chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Injury associated with device, Underdose
Clinical narrative: This spontaneous report was received from a female licensed practical nurse of unknown age reporting on herself, who on unknown dates was vaccinated with the full childhood vaccination series of RECOMBIVAX HB or Hepatitis C vaccine (manufacturer unknown) (route, lot numbers and expiration date were not provided). No suspect or concomitant medications were reported. The licensed practical nurse reported that on an unknown date (reported as recently), she had a titer done for Hepatitis B, and the Hepatitis B titer test was negative or low, even though she had completed the full childhood vaccination series of Hepatitis B vaccine (manufacturer unknown, but RECOMBIVAX HB could not be ruled out at the time of the call). The nurse reported that a decision was made to administered three more doses of RECOMBIVAX HB and then repeat the test. About a week ago, on approximately on 26-MAR-2014, she received a dose pediatric RECOMBIVAX HB (0.5 ml dose) rather than the adult dose (no product confusion discovered, just a medication error; no adverse events reported). The nurse also reported that she had a needle stick (unspecified date and unspecified product involved). At the time of the report, outcome of hepatitis test was negative or low was unknown. Additional information is not expected.
Age: 19.0
Sex: M
Vaccine: FLUN4, SMALL
Symptoms: Pericardial disease
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 31 March 2014. A 19-year-old male subject, with no reported medical history, received ACAM2000 (lot not reported) and Influenza Vaccine (live intranasal, other manufacturer) on 13 November 2013. He had also received Anthrax vaccine (other manufacturer) on 04 November 2013. On 24 November 2013, i.e. 11 days post-vaccination, the subject was diagnosed with unspecified disease of pericardium. Laboratory test results were not available, and outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Chest discomfort, Electrocardiogram normal, Troponin I increased
Clinical narrative: This study case was received on 01 April 2014 from the investigator in a trial. A 29 year old male subject with no relevant past medical history, developed chest pressure 5 days after he received the following vaccines: an injection of ACAM2000, SP Biologics Co., (lot number, route, site and side not reported) and concomitantly, an injection of ANTHRAX, other manufacturer, (lot number, route, site and side not reported) on 17 March 2014. On 22 March 2014, five days later, the subject developed one brief episode of chest pressure which worsened with inspiration, considered mild in severity with no other symptoms. On 27 March 2014, a Troponin I level was reported as <0.10 ng/mL. An electrocardiogram on 27 March 2014 was reported as normal. The subject did not take any medications to treat the event. The stop date of adverse events was reported as recovered/resolved on 23 March 2014. No further information was expected to follow. According to the investigator, the event of chest pressure were considered an other important medical event and possibly related to the trial product. Documents held by sender: None.
Age: 13.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 3 year old patient (gender unknown). The nurse reported that the patient received a dose of PROQUAD (merck) on 27-MAR-2014 in error instead of a dose included M-M-R II. The nurse reported that the patient had two previous doses of M-M-R II. The first dose of M-M-R II was given on 23-APR-2002 and the second dose was administered on 28-SEP-2004, but the second dose of M-M-R II was unverified in a vaccination database and a decision was made to administer another dose of M-M-R II. The nurse reported that the patient had received two previous doses of VARIVAX (merck), the first dose on 23-APR-2002 and the second dose of VARIVAX (merck) was on 16-NOV-2004. No adverse effect reported with the dose of PROQUAD. No product confusion discovered, just medication error. This is one of several reports received from the same reporter. Additional information is not expected.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a 74 Year old female patient with no drug reactions or allergies. On 15-APR-2008 the patient was vaccinated with a dose of ZOSTAVAX, "1 time vaccine", to prevent shingles; lot # and dose not reported. Concomitant therapies included LIPITOR and "low thyroid medication". On approximately 20-MAR-2014 (reported as "about two weeks ago") the patient developed shingles. She stated that she got the shingles on her right breast, between both breasts and her "scapula". The patient sought unspecified medical attention and was given antivirals, pain medication and "prednisone". The outcome of the adverse effect was not reported. Relatedness between use of ZOSTAVAX and shingles development was not reported. Additional information has been requested.
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Pain in extremity, Pyrexia, Skin warm
Clinical narrative: Pt said after getting shot 6 hours later she is getting 102 degree fever. Sore arm and warm to touch.
Age: 39.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Chills, Musculoskeletal stiffness, Pain in extremity, Pyrexia
Clinical narrative: Onset 4 days ago, following Tdap (R arm) and pnuemovax (L arm) injection. On R, ipsilateral side to Tdap injection, although Pt recalled this as pnuemovax side. Vaccine indicated 2/2 smoking status. Subjective fever. Arm hurt, body stiff, chills, no local redness or swelling at injection site. Improving. Was still able to go to work despite this problem. Took ibuprofen for swelling, which helped.
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Cellulitis, Injection site erythema, Injection site streaking
Clinical narrative: PT had red streak from site of injection to his chest and was given antibiotics.
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Blister, Blood pressure increased, Diarrhoea, Local swelling, Neck pain
Clinical narrative: Client started with diarrhea 2-3 loose stools/day.  4/2/12 during the evening she started with a rash on her Left arm. She was still having diarrhea.  Rash spread to face, chin, neck, both arms, wrist, hands and ears.  Describes rash as very itchy.  Areas looked like blisters and some were fluid filled.  They were different sizes. Areas eventually crust over like "an old mosquito bite without the swelling".  Also complained of extreme achiness and swelling of hands arms feet and neck.  Client's blood pressure has increased and is now on blood pressure medication. Still had rash at time of phone call 4/7/14.
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Pain in extremity, Rash pruritic, Scab
Clinical narrative: Client started with diarrhea 2-3 loose stools/day.  4/2/12 during the evening she started with a rash on her Left arm. She was still having diarrhea.  Rash spread to face, chin, neck, both arms, wrist, hands and ears.  Describes rash as very itchy.  Areas looked like blisters and some were fluid filled.  They were different sizes. Areas eventually crust over like "an old mosquito bite without the swelling".  Also complained of extreme achiness and swelling of hands arms feet and neck.  Client's blood pressure has increased and is now on blood pressure medication. Still had rash at time of phone call 4/7/14.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Eye irritation, Injection site erythema, Injection site pruritus, Injection site swelling, Local reaction
Clinical narrative: 5 minutes after injection of flu vaccine patient developed a red raised itchy spot at injection site. 25mg oral Benadryl patient was given. Patient complained 15 minutes later of increased itching over body and was rubbing eyes. 150 mg of Ranitidine was given PO. Observed for another 60 minutes in office, local reaction was no longer raised or reddened. Patient was sleepy but stable with normal respirations, no shortness of breath or wheezing noted.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised, Somnolence
Clinical narrative: 5 minutes after injection of flu vaccine patient developed a red raised itchy spot at injection site. 25mg oral Benadryl patient was given. Patient complained 15 minutes later of increased itching over body and was rubbing eyes. 150 mg of Ranitidine was given PO. Observed for another 60 minutes in office, local reaction was no longer raised or reddened. Patient was sleepy but stable with normal respirations, no shortness of breath or wheezing noted.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: PATIENT DESCRIBES DEEP ACHE IN RIGHT ARM THAT STARTED A DAY AFTER VACCINE ADMINISTRATION.  SHE REPORTS NOT BEING ABLE TO LIFT HER ARM VERY MUCH.  SHE HAS BEEN SELF MEDICATING WITH IBUPROFEN AND ICE PACKS AS DIRECTED BY ADMINISTERING PHARMACIST AND HER OWN PHYSICIAN.  AS OF 3 DAYS AFTER ADMINISTRATION, SYMPTOMS HAVE NOT SUBSIDED MUCH.
Age: 22.0
Sex: F
Vaccine: HEPA
Symptoms: Activities of daily living impaired, Asthenia, Burning sensation, Cardiac disorder, Cardiac flutter
Clinical narrative: The night after the hepatitis a vaccine I noticed my legs were tingling and felt very weird while I was trying to go to sleep.  I went to sleep and got up the next day and went to work.  My legs still felt very odd and weak.  Over the next few days and weeks I experienced tingling, burning pain in my legs and arms.  Around week 4 I noticed it felt hard to breathe.  I would not be able to fall asleep at night because it felt like if I wasn't awake to think to breathe I would stop breathing.  My heart would also feel like it was fluttering or beating weird.  I went to several doctors through out these 10 weeks because none seemed to take me seriously or really be knowledgeable about what this could be.  I was so weak and didn't have energy to do much.  I had to stop working and only worked one hour every 30 days in order to keep my job.  It was all I could do to go to school and come home.  I have always enjoyed exercise and still have not exercised in over 10 weeks now.  Between weeks 3-6 it got very hard to walk.  I would notice myself using my hands to stand up out of a chair.  I also had bad headaches during this time.  I literally felt weird, tingling sensations in my head.  It has now been over 10 weeks, and I still have nerve pain (burning, tingling), especially in my legs and butt area.  I get tired very easily and feel weak still but am doing much better than I have been.  I will get sharp pains in my shoulders or arms and legs occasionally too.
Age: 22.0
Sex: F
Vaccine: HEPA
Symptoms: Chest X-ray normal, Computerised tomogram abnormal, Dyspnoea, Dysstasia, Electrocardiogram normal
Clinical narrative: The night after the hepatitis a vaccine I noticed my legs were tingling and felt very weird while I was trying to go to sleep.  I went to sleep and got up the next day and went to work.  My legs still felt very odd and weak.  Over the next few days and weeks I experienced tingling, burning pain in my legs and arms.  Around week 4 I noticed it felt hard to breathe.  I would not be able to fall asleep at night because it felt like if I wasn't awake to think to breathe I would stop breathing.  My heart would also feel like it was fluttering or beating weird.  I went to several doctors through out these 10 weeks because none seemed to take me seriously or really be knowledgeable about what this could be.  I was so weak and didn't have energy to do much.  I had to stop working and only worked one hour every 30 days in order to keep my job.  It was all I could do to go to school and come home.  I have always enjoyed exercise and still have not exercised in over 10 weeks now.  Between weeks 3-6 it got very hard to walk.  I would notice myself using my hands to stand up out of a chair.  I also had bad headaches during this time.  I literally felt weird, tingling sensations in my head.  It has now been over 10 weeks, and I still have nerve pain (burning, tingling), especially in my legs and butt area.  I get tired very easily and feel weak still but am doing much better than I have been.  I will get sharp pains in my shoulders or arms and legs occasionally too.
Age: 22.0
Sex: F
Vaccine: HEPA
Symptoms: Fatigue, Feeling abnormal, Full blood count normal, Gait disturbance, Headache
Clinical narrative: The night after the hepatitis a vaccine I noticed my legs were tingling and felt very weird while I was trying to go to sleep.  I went to sleep and got up the next day and went to work.  My legs still felt very odd and weak.  Over the next few days and weeks I experienced tingling, burning pain in my legs and arms.  Around week 4 I noticed it felt hard to breathe.  I would not be able to fall asleep at night because it felt like if I wasn't awake to think to breathe I would stop breathing.  My heart would also feel like it was fluttering or beating weird.  I went to several doctors through out these 10 weeks because none seemed to take me seriously or really be knowledgeable about what this could be.  I was so weak and didn't have energy to do much.  I had to stop working and only worked one hour every 30 days in order to keep my job.  It was all I could do to go to school and come home.  I have always enjoyed exercise and still have not exercised in over 10 weeks now.  Between weeks 3-6 it got very hard to walk.  I would notice myself using my hands to stand up out of a chair.  I also had bad headaches during this time.  I literally felt weird, tingling sensations in my head.  It has now been over 10 weeks, and I still have nerve pain (burning, tingling), especially in my legs and butt area.  I get tired very easily and feel weak still but am doing much better than I have been.  I will get sharp pains in my shoulders or arms and legs occasionally too.
Age: 22.0
Sex: F
Vaccine: HEPA
Symptoms: Impaired work ability, Initial insomnia, Metabolic function test normal, Muscular weakness, Musculoskeletal pain
Clinical narrative: The night after the hepatitis a vaccine I noticed my legs were tingling and felt very weird while I was trying to go to sleep.  I went to sleep and got up the next day and went to work.  My legs still felt very odd and weak.  Over the next few days and weeks I experienced tingling, burning pain in my legs and arms.  Around week 4 I noticed it felt hard to breathe.  I would not be able to fall asleep at night because it felt like if I wasn't awake to think to breathe I would stop breathing.  My heart would also feel like it was fluttering or beating weird.  I went to several doctors through out these 10 weeks because none seemed to take me seriously or really be knowledgeable about what this could be.  I was so weak and didn't have energy to do much.  I had to stop working and only worked one hour every 30 days in order to keep my job.  It was all I could do to go to school and come home.  I have always enjoyed exercise and still have not exercised in over 10 weeks now.  Between weeks 3-6 it got very hard to walk.  I would notice myself using my hands to stand up out of a chair.  I also had bad headaches during this time.  I literally felt weird, tingling sensations in my head.  It has now been over 10 weeks, and I still have nerve pain (burning, tingling), especially in my legs and butt area.  I get tired very easily and feel weak still but am doing much better than I have been.  I will get sharp pains in my shoulders or arms and legs occasionally too.
Age: 22.0
Sex: F
Vaccine: HEPA
Symptoms: Nerve conduction studies normal, Neuralgia, Pain in extremity, Paraesthesia, Urine analysis normal
Clinical narrative: The night after the hepatitis a vaccine I noticed my legs were tingling and felt very weird while I was trying to go to sleep.  I went to sleep and got up the next day and went to work.  My legs still felt very odd and weak.  Over the next few days and weeks I experienced tingling, burning pain in my legs and arms.  Around week 4 I noticed it felt hard to breathe.  I would not be able to fall asleep at night because it felt like if I wasn't awake to think to breathe I would stop breathing.  My heart would also feel like it was fluttering or beating weird.  I went to several doctors through out these 10 weeks because none seemed to take me seriously or really be knowledgeable about what this could be.  I was so weak and didn't have energy to do much.  I had to stop working and only worked one hour every 30 days in order to keep my job.  It was all I could do to go to school and come home.  I have always enjoyed exercise and still have not exercised in over 10 weeks now.  Between weeks 3-6 it got very hard to walk.  I would notice myself using my hands to stand up out of a chair.  I also had bad headaches during this time.  I literally felt weird, tingling sensations in my head.  It has now been over 10 weeks, and I still have nerve pain (burning, tingling), especially in my legs and butt area.  I get tired very easily and feel weak still but am doing much better than I have been.  I will get sharp pains in my shoulders or arms and legs occasionally too.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Large red and swollen area, painful surrounding injection site, approximately two inches in diameter- upped thigh.
Age: 1.0
Sex: U
Vaccine: MMR, MMRV
Symptoms: Drug label confusion, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse refers to a 1 year old patient of unknown gender. The patient's current conditions or medical history were not reported. On 27-MAR-2014, also reported as yesterday, the patient was vaccinated with a dose of PROQUAD (Merck) and VARIVAX (Merck) (at the same office visit, separate sites) (dose, route, lot numbers and expiration dates were not reported) instead of M-M-R II and VARIVAX (Merck). The nurse reported that the labels of M-M-R II (Merck) and PROQUAD (Merck) had similar coloration and M-M-R II appears first on the PROQUAD (Merck) label. However the nurse felt that the error was medication error rather than product confusion. No adverse effect reported. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Dizziness, Herpes zoster, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 50 year old female patient with asthma, bronchitis, upper respiratory tract infections, cigarette smoker and allergy to codeine. On 18-MAR-2014 the patient was vaccinated with ZOSTAVAX lot # J012658, 0.65 ml, subcutaneous in the left arm. Dose was not reported. The nurse reported that the patient developed, on 18-MAR-2014, an area of shingles on her left arm, at the injection site after receiving ZOSTAVAX. The injection site was also red, raised and painful. The patient had also been experiencing diarrhea, dizziness and lightheadedness. The patient reported to the physician assistant that she had to use her inhaler (brand or type unspecified). Ice had been applied to the injection site. The patient sought medical attention (office visit). The outcome of developed an area of shingles on her left arm, at the injection site, also been experiencing lightheadedness, also been experiencing dizziness, also been experiencing diarrhea, injection site painful, injection site raised and injection site red was reported as not recovered/not resolved. Reporter causality assessment was not reported. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 50 year old female patient with asthma, bronchitis, upper respiratory tract infections, cigarette smoker and allergy to codeine. On 18-MAR-2014 the patient was vaccinated with ZOSTAVAX lot # J012658, 0.65 ml, subcutaneous in the left arm. Dose was not reported. The nurse reported that the patient developed, on 18-MAR-2014, an area of shingles on her left arm, at the injection site after receiving ZOSTAVAX. The injection site was also red, raised and painful. The patient had also been experiencing diarrhea, dizziness and lightheadedness. The patient reported to the physician assistant that she had to use her inhaler (brand or type unspecified). Ice had been applied to the injection site. The patient sought medical attention (office visit). The outcome of developed an area of shingles on her left arm, at the injection site, also been experiencing lightheadedness, also been experiencing dizziness, also been experiencing diarrhea, injection site painful, injection site raised and injection site red was reported as not recovered/not resolved. Reporter causality assessment was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report was received from a female consumer of an unknown age, via a company representative. medical history and concurrent conditions were not reported. On 24-MAR-2014, the patient was vaccinated with ZOSTAVAX (dose, strength, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. On 26-MAR-2014, the patient developed a red, slightly itchy oval that was 1.5 by 2.5 inches at the injection site. On 27-MAR-2014, the oval had grown to 2.5 by 4 inches and she had put ice on it that night. ON 28-MAR-2014, the redness had gotten lighter and she put ice on it that night as well. On 29-MAR-2014, the color was barely discernible. At the time of the report the outcome was recovering. Additional information has been requested.
Age: 0.75
Sex: U
Vaccine: MMR
Symptoms: Drug administered to patient of inappropriate age, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to a 9 month old patient of unknown gender. The medical assistant reported that on 16-AUG-2010, the patient was administered the first dose of M-M-R II (route unspecified, lot number and expiration date not reported) at less than 12 months of age (9 month old). There was no concomitant medication reported. The medical assistant also reported that on 27-SEP-2012, the patient was administered the second dose of M-M-R II (0.5 ml subcutaneous, lot number and expiration date not reported) at less than 4 to 6 years of age (34 month old). No adverse events were reported. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: This spontaneous report as received from a female consumer of unknown age reporting on herself. On 26-MAR-2014, "last Wednesday", the patient was vaccinated with a dose of ZOSTAVAX (route and lot # not reported). The consumer reported that in 2014, "reported as now", she had red rectangular welt at the injection site. The outcome of red rectangular welt at the injection site was unknown. Additional information is not expected.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a female consumer regarding herself. Patient's historical condition included herpes virus. Patient's drug reactions/allergies included penicillin-developed a rash. Approximately in March 2014 (also reported as "last week") the patient was vaccinated with ZOSTAVAX, subcutaneous. Approximately in March 2014, the patient reported that "next day" a "2 inch line that was a 1/2 inch thick" developed at the injection site as well as itchiness, warm to touch and a "dark pink" appearance at the injection site. On unknown date, the patient received treatment for the adverse event and she was informed by the pharmacist to apply BENADRYL cream. No bad diagnostics studies were performed. The outcome of injection site warm to touch, "dark pink" appearance at the injection site, injection site as well as itchiness and "2 inch line that was a 1/2 inch thick" developed at the injection site was reported as not recovered/not resolved. This is one of two reports from the same source. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old patient. The patient's pertinent medical history included previous therapy with CRESTOR, Hydroxyzine, Fluocinonide Cr (manufacturer unknown) FLONASE and a drug reaction/allergy to sulfa. On 25-MAR-2014, the patient was vaccinated with a dose of ZOSTAVAX vial (dose, route, lot number and expiration date were not reported). On an unspecified date in March 2014, (patient called (contacted) the pharmacy yesterday 27-MAR-2014, exact start date of the injection site reaction was unspecified) the patient developed an injection site reaction described as red, swollen, warm and sore following vaccination with ZOSTAVAX. At the time of the report, the patient was not recovered from injection site reaction. The patient went to the pharmacist for medical attention. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report as received from a company representative from an unknown reporter though a conference refers to a patient of unknown demographics. The patients current conditions or medical history were no reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX vial 19400 PFU (dose, route, lot number and expiration date were not reported). On an unknown date, the patient experienced an unspecified adverse reaction. At the time of the report outcome of unspecified adverse reaction was unknown. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 54 year old female patient who on 11-MAR-2014, was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot number H0119996) that was expired, the patient was vaccinated at health clinic. The vaccine expired on 02-FEB-2014. No adverse effects were reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV2, MNQ, HPV2, MNQ
Symptoms: Blood test normal, Borrelia test negative, Culture urine negative, Cytomegalovirus test negative, Dizziness
Clinical narrative: Dizziness, vertigo, headaches, fatigue. Seen by primary care physician and a neurologist. Bloodwork: Mono, Lyme testing, CBC, CMV, ESR, Thyroid and urine cultures - normal.
Age: 17.0
Sex: F
Vaccine: HPV2, MNQ, HPV2, MNQ
Symptoms: Fatigue, Full blood count normal, Headache, Mononucleosis heterophile test negative, Red blood cell sedimentation rate normal
Clinical narrative: Dizziness, vertigo, headaches, fatigue. Seen by primary care physician and a neurologist. Bloodwork: Mono, Lyme testing, CBC, CMV, ESR, Thyroid and urine cultures - normal.
Age: 17.0
Sex: F
Vaccine: HPV2, MNQ, HPV2, MNQ
Symptoms: Thyroid function test normal, Vertigo
Clinical narrative: Dizziness, vertigo, headaches, fatigue. Seen by primary care physician and a neurologist. Bloodwork: Mono, Lyme testing, CBC, CMV, ESR, Thyroid and urine cultures - normal.
Age: 17.0
Sex: F
Vaccine: HPV2, MNQ, HPV2, MNQ
Symptoms: Blood test, Condition aggravated, Fatigue, Headache, Mononucleosis heterophile test negative
Clinical narrative: Dizziness, vertigo, headaches, fatigue. Seen by primary care physician and a neurologist. Bloodwork: Mono, Lyme testing, CBC, CMV, ESR, Thyroid and urine cultures - normal.
Age: 17.0
Sex: F
Vaccine: HPV2, MNQ, HPV2, MNQ
Symptoms: Nuclear magnetic resonance imaging, Vertigo
Clinical narrative: Dizziness, vertigo, headaches, fatigue. Seen by primary care physician and a neurologist. Bloodwork: Mono, Lyme testing, CBC, CMV, ESR, Thyroid and urine cultures - normal.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Erythema, Local swelling, Pyrexia
Clinical narrative: Redness (left arm), feverish (left arm), swollen (left arm).
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Flushing, Skin warm
Clinical narrative: 2 cm area of erythema surrounded by flushed area, in total it is 4cm in diameter, warmth noted.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site rash, Injection site reaction, Injection site swelling, Local reaction
Clinical narrative: Reported to ER on 4/4/14 with left upper thigh localized reaction at injection site. Swelling, rash of upper (L) thigh. Cool compresses and TYLENOL for treatment (Rash was approx 9.5 cm x 6.5 cm).
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Immediate post-injection reaction, Injection site urticaria, Urticaria
Clinical narrative: Immediate wheal and erythema after injection of PROQUAD oral BENADRYL, improved but urticaria at site remained. No respiratory symptoms.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Expired drug administered
Clinical narrative: Pt was given expired vaccine PROQUAD exp 2/24/14 and was given 2/26/13. Merck contacted.
Age: 1.33
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC13
Symptoms: Injection site swelling
Clinical narrative: Swelling of right vastus lateralis.
Age: 1.03
Sex: M
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Unevaluable event
Clinical narrative: Patient waited in room 20 min. no reactions. Noted.
Age: 47.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chest pain, Dyspnoea, Pruritus generalised
Clinical narrative: Case number PHHY2012US111492, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 466695) website on 04 Dec 2012 with a follow up information received from the quality assurance department (QA reference number: 210025) on 01 Apr 2014. This report refers to a 47-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 1204521 expiry date: 31 May 2013) and PNEUMOVAX (other manufacturer, batch number: H010515) intramuscularly and subcutaneously respectively to her right arm on 24 Sep 2012. Patient reported of itching 10 minutes after receiving influenza and pneumonia vaccine around 2 PM EST and at 3:30 PM reported of itching all over body. Nurse called emergency line and at that time patient began to have SOB (shortness of breath) and chest pain. Nurse gave epinephrine as a treatment. Emergency Medical Team (EMT) arrived and took her to hospital. Outcome of the events were reported as complete recovery. Upon follow up receipt from the quality assurance department( reference number: 210025), it was reported that based on the documents review, the FLUVIRIN batch was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up information received from the quality assurance department on 01 Apr 2014: Batch summary and expiry date of vaccine updated.
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Case number PHHY2013US000831 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 470481) website on 02 Jan 2013 with a follow up information received from the quality assurance department (QA reference number: 209081) on 01 Apr 2014. This report refers to a 17-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number: 1204201, expiry date: 31 May 2013) intramuscularly on 13 Oct 2012. On the same day, due to nervousness at the time of vaccination he fainted shortly within a few seconds after vaccination. He recovered quickly, asked for some water and rested for 15 minutes. The outcome of the events was reported as recovered. The causality and seriousness of the events were not reported. Upon follow up receipt from the quality assurance department (reference number: 209081), it was reported that based on the documents review, the FLUVIRIN batch was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up information received from the quality assurance department on 01 Apr 2014: Batch summary and expiry date of vaccine updated.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Feeling hot, Nausea, Urticaria
Clinical narrative: Case number PHHY2013US000578 is an initial spontaneous report received from vaccine adverse event reporting system website (VAERS reference number: 473229) on 02 Jan 2013 with a follow up information received from the quality assurance department (QA reference number: 209086) on 01 Apr 2014. This report refers to a 24-year-old female patient. Her preexisting condition included of latex allergy. She was vaccinated with FLUVIRIN (batch number: 1204201, expiry date: 31 May 2013) intramuscularly in her arm on 02 Nov 2012. Ten minutes following her first flu shot, patient returned complaining of pain in her chest, feeling hot and nauseous. She also developed hives on her spine. Emergency medical service was called and the paramedics arrived in 15 minutes. She was administered diphenhydramine and was kept under observation. The final outcome was reported as condition unchanged as of 03 Nov 2012. The seriousness and causality were not reported. Upon follow up receipt from the quality assurance department (reference number: 209086), it was reported that based on the documents review, the FLUVIRIN batch was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up information received from the quality assurance department on 01 Apr 2014: Batch summary updated. Updated expiry date.
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Confusional state, Dizziness, Fall, Feeling hot
Clinical narrative: Case number PHHY2013US069459 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 477792) web site on 03 Jul 2013 and a follow-up received from Quality Assurance Department (reference number: 239171) on 03 Apr 2014. This report refers to a 13-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1206901) on to left arm on 07 Dec 2012. On the same day he fainted two minutes after the shot. It was reported that he fell backwards in waiting area bumping first buttocks and next back of head on floor. He seemed to be confused at first and was pale and warm (as per patient). He said that he felt dizzy, looked to be weak and complained of visual disturbances. He was placed on back with feet elevated and was given cold water to sip. He had no loss of consciousness. The final outcome was reported as complete recovery. The causality was not reported. Based on the investigation performed, QA department stated that, the FLUVIRIN (batch number: 1206901) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 239171) on 03 Apr 2014: Updated batch review report.
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Head injury, Pallor, Syncope, Visual impairment
Clinical narrative: Case number PHHY2013US069459 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 477792) web site on 03 Jul 2013 and a follow-up received from Quality Assurance Department (reference number: 239171) on 03 Apr 2014. This report refers to a 13-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1206901) on to left arm on 07 Dec 2012. On the same day he fainted two minutes after the shot. It was reported that he fell backwards in waiting area bumping first buttocks and next back of head on floor. He seemed to be confused at first and was pale and warm (as per patient). He said that he felt dizzy, looked to be weak and complained of visual disturbances. He was placed on back with feet elevated and was given cold water to sip. He had no loss of consciousness. The final outcome was reported as complete recovery. The causality was not reported. Based on the investigation performed, QA department stated that, the FLUVIRIN (batch number: 1206901) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 239171) on 03 Apr 2014: Updated batch review report.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling abnormal, Syncope
Clinical narrative: Case number PHHY2013US069426, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 478562) website on 03 Jul 2013, with the follow-up received from Quality Assurance Department (reference number: 239223) on 03 Apr 2014. This report refers to a 10-year-old male patient. His medical history was not reported. Concomitant medication included montelukast, FLOVENT and fluticasone. He was vaccinated with FLUVIRIN (batch number: 1206901) in the left arm on 08 Dec 2012. On the same day after vaccination he stated that he felt funny and fainted. He had an emergency doctor visit due to these events. The outcome was reported as completely recovered as of 08 Dec 2012. The seriousness and causality of the events was not reported. Based on the investigation performed, QA department stated that, the FLUVIRIN (batch number: 1206901) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 239223) on 03 Apr 2014: Updated batch review report.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Bradyphrenia, Computerised tomogram normal, Coronary artery disease, Diabetes mellitus, Diplegia
Clinical narrative: Case number PHHY2013US032649 is an initial spontaneous report from Vaccine Adverse Event Reporting System (VAERS ID 481970) received on 04 Apr 2013 with a follow up information received from the quality assurance department (QA reference number: 221549) on 03 Apr 2014. This report refers to a 66-year-old female patient. Her medical history included diabetes and coronary disease. She was vaccinated with FLUVIRIN (batch number 1207021, expiry date: 30 Jun 2013) in her left arm on 02 Jan 2013. On 03 Jan 2013, post vaccination she developed symmetrical intermittent paralysis of arms and legs. She had encephalopathy for seven days, fever, generalized global slowing of speech, thinking and motor function. Her CT scan of head was negative. Following these events she visited emergency room. The outcome of the events was reported as complete recovery as of 18 Jan 2013. The seriousness and causality assessment of the events was not reported. Upon follow up receipt from the quality assurance department (reference number: 221549), it was reported that based on the documents review, the FLUVIRIN batch was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up information received from the quality assurance department on 03 Apr 2014: Batch summary, batch number and expiry date of vaccine updated.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Encephalopathy, Hypokinesia, Pyrexia, Slow speech
Clinical narrative: Case number PHHY2013US032649 is an initial spontaneous report from Vaccine Adverse Event Reporting System (VAERS ID 481970) received on 04 Apr 2013 with a follow up information received from the quality assurance department (QA reference number: 221549) on 03 Apr 2014. This report refers to a 66-year-old female patient. Her medical history included diabetes and coronary disease. She was vaccinated with FLUVIRIN (batch number 1207021, expiry date: 30 Jun 2013) in her left arm on 02 Jan 2013. On 03 Jan 2013, post vaccination she developed symmetrical intermittent paralysis of arms and legs. She had encephalopathy for seven days, fever, generalized global slowing of speech, thinking and motor function. Her CT scan of head was negative. Following these events she visited emergency room. The outcome of the events was reported as complete recovery as of 18 Jan 2013. The seriousness and causality assessment of the events was not reported. Upon follow up receipt from the quality assurance department (reference number: 221549), it was reported that based on the documents review, the FLUVIRIN batch was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up information received from the quality assurance department on 03 Apr 2014: Batch summary, batch number and expiry date of vaccine updated.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Dysstasia, Full blood count, Headache, Immunoglobulin therapy
Clinical narrative: Case number PHHY2013US083978 is an initial spontaneous report received from a consumer (patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 488609) website on 06 Aug 2013 with a follow-up received from quality assurance department (QA ref. no.: 246003) on 03 Apr 2014. This report refers to a 62-year-old male patient. His medical history included hyperlipidemia, heart disease (unspecified) and seizures (last seizure on 19 Nov). His concomitant medication included atenolol, LIPITOR, phenytoin, Aspirin, BENADRYL and melatonin. He was vaccinated with FLUVIRIN (batch number: 123123) intramuscularly into left arm on 07 Dec 2012. On 09 Feb 2013, he experienced flu like symptoms, neck pain, headaches, and loss of ability to support himself, loss of ability to walk and loss of ability to protect airways. On 11 Feb 2013, he visited emergency department at hospital and then hospitalized from 14 Feb 2013 to 21 Feb 2013. He was in intensive care unit and his multiple systems were monitored. He underwent laryngoscopy, electronic testing, MRI (nuclear magnetic resonance imaging) of head (brain) and neck, lumbar puncture, complete blood count (CBC) test, comprehensive metabolic panel (CMP) test and liver function test (LFT). The results were not reported. He was diagnosed with post-vaccination viral syndrome. Guillain Barre Syndrome was ruled out. He received IV immunoglobulin (therapy) in the hospital. The outcome was reported as complete recovery as of 24 Mar 2013. Reporter assessed the case as serious (life threatening). Based on the batch review report received from the quality assurance department, it was concluded that the concerned FLUVIRIN (batch number: 123123) was manufactured in accordance with approved internal procedures and is in compliance with the current good manufacturing practices (cGMP) requirements. Follow-up received from Quality assurance department on 03 Apr 2014: Updated batch review report.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza like illness, Intensive care, Laryngoscopy, Liver function test, Lumbar puncture
Clinical narrative: Case number PHHY2013US083978 is an initial spontaneous report received from a consumer (patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 488609) website on 06 Aug 2013 with a follow-up received from quality assurance department (QA ref. no.: 246003) on 03 Apr 2014. This report refers to a 62-year-old male patient. His medical history included hyperlipidemia, heart disease (unspecified) and seizures (last seizure on 19 Nov). His concomitant medication included atenolol, LIPITOR, phenytoin, Aspirin, BENADRYL and melatonin. He was vaccinated with FLUVIRIN (batch number: 123123) intramuscularly into left arm on 07 Dec 2012. On 09 Feb 2013, he experienced flu like symptoms, neck pain, headaches, and loss of ability to support himself, loss of ability to walk and loss of ability to protect airways. On 11 Feb 2013, he visited emergency department at hospital and then hospitalized from 14 Feb 2013 to 21 Feb 2013. He was in intensive care unit and his multiple systems were monitored. He underwent laryngoscopy, electronic testing, MRI (nuclear magnetic resonance imaging) of head (brain) and neck, lumbar puncture, complete blood count (CBC) test, comprehensive metabolic panel (CMP) test and liver function test (LFT). The results were not reported. He was diagnosed with post-vaccination viral syndrome. Guillain Barre Syndrome was ruled out. He received IV immunoglobulin (therapy) in the hospital. The outcome was reported as complete recovery as of 24 Mar 2013. Reporter assessed the case as serious (life threatening). Based on the batch review report received from the quality assurance department, it was concluded that the concerned FLUVIRIN (batch number: 123123) was manufactured in accordance with approved internal procedures and is in compliance with the current good manufacturing practices (cGMP) requirements. Follow-up received from Quality assurance department on 03 Apr 2014: Updated batch review report.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Metabolic function test, Neck pain, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Obstructive airways disorder
Clinical narrative: Case number PHHY2013US083978 is an initial spontaneous report received from a consumer (patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 488609) website on 06 Aug 2013 with a follow-up received from quality assurance department (QA ref. no.: 246003) on 03 Apr 2014. This report refers to a 62-year-old male patient. His medical history included hyperlipidemia, heart disease (unspecified) and seizures (last seizure on 19 Nov). His concomitant medication included atenolol, LIPITOR, phenytoin, Aspirin, BENADRYL and melatonin. He was vaccinated with FLUVIRIN (batch number: 123123) intramuscularly into left arm on 07 Dec 2012. On 09 Feb 2013, he experienced flu like symptoms, neck pain, headaches, and loss of ability to support himself, loss of ability to walk and loss of ability to protect airways. On 11 Feb 2013, he visited emergency department at hospital and then hospitalized from 14 Feb 2013 to 21 Feb 2013. He was in intensive care unit and his multiple systems were monitored. He underwent laryngoscopy, electronic testing, MRI (nuclear magnetic resonance imaging) of head (brain) and neck, lumbar puncture, complete blood count (CBC) test, comprehensive metabolic panel (CMP) test and liver function test (LFT). The results were not reported. He was diagnosed with post-vaccination viral syndrome. Guillain Barre Syndrome was ruled out. He received IV immunoglobulin (therapy) in the hospital. The outcome was reported as complete recovery as of 24 Mar 2013. Reporter assessed the case as serious (life threatening). Based on the batch review report received from the quality assurance department, it was concluded that the concerned FLUVIRIN (batch number: 123123) was manufactured in accordance with approved internal procedures and is in compliance with the current good manufacturing practices (cGMP) requirements. Follow-up received from Quality assurance department on 03 Apr 2014: Updated batch review report.