chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Patient found out she 2 weeks following vaccine, she is pregnant.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Sore arm, tingling in left arm. (Reported on 11/19/2012).
Age: 0.36
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RVX
Symptoms: Diarrhoea
Clinical narrative: Diarrhea x 2 weeks following vaccine.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Lymphadenopathy, Pyrexia
Clinical narrative: Swollen & red arm. Glands swollen under arm. Feverish.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Lymphadenopathy, Pyrexia
Clinical narrative: Swollen & red arm. Glands swollen under arm. Feverish.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling & redness & warm to both injection sites. Mild tenderness to touch. (L) arm 8 cm area erythematous (R) arm 17 cm.
Age: 25.0
Sex: F
Vaccine: PPV
Symptoms: Blister, Erythema, Injection site erythema, Injection site haemorrhage, Injection site pain
Clinical narrative: We saw patient with a reaction to her pneumococcal vaccine. As you know, she is a very pleasant 25-year-old with allergic rhinitis and asthma whose respiratory allergic diseases have been pretty well controlled except frequent rhinorrhea. She was seen her on October 31st and given DYMISTA samples since the nasal steroid alone was inadequate. Her asthma was better controlled with DULCRA 200 2 puffs b.i.d. along with SINGULAIR. She needed her rescue inhaler much less often. At that visit, the pneumococcal vaccine was administered in the left deltoid since it is recommended that asthmatics be kept up to date on the PVAX. On November 1st, she noted a small red bump that morning. Later that day, she had a temperature of 102 that eventually spiked to 104 the next day. On November 2nd, she went to the urgent care with a large red knot and was given prednisone. The area is still exquisitely tender and red with a central purple area. She states it was bubbled up a couple of days ago but that fluid must have popped on the way over her. Overall, the affected area is decreasing except last night she noted some increase in redness at the inferior aspect of the reaction. She has not had any respiratory problems. Her fever has been gone since she was placed on prednisone. At urgent care, they told her she had a viral infection as the cause of her fever but had also given her prednisone presumably because of the large local reaction to the vaccine. On exam today, her left upper arm has an area of erythema of about 12 x 8 cm. Around the central area where the injection was administered, there is a 3 x 2 cm darker ecchymotic lesion. There is some appearance as if it had been a fluid-filled area though now drained. There is currently no drainage, fluctuants or purulence. The area is mildly warm and exquisitely tender.
Age: 25.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Local reaction, Nodule, Pyrexia, Rash erythematous
Clinical narrative: We saw patient with a reaction to her pneumococcal vaccine. As you know, she is a very pleasant 25-year-old with allergic rhinitis and asthma whose respiratory allergic diseases have been pretty well controlled except frequent rhinorrhea. She was seen her on October 31st and given DYMISTA samples since the nasal steroid alone was inadequate. Her asthma was better controlled with DULCRA 200 2 puffs b.i.d. along with SINGULAIR. She needed her rescue inhaler much less often. At that visit, the pneumococcal vaccine was administered in the left deltoid since it is recommended that asthmatics be kept up to date on the PVAX. On November 1st, she noted a small red bump that morning. Later that day, she had a temperature of 102 that eventually spiked to 104 the next day. On November 2nd, she went to the urgent care with a large red knot and was given prednisone. The area is still exquisitely tender and red with a central purple area. She states it was bubbled up a couple of days ago but that fluid must have popped on the way over her. Overall, the affected area is decreasing except last night she noted some increase in redness at the inferior aspect of the reaction. She has not had any respiratory problems. Her fever has been gone since she was placed on prednisone. At urgent care, they told her she had a viral infection as the cause of her fever but had also given her prednisone presumably because of the large local reaction to the vaccine. On exam today, her left upper arm has an area of erythema of about 12 x 8 cm. Around the central area where the injection was administered, there is a 3 x 2 cm darker ecchymotic lesion. There is some appearance as if it had been a fluid-filled area though now drained. There is currently no drainage, fluctuants or purulence. The area is mildly warm and exquisitely tender.
Age: 25.0
Sex: F
Vaccine: PPV
Symptoms: Skin discolouration, Tenderness, Vaccination complication, Viral infection
Clinical narrative: We saw patient with a reaction to her pneumococcal vaccine. As you know, she is a very pleasant 25-year-old with allergic rhinitis and asthma whose respiratory allergic diseases have been pretty well controlled except frequent rhinorrhea. She was seen her on October 31st and given DYMISTA samples since the nasal steroid alone was inadequate. Her asthma was better controlled with DULCRA 200 2 puffs b.i.d. along with SINGULAIR. She needed her rescue inhaler much less often. At that visit, the pneumococcal vaccine was administered in the left deltoid since it is recommended that asthmatics be kept up to date on the PVAX. On November 1st, she noted a small red bump that morning. Later that day, she had a temperature of 102 that eventually spiked to 104 the next day. On November 2nd, she went to the urgent care with a large red knot and was given prednisone. The area is still exquisitely tender and red with a central purple area. She states it was bubbled up a couple of days ago but that fluid must have popped on the way over her. Overall, the affected area is decreasing except last night she noted some increase in redness at the inferior aspect of the reaction. She has not had any respiratory problems. Her fever has been gone since she was placed on prednisone. At urgent care, they told her she had a viral infection as the cause of her fever but had also given her prednisone presumably because of the large local reaction to the vaccine. On exam today, her left upper arm has an area of erythema of about 12 x 8 cm. Around the central area where the injection was administered, there is a 3 x 2 cm darker ecchymotic lesion. There is some appearance as if it had been a fluid-filled area though now drained. There is currently no drainage, fluctuants or purulence. The area is mildly warm and exquisitely tender.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site swelling
Clinical narrative: Swollen Rt deltoid area.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthma, Dermatitis, Erythema
Clinical narrative: Pt. was given flu vaccine & pneumonia vaccine (has asthma) in same arm - 1 inch apart 2nd day arm is red & inflamed.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Varicella virus test negative
Clinical narrative: The primary reporter is medical assistant. Medical assistant reporting that a patient who received 3 doses of VARIVAX is currently showing negative antibody titers to VARIVAX was administered on 05/29/1998, Dose 2 was administered in January 2012 (exact date unspecified) and Dose 3 was administered 6 weeks after Dose 2 (unspecified date). The patient also reported to the physician that she did not respond to 3 doses of hepatitis B vaccine in the past (unspecified brand, unspecified manufacturer). Dates of administration for the hepatitis B vaccine are 05/18/1995, 08/25/1995 and 08/26/1996. The patient then received an additional unspecified number of doses of the hepatitis B vaccine on unspecified date (s), and she later tested positive for hepatitis B antibody titers. All vaccine doses of VARIVAX and hepatitis B vaccine were administered by a different provider (unspecified provider's name). No other details.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Herpes zoster, Musculoskeletal discomfort, Pain, Pruritus
Clinical narrative: Information has been received from a 70 year old consumer with allergy to indomethacin sodium (MSD) (WAES# 1202USA03612) who on 21-DEC-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot # 671611/1161AA, dose, route and expired date unknown), which was recommended friends. There was no concomitant medication. Consumer mentioned that 7 years ago he had "internal shingles" in the left hip area. He also mentioned that he always had some sensitivity after recovering from the first occurrence of shingles. Consumer did not have any "sensitivity" symptoms on the day he received ZOSTAVAX (Merck). He received a vial of ZOSTAVAX (Merck) from a pharmacy and took it to physician's office within 30 minutes to be administered (he was there in 5 minutes). On 22-DEC-2011, the consumer experienced left hip "sensitivity", burning, itching and severe pain. The patient got shingles again. No lab diagnostics study was performed. LYRICA and medications were given for "anti-reverse virus in system". The patient sought medical attention from unspecified physician and unspecified neurologist. At the time of reporting, the patient had 95% recovered. This is one of several reports received from the same source. A preliminary lot check investigation was performed. To date our investigation has found that this lot conformed to quality release parameters and the manufacturing was typical of a lot of ZOSTAVAX (Merck). Additional information will be provided upon finalization of manufacturing investigation. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirement of the Center of Biologics Evaluation and Research and was released. No further information is available.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 70 year old consumer with allergy to indomethacin sodium (MSD) (WAES# 1202USA03612) who on 21-DEC-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot # 671611/1161AA, dose, route and expired date unknown), which was recommended friends. There was no concomitant medication. Consumer mentioned that 7 years ago he had "internal shingles" in the left hip area. He also mentioned that he always had some sensitivity after recovering from the first occurrence of shingles. Consumer did not have any "sensitivity" symptoms on the day he received ZOSTAVAX (Merck). He received a vial of ZOSTAVAX (Merck) from a pharmacy and took it to physician's office within 30 minutes to be administered (he was there in 5 minutes). On 22-DEC-2011, the consumer experienced left hip "sensitivity", burning, itching and severe pain. The patient got shingles again. No lab diagnostics study was performed. LYRICA and medications were given for "anti-reverse virus in system". The patient sought medical attention from unspecified physician and unspecified neurologist. At the time of reporting, the patient had 95% recovered. This is one of several reports received from the same source. A preliminary lot check investigation was performed. To date our investigation has found that this lot conformed to quality release parameters and the manufacturing was typical of a lot of ZOSTAVAX (Merck). Additional information will be provided upon finalization of manufacturing investigation. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirement of the Center of Biologics Evaluation and Research and was released. No further information is available.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a patient of unknown date. The patient was vaccinated with the first dose of VARIVAX (merck) in 1998 and the second dose on 16-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse event was reported. No other information to report. Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a company representative refers to a 68 years old female patient. The patient was vaccinated with ZOSTAVAX. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced severe rash. No treatment information was reported. The outcome of severe rash is unknown. The Pharmacist reported to the field representative that the patient received ZOSTAVAX "d days after" receiving PNEUMOVAX. The pharmacist administered the ZOSTAVAX, but the PNEUMOVAX was administered by the patient's physician (unspecified name). The patient developed a severe rash beginning at the elbow and spreading to her underarm. No further AE information was provided. Additional information requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient was vaccinated with the first dose of VAQTA 50/1.0 U/ML (route, dose and lot # were unknown) in October 2012(reported as one month ago(unspecified date)). The patient received the second dose of VAQTA 50/1.0 U/ML (route, dose and lot # were unknown) today(12-NOV-2012) which was early. No other co-suspects were reported. No concomitant medications were reported. No symptoms reported. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Paraesthesia, Swelling, Tenderness
Clinical narrative: This spontaneous report as received from an approximately 73 years old male consumer concerning on himself with no pertinent medical history and drug reactions or allergies. The patient was vaccinated with a dose of influenza virus vaccine (manufacturer unspecified) (lot #, dose and site of administration were not provided) on approximately 22-AUG-2012. Other suspect therapies included a dose of ZOSTAVAX on approximately 15-SEP-2012 (lot #, dose and site of administration were not provided). Concomitant medications included: RAMIPRIL. The patient reported that he received a dose of ZOSTAVAX about 2 months ago and 3 to 4 days later (On approximately 17-SEP-2012) developed redness and swelling around the injection site. The reaction was a long area on the side of the arm where the injection took place and that was swollen and tender. The patient also explained that he had had a sensation of pins and needles on his back that occurs when he exercises. He explained that the sensation was similar to wearing a wool sweater. The patient had not been able to look at his back to determine if there was rash that was causing this sensation. No treatment was given for the adverse event. No lab diagnostic was performed. The patient did not seek medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. The patient was vaccinated with a dose of (Merck) VARIVAX (lot number, dose and route not reported) and with a dose of MMR II (lot #, dose and route not reported) 21 days apart, "a few years ago" on an unspecified date. No concomitant medications were reported. No adverse effects were reported. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Underdose, Urticaria
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age with no known allergies. The patient was vaccinated with a dose of ZOSTAVAX (lot # H01230 exp date 30-NOV-2013; lot for diluent G018478 exp. date November 2013) (dose and route not reported) on 16-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on an unspecified date (in November 2012) ZOSTAVAX created a "mosquito bite" appearance on the patient's upper arm. The pharmacist reported that she was unable to push the full dose of vaccine into the patients' arms. She followed up with the patient a few days later and the patient stated that the wheal "went away". No treatment information was reported. It was unknown if the patient sought medical attention. The relatedness for mosquito bite appearance on the patient's upper arm is unknown for ZOSTAVAX. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age with no known allergies. The patient was vaccinated with a dose of ZOSTAVAX (lot # H01230 exp date 30-NOV-2013l lot for diluent GF018478 exp. date November 2013) (dose and route not reported) on 08-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on an unspecified date (in 2012) ZOSTAVAX created a "mosquito bite" appearance on the patient's upper arm. The pharmacist reported that she was unable to push the full dose of vaccine into the patients' arms. She followed up with the patient a few days later and the patient stated that the wheal "went away". No treatment information was reported. it was unknown if the patient sought medical attention. The relatedness for mosquito bite appearance on the patient's upper arm is unknown for ZOSTAVAX. This is one of several reports received from the same source. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a 24 years old female patient. Several months ago (in 2012), the patient was vaccinated subcutaneously with a dose of 0.65 ml ZOSTAVAX (Lot not reported) at age of 24. No other co-suspects were reported. No concomitant medications were reported. Additional information is not expected.
Age: 1.0
Sex: U
Vaccine: BCG
Symptoms: No adverse event, Overdose
Clinical narrative: This spontaneous report was received from a consumer concerning his friend's 1 months old baby of unknown gender. On an unknown date, the patient was vaccinated with 2 doses of BCG VACCINE (dose, route and lot number reported) in the same date. No other co-suspects were reported. No concomitant medications were reported. He indicated that there was no reaction to double dose yet. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: This spontaneous report as received from a physician refers to a 62 years old female patient with no drug reactions or allergies. The patient's medical history included shingles. The patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported) in August 2012. No other co-suspects were reported. There were no concomitant medications. The physician reported that three weeks ago (approximately on 26-OCT-2012) the patient developed painful shingles on the same spot on right buttock after receiving ZOSTAVAX. The patient saw the physician and acyclovir was given as treatment. No lab diagnostic tests were performed. The outcome of painful shingles on the same spot on right buttock was unknown. The relatedness for the reported event was not provided for ZOSTAVAX. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Oedema peripheral, Pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 years old female patient. The patient had none pertinent medical history. The patient had none drug allergies. "About 20 years ago", in approximately 1992 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # not reported) "with no problem". On 10-NOV-2012 the patient was administered intramuscularly another dose of PNEUMOVAX 23 (lot # reported as H010515, expiration date reported as 13-FEB-2014). Concomitant medications included ZOLOFT and LUMIGAN. Beginning on 11-NOV-2012 the patient developed pain at the injection site, swelling in the arm in which the vaccine was injected, as well as itching in that arm. The patient sought for medical attention by coming into the pharmacy and speaking with the reporting pharmacist. Oral BENADRYL was given as treatment. Lab diagnostics studies performed were reported as none. It was reported that at the time of reporting, on 15-NOV-2012 these adverse events were improving but had not fully resolved. The present patient status was recovering. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from a medical assistant regarding a 61 years old female patient. On 11-NOV-2005, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot #, route, dose and expiry not reported). Concomitant medications were not reported. On 11-NOV-2005, the patient experienced fever when she received PNUEMOVAX 23. No treatment information was reported. The outcome of fever was unknown. It was unspecified if the patient had sought medical attention. This is 1 of 2 reports regarding the same patient. Additional information is not expected.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 78 years old female patient. The patient did not have any pertinent medical history or drug reactions/allergies. The patient was vaccinated with ZOSTAVAX (route and dose were unknown, lot # was reported as H013017, expiration date was 20-DEC-2012) on 08-NOV-2012. No other co-suspects were reported. Concomitant medications included LOPRESSOR, CRESTOR, metformin and aspirin. On 09-NOV-2012 the patient developed a large area of redness that was warm to touch and continues to spread around injection site" after receiving ZOSTAVAX. Treatment of TYLENOL and ice were given for adverse event. The outcome of event was reported as not recovered/not resolved. No lab diagnosis studies performed. The patient had sought unspecified medical attention. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: This spontaneous report as received from a registered nurse refers to an 8 weeks old male patient with esophageal reflux. The patient had no drug reactions or allergies. The patient was vaccinated with the first dose of ROTATEQ (lot number reported as H012975; expired date 30-JAN-2014) orally on 16-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. On 16-NOV-2012 the patient experienced vomited about 30 seconds after receiving his first dose of ROTATEQ. There was no treatment given for the adverse event. The patient was recovered on 16-NOV-2012. The therapy was continued at the time of report. The patient had sought medical attention as the adverse event happened in office. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age. The patients were vaccinated with MMR II (lot number, dose, route and injection site were not reported) on an unknown date. No other co-suspects were reported. No concomitant medications were reported. An unknown number of patients had been administered MMR II that was improperly stored since 26-OCT-2012. The reporter was unable to provide the exact number or identities of the patient involved at the time of the report. No adverse effects reported. The outcome was unknown at the time of report. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 26.0
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse via representative refers to 4 adult patients of unknown age and gender. Onan unknown date the patients were vaccinated with a dose of LIQUID PEDVAXHIB (lot#, expiration date and route not reported). No concomitant medications were reported. The patients received LIQUID PEDVAXHIB in error when they were supposed to get an unspecified Hepatitis B Vaccine. The patients were not experiencing any known symptoms. No further information is available. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a patient (age and gender unknown). On 09-NOV-2012, the patient was vaccinated with ZOSTAVAX (H016230; 30-NOV-2013) subcutaneously. No other co-suspects were reported. No concomitant medications were reported. On 09-NOV-2012, the medical assistant noted that the patient was administered ZOSTAVAX that were exposed to a temperature excursion that was not supported (38 degrees Fahrenheit for 14 days). No adverse effect reported. At the time of the report, the outcome of the event of ZOSTAVAX were expose to a temperature excursion that was not supported (38 degrees Fahrenheit for 14 days) was unknown. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a patient (age and gender unknown). On 07-NOV-2012, the patient was vaccinated with ZOSTAVAX (H016230; 30-NOV-2013) subcutaneously. No other co-suspects were reported. No concomitant medications were reported. On 07-NOV-2012, the medical assistant noted that the patient was administered ZOSTAVAX that were exposed to a temperature excursion that was not supported (38 degrees Fahrenheit for 14 days). No adverse effect reported. At the time of the report, the outcome of the event of ZOSTAVAX were exposed to  temperature excursion that was not supported (38 degrees Fahrenheit for 14 days) was unknown. Additional information has been requested.
Age: 92.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a 92 years old male patient. The patient was vaccinated with ZOSTAVAX (route, dose and lot # were unknown) in 2009. No other co-suspects were reported. No concomitant medications were reported. The patient was diagnosed with shingles three weeks ago (approximately on 17-OCT-2012). The patient was currently receiving unspecified medication for treatment from primary physician for shingles. The patient sought medical attention via visiting office. The outcome of event was unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer refers to her father of unknown age. The patient was vaccinated with ZOSTAVAX (route, dose and lot # were unknown) on an unknown date in 2012. No other co-suspects were reported. No concomitant medications were reported. "A few months later"(also reported as "A few days ago") the patient developed shingles. The patient had been on steroid medications for many years. The outcome of shingles was reported as not recovered/not resolved. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 65 years old female patient. On 09-NOV-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot #, route, dose and expiry not reported). No concomitant medications were reported. On Sunday evening 11-NOV-2012, the patient experienced pain and redness at the injection site. No treatment was given for the adverse event. At the time of this report, she stated that she did not develop a rash, and that the pain and redness was improving. She has not notified her primary healthcare provider. The patient sought medical attention(consulted the pharmacist). Additional information is not expected.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a registered nurse refers to her 57 years old husband with no drug reactions or allergies and no pertinent medical history. On 23-OCT-2012 the patient was vaccinated subcutaneously with a dose of ZOSTAVAX (Lot# and dose not reported). There were not concomitant medications. On 23-OCT-2012 the patient experienced erythema around the injection site almost immediately after vaccination, and that it lasted about 5 days. Patient recovered on approximately 28-OCT-2012. Patient did not seek for medical attention. No treatment was given. No lab diagnostic studies were performed. This is one of several reports received from a same source. Additional information is not expected.
Sex: F
Vaccine: TD, TDAP, TDAP
Symptoms: Diarrhoea, Emotional disorder, Mobility decreased, Pain in extremity, Vomiting
Clinical narrative: Initial report was received from a healthcare professional on 09 November 2012. The reporter for this case is from the same facility as for non-serious case number 2012-06407. Reporter stated prior adverse event (AE) was filed in June 2012 without patient name. A female patient (age and birth date not reported), received an injection of ADACEL, sanofi pasteur Ltd., lot number C4136BA, (route, site and dose in series reported as unknown) on 22 June 2012. On 29 June 2012, seven days post vaccination, the patient experienced arm pain (unspecified side) since one week post vaccination. The patient was diagnosed as having Parsonage-Turner syndrome and has been seen by three orthopedic physicians. Laboratory and diagnostic testing was reported as none. Treatments were not reported. The patient's past medical history and illness at time of vaccination were reported as unknown. The patient's outcome has been reported as not recovered. Documents held by sender: None.
Sex: F
Vaccine: TD, TDAP, TDAP
Symptoms: Neuralgic amyotrophy, Pain in extremity
Clinical narrative: Initial report was received from a healthcare professional on 09 November 2012. The reporter for this case is from the same facility as for non-serious case number 2012-06407. Reporter stated prior adverse event (AE) was filed in June 2012 without patient name. A female patient (age and birth date not reported), received an injection of ADACEL, sanofi pasteur Ltd., lot number C4136BA, (route, site and dose in series reported as unknown) on 22 June 2012. On 29 June 2012, seven days post vaccination, the patient experienced arm pain (unspecified side) since one week post vaccination. The patient was diagnosed as having Parsonage-Turner syndrome and has been seen by three orthopedic physicians. Laboratory and diagnostic testing was reported as none. Treatments were not reported. The patient's past medical history and illness at time of vaccination were reported as unknown. The patient's outcome has been reported as not recovered. Documents held by sender: None.
Age: 21.0
Sex: M
Vaccine: ANTH, FLUX, SMALL, TYP, ANTH, FLUN3, SMALL, TYP
Symptoms: Chest pain, Pericarditis
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 12 November 2012. A 21-year-old male subject received the following vaccinations on 28 August 2012 an injection of ACAM2000 (lot number not reported), an injection of TYPHIM VI, sanofi pasteur SA (lot number not reported), ANTHRAX (manufacturer and lot number not reported) and an intranasal dose of Influenza, Live (manufacturer and lot number not reported). The subject had no significant medical history. On 10 September 2012, the subject had an abnormal troponin I of 17.90 and an abnormal echocardiogram. On 11 September 2012 the subject had an abnormal MRI (heart). On 10 September 2012, the subject was diagnosed with unspecified disease of pericardium. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 21.0
Sex: M
Vaccine: ANTH, FLUX, SMALL, TYP, ANTH, FLUN3, SMALL, TYP
Symptoms: Cardiac imaging procedure abnormal, Echocardiogram abnormal, Pericardial disease, Troponin I increased
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 12 November 2012. A 21-year-old male subject received the following vaccinations on 28 August 2012 an injection of ACAM2000 (lot number not reported), an injection of TYPHIM VI, sanofi pasteur SA (lot number not reported), ANTHRAX (manufacturer and lot number not reported) and an intranasal dose of Influenza, Live (manufacturer and lot number not reported). The subject had no significant medical history. On 10 September 2012, the subject had an abnormal troponin I of 17.90 and an abnormal echocardiogram. On 11 September 2012 the subject had an abnormal MRI (heart). On 10 September 2012, the subject was diagnosed with unspecified disease of pericardium. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV, PPV
Symptoms: Dizziness, Musculoskeletal pain, Nausea, Swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 65 years old male patient with no drug reactions/allergies, elevated cholesterol, hypertension, gout, hypothyroidism and gastroesophageal reflux disease (GERD) who on 31-OCT-2012, was vaccinated with a dose of PNEUMOVAX 23 0.5 ml IM (lot # 672366/1723AA, Exp: 27-JUL-2013). No other co-suspects were reported. Concomitant medications included: NIASPON, allopurinol, VIIBRYD, ramipril, levothyroxine sodium, aspirin, FISH OIL and PRILOSEC OTC. On 31-OCT-2012 the patient experienced dizziness, lightheadedness, nausea and soreness, redness and swelling of his arm at the injection site after receiving PNEUMOVAX 23. Warm compresses, oral steroid, antihistamine and KEFLEX were administered as a treatment. The outcome of the events was reported as recovered/resolved on 05-NOV-2012. No laboratory diagnostic studies were performed. The patient sought medical attention via office visit. The relatedness for the events was unknown for PNEUMOVAX 23. A lot check for PNEUMOVAX (lot # 672366/.1723AA, Exp: 27-JUL-2013) was requested. This is one of several reports received from the same source (related MARRS # 1211USA006249). Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV, PPV
Symptoms: Dizziness, Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 65 years old male patient with no drug reactions/allergies, elevated cholesterol, hypertension, gout, hypothyroidism and gastroesophageal reflux disease (GERD) who on 31-OCT-2012, was vaccinated with a dose of PNEUMOVAX 23 0.5 ml IM (lot # 672366/1723AA, Exp: 27-JUL-2013). No other co-suspects were reported. Concomitant medications included: NIASPON, allopurinol, VIIBRYD, ramipril, levothyroxine sodium, aspirin, FISH OIL and PRILOSEC OTC. On 31-OCT-2012 the patient experienced dizziness, lightheadedness, nausea and soreness, redness and swelling of his arm at the injection site after receiving PNEUMOVAX 23. Warm compresses, oral steroid, antihistamine and KEFLEX were administered as a treatment. The outcome of the events was reported as recovered/resolved on 05-NOV-2012. No laboratory diagnostic studies were performed. The patient sought medical attention via office visit. The relatedness for the events was unknown for PNEUMOVAX 23. A lot check for PNEUMOVAX (lot # 672366/.1723AA, Exp: 27-JUL-2013) was requested. This is one of several reports received from the same source (related MARRS # 1211USA006249). Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Pain, Pruritus, Skin warm, Swelling
Clinical narrative: This spontaneous report as received from a physician refers to a 61 years old female patient with a history of smoker and Chronic obstructive pulmonary disease (COPD). There were no known allergies. On 28-JAN-2011, the patient received a dose of PNEUMOVAX 23 (lot#, dose frequency and route not provided). On 09-NOV-2012, the patient was vaccinated with a dose of 0.5 mL intramuscular PNEUMOVAX 23 (lot#HO16295; exp. date: 02-NOV-2012) injection in left arm (deltoid), and the flu vaccine (lot#, dose frequency and route not provided) was also administered in the left arm on the same day. 2 to 3 hours later, the patient developed pain and swelling at the injection site. There was no treatment, comfort measures only. It was reported that the patient seek medical attention, he went into office. Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a physician refers to a 61 years old female patient with a history of smoker and Chronic obstructive pulmonary disease (COPD). There were no known allergies. On 28-JAN-2011, the patient received a dose of PNEUMOVAX 23 (lot#, dose frequency and route not provided). On 09-NOV-2012, the patient was vaccinated with a dose of 0.5 mL intramuscular PNEUMOVAX 23 (lot#HO16295; exp. date: 02-NOV-2012) injection in left arm (deltoid), and the flu vaccine (lot#, dose frequency and route not provided) was also administered in the left arm on the same day. 2 to 3 hours later, the patient developed pain and swelling at the injection site. There was no treatment, comfort measures only. It was reported that the patient seek medical attention, he went into office. Additional information is not expected.
Age: 29.0
Sex: M
Vaccine: TTOX
Symptoms: Blood test, Facial paresis, Hypoaesthesia, Muscular weakness, Myalgia
Clinical narrative: Symptoms started with tingling and numbness in hands and feet. This progressed in intensity and spread to the trunk of the body as well as the face. Approximately a week after initial symptoms I began experiencing weakness in the legs as well as muscle soreness and dull pain associated with certain movements. Had trouble controlling some facial muscles. Symptoms increased in intensity for about 2 weeks, leveled off for about 2 weeks, and since have been slowly diminishing but are still present to this day.
Age: 29.0
Sex: M
Vaccine: TTOX
Symptoms: Nuclear magnetic resonance imaging, Pain, Paraesthesia
Clinical narrative: Symptoms started with tingling and numbness in hands and feet. This progressed in intensity and spread to the trunk of the body as well as the face. Approximately a week after initial symptoms I began experiencing weakness in the legs as well as muscle soreness and dull pain associated with certain movements. Had trouble controlling some facial muscles. Symptoms increased in intensity for about 2 weeks, leveled off for about 2 weeks, and since have been slowly diminishing but are still present to this day.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Pyrexia
Clinical narrative: Pt. was taken to the hospital for sx's of high fever. Seen by resident.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Blood culture negative, Body temperature increased, Chest X-ray normal, Dyspnoea, Full blood count normal
Clinical narrative: 7hrs after vaccinations, was woken up from nap to eat. Took bottle normally then vomited large amount. Gagged while vomiting, then started having difficulty breathing. Grunting with breathing. 102.6 degrees. Unable to cry or suck. Went to Emergency Room, admitted.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Grunting, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Poor sucking reflex
Clinical narrative: 7hrs after vaccinations, was woken up from nap to eat. Took bottle normally then vomited large amount. Gagged while vomiting, then started having difficulty breathing. Grunting with breathing. 102.6 degrees. Unable to cry or suck. Went to Emergency Room, admitted.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Respiratory syncytial virus test negative, Retching, Viral test negative, Vomiting
Clinical narrative: 7hrs after vaccinations, was woken up from nap to eat. Took bottle normally then vomited large amount. Gagged while vomiting, then started having difficulty breathing. Grunting with breathing. 102.6 degrees. Unable to cry or suck. Went to Emergency Room, admitted.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Pertussis
Clinical narrative: Initial report received on 06 November 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a six-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number not reported received on 28 February 2012, lot number "C3973AA-C4193AA" received on 24 April 2012 and lot number C4258AA received on 22 June 2012 (routes and sites of administration not reported). The subject developed a cough on 17 July 2012, approximately 25 days after the last dose, and paroxysmal cough on 18 July 2012 without a whoop. The subject also experienced posttussive vomiting, sleep disturbance, and apnea. Laboratory testing included positive PCR on 19 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 19 July 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 15 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 29 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: 0.51
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 06 November 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a six-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number not reported received on 28 February 2012, lot number "C3973AA-C4193AA" received on 24 April 2012 and lot number C4258AA received on 22 June 2012 (routes and sites of administration not reported). The subject developed a cough on 17 July 2012, approximately 25 days after the last dose, and paroxysmal cough on 18 July 2012 without a whoop. The subject also experienced posttussive vomiting, sleep disturbance, and apnea. Laboratory testing included positive PCR on 19 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 19 July 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 15 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 29 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: 0.61
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray abnormal, Cough, Laboratory test abnormal, Pertussis, Pneumonia
Clinical narrative: Initial report received on 06 November 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a 21-month-old male 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 3 doses of PENTACEL; lot number C3603AA received on 01 March 2011, lot number C3782AA received on 19 May 2011 and lot number C3816AB received on 11 August 2011 (route and sites of administration not reported). The subject developed a cough on 08 October 2012, approximately 14 months after the last dose, and paroxysmal cough on 09 October 2012 with a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 10 October 2012. Chest x-ray findings were positive for pneumonia. Corrective treatments consisted of azithromycin starting on 10 October 2012 for 5 days. The subject was hospitalized for 4 days. At the time of final contact on 31 October 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 23 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.61
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 06 November 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a 21-month-old male 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 3 doses of PENTACEL; lot number C3603AA received on 01 March 2011, lot number C3782AA received on 19 May 2011 and lot number C3816AB received on 11 August 2011 (route and sites of administration not reported). The subject developed a cough on 08 October 2012, approximately 14 months after the last dose, and paroxysmal cough on 09 October 2012 with a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 10 October 2012. Chest x-ray findings were positive for pneumonia. Corrective treatments consisted of azithromycin starting on 10 October 2012 for 5 days. The subject was hospitalized for 4 days. At the time of final contact on 31 October 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 23 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.