaccine (non-gsk); non-GSK manufacturer; unknown; right deltoid given on 23 October 2012. Concurrent medications included Hydrochlorothiazide, Lisinopril, FOSAMAX, Omeprazole, CRESTOR and Calcium with vitamin D. On 23 October 2012 the subject received a dose of FLUARIX (.5 ml, unknown route, left deltoid). In October 2012, less than one week after vaccination with FLUARIX, the subject experienced injection site arm cellulitis and on an unspecified date in 2012, less than one month after vaccination with FLUARIX, the subject experienced injection site pain ("felt achy"). The subject was hospitalised overnight beginning on 30 October 2012 and "discharge date was unknown". The subject was treated with antibiotics. Per the pharmacist, at an unknown time after vaccination with FLUARIX and an unknown time after discharge from the hospital, the subject reported that the cellulitis had improved "but she still felt achy". At the time of reporting, the outcome of the injection site pain was unknown.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Hypersensitivity, Nausea, Oedema peripheral, Pyrexia, Skin warm
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site arm cellulitis in a 61-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included allergy to REMICADE, depression, high cholesterol, hypertension and LIPITOR allergy. Concurrent vaccination included pneumococcal vaccine (non-gsk); non-GSK manufacturer; unknown; right deltoid given on 23 October 2012. Concurrent medications included Hydrochlorothiazide, Lisinopril, FOSAMAX, Omeprazole, CRESTOR and Calcium with vitamin D. On 23 October 2012 the subject received a dose of FLUARIX (.5 ml, unknown route, left deltoid). In October 2012, less than one week after vaccination with FLUARIX, the subject experienced injection site arm cellulitis and on an unspecified date in 2012, less than one month after vaccination with FLUARIX, the subject experienced injection site pain ("felt achy"). The subject was hospitalised overnight beginning on 30 October 2012 and "discharge date was unknown". The subject was treated with antibiotics. Per the pharmacist, at an unknown time after vaccination with FLUARIX and an unknown time after discharge from the hospital, the subject reported that the cellulitis had improved "but she still felt achy". At the time of reporting, the outcome of the injection site pain was unknown.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Tenderness
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site arm cellulitis in a 61-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included allergy to REMICADE, depression, high cholesterol, hypertension and LIPITOR allergy. Concurrent vaccination included pneumococcal vaccine (non-gsk); non-GSK manufacturer; unknown; right deltoid given on 23 October 2012. Concurrent medications included Hydrochlorothiazide, Lisinopril, FOSAMAX, Omeprazole, CRESTOR and Calcium with vitamin D. On 23 October 2012 the subject received a dose of FLUARIX (.5 ml, unknown route, left deltoid). In October 2012, less than one week after vaccination with FLUARIX, the subject experienced injection site arm cellulitis and on an unspecified date in 2012, less than one month after vaccination with FLUARIX, the subject experienced injection site pain ("felt achy"). The subject was hospitalised overnight beginning on 30 October 2012 and "discharge date was unknown". The subject was treated with antibiotics. Per the pharmacist, at an unknown time after vaccination with FLUARIX and an unknown time after discharge from the hospital, the subject reported that the cellulitis had improved "but she still felt achy". At the time of reporting, the outcome of the injection site pain was unknown.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site cellulitis, Injection site pain
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site arm cellulitis in a 61-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included allergy to REMICADE, depression, high cholesterol, hypertension and LIPITOR allergy. Concurrent vaccination included pneumococcal vaccine (non-gsk); non-GSK manufacturer; unknown; right deltoid given on 23 October 2012. Concurrent medications included Hydrochlorothiazide, Lisinopril, FOSAMAX, Omeprazole, CRESTOR and Calcium with vitamin D. On 23 October 2012 the subject received a dose of FLUARIX (.5 ml, unknown route, left deltoid). In October 2012, less than one week after vaccination with FLUARIX, the subject experienced injection site arm cellulitis and on an unspecified date in 2012, less than one month after vaccination with FLUARIX, the subject experienced injection site pain ("felt achy"). The subject was hospitalised overnight beginning on 30 October 2012 and "discharge date was unknown". The subject was treated with antibiotics. Per the pharmacist, at an unknown time after vaccination with FLUARIX and an unknown time after discharge from the hospital, the subject reported that the cellulitis had improved "but she still felt achy". At the time of reporting, the outcome of the injection site pain was unknown.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Diarrhoea, Influenza like illness, Injection site erythema, Injection site induration, Injection site inflammation
Clinical narrative: This spontaneous report was received from a student of pharmacy concerning to a 56 years old female patient. On 05-NOV-2012, the patient was vaccinated subcutaneously with a dose of ZOSTAVAX (H012516; Exp. date 09-OCT-2012) (dose not reported). No other co-suspects were reported. Concomitant medications included CELEXA. The evening of 05-NOV-2012, the arm in which the ZOSTAVAX was administered became red and hard; the redness and hardness took up her entire upper arm. The upper arm was also warm to the touch. That evening the patient also experienced flu-like symptoms including diarrhea, vomiting and sweating. The day of the report, the patient also report a bee stinging sensation at the injection site. The outcome of the events was administered became hard, vomiting, diarrhea, bee stinging sensation, sweating and the arm in which (ZOSTAVAX) was administered became red was reported as not recovered/not resolved. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Injection site warmth, Nausea, Vomiting
Clinical narrative: This spontaneous report was received from a student of pharmacy concerning to a 56 years old female patient. On 05-NOV-2012, the patient was vaccinated subcutaneously with a dose of ZOSTAVAX (H012516; Exp. date 09-OCT-2012) (dose not reported). No other co-suspects were reported. Concomitant medications included CELEXA. The evening of 05-NOV-2012, the arm in which the ZOSTAVAX was administered became red and hard; the redness and hardness took up her entire upper arm. The upper arm was also warm to the touch. That evening the patient also experienced flu-like symptoms including diarrhea, vomiting and sweating. The day of the report, the patient also report a bee stinging sensation at the injection site. The outcome of the events was administered became hard, vomiting, diarrhea, bee stinging sensation, sweating and the arm in which (ZOSTAVAX) was administered became red was reported as not recovered/not resolved. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Diarrhoea, Hyperhidrosis, Influenza like illness, Injection site erythema, Injection site induration
Clinical narrative: This spontaneous report was received from a student of pharmacy concerning to a 56 years old female patient. On 05-NOV-2012, the patient was vaccinated subcutaneously with a dose of ZOSTAVAX (H012516; Exp. date 09-OCT-2012) (dose not reported). No other co-suspects were reported. Concomitant medications included CELEXA. The evening of 05-NOV-2012, the arm in which the ZOSTAVAX was administered became red and hard; the redness and hardness took up her entire upper arm. The upper arm was also warm to the touch. That evening the patient also experienced flu-like symptoms including diarrhea, vomiting and sweating. The day of the report, the patient also report a bee stinging sensation at the injection site. The outcome of the events was administered became hard, vomiting, diarrhea, bee stinging sensation, sweating and the arm in which (ZOSTAVAX) was administered became red was reported as not recovered/not resolved. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site warmth, Vomiting
Clinical narrative: This spontaneous report was received from a student of pharmacy concerning to a 56 years old female patient. On 05-NOV-2012, the patient was vaccinated subcutaneously with a dose of ZOSTAVAX (H012516; Exp. date 09-OCT-2012) (dose not reported). No other co-suspects were reported. Concomitant medications included CELEXA. The evening of 05-NOV-2012, the arm in which the ZOSTAVAX was administered became red and hard; the redness and hardness took up her entire upper arm. The upper arm was also warm to the touch. That evening the patient also experienced flu-like symptoms including diarrhea, vomiting and sweating. The day of the report, the patient also report a bee stinging sensation at the injection site. The outcome of the events was administered became hard, vomiting, diarrhea, bee stinging sensation, sweating and the arm in which (ZOSTAVAX) was administered became red was reported as not recovered/not resolved. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Paraparesis
Clinical narrative: Staff at the Public Health Department was not notified by client of any adverse events after her influenza vaccination. Contact was made to client after receiving report on 11/13/2012 from the Health Information Specialist. Upon speaking with the client she divulged that upon walking out to her car from the clinic she began to feel weak and that her son had to help her into the car. Client or son never reentered the clinic for help or to inform us of her situation at that time. Client then stated that on 10/22/2012 she had an appointment with a doctor to have a bladder stimulator put in. The procedure was performed on an outpatient basis on 10/29/2012. Client stated that once arriving home that she collapsed. She went to the Emergency Department that evening. According to the client, stimulator was removed and catheter placed and an MRI was performed. As stated by client, results of that came back WNL. Client was released home without medication/treatment. Client stated that by the next morning the symptoms had not resolved them self. Client stated that she collapsed again and could move her arms, but from her chest down she could not move. She contacted her private physician and they referred her back to the Emergency Department. Again she was told by the ED physician that they could not find any cause for her symptoms. She was asked as a routine question if she had been vaccinated for flu or pneumonia. She stated that she received the flu immunization on 10/18/2012 at Public Health Department. Client was admitted to the hospital on 10/30/2012 where she stayed on the medical floor for 6 days, and then moved to the Rehab floor until released on 11/13/2012. Client is to follow up with the surgical performing doctor. Client stated that she does not feel that this is a reaction from the influenza vaccination, but does however feel that it is due to the recent surgery. Client is at home currently and going to rehab and has a nurse come to her house for assistance.
Age: 50.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Catheter placement, Mobility decreased, Neurostimulator implantation, Nuclear magnetic resonance imaging normal
Clinical narrative: Staff at the Public Health Department was not notified by client of any adverse events after her influenza vaccination. Contact was made to client after receiving report on 11/13/2012 from the Health Information Specialist. Upon speaking with the client she divulged that upon walking out to her car from the clinic she began to feel weak and that her son had to help her into the car. Client or son never reentered the clinic for help or to inform us of her situation at that time. Client then stated that on 10/22/2012 she had an appointment with a doctor to have a bladder stimulator put in. The procedure was performed on an outpatient basis on 10/29/2012. Client stated that once arriving home that she collapsed. She went to the Emergency Department that evening. According to the client, stimulator was removed and catheter placed and an MRI was performed. As stated by client, results of that came back WNL. Client was released home without medication/treatment. Client stated that by the next morning the symptoms had not resolved them self. Client stated that she collapsed again and could move her arms, but from her chest down she could not move. She contacted her private physician and they referred her back to the Emergency Department. Again she was told by the ED physician that they could not find any cause for her symptoms. She was asked as a routine question if she had been vaccinated for flu or pneumonia. She stated that she received the flu immunization on 10/18/2012 at Public Health Department. Client was admitted to the hospital on 10/30/2012 where she stayed on the medical floor for 6 days, and then moved to the Rehab floor until released on 11/13/2012. Client is to follow up with the surgical performing doctor. Client stated that she does not feel that this is a reaction from the influenza vaccination, but does however feel that it is due to the recent surgery. Client is at home currently and going to rehab and has a nurse come to her house for assistance.
Age: 50.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Syncope
Clinical narrative: Staff at the Public Health Department was not notified by client of any adverse events after her influenza vaccination. Contact was made to client after receiving report on 11/13/2012 from the Health Information Specialist. Upon speaking with the client she divulged that upon walking out to her car from the clinic she began to feel weak and that her son had to help her into the car. Client or son never reentered the clinic for help or to inform us of her situation at that time. Client then stated that on 10/22/2012 she had an appointment with a doctor to have a bladder stimulator put in. The procedure was performed on an outpatient basis on 10/29/2012. Client stated that once arriving home that she collapsed. She went to the Emergency Department that evening. According to the client, stimulator was removed and catheter placed and an MRI was performed. As stated by client, results of that came back WNL. Client was released home without medication/treatment. Client stated that by the next morning the symptoms had not resolved them self. Client stated that she collapsed again and could move her arms, but from her chest down she could not move. She contacted her private physician and they referred her back to the Emergency Department. Again she was told by the ED physician that they could not find any cause for her symptoms. She was asked as a routine question if she had been vaccinated for flu or pneumonia. She stated that she received the flu immunization on 10/18/2012 at Public Health Department. Client was admitted to the hospital on 10/30/2012 where she stayed on the medical floor for 6 days, and then moved to the Rehab floor until released on 11/13/2012. Client is to follow up with the surgical performing doctor. Client stated that she does not feel that this is a reaction from the influenza vaccination, but does however feel that it is due to the recent surgery. Client is at home currently and going to rehab and has a nurse come to her house for assistance.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Nausea, Pyrexia
Clinical narrative: Pt called 10/13/12 to report that she had a serious reaction to the flu shot given 10/10/12. She reported she called 911 on Wed. pm with a high fever, weakness and nausea. She was transported from home via ambulance to Hosp and Tx with IV meds. Released early Thurs. am. She states she feels better but not 100%.