chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Exposure during pregnancy, Haemorrhage
Clinical narrative: Information has been received from a registered nurse for GARDASIL, a Pregnancy Registry product, concerning an 18 years old female patient with no pertinent medical history who on 25-JUN-2012, was vaccinated with the first dose of GARDASIL (route and lot# not reported). Concomitant therapy included prenatal vitamins. It was reported that the patient received the first dose of GARDASIL and subsequently found out she was pregnant. No treatment information was reported. LMP: 08-JUN-2012. EDC: 22-JUN-2012. EDD: 15-MAR-2013. At the time of the report, the patient's outcome was unknown. She sought medical attention per office visit. Follow up information was received from the nurse. She reported that this patient was seen in the office on 27-AUG-2012 and should have gotten the second dose of GARDASIL but did not get it because she was pregnant. The next day, 28-AUG-2012, she was seen for bleeding and it was reported that she miscarried that day. It was not reported if any procedures were done. Upon internal review, miscarriage was considered to be medical significant. Additional information is not expected.
Age: 64.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning a 64 year old patient of unknown gender. On 25-OCT-2013, the patient was inadvertently vaccinated with 0.5 milliliter (ml) of VARIVAX (Merck) (lot number and expiry date unspecified), subcutaneously instead of ZOSTAVAX. No concomitant therapy was reported. No adverse effects were reported. Additional information has been requested.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age. The unknown number of patients had received ZOSTAVAX (lot number not provided) and VARIVAX (Merck) (lot number not provided) doses which were exposed to -6.8C for 1.5 hours every 24 hours due to defrost cycle every day. No adverse effect reported. It was unspecified if the patients had sought medical attention. The health care professional contacted during telephone follow-up did not remember which patient might have received these vaccines and could not supply the following information: patient name, date of birth, dates of vaccination, or lot number. She also stated that the vaccines have been moved to a proper storage unit. Follow-up information received from the healthcare worker. Patient information was updated. On 27-SEP-2013 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot#, expiration date and route not reported). This is one of the several reports from the same source. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a 69 year old female patient with spinal pain. The patient's pertinent medical history included spinal pain. The patient had no drug reactions or allergies. In 2009 the patient was vaccinated with ZOSTAVAX (1 time vaccination, route, dosage and lot number unknown). Concomitant therapies included gabapentin and TYLENOL. The patient stated that on 26-SEP-2013 she had gotten shingles after getting the ZOSTAVAX vaccine. She stated it was on her right side on her hip to her groin. She stated she is under doctor's care currently. The patient sought medical attention and received treatment with hydro-morphone and gabapentin. No lab diagnostics studies were performed. The outcome of the shingles was unknown. Additional information is not expected.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age. The unknown number of patients had received ZOSTAVAX (lot number not provided) and VARIVAX (Merck) (lot number not provided) doses which were exposed to -6.8C for 1.5 hours every 24 hours due to defrost cycle every day. No adverse effect reported. It was unspecified if the patients had sought medical attention. The health care professional contacted during telephone follow-up did not remember which patient might have received these vaccines and could not supply the following information: patient name, date of birth, dates of vaccination, or lot number. She also stated that the vaccines have been moved to a proper storage unit. Follow-up information received from the healthcare worker. Patient information was updated. On 30-SEP-2013 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot#, expiration date and route not reported). This is one of the several reports from the same source. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Autoimmune thyroiditis, Blood test, Decreased appetite, Pain in extremity
Clinical narrative: This spontaneous report has been received from a mother who was referring to her daughter. The patient was an approximately 17 years old, not pregnant female with unspecified allergic reaction to penicillin, which started on unspecified date in the past, and with no pertinent medical history. In January 2013, reported as sometime in 2013, the patient was vaccinated with GARDASIL (lot not reported #) first dose, intramuscular (dose, strength not reported). There were no concomitant therapies. It was reported that after the daughter was administered the vaccine she was diagnosed with Hashimoto's thyroiditis, she experienced soreness of the arm, lost twenty pounds and she was losing her hair and appetite, adverse events onset date was reported as March 2013. It was reported that the patient was being monitored and she had blood drawn every sixty to ninety days (no results provided). The patient sought medical attention by office visit on unspecified dates. The patient did not recover from the adverse events. The relatedness between the adverse event and GARDASIL was not assess by the reporter. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Weight decreased
Clinical narrative: This spontaneous report has been received from a mother who was referring to her daughter. The patient was an approximately 17 years old, not pregnant female with unspecified allergic reaction to penicillin, which started on unspecified date in the past, and with no pertinent medical history. In January 2013, reported as sometime in 2013, the patient was vaccinated with GARDASIL (lot not reported #) first dose, intramuscular (dose, strength not reported). There were no concomitant therapies. It was reported that after the daughter was administered the vaccine she was diagnosed with Hashimoto's thyroiditis, she experienced soreness of the arm, lost twenty pounds and she was losing her hair and appetite, adverse events onset date was reported as March 2013. It was reported that the patient was being monitored and she had blood drawn every sixty to ninety days (no results provided). The patient sought medical attention by office visit on unspecified dates. The patient did not recover from the adverse events. The relatedness between the adverse event and GARDASIL was not assess by the reporter. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Headache, Hypoacusis, Ocular hyperaemia, Rash
Clinical narrative: Pt stated that she had headache, cough, mouth sores, rash on chest area. The blood vessels of her eye were red, and had trouble hearing.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Stomatitis
Clinical narrative: Pt stated that she had headache, cough, mouth sores, rash on chest area. The blood vessels of her eye were red, and had trouble hearing.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Pharyngeal oedema
Clinical narrative: Difficulty breathing, throat swelling. EPIPEN, DEPO MEDROL, oxygen.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown and gender age patient. Pertinent medical history, drug reactions or allergies were not reported. On 21-JUN-2013, the patient was vaccinated with an improperly store dose of VARIVAX (Merck), (dose was not reported), lot # H009635, expiration date: 09-MAY-2014. Concomitant medication was not reported. The reporter stated that VARIVAX (Merck) was improperly stored from 03-JUN-2013 to 21-JUN-2013, and the total amount of time that the doses were above the recommended storage range of -15 Celsius (C) was 187.5 hours. Though most the temperatures recorded in that time period were below -10C, there were three occasions where a highest temperature of 0C was recorded. The three temperature excursions were: 1). 88.5 hours to as warm as 0C, 2). 7.5 hours to as warm as -6C, and 3). 88.5 hours to as warm as -8C. No adverse effect had been observed or reported. This is one of four cases linked to the same reporter (MARRS # 1310USA008540, 1310USA010120 and 1310USA010122). Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Within hours of receiving vaccine patients left upper arm was red and swollen from shoulder to elbow. Patient was treated with prednisone.
Age: 16.0
Sex: M
Vaccine: HIBV
Symptoms: Dysphagia, Dyspnoea, Endotracheal intubation, Epiglottic oedema, Epiglottitis
Clinical narrative: This case was reported in a literature article and described the occurrence of epiglottitis in a 16-year-old male subject who was vaccinated with Haemophilus influenzae type b vaccine (manufacturer unspecified). On an unspecified date, the subject received unspecified dose of Haemophilus influenzae type b vaccine (unknown route, site of injection and batch number). At an unspecified time after vaccination, with Haemophilus influenzae type b vaccine, the subject experienced, fever, sore throat, dysphagia and dyspnea, which was diagnosed as epiglottitis. The subject was admitted and brought to the operating room for controlled intubation. A deep plane of anesthesia was obtained via inhalational anesthesia (end tidal sevoflurane) with the subject breathing spontaneously in a sitting position. Direct laryngoscopy revealed grade IV view secondary to an edematous epiglottis. The airway was secured with a 6.5-mm endotracheal tube, by use of a Parsons laryngoscope. The subject was treated with antibiotics for 24 h. He was extubated and discharged.
Age: 16.0
Sex: M
Vaccine: HIBV
Symptoms: Laryngoscopy abnormal, Oropharyngeal pain, Pyrexia
Clinical narrative: This case was reported in a literature article and described the occurrence of epiglottitis in a 16-year-old male subject who was vaccinated with Haemophilus influenzae type b vaccine (manufacturer unspecified). On an unspecified date, the subject received unspecified dose of Haemophilus influenzae type b vaccine (unknown route, site of injection and batch number). At an unspecified time after vaccination, with Haemophilus influenzae type b vaccine, the subject experienced, fever, sore throat, dysphagia and dyspnea, which was diagnosed as epiglottitis. The subject was admitted and brought to the operating room for controlled intubation. A deep plane of anesthesia was obtained via inhalational anesthesia (end tidal sevoflurane) with the subject breathing spontaneously in a sitting position. Direct laryngoscopy revealed grade IV view secondary to an edematous epiglottis. The airway was secured with a 6.5-mm endotracheal tube, by use of a Parsons laryngoscope. The subject was treated with antibiotics for 24 h. He was extubated and discharged.
Age: 75.0
Sex: F
Vaccine: FLUX, UNK
Symptoms: Erythema, Local swelling, Nausea, Pain in extremity, Vomiting
Clinical narrative: 10/31/13 presented at urgent care with nausea vomiting since had flu shot at PCP office on 10/29/13. Also arm pain, swelling and redness since injection.
Age: 75.0
Sex: F
Vaccine: FLUX, UNK
Symptoms: Blood chloride normal, Blood potassium normal, Blood sodium normal, Carbon dioxide increased, Cellulitis
Clinical narrative: 10/31/13 presented at urgent care with nausea vomiting since had flu shot at PCP office on 10/29/13. Also arm pain, swelling and redness since injection.
Age: 75.0
Sex: F
Vaccine: FLUX, UNK
Symptoms: Erythema, Haematocrit decreased, Haemoglobin decreased, Local swelling, Nausea
Clinical narrative: 10/31/13 presented at urgent care with nausea vomiting since had flu shot at PCP office on 10/29/13. Also arm pain, swelling and redness since injection.
Age: 75.0
Sex: F
Vaccine: FLUX, UNK
Symptoms: Pain in extremity, Platelet count decreased, Vomiting, White blood cell count increased
Clinical narrative: 10/31/13 presented at urgent care with nausea vomiting since had flu shot at PCP office on 10/29/13. Also arm pain, swelling and redness since injection.
Age: 60.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a physician concerning a 60 year old patient of unknown gender. On 28-OCT-2013, the patient was inadvertently vaccinated with 0.5 milliliter (ml) of VARIVAX (Merck) (lot number and expiry date unspecified), subcutaneously instead of ZOSTAVAX. This was due to staff error and not product confusion. No concomitant therapy was reported. No adverse effect was reported. Additional information has been requested.
Age: 1.5
Sex: F
Vaccine: FLU3
Symptoms: Gait disturbance, Pyrexia
Clinical narrative: Fever, difficulty walking, limping.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Autoimmune disorder, Dyspnoea, Muscular weakness, Nausea, Rash generalised
Clinical narrative: Nausea, rash (large areas of body), muscle weakness and trembling. SOB. Primary care physician thinks the flu shot triggered an auto immune response.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Nausea, rash (large areas of body), muscle weakness and trembling. SOB. Primary care physician thinks the flu shot triggered an auto immune response.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age. The unknown number of patients had received ZOSTAVAX (lot number not provided) and VARIVAX (Merck) (lot number not provided) doses which were exposed to -6.8C for 1.5 hours every 24 hours due to defrost cycle every day. No adverse effect reported. It was unspecified if the patients had sought medical attention. The health care professional contacted during telephone follow-up did not remember which patient might have received these vaccines and could not supply the following information: patient name, date of birth, dates of vaccination, or lot number. She also stated that the vaccines have been moved to a proper storage unit. Follow-up information received from the healthcare worker. Patient information was updated. On 06-SEP-2013 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot#, expiration date and route not reported). This is one of the several reports from the same source. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Aphasia, Dyskinesia, Seizure like phenomena
Clinical narrative: Approx 3 min after givnig the inj into (L) delt pt had what appeared to be a seizure. Followed by involuntary arm and leg movement on Rt side, then unable to speak. 911 called. Pt taken to ER.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Electromyogram, Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: Received vaccine 10/7/13 - Developed severe pain numbness and tingling consulted PMD. Tx with pain meds/3 courses of steroids Lido patch - EMG 11/13/13 - symptoms worsening after 3 weeks steroids.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Muscle tightness, Pain in extremity
Clinical narrative: Arm sore and muscles tighten up. Can't bend or move arm since flu shot.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Mother of pt called on 10/28/13 to say that child had red, itchy, bumpy area on (L) upper arm and also a mild rash on (R) upper arm in the area where child got vaccines, child is not running a fever or complaining of labored breathing. Parent advised to give dose of TYLENOL or MOTRIN, apply cold or hot compress (to child's comfort) and if signs/symptoms deem necessary contact pediatrician or call 911.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Swelling
Clinical narrative: Developed rash on extremities 2 days after getting flu shot. Rash present today (10/21/) started BENADRYL P.O. To medical aid on unit 10/22 for rash/swelling, Took steroid dose pack and improved.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Urticaria
Clinical narrative: Within 24 hrs fever 101-102 degrees - then 3 days later had hives on arms torso and in mouth, went to her Dr given steroid shot and told to take BENADRYL. 10/30 - fever 99-100 and hives going away.
Sex: U
Vaccine: VARZOS
Symptoms: Chemotherapy
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route not provided). No other co-suspect therapy was reported. Concomitant medications were not provided. The pharmacist reported that a patient told her that a different patient who had received ZOSTAVAX was now (approximately in October 2013) undergoing chemotherapy. At the time of the report patient's outcome was unknown. Additional information is not expected.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age. The unknown number of patients had received ZOSTAVAX (lot number not provided) and VARIVAX (Merck) (lot number not provided) doses which were exposed to -6.8C for 1.5 hours every 24 hours due to defrost cycle every day. No adverse effect reported. It was unspecified if the patients had sought medical attention. The health care professional contacted during telephone follow-up did not remember which patient might have received these vaccines and could not supply the following information: patient name, date of birth, dates of vaccination, or lot number. She also stated that the vaccines have been moved to a proper storage unit. Follow-up information received from the healthcare worker. Patient information was updated. On 01-OCT-2013 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot#, expiration date and route not reported). This is one of the several reports from the same source. Additional information has been requested.
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age. The unknown number of patients had received ZOSTAVAX (lot number not provided) and VARIVAX (Merck) (lot number not provided) doses which were exposed to -6.8C for 1.4 hours every 24 hours due to defrost cycle every day. No adverse effect reported. It was unspecified if the patients had sought medical attention. The health care professional contacted during telephone follow-up did not remember which patient might have received these vaccines and could not supply the following information: patient name, date of birth, dates of vaccination, or lot number. She also stated that the vaccines have been moved to a proper storage unit. Follow-up information received from the healthcare worker. Patient information was updated. On 30-SEP-2013 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot#, expiration date and route not reported). 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 as received from a registered nurse refers to an unknown age and gender patient. Pertinent medical history, drug reactions or allergies were not reported. On 17-JUN-2013, the patient was vaccinated with an improperly stored dose of VARIVAX, (dose was not reported), lot # H009635, expiration date: 09-MAY-2014. Concomitant medication was not reported. The reporter stated that VARIVAX was improperly stored from 03-JUN-2013 to 21-JUN-2013, and the total amount of time that the doses were above the recommended storage range of -15 Celsius (C) was 187.5 hours. Though most of the temperatures recorded in that time period were below -10C, there were three occasions where a highest temperature of 0C was recorded. The three temperature excursions were: 1). 88.5 hours to as warm as 0C, 2). 7.5 hours t as warm as -6C, and 3). 88.5 hours to as warm as -8C. No adverse effect had been observed or reported. This is one of four cases linked to the same reporter (MARR# 1310USA010120, 1310USA010121 and 1310USA010122). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown age and gender patient. Pertinent medical history, drug reactions or allergies were not reported. On 21-JUN-2013, the patient was vaccinated with an improperly stored dose of VARIVAX, (dose was not reported), lot # H009635, expiration date: 09-MAY-2014. Concomitant medication was not reported. The reporter stated that VARIVAX was improperly stored from 03-JUN-2013 to 21-JUN-2013, and the total amount of time that the doses were above the recommended storage range of -15 Celsius (C) was 187.5 hours. Through most of the temperatures recorded in that time period were below -10C, there were three occasions where a highest temperature of 0C was recorded. The three temperature excursions were: 1). 88.5 hours to as warm as 0C, 2). 7.5 hours t as warm as -6C, and 3). 88.5 hours to as warm as -8C. No adverse effect had been observed or reported. This is one of four cases linked to the same reporter (MARR# 1310USA008540, 1310USA010121 and 1310USA010122). Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Red, swollen, sore area at injection site - size of tennis ball from 24 hours after injection until 10/28/13. No other symptoms. Totally resolved at this time.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Decreased appetite, Dizziness, Hypoaesthesia, Nausea
Clinical narrative: Numbness of left arm and leg. Flu shot given on Oct. 21, 2013. On Oct 22, 2013, she felt weak, nauseous and dizzy with anorexia. On Oct 23, 2013 -> developed numbness on left arm and leg. No focal weakness.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Numbness of left arm and leg. Flu shot given on Oct. 21, 2013. On Oct 22, 2013, she felt weak, nauseous and dizzy with anorexia. On Oct 23, 2013 -> developed numbness on left arm and leg. No focal weakness.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Pt. became red around injection site, warm at injection site, itching at injection site.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Paraesthesia
Clinical narrative: 12:43pm = administered FLUZONE. 12:55pm = pt reports throating tingly and dizzy; Called 911; Check BP - 114/82; Paramedics came and rechecked hydration/eating vitals OK. 1:55pm - patient felt OK and left pharmacy.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis
Clinical narrative: Shoulder bursitis treated with prednisone.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Patient stated that she experienced tingling in her left hand where she was injected. At first it was intermittent then it became more frequent as of 10/31/13.
Age: 62.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Raised, red wheal at site of injection on right arm.
Age: 62.0
Sex: F
Vaccine: FLU3, VARZOS, VARZOS
Symptoms: Oral herpes
Clinical narrative: 1 day after receiving a ZOSTAVAX injection patient developed 2 cold sores on her upper lip - drug co. called found no correlation in literature - patient ok.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Tremor
Clinical narrative: Patient said in the evening she had severe shakiness and fatigue.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling, Pain in extremity
Clinical narrative: Within 30 min of receiving PNEUMOVAX and FLUZONE in (L) deltoid he has swelling/pain. 2 days later he had redness/swelling of arm.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site warmth, Local swelling, Nodule, Pyrexia
Clinical narrative: Patient started having chills Sat. night. Arm was swollen with a large knot. Skin around site was warm. Patient had a fever of 102 degrees for 2 days. Went to urgent care Sunday morning - given Rx for ATARAX.
Age: 75.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Rt deltoid area. Patient noticed during shower that she had a red, swollen knot at injection site for shingles vaccine. Normally takes ADVIL. On the day of shingles shot, PCP started her on cephalexin for sinusitis.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Eczema, Rash
Clinical narrative: Patient presented with widespread rash 5 days post immunization. Patient consulted primary care physician and is being treated with topical and oral steroid. Patient cites she has underlying eczema and it was slightly flaring before immunization, but now is far worse.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: Patient stated she had redness down to elbow. Did not complain of any swelling or pain.
Age: 80.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Redness around injection site.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Rash pruritic
Clinical narrative: Patient reported a pruritic large (8 x 9 cm) rash on the arm she received the vaccine.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old female patient with no drug reactions or allergies. On 30-JUN-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J001700, expiry date was 08-MAY-2014) 0.65 milliliter (ml), subcutaneous. Approximately on an unknown date in 2013, the patient was diagnosed with Ramsay Hunt syndrome by an unspecified primary care provider. Approximately on an unknown date in 2013, the patient also experienced pain and numbness in her jaw and ear. The patient had sought medical attention for the same (had been to an unspecified primary care provider). The pharmacist reported that the patient believed that ZOSTAVAX was administered to her incorrectly, but the pharmacist stated that he had administered ZOSTAVAX subcutaneously to the fatty tissue below the deltoid muscle. The outcome of Ramsay Hunt syndrome and pain and numbness in her jaw and ear was reported as not recovered/not resolved. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Ear pain, Herpes zoster oticus, Hypoaesthesia, Pain in jaw
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old female patient with no drug reactions or allergies. On 30-JUN-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J001700, expiry date was 08-MAY-2014) 0.65 milliliter (ml), subcutaneous. Approximately on an unknown date in 2013, the patient was diagnosed with Ramsay Hunt syndrome by an unspecified primary care provider. Approximately on an unknown date in 2013, the patient also experienced pain and numbness in her jaw and ear. The patient had sought medical attention for the same (had been to an unspecified primary care provider). The pharmacist reported that the patient believed that ZOSTAVAX was administered to her incorrectly, but the pharmacist stated that he had administered ZOSTAVAX subcutaneously to the fatty tissue below the deltoid muscle. The outcome of Ramsay Hunt syndrome and pain and numbness in her jaw and ear was reported as not recovered/not resolved. Additional information has been requested.
Age: 84.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site mass
Clinical narrative: This spontaneous report as received from a nurse practitioner, refers to a male patient of currently 87 years old. On 25-JUL-2011 the patient was vaccinated with ZOSTAVAX 19400 PFU (lot# 667611/1356Z, exp. date 26-OCT-2011) (dose and lot number were not provided), subcutaneous. Concomitant medications were not provided. Nurse practitioner reported that a few months after received ZOSTAVAX, on an unknown date, the patient developed a mass on his skin where he got the needle. The patient denied that the "mass" causes him discomfort, and the patient could not determine whether or not it had enlarged over time. The nurse practitioner stated that the mass appeared to be a keloid, and it appeared to originate from his skin. The patient reported that on 24-OCT-2013 he was biopsied and the diagnosis made was basal cell carcinoma. Patient stated that the mass was removed and he had recovered. Upon internal review basal cell carcinoma was considered to be medically significant. The relationship between the ZOSTAVAX and the basal cell carcinoma was not reported. Additional information has been requested.
Age: 84.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Basal cell carcinoma, Biopsy skin abnormal, Injection site mass, Skin neoplasm excision
Clinical narrative: This spontaneous report as received from a nurse practitioner, refers to a male patient of currently 87 years old. On 25-JUL-2011 the patient was vaccinated with ZOSTAVAX 19400 PFU (lot# 667611/1356Z, exp. date 26-OCT-2011) (dose and lot number were not provided), subcutaneous. Concomitant medications were not provided. Nurse practitioner reported that a few months after received ZOSTAVAX, on an unknown date, the patient developed a mass on his skin where he got the needle. The patient denied that the "mass" causes him discomfort, and the patient could not determine whether or not it had enlarged over time. The nurse practitioner stated that the mass appeared to be a keloid, and it appeared to originate from his skin. The patient reported that on 24-OCT-2013 he was biopsied and the diagnosis made was basal cell carcinoma. Patient stated that the mass was removed and he had recovered. Upon internal review basal cell carcinoma was considered to be medically significant. The relationship between the ZOSTAVAX and the basal cell carcinoma was not reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Eye discharge, Eye swelling, Eyelid oedema, Pain
Clinical narrative: Since shot, I had respiratory symptoms that were management, aches. On 10/23/2013, I began to vomit. My eyes started to swell--and were completely swollen shut, oozing out liquid. My nose also swelled three times it's size and I could not breathe. I slept until 10/25/2013 when I was taken by ambulance to the ER and administered by IV saline, prednisone and Benadryl. I have had 16 flu shots annually. First time one that I've had the facial and eye swelling. It was very frightening to me and my family.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Respiratory disorder, Swelling face, Vomiting
Clinical narrative: Since shot, I had respiratory symptoms that were management, aches. On 10/23/2013, I began to vomit. My eyes started to swell--and were completely swollen shut, oozing out liquid. My nose also swelled three times it's size and I could not breathe. I slept until 10/25/2013 when I was taken by ambulance to the ER and administered by IV saline, prednisone and Benadryl. I have had 16 flu shots annually. First time one that I've had the facial and eye swelling. It was very frightening to me and my family.
Age: 20.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Urticaria
Clinical narrative: REDNESS AND HIVES TO NECK AND TRUNK OF BODY. SX'S BEGAN TO DEVELOP AT APPROXIMATELY 12:30 PM. PT REPORTED TO CLINIC AT APPROXIMATELY 12:45 PM. PT RECEIVED EPINEPHRINE 0.3 MG IM X 1 AND BENADRYL 50MG PO X 1. NO ADVERSE RXN'S NOTED. PT TOLERATED WELL D/C'D HOME WITH NO LIMITATIONS.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Respiratory disorder
Clinical narrative: Airways tightened and became SOB.
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster, Injection site pain, Injection site rash, Injection site vesicles
Clinical narrative: This medically confirmed report (initial receipt: 21-Oct-2013) concerns female patient in her 20s. The patient has no pertinent medical history and no known allergies. On 19-Oct-2013, the patient received AFLURIA (batch number: 08449211A) 0.5ml intramuscularly into the right deltoid. On 21-Oct-2013, the patient experienced a painful rash, that hurt really bad, in her right upper shoulder. The rash was a small area six centimetres by four centimetres, with painful little blisters. The patient sought medical attention and was diagnosed with shingles. The patient was prescribed unspecified medication for treatment. Outcome was reported as not recovered.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Local swelling
Clinical narrative: This medically confirmed report (initial receipt 21-Oct-2013) concerns a 31-year-old female patient with a medical history of endometriosis. The patient did not have any allergies or drug reactions. Concomitant medications included an unspecified birth control. On the 18-Oct-2013, the patient received AFLURIA (batch number R53207) via the subcutaneous route. On the 19-Oct-2013, the patient's arm was red and swollen around the injection site. On the 20-Oct-2013, the injection site reaction was a six inch by five inch red welt and her arm was 1.5 times its normal size. Lab diagnostics studies were not performed. Treatment included diphenhydramine. The site greatly improved. The patient was advised not to receive another flu vaccine. Outcome was reported as recovering.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Local swelling
Clinical narrative: This medically confirmed report (initial receipt: 22-Oct-2013) concerns a 47-year old female patient with an allergy to Sulfa. On an unreported date in 2012, the patient received an unspecified influenza virus vaccine (batch number and manufacturer not reported). After vaccination, the arm that it (the vaccine) was administered to became swollen. The patient was hospitalised for two days. Outcome was reported as recovered.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Bacterial infection, Erythema, Exposure during pregnancy, Skin warm
Clinical narrative: Case number PHEH2013US021849 is an initial spontaneous report from pharmacist received on 17 Oct 2013. This case refers to 28-year-old female patient. The patient was 28 weeks pregnant. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 14 Oct 2013. On the same date, after the vaccination, the patient developed redness and warmth on her arm. The redness had spread along her upper arm and down the elbow since administration. The warmth had persisted. The physician prescribed KEFLEX because the physician suspected a bacterial infection along the arm. The outcome of warmth was reported as persisted. The outcome of other events was not reported. The seriousness and causality of events was not reported.
Age: 39.0
Sex: M
Vaccine: PPV, TTOX
Symptoms: Pain, Rash erythematous, Swelling
Clinical narrative: Day after vaccination patient developed red, swollen, painful rash, body aches. Treating with clindamycin 300 mg TID for 10 days and BENADRYL 25 mg as needed.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age. The unknown number of patients had received VARIVAX (Merck) (lot number not provided) doses which were exposed to -6.8C for 1.5 hours every 24 hours due to defrost cycle every day. No adverse effect reported. It was unspecified if the patients had sought medical attention. The health care professional contacted during telephone follow-up did not remember which patient might have received these vaccines and could not supply the following information: patient name, date of birth, dates of vaccination, or lot number. She also stated that the vaccines have been moved to a proper storage unit. This is one of the several reports from the same source. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 year old female patient. The patient had no pertinent medical history and no drug reactions/allergies. On 25-OCT-2013 the patient was vaccinated with PNEUMOVAX23 lot # H021941, exp 11-JUL-2014 intramuscular in the arm. Pharmacist reported that the site in which the PNEUMOVAX23 was administered was on the inner aspect of the upper arm, not the deltoid. Pharmacist further reported that after receiving the vaccination, patient developed redness and soreness at the injection site (onset date was 25-OCT-2013). Treatment was TYLENOL. No labs were performed. The was unknown. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema, Injection site pain, Pruritus, Rash
Clinical narrative: Pt received flu shot 10-19-13. Starting Sunday - pt c/o pain and redness at injection site. That Monday pt had rash/redness on cheeks and redness on chest pt afebrile, itchiness noted. FLUZONE intramuscular injec UH910AA 6-30-14 0.5cc.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker via company representative refers to a patient of unknown age. On an unknown date in 2013, the patient was vaccinated with a dose of VARIVAX (Merck) (lot number, expiry date and route was unknown) and PROQUAD (Merck) (lot number, expiry date and route was unknown) on the same day. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 03-JUL-2013, the patient was vaccinated with a first dose of GARDASIL and on 11-SEP-2013, the patient received the second dose. The patient received the third dose of GARDASIL (Lot number, expiry date, route and dose were not reported for all) as early as 23-OCT-2013. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age. On 19-SEP-2013, the patient was vaccinated with first dose of GARDASIL (lot number, expiry date and route was not reported). On 23-OCT-2013, the patient was vaccinated with second dose of GARDASIL (lot number, expiry date and route was not reported). No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 21-JAN-2013, 18-JUN-2013 and 14-AUG-2013 the patient was separately vaccinated with the first, second and third dose of GARDASIL injection (dose, route, lot # and expiration date unknown). No adverse symptoms were reported. Additional information has been requested.
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. Few days ago, in approximately October-2013 the patient was vaccinated with ZOSTAVAX, subcutaneous in the arm. Concomitant therapies included influenza virus vaccine (manufacturer unknown) in a different arm on the same day as ZOSTAVAX. The arm that ZOSTAVAX was administered, the injection site was pretty swollen and itchy in approximately October 2013. The patient had sought medical attention via a visit to pharmacy. The outcome was unknown. This is one of several reports from same source. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Ocular hyperaemia, Odynophagia, Oropharyngeal pain, Sensation of foreign body
Clinical narrative: Initial report was received on 18 October 2013 from a consumer who is also the patient. A 69 year-old female patient with a history of allergies to PCN (penicillin), tetracycline, shrimp and cat scan dye had received first dose intramuscular left deltoid injection of FLUZONE HIGH DOSE (lot number was unknown) and two hours later, experienced sore throat, food sticking to her throat, painful swallowing, a feeling of rocks in her throat and blood shot eyes. The patient went to the ER and was treated with prednisone, BENADRYL and nebulizer treatments. On 18 October 2013, the patient reported throat was just a little sore. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: none.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Infection, Injection site erythema, Movement disorder
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 76 year old female patient with no medical history or drug allergy. On 27-OCT-2013 the patient was vaccinated with PNEUMOVAX23 (lot# reported as J004196; expiry date: 06-DEC-2014), 0.5 ml, intramuscular. There was no concomitant medication. The next day (28-OCT-2013), patient complained of soreness in arm, that she could not lift her arm, it was red and hot to touch. Pharmacist stated patient went to an unspecified physician at an unspecified time in the last 3 days and patient was diagnosed with an "infection"; pharmacist stated "I'm assuming it's cellulitis." Pharmacist stated there was no redness at the injection site, most notable underneath the arm. Pharmacist stated unspecified physician prescribed BACTRIM and patient "felt good, able to move arm more yet arm still red and hot." Pharmacist stated patient "had a pneumonia shot before" at an unspecified time in the past. The outcome of infection and cellulitis is unknown. No lab tests were performed. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Skin warm
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 76 year old female patient with no medical history or drug allergy. On 27-OCT-2013 the patient was vaccinated with PNEUMOVAX23 (lot# reported as J004196; expiry date: 06-DEC-2014), 0.5 ml, intramuscular. There was no concomitant medication. The next day (28-OCT-2013), patient complained of soreness in arm, that she could not lift her arm, it was red and hot to touch. Pharmacist stated patient went to an unspecified physician at an unspecified time in the last 3 days and patient was diagnosed with an "infection"; pharmacist stated "I'm assuming it's cellulitis." Pharmacist stated there was no redness at the injection site, most notable underneath the arm. Pharmacist stated unspecified physician prescribed BACTRIM and patient "felt good, able to move arm more yet arm still red and hot." Pharmacist stated patient "had a pneumonia shot before" at an unspecified time in the past. The outcome of infection and cellulitis is unknown. No lab tests were performed. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Culture stool positive, Diarrhoea, Faeces discoloured, Rotavirus test positive
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 60 days old male infant patient. On 27-SEP-2013, the patient was vaccinated with the first dose of ROTATEQ 2 ml, suspension, lot # J005073, expiration date 17-SEP-2014, 2 ml, oral. There was no information about concomitant medication, pertinent medical history and drug reactions or allergies. On 01-OCT-2013, the patient's mom called the office to report diarrhea since the vaccination with ROTATEQ on 27-SEP-2013. Mom called again on 03-OCT-2013 and reported that patient's diarrhea was not improving and stool color was changing. On 09-OCT-2013, the patient was brought to the office and stool culture was ordered and culture came back positive for rotavirus. No treatment was given for adverse event. The outcome of events was reported as recovering. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Local swelling, Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist refers to 3 unspecified patients of unknown age and gender. On an unknown date, the 3 patients was vaccinated with a dose of PNEUMOVAX23 (lot# reported as H016295, expiry: November 2013). On an unknown date, the 3 patients experienced severe arm swelling and pain after receiving PNEUMOVAX23. The outcome of severe arm swelling and pain was unknown. Additional information has been requested.
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Cellulitis, Erythema
Clinical narrative: This is a spontaneous report from a contactable other HCP reporting on behalf of a physician. An 83-year-old male patient received PREVNAR 13 (Lot# H017759, Expiration Date 07Jul2014) on 17Oct2013 at 2:09pm, on left arm. Relevant medical history included diabetes, asthma and chronic obstructive pulmonary disease (COPD) and these conditions were ongoing at the time of events. Relevant concomitant medication included DALIRESP and unspecified medications and he was taking these medications at the time of events. Vaccine administered on the same day included Influenza Vaccine on right arm. Vaccine taken within the last four weeks was unknown. On 21Oct2013 the patient experienced cellulitis that was going down the left arm and erythema that was going down the left arm. At the time of the report the clinical outcome of the events was unknown.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with PEDVAXHIB (dose and route unknown) (lot# reported as J000358, exp date 21-OCT-2015). It was reported that the vaccine was improperly stored vaccine (start date unknown). The outcome and action taken not provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from an unknown reporter refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of improperly stored M-M-R II (lot# H020255, Exp date 08-NOV-2014). At the time of report, the status of patient was unknown. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from an unknown reporter refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of improperly stored M-M-R II (lot# reported as H014649, Exp date 08-MAR-2014). At the time of report, the status of patient was unknown. Additional information is not expected.