chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: This spontaneous report as received from an office manager refers to a patient of unknown age and gender. On 10-OCT-2012, the patient was vaccinated with GARDASIL (dose, route and lot not provided). No concomitant medications were reported. The office manager that on 10-OCT-2012 the patient was being administered a dose of GARDASIL from a GARDASIL prefilled syringe but during injection some of the product came out of the syringe tip at the hub of the needle attachment and an incomplete dose was given to the patient. No adverse effect reported. PQC filed. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Fall, Head injury, Syncope
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to a 17-year-old female patient. The patient was vaccinated with dose 1, 0.5 milliliter (ml) GARDASIL (lot # not reported) intramuscularly (IM) on 10-AUG-2012. Other suspect therapies included VAQTA (lot # not reported) dose and route not reported. No concomitant medications were reported. Physician informed the representative that the patient fainted after receiving their first dose of GARDASIL. As she was fainting she fell and hit her head. The patient was sent to the Emergency Room (ER) (hospital name/location unspecified) and she received stitches at the ER and did not need to be admitted to the hospital. According to the representative the patient said that they were not going to continue with the GARDASIL dosing series so therapy had been discontinued. Treatment was received for the event. The patient sought medical attention for the event. The events were resolving at the time of this report. No other adverse event (AE) information was given. This is one of the several reports due to the sibling link and from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 years old female patient with allergies to LISINOPRIL (manufacturer unknown) (MARRS # 1210USA012644) and NSAID, who on 20-OCT-2012 was vaccinated subcutaneously with a dose of ZOSTAVAX (1 vial) (lot number H0125778 in process of validation, expiration date 28-SEP-2013). No other co-suspects were reported. Concomitant medications included levothyroxine sodium and losartan potassium (manufacturer unknown). The pharmacist reported that the patient developed redness at the injection site after receiving a dose of ZOSTAVAX. No treatment information was reported. At the time of the report, the patient was recovering from the adverse event. The patient sought medical attention: saw the pharmacist. No laboratory tests were performed. The relatedness for the adverse event was unknown for ZOSTAVAX. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Pruritus, Urticaria
Clinical narrative: This spontaneous report was received from a 71 years old female consumer reporting on herself with no pertinent Medical History or drug reactions/Allergies who on 17-OCT-2012 was vaccinated once subcutaneously with a dose of ZOSTAVAX (Lot # and dose not reported). No other co-suspects were reported. There were concurrent concomitant medications, but they were not supplied. Consumer said that on 18-OCT-2012, there was bright red spot at injection site, on her left arm. She stated that she later, as the week progressed saw welts on the 3 inch spot on her arm. She believed it to be shingles, but that was not confirmed by a physician, she stated. She advised it seems to be going away, and the itching that was first associated with it, has gone away. She stated it was like a rash around the site. The patient did not seek medical attention. No treatment was given to patient. Patient outcome was recovering/resolving. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a patient of unknown age. The patient was vaccinated intramuscularly with an expired 0.5 ml dose of PEDVAXHIB (lot # 0236Z; exp date 19-OCT-2012) on 25-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. The patient was vaccinated with 0.5 ml of expired dose of VARIVAX subcutaneously (lot # 667490/0784Z, expiry: 08-OCT-2012) on 08-OCT-2012. No concomitant medications were reported. No adverse effect were reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye infection
Clinical narrative: This spontaneous report as received from a 65 years old female patient refers to herself. On 10-AUG-2012, the patient received a dose of ZOSTAVAX (lot #, dose, frequency and route not provided) vaccine, at a pharmacy (unspecified) and then on 17-AUG-2011 she got an eye infection, lasting a month, recovered on approximately 17-SEP-2011. On 21-MAR-2012, she got a second eye infection. The patient at the time of the report was experiencing a third infection approximately in October 2012. The patient was treated with acyclovir, BESIVANCE, ZIRGAN and TOPAMAX. Labs diagnostics studies were not performed. The patient sought medical attention through an office visit. The final outcome of the events was unknown. The relatedness of the events with ZOSTAVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age and gender. In October 2012 (2-3 weeks ago), the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot not provided). There was no concomitant medication. The pharmacist stated that in October 2012 4 days after vaccination had an approximately 1/2 dollar size raised red area at the injection site that was more rashy looking. The pharmacist did not have any further details on this patient. At the time of the report the patient's outcome was unknown. The relatedness for the events was unknown for ZOSTAVAX. This is one of several reports, received from the same source. Additional information is not expected.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer refers to her sister, a 89 years old female patient with shrimp allergy. The patient was vaccinated with ZOSTAVAX on an unknown date in 2002. No other co-suspects were reported. Concomitant medications included: vitamins (unspecified). On an unknown date, early in 2002, the patient obtained shingles after receiving the ZOSTAVAX or during the early stages of the condition. The patient sought medical attention, no treatment information was reported. The outcome of obtained shingles is unknown. The relatedness for obtained shingles was not reported for ZOSTAVAX. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered
Clinical narrative: Information has been received from a registered nurse concerning a patient, who on 22-OCT-2012 was vaccinated with an expired dose of ROTATEQ, 2 ml, orally, lot # 669529/0548AA (expired 20-SEP-2012). No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a female patient, who on 22-OCT-2012 was inadvertently vaccinated with an expired dose of ZOSTAVAX, subcutaneously, lot # 669639/0613AA (expiry date 30-JUN-2012). No adverse effects reported. This is one of two reports from the same source. The other linked report is 1210USA013212. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a doctor of pharmacy refers to a patient of unknown age and gender. On 07-OCT-2012 the patient was vaccinated with 0.5 milliliter (ml) PNEUMOVAX23 (lot # (667995/1150Z), expiration date 04-MAR-2012) intramuscularly (IM). No concomitant medications were reported. Reporter stated that an unspecified patient was administered an expired dose of PNEUMOVAX23. No adverse effect reported. No further information is available. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction
Clinical narrative: This spontaneous report was received from a doctor of pharmacy refers to unknown number of patients with unknown age and gender. On an unknown date the patients were vaccinated with PNEUMOVAX 23 (lot # not reported) dose and route not reported. No concomitant medications were reported. Reporter stated than an unspecified number of unspecified patients have experienced unspecified injection site reactions and soreness after receiving PNEUMOVAX 23 on unspecified dates. No further information is available. The outcome of the reported events were unknown. This is one of the several reports from the same reporter. Additional information is not expected.
Age: 1.91
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician assistant concerning a female patient of unknown age. On 11-JUL-2012 (also reported as 22-JUL-2012), the patient was vaccinated intramuscularly with the first dose of 0.5 ml VAQTA (lot not reported). On 25-OCT-2012, the patient was vaccinated intramuscularly with the second dose of 0.5 ml VAQTA (lot not reported). No other co-suspects were reported. No concomitant medications were reported. There were no adverse effects reported. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 78 years old female consumer reporting on herself with no pertinent medical history, drug reactions or allergies. The patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported) in early 2011. No other co-suspects were reported. No concomitant medications were reported. The consumer reported that around 05-OCT-2012 she developed shingles after receiving ZOSTAVAX. The patient sought unspecified medical attention and was given VALTREX and prednisone (manufacturer unknown) as treatment for shingles. No lab diagnostic tests were performed. The outcome of shingles was reported as recovering (also reported as event did not improve). The relatedness for the reported event was not provided for ZOSTAVAX. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. The patient was vaccinated with PNEUMOVAX 23 on 06-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. On 11-OCT-2012 the patient inadvertently received another dose of PNEUMOVAX 23. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: This spontaneous report was received from a nurse practitioner concerning a female patient in her mid of 60's. On 19-OCT-2012, the patient was vaccinated subcutaneous or intramuscularly with a dose of 0.5 ml PNEUMOVAX 23 (lot not reported). No other co-suspects were reported. No concomitant medications were reported. The nurse practitioner reported that, the evening of 19-OCT-2012, the patient noticed redness and swelling. It was worse the next day. The patient was self-medicated and took some BENADRYL and the symptoms did go away. The relation between the events and PNEUMOVAX 23 was not related. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. The patient was vaccinated with RECOMBIVAX HB intramuscular (dose, and lot # not reported). No other co-suspects were reported. No concomitant medications were reported. A preterm infant received RECOMBIVAX HB, intramuscularly at birth, and also at 2 months and 4 months after birth. No known adverse effects. No treatment information was reported. No further information was available. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Injection site erythema, Nausea
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The pharmacist informed that the patient while was vaccinated with one dose, 0.65 ml ZOSTAVAX on 19-OCT-2012 she experienced bruising, redness at the injection site and nausea. No treatment information was reported. The patient did not seek medical attention. All adverse events (AE) responses were for ZOSTAVAX. The patient outcome due to all events was unknown. The relatedness for redness at the injection site, bruising and nausea was unknown for ZOSTAVAX. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a 84 years old female patient with no pertinent medical history and drug reactions/allergies. On 17-OCT-2012, the patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot # reported as H012521 exp: 09-OCT-2013). Concomitant medications included lisinopril, atorvastatin, metformin and alendronate sodium. The pharmacist stated that 2-3 days after vaccination on approximately 19-OCT-2012, the patient had an approximately 1/2 dollar size raised red area at the injection site. The patient sought medical attention with pharmacy visit, and the patient was told to follow up with the physician. No treatment was given for the event and no labs/diagnostic studies were performed. At the time of the report the patient's outcome was unknown. The relatedness for the event was unknown for ZOSTAVAX. Additional information is not expected. This is one of several reports from the same source.
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. The patient was inadvertently administered ZOSTAVAX (single dose, lot number67054/0659AA) subcutaneously on 15-OCT-2012 that had expired on 04-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. It was unspecified if the patient had sought medical attention. Additional information is not expected.
Age: 3.0
Sex: U
Vaccine: MMR
Symptoms: Mumps, Mumps antibody test positive
Clinical narrative: This spontaneous report as received from a Physician Assistant refers to a 3.5 years old patient. The patient was vaccinated with M-M-R II (0.5 ml dose at 12 to 15 months of age, route and lot # were unknown) approximately in April 2010 (reported as "2 1/2 years ago"). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient who had been vaccinated with M-M-R II presented with mumps at the emergency room. No treatment was given for adverse event. At the report time the outcome of event was unknown. The patient had sought unspecified medical attention. Lab diagnosis studies of "Titers for mumps" had been performed. Additional information is not expected.
Sex: M
Vaccine: BCG
Symptoms: Decreased appetite, Influenza like illness
Clinical narrative: This spontaneous report (local reference number:US12-047886) as received from a physician refers to a male patient of unknown age. On 04-SEP-2012, the patient received an unspecified flu vaccine (lot # and manufacturer unknown) and on 06-SEP-2012 the patient received the first instillation of his second treatment with TICE BCG (lot # unknown). No concomitant medications were reported. Approximately on an unknown date in September 2012, the patient experienced flu like symptoms and decreased appetite within one week after he received. The patient had no fever. The physician asked if there were any interactions with flu vaccine and TICE BCG live. It was unknown if the patient had sought medical attention. No treatment information was reported. The outcome of flu like symptoms and decreased appetite was unknown. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Facial pain, Headache, Skin lesion
Clinical narrative: This spontaneous report as received from a physician refers to a 65 years old female patient.  The patient's medical history included bullous pemphigoid and the patient had chickenpox as a child. The patient was vaccinated with ZOSTAVAX (route, dose and lot # were unspecified by reporter) on 12-OCT-2012. No other co-suspects were reported. Concomitant medications included CELLCEPT 500mg twice daily and prednisone 5mg every other morning. On 13-OCT-2012 (the next day) the patient had a headache and "then the next day", on 14-OCT-2012, had pain in the right face near the ear. The patient then developed a lesion on the upper lip and the physician saw the patient today(on 16-OCT-2012) and it was a clear vesicle on the upper lip. Physician had cultures sent out today(on 16-OCT-2012) to verify whether this vesicle was herpes simplex. Treatment of VALTREX and ADVIL or MOTRIN were given for pain. The outcome of the events were reported as not recovered/not resolved. The patient sought medical attention via visiting office. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age. The Registered Nurse reported that the patient developed cellulitis at the injection site after receiving PNEUMOVAX 23 (Lot#, dose/frequency, route and duration were unspecified) on an unknown date. No treatment information was reported. The outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site nodule
Clinical narrative: This spontaneous report as received from a consumer concerning herself of unknown age and gender with allergies to surfactant in PNEUMOVAX23, who on an unspecified date was vaccinated with PNEUMOVAX23 (dose and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The consumer reported that while in PNEUMOVAX23, developed a huge knot at the vaccination site (date unspecified). No treatment information was reported. The patient sought medical attention. On an unspecified date, the patient recovered from adverse event after stopping therapy. PNEUMOVAX23 was discontinued and not reintroduced. The relatedness for the adverse event was unknown for the PNEUMOVAX23. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a phlebotomy technician concerning to a patient of unknown age and gender who on an unspecified date was vaccinated with RECOMBIVAX HB (dose and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The phlebotomy technician reported that the patient received an improperly stored dose of RECOMBIVAX HB. No symptoms were reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dysgeusia
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a 12 years old female patient who was not pregnant. The patient was vaccinated with first dose of GARDASIL (lot number, route not reported) on an unspecified date approximately 2 months ago in August 2012. No other co-suspects were reported. No concomitant medications were reported. During questioning preparatory to administration of the second dose in the series, the patient mentioned that she experienced a metallic taste in her mouth just after being injection with the vaccine. The patient had sought medical attention via office visit. No treatment was given. No laboratory diagnostics studies were performed. The patient reported that the metallic taste spontaneously resolved at an unspecified time. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Rash generalised, Swollen tongue, Throat irritation
Clinical narrative: 1530 - Tongue swelling, itchy throat, rash to face, neck, arms and torso, slight chest tightness. O2 98%, no wheezing. Administered BENADRYL 25mg IM. 1545 - Itchy throat, rash, chest tightness continued. O2 98%, no wheezes. Administered SOLU-MEDROL 125 mg IM. 1605 - Discharged, asymptomatic, husband given instruction.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Approximately ten minutes after immunization, patient presented with "itching". Upon examination there was a red area warm to touch (~1.5 in diameter). Patient was given BENADRYL 25mg (TQ6 hours). At 7pm patient reported no itching and no redness.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Convulsion, Dyskinesia, Erythema, Posturing, Respiratory arrest
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 year old female patient with a history of anxiety and syncope vasovagal and no previous illnesses was vaccinated on 13-FEB-2012 with the third dose of GARDASIL (lot # 1560AA), I.M, in the left arm, (dose not reported). Concomitant therapy included LOESTRIN 24 FE. On 13-FEB-2012, the patient (Pt) seized about 3-5 minutes after receiving vaccine. She became very red, not breathing, tonic and posturing that lasted about 1-2 minutes. This report was considered non-serious for all events by the agency and required emergency room/doctor visit. The original reporting source was not provided. The VAERS ID # 449545. No further information is available. It has been determined that case # 1205USA01523 is a duplicate of case # 1202USA01969. Therefore, case # 1205USA01523 is being deleted from our files and the cases consolidated into case # 1202USA01969.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site swelling, Injection site warmth, Oedema peripheral
Clinical narrative: Husband came in to report (R) arm had swelled & become red from injection site to inner elbow. Patient referred to PCP for treatment given Cephalexin 500 & Tramadol 50.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Husband came in to report (R) arm had swelled & become red from injection site to inner elbow. Patient referred to PCP for treatment given Cephalexin 500 & Tramadol 50.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Biopsy skin abnormal, Erythema, Granuloma annulare, Induration, Rash
Clinical narrative: Rash that started on right leg then spread to both legs and trunk.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin plaque
Clinical narrative: Rash that started on right leg then spread to both legs and trunk.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Granuloma annulare, Laboratory test, Rash
Clinical narrative: Rash that started on right leg then spread to both legs and trunk.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injected limb mobility decreased, Injection site pain, Injection site warmth, Muscular weakness
Clinical narrative: HUGE swelling, redness the size of a canalope on my arm.Hot to the touch & throbbing like someone punched me really hard at injection site. The redness lasted a few weeks the pain and throbbing lasted over 9 months with a constant throbbing the whole time! I also lost most use of my arm I couldn't sleep on it or raise it above my chest level without causing more pain. I lost muscle strength as well and couldn't lift with that arm for 6 months. To THIS day it still hurts if I move my arm or hold my arm a certain way! The throbbing finally stopped but it never went back to feeling normal. If I raise my arm above chest level it hurts a lot If I do anything that requires I use muscle strength like use that arm to lift myself It hurts at the site of injection as it has since the injection. I WOULD like to know what is going on and WHY the side effects/pain muscle strength loss have lasted so long & what can I do to get my arm back to normal.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Oedema peripheral, Pain
Clinical narrative: HUGE swelling, redness the size of a canalope on my arm.Hot to the touch & throbbing like someone punched me really hard at injection site. The redness lasted a few weeks the pain and throbbing lasted over 9 months with a constant throbbing the whole time! I also lost most use of my arm I couldn't sleep on it or raise it above my chest level without causing more pain. I lost muscle strength as well and couldn't lift with that arm for 6 months. To THIS day it still hurts if I move my arm or hold my arm a certain way! The throbbing finally stopped but it never went back to feeling normal. If I raise my arm above chest level it hurts a lot If I do anything that requires I use muscle strength like use that arm to lift myself It hurts at the site of injection as it has since the injection. I WOULD like to know what is going on and WHY the side effects/pain muscle strength loss have lasted so long & what can I do to get my arm back to normal.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: Symptoms of nausea, tiredness, and headache.  Still occurring two days later.  Taking Tylenol for headache.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Rash
Clinical narrative: Rash to right arm which extended to shoulder, chest and neck. Benadryl 50mg IM administered. Within few minutes symptoms subsided.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Impaired driving ability, Photopsia
Clinical narrative: Starting seeing flashes of light which got progressively worse - could not drive. Then got a headache and was in bed for the afternoon.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Broke out in hives all over body.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient reports a week after receiving the high dose flu vaccine his arm started hurting. Reported this is the second week of pain.
Age: 19.0
Sex: F
Vaccine: RAB
Symptoms: Rash
Clinical narrative: Rash all over neck, back and chest.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Erythema, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain at injection site (Normal).  After that I experienced redness traveling down my arm and swelling traveling down my arm to my elbow.  Extreme fatigue the day after the injection. It has been 2 days to the hour since my flu shot.  The swelling and redness have increased and are approximately 8" from the injection site, traveling down the arm.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Oedema peripheral
Clinical narrative: Pain at injection site (Normal).  After that I experienced redness traveling down my arm and swelling traveling down my arm to my elbow.  Extreme fatigue the day after the injection. It has been 2 days to the hour since my flu shot.  The swelling and redness have increased and are approximately 8" from the injection site, traveling down the arm.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Headache, Paraesthesia, Syncope
Clinical narrative: Headaches, seizures, syncope, tingling.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram abdomen, Ovarian cyst, Ovarian cyst ruptured, Pain, Ultrasound scan
Clinical narrative: She received her 3rd HPV vaccination in October of 2012. She now has ovarian cyst that are very painful and rupture.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth, Paraesthesia, Sensation of heaviness
Clinical narrative: I noticed a red patch on my arm around the injection site. It was a rather large patch that seemed to indicate where the medication was in my arm. It was warm, not hot, to the touch. My arm felt a little heavy and I felt a tingling sensation in my fingers. I first noticed the redness at around 9:00 PM. The tingling sensation began around 9:45 PM.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Eye disorder, Glossodynia, Oedema mouth, Pharyngeal disorder
Clinical narrative: Initial coughing/respiratory; swelling of tongue and mouth; eyes congested; throat swelling, BP 180/100. ER treatment: Benadryl drip, two shots epinephrine over 4 hours, other drip; prednisone tablets 5 days following.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Pharyngeal oedema, Swollen tongue
Clinical narrative: Initial coughing/respiratory; swelling of tongue and mouth; eyes congested; throat swelling, BP 180/100. ER treatment: Benadryl drip, two shots epinephrine over 4 hours, other drip; prednisone tablets 5 days following.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea, Fatigue, Injection site erythema, Injection site pruritus
Clinical narrative: SHORTNESS OF BREATH, SWOLLEN AREA TO SITE, HOT, ITCHY, RED, TIGHTNESS OF CHEST, TIRED.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: SHORTNESS OF BREATH, SWOLLEN AREA TO SITE, HOT, ITCHY, RED, TIGHTNESS OF CHEST, TIRED.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Areflexia, Blood test, Headache, Lumbar puncture, Muscular weakness
Clinical narrative: Extreme pain in all extremities, weight loss, weakness all extremities, loss of all reflexes, debilitating headaches 1/15/12 -> present.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity, Weight decreased, X-ray
Clinical narrative: Extreme pain in all extremities, weight loss, weakness all extremities, loss of all reflexes, debilitating headaches 1/15/12 -> present.
Age: 93.0
Sex: F
Vaccine: VARZOS
Symptoms: Death
Clinical narrative: This spontaneous report as received from an other health professional refers to a female patient of unknown age. The patient was vaccinated with 0.65 ml ZOSTAVAX in 2008. No other co-suspects were reported. Concomitant medications included: PREDNISONE and inhaled corticosteroids (not otherwise specified). The nurse reported that she administered ZOSTAVAX to a patient that had completed a MEDROL Dosepak. The patient completed the MEDROL Dosepak a month prior to the administration of the ZOSTAVAX (administration of the ZOSTAVAX was believed to be in 2008, but nurse was not sure). The nurse reported that the patient had no adverse reaction associated with the administration of the ZOSTAVAX, but then stated that the patient has since died at age 93. On an unknown date the patient experienced death (death). No treatment information was reported. The outcome of death was reported as fatal. The date of death is not known. Nurse did not feel death was associated with ZOSTAVAX vaccination. The nurse asked about using ZOSTAVAX in a patient that is on 10 mg of Prednisone and inhaled corticosteroids. The nurse did not wish to provide additional information at the time of the call and did not wish follow up. Additional information is not expected. It has been determined that case 1210USA013797 is a duplicate of case 1210USA013349. Therefore, case 1210USA013797 is being deleted from our files and the cases consolidated into case 1210USA013349. No new information was reported.
Age: 48.0
Sex: F
Vaccine: HEPA
Symptoms: Abdominal pain upper, Acute myeloid leukaemia, Biopsy bone marrow, Blood test, Dyspnoea
Clinical narrative: Headache, sweats began 06/22/2012.  Symptoms increased over two weeks, and then included nausea, shortness of breath, right upper quadrant pain.  Diagnosed with leukemia (AML) on July 9, 2012.  First Hep A injection given 11/18/2011, booster given 06/05/2012.
Age: 48.0
Sex: F
Vaccine: HEPA
Symptoms: Headache, Hyperhidrosis, Nausea
Clinical narrative: Headache, sweats began 06/22/2012.  Symptoms increased over two weeks, and then included nausea, shortness of breath, right upper quadrant pain.  Diagnosed with leukemia (AML) on July 9, 2012.  First Hep A injection given 11/18/2011, booster given 06/05/2012.
Age: 8.0
Sex: M
Vaccine: FLUX
Symptoms: Haemorrhage, Urticaria
Clinical narrative: Dad notified school nurse that when student got home from school his back was bleeding. When parents looked at back, hives noted. Benadryl administered per parents.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dysphonia, Dyspnoea, Respiratory disorder, Wheezing
Clinical narrative: Cough; hoarseness; wheezing; closing of windpipe - unable to breathe except through nose. Cough lasted through the evening and night.  Inhaler & Vicks Rub helped to open windpipe somewhat.  Visit to doctor next morning, 10/31/2012.  Steroid injection and prescription for cough.  Told to avoid future flu shots.
Age: 24.0
Sex: F
Vaccine: TTOX
Symptoms: Expired drug administered, No adverse event
Clinical narrative: NONE to date. Patient received an expired Td (10/25/12).
Age: 48.0
Sex: F
Vaccine: HEPA, MNQ, PPV
Symptoms: Body temperature increased, Chest X-ray, Chills, Disturbance in attention, Dizziness
Clinical narrative: Woke up with headache and body aches. I commented that "I feel like I was hit by a bus". I went to work at 6:30 AM and continued to feel worse even though I took 2 tablets of Ibuprofen. I could not complete my shift because I had difficulty concentrating because I felt ill. I left work at 11:15 AM. In the afternoon around 3:00 PM I became very chilled (teeth chattering). My temperature was 102. I had taken Ibuprofen around noon but it didn't alleviate my symptoms. At 3:00 PM I took 2 325 mg tablets of Tylenol which lowered my fever to 100. I continued to take Tylenol about every four hours. I woke up to use the bathroom at 12:30 pm and woke up realizing I was laying on the floor. I got up and blacked out again. I was sweating profusely, felt nauseous, and light headed. My son called an ambulance and I went to the ER at about 1:00 AM on 10/31/2012.
Age: 48.0
Sex: F
Vaccine: HEPA, MNQ, PPV
Symptoms: Feeling abnormal, Full blood count, Headache, Hyperhidrosis, Loss of consciousness
Clinical narrative: Woke up with headache and body aches. I commented that "I feel like I was hit by a bus". I went to work at 6:30 AM and continued to feel worse even though I took 2 tablets of Ibuprofen. I could not complete my shift because I had difficulty concentrating because I felt ill. I left work at 11:15 AM. In the afternoon around 3:00 PM I became very chilled (teeth chattering). My temperature was 102. I had taken Ibuprofen around noon but it didn't alleviate my symptoms. At 3:00 PM I took 2 325 mg tablets of Tylenol which lowered my fever to 100. I continued to take Tylenol about every four hours. I woke up to use the bathroom at 12:30 pm and woke up realizing I was laying on the floor. I got up and blacked out again. I was sweating profusely, felt nauseous, and light headed. My son called an ambulance and I went to the ER at about 1:00 AM on 10/31/2012.
Age: 48.0
Sex: F
Vaccine: HEPA, MNQ, PPV
Symptoms: Malaise, Nausea, Pain, Urine analysis
Clinical narrative: Woke up with headache and body aches. I commented that "I feel like I was hit by a bus". I went to work at 6:30 AM and continued to feel worse even though I took 2 tablets of Ibuprofen. I could not complete my shift because I had difficulty concentrating because I felt ill. I left work at 11:15 AM. In the afternoon around 3:00 PM I became very chilled (teeth chattering). My temperature was 102. I had taken Ibuprofen around noon but it didn't alleviate my symptoms. At 3:00 PM I took 2 325 mg tablets of Tylenol which lowered my fever to 100. I continued to take Tylenol about every four hours. I woke up to use the bathroom at 12:30 pm and woke up realizing I was laying on the floor. I got up and blacked out again. I was sweating profusely, felt nauseous, and light headed. My son called an ambulance and I went to the ER at about 1:00 AM on 10/31/2012.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Blood lead normal, Blood mercury normal, Dizziness, Feeling jittery, Headache
Clinical narrative: Multiple non specific c/o that pt reports to getting the flu shot including dizziness, neuralgias, headache, feeling jittery.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Neuralgia
Clinical narrative: Multiple non specific c/o that pt reports to getting the flu shot including dizziness, neuralgias, headache, feeling jittery.
Age: 72.0
Sex: F
Vaccine: FLUX
Symptoms: Muscular weakness
Clinical narrative: 48 hours after INFLUENZA vaccine pt developed weakness to legs.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Malaise, Vomiting
Clinical narrative: Patient reports being "violently ill" the evening after receiving INFLUENZA vaccine. Patient reported vomiting.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dyspnoea, Laboratory test, Malaise, Pyrexia
Clinical narrative: 10/27 Vaccination given (L) deltoid approximately 5 PM. At 7 PM employee reported "shortness of breath, chills, low grade fever felt very ill all throughout night. Noted red raised diffuse rash on trunk, back did not seek medical care. Saw PMD 10/29.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous
Clinical narrative: 10/27 Vaccination given (L) deltoid approximately 5 PM. At 7 PM employee reported "shortness of breath, chills, low grade fever felt very ill all throughout night. Noted red raised diffuse rash on trunk, back did not seek medical care. Saw PMD 10/29.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC
Symptoms: Haematochezia, Irritability, Mucous stools, Occult blood positive
Clinical narrative: Blood and mucus in stool, slight irritability 5 days after Rotateq. Monitoring.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Pain in extremity
Clinical narrative: Sore arm that radiates to the hand and to the back.  Has been hurting times one week.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Throat tightness
Clinical narrative: Employee stated that two hours after receiving vaccine she felt tightness in her chest and felt that her throat was constricting. Employee stated that this feeling never subsided until she fell asleep that night, approximately 12 hours after receiving vaccine. No treatment was given. Employee did state she is very sensitive to any medication.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site rash
Clinical narrative: Have a one inch by three inch RED, raised rash on injection site. Also had headache evening of vaccination. Used ibuprofen and cortisone cream for relief.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Swelling, Urticaria
Clinical narrative: Redness and hives over nearly entire body, swelling of skin at wrists, elbows, knees; Took Benadryl.
Age: 0.15
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Screaming
Clinical narrative: He slept for about 2 1/2 hours and then woke up with high pitched screaming for 3 or more hours (with Tylenol).
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Brain injury, Cerebral ischaemia, Convulsion, Intensive care, Status epilepticus
Clinical narrative: Seizures. Was in status epilepticus. Eventually this caused diffuse anoxic brain injury.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Haematocrit normal, Haemoglobin normal, Influenza, International normalised ratio normal, Local swelling
Clinical narrative: Flu shot 10-2-12. Developed full body rash 10-3-12. Recovered. Got flu Sx-vomiting, rash, swelling to neck/face 10-11-12. Tx ER as is 17 wks pregnant. 23 hr. observation due to vomiting. Recovered & discharged.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Maternal exposure during pregnancy, Platelet count normal, Rash generalised, Swelling face, Ultrasound antenatal screen normal
Clinical narrative: Flu shot 10-2-12. Developed full body rash 10-3-12. Recovered. Got flu Sx-vomiting, rash, swelling to neck/face 10-11-12. Tx ER as is 17 wks pregnant. 23 hr. observation due to vomiting. Recovered & discharged.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting, White blood cell count increased
Clinical narrative: Flu shot 10-2-12. Developed full body rash 10-3-12. Recovered. Got flu Sx-vomiting, rash, swelling to neck/face 10-11-12. Tx ER as is 17 wks pregnant. 23 hr. observation due to vomiting. Recovered & discharged.
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Back pain, Injected limb mobility decreased, Injection site pain, Musculoskeletal pain
Clinical narrative: As soon as injection was given, I felt a lot of pain at the time.  I even commented that this pain was more than normal after a vaccine. The pain has continued for three weeks.  It is achy in my left arm (where vaccine was give), radiates to left shoulder blade and down left side of my back.  Limited range of motion; difficult to put shirts on overhead.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Pruritus generalised, Urticaria
Clinical narrative: ITCHING OVER ENTIRE BODY, HIVES, STILL ITCHING.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Diarrhoea, Pain, Pyrexia
Clinical narrative: I started to feel achy, chilled and some coughing. I had been advise to take Advil or Tylenol as needed and we to bed. I woke up about 6:30 am with the same symptoms, plus diarrhea. No real significant fever(99.1) I've just been pushing fluids and Advil & Tylenol as needed.
Age: 29.0
Sex: M
Vaccine: TTOX
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: AFTER TETANUS SHOT WAS GIVEN DONOR HAS LOC CONSCIOUSNESS A COUPLE SECONDS AFTER GIVING IT THEN BECAME PALE & SWEATY. HE SID HE INITIALLY FELT LT HEADED & FAINT IMMEDIATELY THEN HAD LOC.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: Started getting rashes and then hives on both arms after flu shot administration. Patient took Benadryl and symptoms resolved.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Chest discomfort, Hyperhidrosis, Irritability, Lymphadenopathy
Clinical narrative: "Adverse reaction to flu vaccine rec'd in left arm on 10/16/2012. That night I experienced sweating, leg cramps, irritibility, and chest pressure. Those symptoms subsided by the following day. 10/17/2012, I noticed a sore spot in my left armpit. Palpating the area, I could feel a lump under my skin that felt like a swollen lymph node. I do not have this on the other side of my body. Thursday, 10/18/12, the lump was larger and more sore, and that's when I made the connection that it might be related to the vaccine. Today, 10/19/12, it is more sore, but not larger."
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle spasms, Palpitations
Clinical narrative: "Adverse reaction to flu vaccine rec'd in left arm on 10/16/2012. That night I experienced sweating, leg cramps, irritibility, and chest pressure. Those symptoms subsided by the following day. 10/17/2012, I noticed a sore spot in my left armpit. Palpating the area, I could feel a lump under my skin that felt like a swollen lymph node. I do not have this on the other side of my body. Thursday, 10/18/12, the lump was larger and more sore, and that's when I made the connection that it might be related to the vaccine. Today, 10/19/12, it is more sore, but not larger."
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness, heat, pain at immunization site.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Two days post-injection, patient reports that the area of injection is now red, indurated, warm, and hard. He also reports that the area is itchy and hurts when touched.
Age: 57.0
Sex: M
Vaccine: FLUX
Symptoms: Pruritus
Clinical narrative: Itchiness on the hands, back of the neck, torso sides and back.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Eyelid oedema, Pyrexia
Clinical narrative: Low grade fever, slight swelling of both eyelids. No S.O.B, no inflammation to injection site. Physician called with recommendation to take over the counter oral Benadryl.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal discomfort, Chills, Dizziness, Headache, Hyperhidrosis
Clinical narrative: Sweating, stomach upset, chills, headache, slight dizziness and multiple vomiting.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Sweating, stomach upset, chills, headache, slight dizziness and multiple vomiting.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood test, Body temperature increased, Cardiac monitoring, Chest X-ray
Clinical narrative: REPORTED TO WORK 10/31/2012 AT 12:30 PM D/T NOT FEELING WELL, SAID HAD DIZZINESS, H/A NAUSEA, WENT HOME, FELT BETTER WENT TO CHURCH DINNER, BEGAN FEELING SAME SX AND WENT BACK HOME STATED HAD TEMP OF 102. ON 11/01/2012 REPORTED TO WORK THEN AT 08:25 C/O DIZZINESS, H/A AND BODY ACHES. TEMP 97.2, PULSE 103, B/P 141/92. OBSERVED CHILLS AND WEAKNESS. REFUSED MEDICAL TRANSPORT.  PICKED UP BY FAMILY MEMBER.  ADVISED TO SEEK MED. ATTENTION IMMEDIATELY.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Computerised tomogram head, Dizziness, Headache, Malaise
Clinical narrative: REPORTED TO WORK 10/31/2012 AT 12:30 PM D/T NOT FEELING WELL, SAID HAD DIZZINESS, H/A NAUSEA, WENT HOME, FELT BETTER WENT TO CHURCH DINNER, BEGAN FEELING SAME SX AND WENT BACK HOME STATED HAD TEMP OF 102. ON 11/01/2012 REPORTED TO WORK THEN AT 08:25 C/O DIZZINESS, H/A AND BODY ACHES. TEMP 97.2, PULSE 103, B/P 141/92. OBSERVED CHILLS AND WEAKNESS. REFUSED MEDICAL TRANSPORT.  PICKED UP BY FAMILY MEMBER.  ADVISED TO SEEK MED. ATTENTION IMMEDIATELY.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pain
Clinical narrative: REPORTED TO WORK 10/31/2012 AT 12:30 PM D/T NOT FEELING WELL, SAID HAD DIZZINESS, H/A NAUSEA, WENT HOME, FELT BETTER WENT TO CHURCH DINNER, BEGAN FEELING SAME SX AND WENT BACK HOME STATED HAD TEMP OF 102. ON 11/01/2012 REPORTED TO WORK THEN AT 08:25 C/O DIZZINESS, H/A AND BODY ACHES. TEMP 97.2, PULSE 103, B/P 141/92. OBSERVED CHILLS AND WEAKNESS. REFUSED MEDICAL TRANSPORT.  PICKED UP BY FAMILY MEMBER.  ADVISED TO SEEK MED. ATTENTION IMMEDIATELY.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Diarrhoea, Headache, Influenza, Malaise
Clinical narrative: 11/01/2012 patient is still sick with all possible flu symptoms such as: low grade fever, body aches, headaches, sinus congestion / stuffy nose, sore throat, chest pressure, and infrequent diarrhea.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Nasal congestion, Oropharyngeal pain, Pain, Pyrexia, Sinus congestion
Clinical narrative: 11/01/2012 patient is still sick with all possible flu symptoms such as: low grade fever, body aches, headaches, sinus congestion / stuffy nose, sore throat, chest pressure, and infrequent diarrhea.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Headache, Myalgia, Nausea, Pain in extremity
Clinical narrative: Very bad headache, body muscle aches, nausea, weak, painful arm. Lasted throughout the day and evening. OK by next day.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Convulsion, Flushing
Clinical narrative: Convulsive chills for about 15 minutes and then changed to flushing sensation for about 15 mins.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rash and hives. Itching over 70% of body.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Areflexia, Erythema, Myalgia
Clinical narrative: Muscle pain in arm; arm red; "no reflexes in legs"; "severe muscle pain".
Age: 15.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Condition aggravated, Convulsion
Clinical narrative: 1 day after receiving multiple vaccines, patient had 10 consecutive seizures resulting in hospitalization.