chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Gait disturbance, Headache, Hyperaesthesia, Memory impairment, Muscular weakness
Clinical narrative: (2:00 AM) On about 2/9/10, I woke up paralyzed from the waist down. My legs were ice cold to the touch, and a strange sensation was ascending my body. I called out for help but no one could hear me. In 3-4 hours, my legs began to warm and a pins and needles sensation began. Tingling began and continues to date. My legs regained movement by mid morning. A friend took me to my doctor and a nurse practitioner did not consider my explanation of what happened to be serious. Over succeeding weeks I lost bladder and bowel function. My left eye experienced vision loss, blurry sight, double images, and chronic infection. My speech changed. First I experienced hoarseness, then slurring, and loss of volume. From the morning of onset I have had extreme pain in my lower back, radiating down both legs. My legs and arms became weak and continue to be weak. I fell easily and often. I have developed pressure headaches, I started walking with a strange gait and could not climb stairs without assistance. I had heightened senses and extreme pain when touched. I experienced tremors in my arms and legs. It is extremely painful to sit. I developed balance problems. I could not get out of bed without help. It is challenging to walk. I can no longer do many things I once did easily (i.e. dressing, cooking my meals). I have cognitive problems. I cannot express myself at times and I have difficulty with short term memory. I have difficulty using my hands. I once had beautiful penmanship.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity, Paraesthesia, Paralysis, Peripheral coldness
Clinical narrative: (2:00 AM) On about 2/9/10, I woke up paralyzed from the waist down. My legs were ice cold to the touch, and a strange sensation was ascending my body. I called out for help but no one could hear me. In 3-4 hours, my legs began to warm and a pins and needles sensation began. Tingling began and continues to date. My legs regained movement by mid morning. A friend took me to my doctor and a nurse practitioner did not consider my explanation of what happened to be serious. Over succeeding weeks I lost bladder and bowel function. My left eye experienced vision loss, blurry sight, double images, and chronic infection. My speech changed. First I experienced hoarseness, then slurring, and loss of volume. From the morning of onset I have had extreme pain in my lower back, radiating down both legs. My legs and arms became weak and continue to be weak. I fell easily and often. I have developed pressure headaches, I started walking with a strange gait and could not climb stairs without assistance. I had heightened senses and extreme pain when touched. I experienced tremors in my arms and legs. It is extremely painful to sit. I developed balance problems. I could not get out of bed without help. It is challenging to walk. I can no longer do many things I once did easily (i.e. dressing, cooking my meals). I have cognitive problems. I cannot express myself at times and I have difficulty with short term memory. I have difficulty using my hands. I once had beautiful penmanship.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Sensory disturbance, Speech disorder, Tremor, Urodynamics measurement, Vision blurred
Clinical narrative: (2:00 AM) On about 2/9/10, I woke up paralyzed from the waist down. My legs were ice cold to the touch, and a strange sensation was ascending my body. I called out for help but no one could hear me. In 3-4 hours, my legs began to warm and a pins and needles sensation began. Tingling began and continues to date. My legs regained movement by mid morning. A friend took me to my doctor and a nurse practitioner did not consider my explanation of what happened to be serious. Over succeeding weeks I lost bladder and bowel function. My left eye experienced vision loss, blurry sight, double images, and chronic infection. My speech changed. First I experienced hoarseness, then slurring, and loss of volume. From the morning of onset I have had extreme pain in my lower back, radiating down both legs. My legs and arms became weak and continue to be weak. I fell easily and often. I have developed pressure headaches, I started walking with a strange gait and could not climb stairs without assistance. I had heightened senses and extreme pain when touched. I experienced tremors in my arms and legs. It is extremely painful to sit. I developed balance problems. I could not get out of bed without help. It is challenging to walk. I can no longer do many things I once did easily (i.e. dressing, cooking my meals). I have cognitive problems. I cannot express myself at times and I have difficulty with short term memory. I have difficulty using my hands. I once had beautiful penmanship.
Age: 11.0
Sex: M
Vaccine: FLUN3, HPV4, MNQ, TDAP
Symptoms: Injection site urticaria
Clinical narrative: Client returned to the IZ clinic around 15:10 with MOC, approximately 1-hour after receiving the following vaccines: Tdap, MCV4, HPV4, and Flumist. Client presented with 2 visible hives in the RUE (site where HPV4 was administered)  1 on forearm and one on wrist; client denied shortness of breath, trouble breathing, swelling of tongue or throat. Client was given one 25mg Benadryl tablet while in clinic. MOC educated to immediately take client to the ED if any breathing difficulties such as swelling of tongue or throat or SOB present.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site inflammation, Pain, Urticaria
Clinical narrative: Large inflammation at injection site and started getting pain and welts under rib cage. Pain and increased welts under rib cage have continued for 2 days so far. Dr. diagnosis is Shingles.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Soreness, swelling, redness, and heat at injection site.
Age: 1.15
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: The child developed a 40 mm reddened area and a 15 mm - swollen area at the injection site of MMR vaccine w/i 5 min of administration.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Pityriasis rosea, Rash, Skin exfoliation
Clinical narrative: Onset of rash 4/17/13. Scaly. Began over right shoulder. Seen today 4/24/13 and diagnosed by pityriasis rosea. Began triamcinolone cream.
Age: 56.0
Sex: F
Vaccine: VARCEL
Symptoms: Influenza like illness, Injection site erythema, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: This spontaneous report was received from a 57 year old registered nurse (who is also a patient) regarding herself. The patient has Hashimoto's disease. The patient had a past reaction consisted of hives and swelling lymph nodes after taking LEVAQUIN. On an unknown date in 1998 (reported as 15 years ago) the patient was vaccinated with the first dose of (oka-merck) VARIVAX, (lot number, expiry date was not reported, route was subcutaneous). On 18-APR-2013 the patient was vaccinated with second dose of (oka-merck) VARIVAX, (lot number, expiry date was not reported, route was subcutaneous). Concomitant therapies included SYNTHYROID. On 18-APR-2013, the patient developed redness and swelling about the size of a half dollar at the injection site after receiving the second dose of (oka-merck) VARIVAX. The site was painful, hard and hot. She also developed flu like symptoms. She has gotten better now and only has a small lump on the injection site. She did not have any reaction when she received the first dose of (oka-merck) VARIVAX. She had to get the second dose since the recent test showed negative titer. The patient was treated with ADVIL and fluids. There were no laboratory tests performed. The outcome of the reported events were reported as recovering. The patient did not seek medical attention. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site swelling, Injection site warmth, Viral test negative
Clinical narrative: This spontaneous report was received from a 57 year old registered nurse (who is also a patient) regarding herself. The patient has Hashimoto's disease. The patient had a past reaction consisted of hives and swelling lymph nodes after taking LEVAQUIN. On an unknown date in 1998 (reported as 15 years ago) the patient was vaccinated with the first dose of (oka-merck) VARIVAX, (lot number, expiry date was not reported, route was subcutaneous). On 18-APR-2013 the patient was vaccinated with second dose of (oka-merck) VARIVAX, (lot number, expiry date was not reported, route was subcutaneous). Concomitant therapies included SYNTHYROID. On 18-APR-2013, the patient developed redness and swelling about the size of a half dollar at the injection site after receiving the second dose of (oka-merck) VARIVAX. The site was painful, hard and hot. She also developed flu like symptoms. She has gotten better now and only has a small lump on the injection site. She did not have any reaction when she received the first dose of (oka-merck) VARIVAX. She had to get the second dose since the recent test showed negative titer. The patient was treated with ADVIL and fluids. There were no laboratory tests performed. The outcome of the reported events were reported as recovering. The patient did not seek medical attention. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age (gender not reported). On 17-APR-2013 the patient was vaccinated with an expired dose of GARDASIL (1397AA; expiry date 09-APR-2013) as the third dose in the GARDASIL vaccination series. Dose 3, GARDASIL was vaccinated intramuscularly. No adverse effect reported. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Amniotic fluid volume decreased, Exposure during pregnancy, Foetal disorder, Induced labour
Clinical narrative: This spontaneous retrospective pregnancy report as received from the Nurse Practitioner,, for GARDASIL, a Pregnancy Registry product, refers to a 26 year old female patient. The patient received her third dose of GARDASIL (lot # was 1696AA; exp. date was 12-SEP-2014) 0.5ml, intramuscularly on 26-JUL-2012. The patient had no concomitant medication. There is no medical history and no drug reaction or allergy. At the time of the third dose, the patient was "one week to ten days pregnant". The last menstrual period was approximately on 16-JUL-2012 and the estimated delivery date was on 22-APR-2013. The fetus was followed throughout the pregnancy and monitored for "fetal pyelectasis which the nurse described as a "congenital abnormality of the kidneys" with unspecified diagnostic testing. The mother was induced as a result of low amniotic fluid, and the baby was delivered on 24-MAR-2013. The baby was diagnosed with the kidney abnormality "mentioned above with unspecified diagnostic testing, and the Nurse practitioner stated it had not resolved by her check up appointment in January. The outcome of the event was unknown. The baby's report was captured in Marrs # 1304USA014310. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Incomplete course of vaccination
Clinical narrative: This spontaneous report was received form a consumer concerning her 13 year old daughter. Approximately on an unknown date in October 2011 (reported as October or November 2011), the patient was vaccinated with the first dose of 0.5 milliliter (ml) (reported as standard dose) of GARDASIL (lot number and expiry date unspecified), intramuscularly. Approximately on an unknown date in January 2012, the patient was vaccinated with the second dose of 0.5 ml (reported as standard dose) of GARDASIL (lot number and expiry date unspecified), intramuscularly. The patient did not receive her third dose of GARDASIL. No concomitant medications were reported. This is one of the two reports from the same source. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 59 year old male patient with no pertinent medical history and no drug reactions/allergies. On 04-APR-2013 the patient was vaccinated intramuscularly with ZOSTAVAX (lot # J000445, expiry date 11-APR-2014). There was no concomitant medication. The patient developed tenderness at the injection site on an unspecified date in April 2013. No treatment was given for event. No laboratory diagnostics studies were performed. The outcome of tenderness at the injection site was reported as recovered/resolved. The patient had sought medical attention (unspecified how). Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Unevaluable event
Clinical narrative: See attached neurologist office visit summary.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Incorrect route of drug administration
Clinical narrative: This spontaneous report as received from a nurse of unknown age refers to herself. On 03-JAN-2013 the patient was vaccinated with ZOSTAVAX (0.65 ml, lot # was unknown) intramuscular rather than subcutaneous. No adverse event reaction reported. This is one of several reports received from the same source. Follow-up information was received from the licensed practical nurse. Patient demographics were updated. On 20-DEC-2011, the patient had already a dose of ZOSTAVAX (Lot number, expiry date and dose were not reported) intramuscularly instead of subcutaneously. Since 10-APR-2012, the patient had herpes zoster outbreak 3 times on left upper back. The outcome of herpes zoster outbreaks was unknown. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Tdap administered in left deltoid, student obese-large arms 24 hrs after vaccine given, site is warm, red, slightly raised 3-4 in diameter of left deltoid cool compress applied.
Age: 68.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Diarrhoea, Nausea, Oedema peripheral, Pyrexia, Vomiting
Clinical narrative: 1 wk after receiving Tdap vaccine, pt began with nausea, vomiting, diarrhea, fever, swelling in arm vaccine received. Pt has had symptoms except fever x 4 days. Fever has been high as 102.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Pallor, Rash macular, Respiration abnormal
Clinical narrative: Wed Apr 17, 2013 1625 pm. Mother at window with child, states blotchy rash on face and "breathing funny" At time of assessment, somewhat pale, with blotchy rash on face, not hive-like. RR-40/HR 156. Observed for 20-25 minutes, responsive when moved or stimulated. Rash faded. Mother advised to observe closely tonite, call if any issues, however then doctor. Gave her his cell # to call. Discussed s/s reaction to TYLENOL and DTP, esp to pertussis component of vaccine, mother also has VIS. Mother comfortable with plan of care. Also informed mother that anyone in contact with child should consider having TDAP as we may not vaccinate him with pertussis in the future-including 10 yr old sibling who could receive BOOSTRIX. ADDENDUM NOTE: 447 pm. after vaccines child cried very vigorously then fell asleep. On way to car a blotchy rash was noted so came back in. Pulse ox was 100% and lungs clear. Observed for 20-25 min, rash faded. Of note TYLENOL given by mom for shots red dye so not sure if from dye or pertussis. Will consider deferral of pertussis and use of dye free TYLENOL in future. All adults in contact advised to get pertussis vaccination in case we defer next time.
Age: 81.0
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, and pain at the injection site. No treatment.
Age: 33.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 19-APR-2013 the patient was vaccinated with MMR II, 0.5 ml, subcutaneous. Dose number and lot number were not reported. The nurse reported that the vaccination and expired on 08-APR-2013. The patient was not experiencing any known symptoms. Additional has been requested.
Age: 0.67
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC, RV5
Symptoms: Rash
Clinical narrative: 2 1/2-3 hours after administration of vaccines, child developed rash on trunk, arms & legs & blisters of areas; mom took child to local ER, treated with BENADRYL and hydroxyzine.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a Medical assistant regarding a 14 years old male patient of unknown gender. No pertinent medical history was reported. On 19-APR-2013 the patient was vaccinated with the first dose of GARDASIL (lot number reported as 1397AA expiration date 09-APR-2013) (0.5ml, intramuscular). No other suspect therapies or concomitant medications were reported. The Medical assistant reported that the patient received an expired dose of GARDASIL. No adverse effects reported. Additional information has been requested.
Age: 1.04
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Rash on left upper thigh with swelling, warm to touch and itchy. Site consistent with varicella vaccine administration.
Age: 1.26
Sex: M
Vaccine: DTAP, PNC13, VARCEL
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Rash on left thigh, slightly itch. Consistent with varicella vaccine site.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Injection site erythema, Injection site pain, Injection site swelling, Vaccination complication
Clinical narrative: 3/16/13 developed swelling, redness, pain and tenderness at injection site. Patient given KEFLEX 500mg (3/20/13) one 4 x daily for 7 days. Area 5cm x 5cm. Rechecked on 3/22/13 improved - felt reaction and not cellulitis.
Age: 39.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella virus test positive
Clinical narrative: This spontaneous report was received from a parent consumer refers to a 39 year old female patient. ON an unspecified in 1998 (reported as 15 years ago), the patient was vaccinated with VARIVAX for prevention of chickenpox (lot number, dose, route not reported). It was reported that on an unspecified date in 2009 (reported as on approximately 4 years), her daughter tested, via blood work, as positive for varicella. Her daughter no longer had immunity to VARIVAX. Reporter was also unsure as to if her daughter ever received 2 doses of VARIVAX. The patient did not seek medical attention. The outcome of titers came back equivocal was unknown. The event was unknown related to VARIVAX. Additional information is not expected.
Age: 1.24
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from an office coordinator referring to a 14 month old patient of an unknown gender who on 22-APR-2013, was vaccinated with a dose of (Merck) PROQUAD (supplied lot # H015779, expiration date, 25-JAN-2014) and with a dose of (Merck) VARIVAX (supplied lot # H018423 expiration date, 08-OCT-2014) on the same day. No adverse effects reported. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. On 25-MAR-2013 the patient was vaccinated with ZOSTAVAX. The patient received an expired dose of ZOSTAVAX lot # 1198AA, expiration date 25-OCT-2012. Dosing information and route of administration were not provided. No symptoms reported. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose, Blood test, Exposure during pregnancy, Headache, Loss of consciousness
Clinical narrative: This spontaneous prospective pregnancy report was received form a 26 year old female consumer (reporting on herself). The patient's current condition included Hashimoto's and drug reaction allergy to penicillin. On 18-APR-2013 the patient was vaccinated with GARDASIL (lot number and expiration date not reported) (dose and route not reported, in the right hip). Concomitant therapies included SYNTHROID (dose and manufacturer unspecified). The patient reported that was 28 weeks pregnant (last menstrual period on 05-OCT-2012) and the physician contacted her on 19-APR-2013 to inform that she received the GARDASIL vaccine instead of the Rhogam Shot. The patient stated she nearly passed out after receiving the vaccine, and today (19-APR-2013) she was experiencing headache, nausea and vomiting. The patient did not sought medical attention and no treatment was provided for the adverse events. The patient was in the third trimester when the exposure to the GARDASIL occurred, the pregnancy outcome was pending and the fetal outcome was unknown. It was reported that a Blood work/Glucose testing was made with no results reported. At the time of the report the patient's outcome was unknown. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Vomiting
Clinical narrative: This spontaneous prospective pregnancy report was received form a 26 year old female consumer (reporting on herself). The patient's current condition included Hashimoto's and drug reaction allergy to penicillin. On 18-APR-2013 the patient was vaccinated with GARDASIL (lot number and expiration date not reported) (dose and route not reported, in the right hip). Concomitant therapies included SYNTHROID (dose and manufacturer unspecified). The patient reported that was 28 weeks pregnant (last menstrual period on 05-OCT-2012) and the physician contacted her on 19-APR-2013 to inform that she received the GARDASIL vaccine instead of the Rhogam Shot. The patient stated she nearly passed out after receiving the vaccine, and today (19-APR-2013) she was experiencing headache, nausea and vomiting. The patient did not sought medical attention and no treatment was provided for the adverse events. The patient was in the third trimester when the exposure to the GARDASIL occurred, the pregnancy outcome was pending and the fetal outcome was unknown. It was reported that a Blood work/Glucose testing was made with no results reported. At the time of the report the patient's outcome was unknown. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Injection site pain, Pain in extremity
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 25 year old female patient who on 11-APR-2013, was vaccinated with a dose of GARDASIL, 0.5 ml, intramuscular in the left arm (supplied lot # H020002 expiration date, 08-AUG-2015). The registered nurse reported that the patient had a persistent arm pain after administration of GARDASIL the patient developed immediate pain in the left deltoid muscle after vaccination. The pain had continued since then. The patient called the office on 23-APR-2013 to report that the pain in the area of the left deltoid was the same as the day she got the shot. Additional information has been requested.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Herpes zoster
Clinical narrative: Shingles.
Age: 1.07
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Swollen left thigh with rash, not itchy. Consistent with varicella vaccine site.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: This spontaneous report as received from a Nurse Practitioner via Company Representative refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot # and route not reported). The nurse practitioner reported a patient, who had shingles 3 years ago, was seen in the office for an ear infection on an unspecified date. The patient was administered ZOSTAVAX on that date while in the office. Two days later, the patient was diagnosed with shingles in the ear and on the face. At the time of reporting, the outcome was unknown. The relatedness for the event was unknown for ZOSTAVAX. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Raised are on left on left anterior thigh, red base and some tenderness. Consistent with varicella vaccine site.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Patient getting physical at health department. After physical immunizations were given to update for kindergarten and flu. Asked family to wait in lobby for safety. About 10-15 minutes later they reported child beginning to break out in a rash. Slight rash on face & forearms. BP 80/48, R 18, P 84, rash present. Administered 7.5 ml liquid BENADRYL po x 1 at 2 pm. At 230 pm adm 5ml po x 1.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Pruritus, Skin warm, Swelling
Clinical narrative: 4/13/13 AM small red dime size area at injection site only. 4/14/13 AM silver dollar size raised itchy area surrounded by puffy redness. Redness continued to enlarge to entire back of arm from armpit to elbow was itchy and hot to touch. Began to finally subside 4/18/13.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Wound
Clinical narrative: 10 cm x 6.5 cm mild erythematous non tender slightly raised patch with central injection site puncture to ant (R) thigh 3.5 cm diameter mild erythematous - non tender slightly indurated raised patch with central injection site puncture wound to ant left thigh. Warm compress to thighs twice a day - BENADRYL PRN f/u with PCP in week. Send to ER increase redness fever -puss.
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 unknown number of patients of unknown age. On an unknown date the patients was vaccinated with a dose of PROQUAD (dose, route and lot number unspecified) that stored as high as 8F on multiple occasions beginning on 08-JAN-2013 and continued until 26-FEB-2013. The total amount of time out of range was calculated at 248 hours. No adverse effect reported. It was unknown if the patients had sought medical attention. This is one of several reports received from same source. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain
Clinical narrative: Burned going in. Turned red immediately.
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 unknown number of patients of unknown age. On an unknown date the patients was vaccinated with a dose of VARIVAX (Merck) (dose, route and lot number unspecified) that stored as high as 8F on multiple occasions beginning on 08-JAN-2013 and continued until 26-FEB-2013. The total amount of time out of range was calculated at 248 hours. No adverse effect reported. It was unknown if the patients had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 10.0
Sex: U
Vaccine: HEPA, MMR, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Administered adult dose of Hep A instead of Pediatric. No noticeable reaction after injection. Informed parents VAERS completed for purpose of monitoring.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Patient received Tdap immunization IM in (L) deltoid. Ten minutes after immunization was administered patient stated that arm was numb and could not feel it. Able to feel pressure the next day at 10:00 am patient was able to feel sharp and dull sensation in arm and reported arm was sore, but able to do ADLs.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Pyrexia, Vomiting
Clinical narrative: Pt had a low grade fever, vomiting, large red induration on (R) thigh at injection site.
Age: 24.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Pharyngeal oedema
Clinical narrative: Pt states she had swelling in her throat, not her airway. No trouble breathing, no fever, no induration in vaccine administration areas (deltoid).
Age: 14.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Complex partial seizures, Nuclear magnetic resonance imaging
Clinical narrative: Patient developed complex seizures w/in 24 hours of PROQUAD administration. Shot given on 3/13/13.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Adult dose of Hep A was given, should have been a pediatric dose. No symtpoms, no treatment needed.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Pt. seen for WCV 04/22/13 AM. Mother called 04/23/13 AM - states pt. has red, swollen area Lt. thigh. Pt. seen by provider 04/23/13 PM. Reddened area 'egg sized" with indurated area quarter sized. Was recommended Tx with BENADRYL or ZYRTEC; ice locally.
Age: 1.06
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, bump of injection site. Warm to touch.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt called with adverse rxn of redness, soreness, swelling at injection site of Pneumovax 23.
Age: 16.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Felt faint/light-headed, diaphoretic. Pt was placed prone on exam table, pulse and BP assessed WNL - Given water to drink per pt. request. Allowed to rest til he felt better.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Breast pain, Cellulitis, Erythema
Clinical narrative: Case number PHHY2013US012063 is an initial spontaneous report received from vaccine adverse event reporting system website (VAERS reference number: 474527) on 08 Feb 2013 with a follow-up received from Quality Assurance Department (reference number: 211902) on 18 Apr 2013. This case refers to a 71-year-old female patient. Her medical history included of high blood pressure and underactive thyroid. She was vaccinated with FLUVIRIN (batch number: 12272P) intramuscularly in her right arm on 14 Nov 2012. On 15 Nov 2012 she developed two red and painful areas under right and left breast, "more so on right side". She went to her physician and was diagnosed with cellulitis, possibly triggered by vaccine. The final outcome was reported as condition unchanged. The seriousness was not reported. No other information was available. Batch review report concluded that, based on the document review, it was stated that, the concerned FLUVIRIN vaccine (batch number: 12272P) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow-up received from Quality Assurance Department on 18 Apr 2013: Updated batch review report.
Age: 46.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Demyelination, Hypoaesthesia, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Initial report was received from a healthcare professional on 16 April 2013. A 46-year-old female patient had received an intramuscular injection in the left deltoid of ADACEL, lot number C4379 (corresponding Sanofi Pasteur Inc. lot number U4586AA) on 26 March 2013. Following vaccination, the patient experienced pain at the injection site. On 06 April 2013, the patient experienced numbness to the left side of the face, left arm, down the left side and left leg. The patient had an MRI done which showed demyelinating disease and was now having a work-up for Multiple Sclerosis. At the time of vaccination, the patient had a sinus infection and was taking antibiotics for one week. Medical history included allergies to iodine and bee stings and migraine headaches. Outcome was not recovered. Documents held by sender: None.
Age: 46.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Demyelination, Hypoaesthesia, Injection site pain, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Initial report was received from a healthcare professional on 16 April 2013. A 46-year-old female patient had received an intramuscular injection in the left deltoid of ADACEL, lot number C4379 (corresponding Sanofi Pasteur Inc. lot number U4586AA) on 26 March 2013. Following vaccination, the patient experienced pain at the injection site. On 06 April 2013, the patient experienced numbness to the left side of the face, left arm, down the left side and left leg. The patient had an MRI done which showed demyelinating disease and was now having a work-up for Multiple Sclerosis. At the time of vaccination, the patient had a sinus infection and was taking antibiotics for one week. Medical history included allergies to iodine and bee stings and migraine headaches. Outcome was not recovered. Documents held by sender: None.
Age: 1.33
Sex: M
Vaccine: MMR
Symptoms: Cyanosis, Febrile convulsion, Musculoskeletal stiffness, Pyrexia, Respiratory arrest
Clinical narrative: Baby had a very high fever for 24 hours and then had a febrile seizure lasting 30 seconds where his whole body was tense and shaking. He stopped breathing. Lips were blue etc.
Age: 1.33
Sex: M
Vaccine: MMR
Symptoms: Tremor
Clinical narrative: Baby had a very high fever for 24 hours and then had a febrile seizure lasting 30 seconds where his whole body was tense and shaking. He stopped breathing. Lips were blue etc.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Chills, Headache, Nausea, Pain
Clinical narrative: Body aches, weakness, heart racing, wheezing, headache, nausea, chills, hives on back, stomach, chest, neck, face, and arms.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Palpitations, Urticaria, Wheezing
Clinical narrative: Body aches, weakness, heart racing, wheezing, headache, nausea, chills, hives on back, stomach, chest, neck, face, and arms.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Activities of daily living impaired, Blood test, Headache, Nuclear magnetic resonance imaging, X-ray
Clinical narrative: This spontaneous report as received from the mother of a consumer and refers to a 14 year old male patient. On 28-JAN-2013 the patient was vaccinated with GARDASIL (Product Circular USPI-I-V5011303R017) dose 1, intramuscular. On 28-MAR-2013 the patient was vaccinated with GARDASIL dose 2, intramuscular. The lot numbers and doses were not reported. The patient's mother reports that following the first dose of GARDASIL her son developed headaches (hospitalization, disability). The reporter stated that her son had two emergency room visits (dates of first two emergency room visits were unspecified) and was hospitalized after a third emergency room visit on 20-FEB-2013 for 3 days. The reporter stated that her son had continually headaches and occasionally had throbbing, stabbing, debilitating headaches (headaches rated as scale 1 to 8 on a 10 point scale). The reporter also stated that her son had limited classes in school, was not allowed to read at home or participate in outside activities because of the headaches. The headaches did not change after receiving the second dose of GARDASIL. The patient tried IMITREX for the headaches, but it did not work (date unspecified). The treatment of the headaches had included use of fish oil, magnesium oxide, amitriptyline hydrochloride, riboflavin, and MAXALT (used for intense headaches). The outcome of continually has headaches and occasionally throbbing, stabbing, debilitating headaches was reported as not recovered/not resolved. Reporter causality assessment was not reported. Case is linked to case: 1304USA015288 (same reporter). Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Face and mouth X-ray, Fatigue, Headache, Migraine, Nuclear magnetic resonance imaging
Clinical narrative: This spontaneous report as received from the mother of a consumer and refers to a 14 year old male patient. On 28-JAN-2013 the patient was vaccinated with GARDASIL (Product Circular USPI-I-V5011303R017) dose 1, intramuscular. On 28-MAR-2013 the patient was vaccinated with GARDASIL dose 2, intramuscular. The lot numbers and doses were not reported. The patient's mother reports that following the first dose of GARDASIL her son developed headaches (hospitalization, disability). The reporter stated that her son had two emergency room visits (dates of first two emergency room visits were unspecified) and was hospitalized after a third emergency room visit on 20-FEB-2013 for 3 days. The reporter stated that her son had continually headaches and occasionally had throbbing, stabbing, debilitating headaches (headaches rated as scale 1 to 8 on a 10 point scale). The reporter also stated that her son had limited classes in school, was not allowed to read at home or participate in outside activities because of the headaches. The headaches did not change after receiving the second dose of GARDASIL. The patient tried IMITREX for the headaches, but it did not work (date unspecified). The treatment of the headaches had included use of fish oil, magnesium oxide, amitriptyline hydrochloride, riboflavin, and MAXALT (used for intense headaches). The outcome of continually has headaches and occasionally throbbing, stabbing, debilitating headaches was reported as not recovered/not resolved. Reporter causality assessment was not reported. Case is linked to case: 1304USA015288 (same reporter). Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Phonophobia, Pyrexia, Tension headache
Clinical narrative: This spontaneous report as received from the mother of a consumer and refers to a 14 year old male patient. On 28-JAN-2013 the patient was vaccinated with GARDASIL (Product Circular USPI-I-V5011303R017) dose 1, intramuscular. On 28-MAR-2013 the patient was vaccinated with GARDASIL dose 2, intramuscular. The lot numbers and doses were not reported. The patient's mother reports that following the first dose of GARDASIL her son developed headaches (hospitalization, disability). The reporter stated that her son had two emergency room visits (dates of first two emergency room visits were unspecified) and was hospitalized after a third emergency room visit on 20-FEB-2013 for 3 days. The reporter stated that her son had continually headaches and occasionally had throbbing, stabbing, debilitating headaches (headaches rated as scale 1 to 8 on a 10 point scale). The reporter also stated that her son had limited classes in school, was not allowed to read at home or participate in outside activities because of the headaches. The headaches did not change after receiving the second dose of GARDASIL. The patient tried IMITREX for the headaches, but it did not work (date unspecified). The treatment of the headaches had included use of fish oil, magnesium oxide, amitriptyline hydrochloride, riboflavin, and MAXALT (used for intense headaches). The outcome of continually has headaches and occasionally throbbing, stabbing, debilitating headaches was reported as not recovered/not resolved. Reporter causality assessment was not reported. Case is linked to case: 1304USA015288 (same reporter). Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: This spontaneous report was received from a male patient who is also a physician regarding himself. No medical history was reported. On an unknown date approximately April 2011 (reported as over 2 years ago), the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiry, route not reported), 0.65 ml. No concomitant medications were reported. On an unknown date approximately April 2011, the patient immediately felt pain at the injection site. This prolonged pain lasted for about a week and then the pain went away. The patient stated that receiving the ZOSTAVAX injection was more painful than all the other immunizations he had ever received. No medical attention was sought. No treatment was received. Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Full blood count normal, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 68 year old female patient with no pertinent medical history and no drug reactions/allergies. The patient was intramuscularly vaccinated with the first and second dose of PNEUMOVAX23 int the left deltoid both 0.5 ml, respectively on 30-JUL-2009 and 22-APR-2013. The second dose lot number reported as H017759, expiry date 04-JUL-2014. The nurse was reporting that patient experienced a severe injection site reaction after administration of PNEUMOVAX23. The patient was administered PNEUMOVAX23 intramuscularly on the left deltoid on 22-APR-2013. The patient called the office 3 hours later complaining of redness and swelling below the injection site. The patient was advised to take ADVIL and alternate hot and cold compresses. On 23-APR-2013, the patient came to the office with severe tightness, tenderness, and warmth from the injection site extending past her left elbow. At the time of the report, no additional treatment had been prescribed. On 23-APR-2013 the patient's complete blood count was normal. The outcome of the patient's adverse events was reported as not recovered/not resolved. Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Skin tightness, Swelling, Tenderness
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 68 year old female patient with no pertinent medical history and no drug reactions/allergies. The patient was intramuscularly vaccinated with the first and second dose of PNEUMOVAX23 int the left deltoid both 0.5 ml, respectively on 30-JUL-2009 and 22-APR-2013. The second dose lot number reported as H017759, expiry date 04-JUL-2014. The nurse was reporting that patient experienced a severe injection site reaction after administration of PNEUMOVAX23. The patient was administered PNEUMOVAX23 intramuscularly on the left deltoid on 22-APR-2013. The patient called the office 3 hours later complaining of redness and swelling below the injection site. The patient was advised to take ADVIL and alternate hot and cold compresses. On 23-APR-2013, the patient came to the office with severe tightness, tenderness, and warmth from the injection site extending past her left elbow. At the time of the report, no additional treatment had been prescribed. On 23-APR-2013 the patient's complete blood count was normal. The outcome of the patient's adverse events was reported as not recovered/not resolved. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a nurse manager via Supplier Diversity council refers to unknown patient. The nurse manager who works in a dialysis clinic reported that the breaker tripped and the medication refrigerator was out of power for a day or so. Normally they kept the temperature from 4-8 degree celsius but it got up to 22 degree celsius. The medication they kept was PNEUMOVAX23 (lot# not reported). It was not discolored. The reporter enquired what the range should be used to keep this medication at and was it ok to use and was it still effective if it gets exposed to 22 degree Celsius temperature. 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 nurse refers to unknown number of patients. On an unknown date the patients received improperly stored GARDASIL (dose, route and lot# not reported). The GARDASIL doses were exposed under the recommended temperature for total of 42 hours and the coldest temperature was 24F. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. On an unknown date the patient was vaccinated with the first dose of PEDVAXHIB. The nurse reported that the patient received the second dose of PEDVAXHIB approximately 48 days after receiving first dose and no symptoms reported. Doses of PEDVAXHIB were administered by a different unspecified healthcare provider. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a patient's wife regarding her husband of unknown age. No medical history was reported. On 13-APR-2013 (reported as 1 week ago last Saturday), the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiry, route, dose not reported). No concomitant medications were reported. On an unknown date in April 2013, the patient experienced redness, swelling and warmth at the injection area that was 3 inch in diameter that lasted a week. The outcome of redness, swelling, warmth at the injection area was reported as recovered approximately on an unknown date in April 2013. Patient's wife also mentioned she received ZOSTAVAX 1 week ago last Saturday and was taking VALTREX every day. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative refers to a patient of unknown age and gender. No medical history was reported. On 19-APR-2013, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # 0363AE, expiry: 16-MAR-2013) that was also improperly stored prior to administration. No concomitant medications were reported. No adverse event reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a pharmacist via company representative refers to a patient of unknown age. On an unknown date in 2012, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date and route was not reported). Concomitant medication was not reported. On an unknown date in 2012 (reported as next day), the patient developed hives on the face and neck. The outcome of the event was unknown. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Tenderness
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 62 year old female patient. No medical history was reported. On 08-APR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiry, dose route not reported). No concomitant medication were reported. On 08-APR-2013, an area on a patient's arm from her elbow toward her upper arm became tender and pink after receiving ZOSTAVAX. The pharmacist stated that the area on the patient's arm extended above and below the injection site and remained pink and tender for 4-5 days. The patient was instructed by an unspecified person to take ibuprofen as treatment. It was unspecified if the patient sought medical attention. The patient recovered approximately on 12-APR-2013. Additional information has been requested.