chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Diarrhoea, Eye swelling, Insomnia, Ocular hyperaemia
Clinical narrative: Pt said that 2 1/2 hrs after receiving Flu vaccine her throat tickled & she had cough. Then she started wheezing and couldn't sleep. Then she had fever and was shaking. Then her eyes became red and goopy. Then she had diarrhea & threw up. She had no fever. She did not go to hospital & she recovered next day.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Throat irritation, Tremor, Vomiting, Wheezing
Clinical narrative: Pt said that 2 1/2 hrs after receiving Flu vaccine her throat tickled & she had cough. Then she started wheezing and couldn't sleep. Then she had fever and was shaking. Then her eyes became red and goopy. Then she had diarrhea & threw up. She had no fever. She did not go to hospital & she recovered next day.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Site of injection still hurts, after 1 1/2 months but it has been improving.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Local red swelling at site of injection. 2 inches x 3 inches in size. Taking ZYRTEC 10mg daily, Hydrocortisone cream 1% topically. Shingles vaccine given 10/26/12.
Age: 62.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt came in 2 days after ZOSTAVAX injection and his entire upper right arm area was swollen (around injection sight) from elbow to under arms no pain, just very red & swollen - he gave him BENADRYL.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Headache, Local swelling, Neuralgia
Clinical narrative: Headache, local swelling and redness at glut, neuralgia 3 weeks. Antihistamine, ice, elevation, cold laser treatment.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site inflammation, Syncope
Clinical narrative: Redness and inflammation at injection site. Pt. fainted approx. 7 hours after receiving vaccine.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Pyrexia
Clinical narrative: Cellulitis at injection site, redness, fever.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Fatigue
Clinical narrative: This spontaneous report as received from Nurse Practitioner refers to a 24 years old female patient with no pertinent medical history and no drug reactions/allergies. On 20-AUG-2012 the patient was vaccinated intramuscularly with the first dose of GARDASIL (Product Lot # reported as 0636AE, Exp Date: 01-JAN-2015). No concomitant medications were reported. On 27-AUG-2012 (one week after receiving her first dose of GARDASIL) the patient developed fatigue and weakness. No treatment information was reported. No lab diagnostics studies were performed. The patient had sought unspecified medical attention. The outcome of fatigue and weakness was reported as recovered/resolved. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Pruritus
Clinical narrative: Pain, redness, swelling, itching shoulder to elbow. Antibiotic, BENADRYL & ibuprofen prescribed 10/10 resolved.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a 66 years old male consumer with diabetes and cancer refers to himself. The patient was vaccinated with ZOSTAVAX (lot number not provided) subcutaneously on 02-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. On 18-OCT-2012 the patient experienced shingles. Treatment was given for adverse event. The patient might go in next Friday, approximately on 02-NOV-2012 for blood work. The outcome of shingles was reported as not recovered. The patient visited office for seek medical attention. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist who stated there were an unspecified quantity of MMR II (indication, route, dose and lot # were unknown) doses that experienced a temperature excursion (72F for 14 hours0 and may have been administered to an unspecified number of patients. No adverse effects reported. The outcome of event was unknown. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Oedema peripheral, Pain, Skin warm, Tenderness
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. The patient had no pertinent medical history and no drug reactions or allergies. The patient was vaccinated with PNEUMOVAX 23 (lot number reported as H013847, expired date 15-MAR-2014) (dose, frequency and injection site were not reported) intramuscular injection on an unknown date in October 2012 (within the past ten days). No other co-suspects were reported. There was no concomitant medication. The physician reported that he saw that patient the day after vaccination and that the patient presented with swelling of the upper arm in the mid-bicep region, warmth (lithe area was hot to the touch"), tenderness and pan. The patient started on unspecified antibiotics and mild analgesics. The patient was recovering at the time of report. There was no laboratory diagnostics studies performed. The patient had an office visit for medical attention. There was no laboratory diagnostics studies performed. Physician requests a lot check for the PNEUMOVAX 23. This is one of several reports received from the same source. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report as received from a 63 years old female patient refers to herself. The patient's pertinent medical history was high blood pressure. The patient had allergy to iodine and tetnas. The patient was vaccinated subcutaneously with ZOSTAVAX (1 time vaccine, dose and lot # were unknown) on 19-OCT-2012 (reported to prevent pregnancy). No other co-suspects were reported. Concomitant medications included blood pressure medication and cholesterol medication. On 20-OCT-2012 the patient stated she had a red area about the size of a baseball on her arm where the vaccine was administered. She also stated it was itching. No treatment was given for adverse event. At the report time the outcome of event was unknown. The patient did not sought medical attention. No lab diagnosis studies performed. Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Fatigue, Lethargy, Oropharyngeal pain, Pain in extremity, Pyrexia
Clinical narrative: 1 hour after administration of vaccine had 104 degrees F temp which lasted 48 hours.
Age: 5.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Streptococcus test negative
Clinical narrative: 1 hour after administration of vaccine had 104 degrees F temp which lasted 48 hours.
Age: 5.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Body temperature increased
Clinical narrative: 1 hour after administration of vaccine had 104 degrees F temp which lasted 48 hours.
Age: 65.0
Sex: F
Vaccine: PPV, FLU3, PPV
Symptoms: Local swelling, Pain, Skin warm
Clinical narrative: This spontaneous report as received from a consumer refers to his 65 years old wife with AUGMENTIN and doxycycline allergy. The patient had no pertinent medical history. The patient was vaccinated with PNEUMOVAX 23 (lot number not provided) on 27-SEP-2012. No other co-suspects were reported. Concomitant medications included hormones (unspecified). At the evening of 27-SEP-2012 she developed chills, headache, fever of 102, aching all over, swollen left arm from elbow to shoulder and itching at the injection site. On 29-SEP-2012 she was seen at Urgent Care, and on 30-SEP-2012 she went to ER where she was diagnosed with an infection. Since then, at an unspecified time, she had a cold for 3 days. She continued to have bumps and itching at the injection site. Blood and urine testing were performed (result unknown). Unspecified antibiotics and pain pill, BENADRYL were given for adverse event as treatment. The outcome of adverse events was reported as not recovered. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV, FLU3, PPV
Symptoms: Blood test, Chills, Headache, Infection, Injection site pruritus
Clinical narrative: This spontaneous report as received from a consumer refers to his 65 years old wife with AUGMENTIN and doxycycline allergy. The patient had no pertinent medical history. The patient was vaccinated with PNEUMOVAX 23 (lot number not provided) on 27-SEP-2012. No other co-suspects were reported. Concomitant medications included hormones (unspecified). At the evening of 27-SEP-2012 she developed chills, headache, fever of 102, aching all over, swollen left arm from elbow to shoulder and itching at the injection site. On 29-SEP-2012 she was seen at Urgent Care, and on 30-SEP-2012 she went to ER where she was diagnosed with an infection. Since then, at an unspecified time, she had a cold for 3 days. She continued to have bumps and itching at the injection site. Blood and urine testing were performed (result unknown). Unspecified antibiotics and pain pill, BENADRYL were given for adverse event as treatment. The outcome of adverse events was reported as not recovered. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV, FLU3, PPV
Symptoms: Injection site rash, Nasopharyngitis, Oedema peripheral, Pain, Pyrexia
Clinical narrative: This spontaneous report as received from a consumer refers to his 65 years old wife with AUGMENTIN and doxycycline allergy. The patient had no pertinent medical history. The patient was vaccinated with PNEUMOVAX 23 (lot number not provided) on 27-SEP-2012. No other co-suspects were reported. Concomitant medications included hormones (unspecified). At the evening of 27-SEP-2012 she developed chills, headache, fever of 102, aching all over, swollen left arm from elbow to shoulder and itching at the injection site. On 29-SEP-2012 she was seen at Urgent Care, and on 30-SEP-2012 she went to ER where she was diagnosed with an infection. Since then, at an unspecified time, she had a cold for 3 days. She continued to have bumps and itching at the injection site. Blood and urine testing were performed (result unknown). Unspecified antibiotics and pain pill, BENADRYL were given for adverse event as treatment. The outcome of adverse events was reported as not recovered. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV, FLU3, PPV
Symptoms: Urine analysis
Clinical narrative: This spontaneous report as received from a consumer refers to his 65 years old wife with AUGMENTIN and doxycycline allergy. The patient had no pertinent medical history. The patient was vaccinated with PNEUMOVAX 23 (lot number not provided) on 27-SEP-2012. No other co-suspects were reported. Concomitant medications included hormones (unspecified). At the evening of 27-SEP-2012 she developed chills, headache, fever of 102, aching all over, swollen left arm from elbow to shoulder and itching at the injection site. On 29-SEP-2012 she was seen at Urgent Care, and on 30-SEP-2012 she went to ER where she was diagnosed with an infection. Since then, at an unspecified time, she had a cold for 3 days. She continued to have bumps and itching at the injection site. Blood and urine testing were performed (result unknown). Unspecified antibiotics and pain pill, BENADRYL were given for adverse event as treatment. The outcome of adverse events was reported as not recovered. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash pruritic, Rash vesicular
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 64 years old male patient with gastrooesophageal reflux disease (GERD) and high cholesterol and he had no drug reactions/allergies. The patient was subcutaneously vaccinated with a dose of ZOSTAVAX (dose unspecified) (lot number reported as H011431, expiry date 12-SEP-2013) on 12-SEP-2012. No other co-suspects were reported. Concomitant medications included ZETIA, NEXIUM and TRILIPIX. On "about 17-SEP-2012, "the patient began to have a "rash." The patient was seen in the physician's office on 21-SEP-2012, and an erythematous rash with papular and vesicular lesions was found on the patient's abdomen, arms, and fingers. The patient was seen again in the physician's office on 27-SEP-2012, and the rash was found to have also spread to the legs. The patient was given FAMVIR (manufacturer unspecified) for 1 week. However, this did not resolve the rash. On 02-OCT-2012, the patient went to an unspecified dermatologist, who did a biopsy of the rash. The dermatologist report stated that the rash was consistent with a "drug reaction." The dermatologist gave the patient prednisone and clobetasol cream (manufacturers unspecified) which resolved the erythematous rash on the abdomen only. The patient went to see the physician again on 24-OCT-2012, because there was a new rash that has appeared on the face, neck, chest, and arms which looked different from the previous rash mentioned above. This rash looked more pustular, and drains with a yellow pus. The patient was referred back to the dermatologist. All of the above mentioned rashes were found on both sides of the body. The patient was recovering. The office has requested a lot check on the ZOSTAVAX to see if anyone else has had a similar experience. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Adverse drug reaction, Biopsy, Rash, Rash erythematous, Rash papular
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 64 years old male patient with gastrooesophageal reflux disease (GERD) and high cholesterol and he had no drug reactions/allergies. The patient was subcutaneously vaccinated with a dose of ZOSTAVAX (dose unspecified) (lot number reported as H011431, expiry date 12-SEP-2013) on 12-SEP-2012. No other co-suspects were reported. Concomitant medications included ZETIA, NEXIUM and TRILIPIX. On "about 17-SEP-2012, "the patient began to have a "rash." The patient was seen in the physician's office on 21-SEP-2012, and an erythematous rash with papular and vesicular lesions was found on the patient's abdomen, arms, and fingers. The patient was seen again in the physician's office on 27-SEP-2012, and the rash was found to have also spread to the legs. The patient was given FAMVIR (manufacturer unspecified) for 1 week. However, this did not resolve the rash. On 02-OCT-2012, the patient went to an unspecified dermatologist, who did a biopsy of the rash. The dermatologist report stated that the rash was consistent with a "drug reaction." The dermatologist gave the patient prednisone and clobetasol cream (manufacturers unspecified) which resolved the erythematous rash on the abdomen only. The patient went to see the physician again on 24-OCT-2012, because there was a new rash that has appeared on the face, neck, chest, and arms which looked different from the previous rash mentioned above. This rash looked more pustular, and drains with a yellow pus. The patient was referred back to the dermatologist. All of the above mentioned rashes were found on both sides of the body. The patient was recovering. The office has requested a lot check on the ZOSTAVAX to see if anyone else has had a similar experience. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash pustular, Rash vesicular
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 64 years old male patient with gastrooesophageal reflux disease (GERD) and high cholesterol and he had no drug reactions/allergies. The patient was subcutaneously vaccinated with a dose of ZOSTAVAX (dose unspecified) (lot number reported as H011431, expiry date 12-SEP-2013) on 12-SEP-2012. No other co-suspects were reported. Concomitant medications included ZETIA, NEXIUM and TRILIPIX. On "about 17-SEP-2012, "the patient began to have a "rash." The patient was seen in the physician's office on 21-SEP-2012, and an erythematous rash with papular and vesicular lesions was found on the patient's abdomen, arms, and fingers. The patient was seen again in the physician's office on 27-SEP-2012, and the rash was found to have also spread to the legs. The patient was given FAMVIR (manufacturer unspecified) for 1 week. However, this did not resolve the rash. On 02-OCT-2012, the patient went to an unspecified dermatologist, who did a biopsy of the rash. The dermatologist report stated that the rash was consistent with a "drug reaction." The dermatologist gave the patient prednisone and clobetasol cream (manufacturers unspecified) which resolved the erythematous rash on the abdomen only. The patient went to see the physician again on 24-OCT-2012, because there was a new rash that has appeared on the face, neck, chest, and arms which looked different from the previous rash mentioned above. This rash looked more pustular, and drains with a yellow pus. The patient was referred back to the dermatologist. All of the above mentioned rashes were found on both sides of the body. The patient was recovering. The office has requested a lot check on the ZOSTAVAX to see if anyone else has had a similar experience. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, TDAP, HPV4
Symptoms: Dizziness, Vomiting
Clinical narrative: This spontaneous report as received from a registered nurse refers to an 11 years old male patient with asthma and without drug reaction. The patient was vaccinated with the first dose of 0.5 ml GARDASIL (lot number 0459AE, expiry date 14-DEC-2012) Intramuscularly on 10-OCT-2012. No other co-suspects were reported. Concomitant medications included SINGULAIR, FLOVENT and albuterol. The patient experienced uncontrollable vomiting within 45 minutes after the vaccination. The patient had sought medical attention via office visit. The patient was administered ZOFRAN in the office and completely recovered on 10-OCT-2012. No laboratory studies were performed. This is one of several reports received from the same reporter. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, TDAP, HPV4
Symptoms: Vomiting
Clinical narrative: This spontaneous report as received from a registered nurse refers to an 11 years old male patient with asthma and without drug reaction. The patient was vaccinated with the first dose of 0.5 ml GARDASIL (lot number 0459AE, expiry date 14-DEC-2012) Intramuscularly on 10-OCT-2012. No other co-suspects were reported. Concomitant medications included SINGULAIR, FLOVENT and albuterol. The patient experienced uncontrollable vomiting within 45 minutes after the vaccination. The patient had sought medical attention via office visit. The patient was administered ZOFRAN in the office and completely recovered on 10-OCT-2012. No laboratory studies were performed. This is one of several reports received from the same reporter. Additional information is not expected.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3, FLUX
Symptoms: Asthenia, Asthma, Body temperature increased, Eye irritation, Oral discomfort
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 25 October 2012. A 45-year-old female patient had received an intramuscular injection in the left deltoid of FLUZONE SV, lot number UH717AB, on 24 October 2012. Two and a half hours post-vaccination, the patient experienced an asthma attack, fever to 37.28 degrees Celsius (99.1 degrees Fahrenheit), nausea, weakness, pain in left arm, burning eyes, swollen tongue and throat, blisters inside of mouth, burning lips and it was painful to swallow. Treatment included 40 mg steroids, BENADRYL mouthwash and Albuterol inhaler. The symptoms continued by seem to be slightly less severe. The patient had no illness at the time of vaccination, allergies to avocados, rabbits and ragweed and a history of asthma and interstitial cystitis. The patient's outcome was not recovered. Documents held by sender: None.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3, FLUX
Symptoms: Oral mucosal blistering, Pharyngeal oedema, Swollen tongue
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 25 October 2012. A 45-year-old female patient had received an intramuscular injection in the left deltoid of FLUZONE SV, lot number UH717AB, on 24 October 2012. Two and a half hours post-vaccination, the patient experienced an asthma attack, fever to 37.28 degrees Celsius (99.1 degrees Fahrenheit), nausea, weakness, pain in left arm, burning eyes, swollen tongue and throat, blisters inside of mouth, burning lips and it was painful to swallow. Treatment included 40 mg steroids, BENADRYL mouthwash and Albuterol inhaler. The symptoms continued by seem to be slightly less severe. The patient had no illness at the time of vaccination, allergies to avocados, rabbits and ragweed and a history of asthma and interstitial cystitis. The patient's outcome was not recovered. Documents held by sender: None.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3, FLUX
Symptoms: Asthenia, Asthma, Condition aggravated, Eye irritation, Nausea
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 25 October 2012. A 45-year-old female patient had received an intramuscular injection in the left deltoid of FLUZONE SV, lot number UH717AB, on 24 October 2012. Two and a half hours post-vaccination, the patient experienced an asthma attack, fever to 37.28 degrees Celsius (99.1 degrees Fahrenheit), nausea, weakness, pain in left arm, burning eyes, swollen tongue and throat, blisters inside of mouth, burning lips and it was painful to swallow. Treatment included 40 mg steroids, BENADRYL mouthwash and Albuterol inhaler. The symptoms continued by seem to be slightly less severe. The patient had no illness at the time of vaccination, allergies to avocados, rabbits and ragweed and a history of asthma and interstitial cystitis. The patient's outcome was not recovered. Documents held by sender: None.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3, FLUX
Symptoms: Odynophagia, Oral discomfort, Oral mucosal blistering, Pain in extremity, Pharyngeal oedema
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 25 October 2012. A 45-year-old female patient had received an intramuscular injection in the left deltoid of FLUZONE SV, lot number UH717AB, on 24 October 2012. Two and a half hours post-vaccination, the patient experienced an asthma attack, fever to 37.28 degrees Celsius (99.1 degrees Fahrenheit), nausea, weakness, pain in left arm, burning eyes, swollen tongue and throat, blisters inside of mouth, burning lips and it was painful to swallow. Treatment included 40 mg steroids, BENADRYL mouthwash and Albuterol inhaler. The symptoms continued by seem to be slightly less severe. The patient had no illness at the time of vaccination, allergies to avocados, rabbits and ragweed and a history of asthma and interstitial cystitis. The patient's outcome was not recovered. Documents held by sender: None.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3, FLUX
Symptoms: Pyrexia, Swollen tongue
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 25 October 2012. A 45-year-old female patient had received an intramuscular injection in the left deltoid of FLUZONE SV, lot number UH717AB, on 24 October 2012. Two and a half hours post-vaccination, the patient experienced an asthma attack, fever to 37.28 degrees Celsius (99.1 degrees Fahrenheit), nausea, weakness, pain in left arm, burning eyes, swollen tongue and throat, blisters inside of mouth, burning lips and it was painful to swallow. Treatment included 40 mg steroids, BENADRYL mouthwash and Albuterol inhaler. The symptoms continued by seem to be slightly less severe. The patient had no illness at the time of vaccination, allergies to avocados, rabbits and ragweed and a history of asthma and interstitial cystitis. The patient's outcome was not recovered. Documents held by sender: None.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3, FLUX
Symptoms: Asthma, Condition aggravated, Feeling hot, Hypoaesthesia oral, Oral discomfort
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 25 October 2012. A 45-year-old female patient had received an intramuscular injection in the left deltoid of FLUZONE SV, lot number UH717AB, on 24 October 2012. Two and a half hours post-vaccination, the patient experienced an asthma attack, fever to 37.28 degrees Celsius (99.1 degrees Fahrenheit), nausea, weakness, pain in left arm, burning eyes, swollen tongue and throat, blisters inside of mouth, burning lips and it was painful to swallow. Treatment included 40 mg steroids, BENADRYL mouthwash and Albuterol inhaler. The symptoms continued by seem to be slightly less severe. The patient had no illness at the time of vaccination, allergies to avocados, rabbits and ragweed and a history of asthma and interstitial cystitis. The patient's outcome was not recovered. Documents held by sender: None.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3, FLUX
Symptoms: Oral pain, Oropharyngeal pain, Pyrexia, Salivary hypersecretion, Stomatitis
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 25 October 2012. A 45-year-old female patient had received an intramuscular injection in the left deltoid of FLUZONE SV, lot number UH717AB, on 24 October 2012. Two and a half hours post-vaccination, the patient experienced an asthma attack, fever to 37.28 degrees Celsius (99.1 degrees Fahrenheit), nausea, weakness, pain in left arm, burning eyes, swollen tongue and throat, blisters inside of mouth, burning lips and it was painful to swallow. Treatment included 40 mg steroids, BENADRYL mouthwash and Albuterol inhaler. The symptoms continued by seem to be slightly less severe. The patient had no illness at the time of vaccination, allergies to avocados, rabbits and ragweed and a history of asthma and interstitial cystitis. The patient's outcome was not recovered. Documents held by sender: None.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3, FLUX
Symptoms: Swollen tongue
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 25 October 2012. A 45-year-old female patient had received an intramuscular injection in the left deltoid of FLUZONE SV, lot number UH717AB, on 24 October 2012. Two and a half hours post-vaccination, the patient experienced an asthma attack, fever to 37.28 degrees Celsius (99.1 degrees Fahrenheit), nausea, weakness, pain in left arm, burning eyes, swollen tongue and throat, blisters inside of mouth, burning lips and it was painful to swallow. Treatment included 40 mg steroids, BENADRYL mouthwash and Albuterol inhaler. The symptoms continued by seem to be slightly less severe. The patient had no illness at the time of vaccination, allergies to avocados, rabbits and ragweed and a history of asthma and interstitial cystitis. The patient's outcome was not recovered. Documents held by sender: None.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Lip swelling, Oropharyngeal discomfort
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 70 years old female patient. On an unknown date the patient was vaccinated subcutaneously with ZOSTAVAX (dose unknown, Lot # reported as H013017, exp. 10/2013). No other co-suspects were reported. No concomitant medications were reported. On 24-OCT-2012 the patient experienced lip started to swell up (hospitalization), after receiving the ZOSTAVAX shot. It was reported that the patient was hospitalized, but it was unspecified if it was an emergency room visit. No treatment information was reported. The outcome of lip swelling was reported as recovered/resolved (date unknown). The relatedness for lip swelling was not reported for ZOSTAVAX. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Lip swelling
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 70 years old female patient. On an unknown date the patient was vaccinated subcutaneously with ZOSTAVAX (dose unknown, Lot # reported as H013017, exp. 10/2013). No other co-suspects were reported. No concomitant medications were reported. On 24-OCT-2012 the patient experienced lip started to swell up (hospitalization), after receiving the ZOSTAVAX shot. It was reported that the patient was hospitalized, but it was unspecified if it was an emergency room visit. No treatment information was reported. The outcome of lip swelling was reported as recovered/resolved (date unknown). The relatedness for lip swelling was not reported for ZOSTAVAX. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Erythema, Fatigue, Injection site pain, Myalgia, Nasal congestion
Clinical narrative: Flu-like symptoms and pain at site of injection since she received the injection.
Age: 48.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Nausea, Night sweats, Oropharyngeal pain, Rhinorrhoea, Sinus headache
Clinical narrative: Flu-like symptoms and pain at site of injection since she received the injection.
Age: 48.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Urinary tract infection
Clinical narrative: Flu-like symptoms and pain at site of injection since she received the injection.
Age: 48.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Influenza like illness, Injection site pain
Clinical narrative: Flu-like symptoms and pain at site of injection since she received the injection.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Syncope
Clinical narrative: This spontaneous report as received from a pharmacist as part of a marketing research program conducted by the agency refers to a 13 years old female patient with no relevant medical history. The patient was vaccinated with a dose of GARDASIL (lot #, dose and route not reported) on an unknown date. No other co-suspects were reported. No concomitant medications were reported. The patient experienced seizure (medically significant) and fainted after injection. No treatment information was reported. No diagnostic studies were performed. The outcome of seizure and fainted after injection was reported as recovered/resolved on an unknown date soon after the event. The reporter felt that seizure and fainted after injection were related to therapy with GARDASIL. Upon internal review, seizure was considered to be medically significant. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Throat cancer
Clinical narrative: This spontaneous report as received from a physician assistant refers to a female patient of unknown age. The patient was vaccinated with ZOSTAVAX (lot# unspecified) on an unknown date. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced throat cancer shortly after receiving ZOSTAVAX. No treatment information was reported. The outcome of throat cancer was unknown. Upon internal review throat cancer was determined to be medical significant event. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Insomnia, Pain, Pain in extremity, Weight bearing difficulty
Clinical narrative: Pain, Immobility. Day 1-5: Complete immobility of right and shoulder. Severe pain. Inability to sleep due to stabbing pains in the arm. Day 6-19: Mobility returns to about 85%, pain receded to a bearable state. Day 20: Complete immobility and severe pain as in days 1-5. No signs of amnesia. Day 21 - 30: Mobility returns to about 85%, pain receded to a bearable state. Day 31-60: Mobility returns to about 90-95%. Pain present during movements at a certain angle and/or with extra weight on the arm. Pain varies each day, but is on a bearable level. Visit to a physician postponed due to a 2.5 month trip abroad. Waiting to get back (11/18/12) to visit a physician. Long-term/permanent damage expected.
Age: 46.0
Sex: M
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Injection site pain, Pain, Pain in extremity
Clinical narrative: Extreme soreness in left deltoid where shot was administered. Still sore as of 11/5/2012. Pain when lifting arm over shoulder. Difficulty putting shirts on over head. Feels like someone repeatedly punching me in the arm. No treatment.
Age: 43.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Urticaria
Clinical narrative: Patient had hives on arms, no shortness of breath or difficulty breathing.
Age: 43.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: C-reactive protein increased, Erythema, Nodule, Oedema peripheral, Pruritus
Clinical narrative: Patient had hives on arms, no shortness of breath or difficulty breathing.
Age: 43.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Radioallergosorbent test negative, Rash, Rash erythematous, Rash pruritic, Red blood cell sedimentation rate increased
Clinical narrative: Patient had hives on arms, no shortness of breath or difficulty breathing.
Age: 43.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Skin warm, Tryptase, Urticaria
Clinical narrative: Patient had hives on arms, no shortness of breath or difficulty breathing.
Age: 1.05
Sex: F
Vaccine: FLUX
Symptoms: Rash, Urticaria
Clinical narrative: Rashes and hives discovered when changing baby, approximately 2 weeks after flu shot.
Age: 1.26
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, CSF test normal, Computerised tomogram normal, Diarrhoea, Dyskinesia
Clinical narrative: DIARRHEA, DIFFICULTY SWALLOWING, FEVER 99.4F. MUSCLE WEAKNESS, A/P abnormal tone, stopped talking, decreased muscle control, decreased energy, increased sleeping, numerous pustules in groin area, BP 144/81, Pulse 160-170.
Age: 1.26
Sex: M
Vaccine: FLU3
Symptoms: Dysphagia, Electromyogram abnormal, Hypersomnia, Hypotonia, Muscular weakness
Clinical narrative: DIARRHEA, DIFFICULTY SWALLOWING, FEVER 99.4F. MUSCLE WEAKNESS, A/P abnormal tone, stopped talking, decreased muscle control, decreased energy, increased sleeping, numerous pustules in groin area, BP 144/81, Pulse 160-170.
Age: 1.26
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Rash pustular, Speech disorder developmental, Temporomandibular joint syndrome
Clinical narrative: DIARRHEA, DIFFICULTY SWALLOWING, FEVER 99.4F. MUSCLE WEAKNESS, A/P abnormal tone, stopped talking, decreased muscle control, decreased energy, increased sleeping, numerous pustules in groin area, BP 144/81, Pulse 160-170.
Age: 6.0
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Rash erythematous
Clinical narrative: RED RASH ON RIGHT ARM.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Feeling hot, Heart rate increased, Muscle tightness
Clinical narrative: Heart beats raised from 70s to 90s. Body felt hot, head felt tight, left chest felt tight.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site haemorrhage, Musculoskeletal pain, Pain
Clinical narrative: Shoulder began to hurt, or have soreness when I would try to lift up my two-year old, or take shirt off at the end of the day, etc. Last week it felt like it was subsiding, but this past weekend the soreness is still there..when I tried to sweep, rake, stretch, etc. I took IBProfen, which seemed to help, but not solve. I have never experienced a reaction from past flu shots.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Blood pressure increased, Chills, Cough, Fatigue, Headache
Clinical narrative: Developed progressive muscle pain, fatigue, chills, high fever, headache, elevated blood pressure, and cough.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Myalgia, Pyrexia
Clinical narrative: Developed progressive muscle pain, fatigue, chills, high fever, headache, elevated blood pressure, and cough.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Burning sensation, Drug administered at inappropriate site, Injection site pain, Mobility decreased, Pain in extremity
Clinical narrative: Shot was incorrectly given in the shoulder joint instead of the muscle further down on the arm right beneath the joint.  Since receiving the injection I have been experiencing burning sensations in my arm and decreased arm mobility.  I frequently wake up throughout the night in pain at the location of the injection.  Arm hurts all day long.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Electrocardiogram, Electromyogram, Hypoaesthesia, Injection site swelling, Laboratory test
Clinical narrative: (R) arm pain, swelling at site, pain into (R) scapula, leg weakness, tingling in feet, fingertips off and on then weakness in leg like jelly then numb leg, stops at pubic area.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Lumbar puncture, Muscular weakness, Musculoskeletal pain, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: (R) arm pain, swelling at site, pain into (R) scapula, leg weakness, tingling in feet, fingertips off and on then weakness in leg like jelly then numb leg, stops at pubic area.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: (R) arm pain, swelling at site, pain into (R) scapula, leg weakness, tingling in feet, fingertips off and on then weakness in leg like jelly then numb leg, stops at pubic area.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, FLUN3, HIBV, MMR, VARCEL
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis.
Age: 13.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Cyanosis
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 13 years old female patient with hypocalcemia and no drug reactions/allergies. The patient was vaccinated with dose 1 of GARDASIL (dose, route and lot # not reported) on 10-AUG-2012. On 11-SEP-2012, the patient was vaccinated with the second 0.5 ml dose of GARDASIL (Lot # 1009AA) intramuscularly and a dose of FLUZONE concomitantly. Concomitant medications included: ROCALTROL. The reporter stated that the patient's hands turned blue on 12-SEP-2012 after receiving GARDASIL and FLUZONE concomitantly. This reaction lasted two or three days with chronic blue appearance and continued to happen intermittently to date. There was no discernable pattern to these incidences. The medical assistant reported that the patient's hands continued to turn bluer as they sat together. The patient was seen by her health care professional. The patient was prescribed a tapering dose of prednisone (unspecified manufacturer) 10 mg 3x daily for 3 days, then 2x daily for 3 days, then 1x daily for 3 days to treat the experience, but it did not help. The reporter states that the patient was not going to receive the final shot in the series of GARDASIL injection. The outcome of patient's hands turned blue was reported as not recovered. The relatedness for patient's hands turned blue was unknown for GARDASIL. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram head, Dyskinesia, Eyelid function disorder, Paraesthesia oral, Sensory disturbance
Clinical narrative: Same as states previously.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: VIIth nerve paralysis
Clinical narrative: Same as states previously.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Pt had redness and swelling at injection site on right arm at time of onsite. Mom took pt to ED on 10/26/12 at 1920 area of redness was 2"x4" at time of visit. He was treated for cellutits by taking Keflex 200mg PO BID for 7 days, and to take OTC Motrin and Claritin. Pt f/u with PCP on Monday/Tuesday and improvement noted.
Age: 12.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Fall, Feeling abnormal, Loss of consciousness
Clinical narrative: After administering influenza and Gardasil vaccines, labs were immediately drawn from the child. After removal of the needle for blood collection, the patient fell to her left side, a cabinet breaking her fall. A nurse was able to stop her from falling onto the floor. The patient completely lost consciousness for about 30 seconds. She awoke with no recollection of the incident, feeling as though she had just fallen asleep. BP immediately following the incident was 60/30, within 20 minutes repeat BP was 101/66, HR 70. Mother obtained juice and candy for the child to eat. No bruises or araisions noted. Left office about 30 minutes later feeling well.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Condition aggravated, Full blood count abnormal, Idiopathic thrombocytopenic purpura, Platelet count decreased
Clinical narrative: Acute ITP CBC platelet count 29 K.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Injection site pain, Pain, Pain in extremity, Sleep disorder
Clinical narrative: Patient presented to Health Department on 11/05/2012 and has complained of right arm pain (upper and lower forearm) with movement of extremity.  Also pain with pressure to area and unable to sleep on that side.  No visible swelling, inflammation, redness.  Area of 3 cm bruising noted below deltoid but states area of pain is in deltoid region.  Patient denies trauma to area.
Age: 1.62
Sex: F
Vaccine: DTAP
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Pertussis, Polymerase chain reaction
Clinical narrative: Initial report received on 25 October 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in an 4-year-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received 1 dose of DAPTACEL; lot number C2934BA on 30 May 2008, 2 doses of PENTACEL; lot number C3176AA on 23 July 2008 and 09 October 2008 and another dose of DAPTACEL; lot number C3157AA on 09 November 2009 (routes and sites of administration not reported). The subject developed cough on 03 August 2012, approximately 2 years and 8 months after the last dose. Paroxysmal coughing, without a whoop, began on 07 August 2012. Laboratory testing included positive PCR on 13 August 2012. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin starting on 13 August 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 07 September 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 35 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Aphasia, Asthma, Biopsy skin, Chest pain, Condition aggravated
Clinical narrative: Initial report was received 26 October 2012 from a consumer, who is also the patient. A 52-year-old female patient with a history of asthma and who three days before vaccination had completed a course of CIPRO for an asthma flare-up, had received an intramuscular right deltoid injection of FLUZONE, lot number UM719AA (lot number invalid) "about three weeks ago on Thursday, maybe 04 October 2012" and an unspecified amount of time later, she experienced worsening of asthma with much coughing, wheezing, pain in chest, unable to talk and hives on her arm (which arm not specified). The patient had also received allergy testing on her left forearm on the day of vaccination. Over the next several days the hives on her arm changed to red, itchy round bumps and she continued to have trouble with her asthma. The patient was evaluated by her primary care physician and received steroids as corrective treatment. She continued to have red itchy round bumps on her arm and saw two different dermatologists. The second dermatologist performed a biopsy of the "bumps" on her arm. BENADRYL and steroid cream was prescribed for the bumps. At the time of the report, the bumps had changed to white patches that were dry, very itchy, and the itching was so bad the patient couldn't sleep. Outcome was not recovered. Documents held by sender: None.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dry skin, Insomnia, Rash erythematous, Rash pruritic
Clinical narrative: Initial report was received 26 October 2012 from a consumer, who is also the patient. A 52-year-old female patient with a history of asthma and who three days before vaccination had completed a course of CIPRO for an asthma flare-up, had received an intramuscular right deltoid injection of FLUZONE, lot number UM719AA (lot number invalid) "about three weeks ago on Thursday, maybe 04 October 2012" and an unspecified amount of time later, she experienced worsening of asthma with much coughing, wheezing, pain in chest, unable to talk and hives on her arm (which arm not specified). The patient had also received allergy testing on her left forearm on the day of vaccination. Over the next several days the hives on her arm changed to red, itchy round bumps and she continued to have trouble with her asthma. The patient was evaluated by her primary care physician and received steroids as corrective treatment. She continued to have red itchy round bumps on her arm and saw two different dermatologists. The second dermatologist performed a biopsy of the "bumps" on her arm. BENADRYL and steroid cream was prescribed for the bumps. At the time of the report, the bumps had changed to white patches that were dry, very itchy, and the itching was so bad the patient couldn't sleep. Outcome was not recovered. Documents held by sender: None.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Skin discolouration, Urticaria, Wheezing
Clinical narrative: Initial report was received 26 October 2012 from a consumer, who is also the patient. A 52-year-old female patient with a history of asthma and who three days before vaccination had completed a course of CIPRO for an asthma flare-up, had received an intramuscular right deltoid injection of FLUZONE, lot number UM719AA (lot number invalid) "about three weeks ago on Thursday, maybe 04 October 2012" and an unspecified amount of time later, she experienced worsening of asthma with much coughing, wheezing, pain in chest, unable to talk and hives on her arm (which arm not specified). The patient had also received allergy testing on her left forearm on the day of vaccination. Over the next several days the hives on her arm changed to red, itchy round bumps and she continued to have trouble with her asthma. The patient was evaluated by her primary care physician and received steroids as corrective treatment. She continued to have red itchy round bumps on her arm and saw two different dermatologists. The second dermatologist performed a biopsy of the "bumps" on her arm. BENADRYL and steroid cream was prescribed for the bumps. At the time of the report, the bumps had changed to white patches that were dry, very itchy, and the itching was so bad the patient couldn't sleep. Outcome was not recovered. Documents held by sender: None.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Lip swelling, Swelling face, Swollen tongue, Throat tightness
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 26 October 2012. A 66-year-old female patient had received an intramuscular injection in the left arm of FLUZONE High-Dose, lot number not reported, in October of 2011 and an unspecified amount of time later experienced swollen lips, face, eyes, tongue and felt like her throat was closing. The patient was treated in the emergency room with IV's, Prednisone and BENADRYL. The patient was sent home after two hours and much improved. The patient had no illness at the time of vaccination, allergy to amoxicillin where she experiences hives and a history of high blood pressure and high cholesterol. Concomitant medications included lisinopril and CRESTOR. The patient's outcome was recovered. Documents held by sender: None.