chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV, PPV
Symptoms: Hypertension
Clinical narrative: This spontaneous report was received from a licensed vocational nurse referring to a female patient of unknown age who on 22-AUG-2013, was vaccinated with an expired dose of PNEUMOVAX23 (lot # 672370/1851AA, expiration date, 05-AUG-2013) 0.5 ml, intramuscular. No adverse event reported. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEP, HEPA, MMR, VARCEL
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Diarrhea, vomiting, and fever.
Age: 1.82
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR
Symptoms: Blood culture, Chest X-ray normal, Convulsion, Cough, Diarrhoea
Clinical narrative: Seen at ER on 8-16-13. Fever began the day before, which was also one day after immunizations. Fever con't into 8-16-13 on which day the seizure occurred. Patient had not been medicated with fever reducers prior to having seizure. ER noted cough, nasal congestion, vomiting and diarrhea, and fever 102.9 degrees F.
Age: 1.82
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR
Symptoms: Full blood count, Metabolic function test, Nasal congestion, Pyrexia, Vomiting
Clinical narrative: Seen at ER on 8-16-13. Fever began the day before, which was also one day after immunizations. Fever con't into 8-16-13 on which day the seizure occurred. Patient had not been medicated with fever reducers prior to having seizure. ER noted cough, nasal congestion, vomiting and diarrhea, and fever 102.9 degrees F.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist, concerning a 61 year old female patient with none pertinent medical history or drug reaction allergies. On 19-AUG-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J002241, exp date 21-MAY-2014) (0.65 ml dose, subcutaneous route). Concomitant therapy was not reported. On 20-AUG-2013, the patient developed redness, pain and warmth around the injection site after receiving the ZOSTAVAX. The patient sought medical attention, called the pharmacist on 22-AUG-2013, and no treatment was given for the adverse events. Laboratory diagnostic studies were not performed. At the time of the report the patient's outcome was not recovered. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Presyncope, Syncope
Clinical narrative: This spontaneous report as received from a company representative (information received from a registered nurse) refers to a 12 year old female patient. On 06-AUG-2013 the patient was vaccinated with GARDASIL dose 1, intramuscular. Dose and lot number were not reported. Other suspect therapies included hepatitis A vaccine, (manufacturer unknown) and meningococcal vaccine (manufacturer unknown). Dose, dose number and lot number were not reported. The nurse, who also participated in the care of this patient, reported that the patient experienced syncope, "nearly fainting" in the office "about 20-25 minutes" after administration. The patient recovered on-site with rest and a cold pack and the staff continued observation for another 20 minutes after recovery was achieved. The patient is said to have "fully recovered". Outcome of syncope and nearly fainting was reported as recovered/resolved. Reporter causality assessment was not reported. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report was received from a physician concerning an approximately 74 year old female patient with no pertinent medical history and no drug reactions or allergies. On 23-AUG-2013, the patient was vaccinated with 0.65 milliliter (ml) of ZOSTAVAX (lot number and expiry date reported as J002869 and 14-JUN-2014 respectively), subcutaneously. Concomitant therapies included citalopram and aspirin (reported as baby aspirin). On 24-AUG-2013, the patient developed a 10 X 11 centimeters (cm) erythema around her injection site after receiving ZOSTAVAX. The physician stated that the erythema had progressively gotten worse. The patient sought medical attention. The patient was at physician office at the time of reporting. No treatment was given. No lab tests were performed. The patient was not recovered from the adverse event. The relatedness for the adverse event was unknown for ZOSTAVAX. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pruritus, Pyrexia, Rash vesicular, Urticaria
Clinical narrative: 3 days after PROQUAD - hives bilat. legs, arms, back, face, lip, toes. Itching. Lesion on leg and back are vesicular; otherwise. Eating, playing and sleeping as her usual. Low grade fever.
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: Infant received 2 doses of Hepatitis B vaccine (Recombivax HB) in the hospital.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pyrexia, Skin reaction
Clinical narrative: Pt had local skin reaction at injection site, headache, and fever. Headache and fever resolved with OTC Tylenol. Skin reaction improved with oral Benadryl. Recommended OTC hydrocortisone cream to apply to site too.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Erythema, Rash generalised
Clinical narrative: 1 hour after #3 GARDASIL, developed facial and L arm erythema, slightly raised rash (cheeks, nose, forehead, behind ears). Tx'd with BENADRYL, Medrol Dose Pk.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site erythema
Clinical narrative: Presented to clinic 8-22-13 with erythema to right thigh.
Age: 0.84
Sex: F
Vaccine: DTAP
Symptoms: Rash generalised, Somnolence
Clinical narrative: Rash to entire body beginning 3d after DTap vaccine. some sleepiness.
Age: 6.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Pt <7 yrs old given Tdap instead of DTaP at time of visit at clinic on 7-25-13. No adverse effects. Pt notified of error.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Received Menactra on 8/20. Red, hot, swollen, and painful at injection site. Red area approx. 6 cm in diameter. Dx with cellulitis treated with clindamycin 150 mg.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Pyrexia
Clinical narrative: Temp 103, fever chills, redness at injection site and surrounding area.
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Throat tightness
Clinical narrative: Pt stated his throat felt tight. Approximately 30 minutes after giving HPV (GARDASIL) and MENVEO vaccines. Vital signs were stable BENADRYL 50mg was given. Pt fully recovered.
Age: 1.3
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Abnormal behaviour, Flushing, Rash, Rash generalised, Rash morbilliform
Clinical narrative: At 7PM 8/15/2013 parents noted rapid breathing and rash and went to hospital. Evaluated as viral axanthum, given Tylenol and sent home. Albuterol x1 at home. Seen again at pediatricians around Noon 8/16/2013 for rash on cheeks, arms, and legs. No further fever or breathing diff. Clingy not playful. Generalized morbiliform rash on trunk, extremities. Cheeks flushed.
Age: 1.3
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Respiratory rate increased, Urine analysis, Viral rash
Clinical narrative: At 7PM 8/15/2013 parents noted rapid breathing and rash and went to hospital. Evaluated as viral axanthum, given Tylenol and sent home. Albuterol x1 at home. Seen again at pediatricians around Noon 8/16/2013 for rash on cheeks, arms, and legs. No further fever or breathing diff. Clingy not playful. Generalized morbiliform rash on trunk, extremities. Cheeks flushed.
Age: 11.0
Sex: F
Vaccine: HEP, IPV, MMR
Symptoms: Ear pain, Measles antibody, Otitis externa, Rubella antibody test
Clinical narrative: 7/15/13 Child presents for vaccines. Received Miningo, Hep A/Hep B, TDAP, MMR. 8/9/13 Child presents (L) ear pain - OE. 8/12/13 Child presents for catch up vaccines. Received Polio, Hep B, MMR.
Age: 23.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Rash
Clinical narrative: Rash, hydrocortisone cream, 25mg BENADRYL; rash appeared on day 15.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Patient fainted 10 minutes after Gardasil vaccine was administered. After patient woke up, cold packs were applied. Vitals were stable. Patient observed until recovery.
Age: 33.0
Sex: M
Vaccine: SMALL
Symptoms: Rash
Clinical narrative: Rash, Day 12. 50mg BENADRYL.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Ovarian disorder
Clinical narrative: This spontaneous report as received from a consumer refers to a 16 year old female patient. On an unknown date the patient was vaccinated with GARDASIL (dose, route, indication and lot # not reported). The consumer reported that she read an article in a foreign newspaper that claimed the patient's ovaries were damaged by the GARDASIL vaccine. The consumer stated that this article appeared in a web site and was dated 09-AUG-2013. The outcome of the event is unknown. Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: MNQ
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever (102) aches, chills and HA's - 6 hours post injection. Rest and Tylenol and observation in Health Svc.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist refers to an currently 84 years old female patient. On an unspecified date the patient was vaccinated with a dose of ZOSTAVAX (lot # unspecified), route, dose and location unspecified. The pharmacist reported that the patient who received ZOSTAVAX subsequently developed shingles. At the time of report, the outcome of the shingles was unknown. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Tremor, Vomiting
Clinical narrative: Approximately 1 1/2-2 hrs post injection, patient vomited one time and became very shaky. Hands shook hard enough that patient was unable to shave. Shaking continued to about 8pm. Patient states he was fine the next morning.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a consumer refers to an unknown age female patient. On an unspecified date the patient developed shingles after vaccination with a dose of ZOSTAVAX (lot # unspecified), route, dose and location unspecified. The outcome of shingles was unknown. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to her daughter of unknown age. In August 2012 (about a year ago (date unspecified)) the patient received the first dose of GARDASIL (lot #, expiration, route unspecified) and the second dose of GARDASIL in August 2013 (last week (date unspecified)). No adverse event reported. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RV5
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Right thigh red, swollen, warm to the touch. 3x1.5 cm without fluctuation.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Vaccination complication
Clinical narrative: Right leg swelling that involved 50% of the leg surrounding the injection site. There was associated erythema. There was no induration. Onset was within the first 24 hours. Thought to be due to Kinrix.
Age: 1.66
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC13, VARCEL
Symptoms: Biopsy, Injection site discolouration, Injection site nodule, Ultrasound scan abnormal
Clinical narrative: Left thigh 1.5 cm round violaceous nodules hypoechoic well-circumscribed lesion on ultrasound. Sent to gen surg for possible biopsy or removal.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Nasal congestion, Upper respiratory tract infection, Urticaria
Clinical narrative: Red urticaria / wheals on thigh. URI symptoms - nasal congestion no fever starting day 2 post shot incidental?
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Developed cellulitis at injection site. Treated with BACTRIM DS 800mg - 160mg tabs BID.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Rt and Lt arm redness and swelling and tenderness arm.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, VARZOS, FLU3, PPV, VARZOS
Symptoms: Injection site swelling, Pain
Clinical narrative: Swelling of Rt arm above crease of elbow. Painful to touch. (Not at same site as vaccine).
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, VARZOS, FLU3, PPV, VARZOS
Symptoms: Vaccination site reaction
Clinical narrative: Swelling of Rt arm above crease of elbow. Painful to touch. (Not at same site as vaccine).
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Headache, Hyperhidrosis, Influenza like illness, Pyrexia
Clinical narrative: At 8:30pm patient started violently shaking, had fever (temp unknown), sweating, felt weak and had a headache. He took 500mg of TYLENOL at 8:30 which helped him relax and fall asleep. On the morning of 8/26/13 he still felt flu like symptoms, then it subsided after a few hours. This is the first time patient got high dose.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: At 8:30pm patient started violently shaking, had fever (temp unknown), sweating, felt weak and had a headache. He took 500mg of TYLENOL at 8:30 which helped him relax and fall asleep. On the morning of 8/26/13 he still felt flu like symptoms, then it subsided after a few hours. This is the first time patient got high dose.
Age: 24.0
Sex: F
Vaccine: UNK, FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Pt had hives at injection site.
Age: 24.0
Sex: F
Vaccine: UNK, FLU3
Symptoms: Injection site urticaria
Clinical narrative: Pt had hives at injection site.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Dysphemia
Clinical narrative: Fatigue, loss of motor skills, stuttering and delayed speech. Pain in legs, arm, stomach. Time lasted was from just hours to continually.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Computerised tomogram head, Dysphemia, Full blood count, Laboratory test, Mobility decreased
Clinical narrative: Fatigue, loss of motor skills, stuttering and delayed speech. Pain in legs, arm, stomach. Time lasted was from just hours to continually.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Abdominal pain upper, Blood glucose, Blood test, Computerised tomogram, Dysphemia
Clinical narrative: Fatigue, loss of motor skills, stuttering and delayed speech. Pain in legs, arm, stomach. Time lasted was from just hours to continually.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Fatigue, Pain in extremity, Psychomotor skills impaired, Speech disorder
Clinical narrative: Fatigue, loss of motor skills, stuttering and delayed speech. Pain in legs, arm, stomach. Time lasted was from just hours to continually.
Age: 27.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a 27 year old female consumer refers to herself. No known pertinent medical history or drug reactions/allergies. On 06-AUG-2013, the patient was vaccinated with VARIVAX (Merck) injection (lot #, dose and route not provided). There were no concomitant medications. The patient reported that 12 days after receiving VARIVAX (Merck), on 18-AUG-2013, she became pregnant with LMP of 18-AUG-2013 and EDD of 25-MAY-2014. No laboratory tests were performed. The patient did not seek medical attention. At the time of the report, the pregnancy outcome was unknown. No other adverse events were reported. Additional information is not expected.
Age: 27.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Maternal exposure before pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a 27 year old female consumer refers to herself. No known pertinent medical history or drug reactions/allergies. On 06-AUG-2013, the patient was vaccinated with VARIVAX (Merck) injection (lot #, dose and route not provided). There were no concomitant medications. The patient reported that 12 days after receiving VARIVAX (Merck), on 18-AUG-2013, she became pregnant with LMP of 18-AUG-2013 and EDD of 25-MAY-2014. No laboratory tests were performed. The patient did not seek medical attention. At the time of the report, the pregnancy outcome was unknown. No other adverse events were reported. Additional information is not expected.
Age: 10.0
Sex: F
Vaccine: HEPA
Symptoms: Cold sweat, Decreased appetite, Dizziness, Erythema, Pyrexia
Clinical narrative: Dizzy, wheezing, loss of appetite, very pink cheeks. Fever of 103.7 on 8/26/2013 at 8:30 PM. Still wheezy and clammy with no appetite on 8/28/2013.
Age: 10.0
Sex: F
Vaccine: HEPA
Symptoms: Wheezing
Clinical narrative: Dizzy, wheezing, loss of appetite, very pink cheeks. Fever of 103.7 on 8/26/2013 at 8:30 PM. Still wheezy and clammy with no appetite on 8/28/2013.
Age: 15.0
Sex: M
Vaccine: HPVX
Symptoms: Dizziness, Gastrointestinal disorder, Hypotension, Immediate post-injection reaction, Nausea
Clinical narrative: Immediately after getting vaccine pt became light headed and nauseous, symptoms did not resolve after lying flat for several minutes.  Pt BP was initially 87/52 lying down then 88/52 sitting up.  Secondary to hypotension, GI symptoms and lightheadedness pt was treated with Epi Pen.  Symptoms immediately resolved, BP returned to normal and pt was observed for 30 minutes prior to sending pt home.
Age: 12.0
Sex: M
Vaccine: MMR
Symptoms: Activities of daily living impaired, Blood test, Contusion, Haemorrhage, Idiopathic thrombocytopenic purpura
Clinical narrative: This spontaneous report as received from a consumer refers to her a 12 year old nephew. In January 2013 the patient was vaccinated with M-M-R II injection. Lot# and administration route was unspecified. At a younger age, he had been initially vaccinated, at an unspecified time, with the monovalent Measles vaccine. In 2013, after the M-M-R II, the patient experienced unspecified bleeding issues and bruising, resulting in "ITP"(Idiopathic thrombocytopenic purpura), which required platelet infusion, weekly blood tests, two stays in the Pediatric ICU, and stringent restrictions on his athletic and recreational activities. Two hospitals provided care for this patient. The event did not improve at reporting time. Upon internal review, Idiopathic thrombocytopenic purpura was determined to be medically significant event. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: MMR
Symptoms: Intensive care, Platelet transfusion
Clinical narrative: This spontaneous report as received from a consumer refers to her a 12 year old nephew. In January 2013 the patient was vaccinated with M-M-R II injection. Lot# and administration route was unspecified. At a younger age, he had been initially vaccinated, at an unspecified time, with the monovalent Measles vaccine. In 2013, after the M-M-R II, the patient experienced unspecified bleeding issues and bruising, resulting in "ITP"(Idiopathic thrombocytopenic purpura), which required platelet infusion, weekly blood tests, two stays in the Pediatric ICU, and stringent restrictions on his athletic and recreational activities. Two hospitals provided care for this patient. The event did not improve at reporting time. Upon internal review, Idiopathic thrombocytopenic purpura was determined to be medically significant event. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Febrile convulsion
Clinical narrative: This spontaneous report as received from a consumer refers to a 2 year old female patient. The reporter "had heard" that an unspecified 2 years old female patient experienced febrile seizures after receiving M-M-R II "within the past year" in 2012. No date, lot# or administration information was provided. Upon internal review, febrile seizures was determined to be medically significant event. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: FLUX
Symptoms: Bronchitis, Exposure to communicable disease, Influenza, Sinusitis
Clinical narrative: Initial report was received from a healthcare professional on 17 August 2013, who is also the patient's parent. A female patient (age and date of birth not reported) received an intramuscular injection of Influenza Vaccine (manufacturer unknown) on an unreported date during the shortage a few years ago (lot number, site, and side of administration not reported). The patient was exposed to flu. She ended up with bronchitis, sinusitis, and flu for 6 weeks. The patient's outcome was not reported. The reporter is the same for cases 2013-08969 and 2013-09059. Documents held by sender: none.
Age: 71.0
Sex: M
Vaccine: FLUX
Symptoms: Axonal neuropathy, Dysarthria, Dysphagia, Endotracheal intubation, Facial paresis
Clinical narrative: This literature report (initial receipt 13-Aug-2013) concerns a 71 year old male patient. The patient presented 5 months after initial symptoms with history of sudden onset of mild dysphagia to solids and liquids which became severe over a few hours and dysarthria. 24 hours later, the patient developed proximal upper extremity weakness and 36 hours later lower extremity weakness. Absence of sensory symptoms, autonomic dysfunction or pain. He had received a flu shot (batch and manufacturer unspecified) 3 weeks prior to the onset of symptoms. The patient required intubation, PEG (percutaneous endoscopic gastrostomy) tube. He was treated with 7 plasma exchange followed by IVIG (intravenous immunoglobulin) and intensive rehabilitation. Electrodiagnostic studies showed evidence of a diffuse polyradiculoneuropathy affecting predominantly the upper limbs, and cranial innervated muscles. A follow up visit at 8 month revealed improvement of arm strength with no dysarthria, minimal facial weakness. The event outcome was recovering. Reporter's comments: The pharyngo-cervical-brachial variant is a rare presentation characterized by oropharyngeal, neck and proximal upper extremity weakness, with sparing of the lower extremities. Sensory symptoms and autonomic dysfunction are absent. This patient findings on nerve conduction studies were not consistent with demyelinating pattern, and showed axonal loss and polyradicular movement.
Age: 71.0
Sex: M
Vaccine: FLUX
Symptoms: Gastrostomy tube insertion, Immunoglobulin therapy, Muscular weakness, Nerve conduction studies abnormal, Plasmapheresis
Clinical narrative: This literature report (initial receipt 13-Aug-2013) concerns a 71 year old male patient. The patient presented 5 months after initial symptoms with history of sudden onset of mild dysphagia to solids and liquids which became severe over a few hours and dysarthria. 24 hours later, the patient developed proximal upper extremity weakness and 36 hours later lower extremity weakness. Absence of sensory symptoms, autonomic dysfunction or pain. He had received a flu shot (batch and manufacturer unspecified) 3 weeks prior to the onset of symptoms. The patient required intubation, PEG (percutaneous endoscopic gastrostomy) tube. He was treated with 7 plasma exchange followed by IVIG (intravenous immunoglobulin) and intensive rehabilitation. Electrodiagnostic studies showed evidence of a diffuse polyradiculoneuropathy affecting predominantly the upper limbs, and cranial innervated muscles. A follow up visit at 8 month revealed improvement of arm strength with no dysarthria, minimal facial weakness. The event outcome was recovering. Reporter's comments: The pharyngo-cervical-brachial variant is a rare presentation characterized by oropharyngeal, neck and proximal upper extremity weakness, with sparing of the lower extremities. Sensory symptoms and autonomic dysfunction are absent. This patient findings on nerve conduction studies were not consistent with demyelinating pattern, and showed axonal loss and polyradicular movement.
Age: 71.0
Sex: M
Vaccine: FLUX
Symptoms: Polyneuropathy, Radiculopathy
Clinical narrative: This literature report (initial receipt 13-Aug-2013) concerns a 71 year old male patient. The patient presented 5 months after initial symptoms with history of sudden onset of mild dysphagia to solids and liquids which became severe over a few hours and dysarthria. 24 hours later, the patient developed proximal upper extremity weakness and 36 hours later lower extremity weakness. Absence of sensory symptoms, autonomic dysfunction or pain. He had received a flu shot (batch and manufacturer unspecified) 3 weeks prior to the onset of symptoms. The patient required intubation, PEG (percutaneous endoscopic gastrostomy) tube. He was treated with 7 plasma exchange followed by IVIG (intravenous immunoglobulin) and intensive rehabilitation. Electrodiagnostic studies showed evidence of a diffuse polyradiculoneuropathy affecting predominantly the upper limbs, and cranial innervated muscles. A follow up visit at 8 month revealed improvement of arm strength with no dysarthria, minimal facial weakness. The event outcome was recovering. Reporter's comments: The pharyngo-cervical-brachial variant is a rare presentation characterized by oropharyngeal, neck and proximal upper extremity weakness, with sparing of the lower extremities. Sensory symptoms and autonomic dysfunction are absent. This patient findings on nerve conduction studies were not consistent with demyelinating pattern, and showed axonal loss and polyradicular movement.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Cheilitis, Ear pruritus, Erythema, Herpes zoster, Laser therapy
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 year old female patient with penicillin allergy. On 12-NOV-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot # 0567AE, exp date 04-APR-2013) (0.65 ml, subcutaneous). Concomitant therapy was not reported. The pharmacist reported that the patient developed shingles on 18-AUG-2013 (reported as within the past two days). Additionally, the patient reported that in July 2013 experienced an unspecified cosmetic surgery. After that, on an unspecified date in 2013, she had stitches around her ears, laser around her nose and mouth, and red bumps developed from ear to jaw. The patient thought it was hives and used an unspecified cortisone cream and BACITRACIN. her left ear was itching, it got redder and bumps formed on the left ear as well as on her lips and under her lips. She went to the emergency clinic because she felt soreness in her throat; saw red dots on her tongue and bumps in back of throat. She had already used an antihistamine, but was given a prescription for a large blue (unspecified) pill that she took three times a day. It was reported that the patient sought medical attention by an office visit and VALTREX was given for the adverse event. At the time of the report, the patient's outcome was reported as not recovered. Upon internal review, the cosmetic surgery was considered an other important medical event. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Rash, Rash erythematous, Surgery, Tongue disorder
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 year old female patient with penicillin allergy. On 12-NOV-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot # 0567AE, exp date 04-APR-2013) (0.65 ml, subcutaneous). Concomitant therapy was not reported. The pharmacist reported that the patient developed shingles on 18-AUG-2013 (reported as within the past two days). Additionally, the patient reported that in July 2013 experienced an unspecified cosmetic surgery. After that, on an unspecified date in 2013, she had stitches around her ears, laser around her nose and mouth, and red bumps developed from ear to jaw. The patient thought it was hives and used an unspecified cortisone cream and BACITRACIN. her left ear was itching, it got redder and bumps formed on the left ear as well as on her lips and under her lips. She went to the emergency clinic because she felt soreness in her throat; saw red dots on her tongue and bumps in back of throat. She had already used an antihistamine, but was given a prescription for a large blue (unspecified) pill that she took three times a day. It was reported that the patient sought medical attention by an office visit and VALTREX was given for the adverse event. At the time of the report, the patient's outcome was reported as not recovered. Upon internal review, the cosmetic surgery was considered an other important medical event. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Tongue eruption
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 year old female patient with penicillin allergy. On 12-NOV-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot # 0567AE, exp date 04-APR-2013) (0.65 ml, subcutaneous). Concomitant therapy was not reported. The pharmacist reported that the patient developed shingles on 18-AUG-2013 (reported as within the past two days). Additionally, the patient reported that in July 2013 experienced an unspecified cosmetic surgery. After that, on an unspecified date in 2013, she had stitches around her ears, laser around her nose and mouth, and red bumps developed from ear to jaw. The patient thought it was hives and used an unspecified cortisone cream and BACITRACIN. her left ear was itching, it got redder and bumps formed on the left ear as well as on her lips and under her lips. She went to the emergency clinic because she felt soreness in her throat; saw red dots on her tongue and bumps in back of throat. She had already used an antihistamine, but was given a prescription for a large blue (unspecified) pill that she took three times a day. It was reported that the patient sought medical attention by an office visit and VALTREX was given for the adverse event. At the time of the report, the patient's outcome was reported as not recovered. Upon internal review, the cosmetic surgery was considered an other important medical event. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Activities of daily living impaired, Asthenia, Dyspnoea, Fatigue, Gait disturbance
Clinical narrative: This spontaneous report as received from a female consumer of an unknown age who reporting on herself. In June 2013 reported as mid-June, the patient was vaccinated with ZOSTAVAX, injection in the right arm (route, dose, lot number and exp. date not provided). The patient reported that she had been having several severe side effects after having received ZOSTAVAX. She was being so weak and tired that could barely walk - she went to the hospital on 02-JUL-2013 (it was not reported if the patient was hospitalized). She began to experience neuropathy in her right foot during one of her two hospital visits (also reported as on 02-JUL-2013). Her neuropathy was only in her right foot, and the right side of her body was the injection side (in her right arm). She also had breathing problems from 02-JUL-2013. She could not breathe when laying on her right side. If she accidentally rolled over onto her right side while sleeping, she woke up unable to breathe. Before the onset of these adverse experiences, she reported being very healthy. She reported currently being homebound and on oxygen because of her adverse experiences, for about a month. She had sought treatment from many unspecified physicians, including cardiologists and other specialists and she had been arranged an appointment with a pulmonologist next week. She also spoken with unspecified pharmacists. She made two trips to the hospital (hospital information unspecified), but she did not specify whether or not she was hospitalized on either occasion. The patient had unspecified esophagus tests and other unspecified tests (results not provided). The outcome of events was reported as not recovered/not resolved. Upon internal review, being so weak and tired that could barely walk, neuropathy in right foot and breathing problems were considered as disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Laboratory test, Neuropathy peripheral
Clinical narrative: This spontaneous report as received from a female consumer of an unknown age who reporting on herself. In June 2013 reported as mid-June, the patient was vaccinated with ZOSTAVAX, injection in the right arm (route, dose, lot number and exp. date not provided). The patient reported that she had been having several severe side effects after having received ZOSTAVAX. She was being so weak and tired that could barely walk - she went to the hospital on 02-JUL-2013 (it was not reported if the patient was hospitalized). She began to experience neuropathy in her right foot during one of her two hospital visits (also reported as on 02-JUL-2013). Her neuropathy was only in her right foot, and the right side of her body was the injection side (in her right arm). She also had breathing problems from 02-JUL-2013. She could not breathe when laying on her right side. If she accidentally rolled over onto her right side while sleeping, she woke up unable to breathe. Before the onset of these adverse experiences, she reported being very healthy. She reported currently being homebound and on oxygen because of her adverse experiences, for about a month. She had sought treatment from many unspecified physicians, including cardiologists and other specialists and she had been arranged an appointment with a pulmonologist next week. She also spoken with unspecified pharmacists. She made two trips to the hospital (hospital information unspecified), but she did not specify whether or not she was hospitalized on either occasion. The patient had unspecified esophagus tests and other unspecified tests (results not provided). The outcome of events was reported as not recovered/not resolved. Upon internal review, being so weak and tired that could barely walk, neuropathy in right foot and breathing problems were considered as disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Dyspnoea, Joint swelling, Local swelling, Neuropathy peripheral
Clinical narrative: This spontaneous report as received from a female consumer of an unknown age who reporting on herself. In June 2013 reported as mid-June, the patient was vaccinated with ZOSTAVAX, injection in the right arm (route, dose, lot number and exp. date not provided). The patient reported that she had been having several severe side effects after having received ZOSTAVAX. She was being so weak and tired that could barely walk - she went to the hospital on 02-JUL-2013 (it was not reported if the patient was hospitalized). She began to experience neuropathy in her right foot during one of her two hospital visits (also reported as on 02-JUL-2013). Her neuropathy was only in her right foot, and the right side of her body was the injection side (in her right arm). She also had breathing problems from 02-JUL-2013. She could not breathe when laying on her right side. If she accidentally rolled over onto her right side while sleeping, she woke up unable to breathe. Before the onset of these adverse experiences, she reported being very healthy. She reported currently being homebound and on oxygen because of her adverse experiences, for about a month. She had sought treatment from many unspecified physicians, including cardiologists and other specialists and she had been arranged an appointment with a pulmonologist next week. She also spoken with unspecified pharmacists. She made two trips to the hospital (hospital information unspecified), but she did not specify whether or not she was hospitalized on either occasion. The patient had unspecified esophagus tests and other unspecified tests (results not provided). The outcome of events was reported as not recovered/not resolved. Upon internal review, being so weak and tired that could barely walk, neuropathy in right foot and breathing problems were considered as disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Obstructive airways disorder, Respiration abnormal, Scan abnormal, X-ray abnormal
Clinical narrative: This spontaneous report as received from a female consumer of an unknown age who reporting on herself. In June 2013 reported as mid-June, the patient was vaccinated with ZOSTAVAX, injection in the right arm (route, dose, lot number and exp. date not provided). The patient reported that she had been having several severe side effects after having received ZOSTAVAX. She was being so weak and tired that could barely walk - she went to the hospital on 02-JUL-2013 (it was not reported if the patient was hospitalized). She began to experience neuropathy in her right foot during one of her two hospital visits (also reported as on 02-JUL-2013). Her neuropathy was only in her right foot, and the right side of her body was the injection side (in her right arm). She also had breathing problems from 02-JUL-2013. She could not breathe when laying on her right side. If she accidentally rolled over onto her right side while sleeping, she woke up unable to breathe. Before the onset of these adverse experiences, she reported being very healthy. She reported currently being homebound and on oxygen because of her adverse experiences, for about a month. She had sought treatment from many unspecified physicians, including cardiologists and other specialists and she had been arranged an appointment with a pulmonologist next week. She also spoken with unspecified pharmacists. She made two trips to the hospital (hospital information unspecified), but she did not specify whether or not she was hospitalized on either occasion. The patient had unspecified esophagus tests and other unspecified tests (results not provided). The outcome of events was reported as not recovered/not resolved. Upon internal review, being so weak and tired that could barely walk, neuropathy in right foot and breathing problems were considered as disabling. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Myalgia
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to his friend of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route unknown). The patient experienced chills and myalgia within 24 hours after receiving ZOSTAVAX. These symptoms lasted approximately 1 and 1/2 days. No other adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as reported by a nurse refers to an unspecified number of patients (no demographic information was provided). The nurse reported that a physician's office may possibly have administered VARIVAX (Merck) and M-M-R II that were not stored properly. The nurse was not sure if this was correct information and would investigate. No symptoms were reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 17 year old female patient. In 2010, the patient was vaccinated with the first dose of GARDASIL (lot #, dose and route not reported). On 21-AUG-2013, the patient was vaccinated with the second dose of GARDASIL (lot #, dose and route not reported). No adverse effects were reported). It was unspecified if the patient sought medical attention. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to unspecified number of patients of unknown age. On an unknown date an unspecified number of unspecified patients might have received doses of ZOSTAVAX (lot#, dose and route not reported) that were transported at unspecified temperatures outside of the prescribing information for an unspecified length of time. No adverse effects were reported. It was unspecified if the patient's had sought medical attention. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Agitation, Maternal exposure before pregnancy
Clinical narrative: Information has been received from a 27 year old female patient for VARIVAX (Merck) a Pregnancy Registry product, concerning herself. On 06-AUG-2013 the patient was vaccinated with a dose of VARIVAX (Merck) (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. Approximately on an unknown date in August 2013 (reported as a few days later), the patient learned that she was pregnant (approximately 13 days gestation) with LMP of 08-AUG-2013 and EDD of 15-MAY-2014. The outcome of pregnancy was pending. The patient was not under the care of a physician and was distraught. The patient did not seek any medical attention. No treatment was provided. It was unspecified if any lab tests were performed. Outcome of the event was unknown. The relatedness for distraught was unknown for VARIVAX (Merck). Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash erythematous
Clinical narrative: This spontaneous report was received from a now 75 years old female patient. The patient had no pertinent medical history or drug allergy. In 2007 the patient was vaccinated with ZOSTAVAX, 0.65 ml single injection, subcutaneous. In 2012, "about a year ago", the patient experienced a single, red quarter-sized rash on her face. The patient went to the doctor, who prescribed ZOVIRAX for the rash. The doctor told her she had shingles, based on her clinical experience, but no lab tests were performed. The rash went away about a month later, approximately in 2012. The outcome of event was recovered. 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 healthcare worker who reported that GARDASIL (lot # was unknown) was exposed to 31F for 84 hours over the past two months, which could not be supported. She stated that she was unsure whether any of these doses were administered to patients. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age (gender unspecified). On 23-AUG-2013 the patient was vaccinated with an expired dose of M-M-R II lot # 670080/0402AA, exp. 16-MAR-2013. No adverse effects reported. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash
Clinical narrative: This spontaneous report has been received from a consumer refers to a 59 year old female patient with drug reactions/allergies to penicillin. In July 2012 the patient was vaccinated with  ZOSTAVA (lot # not reported) 1 time vaccine, subcutaneous (dose, strength not reported). The patient had none concomitant medications or pertinent medical history. On 12-AUG-2013, the patient had gotten the shingles after ZOSTAVAX, she developed some spots on her right breast going to her back and rear, this progressed into hives and then the blisters of shingles later, the reporter stated that this was all over her right breast, right side back and hip area. None laboratory diagnosis was performed. No treatment was given for the adverse event. The patient sought unspecified medical attention and was following up with a clinician. The outcome of shingles was unknown. The reporter did not assess the relationship between the therapy with ZOSTAVAX and shingles. Product Quality Complaint (PQC) was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a female patient of unknown age, refers to herself. On 16-AUG-2013 (reported as "had just gotten) the patient was vaccinated with the third dose of GARDASIL (dose, not number and route of administration were not provided). The patient stated that she had just gotten the 3rd shot in the GARDASIL series and now she realized that she was 1.5 months pregnant. The patient did not seek medical attention. The patient became pregnant with last menstrual period (LMP) of approximately 05-JUL-2013 and estimated delivery date (EDD) of 11-APR-2014. Initial exposure to GARDASIL was at approximately 6 weeks (1.5 month). The pregnancy outcome was pending. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site vesicles, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 11-AUG-2013 the patient was vaccinated with ZOSTAVAX, (lot # expiration, dose, route unspecified). On 13-AUG-2013, the patient experienced "redness, pruritus, warm and blister at the injection site, redness, pruritus, warm and blister" at the injection site following the administration of ZOSTAVAX. Pharmacist stated the blister appeared to be a histamine/inflammatory response to the vaccine and did not appear to be shingles related Pharmacist mentioned the patient's blister popped and was now an "open, raw and tender" area. No lab diagnostics studies performed. The patient sought medical attention via contacted pharmacist. CAMPHO-PENIQUE liquid was given for treatment. At the time of report, the event was not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse, refers to a female patient of unknown age. On 27-JUL-2013 the patient was vaccinated with a first dose of GARDASIL (intramuscular , 0.5 ml). The reporter stated that no date was documented in patient's chart for her second dose of GARDASIL and next documented date on patient's chart states that she was administered her third dose of GARDASIL (intramuscular, 0.5 ml) on 06-MAY-2013. Nurse stated that they are unsure if 3 doses of GARDASIL were in fact given to the patient or if only two doses of GARDASIL were given to the patient. No adverse effect reported. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Blood creatinine increased, Blood urea increased, Blood urea nitrogen/creatinine ratio, Cough, Dyspnoea
Clinical narrative: Sudden onset of rhinorrhea, cough, wheezing, SOB s/p vaccination with pneumococcal vaccine. Required O2.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Rhinorrhoea, Wheezing
Clinical narrative: Sudden onset of rhinorrhea, cough, wheezing, SOB s/p vaccination with pneumococcal vaccine. Required O2.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product quality issue, Underdose
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. The pharmacist stated that several times she would only be able to draw up approximately 0.6 mL of reconstituted dose of ZOSTAVAX, injection (route, lot number and exp.date not provided) which would be administered to patients because of foaming issues air bubbles were needed to be pushed out of the needle tip - the reported stated that a small amount of product was loss during this step and therefore a full amount of recommended 0.65 mL dose had not been administered to an unspecified number of unspecified patients. No adverse effect was reported. The outcome of event was unknown. The product quality complaint (PQC) was filed. No further information is available.