chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient who was vaccinated with ZOSTAVAX on an unknown date. On an unknown date the patient experienced redness around injection site after receiving ZOSTAVAX. The outcome of the event was unknown. The relatedness for redness around injection site was unknown for ZOSTAVAX. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to her currently 56 year old sister. On an unspecified date, the patient was vaccinated with a dose of ZOSTAVAX (lot number, route, dose, site not reported). The patient had a reaction to the ZOSTAVAX. Her arm became huge and red. The outcome of the events was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a currently 55 year old female patient. The patient's medical history included shingles. The patient was vaccinated with a dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (Lot # not reported) on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on an unknown date, after receiving the vaccine, the patient did not have a titer. The patient stated that any vaccine she had gotten she did not get a titer. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient was vaccinated with a dose of ZOSTAVAX on 20-SEP-2012. (Lot number reported as 1506Z and Expiration date as 02-FEB-2012). Concomitant medications were not reported. The reporter stated that the patient received ZOSTAVAX on 20-SEP-2012 that had expired on 02-FEB-2012. No adverse effect was reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning a 62 year old female with no reported medical history who on 21-OCT-2011 received a dose of ZOSTAVAX subcutaneously. Concomitant medications included EVISTA. On an unspecified date, the patient developed a mild case of shingles after she received a dose of ZOSTAVAX. The patient sought medical attention and was treated with valacyclovir. No diagnostic test were performed. At the time of reporting, it is unknown if the patient has recovered. No other information is available. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Exposure to vaccinated person, Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age, who was expose through her 61 year old boyfriend who on 21-AUG-2012 was vaccinated subcutaneously on left arm with a 0.65 ml dose of ZOSTAVAX (lot 0564AE exp: 21-MAR-2013). No concomitant medications were reported. The pharmacist stated that on 21-AUG-2012 a client was vaccinated with ZOSTAVAX and the patient called pharmacist to asked if ZOSTAVAX could be transmitted. The patient told to the pharmacist that his girlfriend was experiencing symptoms of shingles, unspecified what type of symptoms. The pharmacist stated that the patient vaccinated did not report any break out or adverse effects from the vaccination himself. The patient's girlfriend may follow up with her health care provider. The outcome of symptoms of shingles was unknown. The relatedness for symptoms of shingles was unknown for ZOSTAVAX. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site rash, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: This spontaneous report as received from a 66 years old female patient with drug allergy to morphine refers to herself. The patient's medical history included pneumonia 5 years ago (in approximately 2007). The patient was vaccinated with PNEUMOVAX 23 (lot # unknown) subcutaneous or intramuscular injection on 05-OCT-2012. No other co-suspects were reported. There were no concomitant medications. On 05-OCT-2012 night, the patient's her injection arm was sore. The upper arm was swollen and very warm to the touch. The swollen moved down to her elbow and she developed a rash. The rash was subsiding, but the arm was still swollen and it was also itched. In addition, she had a headache. The patient had taken ibuprofen and hydrocortisone cream for treatment. The patient sought medical attention by called pharmacist and there was no lab performed for the event. The outcome of her injection arm was sore, headache, the arm itching, the swelling moved down to her elbow, the upper arm was very warm to the touch and the upper arm was swollen was reported as not recovered. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus
Clinical narrative: This spontaneous report as received from a 66 years old female patient with drug allergy to morphine refers to herself. The patient's medical history included pneumonia 5 years ago (in approximately 2007). The patient was vaccinated with PNEUMOVAX 23 (lot # unknown) subcutaneous or intramuscular injection on 05-OCT-2012. No other co-suspects were reported. There were no concomitant medications. On 05-OCT-2012 night, the patient's her injection arm was sore. The upper arm was swollen and very warm to the touch. The swollen moved down to her elbow and she developed a rash. The rash was subsiding, but the arm was still swollen and it was also itched. In addition, she had a headache. The patient had taken ibuprofen and hydrocortisone cream for treatment. The patient sought medical attention by called pharmacist and there was no lab performed for the event. The outcome of her injection arm was sore, headache, the arm itching, the swelling moved down to her elbow, the upper arm was very warm to the touch and the upper arm was swollen was reported as not recovered. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a male consumer of unknown age refers to himself. On unspecified date, the patient was vaccinated with PNEUMOVAX23 (dose, indicating, route and lot not reported). No concomitant medications were reported. The consumer reported that on unspecified date, he was vaccinated with PNEUMOVAX23 and he believed that he and his wife received the PNEUMOVAX23 twice. He does not have any adverse experiences. At the time of the report the patient's outcome was unknown. Additional information is not expected. This is one of several reports received from the same source.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient to unknown age and gender. The patient was vaccinated with lot # 669579/0595AA PNEUMOVAX23 with expiry date of 30-AUG-2012 on 27-SEP-2012. Route was not reported. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a pediatric patient of unknown age. On 03-OCT-2012, the patient experienced vaccinated with a dose of ZOSTAVAX (dose, route, lot number not reported) instead of VARIVAX (Merck) due to human error. No concomitant medications were reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On 05-FEB-2012, the patient was vaccinated with dose 1 RECOMBIVAX HB (dose, route and lot not reported). On 03-MAR-2012, the patient was vaccinated with dose 2 RECOMBIVAX HB (dose, route and lot not reported). On 05-OCT-2012, the patient was vaccinated with dose 3 RECOMBIVAX HB (dose, route and lot number reported). No concomitant medications were reported. The pharmacists stated that the patient did not had adverse effect reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician's assistant refers to a 12 years old female patient. The patient was vaccinated intramuscularly in the right arm with dose 2, 1 ml dose of RECOMBIVAX HB (lot # not reported) on 07-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: This spontaneous report as received from a registered nurse (nurse manager) refers to an employee, a female patient of unknown age. Information regarding medical history was not provided. On 26-SEP-2012 the patient was vaccinated at the office with a single dose of ZOSTAVAX subcutaneously in the right arm. No other co-suspects were reported. No concomitant medications were reported. On 27-SEP-2012, the patient came back to work and experienced a 4 inch round, red, hard, hot area at the injection site. The patient did not receive treatment for the event. The patient did not seek any medical attention. The outcome of '4 inch round, red, hard, hot area at the injection site' was reported as not recovered. A reporter causality was not provided for '4 inch round, red, hard, hot area at the injection site' and ZOSTAVAX. Additional information is not expected.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 77 years old female patient with PEN-VEE K and PERCODAN allergies. The patient was vaccinated IM into the left arm with a 0.5 ml dose of PNEUMOVAX 23 (Lot # reported as H013581, exp 03-MAR-2014) on 08-OCT-2012. No other co-suspects were reported. Concomitant medications included simvastatin (manufacturer unknown), ropinirole, NEXIUM, levothyroxine sodium, and citalopram. On the same date, few hours after administration of PNEUMOVAX 23, the patient developed swelling and a mild rash at the injection site. The patient was seen at the physician's office on 09-OCT-2012 and was prescribed CELEBREX for 2 days, no lab/diagnostic studies were performed. The outcome of the events was reported as not recovered. The relationship between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a currently 60 years old diabetic male patient with no Drug Reactions/Allergies. On an unspecified date, "a long time ago", the patient completed an unspecified hepatitis B vaccine (manufacturer unknown) series (Lot number, dose and route not reported) at an unspecified location by an unspecified healthcare provider. No other co-suspects were reported. No concomitant medications were reported. On 04-OCT-2012, hepatitis B test showed no immunity. The patient sought medical attention by an routine office visit. The relatedness for the event was unknown for Hepatitis B vaccine (manufacturer unknown). Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Incorrect dose administered, Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 66 year old female patient. On an unknown date in July 2012 (reported as late July 2012), the patient was vaccinated with a 1st dose of PNEUMOVAX 23 (dose, route, lot number unspecified). On 05-SEP-2012, the patient was revaccinated with a second dose of PNEUMOVAX 23, 0.5 milliliter, once, intramuscularly to the left deltoid. Lot number H009826 is an invalid lot number for PNEUMOVAX 23. Expiry date was reported as 11-FEB-2014. No concomitant medications were reported. After she received the vaccination in the pharmacy on 05-SEP-2012 as directed by a prescription, she experienced soreness on the left arm, at the injection site (approximately 05-SEP-2012). The patient saw a physician for the event. The patient was unaware at the time of second dose of PNEUMOVAX 23 that she had received the initial dose of PNEUMOVAX 23. The outcome of soreness on the left arm, at the injection site was unknown. The relatedness for soreness on the left arm, at the injection site was unknown for PNEUMOVAX 23. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist regarding an 80 year old female with no pertinent medical history and no drug allergies. On 25-SEP-2012, the female was vaccinated with ZOSTAVAX subcutaneous 0.65 milliliters (site not reported) (lot number: H011050, expiration date 05-SEP-2013 as reported) to prevent shingles. Concomitant medications included: pantoprazole, atorvastatin, losartan (manufacturer unknown), hydrochlorothiazide (manufacturer unknown), alendronate (manufacturer unknown), calcium and vitamin D. On 26-SEP-2012, the female developed an injection-site reaction of redness and swelling. The patient sought medical attention described as visited pharmacy. No treatment was given. At the time of this report, thee vent was not recovered. Additional information is not expected.
Age: 79.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 79 year old male patient with no drug reactions or allergies. On 03-OCT-2012, the patient was vaccinated with a dose of PNEUMOVAX23, 0.5 ml, intramuscular (lot# reported as H009826, expiration date 11-FEB-2014). No other co-suspects were reported. Concomitant medications included: FLUZONE. On 03-OCT-2012, the patient developed tenderness at the injection site after receiving a dose of PNEUMOVAX23. There was no treatment given for tenderness at the injection site. No laboratory tests were performed. The patient's outcome of tenderness at the injection site was unknown. The patient sought medical attention, called the pharmacist. The relatedness for tenderness at the injection site was not reported for PNEUMOVAX23. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a patient of unknown age. On 08-OCT-2012 the patient was vaccinated SC with a 0.65 ml dose of ZOSTAVAX (lot # was reported as H012521, exp date: 09-OCT-2013) exposed to temperature that could not be supported. No adverse effects reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a 66 years old female patient with diabetes. The patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot # reported as H011427, exp 12-SEP-2013) SC in the left arm on 07-OCT-2012. No other co-suspects were reported. Concomitant medications included: hormones (unspecified) and diabetes (unspecified) medications. On 08-OCT-2012, the patient experienced large red rash around injection site after receiving ZOSTAVAX. According to the pharmacist, the injection site area was raised and swollen but pretty diffused and patient reported warmth around injection site. The patient sought medical attention, she spoke to the pharmacist. The patient noticed the size of rash had been increasing. No treatment was given for the events. The outcome of the events was reported as "worsening". The relationship between the events and ZOSTAVAX was not reported.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 53 years old female patient with reactions/allergies to opioids and insomnia. The patient was vaccinated with ZOSTAVAX, which was administered subcutaneously on 29-SEP-2012. The reported lot number was 0564AE (expiration date was not specified). Concomitant therapies included zolpidem tartrate. On 02-OCT-2012 the patient experienced a rash that looks like welts in all the areas of the body where there are sweaty creases. The patient sought medical attention for the event and was treated for the event with CALADRYL. The outcome of rash that looks like welts in all the areas of the body where there are sweaty creases was reported as recovering/resolving. No lab diagnostic studies were performed. The relatedness for the adverse event is unknown for ZOSTAVAX. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 75 years old female patient. The patient did not have any drug reactions/allergies. The patient was vaccinated with ZOSTAVAX (lot # reported as 0422AE, expiration date 27-MAR-2013) subcutaneously in the left arm on 15-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. The patient developed an injection site reaction following vaccination with ZOSTAVAX. The pharmacist reported reaction described as a little red area at the injection that was noted during a phone call on 17-AUG-2012 (exact time frame development of the red area was unspecified). The patient came into the pharmacy today (08-OCT-2012) reporting that they still have a red area at the injection site, described as a red area about the size of a quarter (the skin was described as soft, not hard to the touch). No treatment given for adverse event. The outcome of the event was reported as not recovered/resolved. The patient had sought medical attention via contacting pharmacist. No lab diagnosis studies performed. Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Information has been received from a nurse regarding a 64 year old female with allergies to sulfa and rofecoxib (MSD) (see case # 1210USA006855), and history of allergic rhinitis, depression, GERD, hyperlipidemia, and hypertension. It was reported on 27-AUG-2012, that the patient received a subcutaneous injection of ZOSTAVAX (lot # reported as 0468AE, expiration date April 2013) 0.65 ml. On 28-AUG-2012, the patient experienced injection site reaction that was 1.5 inch x 1.5 inch with redness, swelling, warm to touch. Concomitant medication included XANAX, aspirin, CRESTOR, enalapril (manufacturer unknown), vitamin D, fish oil, fluoxetine, omeprazole, and estrogens, PREMPRO. The sought medical attention (phone call and office visit) and was told to take BENADRYL, cortisone cream and cool compress if needed. The nurse stated that she would report this to VAERS. The events were not resolved. No further information is available. Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a nurse regarding a 64 year old female with allergies to sulfa and rofecoxib (MSD) (see case # 1210USA006855), and history of allergic rhinitis, depression, GERD, hyperlipidemia, and hypertension. It was reported on 27-AUG-2012, that the patient received a subcutaneous injection of ZOSTAVAX (lot # reported as 0468AE, expiration date April 2013) 0.65 ml. On 28-AUG-2012, the patient experienced injection site reaction that was 1.5 inch x 1.5 inch with redness, swelling, warm to touch. Concomitant medication included XANAX, aspirin, CRESTOR, enalapril (manufacturer unknown), vitamin D, fish oil, fluoxetine, omeprazole, and estrogens, PREMPRO. The sought medical attention (phone call and office visit) and was told to take BENADRYL, cortisone cream and cool compress if needed. The nurse stated that she would report this to VAERS. The events were not resolved. No further information is available. Additional information is not expected.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a physician refers to a 71 years old female patient with allergy to grape pie and with no pertinent medical history. The patient was vaccinated with a dose of ZOSTAVAX (Lot # reported as H01133, dose and route not reported) in her left arm on 11-SEP-2012. Concomitant medications included omeprazole, TRUFOPT and XALANTAN. "The next day" on 12-SEP-2012 the patient experienced burning and aching in her ear and right neck, and "2 days later" on 14-SEP-2012 developed a vesicular rash on her right neck. Physician performed test for DNA PCR which was positive for varicella-zoster virus on an unspecified date. The patient contacted physician for medical attention. VALTREX was given for treatment. At the time of this report the patient was still experiencing pain in her right neck and had no recovered. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Ear pain, Herpes zoster, Neck pain, Rash vesicular
Clinical narrative: This spontaneous report as received from a physician refers to a 71 years old female patient with allergy to grape pie and with no pertinent medical history. The patient was vaccinated with a dose of ZOSTAVAX (Lot # reported as H01133, dose and route not reported) in her left arm on 11-SEP-2012. Concomitant medications included omeprazole, TRUFOPT and XALANTAN. "The next day" on 12-SEP-2012 the patient experienced burning and aching in her ear and right neck, and "2 days later" on 14-SEP-2012 developed a vesicular rash on her right neck. Physician performed test for DNA PCR which was positive for varicella-zoster virus on an unspecified date. The patient contacted physician for medical attention. VALTREX was given for treatment. At the time of this report the patient was still experiencing pain in her right neck and had no recovered. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Varicella virus test positive
Clinical narrative: This spontaneous report as received from a physician refers to a 71 years old female patient with allergy to grape pie and with no pertinent medical history. The patient was vaccinated with a dose of ZOSTAVAX (Lot # reported as H01133, dose and route not reported) in her left arm on 11-SEP-2012. Concomitant medications included omeprazole, TRUFOPT and XALANTAN. "The next day" on 12-SEP-2012 the patient experienced burning and aching in her ear and right neck, and "2 days later" on 14-SEP-2012 developed a vesicular rash on her right neck. Physician performed test for DNA PCR which was positive for varicella-zoster virus on an unspecified date. The patient contacted physician for medical attention. VALTREX was given for treatment. At the time of this report the patient was still experiencing pain in her right neck and had no recovered. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: FLU3, VARZOS, VARZOS
Symptoms: Malaise, Pain, Rash, Rash vesicular
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 76 year old female patient with migraines and no drug reactions/allergies who on 26-SEP-2012 was vaccinated with a 0.65 ml dose of ZOSTAVAX subcutaneous (lot number H011050, expiration date 05-SEP-2013). Concomitant medications included: IMITREX. On 26-SEP-2012, the patient developed a painful, itchy rash on her abdomen, chest and back and flu like symptoms after receiving ZOSTAVAX. The patient was seen at the emergency room, where she was evaluated and discharged. She was given BENADRYL and unspecified medications for the pain. At the time of the report, the patient was recovering from the events. It was unknown if the events were related to therapy with ZOSTAVAX. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: FLU3, VARZOS, VARZOS
Symptoms: Influenza like illness, Pain, Rash pruritic
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 76 year old female patient with migraines and no drug reactions/allergies who on 26-SEP-2012 was vaccinated with a 0.65 ml dose of ZOSTAVAX subcutaneous (lot number H011050, expiration date 05-SEP-2013). Concomitant medications included: IMITREX. On 26-SEP-2012, the patient developed a painful, itchy rash on her abdomen, chest and back and flu like symptoms after receiving ZOSTAVAX. The patient was seen at the emergency room, where she was evaluated and discharged. She was given BENADRYL and unspecified medications for the pain. At the time of the report, the patient was recovering from the events. It was unknown if the events were related to therapy with ZOSTAVAX. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Swelling face, Swollen tongue
Clinical narrative: Initial report was received from a health care professional on 05 October 2012. This is a cluster of two patients who received FLUZONE, lot number UH719AA, and experienced adverse events. The other patient was captured in case number 2012-09313. A 59-year-old female patient had received an intramuscular injection in the left deltoid of FLUZONE, lot number UH719AA, on 03 October 2012. On 04 October 2012, the patient reported facial swelling and tongue swelling. The patient was evaluated and prescribed antihistamines daily for several days. The diagnosis was unspecified adverse effect. The patient was not acutely ill at the time of vaccination. The patient had a medical history of hypertension (HTN), hyperlipidemia, muscle ligament dislocation and shoulder pain. Concomitant medications included hydrochlorothiazide (HCTZ), Simvastatin and Loratadine. The patient's outcome was recovered. Documents held by sender: None.
Age: 59.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Adverse event, Swelling face, Swollen tongue
Clinical narrative: Initial report was received from a health care professional on 05 October 2012. This is a cluster of two patients who received FLUZONE, lot number UH719AA, and experienced adverse events. The other patient was captured in case number 2012-09313. A 59-year-old female patient had received an intramuscular injection in the left deltoid of FLUZONE, lot number UH719AA, on 03 October 2012. On 04 October 2012, the patient reported facial swelling and tongue swelling. The patient was evaluated and prescribed antihistamines daily for several days. The diagnosis was unspecified adverse effect. The patient was not acutely ill at the time of vaccination. The patient had a medical history of hypertension (HTN), hyperlipidemia, muscle ligament dislocation and shoulder pain. Concomitant medications included hydrochlorothiazide (HCTZ), Simvastatin and Loratadine. The patient's outcome was recovered. Documents held by sender: None.
Age: 83.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cough, Throat tightness
Clinical narrative: Initial report was received from a health care professional on 05 October 2012. This is a cluster of two patients who received FLUZONE, lot number UH719AA, and experienced adverse events. The other patient was captured in case number 2012-09314. An 83-year-old female patient had received an intramuscular injection in the left deltoid of FLUZONE, lot number UH719AA, on 04 October 2012 and 10 minutes later experienced a cough followed by feeling of throat closure at 15 minutes post-vaccination. The patient was treated with BENADRYL liquid 10 mL and the symptoms resolved. The patient was not acutely ill at the time of vaccination. The patient had allergies to non-steroidal anti-inflammatory drugs (NSAIDs) and penicillin (PCN). Past medical history (PMH) included hypertension (HTN), hyperlipidemia, coronary artery disease (CAD), aortic aneurysm, anxiety and left hip fracture. Concomitant medications included Valium, PLAVIX, CRESTOR, VICODIN and Oxybutin chloride. The patient's outcome was recovered. Documents held by sender; None.
Age: 83.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Adverse event, Cough, Throat tightness
Clinical narrative: Initial report was received from a health care professional on 05 October 2012. This is a cluster of two patients who received FLUZONE, lot number UH719AA, and experienced adverse events. The other patient was captured in case number 2012-09314. An 83-year-old female patient had received an intramuscular injection in the left deltoid of FLUZONE, lot number UH719AA, on 04 October 2012 and 10 minutes later experienced a cough followed by feeling of throat closure at 15 minutes post-vaccination. The patient was treated with BENADRYL liquid 10 mL and the symptoms resolved. The patient was not acutely ill at the time of vaccination. The patient had allergies to non-steroidal anti-inflammatory drugs (NSAIDs) and penicillin (PCN). Past medical history (PMH) included hypertension (HTN), hyperlipidemia, coronary artery disease (CAD), aortic aneurysm, anxiety and left hip fracture. Concomitant medications included Valium, PLAVIX, CRESTOR, VICODIN and Oxybutin chloride. The patient's outcome was recovered. Documents held by sender; None.
Age: 81.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site ulcer
Clinical narrative: Discoloration, swelling, inflammation at the site of injection.
Age: 81.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Inflammation, Injection site discolouration, Injection site inflammation, Injection site swelling
Clinical narrative: Discoloration, swelling, inflammation at the site of injection.
Age: 1.39
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Influenza virus test negative, Nasal congestion, Pyrexia, Rhinorrhoea, Streptococcus test negative
Clinical narrative: Evening of 10/9/2012 - crying unable to sleep (out of character) did not sleep 3AM - fever 102 - MOTRIN was given immediately (between 6AM - 7AM) - seizure/runny nose body shaking/saliva dripping sides of mouth. Bulging eyes not responding at all. Temperature 103.9 MOTRIN given immediately 911 called Dr confirmed this was a side effect from vaccine & from description she had had a febrile seizure.
Age: 1.39
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Tremor
Clinical narrative: Evening of 10/9/2012 - crying unable to sleep (out of character) did not sleep 3AM - fever 102 - MOTRIN was given immediately (between 6AM - 7AM) - seizure/runny nose body shaking/saliva dripping sides of mouth. Bulging eyes not responding at all. Temperature 103.9 MOTRIN given immediately 911 called Dr confirmed this was a side effect from vaccine & from description she had had a febrile seizure.
Age: 1.39
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Convulsion, Crying, Exophthalmos, Febrile convulsion, Pyrexia
Clinical narrative: Evening of 10/9/2012 - crying unable to sleep (out of character) did not sleep 3AM - fever 102 - MOTRIN was given immediately (between 6AM - 7AM) - seizure/runny nose body shaking/saliva dripping sides of mouth. Bulging eyes not responding at all. Temperature 103.9 MOTRIN given immediately 911 called Dr confirmed this was a side effect from vaccine & from description she had had a febrile seizure.
Age: 1.39
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Rhinorrhoea, Salivary hypersecretion, Sleep disorder, Tremor
Clinical narrative: Evening of 10/9/2012 - crying unable to sleep (out of character) did not sleep 3AM - fever 102 - MOTRIN was given immediately (between 6AM - 7AM) - seizure/runny nose body shaking/saliva dripping sides of mouth. Bulging eyes not responding at all. Temperature 103.9 MOTRIN given immediately 911 called Dr confirmed this was a side effect from vaccine & from description she had had a febrile seizure.
Age: 63.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pruritus generalised, Rash
Clinical narrative: Woke up with rash at scalp line and thigh the morning after vaccination.
Age: 63.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Rash
Clinical narrative: Woke up with rash at scalp line and thigh the morning after vaccination.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Muscle spasms, Pain
Clinical narrative: I had the vaccine in my left arm about 11:30 a.m. and started to feel a cramp behind my left knee that afternoon. I took Motrin that evening and again the next day but stopped after Thursday and the pain worsened. I is like a charley horse that will not go away. It is now the following Tuesday and I still have much pain walking and now feel lower back pain as well.
Age: 30.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Reported fever of 103. Pain, redness, swelling and warmth in right arm from shoulder to elbow. Called patient 10/16/2012 08:00 AM and he stated fever gone and arm better. He took Tylenol and did a "home remedy" but did not explain what the "home remedy" was.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Diarrhoea
Clinical narrative: Patient reports diarrhea & chills started day after admin., 2nd lasted almost 4 days.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Erythema, Feeling abnormal, Headache, Hyperhidrosis
Clinical narrative: Patient is a 71 year old male with a PMHx to include diabetes, coronary artery disease, hypertension, reflux, dyslipidemia presents from his apartment with dizziness, headache, diaphoresis, and fevers. Patient reports he saw his primary care physician early this morning for a routine examination and toward the end of the examination he received a flu shot. Patient reports as he was driving home from his appointment he began to feel ill. When he got home he continued to feel ill, however finished up some chores around the house. The couple of hours later he began to feel worse with development of some lightheadedness/dizziness and beginning to feel feverish. Patient was painting a deck at the time and had to stop because of how poorly he felt. Patient attempted to go inside and rest however her symptoms continued to worsen. He also reports developing a headache and some diaphoresis. Patient reports that his headache is severe. "Worst headache of his life", diffuse, dull/achy, nonradiating, no alleviating factors. Patient denies any new neck stiffness/pain. When his wife got home at approximately 1630 she did give him some naproxen. Patient then tended to rest however after a couple hours of rest he continued to feel poor with new redness to his face. His wife he didn't hurt that time which was 102.8 orally at home. After calling the nursing hotline, they were prompted to report him or his department for evaluation. The patient reports prior to examination and flu shot this morning he was feeling quite well. He denies any recent illnesses, cough, congestion, sore throat, chest pain, dyspnea, abdominal pain, nausea, vomiting, diarrhea, rashes. Patient denies any numbness, tingling, or any weakness. Patient has had flu shots in the past, has never had a reaction to his knowledge.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Malaise, Pyrexia
Clinical narrative: Patient is a 71 year old male with a PMHx to include diabetes, coronary artery disease, hypertension, reflux, dyslipidemia presents from his apartment with dizziness, headache, diaphoresis, and fevers. Patient reports he saw his primary care physician early this morning for a routine examination and toward the end of the examination he received a flu shot. Patient reports as he was driving home from his appointment he began to feel ill. When he got home he continued to feel ill, however finished up some chores around the house. The couple of hours later he began to feel worse with development of some lightheadedness/dizziness and beginning to feel feverish. Patient was painting a deck at the time and had to stop because of how poorly he felt. Patient attempted to go inside and rest however her symptoms continued to worsen. He also reports developing a headache and some diaphoresis. Patient reports that his headache is severe. "Worst headache of his life", diffuse, dull/achy, nonradiating, no alleviating factors. Patient denies any new neck stiffness/pain. When his wife got home at approximately 1630 she did give him some naproxen. Patient then tended to rest however after a couple hours of rest he continued to feel poor with new redness to his face. His wife he didn't hurt that time which was 102.8 orally at home. After calling the nursing hotline, they were prompted to report him or his department for evaluation. The patient reports prior to examination and flu shot this morning he was feeling quite well. He denies any recent illnesses, cough, congestion, sore throat, chest pain, dyspnea, abdominal pain, nausea, vomiting, diarrhea, rashes. Patient denies any numbness, tingling, or any weakness. Patient has had flu shots in the past, has never had a reaction to his knowledge.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: Arms went numb from elbow to hand. Went to doctor on 1-14-11 sent to hos, thought I'd had a stroke. Dr at hos checked me out, said I did not have a stroke. Sent me home with instructions to see my doctor next day. Got up next morning and was numb from waist down. Husband took me back to hos where a doctor told him check.
Age: 0.54
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 05 October 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 13 month old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) electronic database. The subject had received 3 doses of PENTACEL on 16 September 2011, 21 November 2011, and 23 January 2012 (lot numbers, routes and sites of administration not reported). The subject developed a cough on 10 August 2012, approximately 7 months after the last dose, and a paroxysmal cough with a whoop on 20 August 2012. The subject also developed catarrhal illness, posttusive vomiting, and sleep disturbance (start dates not reported). Laboratory testing included positive PCR on 24 August 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 24 August 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 28 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 18 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.54
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 05 October 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 13 month old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) electronic database. The subject had received 3 doses of PENTACEL on 16 September 2011, 21 November 2011, and 23 January 2012 (lot numbers, routes and sites of administration not reported). The subject developed a cough on 10 August 2012, approximately 7 months after the last dose, and a paroxysmal cough with a whoop on 20 August 2012. The subject also developed catarrhal illness, posttusive vomiting, and sleep disturbance (start dates not reported). Laboratory testing included positive PCR on 24 August 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 24 August 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 28 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 18 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Heart rate increased
Clinical narrative: Initial report was received from a health care professional on 05 October 2012. A 77 year-old female patient with a history of Vitamin D deficiency, asthma, diabetes, hypertension, elevated cholesterol, eczema and thyroid, had received on 01 October 2012 and intramuscular right deltoid injection of FLUZONE HIGH-DOSE, lot number U4492BA and by the evening of vaccination experienced shortness of breath and a rapid heart rate. The patient was evaluated the next day by a physician however the symptoms had already resolved. The patient had no illness at the time of vaccination. The patient's outcome was recovered. Documents held by sender: None.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Burning sensation, Chills, Disorientation, Immediate post-injection reaction, Laboratory test
Clinical narrative: Initial report was received on 05 October 2012 from a consumer who is also the patient. A 64 year-old female patient with no reported past medical history had received on 04 January 2012 ADACEL (lot number, route and site of administration not reported) and experienced "right away" a feeling of "arm on fire" and then later the same date, had chills, nausea, vomiting, aches and pains. A few weeks after vaccination on 27 February 2012, the patient was driving in the car and "went blank". The patient pulled over and called a friend who took the patient to the ER (emergency room). The patient was hospital for two weeks and had numerous tests (results not reported). Treatments were not reported. The patient had no illness at the time of vaccination. The patient's outcome was recovered (date not reported). Documents held by sender: none.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pain, Vomiting
Clinical narrative: Initial report was received on 05 October 2012 from a consumer who is also the patient. A 64 year-old female patient with no reported past medical history had received on 04 January 2012 ADACEL (lot number, route and site of administration not reported) and experienced "right away" a feeling of "arm on fire" and then later the same date, had chills, nausea, vomiting, aches and pains. A few weeks after vaccination on 27 February 2012, the patient was driving in the car and "went blank". The patient pulled over and called a friend who took the patient to the ER (emergency room). The patient was hospital for two weeks and had numerous tests (results not reported). Treatments were not reported. The patient had no illness at the time of vaccination. The patient's outcome was recovered (date not reported). Documents held by sender: none.
Age: 1.51
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Nasopharyngitis, Pertussis, Post-tussive vomiting
Clinical narrative: Initial report received on 05 October 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 2-year-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) electronic database. The subject had received 4 doses of PENTACEL on 18 January 2010, 22 March 2010, 25 May 2010, and 24 May 2011 (lot numbers, routes and sites of administration not reported). The subject developed cold-like symptoms on 02 September 2012, approximately 15 months after the last dose. On 04 September 2012, the subject developed a cough and paroxysmal coughing without a whoop began on 06 September 2012. The subject also experienced posttussive vomiting, and sleep disturbance (onset dates not reported). No PCR laboratory testing was provided. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 08 September 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 19 September 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 15 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.51
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Sleep disorder
Clinical narrative: Initial report received on 05 October 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 2-year-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) electronic database. The subject had received 4 doses of PENTACEL on 18 January 2010, 22 March 2010, 25 May 2010, and 24 May 2011 (lot numbers, routes and sites of administration not reported). The subject developed cold-like symptoms on 02 September 2012, approximately 15 months after the last dose. On 04 September 2012, the subject developed a cough and paroxysmal coughing without a whoop began on 06 September 2012. The subject also experienced posttussive vomiting, and sleep disturbance (onset dates not reported). No PCR laboratory testing was provided. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 08 September 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 19 September 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 15 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Dysphagia, Dyspnoea, Electrocardiogram normal, Hypotension
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 04 October 2012. A 66-year-old female patient received an intramuscular injection dose of FLUZONE HIGH-DOSE, sanofi pasteur Inc., (lot number not reported) on 25 September 2012. On the same day, 25 September 2012, the patient developed chest pains, shortness of breath, throat swelling, difficulty swallowing and hypotension with blood pressure (BP) 84/50. The patient was taken to the emergency department (ED) and treated with Prednisone and BENADRYL. The patient claims she went into shock and was hospitalized for two days and released from the hospital. The patient stated her electrocardiogram "(EKG) was ok", on date not specified. The patient denied allergies and claimed to be in good health. She denied any illness at time of vaccination and denied any other vaccinations within prior four weeks of vaccination. The patient's outcome was reported as recovered on unspecified date. (and also reported as unknown). Documents held by sender: None.