chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Tenderness
Clinical narrative: This case was received on 06 November 2012 via a third party query tool search on the VAERS database, under reference number 458935. A 20-year-old male patient received the following vaccines on 30 April 2012: ACAM2000 (lot number VV04003A) and TYPHIM Vi (lot number G1124). On 11 May 2012, 11 days post inoculation / vaccination, the patient experienced numerous papulovesicles, 2-4mm in size that were present about the dorsal hands favoring the joint surfaces. Similar appearing papulovesicles were also present about the palmar surfaces and extensor elbows, with few scattered about the extensor forearms. There were areas mildly tender to palpate. Symptoms: rash, other nonspecific skin eruption. Biopsy report from lesions revealed skin on right extensor forearm with chronic superficial perivascular inflammation with overlying spongiosis and focal interface change. The event required emergency visit. The patient took no other medications. Current illnesses was reported as URI (upper respiratory illness). The patient denied ant medical history. The patient recovered on an unspecified date. Documents held by sender: None.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Rash papular, Rash pruritic, Rash pustular
Clinical narrative: This case was received on 06 November 2012 via a third party query tool search on the VAERS database, under reference number 461110. A 20-year-old male patient received the following vaccines on unspecified date: ACAM2000 (lot number VV04003A) and BIOTHRAX (lot number FAV308) and TYPHIM VI (lot number G1130). On an unspecified date after inoculation / vaccination the patient experienced papular rash located to arms bilaterally, belt line, and feet. Symptoms started 5 days prior to the report (however date of report was not provided) described as pruritic and non tender. No associated fever or chills were reported. Only 1 small pustular lesion was noted on the right arm. No medical history was reported. Recovery status was not reported. Documents held by sender: None.
Age: 38.0
Sex: F
Vaccine: ANTH, SMALL, TDAP, TYP
Symptoms: Feeling hot, Injection site reaction, Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: This case was received on 09 November 2012 via a third party query tool search on the VAERS database, under reference number 461634. A 38-year-old female patient with no reported medical history received the following vaccinations on 24 July 2012: ACAM2000 (lot number not reported), anthrax vaccine (manufacturer unknown, lot number not reported), typhoid vaccine (lot number not reported), and BOOSTRIX (lot number not reported). NOTE: Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. On 09 August 2012, the patient experienced a red, raised rash that started on the left arm (near the injection site) and spread to the entire body. The rash itched and felt hot. The patient had an emergency visit on an unknown date. No concomitant medications were reported. No other medical information was provided at this time. The subject's outcome was not reported. Documents held by sender: None.
Age: 15.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Blindness transient, Crying, Dizziness, Nausea, Pallor
Clinical narrative: This medically confirmed report (initial receipt 17-Jan-2013) concerns a 15-year-old female patient. On 16-Jan-2013, the patient received AFLURIA (batch number: 06949211A) 0.5ml intramuscularly. On 16-Jan-2013 shortly after vaccination the patient experienced dizziness, nausea, tingling in the legs, loss of sight in one eye, vomited and became very pale. The paramedics were called, after their arrival the patient regained her sight. She was taken to the emergency room (ER) but was not admitted to hospital. The next morning the patient was home from the ER visit. No further information was provided.
Age: 15.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Paraesthesia, Vomiting
Clinical narrative: This medically confirmed report (initial receipt 17-Jan-2013) concerns a 15-year-old female patient. On 16-Jan-2013, the patient received AFLURIA (batch number: 06949211A) 0.5ml intramuscularly. On 16-Jan-2013 shortly after vaccination the patient experienced dizziness, nausea, tingling in the legs, loss of sight in one eye, vomited and became very pale. The paramedics were called, after their arrival the patient regained her sight. She was taken to the emergency room (ER) but was not admitted to hospital. The next morning the patient was home from the ER visit. No further information was provided.
Age: 15.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Asthenia, Blindness unilateral, Crying, Dizziness, Fear
Clinical narrative: This medically confirmed report (initial receipt 17-Jan-2013) concerns a 15-year-old female patient. On 16-Jan-2013, the patient received AFLURIA (batch number: 06949211A) 0.5ml intramuscularly. On 16-Jan-2013 shortly after vaccination the patient experienced dizziness, nausea, tingling in the legs, loss of sight in one eye, vomited and became very pale. The paramedics were called, after their arrival the patient regained her sight. She was taken to the emergency room (ER) but was not admitted to hospital. The next morning the patient was home from the ER visit. No further information was provided.
Age: 15.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Malaise, Muscle spasms, Muscular weakness, Nausea, Pallor
Clinical narrative: This medically confirmed report (initial receipt 17-Jan-2013) concerns a 15-year-old female patient. On 16-Jan-2013, the patient received AFLURIA (batch number: 06949211A) 0.5ml intramuscularly. On 16-Jan-2013 shortly after vaccination the patient experienced dizziness, nausea, tingling in the legs, loss of sight in one eye, vomited and became very pale. The paramedics were called, after their arrival the patient regained her sight. She was taken to the emergency room (ER) but was not admitted to hospital. The next morning the patient was home from the ER visit. No further information was provided.
Age: 15.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Vomiting
Clinical narrative: This medically confirmed report (initial receipt 17-Jan-2013) concerns a 15-year-old female patient. On 16-Jan-2013, the patient received AFLURIA (batch number: 06949211A) 0.5ml intramuscularly. On 16-Jan-2013 shortly after vaccination the patient experienced dizziness, nausea, tingling in the legs, loss of sight in one eye, vomited and became very pale. The paramedics were called, after their arrival the patient regained her sight. She was taken to the emergency room (ER) but was not admitted to hospital. The next morning the patient was home from the ER visit. No further information was provided.
Age: 15.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Blindness unilateral, Dizziness, Nausea, Pallor, Paraesthesia
Clinical narrative: This medically confirmed report (initial receipt 17-Jan-2013) concerns a 15-year-old female patient. On 16-Jan-2013, the patient received AFLURIA (batch number: 06949211A) 0.5ml intramuscularly. On 16-Jan-2013 shortly after vaccination the patient experienced dizziness, nausea, tingling in the legs, loss of sight in one eye, vomited and became very pale. The paramedics were called, after their arrival the patient regained her sight. She was taken to the emergency room (ER) but was not admitted to hospital. The next morning the patient was home from the ER visit. No further information was provided.
Age: 67.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Angioedema, Blood calcium normal, Blood chloride normal, Blood creatinine increased, Blood glucose increased
Clinical narrative: Received PNEUMOVAX 23 on Jan 14, 2013. On January 15 started having an allergic reaction about 5:30pm with throat irritation. Then hives broke out on throat & chest. By 8:30pm face and neck were extremely swollen. At that time took my husband to emergency room. They gave him BENADRYL and a steroid and said he would be fine by morning. On Wednesday morning he was even worse, passed out with blood pressure of 74/48 taken by 911 responders back to hospital where they said he was in anaphylaxis. Admitted him to hospital was released on Jan 18, 2013. Took until Jan 25, 2013 until fully recovered.
Age: 67.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Blood potassium normal, Blood sodium normal, Blood urea increased, Carbon dioxide normal, Cough
Clinical narrative: Received PNEUMOVAX 23 on Jan 14, 2013. On January 15 started having an allergic reaction about 5:30pm with throat irritation. Then hives broke out on throat & chest. By 8:30pm face and neck were extremely swollen. At that time took my husband to emergency room. They gave him BENADRYL and a steroid and said he would be fine by morning. On Wednesday morning he was even worse, passed out with blood pressure of 74/48 taken by 911 responders back to hospital where they said he was in anaphylaxis. Admitted him to hospital was released on Jan 18, 2013. Took until Jan 25, 2013 until fully recovered.
Age: 67.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Dizziness, Dyspnoea, Eye swelling, Flushing, Haematocrit normal
Clinical narrative: Received PNEUMOVAX 23 on Jan 14, 2013. On January 15 started having an allergic reaction about 5:30pm with throat irritation. Then hives broke out on throat & chest. By 8:30pm face and neck were extremely swollen. At that time took my husband to emergency room. They gave him BENADRYL and a steroid and said he would be fine by morning. On Wednesday morning he was even worse, passed out with blood pressure of 74/48 taken by 911 responders back to hospital where they said he was in anaphylaxis. Admitted him to hospital was released on Jan 18, 2013. Took until Jan 25, 2013 until fully recovered.
Age: 67.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Haemoglobin normal, Hypersensitivity, Loss of consciousness, Neutrophil percentage increased, Oedema mouth
Clinical narrative: Received PNEUMOVAX 23 on Jan 14, 2013. On January 15 started having an allergic reaction about 5:30pm with throat irritation. Then hives broke out on throat & chest. By 8:30pm face and neck were extremely swollen. At that time took my husband to emergency room. They gave him BENADRYL and a steroid and said he would be fine by morning. On Wednesday morning he was even worse, passed out with blood pressure of 74/48 taken by 911 responders back to hospital where they said he was in anaphylaxis. Admitted him to hospital was released on Jan 18, 2013. Took until Jan 25, 2013 until fully recovered.
Age: 67.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Palmar erythema, Pharyngeal oedema, Platelet count normal, Pruritus, Troponin normal
Clinical narrative: Received PNEUMOVAX 23 on Jan 14, 2013. On January 15 started having an allergic reaction about 5:30pm with throat irritation. Then hives broke out on throat & chest. By 8:30pm face and neck were extremely swollen. At that time took my husband to emergency room. They gave him BENADRYL and a steroid and said he would be fine by morning. On Wednesday morning he was even worse, passed out with blood pressure of 74/48 taken by 911 responders back to hospital where they said he was in anaphylaxis. Admitted him to hospital was released on Jan 18, 2013. Took until Jan 25, 2013 until fully recovered.
Age: 67.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Urticaria, White blood cell count normal
Clinical narrative: Received PNEUMOVAX 23 on Jan 14, 2013. On January 15 started having an allergic reaction about 5:30pm with throat irritation. Then hives broke out on throat & chest. By 8:30pm face and neck were extremely swollen. At that time took my husband to emergency room. They gave him BENADRYL and a steroid and said he would be fine by morning. On Wednesday morning he was even worse, passed out with blood pressure of 74/48 taken by 911 responders back to hospital where they said he was in anaphylaxis. Admitted him to hospital was released on Jan 18, 2013. Took until Jan 25, 2013 until fully recovered.
Age: 67.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Anaphylactic reaction, Electrocardiogram, Hypersensitivity, Swelling face, Urticaria
Clinical narrative: Received PNEUMOVAX 23 on Jan 14, 2013. On January 15 started having an allergic reaction about 5:30pm with throat irritation. Then hives broke out on throat & chest. By 8:30pm face and neck were extremely swollen. At that time took my husband to emergency room. They gave him BENADRYL and a steroid and said he would be fine by morning. On Wednesday morning he was even worse, passed out with blood pressure of 74/48 taken by 911 responders back to hospital where they said he was in anaphylaxis. Admitted him to hospital was released on Jan 18, 2013. Took until Jan 25, 2013 until fully recovered.
Age: 67.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Anaphylactic reaction, Chest X-ray, Echocardiogram, Electrocardiogram, Hypersensitivity
Clinical narrative: Received PNEUMOVAX 23 on Jan 14, 2013. On January 15 started having an allergic reaction about 5:30pm with throat irritation. Then hives broke out on throat & chest. By 8:30pm face and neck were extremely swollen. At that time took my husband to emergency room. They gave him BENADRYL and a steroid and said he would be fine by morning. On Wednesday morning he was even worse, passed out with blood pressure of 74/48 taken by 911 responders back to hospital where they said he was in anaphylaxis. Admitted him to hospital was released on Jan 18, 2013. Took until Jan 25, 2013 until fully recovered.
Age: 67.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Local swelling, Loss of consciousness, Swelling face, Throat irritation, Urticaria
Clinical narrative: Received PNEUMOVAX 23 on Jan 14, 2013. On January 15 started having an allergic reaction about 5:30pm with throat irritation. Then hives broke out on throat & chest. By 8:30pm face and neck were extremely swollen. At that time took my husband to emergency room. They gave him BENADRYL and a steroid and said he would be fine by morning. On Wednesday morning he was even worse, passed out with blood pressure of 74/48 taken by 911 responders back to hospital where they said he was in anaphylaxis. Admitted him to hospital was released on Jan 18, 2013. Took until Jan 25, 2013 until fully recovered.
Age: 62.0
Sex: M
Vaccine: FLU3, VARZOS, FLUX, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a 62 years old male patient with diabetes refers to himself. The patient did not have any drug reactions/allergies. The patient was vaccinated with ZOSTAVAX (dose and lot # were unknown) subcutaneously on 31-DEC-2012. No other co-suspects were reported. Concomitant medications included naproxen, gabapentin, HUMALOG and LANTUS insulin. The patient broke out with shingles on 09-JAN-2013, but the symptoms started on 07-JAN-2013. It was confirmed, he stated, by his physician on 11-JAN-2013. The outbreak was on his left side, which was the injection side. The patient was experiencing the Post-Herpetic Neuralgia (PHN) still at the time of reporting. No treatment was given for adverse event. The outcome of event is unknown. The relatedness for event is unknown for ZOSTAVAX. No lab diagnostics studies performed. The patient had sought unspecified medical attention. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: FLU3, VARZOS, FLUX, VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: This spontaneous report as received from a 62 years old male patient with diabetes refers to himself. The patient did not have any drug reactions/allergies. The patient was vaccinated with ZOSTAVAX (dose and lot # were unknown) subcutaneously on 31-DEC-2012. No other co-suspects were reported. Concomitant medications included naproxen, gabapentin, HUMALOG and LANTUS insulin. The patient broke out with shingles on 09-JAN-2013, but the symptoms started on 07-JAN-2013. It was confirmed, he stated, by his physician on 11-JAN-2013. The outbreak was on his left side, which was the injection side. The patient was experiencing the Post-Herpetic Neuralgia (PHN) still at the time of reporting. No treatment was given for adverse event. The outcome of event is unknown. The relatedness for event is unknown for ZOSTAVAX. No lab diagnostics studies performed. The patient had sought unspecified medical attention. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Blindness, Chills, Ear pain, Eye pain
Clinical narrative: Rash & pain to forehead, conjunctivitis rt eye, +preauricular node rt side, shaking.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Eye swelling, Headache, Herpes zoster, Nausea, Pyrexia
Clinical narrative: Rash & pain to forehead, conjunctivitis rt eye, +preauricular node rt side, shaking.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rhinorrhoea
Clinical narrative: Rash & pain to forehead, conjunctivitis rt eye, +preauricular node rt side, shaking.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Conjunctivitis, Headache, Lymphadenopathy, Rash, Tremor
Clinical narrative: Rash & pain to forehead, conjunctivitis rt eye, +preauricular node rt side, shaking.
Age: 20.0
Sex: M
Vaccine: TYP, YF
Symptoms: Palpitations, Pruritus, Urticaria
Clinical narrative: Hives, itching and racing heart. Epi and Benadryl were given.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Debridement, Erythema, Hyperhidrosis, Limb operation
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 72 years old male patient. No allergies listed. The patient was vaccinated with PNEUMOVAX 23 (0.5 ml, intramuscular, left arm, lot # was reported as H009826, expiration date was 11-FEB-2014) on 12-JAN-2013. No other co-suspects were reported. No concomitant medications were reported. The pharmacist stated a few days after vaccination patient's wife called the pharmacy stating her husband had chills, sweats, his left arm was red, swollen and painful. The pharmacist stated it was recommended that patient contact his doctor for follow up. The pharmacist stated the patient came into the pharmacy yesterday (24-JAN-2013) stating he had to be hospitalized. The patient ended up having his left arm opened up and drained and dead tissue had to be removed. Unspecified what hospital, unspecified how long the patient was in the hospital. The pharmacist stated the patient had fully recovered. The relatedness for events were unknown for PNEUMOVAX 23. The reporter considered one or more of these events to be medically significant. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 72 years old male patient. No allergies listed. The patient was vaccinated with PNEUMOVAX 23 (0.5 ml, intramuscular, left arm, lot # was reported as H009826, expiration date was 11-FEB-2014) on 12-JAN-2013. No other co-suspects were reported. No concomitant medications were reported. The pharmacist stated a few days after vaccination patient's wife called the pharmacy stating her husband had chills, sweats, his left arm was red, swollen and painful. The pharmacist stated it was recommended that patient contact his doctor for follow up. The pharmacist stated the patient came into the pharmacy yesterday (24-JAN-2013) stating he had to be hospitalized. The patient ended up having his left arm opened up and drained and dead tissue had to be removed. Unspecified what hospital, unspecified how long the patient was in the hospital. The pharmacist stated the patient had fully recovered. The relatedness for events were unknown for PNEUMOVAX 23. The reporter considered one or more of these events to be medically significant. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Dysphonia, Erythema, Fatigue, Heart rate increased, Skin warm
Clinical narrative: Noticed pain at injection site with redness the size of a 50cent piece; next day area had doubled in size, was very hot to touch and hard; able to move arm, no stiffness noted.
Age: 43.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Swelling, Tenderness
Clinical narrative: Noticed pain at injection site with redness the size of a 50cent piece; next day area had doubled in size, was very hot to touch and hard; able to move arm, no stiffness noted.
Age: 43.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Noticed pain at injection site with redness the size of a 50cent piece; next day area had doubled in size, was very hot to touch and hard; able to move arm, no stiffness noted.
Age: 54.0
Sex: U
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: Numbness in arm. Patient referred to neurologist by PCP.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Rec'd Dtap - within 24 hours - had redness over entire deltoid muscle - swelling & warmth - itching - no c/o pain.
Age: 38.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash generalised, Rash maculo-papular, Rash pruritic, Vaccination complication
Clinical narrative: Severe rash over entire body. Pruritic. Some maculopapular lesions. Seen by dermatologist 12-12-12, rxn thought to be a severe immune response of VARIVAX & squaric acid tx. Given shot KENALOG w/o relief of sx.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Angina pectoris, Condition aggravated, Eye discharge, Mobility decreased
Clinical narrative: Eyes turn red draining large amounts of yellow green puss. High fever on and off for a week. Stress caused angina took several nitro's. Was told to go to hospital but refused. In bed for a week could not walk. (The 1976 flu shot made me sick for years and ruined my never compensated in any way). (Never had a flu shot since 1976 had bad side effect ruined my health). They used big time scare tactics this time.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Ocular hyperaemia, Pyrexia, Stress
Clinical narrative: Eyes turn red draining large amounts of yellow green puss. High fever on and off for a week. Stress caused angina took several nitro's. Was told to go to hospital but refused. In bed for a week could not walk. (The 1976 flu shot made me sick for years and ruined my never compensated in any way). (Never had a flu shot since 1976 had bad side effect ruined my health). They used big time scare tactics this time.
Sex: M
Vaccine: TD
Symptoms: Anaphylactic reaction, Dizziness, Dyspnoea
Clinical narrative: In 2001, a male patient was administered a vaccine against tetanus (specific type of vaccine is unknown) in the emergency room and experienced an anaphylaxis reaction; dizziness, very short of breath. The ER staff immediately treated patient; specific treatment is unknown. Patient has recovered.
Sex: F
Vaccine: HEP
Symptoms: Death
Clinical narrative: MD visit at 1 week - healthy baby. 6 lbs 9 oz born at 39 weeks. ? SIDS death.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Ear pain, Mobility decreased, Pain in extremity
Clinical narrative: Patient states her left arm was sore and could not hardly move, the pain radiated from arm up to her ear after receiving vaccine. Patient instructed to use cold compress and take pain medicine. If the pain is not releived instructed to see PCP.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Diarrhoea, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Body aches, diarrhea, localized swelling, tendernes and redness at injection site and surrounding area.
Age: 1.01
Sex: M
Vaccine: DTAP
Symptoms: Pyrexia, Vomiting
Clinical narrative: Vomiting and fever.
Age: 1.3
Sex: M
Vaccine: MMR, PPV
Symptoms: Cough, Irritability, Lethargy, Pyrexia, Vomiting
Clinical narrative: Was given Prevnar 13 at 11 AM.  Fever of 101.6 at 1:15 PM gave Tylenol. Lethargic. At 6:25 PM had fever of 103.5 - gave more Tylenol.  At 7:50 PM started coughing and vomited.  At 1:30 AM 1/13/13 had 103.2 fever gave Advil.  At 6:40 AM started coughing and vomited.  Called doctor at 9:30 AM.  Still out of sorts and will see if fever comes back. Info I wanted was what does the high fever mean - not handling vaccine well?  Only said did not have to give any more doses - but this was his last one in series.
Age: 44.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Clearly demarcated area of redness, warm to touch on left upper arm aprox 5X8 inches.
Age: 35.0
Sex: F
Vaccine: MEN, TDAP, TYP, YF
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Tenderness, erythema and edema at injection site, warm to touch, treated with antibiotic on 1/28/2013.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Urticaria
Clinical narrative: Severe red rash and hives on the face, neck, chest, back, feet and arms.  No itching with rash.  Gave Benadryl and Prednisone pills for several days, but these did not make the rash go away. Rash lasted 2 weeks and as of 1/31/13 is beginning to subside.  We called our family doctor when the rash began. He refused to see her because he did not administer the shot. He would not prescribe anything for the rash.
Age: 0.28
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Body temperature increased, Diarrhoea, Vomiting
Clinical narrative: In the evening on the day the vaccines were administered patient spiked a time of 103.1 rectal.  He also had vomiting and diarrhea for approx. 3-4 days following the vaccination.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: this spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient was vaccinated with RECOMIVAX HB (lot # was reported as 0384AE and expiry date was 02-NOV-2014, route and dose were not reported) that was exposed to 25 Fahrenheit for an unknown period of time on 13-NOV-2012. No concomitant medications were reported. No adverse symptoms reported. This is one of several reports received from the same reporter. Follow up information was received from the licensed practical nurse who confirmed that none of the patients complained of any adverse experiences after receiving the above vaccines that had been stored incorrectly. Additional information is not expected.
Age: 2.0
Sex: M
Vaccine: PPV
Symptoms: Anuria, Decreased appetite, Dehydration, Depressed level of consciousness, Irritability
Clinical narrative: Prolonged fever T max 103 no response to TYLENOL / MOTRIN / ADVIL. Pt with no food intake for 1 day & no urine output in 24 hours. Pt with extreme irritability & mom had difficulty arousing baby from sleep. Pt came to PCP's office found to be febrile & dehydrated & given 1 dose ROCEPHIN sent to ER where received 3 bags of IV fluids.
Age: 2.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Prolonged fever T max 103 no response to TYLENOL / MOTRIN / ADVIL. Pt with no food intake for 1 day & no urine output in 24 hours. Pt with extreme irritability & mom had difficulty arousing baby from sleep. Pt came to PCP's office found to be febrile & dehydrated & given 1 dose ROCEPHIN sent to ER where received 3 bags of IV fluids.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient was vaccinated with RECOMBIVAX HB (lot # 669597/0294AA and expiry date was 06-SEP-2014, route and dose were not reported) that was exposed to 25 Fahrenheit for an unknown period of time on 22-OCT-2012. No concomitant medications were reported. No adverse symptoms reported. This is one of several reports received from the same reporter. Follow up information was received from the licensed practical nurse who confirmed that none of the patients complained of any adverse experiences after receiving the above vaccines that had been stored incorrectly. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient was vaccinated with RECOMIVAX HB (lot # 669597/0294AA and expiry date was 06-SEP-2014, route and dose were not reported) that was exposed to 25 Fahrenheit for an unknown period of time on 17-OCT-2012. No concomitant medications were reported. No adverse symptoms reported. This is one of several reports received from the same reporter. Follow up information was received from the licensed practical nurse who confirmed that none of the patients complained of any adverse experiences after receiving the above vaccines that had been stored incorrectly. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient was vaccinated with RECOMBIVAX HB (669597/0294AA and expiry date was 06-SEP-2014, route and dose were not reported) that was exposed to 25 Fahrenheit for an unknown period of time on 24-OCT-2012. No concomitant medications were reported. No adverse symptoms reported. This is one of several reports received from the same reporter. Follow up information was received from the licensed practical nurse who confirmed that none of the patients complained of any adverse experiences after receiving the above vaccines that had been stored incorrectly. Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Skin warm
Clinical narrative: This spontaneous report as received from a 66 years old diabetic female registered nurse (also the patient) with drug reaction/allergy to CIPRO, quinine, sulfa and to THEO-DUR refers to herself. She was vaccinated subcutaneously with a 0.65 ml dose of live ZOSTAVAX (lot number not reported) on 22-JAN-2013. No other co-suspects were reported. No concomitant medications were given. On 23-JAN-2013 the patient experienced blisters, warm to touch, and they have spread down her arm. She contacted with the physician. She received steroid injection (route unspecified) as a treatment. No lab diagnostics studies were performed. The outcome of blisters, warm to touch, and they have spread down her arm was reported as recovering/resolving. The relatedness for blisters, warm to touch, and they have spread down her arm was not reported for live ZOSTAVAX. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Oral herpes
Clinical narrative: This spontaneous report was received from a 55  year old female patient regarding herself. The patient had no pertinent medical history. The patient has possibly penicillin allergy. On 28-JAN-2013, the patient was vaccinated with a dose of 0.65 ml live ZOSTAVAX, (lot number reported as 9989115 expiration date and route was not reported) under the skin. No concomitant medications were reported. On 28-JAN-2013, (reported as after 5 hours later) the patient experienced cold sore. On 29-JAN-2013(reported as today) she has a slight headache. Treatment rendered for the event cold sore was DENAVIR (topically one dose only). There were no lab diagnostics performed. At the time of this report the patient had not recovered from the events. The patient stated that she was prone to getting cold sores and headaches and does not think it was related to the live ZOSTAVAX. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patients (unspecified number) of unknown age, who were vaccinated with a dose of VARIVAX (dose, route and lot number were not reported). No other co-suspects were reported. No concomitant medications were reported. The nurse reported that the patients could have received doses of VARIVAX that were improperly stored. The nurse reported that her practice had "dormitory-syle" freezer and when new thermometer was placed in, temperature reading was around 10-15 F. The nurse also reported that could not tell how long VARIVAX might had been exposed to 10-15 F. No adverse effects reported. Additional information has been requested. Update (22-JAN-2013): It was reported that client may have been vaccinated with improperly stored VARIVAX exposed 23F to 28F for 34 days. VARIVAX Lot 0660AE Exp 03/28/2014. Or client may have been vaccinated with VARIVAX exposed 23F to 28F for 21 days. Lot 0082AE Exp 01/03/2014. Captured in MARRS  1301USA005126). No adverse effects reported.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age. The patient was vaccinated with live ZOSTAVAX (dose, route and lot# were unknown) on an unknown date and after an unspecified time period developed a rash. No other co-suspects were reported. No concomitant medications were reported. The outcome of rash is unknown. The relatedness for rash is unknown for live ZOSTAVAX. The patient had sought unspecified medical attention. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient was vaccinated with RECOMBIVAX HB (lot # 669597/0294AA and expiry date was 06-SEP-2014, route and dose were not reported) that was exposed to 25 Fahrenheit for an unknown period of time on 04-OCT-2012. No concomitant medications were reported. No adverse symptoms reported. This is one of several reports received from the same reporter. Follow up information was received from the licensed practical nurse who confirmed that none of the patients complained of any adverse experiences after receiving the above vaccines that had been stored incorrectly. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient was vaccinated with RECOMBIVAX HB (lot # 669597/0294AA and expiry date was 06-SEP-2014, route and dose were not reported) that was exposed to 25 Fahrenheit for an unknown period of time on 01-NOV-2012. No concomitant medications were reported. No adverse symptoms reported. This is one of several reports received from the same reporter. Follow up information was received from the licensed practical nurse who confirmed that none of the patients complained of any adverse experiences after receiving the above vaccines that had been stored incorrectly. additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licenses practical nurse refers to a patient of unknown age and gender. The patient was vaccinated with RECOMBIVAX HB (lot # 669597/0294AA and expiry date was 06-SEP-2014, route and dose were not reported) that was exposed to 25 Fahrenheit for an unknown period of time on 12-OCT-2012. No concomitant medications were reported. No adverse symptoms reported. This is one of several reports received from the same reporter. Follow up information was received from the licensed practical nurse who confirmed that none of the patients complained of any adverse experiences after receiving the above vaccines that had been stored incorrectly. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to six patients of unknown age and gender. The patients were vaccinated with RECOMBIVAX HB (lot #, expiry date, route and dose were not reported) that was exposed to 25 Fahrenheit for an unknown period of time on an unknown date. No concomitant medications were reported. No adverse symptoms reported. This is one of several reports received from the same reporter. Follow up information was received from the licensed practical nurse who confirmed that none of the patients complained of any adverse experiences after receiving the above vaccines that had been stored incorrectly. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received form a licensed practical nurse refers to a patient of unknown age and gender. The patient was vaccinated with RECOMBIVAX HB (lot # 669597/029AA and expiry date was 06-SEP-2014, route and dose were not reported) that was exposed to 25 Fahrenheit for an unknown period of time on 26-OCT-2012. No concomitant medications were reported. No adverse symptoms reported. This is one of several reports received from the same reporter. Follow up information was received from the licensed practical nurse who confirmed that none of the patients complained of any adverse experiences after receiving the above vaccines tha that been stored incorrectly. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to unknown age and gender. The patient was vaccinated with RECOMBIVAX HB (lot # 66957/0294AA and expiry date was 06-SEP-2014, route and dose were not reported) that was exposed to 25 Fahrenheit for an unknown period of time on 05-NOV-2012, No concomitant medications were reported. No adverse symptoms reported. This is one of several reports received from the same reporter. Follow up information was received from the licensed practical nurse who confirmed that none of the patients complained of any adverse experiences after receiving the above vaccines that had been stored incorrectly. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient was vaccinated with RECOMBIVAX HB (lot # 669597/0294AA and expiry date was 06-SEP-2014, route and dose were not reported) that was exposed to 25 Fahrenheit for an unknown period of time on 18-OCT-2012. No concomitant medications were reported. No adverse symptoms reported. This is one of several reports received from the same reporter. Follow up information was received from the licensed practical nurse who confirmed that none of the patients complained of any adverse experiences after receiving the above vaccines that had been stored incorrectly. Additional information is not expected.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Disorientation, Dyspnoea, Malaise, Pain, Urticaria
Clinical narrative: WELT INCREADING IN SIZE, MAX 4" X 4". HIVES WITHIN 6" OF INJECTION SITE. SHORTNESS OF BREATH. DISORIENTATION. PAIN. MALAISE. ONSENT AND END OF SYSTEMIC SYMPTOMS DIRECTLY RELATED TO GROWTH AND DISAPPEARENCE OF LOCALIZED REACTION.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: My arm has been red, swollen, and sore since receiving the vaccine.  It has been three and one-half months since injection, and my arm is still red, swollen, and sore underneath injection site.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Axillary pain, Pain, Swelling, Tenderness
Clinical narrative: Pt says left axilla began to hurt the evening after his injection.  Came to clinic 2 days later.  Left axilla appears swollen.  Pt says it is tender to touch, hurts when he moves his arm.  Injection site appears normal.  Pt says the same thing happened after his HPV#2.  Says it was not as bad, and it got better in about one week.
Age: 19.0
Sex: F
Vaccine: FLU3, HEPAB, MMR, MNQ, TDAP
Symptoms: Injection site pain, Injection site swelling, Local swelling, Neck pain
Clinical narrative: Pain and swelling at injection site and up into left shoulder area and neck.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Oedema peripheral, Tenderness
Clinical narrative: Left arm has large swollen area noted by grandmother.  Sore to touch, denies redness, or warmth.  No fever or rash.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient unknown age and gender. The patient was vaccinated with RECOMBIVAX HB (lot # 669597/)294AA and expiry date was 06-SEP-2014, route and dose were not reported) that was exposed to 25 Fahrenheit for an unknown period of time on 05-OCT-2012. No concomitant medications were reported. No adverse symptoms reported. This is one of several reports received from the same reporter. Follow up information was received from the licensed practical nurse who confirmed that none of the patients complained of any adverse experiences after receiving the above vaccines that had been stored incorrectly. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient was vaccinated with RECOMBIVAX HB (lot # 669597/0294AA and expiry date was 06-SEP-2014, route and dose were not reported) that was exposed to 25 Fahrenheit for an unknown period of time on 09-OCT-2012. No concomitant medications were reported. No adverse symptoms reported. This is one of several reports received from the same reporter. Follow up information was received from the practical nurse who confirmed that none of the patients complained of any adverse experiences after receiving the above vaccines that had been stored incorrectly. Additional information is not expected.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Bronchopneumonia, Cough, Nasopharyngitis, Sneezing
Clinical narrative: Initial report received from a consumer who is the patient on 25 January 2013. This case is not medically confirmed. A 55-year-old female patient had received an intramuscular right arm injection of FLUZONE (lot number unknown) in the 2nd week of December 2012. She developed cold symptoms 2-3 days post-vaccination and since then continues with coughing and sneezing. The patient thought she was exposed to germs in the doctor office where there were other sick people. She received medical evaluation and her physician said she had bronchial pneumonia that was being treated with antibiotic and 4mg of Methylprednisolone every day. Outcome is not recovered. Current illnesses/medical conditions at time of vaccination included: Rheumatoid arthritis and "other problems". Pre-existing medical history included: allergy to "Aspertane", Codeine, Sulfa and other allergies. Documents held by sender: None.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient was vaccinated with RECOMBIVAX HB (lot # 669597/0294AA and expiry date was 06-SEP-2014, route and dose were not reported) that was exposed to 25 Fahrenheit for an unknown period of time on 06-NOV-2012. No concomitant medications were reported. No adverse symptoms reported. This is one of several received from the same reporter. Follow up information was received from the licensed practical nurse who confirmed that none of the patients complained of any adverse experiences after receiving the above vaccines that had been stored incorrectly. Additional information is not expected.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site cellulitis
Clinical narrative: Initial report was received 24 January 2013 from a pharmacy employee. Case not medically confirmed. A 58 year old female patient (age also reported as 57 years) had received a left deltoid dose of FLUZONE ID (lot number UT4471BA) on 21 January 2013, and 3 days later on 24 January 2013 the pharmacist received a call from the MD who reported the patient had cellulitis at the insertion site (vaccination site). The event required medical evaluation. Outcome was not recovered. Documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Influenza, Influenza A virus test positive
Clinical narrative: Initial report was received from a consumer on 21 January 2013. A female child (age and date of birth not reported) had received an injection of FLUZONE, Sanofi Pasteur, (lot number, route and site unknown) on 14 January 2013. On 21 January 2013, the patient tested positive for A strain with the Sophia test. It was unknown if the patient had any illness at the time of vaccination or past medical history. Outcome was not recovered. Documents held by sender: None.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient was vaccinated with RECOMBIVAX HB (lot # 669597/0294AA and expiry date was 06-SEP-2014, route and dose were not reported) that was exposed to 25 Fahrenheit for an unknown period of time on 08-NOV-2012. No concomitant medications were reported. No adverse symptoms reported. This is one of several reports received from the same reporter. Follow up information was received from the licensed practical nurse who confirmed that none of the patient complained of any adverse experiences after receiving the above vaccines that had been stored incorrectly. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient was vaccinated with RECOMBIVAX HB (lot # 669597/0294AA and expiry date was 06-SEP-2014, route and dose were not reported) that was exposed to 25 Fahrenheit for an unknown period of time on 07-NOV-2012. No concomitant medications were reported. No adverse symptoms reported. This is one of several reports received from the same reporter. Follow up information was received from the licensed practical nurse who confirmed that none of the patients complained of any adverse experiences after receiving the above vaccines that had been stored incorrectly. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient was vaccinated with RECOMBIVAX HB (lot # 669597/0294AA and expiry date was 06-SEP-3014, route and dose were not reported) that was exposed to 25 Fahrenheit for an unknown period of time on 15-OCT-2012. No concomitant medications were reported. No adverse symptoms reported. This is one of several reports received from the same reporter. Follow up information was received from the licensed practical nurse who confirmed that none of the patients complained of any adverse experiences after receiving the above vaccines that had been stored incorrectly. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Chest X-ray abnormal, Cough, Pleural effusion, Respiratory disorder, Wheezing
Clinical narrative: Pt got shot at pharmacy Sunday - about 4 hrs later started with wheezing, cough & resp difficulty. Seen at an urgent care - pt given nebulizer treatment & steroid injection. Told she had abnormal CXR w/ "fluids in her lungs".
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Skin lesion, Swelling
Clinical narrative: Red, swollen lesion, about 2" in diameter body aches for 2 days.
Age: 37.0
Sex: F
Vaccine: TD
Symptoms: Urticaria
Clinical narrative: Patient experienced generalized hives. Patient went to the doctor's office on 04/02/2012 and was treated with prednisone. The symptoms lasted a couple of days after treatment. Patient recovered.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: Vaccine given Mon, rx on Wed red, oval, hot to touch. Pt saw MD, gave KEFLEX 500 BID x10.