chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. No pertinent medical history was reported. On 08-AUG-2014, the patient was vaccinated with VARIVAX (Merck) (lot # K002920 and expiration date was 26-FEB-2016) dose 0.5 ml, subcutaneous injection. Concomitant medications was not reported. The physician reported that temperature excursions beginning 11-AUG-2014, with worst case exposure of -3.9C for 110 hours affecting VARIVAX (Merck) with lot # K002920 and expiration date 26-FEB-2016. Excursion supported for use within 3 months. No adverse effects reported. Patient did not sought medical attention. No Product Quality Complaint (PQC) was involved. This is one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a patient of age 14 (unspecified units) (unknown gender). No pertinent medical history was reported. On 11-SEP-2014, the patient was vaccinated with VARIVAX (Merck) (lot # K002920 and expiration date was 26-FEB-2016) dose 0.5 ml, subcutaneous injection. Concomitant medications was not reported. The physician reported that temperature excursions beginning 11-AUG-2014, with worst case exposure of -3.9C for 110 hours affecting VARIVAX (Merck) with lot # K002920 and expiration date 26-FEB-2016. Excursion supported for use within 3 months. No adverse effects reported. Patient did not sought medical attention. No Product Quality Complaint (PQC) was involved. This is one of the several patients from the same source. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient with no drug reactions/allergies. On 08-OCT-2014 the patient was vaccinated with ZOSTAVAX, lot# reported as K008881, expiry date 20-SEP-2015, (dose and route not reported). Pharmacist reported patient received ZOSTAVAX and experienced a red, itchy, sore and raised rash at the injection site. VZV was not offered as pharmacist terminated the call. No treatment was given for the events. None lab diagnostics studies were performed. The outcome of a red, itchy, sore and raised rash at the injection site was reported as not recovered. The patient had seen the pharmacist. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 75 year old male patient. On 03-OCT-2014 the patient was vaccinated with an expired dose of ZOSTAVAX (Lot # unknown, expiration date: 20-SEP-2014) (dose and route not reported). No adverse effects were reported. It was also reported that ZOSTAVAX vial's label was "very lightly printed". 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 pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. The pharmacist reported that on 06-OCT-2014, the patient was vaccinated with expired dose of PNEUMOVAX 23 lot # J007786, expiration date 25-SEP-2014, 0.5 ml, intramuscular. No adverse effect reported. Co-suspect and concomitant therapies were not reported. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Clonus, Convulsion, Electroencephalogram normal, Nuclear magnetic resonance imaging
Clinical narrative: 9/9/14 2:30A had generalized seizure with clonic movements of all extremities. Pt taken to ER by ambulance.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning an unspecified number of patients (demographics unknown). On 18-SEP-2014, the patients were inadvertently administered with improperly stored GARDASIL (lot # J006236; expiration date: 25-FEB-2016) (dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning an unspecified number of patients (demographics unknown). On 18-SEP-2014, the patients were inadvertently administered with improperly stored GARDASIL (Lot # K006095; expiration date: 02-FEB-2017) (dose and route were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Patient came to our office after getting the vaccine 24 hours ago. She started w/pruritic rash on her shoulder, trunk and legs.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies were not provided. On 13-OCT-2014, the patient was vaccinated inadvertently with an expired dose of VARIVAX (Merck), Lot # H017440 and expiration date on 19-SEP-2014. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Register Nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 06-OCT-2014, the patient was vaccinated with ZOSTAVAX, subcutaneous, lot number reported as J007855, expiration date 28-SEP-2014 (dose was not reported). Secondary and concomitant therapies were not reported. Nurse reported that a unspecified patient received an expired dose of ZOSTAVAX vaccine on 06-OCT-2014. No adverse events were reported. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain redness and swelling at all injection sites.
Age: 12.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Rash papulosquamous
Clinical narrative: Developed papulosquamous rash on trunk several days after vaccines administered and persisted for 2 weeks.
Age: 37.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Headache
Clinical narrative: Complained of headache approx 20-30 min. after getting vaccines on 10/9/14. Checked with client 10/14/14 and there is no problem.
Age: 5.0
Sex: F
Vaccine: HPVX
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 5 year old female patient. The patient's pertinent medical history, drug reactions/allergies were not provided. On 23-SEP-2014, a five year old patient was vaccinated with a dose of HPV (manufacturer unknown) (units not provided) lot number and expiration date not provided. No adverse effects were reported. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Local swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a male patient of unknown age. On 01-OCT-2014, the patient was vaccinated with PNEUMOVAX 23 (lot was reported as K007824; expiration date: 05-NOV-2015) (dose and route were not provided). On an unknown date in October 2014, the patient experienced swelling of the arm where PNEUMOVAX 23 was administered. The patient sought medical attention on an unspecified date at the office of unspecified physician and was prescribed KEFLEX and Clindamycin. The outcome of swelling of the arm where PNEUMOVAX 23 was administered was unknown. This is one of several reports from the same source. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dyspnoea, Eye pruritus, Injection site pain, Injection site warmth
Clinical narrative: 08/04/14 Pt had vaccines in office in afternoon. 08/05/14 Patient woke and stated her eyes felt very itchy. She also felt SOB. She had to leave for work. She progressively got worse took CLAIRITIN with no relief. SOB became progressively worse Rt arm where ADACEL was placed was hot to touch and she denied throat closing. Was given in office Albuterol and felt improved. SOB was dissipating. Was D/C'd with albuterol MEDROL Pak. Called next day Pt states felt 90% better.
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot # J005068; expiration date: 18-JAN-2015) (dose and route were not provided). On an unknown date, the patient experienced swelling in the arm where PNEUMOVAX 23 was administered. Unspecified if the patient sought medical attention. The outcome of swelling in the arm where PNEUMOVAX 23 administered was unkonwn. This is one of several reports from the same source. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Erythema and warmth around injection site. 1 1/2 inch x 1 1/4 inch area for about 4-5 days then increased to 2 x 2 inch area. Itched when size grew, as well as radiated heat.
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Cellulitis, Feeling cold, Pyrexia, Soft tissue infection
Clinical narrative: Pt felt feverish/cold. Cellulitis skin/soft tissue infection.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Pt gently slid to floor from chair into a sitting position against the wall. Brief loss of consciousness of about 5 seconds.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown ages and genders. On an unknown dates the patients were vaccinated with GARDASIL (route, dose number, dosage and lot number unknown) that was improperly stored. No adverse effects were reported. The physician also reported that improperly stored PEDVAXHIB (MARRS no. 1410USA006928) and VAQTA (MARRS no. 1410USA006929) were also administered. This is one of three reports on the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown ages and genders. On an unknown dates the patients were vaccinated with PEDVAXHIB (route, dose number, dosage and lot number unknown) that was improperly stored. No adverse effects were reported. The physician also reported that improperly stored GARDASIL (MARRS no. 1410USA003800) and VAQTA (MARRS no. 1410USA006929) were also administered. This is one of three reports on the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown ages and genders. On an unknown dates the patients were vaccinated with VAQTA (route, dose number, dosage and lot number unkonwn) that was improperly stored. No adverse effects were reported. The physician also reported that improperly stored PEDVAXHIB (MARRS no. 1410USA006928) and GARDASIL (MARRS no. 1410USA003800) were also administered. This is one of three reports on the same reporter. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 12 year old (reported as 12 or 13 year old) female patient. There were no pertinent medical history and allergies. In May (year not reported) the patient was vaccinated with GARDASIL dose 1. Patient received second dose of GARDASIL in July (year Unknown). No concomitant medication was reported. On an unknown date the patient experienced swelling of the lymph nodes underneath her collar bone on the left side of her body like the size of the piece of corn in May and July after receiving the first and second doses of GARDASIL. Treatment was not given. No lab diagnostics were performed. There was no intervention to prevent serious criteria. Product quality complaint was not involved. The outcome of swelling of the lymph nodes underneath her collar bone on the left side of her body was unknown. The causality of swelling of the lymph nodes underneath her collar bone on the left side of her body with GARDASIL was unknown. Additional information has been requested.
Age: 58.0
Sex: U
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Diarrhoea, Musculoskeletal pain
Clinical narrative: Symptoms: Acites in joints, chills, diarrhea, shoulder pain- Symptoms appeared on Wednesday- shot given on Monday.
Age: 16.0
Sex: F
Vaccine: HPV4, HEPA, HPV4, HEPA, HEPA, HPV4
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive, No adverse event
Clinical narrative: This prospective pregnancy case was reported by a physician and described the occurrence of vaccine expose during pregnancy in a female subject of unspecified age who was vaccinated with HAVRIX (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of HAVRIX (unknown route and injection site; lot number not provided). Her last menstrual period was on an unspecified date and estimated date of delivery was not provided. The subject was exposed to the vaccine during pregnancy (unknown trimester). The outcome of the pregnancy was unknown.   Follow-up information received on 08 October 2014 from the physician. The 16-year-old female patient received HAVRIX (batch number 5B23A, expiry date unknown). Co-suspect products included GARDASIL. Concomitant products included PRENATAL vitamins (unknown). On 30 July 2014, the patient received HAVRIX (intramuscular) .5ml and GARDASIL (intramuscular) .5 ml. The patient's last menstrual period was on an unknown date and estimated date of delivery was 19th December 2014.  This was a normal conception. The patient received HAVRIX during the second trimester of pregnancy. The pregnancy was ongoing.
Age: 16.0
Sex: F
Vaccine: HPV4, HEPA, HPV4, HEPA, HEPA, HPV4
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive
Clinical narrative: This prospective pregnancy case was reported by a physician and described the occurrence of vaccine expose during pregnancy in a female subject of unspecified age who was vaccinated with HAVRIX (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of HAVRIX (unknown route and injection site; lot number not provided). Her last menstrual period was on an unspecified date and estimated date of delivery was not provided. The subject was exposed to the vaccine during pregnancy (unknown trimester). The outcome of the pregnancy was unknown.   Follow-up information received on 08 October 2014 from the physician. The 16-year-old female patient received HAVRIX (batch number 5B23A, expiry date unknown). Co-suspect products included GARDASIL. Concomitant products included PRENATAL vitamins (unknown). On 30 July 2014, the patient received HAVRIX (intramuscular) .5ml and GARDASIL (intramuscular) .5 ml. The patient's last menstrual period was on an unknown date and estimated date of delivery was 19th December 2014.  This was a normal conception. The patient received HAVRIX during the second trimester of pregnancy. The pregnancy was ongoing.
Age: 16.0
Sex: F
Vaccine: HPV4, HEPA, HPV4, HEPA, HEPA, HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This prospective pregnancy case was reported by a physician and described the occurrence of vaccine expose during pregnancy in a female subject of unspecified age who was vaccinated with HAVRIX (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of HAVRIX (unknown route and injection site; lot number not provided). Her last menstrual period was on an unspecified date and estimated date of delivery was not provided. The subject was exposed to the vaccine during pregnancy (unknown trimester). The outcome of the pregnancy was unknown.   Follow-up information received on 08 October 2014 from the physician. The 16-year-old female patient received HAVRIX (batch number 5B23A, expiry date unknown). Co-suspect products included GARDASIL. Concomitant products included PRENATAL vitamins (unknown). On 30 July 2014, the patient received HAVRIX (intramuscular) .5ml and GARDASIL (intramuscular) .5 ml. The patient's last menstrual period was on an unknown date and estimated date of delivery was 19th December 2014.  This was a normal conception. The patient received HAVRIX during the second trimester of pregnancy. The pregnancy was ongoing.
Age: 16.0
Sex: F
Vaccine: HPV4, HEPA, HPV4, HEPA, HEPA, HPV4
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This prospective pregnancy case was reported by a physician and described the occurrence of vaccine expose during pregnancy in a female subject of unspecified age who was vaccinated with HAVRIX (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of HAVRIX (unknown route and injection site; lot number not provided). Her last menstrual period was on an unspecified date and estimated date of delivery was not provided. The subject was exposed to the vaccine during pregnancy (unknown trimester). The outcome of the pregnancy was unknown.   Follow-up information received on 08 October 2014 from the physician. The 16-year-old female patient received HAVRIX (batch number 5B23A, expiry date unknown). Co-suspect products included GARDASIL. Concomitant products included PRENATAL vitamins (unknown). On 30 July 2014, the patient received HAVRIX (intramuscular) .5ml and GARDASIL (intramuscular) .5 ml. The patient's last menstrual period was on an unknown date and estimated date of delivery was 19th December 2014.  This was a normal conception. The patient received HAVRIX during the second trimester of pregnancy. The pregnancy was ongoing.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Activities of daily living impaired, Asthenia, Blood creatinine normal, Blood culture negative, Diarrhoea
Clinical narrative: Per daughter, mom had high fever, ambulance was called by 11 am by daughter on 10/2/14. Pt was at ER and admitted for cellulitis. Unable to speak to patient.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Haematocrit decreased, Haemoglobin decreased, Injected limb mobility decreased, Local swelling, Mobility decreased
Clinical narrative: Per daughter, mom had high fever, ambulance was called by 11 am by daughter on 10/2/14. Pt was at ER and admitted for cellulitis. Unable to speak to patient.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Neutrophil count normal, Pain in extremity, Platelet count decreased, Pyrexia, White blood cell count increased
Clinical narrative: Per daughter, mom had high fever, ambulance was called by 11 am by daughter on 10/2/14. Pt was at ER and admitted for cellulitis. Unable to speak to patient.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Pyrexia
Clinical narrative: Per daughter, mom had high fever, ambulance was called by 11 am by daughter on 10/2/14. Pt was at ER and admitted for cellulitis. Unable to speak to patient.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Erythema, Joint range of motion decreased, Pain, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patient. Patient's current condition and medical history was not reported. On 08-OCT-2014, the patient was vaccinated with PNEUMOVAX23 (lot # reported as J00504, expiration date: 04-DEC-2014) 0.5 ml, intramuscular in the right deltoid. No concomitant medication was reported. On 09-OCT-2014, the patient experienced soreness, redness and a rash at the injection site, as well as limited range of motion in her right arm and fatigue. Patient was advised to see her primary health care provider. The patient did not seek medical attention but took ADVIL as treatment. There was no product quality complaint involved. The outcome of the events was reported as not recovered. Causality between PNEUMOVAX23 and the events was not provided. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Fatigue, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patient. Patient's current condition and medical history was not reported. On 08-OCT-2014, the patient was vaccinated with PNEUMOVAX23 (lot # reported as J00504, expiration date: 04-DEC-2014) 0.5 ml, intramuscular in the right deltoid. No concomitant medication was reported. On 09-OCT-2014, the patient experienced soreness, redness and a rash at the injection site, as well as limited range of motion in her right arm and fatigue. Patient was advised to see her primary health care provider. The patient did not seek medical attention but took ADVIL as treatment. There was no product quality complaint involved. The outcome of the events was reported as not recovered. Causality between PNEUMOVAX23 and the events was not provided. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Injected limb mobility decreased, Myalgia, Pain, Pain in extremity
Clinical narrative: Pt experienced pain in arm/shoulder 5 days after flu shot.
Age: 43.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Pt experienced pain in arm/shoulder 5 days after flu shot.
Age: 13.0
Sex: M
Vaccine: FLUX
Symptoms: Flushing, Urticaria
Clinical narrative: Large hives all over abdomen and on Left thigh. Face flushed. Gave him 25 mg of Benadryl and monitored him closely.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dizziness, Eye swelling, Local swelling, Oedema mouth
Clinical narrative: Swelling in arms, eyes, throat, lightheadedness, coughing, soft pallet swelling.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal oedema
Clinical narrative: Swelling in arms, eyes, throat, lightheadedness, coughing, soft pallet swelling.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Severely sore arm where administered, range of motion limited.
Age: 56.0
Sex: F
Vaccine: MMR
Symptoms: Parotid gland inflammation, Parotitis
Clinical narrative: Mild left salivary gland inflammation and parotitis.  Treatment - alternate ibuprofen and Tylenol; cool compress as tolerated.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Itching - Red Welted Area - Growing Larger.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Area of injection hot, swollen and red.  Redness growing.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Chills, Headache, Myalgia, Nausea
Clinical narrative: Began with muscle aches. Started fever that went up to 103. Achy joints. Shivers. Severe headache. Nausea.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Began with muscle aches. Started fever that went up to 103. Achy joints. Shivers. Severe headache. Nausea.
Age: 0.8
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Dyskinesia, Eye movement disorder, Unresponsive to stimuli
Clinical narrative: Mother noted abnormal movements of the upper and lower extremities, eyes rolled to the back and lasted a few minutes and she was unresponsive.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Itching and redness around injection site.  Redness continued to expand to 6 cm x 8cm over next few hours.  Became hot and firm.
Age: 49.0
Sex: F
Vaccine: FLUC3
Symptoms: Abdominal pain upper, Burning sensation, Dyspnoea, Feeling abnormal, Hypoaesthesia
Clinical narrative: Reported numbness and tingling and swelling in arm where flu shot was given and numbness in legs and swelling. L arm and hand where shot was given was darker that R hand and arm. State her brain felt "foggy". Sent to ED.
Age: 49.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site anaesthesia, Injection site reaction, Injection site swelling, Local swelling, Paraesthesia
Clinical narrative: Reported numbness and tingling and swelling in arm where flu shot was given and numbness in legs and swelling. L arm and hand where shot was given was darker that R hand and arm. State her brain felt "foggy". Sent to ED.
Age: 49.0
Sex: F
Vaccine: FLUC3
Symptoms: Skin discolouration
Clinical narrative: Reported numbness and tingling and swelling in arm where flu shot was given and numbness in legs and swelling. L arm and hand where shot was given was darker that R hand and arm. State her brain felt "foggy". Sent to ED.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Tongue discolouration
Clinical narrative: Black spot on tongue.
Age: 6.0
Sex: M
Vaccine: FLUN4
Symptoms: Computerised tomogram normal, Convulsion, Drooling, Tremor, Unresponsive to stimuli
Clinical narrative: Patient was asleep next to mother and started shaking all over, eyes open, not responding x 15 seconds. Slow to respond, drooling, couldn't hear or see. Went to ER Diagnosed with a seizure.
Age: 11.0
Sex: M
Vaccine: FLUX
Symptoms: Musculoskeletal pain
Clinical narrative: Significant shoulder pain soon after the flu shot that has gotten worse overnight.  He is in a great deal of pain the next morning.
Age: 79.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Arthralgia, Asthenia, Blood electrolytes, Chills, Electrocardiogram
Clinical narrative: General feeling of not feeling well, weakness, generalized tingling, achy joints & muscles, hard chills/shaking/shivering for hours, nausea/ vomiting, all progressed very rapidly, & was very frightening. Went to hospital, treated with IV, meds for nausea IV, dismissed several hours later.
Age: 79.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Full blood count, Malaise, Myalgia, Nausea, Paraesthesia
Clinical narrative: General feeling of not feeling well, weakness, generalized tingling, achy joints & muscles, hard chills/shaking/shivering for hours, nausea/ vomiting, all progressed very rapidly, & was very frightening. Went to hospital, treated with IV, meds for nausea IV, dismissed several hours later.
Age: 79.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Tremor, Troponin, Vomiting
Clinical narrative: General feeling of not feeling well, weakness, generalized tingling, achy joints & muscles, hard chills/shaking/shivering for hours, nausea/ vomiting, all progressed very rapidly, & was very frightening. Went to hospital, treated with IV, meds for nausea IV, dismissed several hours later.
Age: 79.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Asthenia, Chills, Electrocardiogram, Laboratory test, Nausea
Clinical narrative: General feeling of not feeling well, weakness, generalized tingling, achy joints & muscles, hard chills/shaking/shivering for hours, nausea/ vomiting, all progressed very rapidly, & was very frightening. Went to hospital, treated with IV, meds for nausea IV, dismissed several hours later.
Age: 79.0
Sex: M
Vaccine: FLUX, FLU3
Symptoms: Paraesthesia, Vomiting
Clinical narrative: General feeling of not feeling well, weakness, generalized tingling, achy joints & muscles, hard chills/shaking/shivering for hours, nausea/ vomiting, all progressed very rapidly, & was very frightening. Went to hospital, treated with IV, meds for nausea IV, dismissed several hours later.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Fatigue
Clinical narrative: Feeling tired/fatigued and had developed a cough soon after the injection.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Hyperhidrosis, Hypoaesthesia, Injection site anaesthesia, Injection site pain
Clinical narrative: Patient did not report any problems at the time of administration.  45 minutes after administration the patient notified us that she experienced pain at the injection site which started 5-10 minutes after the vaccine was administered.  The patient stated started as numbness and tingling in arm which traveled from the administration site down to the tips of fingers.  Stated 5-10 minutes after adminsitration and worsened over the 45 minutes.  Observed the patient for 15 additional minutes and symptoms had not changed.  She also stated that she was feeling hot and diaphoretic.  Advised to take ibuprofen.  Patient took 400mg ibuprofen. 1 hour later (2 hours after administration) patient stated localized numbness resolved but still with pain in elbow and tingling fingertips.  Also stating pain in shoulder blade area.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Musculoskeletal pain, Paraesthesia
Clinical narrative: Patient did not report any problems at the time of administration.  45 minutes after administration the patient notified us that she experienced pain at the injection site which started 5-10 minutes after the vaccine was administered.  The patient stated started as numbness and tingling in arm which traveled from the administration site down to the tips of fingers.  Stated 5-10 minutes after adminsitration and worsened over the 45 minutes.  Observed the patient for 15 additional minutes and symptoms had not changed.  She also stated that she was feeling hot and diaphoretic.  Advised to take ibuprofen.  Patient took 400mg ibuprofen. 1 hour later (2 hours after administration) patient stated localized numbness resolved but still with pain in elbow and tingling fingertips.  Also stating pain in shoulder blade area.
Age: 5.0
Sex: M
Vaccine: FLUN4
Symptoms: Eye swelling, Lip swelling
Clinical narrative: Swelling of lips and eyes on one side of face. No difficulty breathing. He had also been outside at the time.
Age: 52.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Activities of daily living impaired, Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Next day patient reports fever of 102 degrees F resulting in the patient staying home in bed. Spot in the right deltoid where PPSV 23 vaccine was administered was reported by patient to be red, warm, sore and inflamed. 72 hours after injection, erythema expanded. Six days after injection, patient was seen by physician, and physician noted erythema with mildly increased warmth. Affected area was from the right deltoid down to the mid humerus for a total of about 18 cm long and 10 cm wide. Physician's recommendations included acetaminophen and cold compresses. Eight days after injection, patient reports symptoms to almost be resolved.
Age: 52.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Pyrexia
Clinical narrative: Next day patient reports fever of 102 degrees F resulting in the patient staying home in bed. Spot in the right deltoid where PPSV 23 vaccine was administered was reported by patient to be red, warm, sore and inflamed. 72 hours after injection, erythema expanded. Six days after injection, patient was seen by physician, and physician noted erythema with mildly increased warmth. Affected area was from the right deltoid down to the mid humerus for a total of about 18 cm long and 10 cm wide. Physician's recommendations included acetaminophen and cold compresses. Eight days after injection, patient reports symptoms to almost be resolved.
Age: 64.0
Sex: F
Vaccine: FLUX, PPV, VARZOS
Symptoms: Blister, Culture, Erythema, Pain in extremity, Swelling
Clinical narrative: Arm pain, swelling and redness.  Now with blisters.
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Headache, Pyrexia
Clinical narrative: Low grade fever, headache, dizziness. Patient seen in ER.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Condition aggravated, Convulsion, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Patient is ex-23 weeker with hx of seizure disorder received influenza vaccine on 10/14 and approximately 1 hour later starting having a seizure; the seizure lasted 5 hours and persisted despite multiple AEDs (Ativan, fosphenytoin, phenobarbital, Diastat). The seizure was consistent with his previous seizures but had an additional element of "whole body stiffening." He normally seizes approximately once every 1-2 months. Was apparently afebrile at the outside hospital, though he developed a low-grade fever the day after the seizure.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Decreased appetite, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Slight sore throat, extreme fatigue, headache, body aches, loss of appetite, mild dizziness and nausea lasting through the weekend into Wed-10/15.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pain
Clinical narrative: Slight sore throat, extreme fatigue, headache, body aches, loss of appetite, mild dizziness and nausea lasting through the weekend into Wed-10/15.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia, Urticaria
Clinical narrative: Started with severe arm pain the day before. A fever of 101 spiked at 11:00 am. Hives developed on that arm at 8:00 pm that evening.
Age: 1.0
Sex: M
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Immunoglobulin therapy, Platelet count decreased, Rash generalised, Urticaria
Clinical narrative: Full body rash and hives, a plt count of 1, RHO(D) Immune Glob given via IV.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Headache for two days followed by 3 days of fever ad chills events, general aches.
Age: 38.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Hypersensitivity, Injection site pain, Injection site swelling
Clinical narrative: Pt. presented to ER at 2200 on 10/13/14 for pain/swelling to left shoulder radiating to left elbow. Pt. treated with IV BENADRYL, DEMEROL 50mg and PHENERGAN 25mg. Pt. was discharged with oral pain medication received teaching and handouts on hypersensitivity reaction. Patient advised to follow up in clinic in A.M. Pt. was seen in clinic on 10/14/14 at 9:12 A.M. and advised to continue current medication regimen along with Prednisone 20mg TID #15. Patient returned to clinic at 4PM and was admitted to county hospital for allergic reaction.
Age: 38.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Chills, Erythema, Feeling abnormal, Headache, Hypersensitivity
Clinical narrative: Pt. presented to ER at 2200 on 10/13/14 for pain/swelling to left shoulder radiating to left elbow. Pt. treated with IV BENADRYL, DEMEROL 50mg and PHENERGAN 25mg. Pt. was discharged with oral pain medication received teaching and handouts on hypersensitivity reaction. Patient advised to follow up in clinic in A.M. Pt. was seen in clinic on 10/14/14 at 9:12 A.M. and advised to continue current medication regimen along with Prednisone 20mg TID #15. Patient returned to clinic at 4PM and was admitted to county hospital for allergic reaction.
Age: 38.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site cellulitis, Oedema peripheral, Pain in extremity, Pruritus, Rash
Clinical narrative: Pt. presented to ER at 2200 on 10/13/14 for pain/swelling to left shoulder radiating to left elbow. Pt. treated with IV BENADRYL, DEMEROL 50mg and PHENERGAN 25mg. Pt. was discharged with oral pain medication received teaching and handouts on hypersensitivity reaction. Patient advised to follow up in clinic in A.M. Pt. was seen in clinic on 10/14/14 at 9:12 A.M. and advised to continue current medication regimen along with Prednisone 20mg TID #15. Patient returned to clinic at 4PM and was admitted to county hospital for allergic reaction.
Age: 38.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Swelling
Clinical narrative: Pt. presented to ER at 2200 on 10/13/14 for pain/swelling to left shoulder radiating to left elbow. Pt. treated with IV BENADRYL, DEMEROL 50mg and PHENERGAN 25mg. Pt. was discharged with oral pain medication received teaching and handouts on hypersensitivity reaction. Patient advised to follow up in clinic in A.M. Pt. was seen in clinic on 10/14/14 at 9:12 A.M. and advised to continue current medication regimen along with Prednisone 20mg TID #15. Patient returned to clinic at 4PM and was admitted to county hospital for allergic reaction.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Migraine
Clinical narrative: Severe, migraine type headache lasting four days.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: Painful burning and stinging while vaccine was injected into the muscle.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Rash, Rash erythematous, Rash pruritic, Skin warm
Clinical narrative: Red, swelling at vaccine site, then hot on arm next 3 days. Two weeks later itchy red rash on chest. Starting third week red itchy rash on neck creeping toward face.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccination site swelling
Clinical narrative: Red, swelling at vaccine site, then hot on arm next 3 days. Two weeks later itchy red rash on chest. Starting third week red itchy rash on neck creeping toward face.
Sex: U
Vaccine: TDAP
Symptoms: Choking sensation, Hypoaesthesia
Clinical narrative: Initial report received from a healthcare professional on 09 October 2014. It pertains to one of two patients from the same facility who experienced adverse events after administration of ADACEL; details for the other patient are captured in case number 2014SA140248. A patient (age, gender, and past medical history not reported) received a dose of ADACEL (lot number C4695AA) on 30 September 2014. At an unspecified amount of time later, on the same day as vaccination, the patient experienced a choking sensation and right arm numbness. The patient received an unspecified treatment, and subsequently recovered. No additional information was provided. Documents held by sender: None.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Cough, Fatigue, Hyperhidrosis, Nausea
Clinical narrative: Extremely fatigued (normally patient works at this time); Feverish (never took temp), chills, sweats, dry cough, nausea, whole body aches. Better today.In office Temp 98.2 F (2.5 hours after Tylenol. She has treated with rest, fluids, light diet, Tylenol.  No other symptoms. Appears to be recovering now. Will be seen tomorrow again in follow up.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pyrexia
Clinical narrative: Extremely fatigued (normally patient works at this time); Feverish (never took temp), chills, sweats, dry cough, nausea, whole body aches. Better today.In office Temp 98.2 F (2.5 hours after Tylenol. She has treated with rest, fluids, light diet, Tylenol.  No other symptoms. Appears to be recovering now. Will be seen tomorrow again in follow up.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: PATIENT'S MOTHER REPORTED ADVERSE EVENT ON 10/15/14.  MOTHER STATED THAT PATIENT DEVELOPED HIVES AROUND 8 PM ON 10/13/14.  HER HIVES STARTED ON HER EYELIDS AND EVENTUALLY SPREAD TO RIGHT SIDE OF FACE, THORAX, BILATERAL EXTREMITIES, AND BACK.  PATIENT TOOK A DOSE OF BENADRYL AND USED HYDROCORTISONE 1% CREAM FOR HER SYMPTOMS ON 10/13/14 AND HAD SOME RELIEF.  PATIENT HAD NEW SITES OF HIVES ON THE MORNING OF 10/14/14 AND TOOK ANOTHER DOSE OF BENADRYL.  HIVES RESOLVED THE EVENING OF 10/14/14 AND PATIENT IS SYMPTOM FREE ON 10/15/14.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Conjunctivitis, Cough, Dysphonia, Eye swelling, Eyelid margin crusting
Clinical narrative: Began to have a runny nose and itchy throat around 8:30 p.m. Escalated through the night into a cough and hoarse throat. Work up around 6:30 a.m. with conjunctivitis in both eyes (both eyes were red, matted shut and very swollen). Face and hands were slightly swollen throughout the morning. Left work around 2:30 p.m. on 10/14/2014 and took a Benadryl. Took a nap and awoke around 7:30 p.m. and my eyes were beginning to recover. On the morning of 10/15/2014 woke up feeling much better.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Ocular hyperaemia, Rhinorrhoea, Swelling face, Throat irritation
Clinical narrative: Began to have a runny nose and itchy throat around 8:30 p.m. Escalated through the night into a cough and hoarse throat. Work up around 6:30 a.m. with conjunctivitis in both eyes (both eyes were red, matted shut and very swollen). Face and hands were slightly swollen throughout the morning. Left work around 2:30 p.m. on 10/14/2014 and took a Benadryl. Took a nap and awoke around 7:30 p.m. and my eyes were beginning to recover. On the morning of 10/15/2014 woke up feeling much better.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Musculoskeletal pain, Pain in extremity
Clinical narrative: Pain in arm and shoulder (still ongoing as of 10/15/2014); Severe chills on 10/16/2014 about 6:00 PM.
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Influenza like illness, Injection site cellulitis
Clinical narrative: 1 hour had redness, developed flu like sx but no fever. Seen in clinic yesterday, +mild cellulitis at site of injection.
Age: 67.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: Zostavax arm - injection site warm to the touch/swollen to the size of a half dollar. Fluzone arm - injection shot slightly inflamed. Arm hot to the touch and growing in size. No systemic side effects/signs of anaphylaxis.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Pt's husband said pt had hives. Pt was taken to emergency room and was kept there for 2 days and 1 night.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Fatigue, Headache, Heart rate increased
Clinical narrative: Fever, rapid heart beat, chills, aches in all joints, extreme headache, fatigue, sleepy.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Somnolence
Clinical narrative: Fever, rapid heart beat, chills, aches in all joints, extreme headache, fatigue, sleepy.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Axillary pain, Lymphoedema
Clinical narrative: Lymphedema right axilla with radiating pain. History of conjunctival hemorrhages previously.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site nodule, Injection site pain, Injection site warmth
Clinical narrative: Injection site became very hot to the touch.  Large palpable knot is present at site as well.  Sore to touch.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Blood glucose, Hyperhidrosis, Tremor, Visual impairment
Clinical narrative: Diaphoretic, trembled, stated, "vision spotty". Did not lose consciousness.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Eye swelling, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: LEFT DELTOID SWOLLEN,RED, HOT, ITCHING, AND PAINFUL. ALSO LEFT EYE SWOLLEN.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site warmth
Clinical narrative: LEFT DELTOID SWOLLEN,RED, HOT, ITCHING, AND PAINFUL. ALSO LEFT EYE SWOLLEN.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Diarrhoea, Nausea
Clinical narrative: Chills, diarrhea and nausea.
Age: 0.13
Sex: M
Vaccine: DTAPIPVHIB, RV5
Symptoms: Crying
Clinical narrative: NON STOP CRYING FOR 4 HOURS.
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Vertigo
Clinical narrative: Severe vertigo, and fatigue.
Age: 86.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Mass, Skin warm, Swelling
Clinical narrative: Patient felt a lump which has gotten smaller over the last few days.  Today a week later the area is still red and slightly raised and warm to touch.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Dry eye, Paraesthesia, Skin warm
Clinical narrative: Felt weird feeling on left side of face/body (Received shot in left shoulder).  The only way I could describe it was that the face symptoms almost felt like a very minor sensation of novacane (like during/after a detal procedure).  But not the numbness when that fully sets in, the early onset feeling before numbess.  I didn't feel numb.  My left eye also felt a little dry (possibly).  My left leg felt a little bit of this weird sensation too.  I actually looked in the mirror to see if the left side of my face looked any different (it didnt).  My left ear also got warm/pink.  My ears getting warm/pink is a typical sign of a cold (for me).  These symptoms lasted at least until Monday 10/13/14 -dissipating a little each subsequent day.  So, approx. 4 days.  I received no treatment for these side effects except maybe over the counter ibuprofen. I hope this helps.  It was the first time I have received a flu shot.
Age: 1.72
Sex: F
Vaccine: HEPA, HIBV, PNC13
Symptoms: Injection site erythema
Clinical narrative: Upon awakening, mother noted red area 5 inches by 1.5 inches from the injection site of Hepatitis A and HIB. Child was able to walk and was oriented to surroundings.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hypoaesthesia, Injection site pain, Pain, Vision blurred
Clinical narrative: Pt describes a numb L arm that resolved next day. Next day she had lightheadedness, dizziness and blurred vision. The site (L arm) was sore and pt had body aches. Pt continues to have blurred vision.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Hypersomnia, Lethargy
Clinical narrative: Extreme lethargy.  Slept 8 hours during the day and another 9 hours that evening.  this reaction is not life threatening but I thought I should report it anyway.
Age: 2.0
Sex: M
Vaccine: FLUN4
Symptoms: Eye swelling, Rash papular
Clinical narrative: Small red bumps around eyes with a small amount of swelling.  No wheezing, difficulty breathing.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Musculoskeletal discomfort
Clinical narrative: Improper administration- Injected too high- hit bone and has had shoulder discomfort for 2 weeks. Patient will be seeing provider.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Headache, Malaise, Pain, Sinus congestion
Clinical narrative: Body aches, sinus congestion, headache, cough, general malaise.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Neck pain
Clinical narrative: Patient stated that she experienced right shoulder & neck pain. Went to emergency room. Received pain medication. Followed up with PCP & received more pain medication & steroids.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Erythema, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site was reddish purple, swollen and warm to touch.  Has one inch by 4 inch area with bruising in the center and redness with slight swelling and area warm to touch at 1500 on 10/15/14.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Skin warm
Clinical narrative: Injection site was reddish purple, swollen and warm to touch.  Has one inch by 4 inch area with bruising in the center and redness with slight swelling and area warm to touch at 1500 on 10/15/14.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling of site and the arm from shoulder to elbow.  Cold pack applied.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injection site erythema, Injection site swelling, Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: 10/8/14 Redness/Swelling at injection site, hives and itching on body intermittently. 10/9/14 Increased swelling at injection site, left fingertip numbness, itching intermittently on body. 10/10/14 Facial numbness on left side of face, right/left side facial numbness in PM, tingling. 10/15/14 Facial numbness, scalp numbness intermittently, "heaviness" in arms bilaterally. Denies difficulty with speech, coordination. Reports reaction at age 21 after PPD test (Redness, burning, swelling, numbness).