chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.74
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives onset > 24 hours after receiving .25 pediatric pre-filled flu vaccine. Instructed to take BENADRYL and hives resolved in 1 1/2 days after administration.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Rash, Rash pruritic
Clinical narrative: On 10/31/12 patient reporting rash on arms, neck and chest. Rash itchy and painful.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Flushing, Headache, Nausea, Nervousness
Clinical narrative: 11/3/12 730 Headache, flushed, queasy, shaky, lightheaded. 11/4/12 Temp 99 degrees F. Flushed.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pain
Clinical narrative: Next morning (~ 16-20 hours) woke up with red area - large very painful. Saw Dr and put on antibiotics & steroid shot.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Next morning (~ 16-20 hours) woke up with red area - large very painful. Saw Dr and put on antibiotics & steroid shot.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site erythema, Pain, Pain in extremity
Clinical narrative: Redness to site (injection site), (L) palm throbbing/HA, treated in Immed. Care with DURICEF.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: After receiving FLUZONE HD, patient felt as she had the flu. She is normally healthy and has not been in contact with other sick people. She had a fever and has been very achy. Resolved after 1 week.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain
Clinical narrative: Within 30 minutes after Flu shot she experienced ipsilateral neck pain that lasted 1 week. Treated with Naproxen.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Pain to injection site x 1 week. Unable to reach for phone or put on clothes without pain to injection site treated with ROBAXIN.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dizziness, Headache, Immediate post-injection reaction, Throat tightness
Clinical narrative: Tightness in throat & chest / head heaviness / lightheadedness immed. after Flu vaccine. Treated with Prednisone at Immed Care.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Rash, Swollen tongue, Vision blurred
Clinical narrative: Treated in ED with BENADRYL for c/o blurry vision. Rash on hands & back / tongue swollen.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Immediate post-injection reaction, Inflammation, Swelling
Clinical narrative: Immediate swelling - cellulitis vs inflammation measuring 25cm x 15cm.
Age: 49.0
Sex: U
Vaccine: FLU3
Symptoms: Pain in extremity, Rash
Clinical narrative: Odd rash and prolonged soreness in upper forearm.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Gout, Oedema peripheral, Pain in extremity
Clinical narrative: He experienced swelling on right foot (toes & arch) a few hours after flu shot & didn't know if it was related. It felt like gout & was painful. He took some VICODIN & CELEBREX. Pain & swelling resolved next day.
Age: 1.35
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: 4 hours after vaccines got hives.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Immediate post-injection reaction, Pain
Clinical narrative: Bruising lasting > 2 weeks. Bruising was immediate. Soreness lasting couple of days.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Muscle pain 2 week after injection pt. did not seek treatment because she does not have insurance.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swelling and tenderness (L) arm after vaccination.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Injection site reaction, Myalgia
Clinical narrative: Patient called on Mon. 10-29-12 to report reaction after getting Flu vacc. At site of injection his muscle was achy for 1 1/2 day onset 4pm/same day. By midnite patient had explosive, watery, severe diarrhea, lasting 3 days (until Tues 10-23-12).
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: C-reactive protein increased, Decreased appetite, Discomfort, Dizziness, Headache
Clinical narrative: 10/31/12 @ 1530 was given booster TDAP vaccination in (L) deltoid IM. Could not remember last tetanus vaccination. Given instructions for OTC anti-inflammation use and arm movement. Awoke 11/1/12 @ 0300 with lest arm discomfort/aching and headache. 11/2/12 & 11/3/12 noted night sweats, loss of appetite, dizziness and swelling in left upper arm with lump formation where injection was given. 11/4/12 noted further swelling in fingers (L) hand and (L) arm. Presented to hospital emergency department 11/4/12 @ 1319 for evaluation & treatment of left upper arm cellulitis. Given IV Doxycycline 100mg and VICODIN p.o. for pain. Sent home 11/4/12 with script Doxycycline 100mg p.o. twice daily for 10 days and ULTRAM p.o 50mg as needed for pain every 6 hours. Recovering.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site cellulitis, Injection site mass, Injection site swelling, Night sweats, Oedema peripheral
Clinical narrative: 10/31/12 @ 1530 was given booster TDAP vaccination in (L) deltoid IM. Could not remember last tetanus vaccination. Given instructions for OTC anti-inflammation use and arm movement. Awoke 11/1/12 @ 0300 with lest arm discomfort/aching and headache. 11/2/12 & 11/3/12 noted night sweats, loss of appetite, dizziness and swelling in left upper arm with lump formation where injection was given. 11/4/12 noted further swelling in fingers (L) hand and (L) arm. Presented to hospital emergency department 11/4/12 @ 1319 for evaluation & treatment of left upper arm cellulitis. Given IV Doxycycline 100mg and VICODIN p.o. for pain. Sent home 11/4/12 with script Doxycycline 100mg p.o. twice daily for 10 days and ULTRAM p.o 50mg as needed for pain every 6 hours. Recovering.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Red blood cell sedimentation rate increased, White blood cell count decreased
Clinical narrative: 10/31/12 @ 1530 was given booster TDAP vaccination in (L) deltoid IM. Could not remember last tetanus vaccination. Given instructions for OTC anti-inflammation use and arm movement. Awoke 11/1/12 @ 0300 with lest arm discomfort/aching and headache. 11/2/12 & 11/3/12 noted night sweats, loss of appetite, dizziness and swelling in left upper arm with lump formation where injection was given. 11/4/12 noted further swelling in fingers (L) hand and (L) arm. Presented to hospital emergency department 11/4/12 @ 1319 for evaluation & treatment of left upper arm cellulitis. Given IV Doxycycline 100mg and VICODIN p.o. for pain. Sent home 11/4/12 with script Doxycycline 100mg p.o. twice daily for 10 days and ULTRAM p.o 50mg as needed for pain every 6 hours. Recovering.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blister, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Pt called in on 11/3 to report her adverse rxn to the influenza vaccine given on 11/2. Pt reported rash, redness, and swelling around the injection site. The area affected was ~8 in by 3 in. Small blisters/bubbles in the skin formed. Pt came into the pharmacy on 11/5, and the skin problems were improved. Skin was still slightly red, especially area around smallpox scar.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site vesicles
Clinical narrative: Injection site broke out in blisters the next day - blisters resolving.
Age: 0.21
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Haematemesis
Clinical narrative: Vaccine admin on 9/5/12. Small hematemesis on 9/7/12.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain, Vomiting
Clinical narrative: Soreness at injection site. Vomiting started at approx. 2 hrs after receiving vaccine. Whole body aches.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: The patient received his flu vaccine on 10/27/12 & returned to the office with a 3x2 1/2 inch erythematous, warm, swollen area at the site of the vaccination.
Age: 61.0
Sex: M
Vaccine: HEPA
Symptoms: Ear pain, Increased upper airway secretion, Insomnia, Odynophagia, Oropharyngeal pain
Clinical narrative: Doctor appointment on Sat. Sept. 29, 2012. Pharyngitis caused by a virus. Very very bad sore throat that I feel in my ears and painful when I would swallow; could not sleep, throat drainage; temperature high; still have mild drainage.
Age: 61.0
Sex: M
Vaccine: HEPA
Symptoms: Pyrexia, Streptococcus test negative, Viral pharyngitis
Clinical narrative: Doctor appointment on Sat. Sept. 29, 2012. Pharyngitis caused by a virus. Very very bad sore throat that I feel in my ears and painful when I would swallow; could not sleep, throat drainage; temperature high; still have mild drainage.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Onset 48 hrs. after injection. 2 areas of swelling near site of injection 1.5 & 1.0 cm - left deltoid. Slightly tender with palpation - slight itching.
Age: 74.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Client called 10-25-12 c/o soreness and redness in arm where received Tdap vaccine. States is beginning to get better but still has soreness & redness.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Dermatitis contact, Rash generalised
Clinical narrative: 10/18/12 - Woke up with rash - covered all over body. Seen in ER dx contact dermatitis, PRELONE Rx given.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Local reaction, Pruritus, Skin warm
Clinical narrative: (R) arm 8 x 12 cm red, hot induration itching - local reaction. No anaphylaxis. No generalized reaction.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Dry skin, Oedema peripheral, Rash generalised
Clinical narrative: Rash-like dried skin over complete body. Swelling in hands & ft. Given vaccine in PM on 10-16-12 - woke up with rash in AM on 10-18-12. Rash disappeared by AM on 10-22-12. Discontinued breast feeding infant.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral
Clinical narrative: Left arm swelling.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza, Nasopharyngitis
Clinical narrative: Patient said she had a really bad cold for about 7-10 days after she had the high dose vaccine. She said the "flu" and wanted us to report the incident.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chest discomfort, Dizziness, Eye discharge, Eye irritation
Clinical narrative: Chest tightness, eyes burning, dizziness, weakness, overall fast onset of symptoms; goop out of her eyes.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Chills, Choking, Eye discharge, Eye irritation
Clinical narrative: Feeling of choking, vomiting, aches, chills, discharge from eyes, chest tightness, burning eyes, muscles locking.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle disorder, Pain, Vomiting, X-ray normal
Clinical narrative: Feeling of choking, vomiting, aches, chills, discharge from eyes, chest tightness, burning eyes, muscles locking.
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Mobility decreased, Pain in extremity
Clinical narrative: Bursitis like pain in upper deltoid restricting use of shoulder.
Age: 56.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Pain, Pain of skin
Clinical narrative: Joint pains, body ache, aches in hair follicle, scalp.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Flu shot on 10/24/12. Noticed on 10/25/12 when removed band-aid. Quarter size redness, warm to touch, slightly swollen. Took BENADRYL Thurs night 10/25 and arm was fine on AM of 10/26.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Feeling hot
Clinical narrative: Warm feeling - felt like I could pass out!
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site warmth, Lip swelling, Pruritus
Clinical narrative: Given 10-4-12 pt present at PCP on 10/8/12 with rash on (L) deltoid size of a plum, red, hot to touch. Also general macular rash from neck to waist, itchy. Lower lip swelling went down with BENADRYL.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash macular
Clinical narrative: Given 10-4-12 pt present at PCP on 10/8/12 with rash on (L) deltoid size of a plum, red, hot to touch. Also general macular rash from neck to waist, itchy. Lower lip swelling went down with BENADRYL.
Age: 92.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pain in extremity, Urinary incontinence, Weight bearing difficulty
Clinical narrative: That evening, he states he had chills. Then 3 episodes of loss of bladder control. Then on 10/12/12 he had pain in his left leg and couldn't put weight on it. Two days later he was fine.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen, painful, itchy and warm to the touch at puncture site.
Age: 95.0
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Dull pain lasting more than 1 week. Hurts to lay on. No redness or swelling.
Age: 73.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Abdominal discomfort, Headache, Injection site erythema, Pruritus, Pyrexia
Clinical narrative: Bright red area around injection site, feverish, tender, itching, headache, upset stomach sought treatment from primary care physician who advised BENADRYL and TYLENOL. Injection site is almost completely resolved in 5 days.
Age: 73.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Tenderness
Clinical narrative: Bright red area around injection site, feverish, tender, itching, headache, upset stomach sought treatment from primary care physician who advised BENADRYL and TYLENOL. Injection site is almost completely resolved in 5 days.
Age: 1.04
Sex: M
Vaccine: FLU3, MMR, PNC13, VARCEL
Symptoms: Condition aggravated, Febrile convulsion, Otitis media
Clinical narrative: Several hours after immunizations patient had 2 short febrile seizures. He presented to the local ER & MD diagnosed with (B) OM.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: C-reactive protein, Contusion, Differential white blood cell count, Fibrin D dimer, Full blood count
Clinical narrative: Pt went to ER about 21:27, Dx with localized reaction to pneumonia vaccine. Pain started about 2 hours after inj. Contusion at shot site & swelling, tender warmth, erythema from elbow to delt. noted by ER doctor. Home to rest. NORCO - pain. Apply warm moist cloth TID. Pt improved 70% 2315, pt not found in room at 2310.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Pt went to ER about 21:27, Dx with localized reaction to pneumonia vaccine. Pain started about 2 hours after inj. Contusion at shot site & swelling, tender warmth, erythema from elbow to delt. noted by ER doctor. Home to rest. NORCO - pain. Apply warm moist cloth TID. Pt improved 70% 2315, pt not found in room at 2310.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Local reaction, Pain
Clinical narrative: Pt went to ER about 21:27, Dx with localized reaction to pneumonia vaccine. Pain started about 2 hours after inj. Contusion at shot site & swelling, tender warmth, erythema from elbow to delt. noted by ER doctor. Home to rest. NORCO - pain. Apply warm moist cloth TID. Pt improved 70% 2315, pt not found in room at 2310.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema peripheral, Pharyngeal oedema, Pyrexia, Swelling face, Urticaria
Clinical narrative: Allergic urticaria, swollen throat, hands, feet, face, hives, fever 5 days. Clinic on 10/20, 10/21/2012. Diphendyramine 25mg, Prednisone 10mg 10 days. 10/23/12 Dr. injection BENADRYL.
Age: 15.0
Sex: F
Vaccine: FLU3, HPV4, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Cardiac monitoring, Fall, Immediate post-injection reaction, Syncope
Clinical narrative: Syncopal episodes within seconds of administering HPV #1; lasted about 15 sec. Had blood work done a few minutes prior to vaccine administration; fell off bed.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Nuclear magnetic resonance imaging normal, Paraesthesia
Clinical narrative: Received flu shot, walking across parking lot to return to work approx. 15 min. after shot left side of face began to tingle, & then became numb (numbness - included eyelid, eyebrow & forehead as well as entire left side of face).
Age: 70.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site erythema, Injection site haematoma, Injection site swelling
Clinical narrative: Hematoma, swelling, redness at injection site and surrounding area.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Cellulitis, Rash, Rash erythematous, Skin warm
Clinical narrative: After approximately 12-24 hours after vaccination, patient experienced a red warm rash encircle her arm. Patient reported rash on 10/26 and instructed to take some BENADRYL by me (RPh) and if the rash either got larger or didn't regress to go to ER. Patient later went to ER and diagnosed with cellulitis and started on antibiotics.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Blood culture negative, Cellulitis
Clinical narrative: After approximately 12-24 hours after vaccination, patient experienced a red warm rash encircle her arm. Patient reported rash on 10/26 and instructed to take some BENADRYL by me (RPh) and if the rash either got larger or didn't regress to go to ER. Patient later went to ER and diagnosed with cellulitis and started on antibiotics.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Maternal exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: Information has been received from a physician for GARDASIL, a Pregnancy Registry product, concerning a 24 years old female patient with diabetes and none drug allergies. The patient's history of previous pregnancies and live births was not known. The patient was vaccinated with last dose GARDASIL (lot# was unknown) early in the first trimester of pregnancy (believed to be week 4 or 5 of the pregnancy) in September 2012. Concomitant medications included: LANTUS. The patient became pregnant with an LMP of 18-AUG-2012 and an EDD of 25-MAY-13. Initial exposure to GARDASIL was at 4 or 5 week(s). The patient was exposed to GARDASIL during trimester 1. Patient had sought medical attention. Ultrasound and Unspecified pregnant test were performed. There was no treatment given for the adverse event. The outcome of the pregnancy was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy
Clinical narrative: This spontaneous report was received from a consumer (mother) refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (lot # not reported) dose and route not reported. No concomitant medications were reported. The consumer reported that her daughter developed a lymph node in her neck after receiving GARDASIL. The outcome of the reported event was unknown. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from a physician refers to a 13-year-old female patient, with no drug reactions or allergies and no pertinent medical history. Current condition included contact dermatitis of the nose. The patient was vaccinated with dose 1, 0.5 milliliter (ml) GARDASIL (lot # 0636AE, expiration date unspecified) intramuscularly on 15-AUG-2012. Concomitant medications included: Z-PAK (reported as Z-Pack). The patient had been seen for contact dermatitis of her nose on 15-AUG-2012 and was prescribed Z-PAK and was administered GARDASIL, on the same visit. On the same date on 15-AUG-2012 the patient developed fever 102 degrees. The fever resolved on 16-AUG-2012. The physician did not administer the scheduled second dose of GARDASIL on 27-SEP-2012 because of the fever with the first dose. Treatment information was unspecified by the reporter. Medical attention was not sought for the events. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HIBV, HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to patients of unknown age and gender. The patients were vaccinated with GARDASIL. No concomitant medications were reported. The nurse reported that unknown number of patients received improperly stored GARDASIL (lot# dose and route not reported). The vaccine was exposed to 0 degree Centigrade (0 C) for 60 days. No adverse effects reported. No further information is available. This is one of the several reports from the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea, Syncope
Clinical narrative: This spontaneous report was received from a patient's father refers to a 14-year-old female patient with no pertinent medical history and no drug reactions/allergies. On 18-SEP-2012 the patient was vaccinated with dose 1 GARDASIL (lot # not reported). No concomitant medications were reported. Patient's father stated that a few minutes after his daughter had gotten the first shot of GARDASIL she fainted. She was woken up with smelling salts. She was still experiencing dizziness and nausea, however she was recovering. The reporter was unsure if the patient would receive the next doses of GARDASIL. No further adverse event (AE) information was provided. Patient sought medical attention in the doctor's office. Additional information is not expected.
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, HPV4, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a physician concerning a female patient of 7 months old who on 22-OCT-2012, was vaccinated with GARDASIL accidentally. No other co-suspects were reported. Concomitant medications included PEDIARIX, ROTATEQ and PREVNAR 13. There was no reported adverse reactions. The outcome of inappropriate age at vaccine administration was unknown. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a 26 years old female patient refers to herself. Patient stated her misuse of getting 2 of the 3 GARDASIL. The patient stated she received first dose of GARDASIL (subcutaneous, Lot#, dose unspecified) in June 2011 and second dose (Lot#, dose, route unspecified) in October 2011, but had not ever received the 3rd dose. The patient did not sought medical attention and no treatment was given for the event. The outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Limb discomfort, Oedema peripheral
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. The patient had no pertinent medical history and no drug reactions or allergies. The patient was vaccinated with PNEUMOVAX 23 (lot number reported as H013847, expired date 15-MAR-2014) (dose, frequency and injection site were not reported) intramuscular injection on 24-OCT-2012. No other co-suspects were reported. There was no concomitant medication. On 26-OCT-2012 the patient was seen in the practice, complaining of discomfort, redness, and less heat and swelling of the arm, compared to the first two patients  (MARRS#1210USA014326 and 1210USA014757). Physician noted that the patient two days post-vaccination, as compared to one day post-vaccination for patients 1 and 2. The patient was recovering at the time of report. There was no laboratory diagnostics studies performed. The patient had an office visit for medical attention. Physician requests a lot check for the PNEUMOVAX 23. This is one of several reports received from the same source. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Feeling abnormal, Headache, Injection site swelling, Nausea, Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist refers to a currently 65 years old male patient with cirrhosis and allergy to etodolac who in June 2012 was vaccinated in the left upper arm with the first dose of PNEUMOVAX 23, (lot # (H010661), Exp date 02-FEB-2014) (dose and route not reported). No other co-suspects were reported. Concomitant medications included lisinopril (manufacturer unknown), COREG, hydrochlorothiazide (manufacturer unknown), amlodipine and NAPROSYN. The pharmacist reported that the patient was vaccinated in the right upper arm with a dose of PNEUMOVAX 23 yesterday, on 25-OCT-2012 around noon. After injection yesterday (on 25-OCT-2012), patient stated he experienced arm soreness and a "strange feeling". Patient stated this morning (on 26-OCT-2012), he woke up with headache, nausea, arm soreness and swelling around the injection site. The pharmacist reported that the patient's physician had left the hospital and can no longer be reached. Patient was treated with TYLENOL and sought medical attention, but how was unknown. There were none lab diagnostics studies performed. At the time of reporting, patient's outcome was not recovered. Action taken with PNEUMOVAX 23 was not applicable. The relatedness between the events and PNEUMOVAX 23 was unknown. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unknown number of adults patients with unspecified age, gender, pertinent medical history or drug reaction/allergies. On an unspecified date, the patients were vaccinated with ZOSTAVAX (dose, lot numbers were not reported). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the reporting stated that unknown number of adults were vaccinated with improperly stored ZOSTAVAX. Treatment was not reported. The patient's outcome were not reported. No adverse event was reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. This is a report from several reports from the same source. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: This spontaneous report as received from a pharmacist via a field employee refers to a 60 year old male patient. On an unknown date the patient was vaccinated with a single 0.65 ml dose of ZOSTAVAX. No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient developed a rash that started at the injection and spread to the jaw. The patient sought unspecified medical attention. No treatment information was reported. At the time of the report, the outcome of the events was reported as recovering. Additional information is not expected.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 years old male patient with none Drug Reactions/Allergies. The patient was vaccinated IM with a dose of PNEUMOVAX 23 (Lot number HO 09826; expiration date 11-FEB-2014) into the right arm on 01-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. On 01-OCT-2012, following the PNEUMOVAX 23, the patient developed decreased mobility in his right arm. No treatment was given for the event. At the time of the report, the patient had not recovered from decreased mobility in his right arm. The relatedness for decreased mobility in his right arm was not reported for PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site rash, Injection site streaking, Pyrexia
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age. The patients were vaccinated with PNEUMOVAX 23 (dose and route were unknown, lot # reported as H013581, expiration date 03-MAR-2014). The reporter requested a lot # check. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patients experienced redness around injection site, rash around injection site and fever. The patients sought medical attention by an office visit. No treatment information was reported. The reporter did not have detailed individual patient information but she said 6 patients experienced redness and rash around injection site and a couple of patients experienced fever as well (patients without fever were captured in MARRS Case # 1210USA013157, same reporter link) and one patient experienced "red streak" around injection site (MARRS Case # 1211USA001593, same reporter link). the outcome of rash around injection site, redness around injection site and fever is unknown. The relatedness for redness around injection site, rash around injection site, and fever was not reported for PNEUMOVAX 23. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a 41-year-old female patient. Current conditions included migraine, muscle inflammation, hypothyroidism, allergic to latex, allergic to sulfa and drug allergy. Historical drugs included cephalothin hydroxyzine, IMITREZ, PAXIL, penicillin, PROZAC, sulfa, vancomycin, sertraline and zolmitriptan. Patient experienced drug reactions/allergies with these drugs. On 06-OCT-2012 the patient was vaccinated with, 0.5 milliliter (ml) PNEUMOVAX 23 (lot # (H010661), expiration date unknown) intramuscularly. No concomitant medications were reported. The reporter mentioned that on 06-OCT-2012 patient developed fever after receiving PNEUMOVAX 23. Outcome of the reported event was unknown. It was unknown whether this was a 1st dose or (reported as of) 2nd dose. Patient sought medical attention, but unknown how did she sought it. No further information is available. This is second of the two reports from the same source. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Abdominal discomfort, Abdominal distension, Maternal exposure during pregnancy, Nausea, Ultrasound antenatal screen
Clinical narrative: This spontaneous prospective pregnancy report as received from a registered nurse refers to a 19 years old female patient with no pertinent medical history and no Drug Reactions/Allergies. The patient was vaccinated SC with a dose of VARIVAX (Merck) (lot number 671027/1067AA; expiration date 05-JUL-2013) on 30-JUL-2012. No other co-suspects were reported. Concomitant medications included cefdinir and pseudoephedrine. On 29-OCT-2012, the patient went to the physician's office with complaints of "upset stomach and nausea". The physician noticed that the patient's abdomen was distended. ZOFRAN was given for the nausea. The patient reported that her last menstrual period was on 15-OCT-2012 and that she has been experiencing menstrual periods on a regular basis. She was sent for an ultrasound on 30-OCT-2012. The ultrasound found that the patient was pregnant and might have been pregnant since May of 2012. The patient was exposed to VARIVAX (Merck) during trimester 1 and 2. On an unspecified date, the nausea resolved. At the time of the report, the patient's outcome for menstrual periods on a regular basis was unknown. The patient continued to be pregnant. The relatedness for patient's abdomen was distended and menstrual periods on a regular basis was not reported for VARIVAX (Merck). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site rash, Injection site streaking
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown. The patient was vaccinated with PNEUMOVAX 23 (dose and route were unknown, Lot # reported as H013581, expiration date 03-MAR-2014). The reporter requested a Lot # check. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced redness around injection site, rash around injection site, and "red streak" around injection site. The patient sought medical attention by an office visit. No treatment information was reported. The reporter did not have detailed individual patient information but she said 6 patients redness and rash around injection site and a couple of patients experienced fever as well (MARRS Case # 1210USA013157 and MARRS Case # 1211USA001592 respectively, same reporter link) and one patient experienced "red streak" around injection site. The outcome of rash around injection site, redness around injection site and "red streak" around injection site is unknown. The relatedness for redness around injection site, rash around injection site and "red streak" around injection site was not reported for PNEUMOVAX 23. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a male patient of unknown age. The patient was vaccinated with ZOSTAVAX (lot # was unknown) on unknown date. On an unknown date the patient experienced redness and tenderness at injection site that subsided after few days. The patient did not seek medical attention. No treatment information was reported. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age who on 09-OCT-2012 was vaccinated on left arm with a dose of ZOSTAVAX (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that initially post vaccinated the patient experienced some soreness after the injection, which resolved. Now weeks later, the patient had left arm pain throughout her whole arm, not at injection site. No swelling, no rash and no warmth. The pharmacist stated that the patient was doing some gardening recently and did not know if that could be attributed to the pain. The patient sought medical attention, she talked with the pharmacist. The patient did not receive any treatment for the event. At the time of the report, the patient had not recovered from the adverse event. The relatedness for the adverse events was unknown for ZOSTAVAX. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient who was vaccinated oral with ROTATEQ (lot # (669476/1529Z, 03-SEP-2012) on 08-OCT-2012. It is not known which dose in the ROTATEQ vaccination series this is. No adverse effect reported. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site streaking, Injection site swelling
Clinical narrative: This spontaneous report was received from a registered pharmacist refers to an approximately 70-year-old female patient with no drug reactions or allergies. On 13-SEP-2012 the patient was vaccinated with a dose of ZOSTAVAX (lot # 0242AE, expiration date 01-APR-2013) dose and route not reported. No concomitant medications were reported. Pharmacist reported that the patient experienced a painful red line going down from injection site down to her elbow after receiving ZOSTAVAX. It was red, little bit swollen and painful, and the red line appeared approximately on an unknown date in September 2012, within a couple of days of receiving ZOSTAVAX. Patient applied some cold packs to the area and pain was relieved. Patient came in on 03-OCT_2012 (reported as yesterday) and spoke to pharmacist. Patient still had about 2 inches of line going down from the injection site. The event pain resolved on an unknown date. The event red line did not resolve at the time of this report. The outcome of other reported events were unknown. The patient sought medical attention by speaking to the pharmacist. The is one of several reports from the same reporter. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacy technician refers to a 63-year-old male patient. Concurrent conditions included allergy to drugs such as simvastatin (manufacturer unknown) and cholestyramine. Patient experienced both allergies and unspecified adverse events (AE's) with cholestyramine in the past. On 06-OCT-2012 the patient was vaccinated with PNEUMOVAX 23 (lot # H010661), expiration date unknown) intramuscularly. No concomitant medications were reported. The reporter mentioned a patient received PNEUMOVAX 23 approximately on 06-OCT-2012 and developed fever. It was unknown if this was the 1st dose or 2nd dose of PNEUMOVAX 23. Patient sought medical attention for the event but how he sought it was unknown. The outcome of the reported event was unknown. No further information is available. This is one of the two reports from the same reporter. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report as received from a registered nurse refers to a now 38 years old female patient without pertinent medical history. The patient received 3 doses of RECOMBIVAX HB (lot number, dose, route and injection site were not reported) on an unspecified date "years ago". No other co-suspects were reported. There was no concomitant medication. The patient was found to have negative hepatitis B antibody titers. There was no treatment given for adverse event. Laboratory diagnostics study hepatitis B antibody titer was performed. The present status of the patient was negative antibody titer at the time of report. The patient had an office visit for medical attention. Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a female patient of unknown age regarding herself. Approximately on 28-SEP-2012 (reported as last Friday) the patient was vaccinated with VARIVAX (lot # not reported) single vial dose. The patient stated that instead of receiving the ZOSTAVAX (Merck) her physician had accidentally given her the VARIVAX (merck). The physician may have ordered the incorrect product for the patient. No adverse reactions. No further adverse event (AE) information was reported. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash, Pruritus generalised
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 73 year old female patient. Drug reactions and allergies were reported as none. On 05-OCT-2012, the patient was vaccinated with ZOSTAVAX (dosing details and route was not reported). Lot number was reported as H012577 and expiry date as 28-SEP-2013. No concomitant medications were reported. The patient had called the pharmacy the next day on 06-OCT-2102 and complained of rash around injection site that was 5 inch in diameter and itching. The patient reported to the pharmacist that itching was not just around injection site but all over the body and the pharmacist recommended BENADRYL. On 07-OCT-2012, the pharmacist followed up with the patient and the patient stated that the itching was better and was reduced to just around the injection site. The outcome of rash around injection site that was 5 inch in diameter and itching was reported as recovering/resolving. The patient experienced similar adverse events with PNEUMOVAX 23 and AFLURIA: 1210USA004393 and 1210USA004394. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Axillary pain, Fatigue, Malaise, Pyrexia, Swelling
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 05-OCT-2012 the patient was vaccinated with PNEUMOVAX23 (lot # H013847, expiration date unknown) dose and route not reported. No concomitant medications were reported. The physician reported that the patient experienced adverse effects of malaise, fatigue, swelling, fever and under-arm pain. The date of birth was not available for this patient nor was the specific information about the patient. The patient did not recover from the reported events as the time of this report. Treatment was not given for the events. The patient sought medical attention by notifying the physician. The physician was enquiring if there had been an increased in reports of adverse effects from this lot of PNEUMOVAX23 and was it possible that this lot of PNEUMOVAX23 was contaminated. This one of the several reports from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Myositis
Clinical narrative: This spontaneous report was received from a 65-year-old female patient regarding herself. The patient was vaccinated with, 0.65 milliliter (ml) ZOSTAVAX (lot # 03668AE, expiration date 23-MAR-2013) subcutaneously on 15-SEP-2012. The patient did not have any pertinent medical history and drug reactions/allergies. Concomitant medications included sertraline hydrochloride, SINGULAIR, PREMARIN, FLONASE and topiramate. Patient reported that after receiving ZOSTAVAX she developed inflammation in her lower back which spread to her neck on 16-SEP-2012. She stated it was not a rash, but muscle inflammation on 16-SEP-2012. The patient went to her doctor who gave an injection of a muscle relaxant, and also prescribed some pain and anti-inflammatory medication. The patient stated her condition had improved but she had not yet recovered. The events were resolving. Additional information is not expected.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 73 years old female patient with drug allergies to codeine. The patient was subcutaneously vaccinated with a dose of 0.65 ZOSTAVAX (lot number reported as 0565AE, expiry date 23-MAR-2013) on 22-OCT-2012. NO other co-suspects were reported. No concomitant medications were reported. On an unknown date of October 2012, the patient experienced redness, itching, swelling and soreness around injection site after receiving ZOSTAVAX. The patient also developed little "pinkish" area within the redness around injection site and she went to see physician. The physician (name unspecified0 prescribed antibiotic (name unspecified) for the patient. The outcome of redness around injection site, little "pinkish" area within the redness around injection site, soreness around injection site, swelling around injection site and itching around injection site was unknown. Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site mass
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 years old female patient with not known allergies. The patient was vaccinated SC with a dose of ZOSTAVAX (Lot number H013020, expiration date: 09-OCT-2013) 0.65 ml into the right arm on 27-OCT-2012. Other suspect therapies included influenza virus vaccine (unspecified) (manufacturer unknown) (Lot number, dose and route not reported) into the left arm, on an unspecified date. No concomitant medications were reported. Pharmacist reported that in approximately 27-OCT-2012, the patient developed a lump at the injection site of right arm. No treatment information was reported. At the time of the report, the patient had not recovered from lump at the injection site of right arm. The relatedness for lump at the injection site of right arm was not reported for ZOSTAVAX and influenza virus vaccine (unspecified) (manufacturer unknown). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Oedema peripheral, Pain in extremity, Pyrexia, Skin warm, Tenderness
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. The patient had no pertinent medical history and no drug reactions or allergies. The patient was vaccinated with PNEUMOVAX23 (lot number reported as H013847, expired date 15-MAR-2014) (dose, frequency and injection site were not reported) intramuscular injection on an unknown date in October 2012 (within the past ten days). No other co-suspects were reported. There was no concomitant medication. The physician reported that he saw the patient day after vaccination and that the patient presented with swelling of the upper arm in the mid-bicep region, warmth, (the area was hot to the touch"), tenderness and pain. The patient might have had a low-grade fever. The patient started on unspecified antibiotics and mild analgesics. The patient was recovering at the time of report. There was no laboratory diagnostics studies performed. The patient had an office visit for medical attention. Physician requests a lot check for the PNEUMOVAX23. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, Incorrect dose administered
Clinical narrative: This spontaneous report was received from a doctor of pharmacy refers to a patient of unknown age and gender. Information regarding the patient's medical history was not provided. In 2011 (reported as 'last year on an unspecified date') the patient was vaccinated with dose 1 ZOSTAVAX (dose, lot number, and route not provided). No other co-suspects were reported. No concomitant medications were reported. On 10-OCT-2012, the patient received a second dose of ZOSTAVAX (dose and route not reported). The lot number for the second dose was reported as H012575 with expiry date 28-SEP-2012. The reporter did not state if the patient was experiencing any adverse effects. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unknown number of children patients with unspecified age, gender, pertinent medical history or drug reaction / allergies. On an unspecified date, the patients were vaccinated with improperly stored VARIVAX (Merck) (dose, lot numbers were not reported). No other co-suspects were reported. No concomitant medications were reported. Treatment was not reported. The patients' outcome were not reported. No adverse effects reported at this time. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. This is a report from several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Axillary pain, Fatigue, Malaise, Pyrexia, Swelling
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. on 05-OCT-2012 the patient was vaccinated with PNEUMOVAX 23 (lot # H013847, expiration date unknown) dose and route not reported. No concomitant medications reported. The physician reported that the patient experienced adverse effects of malaise, fatigue, swelling, fever and under-arm pain. The date of birth was not available for this patient nor was the specific information about the patient. The patient did not recover from the reported events at the time of this report. Treatment was not given for the events. The patient sought medical attention by notifying the physician. The physician was enquiring if there had been an increase in reports of adverse effects from this lot of PNEUMOVAX 23 and was it possible that this lot of PNEUMOVAX 23 was contaminated. This is one of the several reports from the same reporter. Additional information has been requested.