chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Mobility decreased, Neck pain
Clinical narrative: Patient claimed soreness in Right shoulder of neck after immunization. The next morning had difficulty getting out of bed, took a "pain pill" and felt better. Now is spreading to left side but much less severe.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: HPV # 2 - pt had at 8:30/AM - went to school - at 11 AM c/o being lightheaded and nausea. Mother states "had similar reaction" with HPV #1, but did not report. Increased fluids - pt had no further problems.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site pain, Injection site rash, Injection site warmth, Pyrexia
Clinical narrative: Rash developed on arm at injection site 7" x 4", inflamed and tender, and hot - patient had low grade fever.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site erythema, Injection site nodule, Local swelling
Clinical narrative: Red/purple knot at injection site. Left arm. Swollen.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Pt developed shingle rash and pain.
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Concussion, Head injury, Loss of consciousness, Syncope
Clinical narrative: Patient passed out/fainted, after shot and walking hit his head. Patient was taken to ER via ambulance and had a concussion. Pt was doing okay the next day.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pain
Clinical narrative: "3" circle around site of injection. Very sore and kind of hard". Originally said was not to the touch but then said was not really hot.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: Soreness began within 4-6 hrs - worsened 24 hr period. 24 hrs after shots I experienced chills and fever of 101.9 degrees. Pain arm was severe. Improvement after 48 hrs.
Age: 53.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site inflammation
Clinical narrative: Area around injection site became inflamed and red. A few days later reaction spread farther to under side of arm. Area also looked bruised.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site infection, Injection site pustule
Clinical narrative: Patient developed a skin infection (pustule) at injection site. Pt saw his dr for a course of cephalexin.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Bright. Red rash at site of injection circular round looks more like bug bite.
Sex: U
Vaccine: FLU3
Symptoms: Lip swelling, Pharyngeal oedema, Swelling face
Clinical narrative: After 45 min. pt complains about swelling of the throat, I did not see anything, so I asked pt to go to an urgent care close to us - > she had epipen and bec. after almost 1 1/2 she developed swelling of the face and lips -> was treated and know she is fine.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a female patient of unknown age. On an unknown date the patient was vaccinated with the first dose of GARDASIL (dose, route and lot # not reported) in her hip. The patient reported that she was late to receive her second injection in the series of GARDASIL. She did not specify exactly how late she was to receive the second injection. No adverse effects were reported. Additional information has been requested.
Age: 1.04
Sex: F
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 12 month old patient of unknown gender. The nurse reported that the patient received a dose of VARIVAX (Merck) (lot # unspecified) (route, dose and location unspecified) on 12-JUN-2002 and then vaccinated with a dose of MMR II (lot # unspecified) (HSA) (route, dose and location unspecified) on 25-JUN-2002. The patient had received VARIVAX (Merck) and MMR II at different times within a period less than 28 days. No adverse effect reported. Follow up has been received from the Registered Nurse. It was reported that there was no problem with this child and there was no problem with the product. These vaccinating dates were not given by their facility. They were called to about collecting the problem. VARIVAX (Merck) was given on 12-JUN-2002 and MMR II on 25-JUN-2002. It was too close. MMR II (lot # not reported) (dose and route not reported) was given on 07-OCT-2013 to correct. This is one of several reports received from the same reporter. It was linked to MARRS # 1310USA001833 and MARRS# 1310USA001834. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Vomiting
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 20 year old female patient (student) with allergy to amoxicillin. The patient's pre-existing medical condition included dysmenorrhea and tension headache. Patient came into the physician's office on 11-OCT-2013 for her third dose of GARDASIL (lot#, dose and route not reported). Patient declined receiving the medications and stated that on 11-JUN-2013 at 11:00 AM, the patient was vaccinated with second dose of GARDASIL (lot# H020002, expire date as 08-AUG-2015, intramuscular in the right deltoid, dose unspecified), she had nausea and vomiting the following day, on 12-JUN-2013. The outcome of nausea and vomiting was reported as recovered (unspecified date in 2013). Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report was received from a healthcare worker concerning a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot number and expiry date were reported as H015749 and 08-JUN-2014 respectively, dose and route unspecified). No concomitant therapy was reported. On an unknown date, the patient developed cellulitis after receiving one dose of PNEUMOVAX 23. It was unspecified if the patient sought any medical attention. The outcome of cellulitis was unknown. The relatedness for cellulitis was unknown for PNEUMOVAX 23. The healthcare worker requested lot check on behalf of physician. This is one of the two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report was received from a healthcare worker concerning a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot number and expiry date were reported as J004747 and 20-JUL-2014 respectively, dose and route unspecified). No concomitant therapy was reported. On an unknown date, the patient developed cellulitis after receiving one dose of PNEUMOVAX 23. It was unspecified if the patient sought any medical attention. The outcome of cellulitis was unknown. The relatedness for cellulitis was unknown for PNEUMOVAX 23. The healthcare worker requested lot check on behalf of physician. This is one of the two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of GARDASIL (lot#, dose and route were unknown). On an unknown date the patient experienced injections site reaction after receiving the dose of GARDASIL. The outcome of event was unknown. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product name confusion
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 30-OCT-2013 the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (lot # reported as J006827, EXP date 14-SEP-2014) intramuscularly. The reporter reported that the patient was going to receive an unspecified flu shot (manufacturer unknown) in the same vaccination session and that she administered the ZOSTAVAX intramuscularly due to product confusion. No adverse effects reported. It was unknown if the patient sought medical attention. At the time of report, the status of patient was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Adverse event, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On an unknown date in 2010, the patient was vaccinated with dose 1, GARDASIL (lot#, expiration date and route not reported). Patient sought medical attention on 24-OCT-2013 for "another problem" which began on an unspecified date approximately in 2013. On 24-OCT-2013 the patient was vaccinated with dose 2 GARDASIL (lot#, expiration date and route not reported). The outcome of the reported event was unknown. Physician additionally stated that the "problem" was not related to GARDASIL. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received refers to a patient of unknown age. On an unknown date the patient was vaccinated with an improperly stored vaccine of MMR II (lot # H014649, expired date 03-AUG-2014). The original reporter is unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a consumer refers to her daughter of unknown age. On 04-OCT-2013 the patient was vaccinated with 0.5 milliliter (ml) (reported as standard dose) dose 1, GARDASIL (lot # and expiration date not reported) intramuscularly. Patient was currently 5 weeks pregnant with Last Menstrual Period of 20-SEP-2013 and Estimated Delivery Date of 27-JUN-2014. Initial exposure to GARDASIL was at 2 weeks. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: This spontaneous report was received from a female patient of unknown age. On an unknown date in 2007 the patient was vaccinated with doses 1 and 2 GARDASIL (lot #, expiration date and route not reported). She never received the third dosage. She did not report any side effects. Additional information is not expected.
Age: 72.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Pruritus, Rash vesicular
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning an approximately 72 year old female patient with no pertinent medical history and no drug reactions or allergies. On 23-OCT-2013, the patient was vaccinated with 0.65 milliliter (ml) of ZOSTAVAX (lot number and expiry date were reported as J005721 and 29-AUG-2014 respectively), subcutaneously. Concomitant therapy included FLUZONE (lot number, expiry date, dose and route unspecified) administered on 23-OCT-2013. On 23-OCT-2013, the patient experienced intense itching on her trunk and legs later that day. Approximately on an unknown date in 2013 (reproted as after a few days), the patient developed raised bumps on her trunk and legs that looked like chickenpox. The patient did not seek any medical attention. The patient was treated with over the counter (OTC) BENADRYL. No lab tests were performed. The patient was recovering from the events. The relatedness for the events was unknown for ZOSTAVAX. VZVIP packet was declined by pharmacist. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to an unspecified number of patients of unknown age. On an unknown date the unspecified number of patients were vaccinated with ZOSTAVAX (lot number, expiration date, dose, route and indication not reported). The pharmacist stated that "in general, we have seen swelling, redness, and a rash around the injection site after the administration of ZOSTAVAX in an unspecified number of patients." No patient specific information was reported. The outcome of the events was unknown. It was unspecified if the patient's had sought medical attention. Additional information has been requested.
Age: 81.0
Sex: U
Vaccine: FLU3, FLU3, FLU3
Symptoms: Cold sweat, Dizziness, Headache, Hyperhidrosis, Pain in extremity
Clinical narrative: Slight soreness in arm - severe headache severe dizziness - could not go to bed - slept sitting up on chair for 2 nights. Sat most of the time for slight relief - unable to move around - all this was so very bad!! This began 1 1/2 days after the shot, FLUVIRIN, all this lasted for 5 full days. This was very bad to encounter.
Age: 81.0
Sex: U
Vaccine: FLU3, FLU3, FLU3
Symptoms: Dizziness, Headache, Hypokinesia, Pain in extremity
Clinical narrative: Slight soreness in arm - severe headache severe dizziness - could not go to bed - slept sitting up on chair for 2 nights. Sat most of the time for slight relief - unable to move around - all this was so very bad!! This began 1 1/2 days after the shot, FLUVIRIN, all this lasted for 5 full days. This was very bad to encounter.
Age: 81.0
Sex: U
Vaccine: FLU3, FLU3, FLU3
Symptoms: Chills, Myalgia, Pain in extremity
Clinical narrative: Slight soreness in arm - severe headache severe dizziness - could not go to bed - slept sitting up on chair for 2 nights. Sat most of the time for slight relief - unable to move around - all this was so very bad!! This began 1 1/2 days after the shot, FLUVIRIN, all this lasted for 5 full days. This was very bad to encounter.
Age: 53.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Pain, Rash, Skin sensitisation
Clinical narrative: One hour later after flu shot, pt got tingling feeling on the left torso. Later he said he got shingles.
Age: 53.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Herpes zoster, Paraesthesia
Clinical narrative: One hour later after flu shot, pt got tingling feeling on the left torso. Later he said he got shingles.
Sex: F
Vaccine: VARZOS, PPV
Symptoms: Erythema, Fatigue, Injection site pain, Swelling
Clinical narrative: This spontaneous report as received from a medical assistant refers to a female patient of unknown age with high blood pressure and hypothyroidism. Medical assistant reported that the patient received an unspecified pneumococcal vaccine (manufacturer unknown) about six years age and on 22-OCT-2013 was administered PNEUMOVAX23 (lot number, dose and route were not reported). Concomitant medications were not reported. Patient called the physician's office on 24-OCT-2013 and stated that she experienced redness and arm swelling on an unspecified date (in October 2013) in the arm she received the routine immunization. The outcome of redness and arm swelling was not reported. The relationship between the PNEUMOVAX23 and the events was not reported. No lab diagnostics studies were performed. This case is linked to case 1311USA004592 via same reporter link. Additional information has been requested.
Sex: F
Vaccine: VARZOS, PPV
Symptoms: Erythema, Local swelling
Clinical narrative: This spontaneous report as received from a medical assistant refers to a female patient of unknown age with high blood pressure and hypothyroidism. Medical assistant reported that the patient received an unspecified pneumococcal vaccine (manufacturer unknown) about six years age and on 22-OCT-2013 was administered PNEUMOVAX23 (lot number, dose and route were not reported). Concomitant medications were not reported. Patient called the physician's office on 24-OCT-2013 and stated that she experienced redness and arm swelling on an unspecified date (in October 2013) in the arm she received the routine immunization. The outcome of redness and arm swelling was not reported. The relationship between the PNEUMOVAX23 and the events was not reported. No lab diagnostics studies were performed. This case is linked to case 1311USA004592 via same reporter link. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Death
Clinical narrative: Case number PHEH2013US022855 is a combined spontaneous report both initial and follow-up was received from a nurse on 30 Oct 2013 and 31 Oct 2013. This report refers to an 80-year-old female patient. Her medical history included hypertension. She had no history of epilepsy or seizures. She was vaccinated with FLUVIRIN (batch number: 1308501, expiry date: Mar 2014) at a dose of 0.5 ml intramuscularly on 24 Oct 2013 at 7:20 am. She had no distress for the entire day and she was normal. On 25 Oct 2013, the next day after vaccination, she was found dead with lots of foam at the lips (mouth). Cause of death was unknown. Health department's request for an autopsy was refused because officials and family did not believe that the death was related to the vaccine. No other information was provided.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Death, Foaming at mouth
Clinical narrative: Case number PHEH2013US022855 is a combined spontaneous report both initial and follow-up was received from a nurse on 30 Oct 2013 and 31 Oct 2013. This report refers to an 80-year-old female patient. Her medical history included hypertension. She had no history of epilepsy or seizures. She was vaccinated with FLUVIRIN (batch number: 1308501, expiry date: Mar 2014) at a dose of 0.5 ml intramuscularly on 24 Oct 2013 at 7:20 am. She had no distress for the entire day and she was normal. On 25 Oct 2013, the next day after vaccination, she was found dead with lots of foam at the lips (mouth). Cause of death was unknown. Health department's request for an autopsy was refused because officials and family did not believe that the death was related to the vaccine. No other information was provided.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dry mouth, Hypoaesthesia oral, Oropharyngeal pain, Rash, Skin warm
Clinical narrative: Case number PHEH2013US022883 is a combined initial and follow-up spontaneous report from the nurse received on 30 Oct 2013 and on 31 Oct 2013. This report refers to a 44-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1308501, expiry date, Mar 2014) intramuscularly at a dose of 0.5 ml, on 27 Oct 2013 (at 04:29 pm). On the same date (at 04:45 pm), she experienced an anaphylactic shock and had rashes, generalized pain, dry mouth, a red neck, very hot body temperature, pain in hips, chest pain, difficulty breathing, difficult swallowing and a hoarse voice. She also had cervical pain, dorsal pain, muscle pain in shoulders and palpitations. The patient was given BENADRYL 50 mg, intravenous, PEPCID, MAALOX and VISTARIL immediately after the events. The patient was taken to emergency room on 27 Oct 2013 for the complaints of pressure in chest and numbness in hands. On 29 Oct 2013 patient still had cervical pain, dorsal pain, muscle pain in shoulders and palpitations. She was given methylprednisolone. She took it for one day only and discontinued on her own because she did not want any side effects from it. In the night of 30 Oct 2013, the patient was much improved. The seriousness of the events was not reported. The physician did not provide a causal relationship but the nurse felt the events were related to the FLUVIRIN.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Anaphylactic shock, Arthralgia, Back pain, Body temperature increased, Chest discomfort
Clinical narrative: Case number PHEH2013US022883 is a combined initial and follow-up spontaneous report from the nurse received on 30 Oct 2013 and on 31 Oct 2013. This report refers to a 44-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1308501, expiry date, Mar 2014) intramuscularly at a dose of 0.5 ml, on 27 Oct 2013 (at 04:29 pm). On the same date (at 04:45 pm), she experienced an anaphylactic shock and had rashes, generalized pain, dry mouth, a red neck, very hot body temperature, pain in hips, chest pain, difficulty breathing, difficult swallowing and a hoarse voice. She also had cervical pain, dorsal pain, muscle pain in shoulders and palpitations. The patient was given BENADRYL 50 mg, intravenous, PEPCID, MAALOX and VISTARIL immediately after the events. The patient was taken to emergency room on 27 Oct 2013 for the complaints of pressure in chest and numbness in hands. On 29 Oct 2013 patient still had cervical pain, dorsal pain, muscle pain in shoulders and palpitations. She was given methylprednisolone. She took it for one day only and discontinued on her own because she did not want any side effects from it. In the night of 30 Oct 2013, the patient was much improved. The seriousness of the events was not reported. The physician did not provide a causal relationship but the nurse felt the events were related to the FLUVIRIN.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chest pain, Dry mouth, Dysphagia, Dysphonia, Dyspnoea
Clinical narrative: Case number PHEH2013US022883 is a combined initial and follow-up spontaneous report from the nurse received on 30 Oct 2013 and on 31 Oct 2013. This report refers to a 44-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1308501, expiry date, Mar 2014) intramuscularly at a dose of 0.5 ml, on 27 Oct 2013 (at 04:29 pm). On the same date (at 04:45 pm), she experienced an anaphylactic shock and had rashes, generalized pain, dry mouth, a red neck, very hot body temperature, pain in hips, chest pain, difficulty breathing, difficult swallowing and a hoarse voice. She also had cervical pain, dorsal pain, muscle pain in shoulders and palpitations. The patient was given BENADRYL 50 mg, intravenous, PEPCID, MAALOX and VISTARIL immediately after the events. The patient was taken to emergency room on 27 Oct 2013 for the complaints of pressure in chest and numbness in hands. On 29 Oct 2013 patient still had cervical pain, dorsal pain, muscle pain in shoulders and palpitations. She was given methylprednisolone. She took it for one day only and discontinued on her own because she did not want any side effects from it. In the night of 30 Oct 2013, the patient was much improved. The seriousness of the events was not reported. The physician did not provide a causal relationship but the nurse felt the events were related to the FLUVIRIN.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Erythema, Hypoaesthesia, Myalgia, Neck pain, Pain
Clinical narrative: Case number PHEH2013US022883 is a combined initial and follow-up spontaneous report from the nurse received on 30 Oct 2013 and on 31 Oct 2013. This report refers to a 44-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1308501, expiry date, Mar 2014) intramuscularly at a dose of 0.5 ml, on 27 Oct 2013 (at 04:29 pm). On the same date (at 04:45 pm), she experienced an anaphylactic shock and had rashes, generalized pain, dry mouth, a red neck, very hot body temperature, pain in hips, chest pain, difficulty breathing, difficult swallowing and a hoarse voice. She also had cervical pain, dorsal pain, muscle pain in shoulders and palpitations. The patient was given BENADRYL 50 mg, intravenous, PEPCID, MAALOX and VISTARIL immediately after the events. The patient was taken to emergency room on 27 Oct 2013 for the complaints of pressure in chest and numbness in hands. On 29 Oct 2013 patient still had cervical pain, dorsal pain, muscle pain in shoulders and palpitations. She was given methylprednisolone. She took it for one day only and discontinued on her own because she did not want any side effects from it. In the night of 30 Oct 2013, the patient was much improved. The seriousness of the events was not reported. The physician did not provide a causal relationship but the nurse felt the events were related to the FLUVIRIN.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Palpitations, Rash
Clinical narrative: Case number PHEH2013US022883 is a combined initial and follow-up spontaneous report from the nurse received on 30 Oct 2013 and on 31 Oct 2013. This report refers to a 44-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1308501, expiry date, Mar 2014) intramuscularly at a dose of 0.5 ml, on 27 Oct 2013 (at 04:29 pm). On the same date (at 04:45 pm), she experienced an anaphylactic shock and had rashes, generalized pain, dry mouth, a red neck, very hot body temperature, pain in hips, chest pain, difficulty breathing, difficult swallowing and a hoarse voice. She also had cervical pain, dorsal pain, muscle pain in shoulders and palpitations. The patient was given BENADRYL 50 mg, intravenous, PEPCID, MAALOX and VISTARIL immediately after the events. The patient was taken to emergency room on 27 Oct 2013 for the complaints of pressure in chest and numbness in hands. On 29 Oct 2013 patient still had cervical pain, dorsal pain, muscle pain in shoulders and palpitations. She was given methylprednisolone. She took it for one day only and discontinued on her own because she did not want any side effects from it. In the night of 30 Oct 2013, the patient was much improved. The seriousness of the events was not reported. The physician did not provide a causal relationship but the nurse felt the events were related to the FLUVIRIN.
Age: 11.0
Sex: F
Vaccine: FLU3, MNQ, FLU3, MNQ, FLU3, MEN
Symptoms: CSF protein increased, Gait disturbance, Headache, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: Paresthesias in extremities, upper and lower weakness in legs and arms, fatigue, myalgias, slurred speech, unsteady gait, ataxic gait.
Age: 11.0
Sex: F
Vaccine: FLU3, MNQ, FLU3, MNQ, FLU3, MEN
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal abnormal, Pain in jaw, Paraesthesia
Clinical narrative: Paresthesias in extremities, upper and lower weakness in legs and arms, fatigue, myalgias, slurred speech, unsteady gait, ataxic gait.
Age: 11.0
Sex: F
Vaccine: FLU3, MNQ, FLU3, MNQ, FLU3, MEN
Symptoms: Ataxia, CSF glucose normal, CSF protein increased, CSF white blood cell count negative, Dysarthria
Clinical narrative: Paresthesias in extremities, upper and lower weakness in legs and arms, fatigue, myalgias, slurred speech, unsteady gait, ataxic gait.
Age: 11.0
Sex: F
Vaccine: FLU3, MNQ, FLU3, MNQ, FLU3, MEN
Symptoms: Fatigue, Gait disturbance, Muscular weakness, Myalgia, Nuclear magnetic resonance imaging brain
Clinical narrative: Paresthesias in extremities, upper and lower weakness in legs and arms, fatigue, myalgias, slurred speech, unsteady gait, ataxic gait.
Age: 11.0
Sex: F
Vaccine: FLU3, MNQ, FLU3, MNQ, FLU3, MEN
Symptoms: Nuclear magnetic resonance imaging spinal, Paraesthesia, Red blood cells CSF positive
Clinical narrative: Paresthesias in extremities, upper and lower weakness in legs and arms, fatigue, myalgias, slurred speech, unsteady gait, ataxic gait.
Age: 11.0
Sex: F
Vaccine: FLU3, MNQ, FLU3, MNQ, FLU3, MEN
Symptoms: Blood test, Guillain-Barre syndrome, Hypoaesthesia, Lumbar puncture abnormal, Nuclear magnetic resonance imaging
Clinical narrative: Paresthesias in extremities, upper and lower weakness in legs and arms, fatigue, myalgias, slurred speech, unsteady gait, ataxic gait.
Age: 26.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Burning sensation, Fatigue, Local swelling, Pain, Pruritus
Clinical narrative: Pt reports: 1 1/2 hours after receiving flu vaccine - hands and feet itching, swollen, red lasted several days and still occ. symptoms occurring on 11/4 but to much lesser extent. Extreme fatigue - 4 days. Generalized achiness - 4 days.
Age: 26.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Erythema, Fatigue, Local swelling, Pain, Pruritus
Clinical narrative: Pt reports: 1 1/2 hours after receiving flu vaccine - hands and feet itching, swollen, red lasted several days and still occ. symptoms occurring on 11/4 but to much lesser extent. Extreme fatigue - 4 days. Generalized achiness - 4 days.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Heart rate increased, Respiratory disorder
Clinical narrative: 11/03/2013 - in 2 hour after injection quick change in eye sight - feel dizzy - lasts 1 sec on the next day 11-04-13 feel dizzy, difficulty breathing, weakness, fast heart beat.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Dizziness, Dyspnoea, Heart rate increased, Visual impairment
Clinical narrative: 11/03/2013 - in 2 hour after injection quick change in eye sight - feel dizzy - lasts 1 sec on the next day 11-04-13 feel dizzy, difficulty breathing, weakness, fast heart beat.
Age: 58.0
Sex: M
Vaccine: FLUX
Symptoms: Bedridden, Increased upper airway secretion, Influenza, Insomnia, Oropharyngeal pain
Clinical narrative: Early symptoms began as sore throat and body aches on Friday evening; took Tylenol for aches; had difficulty sleeping d/t post-nasal drainage; was bed-ridden Saturday and taking measures to reduce flu symptoms; began producing phlegm Sat. evening; color of phlegm produced today, Monday, is of light-green color; symptoms are subsiding.
Age: 58.0
Sex: M
Vaccine: FLUX
Symptoms: Pain, Upper-airway cough syndrome
Clinical narrative: Early symptoms began as sore throat and body aches on Friday evening; took Tylenol for aches; had difficulty sleeping d/t post-nasal drainage; was bed-ridden Saturday and taking measures to reduce flu symptoms; began producing phlegm Sat. evening; color of phlegm produced today, Monday, is of light-green color; symptoms are subsiding.
Age: 49.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Dizziness, Hyperhidrosis, Loss of consciousness, Nausea
Clinical narrative: Nausea, profuse sweating, weakness, dizzyness that led to blacking out. Blacked out for about 5 minutes. Recovery to feeling o.k. took about 20 minutes.  Felt weak for another couple of hours.  ~6 hours before feeling completely normal. No treatment.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blindness unilateral, Laboratory test normal, Nuclear magnetic resonance imaging brain normal, Optic ischaemic neuropathy, Scan abnormal
Clinical narrative: Lost central vision in left eye, day after vaccine. Ophthalmologist started aspirin therapy. Had extensive lab work, MRI of Brain, Carotid Scan, saw several specialists - Will be having Nuclear thyroid scan and sonogram.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Thyroid neoplasm
Clinical narrative: Lost central vision in left eye, day after vaccine. Ophthalmologist started aspirin therapy. Had extensive lab work, MRI of Brain, Carotid Scan, saw several specialists - Will be having Nuclear thyroid scan and sonogram.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Deafness, Guillain-Barre syndrome, Musculoskeletal stiffness, Neuralgia, Paraesthesia
Clinical narrative: Apparently contracted GBS from a HIGH DOSE flu vaccine which caused some severe nerve pain, affecting tendons (finger, ankle, heel), daily that changes locations such as shoulders, neck (constant stiff neck) wrists, knee areas; tingling in arms; and then overnight on 10/27/13 got up with a significant loss of hearing (at least a 30% loss).
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Seizure like phenomena
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 12 year old (also reported as 11 to 12) male patient. Approximately on an unknown date in August 2013 (reported as 3 months ago), the patient was vaccinated with a dose of GARDASIL (Lot number, expiry date, route and dose were not reported). Approximately on an unknown date in August 2013 (reported as 3 months ago), the patient experienced seizure like motions. Patient was awake during the seizure-like motions and recovered on an unknown date in 2013. Upon internal review the event seizure-like motions was considered as medically significant. Additional information is not expected.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Chills, Eyelid function disorder, Headache, Hyperhidrosis
Clinical narrative: This spontaneous report as received from a 51 year old female patient with no pertinent medical history and no drug reactions or allergies, refers to herself. On 07-NOV-2013 the patient was vaccinated with the dose of ZOSTAVAX one time vaccine (dose, lot number and route of administration were not reported) in the right arm. On 07-NOV-2013, the patient become ill, had to call ambulance and was taken to Emergency Room. It was reported that the patient was hospitalized. The patient had headache, it was hard to open her eyes, could not focus, was sweating and had chills, had rush down her body. Blood work was done on 07-NOV-2013 (reported as yesterday) in emergency room for vaccine reaction (results not provided). The patient was treated for the events with generic BENADRYL given intravenously (IV) as fluid in emergency room and was prescribed 2 medication, hydroxyzine (unspecified) and hydrocortisone (HCO) (unspecified) as needed. The patient was feeling better at the time of the report. The relatedness between the events and ZOSTAVAX was not reported. Upon internal review reported events were considered to be medically significant due to generic BENADRYL used by intravenous route for treatment. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Sensory disturbance, Vision blurred
Clinical narrative: This spontaneous report as received from a 51 year old female patient with no pertinent medical history and no drug reactions or allergies, refers to herself. On 07-NOV-2013 the patient was vaccinated with the dose of ZOSTAVAX one time vaccine (dose, lot number and route of administration were not reported) in the right arm. On 07-NOV-2013, the patient become ill, had to call ambulance and was taken to Emergency Room. It was reported that the patient was hospitalized. The patient had headache, it was hard to open her eyes, could not focus, was sweating and had chills, had rush down her body. Blood work was done on 07-NOV-2013 (reported as yesterday) in emergency room for vaccine reaction (results not provided). The patient was treated for the events with generic BENADRYL given intravenously (IV) as fluid in emergency room and was prescribed 2 medication, hydroxyzine (unspecified) and hydrocortisone (HCO) (unspecified) as needed. The patient was feeling better at the time of the report. The relatedness between the events and ZOSTAVAX was not reported. Upon internal review reported events were considered to be medically significant due to generic BENADRYL used by intravenous route for treatment. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: FLU3, HEPA, HPV4, MNQ
Symptoms: Convulsion, Electroencephalogram abnormal, General physical condition abnormal, Nasopharyngitis, Nuclear magnetic resonance imaging
Clinical narrative: "Cold". Looked run down within few days of vaccination. Oct. 2, 2012 - first mild "spells", increasing in frequency and intensity. Oct. 26 - 17 seizures/24 hrs., day and night.
Age: 52.0
Sex: F
Vaccine: DT
Symptoms: Activities of daily living impaired, Immediate post-injection reaction, Impaired driving ability, Injection site pain, Insomnia
Clinical narrative: Immediate and excruciating pain upon administration of tetanus shot 10/13/12 1:15 PM. Inability to raise arm without extreme pain for over 2 weeks. Pain at site of injection has continued as well as radiating pain into shoulder area for one year. X-ray and MRI's done - rotator cuff shows small tear. Physical therapy 3x a week from 4/22/13 thru 7/11/13 with no improvement. Cortisone shot 2x provided only short temp. relief. One year after inoculation - inability to raise arm, sleep, drive, change clothes, or do any physical activity without pain.
Age: 52.0
Sex: F
Vaccine: DT
Symptoms: Mobility decreased, Nuclear magnetic resonance imaging abnormal, Pain, Rotator cuff syndrome, X-ray limb abnormal
Clinical narrative: Immediate and excruciating pain upon administration of tetanus shot 10/13/12 1:15 PM. Inability to raise arm without extreme pain for over 2 weeks. Pain at site of injection has continued as well as radiating pain into shoulder area for one year. X-ray and MRI's done - rotator cuff shows small tear. Physical therapy 3x a week from 4/22/13 thru 7/11/13 with no improvement. Cortisone shot 2x provided only short temp. relief. One year after inoculation - inability to raise arm, sleep, drive, change clothes, or do any physical activity without pain.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Angiogram, Pharyngeal oedema, Swollen tongue, Throat tightness, Tongue disorder
Clinical narrative: C/O throat swelling and feeling like her tongue was thick and swollen. Symptoms lasted several hours and subsided after she vomited. Admitted because of "tightness in her throat".
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: C/O throat swelling and feeling like her tongue was thick and swollen. Symptoms lasted several hours and subsided after she vomited. Admitted because of "tightness in her throat".
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: The patient complained of itching starting 2-3 days after the shot. First tried BENADRYL and then was put on a steroid for his doctor.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Joint range of motion decreased, Pain, Paraesthesia
Clinical narrative: Since injection have had continuous pain/aching/soreness in (L) arm from shoulder to elbow. (During the injection in (L) deltoid - felt burning down to elbow and some tingling in hand then and still intermittent). Decreased range of motion in some positions due to pain.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Pt was administered vaccine on 11/5/13 and just today, 11/12/13. She noticed a red area about the size of half dollar around the injection area. It was not bumpy, warm, or irritated. Pt told to monitor area and to call back if any worsening of symptoms.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Eye pruritus, Eyelid oedema, Lip oedema, Musculoskeletal stiffness
Clinical narrative: Flu shot given 1:15 pm. Later that afternoon had cold symptoms with hoarseness. Woke up the next morning with itchy eyes, edema of lips, puffy eyes, facial tightness, sore stiff neck. Sent to physician's office for evaluation. (Also had rash on face and neck) BENADRYL given, sent home.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Nasopharyngitis, Neck pain, Rash, Skin tightness
Clinical narrative: Flu shot given 1:15 pm. Later that afternoon had cold symptoms with hoarseness. Woke up the next morning with itchy eyes, edema of lips, puffy eyes, facial tightness, sore stiff neck. Sent to physician's office for evaluation. (Also had rash on face and neck) BENADRYL given, sent home.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Vertigo
Clinical narrative: Vertigo.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Patient had syncope about 5-7 minutes following vaccine.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Flushing
Clinical narrative: Pt. began to feel woozy - then became flushed - we kept her with us and her fellow RN's. This lasted about 5-10 minutes. We decided to give her BENADRYL 50 mg SC - she then seemed to recover and went back to work. Suggested she not drive home alone - she left with RN's to rescue unit.
Age: 88.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: 10-29-13 - Vaccine on 10-25-13, onset evening of 10-27-13 c/o deep pain to (L) arm 9 - 10 on pain scale with some pain in (R) arm as well relieved with hot water bottles. Next day 'light pain' worsened last night 10-28-13. Came into clinic 10-29-13. Has appt with PMD in "3-4 days". Called and reported to PCP. Spoke with someone in office who offered pt appt today. He declined instead to call us if change in status care. 11-12-13 F/U with pt stated pain persisted 8 days and resolved did see MD for scheduled visit.
Age: 45.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Swelling
Clinical narrative: Red/swollen 55 mm induration.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain
Clinical narrative: Developed stinging pain (that awakened me in the middle of the night) and numbness in (L) arm one week post flu immunization (L) arm. Episodes occurred frequently for 3 weeks til I went to Occ Helath and received MEDROL Dose Pak and NAPROSYN.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site swelling, Pyrexia, Swelling
Clinical narrative: Inject site reaction, swelling all upper arm aside from injection site, down inside of left arm. Pt. gave ice therapy. Red, swollen and pt had fever, took TYLENOL. After 3 days was better although not entirely gone.
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Bacterial test positive, Decreased appetite, Fatigue, Feeling abnormal
Clinical narrative: Case number PHEH2013US022858 is an initial spontaneous report received from a consumer on 30 Oct 2013. This report refers to an adult female patient whose age was not reported. Her medical history included sickness due to shingles for over a year which was continuing and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on an unknown date (reported as a week ago). On an unknown date after vaccination (about a week ago), she started experiencing adverse reactions. She stated that she felt like she was dying. She reported that doctor refused to see her since she hasn't been there in over a year. She was not eating and was throwing up and had bad muscle aches. She was very tired and could not do anything. She felt like she was working for 6 months. She was running a fever also, but not very high. She had bacteria in the blood stream. She felt like someone had beat her up and her knees in the front were swollen. She was not able to walk anywhere. She had soreness and could hardly get out of bed. The outcome of the event was reported as unknown. No further information was provided.
Sex: F
Vaccine: FLU3
Symptoms: Joint swelling, Mobility decreased, Myalgia, Pain, Pyrexia
Clinical narrative: Case number PHEH2013US022858 is an initial spontaneous report received from a consumer on 30 Oct 2013. This report refers to an adult female patient whose age was not reported. Her medical history included sickness due to shingles for over a year which was continuing and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on an unknown date (reported as a week ago). On an unknown date after vaccination (about a week ago), she started experiencing adverse reactions. She stated that she felt like she was dying. She reported that doctor refused to see her since she hasn't been there in over a year. She was not eating and was throwing up and had bad muscle aches. She was very tired and could not do anything. She felt like she was working for 6 months. She was running a fever also, but not very high. She had bacteria in the blood stream. She felt like someone had beat her up and her knees in the front were swollen. She was not able to walk anywhere. She had soreness and could hardly get out of bed. The outcome of the event was reported as unknown. No further information was provided.
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Case number PHEH2013US022858 is an initial spontaneous report received from a consumer on 30 Oct 2013. This report refers to an adult female patient whose age was not reported. Her medical history included sickness due to shingles for over a year which was continuing and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on an unknown date (reported as a week ago). On an unknown date after vaccination (about a week ago), she started experiencing adverse reactions. She stated that she felt like she was dying. She reported that doctor refused to see her since she hasn't been there in over a year. She was not eating and was throwing up and had bad muscle aches. She was very tired and could not do anything. She felt like she was working for 6 months. She was running a fever also, but not very high. She had bacteria in the blood stream. She felt like someone had beat her up and her knees in the front were swollen. She was not able to walk anywhere. She had soreness and could hardly get out of bed. The outcome of the event was reported as unknown. No further information was provided.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site infection, Injection site inflammation, Injection site rash, Injection site warmth
Clinical narrative: Patient received vaccine on 10/30/13 and noticed a small raised bump at the injection on 11/1/13. Patient took Ibuprofen and BENADRYL to help with inflammation. On 11/4/13 patient went to MD; the site of inflammation was very large, raised, red, and hot. The MD gave ABX for infection.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt called reporting swelling and a nickel sized red circle surrounding the injection site 2-3 days after. Patient used one dose of BENADRYL and reported that her symptoms then resolved.
Age: 6.0
Sex: M
Vaccine: DTAP, HEP
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Rash macular
Clinical narrative: Rt. shoulder to below elbow swollen. Warm to touch, red splotches. BENADRYL and Ibuprofen given by mom. Mom called doctor, advised to apply cold compresses and continue BENADRYL.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Rash, Rash erythematous
Clinical narrative: Patient had a flu vaccine at pharmacy. Came to clinic 30 min later. C/O feeling hot and red in face. Neck, arms and chest were red with a rash. Patient given IM epi and BENADRYL.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Arthritis, Condition aggravated, Headache, Injection site erythema
Clinical narrative: Itching, swelling, tingling and headache, redness in (L) deltoid. Joint hurt b/c patient - has arthritis.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Pruritus, Swelling
Clinical narrative: Itching, swelling, tingling and headache, redness in (L) deltoid. Joint hurt b/c patient - has arthritis.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered, Injection site extravasation, Vomiting
Clinical narrative: After needle was withdrawn from arm, a large amount of vaccine dripped down pt's arm. Per CDC recommendation, I repeated the dose since the patient received less than the recommended dose, but used approximately 0.25 mL, not the entire dose. The following day, pt reported vomiting.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Eye swelling, Pruritus, Skin burning sensation, Skin plaque
Clinical narrative: Receive flu injection on 10-29-13. Starting Wed. morning burning and itching of skin. Also "some trouble breathing". Went to ER Thursday night and Friday morning. Has hives/whelps "all over" "plaque-like", swelling eyes. Currently on BENADRYL, Prednisone, PEPCID. SOLUMEDROL given at ER. To try to see allergist.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Receive flu injection on 10-29-13. Starting Wed. morning burning and itching of skin. Also "some trouble breathing". Went to ER Thursday night and Friday morning. Has hives/whelps "all over" "plaque-like", swelling eyes. Currently on BENADRYL, Prednisone, PEPCID. SOLUMEDROL given at ER. To try to see allergist.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Headache, nausea, red, swollen, warm inj site, throat itchiness, weakness, pale, L upper arm.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pallor, Throat irritation
Clinical narrative: Headache, nausea, red, swollen, warm inj site, throat itchiness, weakness, pale, L upper arm.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous
Clinical narrative: States she had rash on neck to hairline/chin all around. Red small bumps on neck/chin. CLARITIN, BENADRYL 25 mg HS.