chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Induration, Local swelling, Pain, Pruritus
Clinical narrative: Itching after injection x 1 wk. Took BENADRYL 1-2 x/day Ibuprofen for dull achiness, 600mg bid, but also takes for H/A. Still has indurated area (never went away) pea shaped 5 mm wide, 1-2 mm raised. Still achy occasionally.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 59 years old female patient. The patient was vaccinated with ZOSTAVAX on AUG-2011 [Lot# unspecified]. No other co-suspects were reported. No concomitant medications were reported. On 17-NOV-2012 the patient experienced shingles outbreak with a rash around her abdomen. Treatment with anti-viral medication was received. The outcome of shingles outbreak is unknown. The relatedness for shingles is unknown for ZOSTAVAX. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pruritus
Clinical narrative: This spontaneous report was received from a 60 years old female consumer reporting on herself with no pertinent medical history, drug reactions or allergies. The patient was vaccinated with ZOSTAVAX on 05-DEC-2012. No other co-suspects were reported. There were no concomitant medications. The consumer reported that on 06-DEC-2012 she had itching sensation where the shot was given and also some redness on the arm. It was unknown if the patient sought medical attention. No treatment was given for the event. The outcome of itching sensation where the shot was given and some redness on the arm was unknown. The relatedness for the reported events was not provided for ZOSTAVAX. Additional information is not expected.
Age: 1.07
Sex: M
Vaccine: FLU3, HEPA, MMR, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 months old male patient. The patient was inadvertently vaccinated with 0.65 ml ZOSTAVAX on left thigh (lot# reported as H018091, expiry date on 04-JAN-2014) instead of VARIVAX (Merck) on 06-DEC-2012. Route was unspecified. Concomitant medications included hepatitis A virus vaccine (manufacturer unspecified), M-M-R II and influenza virus vaccine (manufacturer unspecified). No adverse effects reported at this time. This is one of several report received from the same source, 1212USA004226. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to 23 patients of unknown age and gender. The patient were vaccinated with RECOMBIVAX HB (lot # 0294AE and expiry date was 06-SEP-2014, routed and dose were not reported) that was exposed to 25 Fahrenheit for an unknown period of time, on 03-OCT-2012, 04-OCT-2012, 05-OCT-2012, 09-OCT-2012, 12-OCT-2012, 15-OCT-2012, 17-OCT-2012, 18-OCT-2012, 22-OCT-2012, 24-OCT-2012, 26-OCT-2012, 01-NOV-2012, 05-NOV-2012, 06-NOV-2012, 07-NOV-2012 and 08-NOV-2012. The patient were vaccinated with RECOMBIVAX HB (lot number 0420AE, expiry date was 02-NOV-20154, route and dose were not reported) that was exposed to 25 Fahrenheit for an unknown period of time, On 13-nov-2012. No concomitant medications were reported. No adverse symptoms reported. This is one of the several reports received from the same reporter (MARRS# 1212USA000913, 1212USA003709, 1212USA003710, 1212USA003711, 1212USA003712, 1212USA003713, 1212USA003714 and 1212USA004285). Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Haematoma, Injection site haemorrhage
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 60 year old female patient. The patient has sulfa allergy and penicillin allergy. The patient had no pertinent medical history. On 16-NOV-2012, the patient was vaccinated with 1 vial of ZOSTAVAX, (lot number reported as H017448, expiration date 20-DEC-2013, route subcutaneous). There was no concomitant medication reported. On 16-NOV-2012, the patient bled at the injection site during administration of ZOSTAVAX and developed hematoma (larger than silver dollar) on the arm. There was no treatment rendered for the events. There were no laboratory diagnostics performed. On an unknown date, the patient recovered from the events. The patient sought medical attention (patient saw the pharmacist). Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age with no drug reactions/allergies, who in 1997 was vaccinated with a dose of unknown pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (dose, route and lot # not reported) and experienced severe injection site reaction with swelling. No other co-suspects were reported. No concomitant medications were reported. The physician was unable to determine the name or manufacturer of this vaccine. The patient had received other unknown vaccines since 1997, and had not an adverse experience. The outcome of severe injection site reaction with swelling was reported as recovered/resolved (date unknown). The patient sought unspecified medical attention. The relatedness for severe injection site reaction with swelling was unknown for pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown). Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash pruritic, Urticaria
Clinical narrative: This spontaneous report as received from a patient of unknown age. The patient was vaccinated with a dose of zoster vaccine live(manufacturer unknown) (Lot#, dose/frequency, route and duration were unspecified) at the doctor's office on 12-JUN-2012 and a few days later in June 2012 the patient broke out with a rash that drove the patient crazy because it itched so bad, and then broke out with big red welts, and they itchy terribly also. The patient had been to two dermatologists and they had given patient lots of different creams to put on them but nothing really helped. The patient had been on a low dose of prednisone for quite some time and the doctor wanted the patient to stop taking it, but when patient stopped taking it patient broke out again. Patient reported that it had been almost 6 months and patient was still breaking out with welts, but not as bad as patient did 6 months ago. The outcome of the rash itched was unknown. Patient was curious to know if there was anyone asked about allergic reactions from the shingles shot or had the same problem. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a medical assistant refers to a male patient of unknown age. The patient was vaccinated with VARIVAX (Merck) in 2008. No other co-suspects were reported. No concomitant medications were reported. In 2008 the patient was administered two doses of VARIVAX seven weeks apart. On an unknown date the patient experienced titers are too low. No treatment information was reported. The outcome of administered two doses of VARIVAX seven weeks apart is unknown. The outcome of titer too low was reported as not recovered/not resolved. Administered two doses of VARIVAX seven weeks apart is not related to VARIVAX (Merck). The relatedness for titer too low is unknown for VARIVAX (Merck). Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 63 years old male patient with no pertinent medical history, drug reactions to allergies. The patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot # not reported) "7 days ago" on 03-DEC-2012. No other co-suspects were reported. There were no concomitant medications. The pharmacist reported that two days ago on 08-DEC-2012 the patient developed a rash on his arms and face after being administered ZOSTAVAX. The patient contacted the pharmacist. Hydrocortisone cream was given as treatment for the event. The outcome of rash on his arms and face after being administered ZOSTAVAX was reported as not recovered. The relatedness for the event was not provided for ZOSTAVAX. Additional information is not expected.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 57 years old female patient with no pertinent medical history, drug reactions or allergies. The patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot # H011049; exp date 25-OCT-2012) on 22-OCT-2012. No other co-suspects were reported. Concomitant medications included: penicillin (unspecified). The pharmacist reported that the patient received a dose of ZOSTAVAX, and "two or three days later" (approximately on 24-OCT-2012) returned to the pharmacy and showed him a reddened area on the injection site. The pharmacist reported that the area was not warm, and not hard, and was about the size of a quarter. The pharmacist could not specify the reason for the patient's penicillin (manufacturer unspecified) therapy. No treatment was given for the event. The outcome of redness area on the injection site the sizes of a quarter was unknown. The relatedness for the reported event was not provided for ZOSTAVAX. Additional information is not expected.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report refers to a 76 years old male patient. The patient was vaccinated with, .65 ml ZOSTAVAX on 21-MAR-2010. No other suspect therapies were reported. Concomitant medications included gabapentin. On 29-NOV-2012 the patient experienced herpes zoster infection. The patient has a history of cancer but was in remission at the time of the vaccination. Patient was treated with Valacyclovir and ZOFRAN. The outcome of herpes zoster infection is unknown. The relatedness for herpes zoster infection is unknown for ZOSTAVAX. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: VARCEL
Symptoms: Body temperature increased, Malaise, Polymerase chain reaction, Pruritus, Skin lesion
Clinical narrative: Initial information has been received from an other health professional refers to a 20 years old male patient with hemiplegic cerebral palsy, seizure disorder and botulinum toxin pertussis allergy, who on 31-AUG-2006, the patient was vaccinated with a dose of (Merck) VARIVAX (dose, route, indication and lot number were not reported). On 13-AUG-2009, the patient received a dose of (Merck) VARIVAX (dose, route, indication and lot number were not reported). No other co-suspects were reported. Concomitant medications included: clindamycin. In November 2012, the patient experienced chickenpox and other systemic symptoms as: itching, an malaise. The patient had a maximum temperature of 40 degrees C. The patient had a hundred of lesions in the face, chest, back and abdomen. The patient had not a recent exposure to chickenpox. The vaccine did not developed rash. On 19-NOV-2012, VZVIP specimen was obtained from vesicle or lesion from skin. No treatment information was reported. At the time of report, the patient recovered from the events (approximately in 2012). Additional information is not expected.
Age: 17.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Initial information has been received from an other health professional refers to a 20 years old male patient with hemiplegic cerebral palsy, seizure disorder and botulinum toxin pertussis allergy, who on 31-AUG-2006, the patient was vaccinated with a dose of (Merck) VARIVAX (dose, route, indication and lot number were not reported). On 13-AUG-2009, the patient received a dose of (Merck) VARIVAX (dose, route, indication and lot number were not reported). No other co-suspects were reported. Concomitant medications included: clindamycin. In November 2012, the patient experienced chickenpox and other systemic symptoms as: itching, an malaise. The patient had a maximum temperature of 40 degrees C. The patient had a hundred of lesions in the face, chest, back and abdomen. The patient had not a recent exposure to chickenpox. The vaccine did not developed rash. On 19-NOV-2012, VZVIP specimen was obtained from vesicle or lesion from skin. No treatment information was reported. At the time of report, the patient recovered from the events (approximately in 2012). Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Inflammation, Injection site reaction, Muscle spasms
Clinical narrative: This spontaneous report as received from a Nurse practitioner via a company representative refers to a female patient of unknown age. The patient's medical history included varicella. The patient was vaccinated with VARIVAX (Merck). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced injection area reaction that resembled a charlie horse above the elbow after receiving VARIVAX. The patient's entire upper arm was inflamed in red. No treatment information was reported. The outcome of injection area reaction was reported as recovered/resolved. The relatedness for injection area reaction is unknown for VARIVAX (Merck). Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Mass, Neck pain, Pain in jaw
Clinical narrative: This spontaneous report as received from a consumer refers to a 50 years old male patient with routine vaccination. The patient was vaccinated with, 1 DF ZOSTAVAX on 29-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. The patient developed a very severe pain after receiving ZOSTAVAX. On an unknown date the pain occurred on the left side of his neck and jaw. He stated that he received the vaccine on 29NOV2012, and the next day he started getting sharp pain on the left side of his throat area. The pain is not in his throat, not as a sore throat would be, but rather on the outside of the throat area of his neck. The patient explained that he also developed a medium hard lump under his jaw. No treatment information was reported. The outcome of developed a severe pain and developed a medium lump under his jaw is unknown. The relatedness for developed a severe pain and developed a medium hard lump under his neck is unknown for ZOSTAVAX. No further AE information was provided.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Herpes zoster, Pain, Pruritus
Clinical narrative: This spontaneous report was received from a 66 years old male consumer with no pertinent medical history, drug reactions or allergies. The patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported) about three months ago (approximately in September 2012). No other co-suspects were reported. Concomitant medications included CELEXA and pantoprazole. The consumer reported that he developed a case of shingles. On 03-DEC-2012 (also reported as 04-DEC-2012) he noticed a small rash on the inside of his left thigh, near his groin. The area started to itch and burn. By 06-DEC-2012 the rash got worse and started to blister. He saw his healthcare professional (HCP) on 07-DEC-2012 and the HCP confirmed it was a case of Shingles. The patient was put on antibiotic and a pain pill (manufacturer unspecified) as treatment for the event. No lab diagnostic test were performed. The outcome of shingles was reported as not recovered. The relatedness for the reported event was not provided for ZOSTAVAX. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a 66 years old male consumer with no pertinent medical history, drug reactions or allergies. The patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported) about three months ago (approximately in September 2012). No other co-suspects were reported. Concomitant medications included CELEXA and pantoprazole. The consumer reported that he developed a case of shingles. On 03-DEC-2012 (also reported as 04-DEC-2012) he noticed a small rash on the inside of his left thigh, near his groin. The area started to itch and burn. By 06-DEC-2012 the rash got worse and started to blister. He saw his healthcare professional (HCP) on 07-DEC-2012 and the HCP confirmed it was a case of Shingles. The patient was put on antibiotic and a pain pill (manufacturer unspecified) as treatment for the event. No lab diagnostic test were performed. The outcome of shingles was reported as not recovered. The relatedness for the reported event was not provided for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. The patient was vaccinated with PNEUMOVAX 23 on 22-OCT-2012 (route of administration and anatomical location were not reported). No other co-suspects were reported. No concomitant medications were reported. On 05-DEC-2012 the patient received another dose of PNEUMOVAX 23. No treatment information was reported. No symptoms reported. The outcome of received one dose of PNEUMOVAX on 22-OCT-2012 and another dose on 05-DEC-2012 is unknown. No other details. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site urticaria, Injection site warmth, Pain, Skin warm
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 years old female patient with immunization. The patient was vaccinated with, .65 ml ZOSTAVAX on 29-NOV-2012. Product Lot # H017449 exp 12/20/2013. No other co-suspects were reported. No concomitant medications were reported. On 29-NOV-2012 the patient experienced pain and warmth, 1 day after onset of therapy, injection site warmth and red raised welt on the injection site which measures 2 inches in diameter. No treatment information was reported. The outcome of pain and warmth, injection site warmth and red raised welt on the injection site which measures 2 inches in diameter is unknown. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 years old female patient with immunization. The patient was vaccinated with, .65 ml ZOSTAVAX [Lot # H017447, exp 20-DEC-2013] on 06-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. On 06-DEC-2012 the patient experienced tingling and numbness throughout her body intermittently about 3 to 4 times within 30 minutes of vaccination. The patient was being observed in the pharmacy by the pharmacist at the time of reporting. No treatment information was reported. The outcome of tingling and numbness throughout her body is unknown. The relatedness for tingling and numbness throughout her body is unknown for ZOSTAVAX. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Urticaria
Clinical narrative: This patient received her annual FLUMIST vaccine on 11/4/2012 (CSL, lot #AH2193). She reported approximately 1 hour later her left shoulder was itching with warm red raised bumps to upper arm (she termed "nodules or hives"). This lasted for an hour resolving spontaneously. Approximately 3-4 hours later, these "itchy hives were to both shoulders with subjective nodules/hives felt while scratching on the back of both hands. This again lasted 1 hour before resolving spontaneously. That evening (11/4/2012) these "hives" returned to bilateral arms, upper lateral thighs, and were on her back. She did not take any medication for this itchy rash. On 11/5/2012 she noted some redness to face (no hives) with resolution of thigh hives/itching but her palms - fingers felt fat and puffy with reddened area about thumb and to base of fingers. She denied any nasal symptoms (runny nose, swelling, congestion, itching), sore throat, and pain, headaches, fever/chills, myalgia or fatigue. She denied use of new clothing, detergents, deodorants, lotions, perfume/creams, make-up, etc. She had eaten no new foods. She has received FLUMIST 4 times (11/09, 1/09, 1/08, 12/06) with TIV influenza in 2010, 2006, 2005, 2003 and 2002 without reaction. 11/5/2012 HC Exam: Skin-Brown toned. Face: fine redness to bilateral infraorbital regions and over nasal bridge; Right and left palm with red skin hue to the thenar regions up later side palm and over metacarpal region - center of palm is normal skin tone; Palmer -thenar region left hand (base of thumb) with a raised red itchy hive about 5cm by 2-3 cm - however there are no sharp distinctive edges. Area was warm to touch and firmer than non-affected skin, no swelling noted. There was 1-2 scattered flat pin point to dime size red flat patches to left lateral -posterior thoracic region, and to tops of both left/right knees. No rash to her torso. 11/6-28/2012 she advised full resolution of symptoms after 24 hour use of ZYRTEC (continued meds x 7 days), and has had no further recurrence.
Age: 43.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: C-reactive protein increased, Erythema, Nodule, Oedema peripheral, Pruritus
Clinical narrative: This patient received her annual FLUMIST vaccine on 11/4/2012 (CSL, lot #AH2193). She reported approximately 1 hour later her left shoulder was itching with warm red raised bumps to upper arm (she termed "nodules or hives"). This lasted for an hour resolving spontaneously. Approximately 3-4 hours later, these "itchy hives were to both shoulders with subjective nodules/hives felt while scratching on the back of both hands. This again lasted 1 hour before resolving spontaneously. That evening (11/4/2012) these "hives" returned to bilateral arms, upper lateral thighs, and were on her back. She did not take any medication for this itchy rash. On 11/5/2012 she noted some redness to face (no hives) with resolution of thigh hives/itching but her palms - fingers felt fat and puffy with reddened area about thumb and to base of fingers. She denied any nasal symptoms (runny nose, swelling, congestion, itching), sore throat, and pain, headaches, fever/chills, myalgia or fatigue. She denied use of new clothing, detergents, deodorants, lotions, perfume/creams, make-up, etc. She had eaten no new foods. She has received FLUMIST 4 times (11/09, 1/09, 1/08, 12/06) with TIV influenza in 2010, 2006, 2005, 2003 and 2002 without reaction. 11/5/2012 HC Exam: Skin-Brown toned. Face: fine redness to bilateral infraorbital regions and over nasal bridge; Right and left palm with red skin hue to the thenar regions up later side palm and over metacarpal region - center of palm is normal skin tone; Palmer -thenar region left hand (base of thumb) with a raised red itchy hive about 5cm by 2-3 cm - however there are no sharp distinctive edges. Area was warm to touch and firmer than non-affected skin, no swelling noted. There was 1-2 scattered flat pin point to dime size red flat patches to left lateral -posterior thoracic region, and to tops of both left/right knees. No rash to her torso. 11/6-28/2012 she advised full resolution of symptoms after 24 hour use of ZYRTEC (continued meds x 7 days), and has had no further recurrence.
Age: 43.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Radioallergosorbent test negative, Rash, Rash erythematous, Rash pruritic, Red blood cell sedimentation rate increased
Clinical narrative: This patient received her annual FLUMIST vaccine on 11/4/2012 (CSL, lot #AH2193). She reported approximately 1 hour later her left shoulder was itching with warm red raised bumps to upper arm (she termed "nodules or hives"). This lasted for an hour resolving spontaneously. Approximately 3-4 hours later, these "itchy hives were to both shoulders with subjective nodules/hives felt while scratching on the back of both hands. This again lasted 1 hour before resolving spontaneously. That evening (11/4/2012) these "hives" returned to bilateral arms, upper lateral thighs, and were on her back. She did not take any medication for this itchy rash. On 11/5/2012 she noted some redness to face (no hives) with resolution of thigh hives/itching but her palms - fingers felt fat and puffy with reddened area about thumb and to base of fingers. She denied any nasal symptoms (runny nose, swelling, congestion, itching), sore throat, and pain, headaches, fever/chills, myalgia or fatigue. She denied use of new clothing, detergents, deodorants, lotions, perfume/creams, make-up, etc. She had eaten no new foods. She has received FLUMIST 4 times (11/09, 1/09, 1/08, 12/06) with TIV influenza in 2010, 2006, 2005, 2003 and 2002 without reaction. 11/5/2012 HC Exam: Skin-Brown toned. Face: fine redness to bilateral infraorbital regions and over nasal bridge; Right and left palm with red skin hue to the thenar regions up later side palm and over metacarpal region - center of palm is normal skin tone; Palmer -thenar region left hand (base of thumb) with a raised red itchy hive about 5cm by 2-3 cm - however there are no sharp distinctive edges. Area was warm to touch and firmer than non-affected skin, no swelling noted. There was 1-2 scattered flat pin point to dime size red flat patches to left lateral -posterior thoracic region, and to tops of both left/right knees. No rash to her torso. 11/6-28/2012 she advised full resolution of symptoms after 24 hour use of ZYRTEC (continued meds x 7 days), and has had no further recurrence.
Age: 43.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Skin warm, Tryptase, Urticaria
Clinical narrative: This patient received her annual FLUMIST vaccine on 11/4/2012 (CSL, lot #AH2193). She reported approximately 1 hour later her left shoulder was itching with warm red raised bumps to upper arm (she termed "nodules or hives"). This lasted for an hour resolving spontaneously. Approximately 3-4 hours later, these "itchy hives were to both shoulders with subjective nodules/hives felt while scratching on the back of both hands. This again lasted 1 hour before resolving spontaneously. That evening (11/4/2012) these "hives" returned to bilateral arms, upper lateral thighs, and were on her back. She did not take any medication for this itchy rash. On 11/5/2012 she noted some redness to face (no hives) with resolution of thigh hives/itching but her palms - fingers felt fat and puffy with reddened area about thumb and to base of fingers. She denied any nasal symptoms (runny nose, swelling, congestion, itching), sore throat, and pain, headaches, fever/chills, myalgia or fatigue. She denied use of new clothing, detergents, deodorants, lotions, perfume/creams, make-up, etc. She had eaten no new foods. She has received FLUMIST 4 times (11/09, 1/09, 1/08, 12/06) with TIV influenza in 2010, 2006, 2005, 2003 and 2002 without reaction. 11/5/2012 HC Exam: Skin-Brown toned. Face: fine redness to bilateral infraorbital regions and over nasal bridge; Right and left palm with red skin hue to the thenar regions up later side palm and over metacarpal region - center of palm is normal skin tone; Palmer -thenar region left hand (base of thumb) with a raised red itchy hive about 5cm by 2-3 cm - however there are no sharp distinctive edges. Area was warm to touch and firmer than non-affected skin, no swelling noted. There was 1-2 scattered flat pin point to dime size red flat patches to left lateral -posterior thoracic region, and to tops of both left/right knees. No rash to her torso. 11/6-28/2012 she advised full resolution of symptoms after 24 hour use of ZYRTEC (continued meds x 7 days), and has had no further recurrence.
Age: 47.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Asthenia, Blood pressure increased, Chest discomfort, Chills, Discomfort
Clinical narrative: Shortly after receiving intradermal influenza vaccine reported "felt funny" felt heart racing & hot & cold, chills BP 120/80 P 100 regular c/o "not feeling right" approx 45 min after that reported throat felt "funny". No SOB BENADRYL 25mg given with some relief. Referred to E.D. but declined.
Age: 47.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Dizziness, Feeling cold, Oropharyngeal discomfort, Pharyngeal oedema, Tachycardia
Clinical narrative: Shortly after receiving intradermal influenza vaccine reported "felt funny" felt heart racing & hot & cold, chills BP 120/80 P 100 regular c/o "not feeling right" approx 45 min after that reported throat felt "funny". No SOB BENADRYL 25mg given with some relief. Referred to E.D. but declined.
Age: 47.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Tremor
Clinical narrative: Shortly after receiving intradermal influenza vaccine reported "felt funny" felt heart racing & hot & cold, chills BP 120/80 P 100 regular c/o "not feeling right" approx 45 min after that reported throat felt "funny". No SOB BENADRYL 25mg given with some relief. Referred to E.D. but declined.
Age: 47.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Chills, Feeling abnormal, Feeling of body temperature change, Palpitations, Throat irritation
Clinical narrative: Shortly after receiving intradermal influenza vaccine reported "felt funny" felt heart racing & hot & cold, chills BP 120/80 P 100 regular c/o "not feeling right" approx 45 min after that reported throat felt "funny". No SOB BENADRYL 25mg given with some relief. Referred to E.D. but declined.
Age: 47.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Asthenia, Blood pressure increased, Dizziness, Electrocardiogram abnormal, Fatigue
Clinical narrative: Shortly after receiving intradermal influenza vaccine reported "felt funny" felt heart racing & hot & cold, chills BP 120/80 P 100 regular c/o "not feeling right" approx 45 min after that reported throat felt "funny". No SOB BENADRYL 25mg given with some relief. Referred to E.D. but declined.
Age: 47.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Neuropathy peripheral, Tachycardia, Tremor
Clinical narrative: Shortly after receiving intradermal influenza vaccine reported "felt funny" felt heart racing & hot & cold, chills BP 120/80 P 100 regular c/o "not feeling right" approx 45 min after that reported throat felt "funny". No SOB BENADRYL 25mg given with some relief. Referred to E.D. but declined.
Age: 25.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Blood culture, CSF culture, Cellulitis, Gram stain negative, Incisional drainage
Clinical narrative: Swelling and pain at site of injection, fever, possible cellulitis, required surgery treated with antibiotics.  Patient will require wound care.
Age: 25.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Infection, Injection site erythema, Injection site pain, Injection site swelling, Muscle oedema
Clinical narrative: Swelling and pain at site of injection, fever, possible cellulitis, required surgery treated with antibiotics.  Patient will require wound care.
Age: 25.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Nuclear magnetic resonance imaging abnormal, Purulent discharge, Pyrexia, White blood cell count increased
Clinical narrative: Swelling and pain at site of injection, fever, possible cellulitis, required surgery treated with antibiotics.  Patient will require wound care.
Age: 25.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Compartment syndrome, Injection site erythema, Injection site pain, Injection site streaking, Laboratory test
Clinical narrative: Swelling and pain at site of injection, fever, possible cellulitis, required surgery treated with antibiotics.  Patient will require wound care.
Age: 25.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Surgery
Clinical narrative: Swelling and pain at site of injection, fever, possible cellulitis, required surgery treated with antibiotics.  Patient will require wound care.
Age: 25.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Culture wound, Injection site pain, Injection site swelling, Nuclear magnetic resonance imaging, Pyrexia
Clinical narrative: Swelling and pain at site of injection, fever, possible cellulitis, required surgery treated with antibiotics.  Patient will require wound care.
Age: 25.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Surgery, Ultrasound scan
Clinical narrative: Swelling and pain at site of injection, fever, possible cellulitis, required surgery treated with antibiotics.  Patient will require wound care.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Aphthous stomatitis, Oral pain
Clinical narrative: Canker sore under tongue.  Very painful.  Have never had a canker sore previously.  Now recurrent.  No treatment.
Age: 21.0
Sex: F
Vaccine: HEPA, MEN
Symptoms: Anxiety, Decreased appetite, Dyspnoea, Injection site pain, Pyrexia
Clinical narrative: Beginning with low fever, pain at the injection site (lasted 3 days), then by the afternoon of the vaccine, severe anxiety leading to an emergency room visit because of trouble breathing.  Complete lack of appetite, underweight patient.
Age: 21.0
Sex: F
Vaccine: HEPA, MEN
Symptoms: Underweight
Clinical narrative: Beginning with low fever, pain at the injection site (lasted 3 days), then by the afternoon of the vaccine, severe anxiety leading to an emergency room visit because of trouble breathing.  Complete lack of appetite, underweight patient.
Age: 0.5
Sex: F
Vaccine: FLUX, RVX, UNK
Symptoms: Vomiting
Clinical narrative: First time vomiting (it was vomit not spitup).
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient said since he got the vaccine, he has been experiencing pain on his arm & get worse when he lift his arm up.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Confusional state, Dizziness, Dysarthria, Dysphagia, Feeling drunk
Clinical narrative: Rash, dizziness, feeling lightheaded, drunk. Later hives, itching, severe itching, flushing. Stated tongue feels bigger. Stated some difficulty swallowing. After BENADRYL and later afternoon slurred speech, some confusion.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Flushing, Pruritus, Rash, Tongue disorder, Urticaria
Clinical narrative: Rash, dizziness, feeling lightheaded, drunk. Later hives, itching, severe itching, flushing. Stated tongue feels bigger. Stated some difficulty swallowing. After BENADRYL and later afternoon slurred speech, some confusion.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Computerised tomogram normal, Electroencephalogram normal, Headache
Clinical narrative: Pt given first MENACTRA 2/22/12 at clinic. 2nd MENACTRA 8/3/12 in our office. Pt c/o persistent headaches since he received 2nd vaccine.
Age: 10.0
Sex: M
Vaccine: FLU3, HEPA, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Local swelling, redness and pain at the injection site (Lt shoulder).
Age: 52.0
Sex: U
Vaccine: FLU3
Symptoms: Oral pain, Pain in jaw
Clinical narrative: Soreness in mouth and jaw with some swelling. Lasted from midnight to about 4-5 AM. Woke up patient in pain.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Conjunctival haemorrhage, Eye swelling, Pruritus, Rash erythematous
Clinical narrative: Flu shot admin 12/7/12 - 8:30 AM, 4 hours later felt itching & developed fine red bumps around eyes and ears. Approximately 2:30 pm subconjunctival hemorrhage (B). Next AM eyes were swollen shut.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pain, Productive cough
Clinical narrative: Sore throat, body aches, productive cough.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, Laboratory test, Middle ear effusion, Nausea, Vertigo
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 03 December 2012. This case also involved a case of misuse (inappropriate age at the time of vaccination). A 70-year-old patient (reported as 71-years-old) had received an intradermal injection in the left deltoid of FLUZONE INTRADERMAL (lot number not reported) on 06 November 2012. On 20 November 2012, the patient developed vertigo and nausea. The patient was seen by a nurse practitioner and was told the exam was negative except fluid in ears. The patient was sent to a physician, diagnosed with vertigo and treated with Valium 2mg three times a day (TID). The patient also had tests for vertigo. Symptoms persisted. The patient had no illness at the time of vaccination. Concomitant medications included SAM-E, green coffee extract, vitamin D3 and CoQ 10. Outcome was not recovered. Documents held by sender: None.
Age: 53.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Anxiety, Injection site erythema, Injection site swelling, Injection site warmth, Lymphadenopathy
Clinical narrative: Initially sick, malaise, nausea, anxiety, next day lymph glands on right swollen, injection site red, hot, raised, swollen size of grapefruit on 11/16/12 MD prescribed cephalexin 250 mg QID fluocinonide 0.15 BID.
Age: 53.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Malaise, Nausea
Clinical narrative: Initially sick, malaise, nausea, anxiety, next day lymph glands on right swollen, injection site red, hot, raised, swollen size of grapefruit on 11/16/12 MD prescribed cephalexin 250 mg QID fluocinonide 0.15 BID.
Age: 30.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Soreness at injection site several hours later 24 hours later swelling, redness, some warmth at site, fever, chills, temp up to 101 degrees F oral, aches, muscle tightness, mild itching at site. No anaphylaxis. Improved symptoms after 3 days using ibuprofen, ice, TYLENOL for fever.
Age: 30.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site warmth, Joint swelling, Muscle tightness, Pyrexia
Clinical narrative: Soreness at injection site several hours later 24 hours later swelling, redness, some warmth at site, fever, chills, temp up to 101 degrees F oral, aches, muscle tightness, mild itching at site. No anaphylaxis. Improved symptoms after 3 days using ibuprofen, ice, TYLENOL for fever.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 3/4 inch diameter redness right thigh warm to touch hard spot at injection site placed on KEFLEX.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain
Clinical narrative: Patient presented at pharmacy 12/8/12 at 7 pm. She had visible redness that radiated up and down her left arm above and below her injection site. She stated the area was painful and she had had a headache since the inj. was given.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Eczema, Injection site pain, Lethargy, Musculoskeletal pain, Pain
Clinical narrative: (L) deltoid began hurting at 10 AM (3 hrs post vaccine); pain moved up shoulder to (L) side of jaw. Skin rash/eczema began 3 days later over legs, scalp. Felt achy over entire body & lethargic x 1 week. Pain in (L) arm & (L) shoulder lasted (1) month.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Pain in jaw, Rash
Clinical narrative: (L) deltoid began hurting at 10 AM (3 hrs post vaccine); pain moved up shoulder to (L) side of jaw. Skin rash/eczema began 3 days later over legs, scalp. Felt achy over entire body & lethargic x 1 week. Pain in (L) arm & (L) shoulder lasted (1) month.
Age: 8.0
Sex: M
Vaccine: TYP
Symptoms: Eyelid oedema
Clinical narrative: 11-28-12 at 4:20 typhoid (IM) Vi vaccine given. Pt left office with parents, no c/o. At 5;15 mother called, pt with lower eye lid swelling on one eye. No other symptoms. Advised & given BENADRYL liquid. At 6:30 no improvement in swelling, no worsening. No other symptoms. Has eaten dinner & had plenty of fluids. Advised BENADRYL before bed. Mom will give ALLEGRA in an (see back).
Age: 62.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt called office on 12/11 to report she received ZOSTAVAX at pharmacy on 12/9. Noted red, swollen area at site on 12/10 PM. Advised cool compresses & Ibuprofen. In office 12/13 with with family site noted added CLARITIN or BENADRYL to Rx. Also reported that she received flu shot in same arm on same day.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 14 years old female patient. The patient was vaccinated with the first and the second dose of GARDASIL (dose, route, lot number and expt. date were not reported) on 05-DEC-2011 and 20-SEP-2012, respectively. No other co-suspects were reported. No concomitant medications were reported. No adverse effect has been observed or reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a female patient of unknown age. In 2009 the patient was vaccinated with the first dose of GARDASIL (route of administration and anatomical location were not reported). No other co-suspects were reported. No concomitant medications were reported. It was reported that today (date of report 05-DEC-2012) the patient will receive her 2nd dose (inappropriate schedule of vaccine administration). No treatment information was reported. The outcome of received her first dose of GARDASIL in 2009 and will receive her 2nd dose today is unknown. No other information provided. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, 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 2nd dose of GARDASIL (Lot #, dose/frequency, route and duration were unspecified) on 26-NOV-2012 with the GARDASIL that was exposed to an unspecified high temperature excursion. No further information provided regarding the date that therapy started. No adverse effects were reported. The outcome was unknown. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Immediate post-injection reaction, Injection site induration, Injection site swelling
Clinical narrative: Immediately following IM injection patient experienced swelling & hardness around injection site. Skin was slightly bruised. Patient called from home approx. 2 hrs. following injection to report swelling decreased.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site inflammation
Clinical narrative: See attached. Patient presented to the pharmacy on 12-4-2012 with a 2 cm reddened area around the injection site. On 12-6-2012 we received a prescription from dr for cephalexin to treat a 5-7 cm area of mild cellulitis around injection site. When patient picked up the prescription I could see the reddened area around the area of the injection. On 12-7 2012 patient presented to show the reddened area was subsiding. On 12-12-2-12 patient presented to show the area was subsiding further but was still red and inflamed somewhat. The area was still about 4 cm in length. Phones patient on 12-13-2012. She states the reddened area is resolving.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypoaesthesia, Skin lesion, Stomatitis, Swelling
Clinical narrative: Dr office & pt/pt wife want reported that pt had wife give oral sex and now has dr diagnosed shingles on corner of mouth -> swelling & numbness & another lesion in mouth. Not herpes simplex. Pt got 1st shingles lesion on Tuesday 12/4/12 & dr on 12-8-12 Diagnosed. Again wife diagnosed w/shingles & wanted reported as a contagious issue. They wish this to be somewhat anonymous please.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Flushing, Heart rate increased, Hypertension
Clinical narrative: Pt was feeling hot and flushing also had fast heartbeat - gave her water and called 911 - measured BP (it was high = 172).
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Pt/child was given flu nasal vaccine that expired 12-3-12 (on 12-6-12). No adverse reaction per mother - revaccination advised/offered.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site discolouration, Injection site nodule, Injection site pain
Clinical narrative: This spontaneous report as received from a physician refers to a 17 years old non-pregnant female patient with depression, anxiety and migraine and no drug reactions or allergies. The patient was vaccinated with GARDASIL on 14-NOV-2012 (dose, route, site of administration and lot # not reported). No other co-suspects were reported. Concomitant medications included citalopram, trazodone and propranolol. On 14-NOV-2012, the patient experienced small palpable nodule at injection site that was still painful at the reporting date. The physician also noted mild discolouration at site. NO treatment was given. There was no laboratory diagnostics performed. The patient did not seek medical attention. The relatedness for small palpable nodule at injection site that was still painful and mild discolouration at site was not reported for GARDASIL. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Nasopharyngitis, Oedema peripheral, Pain in extremity
Clinical narrative: As per pt. notice when flu shot was given on 09/14/12 pt. arm got swollen an hour after flu shot given. Pt. complaining pain on her arm. Also, pt. start getting cough and cold. No fever.
Age: 46.0
Sex: F
Vaccine: FLUN3
Symptoms: Swelling face, Swollen tongue
Clinical narrative: Patient developed a swollen tongue and swollen cheeks.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Chills, Injection site induration, Injection site swelling, Lymphadenopathy, Malaise
Clinical narrative: Night of immunization approx. 6 PM, feeling very will, swollen glands, chills, large red indurated area at site. Fever range 99-101.0. Next day, swelling at site large than borders marked. Tx: Urgent Care. Rx: BACTRIM, ATARAX. General malaise continues to be resolving.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: Night of immunization approx. 6 PM, feeling very will, swollen glands, chills, large red indurated area at site. Fever range 99-101.0. Next day, swelling at site large than borders marked. Tx: Urgent Care. Rx: BACTRIM, ATARAX. General malaise continues to be resolving.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 12/11/12 pt seen by family practice MD for 15 cm x 15 cm area redness, warmth, swelling & tenderness at inj site Dx cellulitis KEFLEX 500mg QID x 10 days. 12/13/12 "getting better"
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site oedema, Injection site swelling
Clinical narrative: On 12/7/12 patient received 2 vaccinations in left deltoid region - PNEUMOVAX, FLUVIRIN. On 12/10/12, patient was reported to have edema and swelling at injection site. Patient was treated by MD and prescribed KEFLEX. Reaction was not differentiated between adverse effect or cellulitis. Patient recovered and well.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Symptoms not reported to me until several months afterwards and was treated at another facility in another city. Flu shots given 1/6/09, 11/1/10. ? G-B Syndrome.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Swelling
Clinical narrative: Erythema and swelling over 3.5" x 3.25" area started on KEFLEX for possible cellulitis.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Patient has large red spot at injection site hard lump underneath skin.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Reaction at site of injection. 12.5 cm redness on (L) upper arm. Firm, warm, tender, itchy. Cannot exclude infection.
Age: 80.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Swelling
Clinical narrative: Swelling and left arm pain.