chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Nausea, Oropharyngeal pain
Clinical narrative: This spontaneous report as received from the patient's husband and as well as the 75 year old female patient regarding herself. Patient's medical history was none, drug reactions/allergies were none. On 16-SEP-2013, the patient was vaccinated with a dose of ZOSTAVAX Refrigerated VIAL 19400 PFU (Lot number, expiry date, route and dose were not reported). Concomitant therapies included Cymbalta, lisinopril (manufacturer unknown), metoprolol, hydrochlorothiazide (manufacturer unknown) and alendronate sodium (manufacturer unknown). Around 30-SEP-2013, the patient experienced wooziness, muscle ache, joint ache, nausea and headache. The patient sought medical attention and has called the doctor and the doctor has prescribed Methylprednisolone, 4 mg oral tablets, taken as a "dose pack" over the course of 5 days. The patient's husband was refusing to administer this medication to himself and his wife due to the adverse events that were reported in the PI (package insert) of this specific medication. Lab Diagnostics Studies Performed was none. No treatment was taken. The patient had recovered from most of the symptoms but the joint and muscle pain was still present, although it seemed to be getting better with time. Approximately on an unknown date in 2013, the events wooziness, headache and nausea were recovered/resolved. The outcome of joint ache and muscle ache was reported as recovering/resolving. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a physician assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On 16-SEP-2013 the patient was vaccinated with a dose of PNEUMOVAX23 lot # H017801 (expiry date: 09-JUL-2014), 0.5 ml, intramuscular. No concomitant medications were reported. The physician assistant reported that the physician informed the physician assistant, that the patient developed an unspecified rash (on 16-SEP-2013) after receiving PNEUMOVAX23. The physician had requested information on the solvent used for PNEUMOVAX23. The outcome of the unspecified rash was unknown. No reporter causality was provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age (gender not reported). The patient was vaccinated with the first and the second dose of GARDASIL in August 2012 and on 29-AUG-2013, respectively. No adverse effects were reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient in her early sixties. On an unknown date the patient was vaccinated with ZOSTAVAX 0.65 ml subcutaneous in the arm to prevent shingles (lot # not reported). The pharmacist reported that the patient reported rash at injection site starting on the same day that the ZOSTAVAX vaccine was received. The rash was located on an unspecified arm and lasted a few weeks. The outcome of rash at injection site was reported as recovered. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 09-SEP-2013, the patient ws inadvertently administered GARDASIL (lot number was reported as 0181AA, expiry date was 31-JUL-2013, route and dose were not reported) that had expired on 31-JUL-2013. No adverse effects re ported. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 years old male patient. The pharmacist reported that on an unspecified date the patient developed redness and swelling at the injection site after ZOSTAVAX (lot # J002865, expiry date: 07-JUN-2014), at unspecified location intramuscularly was administered on 30-SEP-2013. No concomitant medication, drug reactions/allergies were provided. The patient had no pertinent medical history. No treatment was given for the events. No lab diagnostic studies were performed. The patient had sought medical attention via went to pharmacist. At the time of report, the outcome of the events was not recovered. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to two patients of unknown age. On 08-OCT-2013, the patients were inadvertently vaccinated with a dose of M-M-R II, (lot number 009784, expiry date 15-MAY-2014) which was improperly stored. No adverse effects reported. Additional information is not expected.
Sex: U
Vaccine: HEP, HEPA, RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and unknown gender. The nurse reported that an unspecified number of patients may have received VAQTA (25/0.5 U/ML, dosing information and route were unknown), RECOMBIVAX HB (dosing information and route were unknown) and ROTATEQ (dosing information and route were unknown) exposed to 19F and 59F for a total of 15 months. Nurse stated the minimum and maximum were never cleared off of the facilities monitoring device, so he is unable to provide how long the vaccines were exposed to each out of range temperature. All products were found to be unsupported by in-house stability data. The nurse was unable to provide dates of administration as well as product lot number/expiration dates for the vaccines in question. No adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. on 19-SEP-2013 the patient was inadvertently vaccinated with a dose of PNEUMOVAX 23 (dose and lot number not provided), subcutaneous in the triceps, instead of a dose of ZOSTAVAX (Merck). No adverse events were reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea
Clinical narrative: Information has been received from a 66 year-old female consumer with hypothyroidism and no known drug reactions or allergies reporting on herself. On 09-OCT-2013, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously (dose and lot # not provided). Concomitant medications included EFFEXOR and AMOUR THYROID tablets. It was reported that, on 09-OCT-2013, the patient experienced nausea and headache after receiving ZOSTAVAX. No treatment was given. The patient did not seek medical attention. No lab tests were done. At the time of the report, the patient was recovering from nausea and headache. Relatedness between nausea and headache and ZOSTAVAX was not reported. Additional information is not expected.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 year old female patient with depression, high cholesterol and TYLENOL allergy. On 03-SEP-2013 the patient was vaccinated with a first dose of ZOSTAVAX lot # H021712 exp date 06-MAR-2014, subcutaneous (dose not reported) to prevent shingles. Concomitant therapies included CELEXA and simvastatin (manufacturer unknown). In an approximately September 2013 (reported as soon after this) the patient experienced bruising at the site of injection. The outcome of bruising at the site of injection was reported as recovered on 21-SEP-2013. The patient's event was not treated. The patient sought medical attention: went to pharmacist. No lab diagnostics studies were performed. Relatedness between the patient's event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 36.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Blood creatine phosphokinase MB, Blood creatine phosphokinase normal, Chest X-ray normal, Dizziness, Dyspnoea
Clinical narrative: 36 y/o male referred to VHC (15MAR13, 1300 EST) for evaluation of primary SPV site (LUE) on day #10 following immunization. Patient received primary SPV (LUE) and AVA #8 (RUE) on 05MAR13 in preparation for travel in early APR 2013 (2 weeks). Also received rabies booster on 27FEB13. Patient denies viral or GI illness within 30 days prior to receipt of vaccines. Patient c/o not being able to sleep last night due to throbbing and pain LUE. Rates pain last night as "8"/10 and now is about "7"/10. Endorses itching, warmth, throbbing and redness about the size of an orange at SPV site (LUE) with red streaking (lymphangitis) going toward downward toward left axilla. Tenderness under left axilla. Reports having a HA and feeling lightheaded and very fatigued / SOB since Wednesday 13MAR13 (day #8 s/p SPV). Did warm-up exercises during PT on Wednesday and had to quit due to fatigue and SOB. Denies CP or deep pressure in center of chest. No diaphoresis, pallor, N or V. No radiation of pain to jaw, back of throat or to left arm, but his left arm feels kind of numb today from the localized swelling and redness at SPV site. Denies flu-like sx or chills. Denies positional or pleuritic SOB, made worse when supine. Not able to raise left arm higher than shoulder level. Pain (LUE) is impeding his ability to perform duties carrying boxes at work.
Age: 36.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Fatigue, Haematocrit normal, Haemoglobin normal, Headache, Hypoaesthesia
Clinical narrative: 36 y/o male referred to VHC (15MAR13, 1300 EST) for evaluation of primary SPV site (LUE) on day #10 following immunization. Patient received primary SPV (LUE) and AVA #8 (RUE) on 05MAR13 in preparation for travel in early APR 2013 (2 weeks). Also received rabies booster on 27FEB13. Patient denies viral or GI illness within 30 days prior to receipt of vaccines. Patient c/o not being able to sleep last night due to throbbing and pain LUE. Rates pain last night as "8"/10 and now is about "7"/10. Endorses itching, warmth, throbbing and redness about the size of an orange at SPV site (LUE) with red streaking (lymphangitis) going toward downward toward left axilla. Tenderness under left axilla. Reports having a HA and feeling lightheaded and very fatigued / SOB since Wednesday 13MAR13 (day #8 s/p SPV). Did warm-up exercises during PT on Wednesday and had to quit due to fatigue and SOB. Denies CP or deep pressure in center of chest. No diaphoresis, pallor, N or V. No radiation of pain to jaw, back of throat or to left arm, but his left arm feels kind of numb today from the localized swelling and redness at SPV site. Denies flu-like sx or chills. Denies positional or pleuritic SOB, made worse when supine. Not able to raise left arm higher than shoulder level. Pain (LUE) is impeding his ability to perform duties carrying boxes at work.
Age: 36.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Impaired work ability, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: 36 y/o male referred to VHC (15MAR13, 1300 EST) for evaluation of primary SPV site (LUE) on day #10 following immunization. Patient received primary SPV (LUE) and AVA #8 (RUE) on 05MAR13 in preparation for travel in early APR 2013 (2 weeks). Also received rabies booster on 27FEB13. Patient denies viral or GI illness within 30 days prior to receipt of vaccines. Patient c/o not being able to sleep last night due to throbbing and pain LUE. Rates pain last night as "8"/10 and now is about "7"/10. Endorses itching, warmth, throbbing and redness about the size of an orange at SPV site (LUE) with red streaking (lymphangitis) going toward downward toward left axilla. Tenderness under left axilla. Reports having a HA and feeling lightheaded and very fatigued / SOB since Wednesday 13MAR13 (day #8 s/p SPV). Did warm-up exercises during PT on Wednesday and had to quit due to fatigue and SOB. Denies CP or deep pressure in center of chest. No diaphoresis, pallor, N or V. No radiation of pain to jaw, back of throat or to left arm, but his left arm feels kind of numb today from the localized swelling and redness at SPV site. Denies flu-like sx or chills. Denies positional or pleuritic SOB, made worse when supine. Not able to raise left arm higher than shoulder level. Pain (LUE) is impeding his ability to perform duties carrying boxes at work.
Age: 36.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Injection site streaking, Injection site swelling, Injection site warmth, Insomnia, Lymphangitis
Clinical narrative: 36 y/o male referred to VHC (15MAR13, 1300 EST) for evaluation of primary SPV site (LUE) on day #10 following immunization. Patient received primary SPV (LUE) and AVA #8 (RUE) on 05MAR13 in preparation for travel in early APR 2013 (2 weeks). Also received rabies booster on 27FEB13. Patient denies viral or GI illness within 30 days prior to receipt of vaccines. Patient c/o not being able to sleep last night due to throbbing and pain LUE. Rates pain last night as "8"/10 and now is about "7"/10. Endorses itching, warmth, throbbing and redness about the size of an orange at SPV site (LUE) with red streaking (lymphangitis) going toward downward toward left axilla. Tenderness under left axilla. Reports having a HA and feeling lightheaded and very fatigued / SOB since Wednesday 13MAR13 (day #8 s/p SPV). Did warm-up exercises during PT on Wednesday and had to quit due to fatigue and SOB. Denies CP or deep pressure in center of chest. No diaphoresis, pallor, N or V. No radiation of pain to jaw, back of throat or to left arm, but his left arm feels kind of numb today from the localized swelling and redness at SPV site. Denies flu-like sx or chills. Denies positional or pleuritic SOB, made worse when supine. Not able to raise left arm higher than shoulder level. Pain (LUE) is impeding his ability to perform duties carrying boxes at work.
Age: 36.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Lymphocyte percentage increased, Metabolic function test normal, Metamyelocyte percentage increased, Monocyte count increased, Myelocyte percentage increased
Clinical narrative: 36 y/o male referred to VHC (15MAR13, 1300 EST) for evaluation of primary SPV site (LUE) on day #10 following immunization. Patient received primary SPV (LUE) and AVA #8 (RUE) on 05MAR13 in preparation for travel in early APR 2013 (2 weeks). Also received rabies booster on 27FEB13. Patient denies viral or GI illness within 30 days prior to receipt of vaccines. Patient c/o not being able to sleep last night due to throbbing and pain LUE. Rates pain last night as "8"/10 and now is about "7"/10. Endorses itching, warmth, throbbing and redness about the size of an orange at SPV site (LUE) with red streaking (lymphangitis) going toward downward toward left axilla. Tenderness under left axilla. Reports having a HA and feeling lightheaded and very fatigued / SOB since Wednesday 13MAR13 (day #8 s/p SPV). Did warm-up exercises during PT on Wednesday and had to quit due to fatigue and SOB. Denies CP or deep pressure in center of chest. No diaphoresis, pallor, N or V. No radiation of pain to jaw, back of throat or to left arm, but his left arm feels kind of numb today from the localized swelling and redness at SPV site. Denies flu-like sx or chills. Denies positional or pleuritic SOB, made worse when supine. Not able to raise left arm higher than shoulder level. Pain (LUE) is impeding his ability to perform duties carrying boxes at work.
Age: 36.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Neutrophil percentage increased, Pain, Pain in extremity, Platelet count normal, Red blood cell count normal
Clinical narrative: 36 y/o male referred to VHC (15MAR13, 1300 EST) for evaluation of primary SPV site (LUE) on day #10 following immunization. Patient received primary SPV (LUE) and AVA #8 (RUE) on 05MAR13 in preparation for travel in early APR 2013 (2 weeks). Also received rabies booster on 27FEB13. Patient denies viral or GI illness within 30 days prior to receipt of vaccines. Patient c/o not being able to sleep last night due to throbbing and pain LUE. Rates pain last night as "8"/10 and now is about "7"/10. Endorses itching, warmth, throbbing and redness about the size of an orange at SPV site (LUE) with red streaking (lymphangitis) going toward downward toward left axilla. Tenderness under left axilla. Reports having a HA and feeling lightheaded and very fatigued / SOB since Wednesday 13MAR13 (day #8 s/p SPV). Did warm-up exercises during PT on Wednesday and had to quit due to fatigue and SOB. Denies CP or deep pressure in center of chest. No diaphoresis, pallor, N or V. No radiation of pain to jaw, back of throat or to left arm, but his left arm feels kind of numb today from the localized swelling and redness at SPV site. Denies flu-like sx or chills. Denies positional or pleuritic SOB, made worse when supine. Not able to raise left arm higher than shoulder level. Pain (LUE) is impeding his ability to perform duties carrying boxes at work.
Age: 36.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Red blood cell morphology normal, Red cell distribution width normal, Tenderness, Troponin T normal, Urine analysis normal
Clinical narrative: 36 y/o male referred to VHC (15MAR13, 1300 EST) for evaluation of primary SPV site (LUE) on day #10 following immunization. Patient received primary SPV (LUE) and AVA #8 (RUE) on 05MAR13 in preparation for travel in early APR 2013 (2 weeks). Also received rabies booster on 27FEB13. Patient denies viral or GI illness within 30 days prior to receipt of vaccines. Patient c/o not being able to sleep last night due to throbbing and pain LUE. Rates pain last night as "8"/10 and now is about "7"/10. Endorses itching, warmth, throbbing and redness about the size of an orange at SPV site (LUE) with red streaking (lymphangitis) going toward downward toward left axilla. Tenderness under left axilla. Reports having a HA and feeling lightheaded and very fatigued / SOB since Wednesday 13MAR13 (day #8 s/p SPV). Did warm-up exercises during PT on Wednesday and had to quit due to fatigue and SOB. Denies CP or deep pressure in center of chest. No diaphoresis, pallor, N or V. No radiation of pain to jaw, back of throat or to left arm, but his left arm feels kind of numb today from the localized swelling and redness at SPV site. Denies flu-like sx or chills. Denies positional or pleuritic SOB, made worse when supine. Not able to raise left arm higher than shoulder level. Pain (LUE) is impeding his ability to perform duties carrying boxes at work.
Age: 36.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: White blood cell count
Clinical narrative: 36 y/o male referred to VHC (15MAR13, 1300 EST) for evaluation of primary SPV site (LUE) on day #10 following immunization. Patient received primary SPV (LUE) and AVA #8 (RUE) on 05MAR13 in preparation for travel in early APR 2013 (2 weeks). Also received rabies booster on 27FEB13. Patient denies viral or GI illness within 30 days prior to receipt of vaccines. Patient c/o not being able to sleep last night due to throbbing and pain LUE. Rates pain last night as "8"/10 and now is about "7"/10. Endorses itching, warmth, throbbing and redness about the size of an orange at SPV site (LUE) with red streaking (lymphangitis) going toward downward toward left axilla. Tenderness under left axilla. Reports having a HA and feeling lightheaded and very fatigued / SOB since Wednesday 13MAR13 (day #8 s/p SPV). Did warm-up exercises during PT on Wednesday and had to quit due to fatigue and SOB. Denies CP or deep pressure in center of chest. No diaphoresis, pallor, N or V. No radiation of pain to jaw, back of throat or to left arm, but his left arm feels kind of numb today from the localized swelling and redness at SPV site. Denies flu-like sx or chills. Denies positional or pleuritic SOB, made worse when supine. Not able to raise left arm higher than shoulder level. Pain (LUE) is impeding his ability to perform duties carrying boxes at work.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Chills, Diarrhoea
Clinical narrative: Within 2 hrs of receiving vaccination, I became so dizzy. I had trouble standing in 3 hrs, I was vomiting, diarrhea. Within two hours of receiving the vaccination, I first noticed my throat felt like it as going to become sore, then I became dizzy, very light headed and sick to my stomach. Within the third hour I had a bad headache and was vomiting and having diarrhea and severe chills. I then knew enough to start drinking water as much as possible and I took PEPTO to easy the stomach distress. This went on well in to late hours that same day. I had to get up 3 more time that night with vomiting and diarrhea. The next day left weak and very sore in the stomach and painful joints  in the legs, shoulders and neck. The main reason for sending this information to you is: this is now 4 days later and I am still having diarrhea, joint pain as well as stomach distress. These symptoms are not as severe but nevertheless they are still with me.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspepsia, Dysstasia, Headache, Nausea
Clinical narrative: Within 2 hrs of receiving vaccination, I became so dizzy. I had trouble standing in 3 hrs, I was vomiting, diarrhea. Within two hours of receiving the vaccination, I first noticed my throat felt like it as going to become sore, then I became dizzy, very light headed and sick to my stomach. Within the third hour I had a bad headache and was vomiting and having diarrhea and severe chills. I then knew enough to start drinking water as much as possible and I took PEPTO to easy the stomach distress. This went on well in to late hours that same day. I had to get up 3 more time that night with vomiting and diarrhea. The next day left weak and very sore in the stomach and painful joints  in the legs, shoulders and neck. The main reason for sending this information to you is: this is now 4 days later and I am still having diarrhea, joint pain as well as stomach distress. These symptoms are not as severe but nevertheless they are still with me.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Throat irritation, Vomiting
Clinical narrative: Within 2 hrs of receiving vaccination, I became so dizzy. I had trouble standing in 3 hrs, I was vomiting, diarrhea. Within two hours of receiving the vaccination, I first noticed my throat felt like it as going to become sore, then I became dizzy, very light headed and sick to my stomach. Within the third hour I had a bad headache and was vomiting and having diarrhea and severe chills. I then knew enough to start drinking water as much as possible and I took PEPTO to easy the stomach distress. This went on well in to late hours that same day. I had to get up 3 more time that night with vomiting and diarrhea. The next day left weak and very sore in the stomach and painful joints  in the legs, shoulders and neck. The main reason for sending this information to you is: this is now 4 days later and I am still having diarrhea, joint pain as well as stomach distress. These symptoms are not as severe but nevertheless they are still with me.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Pyrexia, Throat tightness
Clinical narrative: Throat started feeling odd at 1:30. Then my voice changed and throat started to close more by 4:00. Onset of fever. By 5:30 I had 10:30. It broke at 10:30pm. I took 50 mg BENADRYL at 4:10. 1 ADVIL at 5:00.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Skin warm, Urticaria
Clinical narrative: Pt presented w/ a large red welt on her deltoid. It was hot and itchy. She was told by PA to use cold compresses.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: Patient went to her physician because she had pain in her right arm. She showed me her arm and she presented a red spot near her axilla. Prescriber gave her a prescription of DURICEF 500mg every 12 hours for 7 days.
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Chest pain, Diplopia, Dizziness, Headache
Clinical narrative: Dizzy around 7 pm; tickle throat; no sneezing; no coughing - no congestion (4 of 10) sore throat, H/A, body aches, stomach pains (nausea) seeing double, photophobia chest pain (L) side. Taking - TYLENOL ADVIL. Not on medications - ?anxiety. Called private MD - Take TYLENOL and ADVIL.
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Oropharyngeal pain, Pain, Photophobia, Throat irritation
Clinical narrative: Dizzy around 7 pm; tickle throat; no sneezing; no coughing - no congestion (4 of 10) sore throat, H/A, body aches, stomach pains (nausea) seeing double, photophobia chest pain (L) side. Taking - TYLENOL ADVIL. Not on medications - ?anxiety. Called private MD - Take TYLENOL and ADVIL.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Within 6 hours his right upper arm was red and within 24 hours his entire upper arm was very swollen from shoulder to elbow with redness one inch past elbow. Given BENADRYL and oral antibiotics. Arm better by 10/7/13.
Age: 56.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Activities of daily living impaired, Feeling abnormal, Headache, Migraine, Nausea
Clinical narrative: 1st day after having vaccines, day long headache and nausea and no medicine taken helped. Had to miss work. 2nd day better but later in the day had a migraine. 3rd day dull ache and very cloudy feeling.
Age: 56.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Pain
Clinical narrative: 1st day after having vaccines, day long headache and nausea and no medicine taken helped. Had to miss work. 2nd day better but later in the day had a migraine. 3rd day dull ache and very cloudy feeling.
Age: 59.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia
Clinical narrative: Pain in shoulder joint developed less than 12 hours after vaccination.
Age: 59.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Bursitis, Injection site pain, Injection site swelling
Clinical narrative: Pain in shoulder joint developed less than 12 hours after vaccination.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender, who on unspecified dates were administered the improperly stored GARDASIL (doses and routes not reported) lot # 0555AE exp: 14-DEC-2014. The reporter stated that a satellite office had experienced an ongoing temperature excursion from December of 2012 through September of 2013. During this temperature excursions GARDASIL was not supported and was affected. This is one of several reports received from the same source. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Condition aggravated, Pain, Pallor, Rheumatoid arthritis
Clinical narrative: Pt's RA symptom: became worse after getting flu vaccine. Face white, RA flare up symptoms. Swollen arm and tender pain in joints. Excruciating pain.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Hypoaesthesia, Immediate post-injection reaction, Paraesthesia, Vision blurred
Clinical narrative: 10-9-13 received Flu vaccination at work reports immediate flushing, heat throughout body blurred vision past in several minutes also had bilateral numbness 4 and 5 finger and tingling from elbow through finger tips 5 hours later continued with numbness and tingling in hand, fingers.
Age: 24.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Electromyogram, Injection site reaction, Muscle atrophy, Muscle disorder, Nuclear magnetic resonance imaging
Clinical narrative: Received Hep A/B on June 13 with no issues then Aug 14 woke up with the area she received the vaccine with her muscle sunken in and atrophied. There were no other injuries vaccine the only thing that occurred for that to happen to arm.
Age: 24.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: X-ray
Clinical narrative: Received Hep A/B on June 13 with no issues then Aug 14 woke up with the area she received the vaccine with her muscle sunken in and atrophied. There were no other injuries vaccine the only thing that occurred for that to happen to arm.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Bone pain, Pain in extremity
Clinical narrative: Pt. reported extremely sore arm and hand, she said her "shoulder bone" felt broken. This has lasted 3 weeks since her immunization.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Local swelling, Pyrexia, Swelling
Clinical narrative: Within 1 hour of administration had swelling of corresponding arm (left arm), subsequent redness: 1 day later fever, chills, swelling slightly improved.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea, Eye swelling, Flushing, Hyperhidrosis
Clinical narrative: Went home from work and 4 hours after vaccine began with throat tightening, shortness of breath. Wheezing, eyes swelling. Use inhaler for history of asthma, Ibuprofen went to bed, restless all night and at 2 pm felt nausea and chest tightness remained, at 9:30 AM evaluated Temp 99.2 BP 136/85 general flushing, slight diaphoresis. Seen by occupational health physician.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Restlessness, Throat tightness, Wheezing
Clinical narrative: Went home from work and 4 hours after vaccine began with throat tightening, shortness of breath. Wheezing, eyes swelling. Use inhaler for history of asthma, Ibuprofen went to bed, restless all night and at 2 pm felt nausea and chest tightness remained, at 9:30 AM evaluated Temp 99.2 BP 136/85 general flushing, slight diaphoresis. Seen by occupational health physician.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, Influenza, Pyrexia
Clinical narrative: This spontaneous report as received from consumer, as part of a marketing research program, refers to a 52 year old female patient reporting on herself. On an unknown date since 1998 the patient has been vaccinated with several doses (5 x since 1998 up 6 7 doses (not sure)) of PNEUMOVAX23. There was no concomitant medication reported. In approximately 2010 the patient received the 7th dose of PNEUMOVAX23, after this dose (only at last dose) the patient experienced high fever and flu symptoms. Action taken regarding therapy with PNEUMOVAX23 was reported as discontinued. The outcomes of flu symptoms and high fever were reported as recovering/resolving. The patient considered the adverse events to be not serious. The patient also considered the adverse events to be related to PNEUMOVAX23. Additional information has been requested.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Loss of consciousness
Clinical narrative: Patient became lightheaded and dizzy about 4 minutes after shot. Layed down on floor. I SOB, lost consciousness for about 50 seconds paramedics came and stayed about 3 or 4 minutes and left. He sat up for a while on floor then moved to chair and was ok. Spent about 20 or 30 minutes in store.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Inflammation, Local swelling
Clinical narrative: Left arm swollen (inflamed) pt went to convenient care. Was given prednisone.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, tenderness at site of injection.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Rash, Swelling
Clinical narrative: Pt received flu and pneumonia vaccine. Pt experienced swelling/rash/redness on lower half of arm.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Sleep disorder
Clinical narrative: Staff member reported reaction on left upper arm. Red raised area noted on left upper arm measuring 4cm x 5cm. Area warm and fevered in appearance. Staff member expressed she was unable to sleep on left side due to arm pain. Reported to RN. Advised staff member to go to Health Center for follow up per RN.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Musculoskeletal pain, Tendonitis
Clinical narrative: Shoulder pain following the injection that has persisted since injection.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood test normal, Drug administered at inappropriate site, X-ray normal
Clinical narrative: Shoulder pain following the injection that has persisted since injection.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 1.09
Sex: M
Vaccine: FLU3, HEPA, PNC13, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Pt received VARIVAX 9/27/13. Came in 10/9/13 with Varicella disease.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis
Clinical narrative: Flu shot reaction (L) shoulder cellulitis KEFLEX 500 mg 3x/day #30.
Age: 0.76
Sex: M
Vaccine: DTAPHEPBIP, PNC
Symptoms: Pyrexia
Clinical narrative: 104 fev for approx 48 hours after vaccines given. Mom just told us of reaction today.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Rec'd AFLURIA IM left deltoid on 10-8-13. Reported tenderness, erythema and bump took ALEVE x 1. 10-11-13 pt reports resolved.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Severe pain in right should. near injection site. Pain comes and goes without regard to activity. Pain is still present as of day 17 post immunization.
Age: 54.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Burning sensation, Erythema, Pain, Swelling
Clinical narrative: Redness, burning sensation, swollen, body aches from head to toe.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea, Erythema, Flushing, Hyperhidrosis
Clinical narrative: States has had flu injection every yr. since age 8. Received flu IM injection at 6:30 am at 6:50 am patient returns to provider - Diaphoretic, facial flushing, red swelling in L) arm. Denies resp. distress. Attempted to take BP, but machine didn't give result. HR 80 and reg, Lungs clear. Went to ER - after in ER states chest felt heavy. Later said was short of breath. Wheezing per Dr. States rash on chest.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Rash, Wheezing
Clinical narrative: States has had flu injection every yr. since age 8. Received flu IM injection at 6:30 am at 6:50 am patient returns to provider - Diaphoretic, facial flushing, red swelling in L) arm. Denies resp. distress. Attempted to take BP, but machine didn't give result. HR 80 and reg, Lungs clear. Went to ER - after in ER states chest felt heavy. Later said was short of breath. Wheezing per Dr. States rash on chest.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Severe pain in arm with PNEUMOVAX-23 injection pt. said it was so painful that she couldn't lift up her arm.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Myaglia.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy
Clinical narrative: Evening of vaccination and next day the left side only - there was swollen gland/neck. (Same side of vaccination flu). There was no pain or warmth just swollen gland. Pt saw MD to ask about it. Then it got better. No other problem.
Age: 43.0
Sex: F
Vaccine: FLUC3
Symptoms: Anxiety, Dyspnoea, Erythema, Feeling hot, Induration
Clinical narrative: Redness, heat, tenderness, firmness 10 cm local reaction - 15 min following inj. quickly followed by anxiety, SOB, nausea, shaking and thickness of tongue.
Age: 43.0
Sex: F
Vaccine: FLUC3
Symptoms: Local reaction, Nausea, Tenderness, Tongue disorder, Tremor
Clinical narrative: Redness, heat, tenderness, firmness 10 cm local reaction - 15 min following inj. quickly followed by anxiety, SOB, nausea, shaking and thickness of tongue.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Pain
Clinical narrative: Localized pain, swelling at injection site left upper arm.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Chills, Hyperhidrosis, Injection site erythema, Injection site pain
Clinical narrative: Pain/redness at site. Myalgias and arthralgias whole body. Chills and sweats.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Myalgia
Clinical narrative: Pain/redness at site. Myalgias and arthralgias whole body. Chills and sweats.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Pyrexia
Clinical narrative: Fever 102 degrees with erythema, pain induration lateral aspect of upper portion (L) arm.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling, Pain in extremity, Pruritus, Skin warm
Clinical narrative: Swollen (L) arm, red, hot to the touch spreading to the entire (L) arm, itchy, painful. Pt applies ice, takes BENADRYL, Ibuprofen OTC.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster
Clinical narrative: This spontaneous report as received from a currently 73 year old female patient. The patient had no pertinent medical history nor drug reactions or allergies. On an unknown date the patient was vaccinated with ZOSTAVAX vial (route, dose no, dosage and lot number unknown). Concomitant therapies included LIPITOR. On an unknown date the patient developed blisters on her ankle and was diagnosed with shingles after ZOSTAVAX. The patient sought medical attention, (saw the doctor) but had no lab diagnostic studies performed. The patient was reported as recovering from the event. Additional information has been requested.
Age: 0.9
Sex: U
Vaccine: HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a 9 month old patient of unknown gender. On 23-SEP-2013 the infant patient was accidentally vaccinated with GARDASIL (0.5 ml, lot number and expiration date not reported) intramuscular, one shot instead RECOMBIVAX HB. There was no concomitant medication reported. The physician also reported that she sent the infant to an unspecified emergency room to be evaluated after receiving GARDASIL. No adverse effect reproted. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Injection site swelling, Neck pain, Pain in extremity
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 65 year old female patient with a medical history of fibromyalgia, Hashimoto's thyroiditis, lymphadenectomy, breast cancer in 2010. The patient had a drug reaction or allergy to penicillin. The patient had experienced nausea and vomiting after taking erythromycin in the past. On 20-AUG-2013 the patient was vaccinated with ZOSTAVAX (subcutaneous in the right arm; dose number and dosage unknown; lot # J001003 exp 24-APR-2014). Concomitant therapies included tramadol, sertraline, ARMOUR THYROID TABLETS, ATIVAN and FLONASE. The nurse reported that approximately on 27-AUG-2013 (reported as: one week after receiving ZOSTAVAX) the patient stated she developed "a searing ache and throbbing in her right upper arm and right shoulder, and joint and neck pain" after receiving ZOSTAVAX. The nurse stated the patient received ZOSTAVAX in her right arm, but also developed achiness in her left upper arm after receiving the vaccine. On 20-SEP-2013 the patient developed "puffiness" at the injection site. It was recommended by an unspecified healthcare provider that the patient be treated with "moist heat and pressure point therapy". The patient was reported as recovering from the adverse events. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site warmth
Clinical narrative: 3" diameter lump, at site of injection patient reported warmth, itchiness, and redness. Taking topical BENADRYL.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a medical assistant refers to a multiple unspecified patients of unknown age and gender, who on unspecified dates were administered the improperly stored GARDASIL lot # H012873 exp. 05-MAR-2015 (doses and routes not reported). The reporter stated that a satellite office had experienced an ongoing temperature  excursion from December of 2012 through September of 2013. During this temperature excursions  GARDASIL was not supported and was affected. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender, who on an unspecified dates were administered the improperly stored VARIVAX (merck) (doses and routes not reported) lot # reported as 1629AA, exp: 18-OCT-2013. The reporter stated that a satellite office had experienced an ongoing temperature excursion from December of 2012 through September of 2013. During this temperature excursions VARIVAX (merck) was not supported and was affected. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender, who on an unspecified dates were administered the improperly stored VARIVAX (merck) (doses and routes not reported) lot # reported as H013181, exp: 05-JUL-2014. The reporter stated that a satellite office had experienced an ongoing temperature excursion from December of 2012 through September of 2013. During this temperature excursions VARIVAX (merck) was not supported and was affected. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender, who on an unspecified dates were administered the improperly stored VARIVAX (doses and routes not reported) lot # H018456, exp: 09-OCT-2014. The reporter stated that a satellite office had experienced an ongoing temperature excursion form December of 2012 through September of 2013. During this temperature excursions VARIVAX was not supported and was affected. This is one of several reports received from the same source. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chest pain, Cystitis, Herpes zoster, Nausea
Clinical narrative: This spontaneous report was received from a 84 year old female patient reporting on herself. On 15-DEC-2010 (also reported as two weeks ago) the patient was vaccinated with ZOSTAVAX (lot number and expiration date not reported) oral. Concomitant therapies included VICODIN. On approximately 11-SEP-2013 (two weeks ago) the patient advised of pain from middle of chest, middle of back and rash. She stated it was very painful especially in the mornings. The pain eases later in the day. Her rash was not itchy. Her doctor prescribed VICODIN for the pain but it made her feel sick to her stomach. He also prescribed prednisone (manufacturer unknown) but she was not itchy and VALTREX for the shingles virus. Her pain has not eased since she first got it two weeks ago. She also had a bladder infection when she had the Doctor appointment (on unspecified date in September 2013) but no medication was prescribed just a urine test (for bladder infection, results not provided). The outcomes of the events were reported as not recovered. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Urine analysis
Clinical narrative: This spontaneous report was received from a 84 year old female patient reporting on herself. On 15-DEC-2010 (also reported as two weeks ago) the patient was vaccinated with ZOSTAVAX (lot number and expiration date not reported) oral. Concomitant therapies included VICODIN. On approximately 11-SEP-2013 (two weeks ago) the patient advised of pain from middle of chest, middle of back and rash. She stated it was very painful especially in the mornings. The pain eases later in the day. Her rash was not itchy. Her doctor prescribed VICODIN for the pain but it made her feel sick to her stomach. He also prescribed prednisone (manufacturer unknown) but she was not itchy and VALTREX for the shingles virus. Her pain has not eased since she first got it two weeks ago. She also had a bladder infection when she had the Doctor appointment (on unspecified date in September 2013) but no medication was prescribed just a urine test (for bladder infection, results not provided). The outcomes of the events were reported as not recovered. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dizziness, Epistaxis, Feeling hot, Hyperhidrosis, Hypertension
Clinical narrative: Pt passed out and was sweating the moment after she got the shot. Was hot, dizzy, and her B pressure was high. Since that day, Pt has suffered from extreme high blood pressure, dizziness, nausea, swollen never in left eye. In the hospital for days and as she gets older more symptoms appear. Symptoms started immediately with passing out and nose bleeds. Then more symptoms appeared as time went on.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Immediate post-injection reaction, Loss of consciousness, Nausea, Swelling
Clinical narrative: Pt passed out and was sweating the moment after she got the shot. Was hot, dizzy, and her B pressure was high. Since that day, Pt has suffered from extreme high blood pressure, dizziness, nausea, swollen never in left eye. In the hospital for days and as she gets older more symptoms appear. Symptoms started immediately with passing out and nose bleeds. Then more symptoms appeared as time went on.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Pyrexia
Clinical narrative: 104 fev x 48 hours after immunizations. * Mom just told us about reaction today*.
Age: 63.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Pruritus, Swelling, Urticaria
Clinical narrative: Hives started appearing 24 hrs after injection. Patient went to urgent care on 9-16-13 they gave her prednisone IM and an rx for oral prednisone. Hives were gone on 9-19-13.
Age: 63.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Urticaria
Clinical narrative: Hives started appearing 24 hrs after injection. Patient went to urgent care on 9-16-13 they gave her prednisone IM and an rx for oral prednisone. Hives were gone on 9-19-13.
Age: 14.0
Sex: F
Vaccine: FLUN4, HPV4
Symptoms: Abdominal pain upper, Dizziness, Headache, Myalgia, Nausea
Clinical narrative: Fainted as the vaccine went into her body.  Headache, dizziness, nausea, muscle pain, stomach ache 12 hours later still.
Age: 14.0
Sex: F
Vaccine: FLUN4, HPV4
Symptoms: Syncope
Clinical narrative: Fainted as the vaccine went into her body.  Headache, dizziness, nausea, muscle pain, stomach ache 12 hours later still.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Autoimmune disorder, Biopsy, Blood test, Drug hypersensitivity, Dyspnoea
Clinical narrative: I had severe shortness of breath that lasted 2 days. My knees and ankles swelled which lasted a few weeks. I was being treated for an autoimmune condition. I am allergic to Nyacin--my entire face was swollen.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Joint swelling, Swelling face
Clinical narrative: I had severe shortness of breath that lasted 2 days. My knees and ankles swelled which lasted a few weeks. I was being treated for an autoimmune condition. I am allergic to Nyacin--my entire face was swollen.
Age: 36.0
Sex: F
Vaccine: FLUX, HEP
Symptoms: Cough, Dyspnoea, Fatigue, Ocular hyperaemia, Pruritus
Clinical narrative: Difficulty breathing, itchy irritated skin, red eyes, coughing, blurred vision, fatigue.
Age: 36.0
Sex: F
Vaccine: FLUX, HEP
Symptoms: Skin irritation, Vision blurred
Clinical narrative: Difficulty breathing, itchy irritated skin, red eyes, coughing, blurred vision, fatigue.