chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash vesicular, Skin lesion
Clinical narrative: Developed lesions on (L) hand, wrist, (R) ear, neck, chest, hair 6/17/14. On 6/18/14 (L) ear developed lesions. Looks like chickenpox, itchy - not painful. Contacted PCP who ordered Acyclovir 800mg 5x day x 7 days.
Age: 70.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 70 year old patient. There was no information regarding to medical history/concurrent conditions and concomitant medication. On 12-JUN-2014 the patient was vaccinated with the first dose of (Oka/Merck) VARIVAX lot # J000151, expiry date 07-JAN-2015, 0.5 ml, subcutaneous for chicken pox vaccine which was prescripted from unspecified physician. Pharmacist stated in contacting unspecified physician office for suggesting booster date for (Oka/Merck) VARIVAX, it was discovered ZOSTAVAX was the desired vaccine. No adverse effects reported. The outcome of event was not reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Injection site reaction, Lymphadenopathy, Pain of skin
Clinical narrative: This spontaneous report as received from a pharmacy student refers to a 66 year old female patient with unspecified cholesterol condition. The patient had no drug reaction/allergies. On 09-JUN-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot# reported as J008736 which was not valid for ZOSTAVAX, expiration date 16-JAN-2015, once, subcutaneously in the left arm (dose and strength not reported. Concomitant therapies included simvastatin (manufacture unknown). The pharmacy student stated that the patient who experienced adverse events after receiving ZOSTAVAX injection on 09-JUN-2014. The patient reported to pharmacy student that she developed injection site reaction in left arm, raised and hard bilateral lymph nodes in a swollen neck, and a itchy, red, and sore in the scalp on head since unspecified date (in approximately June 2014). The pharmacy student stated that it was confirmed with the patient over the phone that this scalp was not a rash. The patient did not seek medical attention. The outcome of the events was unknown. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: This spontaneous report as received from a pharmacy student refers to a 66 year old female patient with unspecified cholesterol condition. The patient had no drug reaction/allergies. On 09-JUN-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot# reported as J008736 which was not valid for ZOSTAVAX, expiration date 16-JAN-2015, once, subcutaneously in the left arm (dose and strength not reported. Concomitant therapies included simvastatin (manufacture unknown). The pharmacy student stated that the patient who experienced adverse events after receiving ZOSTAVAX injection on 09-JUN-2014. The patient reported to pharmacy student that she developed injection site reaction in left arm, raised and hard bilateral lymph nodes in a swollen neck, and a itchy, red, and sore in the scalp on head since unspecified date (in approximately June 2014). The pharmacy student stated that it was confirmed with the patient over the phone that this scalp was not a rash. The patient did not seek medical attention. The outcome of the events was unknown. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Erythema, Skin warm
Clinical narrative: PT HAD VERY RED AND SLIGHTY WARM ABOUT 30MM ROUND.
Age: 54.0
Sex: F
Vaccine: DTAP
Symptoms: Arthralgia, Lymph node pain, Lymphadenopathy, X-ray of pelvis and hip
Clinical narrative: Painfully sore joints in hip and back. Painful swollen gland on collarbone.
Age: 7.0
Sex: M
Vaccine: DTAPHEPBIP, MMRV
Symptoms: Headache, Injection site erythema, Injection site rash, Pain in extremity, Pyrexia
Clinical narrative: Complaining of left arm pain(soreness), headache,Fever-102-oral, redness and small bumps at injection site. Taken to ER between 5 and 6PM. Scheduled for follow-up with M.D.on Tuesday, June 24th 2014.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Dyskinesia, Headache, Loss of consciousness, Nausea
Clinical narrative: Syncope: passed out within one minute of administration with body jerking. I help my daughter on the table. It lasted 30 seconds. She had nausea and had diarrhea and headache one hour following the shot.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Syncope: passed out within one minute of administration with body jerking. I help my daughter on the table. It lasted 30 seconds. She had nausea and had diarrhea and headache one hour following the shot.
Age: 1.27
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Non-bloody diarrhea, fever of 105.2.
Age: 0.24
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Erythema, Livedo reticularis, Rash generalised, Rash maculo-papular, Urticaria
Clinical narrative: Developed a rash in body and unusual mottling in lower extremities, consisting of dark pink feet progressing to bright red and dark purple horizontal band mid calf and pink upper thighs.  Bands of differing color were very clearly demarcated. Raised red/pink rash with white centers evenly distributed on bottom of feet.  Red irregular shaped areas about noted on left chest, top of head, in folds of arms and knees. Feet bright red with maculopapular rash.  No respiratory distress; no drooling; child alert.  Epi 0.05ml given IM in Rt anterior thigh @10:44 with agreement of parent. Sent to ER @10:48.  Leaving ER @ 2:30PM and hive appeared on top of head.  Given Dexamethasone 0.5ml.  Had Pediatric follow up appointment on 6/13/14.
Age: 8.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Weight bearing difficulty
Clinical narrative: Pain and swelling around injection site; patient refuses to bear weight on leg.
Age: 49.0
Sex: M
Vaccine: HEP
Symptoms: Fatigue, Injection site pain
Clinical narrative: Soreness at injection site, Fatigue.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt reports the redness started in the evening of 6/17/14. Was getting worst the next day 6/18/2014-increasing redness, pain, swelling,warmth from left elbow to left shoulder. Pt was seen 6/18 by Dr. and was started on antibiotics.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Diarrhoea, Injection site rash, Vomiting
Clinical narrative: Rash at injection site. Then the next day vomiting and diarrhea all day.
Age: 60.0
Sex: M
Vaccine: PNC13
Symptoms: Dysgeusia, Hypoaesthesia oral, Immediate post-injection reaction, Paraesthesia oral
Clinical narrative: Immediately after injection, pt noted salty taste in mouth. This subsided but pt also reported numbness/tingling of tongue - tip -> 1/3. Denied SOB, swelling, difficulty swallowing. Pt followed x24 hrs - sx minimally subsided; not complete resolution.
Sex: U
Vaccine: MMR
Symptoms: Meningitis
Clinical narrative: This literature market report was received from an author. Abstract: Studies assessing the economic burden of a mumps outbreak in a highly vaccinated population are limited. A mumps investigation was conducted in an affected village with a highly vaccinated population. To understand the epidemiology, standardized mumps case definition and active surveillance were used to identify mumps cases. In addition, an economic assessment of a combined outbreak investigation and third dose MMR vaccine intervention was performed; estimated by retrospectively evaluating public health response-related activities including use of a third dose of MMR vaccine. From 24-SEP-2009 through 15-JUN-2010, 790 mumps cases were reported-64% were male and highest attack rate was among 11-17 year age group (99.1 cases per 1000 individuals). Of the 658 cases with known vaccination history, 83.6% had documentation of 2 doses of mumps containing vaccine. No deaths were reported. The 2 major exposure settings were schools (71.8%) and households (22.5%). Mumps cases were classified according to the 2008 mumps definition of the Council of State and Territorial Epidemiologists (CSTE). A clinical case was defined as an illness with acute onset of the parotitis, lasting at least 2 days, and without other apparent cause. Clinically compatible illness was defined as that which may present as aseptic meningitis, encephalitis, hearing loss, orchitis, oophoritis, parotitis, or other salivary gland swelling, mastitis or pancreatitis. Laboratory confirmation included isolation of mumps virus from clinical specimen, or detection of mumps nucleic acid, or detection of mumps IgM antibody, or demonstrated of a 4-fold increase in mumps IgG antibody titer. Mumps cases were then classified epidemiologically. A probable case was defined as that which meets the clinical case definition without confirmation and was epidemiologically linked to a clinically compatible case. A confirmed case was defined as a case that met the clinical case definition or had clinically compatible illness, and was either laboratory confirmed or was epidemiologically linked to a confirmed case. This report refers to a patient of unknown age and gender who had 2 documented dose of measles, mumps, and rubella virus vaccine, live (manufacturer unknown) (dose, route and lot # were not reported). On an unknown date the patient developed meningitis. The outcome of meningitis is unknown. The reporter considered meningitis to be related to Measles, Mumps, and Rubella Virus Vaccine, Live (manufacturer unknown). Upon internal view, meningitis was considered to be medically significant. This is one of the several reports with literature linked. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Tendonitis
Clinical narrative: This spontaneous report as received from a nurse refers to a currently 51 year old female patient. There was none pertinent medical history and drug reactions or allergies. On 16-MAY-2014 the patient was vaccinated with PNEUMOVAX 23 lot # J010396, expiration date: 16-FEB-2015, 1 single shot, subcutaneous for the prevention of pneumococcal disease (strength, dose and dose number were not reported). There were no concomitant medications. On an unknown date in 2014, after receiving PNEUMOVAX 23, the patient developed bicipital tendonitis. The patient sought medical attention. No treatment was given for the adverse event. No laboratory diagnostic studies were performed. The outcome of bicipital tendonitis was reported as recovering. The causality between PNEUNOMOVAX 23 and the bicipital tendonitis was not reported. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Musculoskeletal stiffness, Staring
Clinical narrative: Staring episode, then stiffness and numbness (L) hand.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of VARIVAX (Merck) (route, lot # and expiration date were not provided). On an unknown date, an unspecified number of patients received VARIVAX (Merck) exposed to minus 14 degrees C for 6 hours. No adverse symptoms were reported. At the time of the report, the patients' status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of PROQUAD (route lot # and expiration date were not provided). On an unknown date, an unspecified number of patients received PROQUAD exposed to minus 14 degrees C for 6 hours. No adverse symptoms were reported. At the time of the report, the patients' status was unknown. This is one of several reports received from the same source. 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 registered nurse refers to an unspecified patients of unknown age and gender. On an unknown date 5 doses of GARDASIL (dose, route of administration, LOT# and expiration date were not provided) all of which reached the temperature outside the product information, have been administered to unspecified patients. The temperature was supported. No adverse effects were reported. This is one of several reports from the same source (MARRS# 1406USA008284, 1406USA008285, 1406USA007026). Additional information has been requested.
Sex: F
Vaccine: MMR, MMR
Symptoms: Antibody test negative, Headache, Measles, Measles antibody positive, Morbillivirus test positive
Clinical narrative: This spontaneous report as received from a physician refers to a mid 20's female patient. On an unspecified date, when the patient was a child the patient received MMR II. On 08-MAY-2014, the patient showed negative titers. As a result the patient received on 21-MAY-2014 a dose of MMR II for vaccination. On 08-JUN-2014 the patient experienced pain in the right jaw (parotitis) and headache. The reporter stated that the patient had a buckle swab completed on 09-JUN-2014 which showed positive for an active measles infection. The patient did not received treatment for the adverse event. The outcome of showed negative titers, headache, showed positive for an active measles infection and pain in the right jaw (parotitis) was unknown. Additional information has been requested.
Sex: F
Vaccine: MMR, MMR
Symptoms: Pain in jaw, Parotitis
Clinical narrative: This spontaneous report as received from a physician refers to a mid 20's female patient. On an unspecified date, when the patient was a child the patient received MMR II. On 08-MAY-2014, the patient showed negative titers. As a result the patient received on 21-MAY-2014 a dose of MMR II for vaccination. On 08-JUN-2014 the patient experienced pain in the right jaw (parotitis) and headache. The reporter stated that the patient had a buckle swab completed on 09-JUN-2014 which showed positive for an active measles infection. The patient did not received treatment for the adverse event. The outcome of showed negative titers, headache, showed positive for an active measles infection and pain in the right jaw (parotitis) was unknown. Additional information has been requested.
Sex: F
Vaccine: MMR, MMR
Symptoms: Parotitis, Polymerase chain reaction, Rubulavirus test positive
Clinical narrative: This spontaneous report as received from a physician refers to a mid 20's female patient. On an unspecified date, when the patient was a child the patient received MMR II. On 08-MAY-2014, the patient showed negative titers. As a result the patient received on 21-MAY-2014 a dose of MMR II for vaccination. On 08-JUN-2014 the patient experienced pain in the right jaw (parotitis) and headache. The reporter stated that the patient had a buckle swab completed on 09-JUN-2014 which showed positive for an active measles infection. The patient did not received treatment for the adverse event. The outcome of showed negative titers, headache, showed positive for an active measles infection and pain in the right jaw (parotitis) was unknown. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Local swelling, Pain
Clinical narrative: Swelling from shoulder to base of triceps, very red, and painful to touch. Circled redness noted measured swollen area 4.5 inches top to bottom 2.25 inches side to side.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Pain, Urticaria
Clinical narrative: Generalized achiness overnight and covered with hives over face, trunk, shoulders and legs.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to an unknown age and gender patient. Medical history was not reported. On 16-JUN-2014 the patient was vaccinated with the fourth dose of GARDASIL injection, lot number, strength, and route were not provided. Concomitant therapy was not reported. The pharmacist informed that on 16-JUN-2014, the patient received an extra, fourth dose of GARDASIL inadvertently. No adverse effects were reported. The outcome of the event was unknown. Additional information has been requested.
Age: 24.0
Sex: M
Vaccine: RAB
Symptoms: Rash
Clinical narrative: Palmar rash- both hands.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 18-JUN-2014 the patient was vaccinated with an expired dose of ZOSTAVAX 19400PFU (lot # H021710, expiration date 07-MAR-2014, dose, route, indication not reported). No adverse effect had been observed or reported. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site rash, Injection site vesicles
Clinical narrative: The day after the patient had the Varicella vaccine she developed painful red rash with blistering to (R) upper arm around site of injection. Seen at Urgent Care for treatment on 6/9/14 - started on clindamycin. Dx. with "cellulitis".
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients. On 10-JUN-2014, an unspecified number of patients were administered PROQUAD (lot#, expiration date, dose, route and indication not reported that were exposed to improperly stored temperatures outside the product insert. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to 4 patients of unknown age and gender. on an unknown date the patients were vaccinated with (Oka/Merck) VARIVAX, 0.5 ml, subcutaneous. No other concomitant therapies reported. On an unknown date the nurse reported that 4 patients each received a dose of (Oka/Merck) VARIVAX that had been exposed to temperatures warmer than the recommended temperatures in the prescribing information (18.1F 22.3F during daily defrost cycles). No adverse effect reported. The outcome of the event was unknown. The causality of the events was unspecified. No PQC involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Cardiac disorder
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On 20-JUN-2012, the patient was vaccinated with the first dose of RECOMBIVAX HB, 2.5/0.5, injection (lot number not provided). On 20-JUL-2012, the patient was vaccinated with the second dose of RECOMBIVAX HB, 2.5/0.5, injection (lot number not provided). On an unspecified date, the physician (unspecified) discontinued the third dose of RECOMBIVAX HB because the patient was having unspecified cardiac issues. The reporter stated that the physician would now like to have the patient receive the third dose. At the time of the report, it was unknown if the patient received the third dose of RECOMBIVAX HB. The causal relationship between RECOMBIVAX HB and the event was unknown. The outcome of the event was unknown. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: TDAP
Symptoms: Electroneuromyography, Sensory disturbance
Clinical narrative: Tickling of both hand fingers - started 10 days after getting Tdap vaccine. Saw neurologist EMG done - normal.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Fainted after 10 minutes of the vaccine. Patient laid down until she felt better. The doctor took her blood pressure and it was WNL.
Age: 16.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Erythema, Induration, Skin warm, Tenderness
Clinical narrative: Pt c/o (L) arm feeling "hard" on the day the vaccines were administered (after receiving the vaccines). The next day (6/18) the arm was red. Today c/o tenderness, redness, and warmth of (L) arm. Started cefadroxil antibiotic today.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mild erythema, mild swelling on (R) deltoid. Advised ice, BENADRYL r/o ibuprofen.
Age: 40.0
Sex: F
Vaccine: VARCEL
Symptoms: Corneal abrasion, Herpes ophthalmic, Herpes virus infection
Clinical narrative: Received VARIVAX 4/4/14. Diagnosed with a secondary herpetic infection of the eye in the area of a previous corneal abrasion 6/18/14.
Age: 29.0
Sex: M
Vaccine: JEV1, TYP, YF
Symptoms: Loss of consciousness
Clinical narrative: Passed out right after the last shot. Unconscious for a very short period - less than 5 seconds. BP=116/65 mmHg, T 98.1 degrees F, HR=67 bpm, RR=13 cycles.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mild erythema and swelling on (R) deltoid. Advised ice, can try BENADRYL and ibuprofen.
Age: 13.0
Sex: M
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Redness and induration noted to where varicella and meningococcal vaccine was given. Area warm to the touch. No trouble breathing, SOB or other systemic reactions noted.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Mass, Mobility decreased, Musculoskeletal pain, Periarthritis, X-ray limb
Clinical narrative: Frozen shoulder, couldn't lift arm up past 45 degree angle. Lump on collar bone. Deep aching shoulder pain constantly even at night.
Age: 19.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, VARCEL
Symptoms: Dizziness, Injection site erythema, Injection site irritation, Injection site pain, Injection site vesicles
Clinical narrative: Observed reddened area with small blisters at injection site. Patient states area is tender, irritated feeling and she has experienced periodic feeling of being light-headed and nauseated.
Age: 19.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, VARCEL
Symptoms: Nausea
Clinical narrative: Observed reddened area with small blisters at injection site. Patient states area is tender, irritated feeling and she has experienced periodic feeling of being light-headed and nauseated.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Back pain, Chills, Exposure during pregnancy, Feeling abnormal
Clinical narrative: I went to bed with my arm feeling extremely achy. I woke up a few hours later with a terrible stomach ache, the chills (probably had a fever), and redness/slight swelling in the arm where the shot was received. I also felt achy in my back & neck & shoulder.  I took some Tylenol which helped with the aches & fever. It's now noon on 6/19 and I'm still feeling pretty miserable.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: I went to bed with my arm feeling extremely achy. I woke up a few hours later with a terrible stomach ache, the chills (probably had a fever), and redness/slight swelling in the arm where the shot was received. I also felt achy in my back & neck & shoulder.  I took some Tylenol which helped with the aches & fever. It's now noon on 6/19 and I'm still feeling pretty miserable.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: I went to bed with my arm feeling extremely achy. I woke up a few hours later with a terrible stomach ache, the chills (probably had a fever), and redness/slight swelling in the arm where the shot was received. I also felt achy in my back & neck & shoulder.  I took some Tylenol which helped with the aches & fever. It's now noon on 6/19 and I'm still feeling pretty miserable.
Age: 1.0
Sex: M
Vaccine: MMR, PPV, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever x 48 hours to 102 degrees.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling 5cm x 8cm descending from injection site.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Pain
Clinical narrative: Pain and dark bruises lasting for over 1 week.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4, FLU3, HPV4
Symptoms: Fall, Head injury, Immediate post-injection reaction, Syncope, Tooth loss
Clinical narrative: This spontaneous report as received from a physician refers to a 14 year old female patient. On 19-NOV-2010, the patient was vaccinated with the first dose of GARDASIL (dose, route and lot # not reported) and a dose of influenza virus vaccine (manufacturer unknown) dose, route and lot # not reported). The physician reported that on 19-NOV-2010, the patient experienced a fainting episode, immediately following the GARDASIL administration. The physician reported that the patient hit her head during the fall and knocked out one of her teeth. The patient did not receive treatment for the adverse events. At the time of the report, the patient's outcome was unknown. Follow up information has been received from a physician on 18-JUN-2014. Regarding to a 14 year old female patient. None illness at the time of vaccination, the patient did not suffer any adverse event following prior vaccination and there was not preexisting allergies, birth defects or medical conditions. 19-NOV-2010 at 16:15 hours, the patient was vaccinated with the first dose of GARDASIL lot number 12312 on her left arm (dosage and route were not reported) and a dose of AFLURIA (Lot number KT3775BA) dosage and route were not reported. The physician stated that on 19-NOV-2010 at 16:15 the patient apparently saw blood on her arms when she removed the gauze, got dizzy and passed out hitting her head on the window sill next to their exit door. Patient's mother was standing at the window checking out when she went down. She regained consciousness immediately and was taken care of immediately by the medical assistant. The physician was called and observed that the patient was awake alert and pupils were equal and reactive to light. She had a laceration on her forehead measuring about 2 cm in length that was cleansed and steri-strips were applied. She also had a laceration on her upper lip measuring about 1 cm length that was cleansed and steri-strips were applied. When she felt she hit her mouth and knocked out her upper left front tooth. The tooth was held in place by her braces. She also had blood in her mouth but airways was opened and the bleeding stopped. The physician also stated that the assisted the patient to her mother's vehicle where she was secured in a seatbelt and her mother took her to emergency room while the physician called to the emergency room to notify them that the patient was on her way. The outcome of blood in her mouth was recovered while the outcome of the other events was unknown. Upon internal review, loss of consciousness was determined to be medically significant. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4, FLU3, HPV4
Symptoms: Dizziness, Fall, Haemorrhage, Head injury, Immediate post-injection reaction
Clinical narrative: This spontaneous report as received from a physician refers to a 14 year old female patient. On 19-NOV-2010, the patient was vaccinated with the first dose of GARDASIL (dose, route and lot # not reported) and a dose of influenza virus vaccine (manufacturer unknown) dose, route and lot # not reported). The physician reported that on 19-NOV-2010, the patient experienced a fainting episode, immediately following the GARDASIL administration. The physician reported that the patient hit her head during the fall and knocked out one of her teeth. The patient did not receive treatment for the adverse events. At the time of the report, the patient's outcome was unknown. Follow up information has been received from a physician on 18-JUN-2014. Regarding to a 14 year old female patient. None illness at the time of vaccination, the patient did not suffer any adverse event following prior vaccination and there was not preexisting allergies, birth defects or medical conditions. 19-NOV-2010 at 16:15 hours, the patient was vaccinated with the first dose of GARDASIL lot number 12312 on her left arm (dosage and route were not reported) and a dose of AFLURIA (Lot number KT3775BA) dosage and route were not reported. The physician stated that on 19-NOV-2010 at 16:15 the patient apparently saw blood on her arms when she removed the gauze, got dizzy and passed out hitting her head on the window sill next to their exit door. Patient's mother was standing at the window checking out when she went down. She regained consciousness immediately and was taken care of immediately by the medical assistant. The physician was called and observed that the patient was awake alert and pupils were equal and reactive to light. She had a laceration on her forehead measuring about 2 cm in length that was cleansed and steri-strips were applied. She also had a laceration on her upper lip measuring about 1 cm length that was cleansed and steri-strips were applied. When she felt she hit her mouth and knocked out her upper left front tooth. The tooth was held in place by her braces. She also had blood in her mouth but airways was opened and the bleeding stopped. The physician also stated that the assisted the patient to her mother's vehicle where she was secured in a seatbelt and her mother took her to emergency room while the physician called to the emergency room to notify them that the patient was on her way. The outcome of blood in her mouth was recovered while the outcome of the other events was unknown. Upon internal review, loss of consciousness was determined to be medically significant. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4, FLU3, HPV4
Symptoms: Laceration, Lip injury, Loss of consciousness, Mouth haemorrhage, Syncope
Clinical narrative: This spontaneous report as received from a physician refers to a 14 year old female patient. On 19-NOV-2010, the patient was vaccinated with the first dose of GARDASIL (dose, route and lot # not reported) and a dose of influenza virus vaccine (manufacturer unknown) dose, route and lot # not reported). The physician reported that on 19-NOV-2010, the patient experienced a fainting episode, immediately following the GARDASIL administration. The physician reported that the patient hit her head during the fall and knocked out one of her teeth. The patient did not receive treatment for the adverse events. At the time of the report, the patient's outcome was unknown. Follow up information has been received from a physician on 18-JUN-2014. Regarding to a 14 year old female patient. None illness at the time of vaccination, the patient did not suffer any adverse event following prior vaccination and there was not preexisting allergies, birth defects or medical conditions. 19-NOV-2010 at 16:15 hours, the patient was vaccinated with the first dose of GARDASIL lot number 12312 on her left arm (dosage and route were not reported) and a dose of AFLURIA (Lot number KT3775BA) dosage and route were not reported. The physician stated that on 19-NOV-2010 at 16:15 the patient apparently saw blood on her arms when she removed the gauze, got dizzy and passed out hitting her head on the window sill next to their exit door. Patient's mother was standing at the window checking out when she went down. She regained consciousness immediately and was taken care of immediately by the medical assistant. The physician was called and observed that the patient was awake alert and pupils were equal and reactive to light. She had a laceration on her forehead measuring about 2 cm in length that was cleansed and steri-strips were applied. She also had a laceration on her upper lip measuring about 1 cm length that was cleansed and steri-strips were applied. When she felt she hit her mouth and knocked out her upper left front tooth. The tooth was held in place by her braces. She also had blood in her mouth but airways was opened and the bleeding stopped. The physician also stated that the assisted the patient to her mother's vehicle where she was secured in a seatbelt and her mother took her to emergency room while the physician called to the emergency room to notify them that the patient was on her way. The outcome of blood in her mouth was recovered while the outcome of the other events was unknown. Upon internal review, loss of consciousness was determined to be medically significant. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4, FLU3, HPV4
Symptoms: Tooth loss
Clinical narrative: This spontaneous report as received from a physician refers to a 14 year old female patient. On 19-NOV-2010, the patient was vaccinated with the first dose of GARDASIL (dose, route and lot # not reported) and a dose of influenza virus vaccine (manufacturer unknown) dose, route and lot # not reported). The physician reported that on 19-NOV-2010, the patient experienced a fainting episode, immediately following the GARDASIL administration. The physician reported that the patient hit her head during the fall and knocked out one of her teeth. The patient did not receive treatment for the adverse events. At the time of the report, the patient's outcome was unknown. Follow up information has been received from a physician on 18-JUN-2014. Regarding to a 14 year old female patient. None illness at the time of vaccination, the patient did not suffer any adverse event following prior vaccination and there was not preexisting allergies, birth defects or medical conditions. 19-NOV-2010 at 16:15 hours, the patient was vaccinated with the first dose of GARDASIL lot number 12312 on her left arm (dosage and route were not reported) and a dose of AFLURIA (Lot number KT3775BA) dosage and route were not reported. The physician stated that on 19-NOV-2010 at 16:15 the patient apparently saw blood on her arms when she removed the gauze, got dizzy and passed out hitting her head on the window sill next to their exit door. Patient's mother was standing at the window checking out when she went down. She regained consciousness immediately and was taken care of immediately by the medical assistant. The physician was called and observed that the patient was awake alert and pupils were equal and reactive to light. She had a laceration on her forehead measuring about 2 cm in length that was cleansed and steri-strips were applied. She also had a laceration on her upper lip measuring about 1 cm length that was cleansed and steri-strips were applied. When she felt she hit her mouth and knocked out her upper left front tooth. The tooth was held in place by her braces. She also had blood in her mouth but airways was opened and the bleeding stopped. The physician also stated that the assisted the patient to her mother's vehicle where she was secured in a seatbelt and her mother took her to emergency room while the physician called to the emergency room to notify them that the patient was on her way. The outcome of blood in her mouth was recovered while the outcome of the other events was unknown. Upon internal review, loss of consciousness was determined to be medically significant. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: HEPA, VARZOS, HEPA, VARZOS
Symptoms: Back pain, Breast pain, Headache, Herpes zoster, Influenza like illness
Clinical narrative: This spontaneous report as received from a 56 year old female patient refers to herself. No concurrent conditions or medical history were provided. On 06-JUN-2014, the patient was vaccinated (at an Health Department by a nurse) with a dose of ZOSTAVAX. 1 subcutaneous injection (dose, lot#, expiry date unspecified). Other suspect therapies included an unspecified hepatitis A vaccine (manufacturer unknown) given with ZOSTAVAX. No concomitant medications were reported. On 07-JUN-2014, the patient had a gradual onset of feeling like she was coming down with the flu. Her symptoms included chills, fevers, and achiness and she was having trouble sleeping. The patient stated that initially her back was hurting and then she noticed a rash under and on top of her left breast, and on her back. Her rash was primarily on her left side. Over the last few days (since 07-JUN-2014) she was experiencing a high degree of pain where she had the rash. The consumer reported visiting her physician (demographics unspecified) on an unknown date and her physician diagnosed her with Shingles. The physician prescribed the consumer acyclovir (manufacturer, dose and frequency unspecified) as a treatment. The adverse event did not improve.  The outcome of events was reported as not recovered. The relatedness between event and ZOSTAVAX or hepatitis A vaccine (manufacturer unknown) was not reported. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: HEPA, VARZOS, HEPA, VARZOS
Symptoms: Malaise, Musculoskeletal pain, Rash
Clinical narrative: This spontaneous report as received from a 56 year old female patient refers to herself. No concurrent conditions or medical history were provided. On 06-JUN-2014, the patient was vaccinated (at an Health Department by a nurse) with a dose of ZOSTAVAX. 1 subcutaneous injection (dose, lot#, expiry date unspecified). Other suspect therapies included an unspecified hepatitis A vaccine (manufacturer unknown) given with ZOSTAVAX. No concomitant medications were reported. On 07-JUN-2014, the patient had a gradual onset of feeling like she was coming down with the flu. Her symptoms included chills, fevers, and achiness and she was having trouble sleeping. The patient stated that initially her back was hurting and then she noticed a rash under and on top of her left breast, and on her back. Her rash was primarily on her left side. Over the last few days (since 07-JUN-2014) she was experiencing a high degree of pain where she had the rash. The consumer reported visiting her physician (demographics unspecified) on an unknown date and her physician diagnosed her with Shingles. The physician prescribed the consumer acyclovir (manufacturer, dose and frequency unspecified) as a treatment. The adverse event did not improve.  The outcome of events was reported as not recovered. The relatedness between event and ZOSTAVAX or hepatitis A vaccine (manufacturer unknown) was not reported. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: HEPA, VARZOS, HEPA, VARZOS
Symptoms: Back pain, Chills, Herpes zoster, Influenza like illness, Insomnia
Clinical narrative: This spontaneous report as received from a 56 year old female patient refers to herself. No concurrent conditions or medical history were provided. On 06-JUN-2014, the patient was vaccinated (at an Health Department by a nurse) with a dose of ZOSTAVAX. 1 subcutaneous injection (dose, lot#, expiry date unspecified). Other suspect therapies included an unspecified hepatitis A vaccine (manufacturer unknown) given with ZOSTAVAX. No concomitant medications were reported. On 07-JUN-2014, the patient had a gradual onset of feeling like she was coming down with the flu. Her symptoms included chills, fevers, and achiness and she was having trouble sleeping. The patient stated that initially her back was hurting and then she noticed a rash under and on top of her left breast, and on her back. Her rash was primarily on her left side. Over the last few days (since 07-JUN-2014) she was experiencing a high degree of pain where she had the rash. The consumer reported visiting her physician (demographics unspecified) on an unknown date and her physician diagnosed her with Shingles. The physician prescribed the consumer acyclovir (manufacturer, dose and frequency unspecified) as a treatment. The adverse event did not improve.  The outcome of events was reported as not recovered. The relatedness between event and ZOSTAVAX or hepatitis A vaccine (manufacturer unknown) was not reported. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: HEPA, VARZOS, HEPA, VARZOS
Symptoms: Pain, Pyrexia, Rash
Clinical narrative: This spontaneous report as received from a 56 year old female patient refers to herself. No concurrent conditions or medical history were provided. On 06-JUN-2014, the patient was vaccinated (at an Health Department by a nurse) with a dose of ZOSTAVAX. 1 subcutaneous injection (dose, lot#, expiry date unspecified). Other suspect therapies included an unspecified hepatitis A vaccine (manufacturer unknown) given with ZOSTAVAX. No concomitant medications were reported. On 07-JUN-2014, the patient had a gradual onset of feeling like she was coming down with the flu. Her symptoms included chills, fevers, and achiness and she was having trouble sleeping. The patient stated that initially her back was hurting and then she noticed a rash under and on top of her left breast, and on her back. Her rash was primarily on her left side. Over the last few days (since 07-JUN-2014) she was experiencing a high degree of pain where she had the rash. The consumer reported visiting her physician (demographics unspecified) on an unknown date and her physician diagnosed her with Shingles. The physician prescribed the consumer acyclovir (manufacturer, dose and frequency unspecified) as a treatment. The adverse event did not improve.  The outcome of events was reported as not recovered. The relatedness between event and ZOSTAVAX or hepatitis A vaccine (manufacturer unknown) was not reported. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Headache, Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt states appx. 30 hrs after immunization with the Shingles vaccine he had a 10/10 headache, redness and swelling at injection site and an "explosion" of pain with any movement of his arm. Pt states it feels like a "nerve flare" in his arm. I spoke with the patient today who states both headache and arm pain have improved substantially since yesterday but we did call our Consulting Nurse Service on 06/16/14 and was seen by his PCP on the same day for his headache/arm pain/vaccine reaction. It may be noteworthy to include the patient had taken Acyclovir starting on 05/12/14 daily for 7days.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling, Pain, Pain in extremity
Clinical narrative: Pt states appx. 30 hrs after immunization with the Shingles vaccine he had a 10/10 headache, redness and swelling at injection site and an "explosion" of pain with any movement of his arm. Pt states it feels like a "nerve flare" in his arm. I spoke with the patient today who states both headache and arm pain have improved substantially since yesterday but we did call our Consulting Nurse Service on 06/16/14 and was seen by his PCP on the same day for his headache/arm pain/vaccine reaction. It may be noteworthy to include the patient had taken Acyclovir starting on 05/12/14 daily for 7days.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Burning sensation, Contusion, Injection site pain, Pain
Clinical narrative: Pt states appx. 30 hrs after immunization with the Shingles vaccine he had a 10/10 headache, redness and swelling at injection site and an "explosion" of pain with any movement of his arm. Pt states it feels like a "nerve flare" in his arm. I spoke with the patient today who states both headache and arm pain have improved substantially since yesterday but we did call our Consulting Nurse Service on 06/16/14 and was seen by his PCP on the same day for his headache/arm pain/vaccine reaction. It may be noteworthy to include the patient had taken Acyclovir starting on 05/12/14 daily for 7days.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain in extremity, Skin discolouration, Tenderness
Clinical narrative: Pt states appx. 30 hrs after immunization with the Shingles vaccine he had a 10/10 headache, redness and swelling at injection site and an "explosion" of pain with any movement of his arm. Pt states it feels like a "nerve flare" in his arm. I spoke with the patient today who states both headache and arm pain have improved substantially since yesterday but we did call our Consulting Nurse Service on 06/16/14 and was seen by his PCP on the same day for his headache/arm pain/vaccine reaction. It may be noteworthy to include the patient had taken Acyclovir starting on 05/12/14 daily for 7days.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site reaction, Muscular weakness
Clinical narrative: Right Shoulder area (same right shoulder where Shingles Vaccine was administered Aug 8, 2013) muscles and joint felt as though the shoulder was dislocating, when shoulder was in a resting position. Onset was while patient was sitting in a meeting August 13, 2013.  Patient called Primary Care Physician within 2 hours of onset to ask if this would be expected side effect from recent Shingles Vacination, or if other patients who had recent Shingles Vaccine had similiar side effect. Patent saw Dr that afternoon (Aug 13, 2013). Subsequent weakness in right leg and continued problem in right shoulder persisting at least 1 year to present (June 20, 2014)
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain, Insomnia
Clinical narrative: This spontaneous report as received from a physician and a nurse via a company representative refers to a 56 year old female patient. Concomitant medication and pertinent medical history were not provided. On 04-JUN-2014 the patient was vaccinated with PNEUMOVAX 23 (injection, lot # J011998, expiration date 12-FEB-2015, 1 shot, dose and route were unspecified). The injection was given above the normal injection site area, in the shoulder joint. On 04-JUN-2014, "within an hour or two" of receiving PNEUMOVAX 23, the patient had extreme pain in the injection arm. The patient experienced loss of movement in the right (injection) arm; she could not lift the limb and the pain gradually increased to where she couldn't sleep, movement was painful, and there was obvious swelling and a tingling and burning sensation up and down the arm. In addition, the patient had a fever of 102F-103F. The patient went to urgent care for medical attention and was put on an unspecified "prednisone pack" (manufacture unknown) (dose, route and frequency were not provided) for 6 days. When the pack was removed, the pain and fever returned. No lab diagnostics studies were performed. The outcome of the events was reported as not recovered. Causality assessment was not provided by the reporter. The reporter considered the adverse events resulted in significant disability and incapacity. Additional information has been requested.