chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 90.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Skin warm, Swelling face
Clinical narrative: Initial report was received from a healthcare professional on 12 October 2013. A 90-year-old female patient with no known medical history and allergies had received an intramuscular dose of FLUZONE HD (Sanofi Pasteur, batch number U4717AA) in the left deltoid on 11 October 2013. On 12 October 2013 A.M, the patient presented with facial swelling and with "white ring" around needle injection site, and red, swollen, hot to touch, area around injection site with "hard area that can be felt beneath injection site". No information was reported on any corrective treatment given. At the time of the report, the patient had not recovered. Documents held by sender: None.
Age: 90.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pallor, Injection site swelling, Injection site warmth
Clinical narrative: Initial report was received from a healthcare professional on 12 October 2013. A 90-year-old female patient with no known medical history and allergies had received an intramuscular dose of FLUZONE HD (Sanofi Pasteur, batch number U4717AA) in the left deltoid on 11 October 2013. On 12 October 2013 A.M, the patient presented with facial swelling and with "white ring" around needle injection site, and red, swollen, hot to touch, area around injection site with "hard area that can be felt beneath injection site". No information was reported on any corrective treatment given. At the time of the report, the patient had not recovered. Documents held by sender: None.
Age: 90.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Swelling face
Clinical narrative: Initial report was received from a healthcare professional on 12 October 2013. A 90-year-old female patient with no known medical history and allergies had received an intramuscular dose of FLUZONE HD (Sanofi Pasteur, batch number U4717AA) in the left deltoid on 11 October 2013. On 12 October 2013 A.M, the patient presented with facial swelling and with "white ring" around needle injection site, and red, swollen, hot to touch, area around injection site with "hard area that can be felt beneath injection site". No information was reported on any corrective treatment given. At the time of the report, the patient had not recovered. Documents held by sender: None.
Age: 55.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Mobility decreased, Pain, Weight bearing difficulty
Clinical narrative: Immediately following injection, she stated it felt like it "went into the joint." She has very sore arm and states it is too painful to move.
Age: 55.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Immediate post-injection reaction, Pain, Pain in extremity
Clinical narrative: Immediately following injection, she stated it felt like it "went into the joint." She has very sore arm and states it is too painful to move.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Constant ache and pain in shoulder and arm.
Age: 24.0
Sex: F
Vaccine: FLUX
Symptoms: Dysphonia, Oropharyngeal pain, Thirst
Clinical narrative: Sore throat, hoarseness, and persistent thirst.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Dysstasia, Fall
Clinical narrative: Sudden dizziness, unable to stand, fell down after standing up.
Age: 0.17
Sex: M
Vaccine: DTAP
Symptoms: Abnormal behaviour, Discomfort, Screaming
Clinical narrative: Patient screamed for 2 hours straight. Couldn't settle down. Seemed very uncomfortable and just was not himself. It was a nightmare!
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MEN, TDAP, VARCEL
Symptoms: Loss of consciousness
Clinical narrative: Within minutes of getting her Gardasil vaccine she said, "mom, everything is going black." The ladies at the health dept. helped me get her to a table to lay her down on and told me this was a common reaction to this vaccine.
Age: 2.0
Sex: M
Vaccine: FLUN4, HEPA
Symptoms: Abscess, Bursitis, Incisional drainage, Injected limb mobility decreased, Injection site pain
Clinical narrative: Unclear that it is linked to vaccine. 10/10/13 (R) deltoid IM vaccine. 10/12/13 (approx) fever/(R) arm pain x 24 hrs - treated at urgent care, no records available better then 10/20/13 - fever (R) arm/shoulder hot and limited ROM --> admitted - Xray OK, MRI showed bursitis clinda x 21 days and I and D in OR. No skin infection ever apparent.
Age: 2.0
Sex: M
Vaccine: FLUN4, HEPA
Symptoms: Injection site warmth, Nuclear magnetic resonance imaging abnormal, Pain in extremity, Pyrexia, X-ray normal
Clinical narrative: Unclear that it is linked to vaccine. 10/10/13 (R) deltoid IM vaccine. 10/12/13 (approx) fever/(R) arm pain x 24 hrs - treated at urgent care, no records available better then 10/20/13 - fever (R) arm/shoulder hot and limited ROM --> admitted - Xray OK, MRI showed bursitis clinda x 21 days and I and D in OR. No skin infection ever apparent.
Age: 75.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Pruritus generalised, Rash generalised, Urticaria
Clinical narrative: Rash, hives, and itchiness started at 3:00 am. Located all over body - mostly under arms, fingers, and feet. Pt. took BENADRYL at 6 AM.
Age: 75.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Pruritus
Clinical narrative: Rash, hives, and itchiness started at 3:00 am. Located all over body - mostly under arms, fingers, and feet. Pt. took BENADRYL at 6 AM.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Blood thyroid stimulating hormone, Exposure during pregnancy
Clinical narrative: Information has been received from a physician for GARDASIL, a Pregnancy Registry product, concerning an actually 16 year old female patient with no pertinent medical history and no drug reactions or allergies, who on 16-AUG-2012 was vaccinated with the first dose of GARDASIL (lot number not reported), on 23-FEB-2011, the patient received the second does of GARDASIL (Lot number 668261/1397AA) and on 28-OCT-2011, the patient received the third dose of GARDASIL (Lot number 668261/1397AA). Doses and routes were not reported for any of the vaccine administered. There was no concomitant medications. The physician reproted that the patient completed the "3 shots" of the GARDASIL and later found out that she was pregnant. On an unspecified date serum thyroid-stimulating hormone (TSH) (blood work) was performed, results not provided. It was reported that the patient did not remember her last menstrual period but she thought it was in September. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report was received from an unspecified reporter via a company representative concerning a patient of unknown age and gender. On an unknown date, the patient was vaccinated with an expired dose of M-M-R II (lot number unspecified, expiry date was reported as March 2013, dose and route unspecified). No concomitant therapy was reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with liquid PEDVAXHIB (lot #, expiration date, route, dose and frequency unknown). On unknown dates the patient inadvertently received liquid PEDVAXHIB at 2, 4, and 6 months. No adverse effects were reported. Additional information has been requested.
Age: 40.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 40 year old male patient. On 10-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J004269, expiration date 02-JUL-2013, dose not reported, subcutaneously) and a dose of FLUVIRIN at two separate injection sites. There was no concomitant medication, pertinent medical history or drug reactions/allergies. Approximately in October 2013 ("over the weekend") the patient experienced an injection site reaction at the site in which he received the ZOSTAVAX. The site of the reaction was "an oval shape (couple of inches), red and more red in the center" and tender. There was no treatment given for the events. No lab diagnostics studies performed. The patient sought medical attention via visited pharmacy. The outcome of the events was reported as recovering. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from an office manager concerning a patient, who was intended to received ZOSTAVAX but, on 17-OCT-2013, was inadvertently administered VARIVAX (Merck), 0.5 ml dose, subcutaneously (lot # not provided) due to a nursing error. No adverse effects were reported. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Rt arm red swollen from shoulder to elbow - tissue swelling.
Age: 0.08
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse, refers to a 4 week old patient (gender was not reported). On 07-OCT-2013 the patient was inadvertently vaccinated with ROTATEQ, 2 ml, oral. The patient's date of birth is 06-SEP-2013. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 10-OCT-2013 the patient was vaccinated with an expired dose of VARIVAX (Merck) injection (lot # 671232/1272AA, expiry date: AUG-2013 as reported), (dose, route and location unspecified). No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of over 60 years. Her medical history was unknown. On an unknown date, the patient was vaccinated with ZOSTAVAX, lot # J000444, 0.65 ml, subcutaneous. No co-suspected or concomitant medications were reported. After receiving the vaccination, the patient experienced redness and a lump on the arm at the injection site. The patient went back to the pharmacy because of the event. The event ws treated with BENADRYL. The outcome of redness and a lump on the arm at the injection site was unknown and a causality assessment was not provided. This case report is cross-linked with case 1310USA010377, received from the same reporter, also reporting a female patient of over 60, who experienced the same adverse event about a month earlier, receiving ZOSTAVAX (lot number unknown). Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of over 60 years. Her medical history was unknown. On an unknown date, the patient was vaccinated with ZOSTAVAX. No co-suspected or concomitant medications were reported. After receiving the vaccination, the patient experienced redness and a lump on the arm at the injection site. The outcome of redness and a lump on the arm at the injection site was unknown and a causality assessment was not provided. The case report is cross-lined with case 1310USA004163. received from the same reporter, also regarding a female patient of over 60, who experienced the same adverse event about a month later, after receiving ZOSTAVAX (lot number unknown). Additional information has been requested.
Sex: U
Vaccine: FLU3, HEP, HEPA
Symptoms: Product packaging issue
Clinical narrative: This spontaneous report was received from a physician. The physician reported that the appearance of VAQTA vial was similar looking to FLUZONE for ages three and up. He stated that the VAQTA comes with a purple plunger and so does FLUZONE. He also stated that the appearance of the RECOMBIVAX HB vial was similar looking to FLUZONE for under three years of age. He reported that the RECOMBIVAX HB comes with a yellow plunger and so does FLUZONE. The physician stated that a mistake can easily happen because of the similar appearances especially when you work in a busy pediatric office. He confirmed that a mistake did not occur. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Polymerase chain reaction, Rash vesicular, Varicella virus test negative
Clinical narrative: This spontaneous report as received from a physician refers to 84 years old female patient with psoriasis and hypothyroidism. The patient's medical history included lisinopril (manufacturer unknown) caused cough (Same Patient Link: MARRS # 1310USA010372). On 02-OCT-20132, the patient was vaccinated with a dose of ZOSTAVAX lot # J004600, exp. date 18-JUL-2014 (route and dose not reported). Concomitant therapies included SYNTHROID, vitamin D (unspecified) and losartan potassium (manufacturer unknown. On 03-OCT-2013, the patient experienced varicella-like rash in an unspecified location on the patient's body. The outcome of varicella-like rash was reported as not recovered/not resolved. There was no treatment given for the patient's event. It ws reported that the patient called physician (in Friday, 04-OCT-2013). Relatedness was not reported. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild type (WT) VZV strain or with the OKA/Merck vaccine strain. Varicella Zoster Virus (VZV) strain identification polymerase chain reaction (PCR) was performed in an approximately October 2013 (date sample obtained was 07-OCT-2013), date arrived to laboratory was 09-OCT-2013): final results were negative-adequate specimen, no VZV detected (sample: vesicle/lesion and swab of left hand). It was also reported that VZV DNA was not amplified and beta-globin DNA was amplified. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Reddened and warm at site. Sore. Approximately 50 mm circumference Received 10/21/13 at 9am Patient to notify our office if she seeks medical attention.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 year old female patient with no pertinent medical history and no drug reactions/allergies. On 18-OCT-2013 the patient was vaccinated with ZOSTAVAX (vial, lot # reported as J005850, exp date is 17-AUG-2013, 0.65 ml/once). Concomitant therapies included lorazepam and methocarbamol. It was reported that the patient developed red, oblong, hard and warm area at the injection site (unspecified date in October 2013) after receiving the dose of ZOSTAVAX. Patient had sought medical attention via calling the pharmacist. No lab diagnostics studies were performed and no treatment was given for the events. The outcome of red, oblong, hard, and warm area at the injection site was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On an unknown date the patient ws vaccinated with PNEUMOVAX23 (dose and route unknown). It was reported that the patient developed an unspecified rash at the injection site "shortly after" administration of PNEUMOVAX23 (onset date unknown). It was also reported as therapy discontinued and not reintroduced. The outcome was unknown. Additional information has been requested.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Vomiting
Clinical narrative: Felt sick to stomach and vomited three times that evening.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Erythema, Pharyngeal oedema, Pruritus, Rash erythematous
Clinical narrative: Friday p.m. face became swollen, itchy, red also arms, legs. Rash flat and red. Throat swollen. Epi-pen given by self. Called M.D.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face, Urine analysis
Clinical narrative: Friday p.m. face became swollen, itchy, red also arms, legs. Rash flat and red. Throat swollen. Epi-pen given by self. Called M.D.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Haemorrhage, Injection site bruising
Clinical narrative: Patient had bruise at injection site and bleed after injection patient is taking LOVENOX.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 27-SEP-2013 the patient was vaccinated with M-M-R II (reported lot # H018950 corresponding with lot # 1483AA, expiration date 18-OCT-2014). The vaccine was exposed to temperature exposures of 50F for 85 minutes, 47F for 15 minutes, 48F for 35 minutes, 52F for 95 minutes, 48F for 40 minutes on 20-SEP-2013 and 48F for 45 minutes on 25-SEP-2013. No known adverse effects. This case is linked to case: 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008406 and 1310USA008407 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received form a nurse refers to a patient of unknown age and gender. On 27-SEP-2013 the patient was vaccinated with M-M-R II (reported lot # H018950 corresponding with lot # 1483AA: expiration date: 18-OCT-2014). The vaccine was exposed to temperature exposures of 50F for 85 minutes, 47F for 15 minutes, 48 F for 35 minutes, 52F for 95 minutes, 48 F for 30 minutes on 20-SEP-2013 and 48F for 45 minutes on 25-SEP-2013. No known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008406 and 1310USA008407 (same reporter linked). Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Local reaction
Clinical narrative: Patient developed redness and pain at injection site --> Local reaction.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received form a nurse refers to a patient of unknown age and gender. On 27-SEP-2013 the patient was vaccinated with M-M-R II (reported lot # H018950 corresponding with lot # 1483AA: expiration date: 18-OCT-2014). The vaccine was exposed to temperature exposures of 50F for 85 minutes, 47F for 15 minutes, 48 F for 35 minutes, 52F for 95 minutes, 48 F for 30 minutes on 20-SEP-2013 and 48F for 45 minutes on 25-SEP-2013. No known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008406 and 1310USA008407 (same reporter linked). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received form a nurse refers to a patient of unknown age and gender. On 27-SEP-2013 the patient was vaccinated with M-M-R II (reported lot # H018950 corresponding with lot # 1483AA: expiration date: 18-OCT-2014). The vaccine was exposed to temperature exposures of 50F for 85 minutes, 47F for 15 minutes, 48 F for 35 minutes, 52F for 95 minutes, 48 F for 30 minutes on 20-SEP-2013 and 48F for 45 minutes on 25-SEP-2013. No known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008406 and 1310USA008407 (same reporter linked). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received form a nurse refers to a patient of unknown age and gender. On 27-SEP-2013 the patient was vaccinated with M-M-R II (reported lot # H018950 corresponding with lot # 1483AA: expiration date: 18-OCT-2014). The vaccine was exposed to temperature exposures of 50F for 85 minutes, 47F for 15 minutes, 48 F for 35 minutes, 52F for 95 minutes, 48 F for 30 minutes on 20-SEP-2013 and 48F for 45 minutes on 25-SEP-2013. No known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008406 and 1310USA008407 (same reporter linked). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received form a nurse refers to a patient of unknown age and gender. On 27-SEP-2013 the patient was vaccinated with M-M-R II (reported lot # H018950 corresponding with lot # 1483AA: expiration date: 18-OCT-2014). The vaccine was exposed to temperature exposures of 50F for 85 minutes, 47F for 15 minutes, 48 F for 35 minutes, 52F for 95 minutes, 48 F for 30 minutes on 20-SEP-2013 and 48F for 45 minutes on 25-SEP-2013. No known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008406 and 1310USA008407 (same reporter linked). Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Dysphagia, Flushing, Increased upper airway secretion, Lacrimation increased, Pain
Clinical narrative: When patient returned home stated he had difficulty swallowing, tightness in throat and thick heavy phlegm - body aches, fever, AA flushing watery eyes, no reaction site effects less than 8 hours felt better no treatment.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Throat tightness
Clinical narrative: When patient returned home stated he had difficulty swallowing, tightness in throat and thick heavy phlegm - body aches, fever, AA flushing watery eyes, no reaction site effects less than 8 hours felt better no treatment.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Blood pressure increased, Dyspnoea, Ear discomfort
Clinical narrative: Pt presented within couple minutes of vaccine admin. with difficulty breathing. Vitals were obtained and BP markedly elevated (syst 170-180). Symptoms progressed rapidly with pt complaining of burning of ears and then severe pain in hips. Paramedics were called. Epipen was administered. Pt symptoms improved quickly after epipen admin. Pt transported to ER.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 27-SEP-2013 the patient was vaccinated with M-M-R II (reported lot # H018950 corresponding with lot # 1483AA; expiration date 18-OCT-2014). The vaccine was exposed to temperature exposures of 50F for 85 minutes, 47F for 15 minutes, 48F for 35 minutes, 52 F for 95 minutes, 48F for 30 minutes on 20-SEP-2013 and 48F for 45 minutes on 25-SEP-2013. No known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008406 and 1310USA008407 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 17-SEP-2013 the patient was vaccinated with M-M-R II (lot #H015829, expiration date 24-Aug-2014). The vaccine was exposed to temperature exposures of 52F, on 29-AUG-2013 for 40 minutes, on 09-SEP-2013 for 1 hr and 25 minutes, on 10-SEP-2013 for 15 minutes and on 17-SEP-2013 for 35 minutes. No known adverse effects. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 30-SEP-2013 the patient was vaccinated with M-M-R II (reported batch # H018950 corresponding with lot # 1483AA; expiration date 18-OCT-2014). The vaccine was exposed to temperature exposures for 50F for 85 minutes, 47F for 15 minutes, 48F for 35 minutes, 52 F for 95 minutes, 48F for 30 minutes on 20-SEP-2013 and 48F for 45 minutes on 25-SEP-2013. No known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008406 and 1310USA008407 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 30-SEP-2013 the patient was vaccinated with M-M-R II (reported batch # H018950 corresponding with lot # 1483AA; expiration date 18-OCT-2014). The vaccine was exposed to temperature exposures for 50F for 85 minutes, 47F for 15 minutes, 48F for 35 minutes, 52 F for 95 minutes, 48F for 30 minutes on 20-SEP-2013 and 48F for 45 minutes on 25-SEP-2013. No known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008406 and 1310USA008407 (same reporter link). Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Arnold-Chiari malformation, Brain compression, Brain oedema, Headache
Clinical narrative: This spontaneous report as received from a registered nurse referring to her daughter an approximately 17 year old female patient with allergic to cockroaches. On an unknown date, the patient was vaccinated with GARDASIL 3 doses for vaccination (dose, concentration and lot number were not reported). Concomitant therapies were not reported. In January 2013 (exact date unspecified), the patient experienced headaches that were diagnosed as a Chiari malformation (with 4 mm extension of the cerebral tonsils into the spinal column caused by cerebral edema). The reporter stated that her daughter had experienced horrible pain, headaches, tingling and numbness of the extremities, and incontinence since January 2013. The reporter stated that her daughter had trouble getting through a day of school, and has missed school due to the pain, headaches and incontinence. The patient sought medical attention, she contacted her physician. A magnetic resonance imaging (MRI) was performed, but results were not provided. Patient received treatment with unspecified medication for headaches. The outcome of the events was reported as not recovered. The reporter considered the events to be disability and compression of brain stem to be life threatening. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Incontinence, Nuclear magnetic resonance imaging, Pain, Paraesthesia
Clinical narrative: This spontaneous report as received from a registered nurse referring to her daughter an approximately 17 year old female patient with allergic to cockroaches. On an unknown date, the patient was vaccinated with GARDASIL 3 doses for vaccination (dose, concentration and lot number were not reported). Concomitant therapies were not reported. In January 2013 (exact date unspecified), the patient experienced headaches that were diagnosed as a Chiari malformation (with 4 mm extension of the cerebral tonsils into the spinal column caused by cerebral edema). The reporter stated that her daughter had experienced horrible pain, headaches, tingling and numbness of the extremities, and incontinence since January 2013. The reporter stated that her daughter had trouble getting through a day of school, and has missed school due to the pain, headaches and incontinence. The patient sought medical attention, she contacted her physician. A magnetic resonance imaging (MRI) was performed, but results were not provided. Patient received treatment with unspecified medication for headaches. The outcome of the events was reported as not recovered. The reporter considered the events to be disability and compression of brain stem to be life threatening. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 30-SEP-2013 the patient was vaccinated with M-M-R II (reported batch # H018950 corresponding with lot # 1483AA; expiration date 18-OCT-2014). The vaccine was exposed to temperature exposures for 50F for 85 minutes, 47F for 15 minutes, 48F for 35 minutes, 52 F for 95 minutes, 48F for 30 minutes on 20-SEP-2013 and 48F for 45 minutes on 25-SEP-2013. No known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008406 and 1310USA008407 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 30-SEP-2013 the patient was vaccinated with M-M-R II (reported batch # H018950 corresponding with lot # 1483AA; expiration date 18-OCT-2014). The vaccine was exposed to temperature exposures for 50F for 85 minutes, 47F for 15 minutes, 48F for 35 minutes, 52 F for 95 minutes, 48F for 30 minutes on 20-SEP-2013 and 48F for 45 minutes on 25-SEP-2013. No known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008406 and 1310USA008407 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 01-OCT-2013 the patient was vaccinated with M-M-R II (reported batch # H018950 corresponding with lot # 1483AA; expiration date 18-OCT-2014). The vaccine was exposed to temperature exposures for 50F for 85 minutes, 47F for 15 minutes, 48F for 35 minutes, 52 F for 95 minutes, 48F for 30 minutes on 20-SEP-2013 and 48F for 45 minutes on 25-SEP-2013. No known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008404, 1310USA008405, 1310USA008406 and 1310USA008407 (same reporter link). Additional information has been requested.
Age: 63.0
Sex: U
Vaccine: PPV, VARZOS
Symptoms: Infection, Injection site erythema, Injection site warmth, Loss of consciousness
Clinical narrative: Where pneumovax given: red warm spot reported 2 days after receiving vaccine, "passed out" - did not hurt himself. Went to MD - taking Keflex for infection.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 01-OCT-2013 the patient was vaccinated with M-M-R II (reported batch # H018950 corresponding with lot # 1483AA; expiration date 18-OCT-2014). The vaccine was exposed to temperature exposures for 50F for 85 minutes, 47F for 15 minutes, 48F for 35 minutes, 52 F for 95 minutes, 48F for 30 minutes on 20-SEP-2013 and 48F for 45 minutes on 25-SEP-2013. No known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008405, 1310USA008406 and 1310USA008407 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 02-OCT-2013 the patient was vaccinated with M-M-R II (reported batch # H018950 corresponding with lot # 1483AA; expiration date 18-OCT-2014). The vaccine was exposed to temperature exposures for 50F for 85 minutes, 47F for 15 minutes, 48F for 35 minutes, 52 F for 95 minutes, 48F for 30 minutes on 20-SEP-2013 and 48F for 45 minutes on 25-SEP-2013. No known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405 and 1310USA008406 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 02-OCT-2013 the patient was vaccinated with M-M-R II (reported batch # H018950 corresponding with lot # 1483AA; expiration date 18-OCT-2014). The vaccine was exposed to temperature exposures for 50F for 85 minutes, 47F for 15 minutes, 48F for 35 minutes, 52 F for 95 minutes, 48F for 30 minutes on 20-SEP-2013 and 48F for 45 minutes on 25-SEP-2013. No known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405 and 1310USA008407 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 01-OCT-2013 the patient was vaccinated with M-M-R II (reported batch # H018950 corresponding with lot # 1483AA; expiration date 18-OCT-2014). The vaccine was exposed to temperature exposures for 50F for 85 minutes, 47F for 15 minutes, 48F for 35 minutes, 52 F for 95 minutes, 48F for 30 minutes on 20-SEP-2013 and 48F for 45 minutes on 25-SEP-2013. No known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008406 and 1310USA008407 (same reporter link). Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry mouth, Glossodynia
Clinical narrative: This spontaneous report as received from a 75 year old female patient with no pertinent medical history and no drug reactions or drug allergies refers to herself. On 27-SEP-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot number, dose, frequency, route and site of administration were not reported). Concomitant therapies included levothyroxine sodium (manufacturer unknown) an simvastatin (manufacturer unknown). On 30-SEP-2013, the patient felt her mouth was very dry and her tongue burned, especially when she drank or ate. The patient reported she was experiencing side effects since getting ZOSTAVAX. The patient did not seek medical attention. There was no treatment given for adverse events. No lab diagnostics studies were performed. The patient did not recover from adverse events. The relatedness between vaccination with a dose of ZOSTAVAX and adverse events was not reported. Additional information is not expected.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthma, Bronchospasm, Upper respiratory tract infection
Clinical narrative: This spontaneous report as received from a physician refers to a 61 year old male patient with no pertinent medical history and no drug reactions or drug allergies. On 30-SEP-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot number, indication, dose, route and site of administration were not reported). Approximately on 01-OCT-2013 (reported as one to 2 days after vaccination) the patient experienced bronchospasm, upper respiratory infection and asthma. The patient sought medical attention via contacting physician. The inhaled steroids (unspecified) were given as a treatment for adverse events. The patient did not recover from bronchospasm, upper respiratory infection and asthma at the time of report. The relatedness between vaccination with ZOSTAVAX and bronchospasm, upper respiratory infection and asthma was not reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: 3 cm areas of erythema surrounding injection site.
Age: 57.0
Sex: M
Vaccine: HEPAB, IPV, TYP, YF
Symptoms: Nausea, Vomiting
Clinical narrative: Patient reported nausea and vomited several times (3x) that late afternoon/evening. He went to sleep and woke up with no s/s.
Age: 31.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Blister, Exposure during pregnancy, Purulent discharge, Urticaria, Wheezing
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 10 October 2013. A female patient (age and date of birth not reported) who was 8 months pregnant received a dose one injection of H1N1 (manufacturer, lot number, route and site not reported) in October of 2009. Two to three days post-vaccination, the patient developed wheezing, urticaria and pus filled blisters. The patient was treated in the emergency room with BENADRYL, corticosteroids and Albuterol. The patient had no illness at the time of vaccination. No additional information was available. The outcome of the pregnancy was unknown. Outcome of the events was recovered. Documents held by sender: None.
Age: 55.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Laboratory test, Syncope
Clinical narrative: Initial report was received on 08 October 2013 from a health care professional. A 55 year-old female patient with a past medical history of hypothyroidism had received on 22 October 2009 a dose of H1N1, lot number UP001AA (route and site of administration not reported) and three days later on 25 October 2009, developed fainting spells. According to the reporter, multiple tests were conducted to establish causality (results were not reported). Concomitant medications included SYNTHROID. Illness at the time of vaccination was denied. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: none.