chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Injection site erythema, Injection site streaking, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 60 year old female patient with allergy to SULFA, allergy to CIPRO, allergy to CRESTOR and dexamethasone (manufacturer unknown) allergy. The patient's medical history included hyperlipidaemia, arthritis and fibromyalgia. On 12-AUG-2014 the patient was vaccinated with ZOSTAVAX lot # K000996, 0.5 ml, intramuscular for prevention of shingles. Concomitant therapies included NEURONTIN, ASPIRIN and NIASTAN. On 12-AUG-2014, the patient experienced massive diarrhea, almost fainted, injection site was warm to touch with red streaks on arm and swollen after receiving KEFLEX and was discharged home. There was no hospitalization. Venous Doppler scan was performed which was normal. Unspecified lab studies were also performed. The outcome of events was unknown. Product quality complaint was not involved. Causality of events with ZOSTAVAX was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test, Presyncope, Ultrasound Doppler normal
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 60 year old female patient with allergy to SULFA, allergy to CIPRO, allergy to CRESTOR and dexamethasone (manufacturer unknown) allergy. The patient's medical history included hyperlipidaemia, arthritis and fibromyalgia. On 12-AUG-2014 the patient was vaccinated with ZOSTAVAX lot # K000996, 0.5 ml, intramuscular for prevention of shingles. Concomitant therapies included NEURONTIN, ASPIRIN and NIASTAN. On 12-AUG-2014, the patient experienced massive diarrhea, almost fainted, injection site was warm to touch with red streaks on arm and swollen after receiving KEFLEX and was discharged home. There was no hospitalization. Venous Doppler scan was performed which was normal. Unspecified lab studies were also performed. The outcome of events was unknown. Product quality complaint was not involved. Causality of events with ZOSTAVAX was unknown. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: This spontaneous report as received from a nurse refers to a 49 year old female patient. In 2009 the patient was vaccinated with her first dose of PNEUMOVAX 23 (lot#, dose, route not reported). On 29-AUG-2014 the patient was vaccinated with her second dose of PNEUMOVAX 23 (lot # K004281, expiration date 22-MAR-2015, dose 0.5 ml, intramuscular). Concomitant therapies included SYNTHROID, Phentermine, Losartan potassium (manufacturer unknown), Vitamin D (unspecified) (OTC), BENADRYL, Sumatriptan, PROAIR and magnesium (unspecified) (OTC). The nurse reported that the patient reported to her a low grade fever and pain, swelling, warmth and redness from the injection site down to her elbow on an unspecified date in 2014. The nurse reported that the patient called to physician who sent her to an urgent care center. The patient was not admitted to the hospital. The patient was prescribed unspecified steroids and antibiotics which had begun to improve symptoms. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patient of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the unspecified patients were vaccinated with improperly stored PNEUMOVAX 23, (dose, route and lot were not provided. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected, because is not possible contact the physician.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect dose administered
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The physician reported that on 26-AUG-2014 the patient was mistakenly administered 2 doses of PROQUAD (Merck) inj during the same office visit (dose, route and lot number not provided). No adverse effects reported. Additional information has been requested.
Age: 27.0
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 27 year old male patient. Since an unknown date the patient had received PNEUMOVAX 23 (manufacturer unknown) every 5 years to prevent pneumonia (dose, route, anatomical location, lot number and expiration date were unspecified). The patient has had or 4 doses since an unknown date by an unspecified healthcare provider. No concomitant therapies were reported. No adverse effects were reported. The patient did not seek medical attention. The outcome of the event was unknown. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Mild local pain on left deltoid arm on site of shot. Systemic rash like bumps on linear surface of axillary, upper limbs and legs, abdomen, back except feet and hands, head, neck. Not rash on exposed areas, induration bump on buttocks itching and groin area and waist rash. No neuropathic pain. No large bristle vesicle or pustule only fine vesicle. Rash distributes on newer route of limbs. No fever. No systemic symptoms. Still exist rash on 8/19/14.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Induration, Injection site pain, Pruritus, Rash
Clinical narrative: Mild local pain on left deltoid arm on site of shot. Systemic rash like bumps on linear surface of axillary, upper limbs and legs, abdomen, back except feet and hands, head, neck. Not rash on exposed areas, induration bump on buttocks itching and groin area and waist rash. No neuropathic pain. No large bristle vesicle or pustule only fine vesicle. Rash distributes on newer route of limbs. No fever. No systemic symptoms. Still exist rash on 8/19/14.
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Dysphagia, Headache, Pyrexia
Clinical narrative: Patient reports swelling of throat and taking BENADRYL to alleviate symptoms. Fever reported as well.
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Pharyngeal oedema, Pyrexia
Clinical narrative: Patient reports swelling of throat and taking BENADRYL to alleviate symptoms. Fever reported as well.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MEN
Symptoms: Abasia, Back pain, Blood test normal, Borrelia test negative, Computerised tomogram abdomen normal
Clinical narrative: This spontaneous report as received from a consumer refers to her 17 year old female daughter. Patient did not had any pertinent medical history, drug reactions or allergies. On 18-AUG-2014, the patient was vaccinated with first dose of GARDASIL 1 single shot (dose, strength, frequency and lot number were not reported). Other suspect therapies included meningococcal vaccine (unspecified) (dose, strength frequency lot number and indication were not reported). There was no concomitant medication. The reporter stated that "shortly after receiving the first dose of GARDASIL the patient developed a fever, she experienced pain near her coccyx bone and she was having difficulty walking". The outcome of the events was reported as not recovered. No treatment was given for the adverse events. A blood work test, a chest x-ray and a Computerized tomogram (CAT) scan were performed (no result were reported). It was reported that the patient sought medical attention. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MEN
Symptoms: Computerised tomogram normal, Full blood count normal, Mononucleosis heterophile test negative, Pyrexia, Spinal X-ray
Clinical narrative: This spontaneous report as received from a consumer refers to her 17 year old female daughter. Patient did not had any pertinent medical history, drug reactions or allergies. On 18-AUG-2014, the patient was vaccinated with first dose of GARDASIL 1 single shot (dose, strength, frequency and lot number were not reported). Other suspect therapies included meningococcal vaccine (unspecified) (dose, strength frequency lot number and indication were not reported). There was no concomitant medication. The reporter stated that "shortly after receiving the first dose of GARDASIL the patient developed a fever, she experienced pain near her coccyx bone and she was having difficulty walking". The outcome of the events was reported as not recovered. No treatment was given for the adverse events. A blood work test, a chest x-ray and a Computerized tomogram (CAT) scan were performed (no result were reported). It was reported that the patient sought medical attention. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MEN
Symptoms: Blood test, Chest X-ray, Computerised tomogram, Gait disturbance, Pain
Clinical narrative: This spontaneous report as received from a consumer refers to her 17 year old female daughter. Patient did not had any pertinent medical history, drug reactions or allergies. On 18-AUG-2014, the patient was vaccinated with first dose of GARDASIL 1 single shot (dose, strength, frequency and lot number were not reported). Other suspect therapies included meningococcal vaccine (unspecified) (dose, strength frequency lot number and indication were not reported). There was no concomitant medication. The reporter stated that "shortly after receiving the first dose of GARDASIL the patient developed a fever, she experienced pain near her coccyx bone and she was having difficulty walking". The outcome of the events was reported as not recovered. No treatment was given for the adverse events. A blood work test, a chest x-ray and a Computerized tomogram (CAT) scan were performed (no result were reported). It was reported that the patient sought medical attention. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MEN
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a consumer refers to her 17 year old female daughter. Patient did not had any pertinent medical history, drug reactions or allergies. On 18-AUG-2014, the patient was vaccinated with first dose of GARDASIL 1 single shot (dose, strength, frequency and lot number were not reported). Other suspect therapies included meningococcal vaccine (unspecified) (dose, strength frequency lot number and indication were not reported). There was no concomitant medication. The reporter stated that "shortly after receiving the first dose of GARDASIL the patient developed a fever, she experienced pain near her coccyx bone and she was having difficulty walking". The outcome of the events was reported as not recovered. No treatment was given for the adverse events. A blood work test, a chest x-ray and a Computerized tomogram (CAT) scan were performed (no result were reported). It was reported that the patient sought medical attention. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site discomfort, Injection site mass
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient. There were no pertinent medical history or drug reactions/allergies. On 05-AUG-2014, the patient was vaccinated with ZOSTAVAX vial, 19400 PFU, (lot # J012659, expired date: 10-JAN-2015, (dose and route were not reported). There was no concomitant medication. The patient experienced a lump at the injection site (approximately in August 2014) for 4 days following the ZOSTAVAX administered. No rash present. The patient reported that "it appeared like the administered vaccine remained at the injection site and sis not absorb for 4 days". The patient "rubbed the area until it went away". No treatment was given for the adverse event. No lab diagnostics studies were performed. The patient sought medical attention by pharmacy visit. The patient recovered from adverse event on an unknown date in 2014. The relationship between adverse event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site mass
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient. There were no pertinent medical history or drug reactions/allergies. On 05-AUG-2014, the patient was vaccinated with ZOSTAVAX vial, 19400 PFU, (lot # J012659, expired date: 10-JAN-2015, (dose and route were not reported). There was no concomitant medication. The patient experienced a lump at the injection site (approximately in August 2014) for 4 days following the ZOSTAVAX administered. No rash present. The patient reported that "it appeared like the administered vaccine remained at the injection site and sis not absorb for 4 days". The patient "rubbed the area until it went away". No treatment was given for the adverse event. No lab diagnostics studies were performed. The patient sought medical attention by pharmacy visit. The patient recovered from adverse event on an unknown date in 2014. The relationship between adverse event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Axillary pain, Burning sensation
Clinical narrative: Severe armpit pain and burning sensation.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site infection, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Per parents when they arrived home after receiving immunizations,left thigh area where immunization was administered was unusually red than the right thigh where one vaccine had been administered.They brought patient in on the 08/28/2014 at about 15:40 .Left thigh was noticeably raised,warm to touch.It was localised in just the left mid thigh area.No swollen lymph nodes noted.Patient refused pain but complained of pain during gentle palpation.No s/s of cellulitis noted in the spots where the vaccine were administered at an inch apart.Dr was notified who checked patient and prescribed Desonide cream.Parent denied any other symptoms.No fever.Parents reported on 09/02/2014 that they had taken their son to the Dr again on 08/29/2014 and was given antibiotics for a localised infection to the area where the vaccines were given.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: This spontaneous report as received from a field representative via nurse practitioner refers to a 21 year old female patient. There were no pertinent medical history or drug allergies/reactions. The patient has no history of seizures, but that her sister did have a history of seizures. On 29-AUG-2014, the patient was vaccinated with GARDASIL, injection, (dose, lot # and expired date were not reported) intramuscular in the office. There was no concomitant medication. Within a short amount of time after administration (on an unknown date in 2014) the patient experienced some kind of seizure activity (the specific activity was unspecified). On an unknown date in 2014, the patient recovered and walked out of the office on her own however the Nurse Practitioner suggested the patient seek medical attention at the local Emergency Room, but it was unspecified if the patient did so. The treatment for adverse event was not given while in the office, and was unspecified outside of the office. Lab diagnostics studies were not performed while in the office, and were unspecified outside of the office. The relationship between adverse event and GARDASIL was not reported. Upon internal interview, adverse event was considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Anaphylactic reaction
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. The patient's medical history included allergic rhinitis, iatrogenic hypothyroidism and fibromyalgia. The patient had no drug reactions/allergies. On 14-AUG-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (injection, lot # was reported as K004148, expiration date and dose was not reported) intramuscularly. Concomitant medications included desipramine, levothyroxine sodium (manufacture unknown), RHINOCORT AQUA, MEDROL PREDNISONE, BENADRYL, SINGULAIR, VIIBRYD, ORTHTRICYCLEN. The patient experienced an anaphylactic reaction after receiving PNEUMOVAX 23 on 14-AUG-2014. The patient had sought for medical attention by office visit on an unspecified date. Treatment given for the anaphylactic reaction included EPINEPHRINE. MEDROL PREDNISONE and BENADRYL. The patient recovered on 14-AUG-2014. The reporter considered the anaphylactic reaction as life threatening and needing intervention to prevent serious criteria. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Flushing, Tremor, Vision blurred
Clinical narrative: Tremors, flushing, difficulty breathing, blurred vision.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: rash
Age: 11.0
Sex: M
Vaccine: HPV2
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse effects- pt. was given Cervarix instead of Gardasil.
Age: 11.0
Sex: M
Vaccine: HPV2
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse reaction- pt. was given Cervarix instead of Gardasil.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Headache, Injected limb mobility decreased, Injection site erythema, Injection site induration
Clinical narrative: Unable to abduct arm where injection was given, then swelling, hardness, redness, very warm from injection site to elbow. Still present today. Taking TYLENOL and ADVIL. Warm-cool packs to arm. Aching in back, headache.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Unable to abduct arm where injection was given, then swelling, hardness, redness, very warm from injection site to elbow. Still present today. Taking TYLENOL and ADVIL. Warm-cool packs to arm. Aching in back, headache.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Decreased appetite, Fatigue, Pain
Clinical narrative: After patient received vaccine she started complaining of body aches, fatigue, and decreased appetite. Patient has had symptoms for 1 week
Age: 0.8
Sex: M
Vaccine: DTAP
Symptoms: Abdominal discomfort, Emotional distress, Irritability, Poor quality sleep, Pyrexia
Clinical narrative: Fever (103 deg), inconsolable, fussy, restless sleep, abdominal distress
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Fatigue and headache, then also fever/chills, muscle aches and stomach cramps all night long; very painful.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia
Clinical narrative: Fatigue and headache, then also fever/chills, muscle aches and stomach cramps all night long; very painful.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Dysgeusia, Headache, Malaise
Clinical narrative: Metallic taste in mouth within a few minutes that persists, then later headache, backache, malaise.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Significant swelling and redness at site of injection.  Diameter 8-9 cm.  PA prescribed Keflex
Age: 17.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Back pain, Blood calcium decreased, Blood glucose increased, Blood potassium decreased, Blood urea decreased
Clinical narrative: Mom indicated headache,other symptoms immediately after vaccine and then developed "cellulitis like" symptoms at injection site.
Age: 17.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: C-reactive protein increased, CSF glucose increased, Chills, Computerised tomogram abnormal, Cough
Clinical narrative: Mom indicated headache,other symptoms immediately after vaccine and then developed "cellulitis like" symptoms at injection site.
Age: 17.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Dizziness, Electrocardiogram abnormal, Erythema, Glycosylated haemoglobin increased, Headache
Clinical narrative: Mom indicated headache,other symptoms immediately after vaccine and then developed "cellulitis like" symptoms at injection site.
Age: 17.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Hot flush, Hypokalaemia, Immediate post-injection reaction, Injection site cellulitis, Leukocytosis
Clinical narrative: Mom indicated headache,other symptoms immediately after vaccine and then developed "cellulitis like" symptoms at injection site.
Age: 17.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Local swelling, Lymphocyte percentage decreased, Musculoskeletal pain, Myalgia, Nausea
Clinical narrative: Mom indicated headache,other symptoms immediately after vaccine and then developed "cellulitis like" symptoms at injection site.
Age: 17.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Neutrophil percentage increased, Post lumbar puncture syndrome, Pyrexia, Rash, Red blood cell sedimentation rate increased
Clinical narrative: Mom indicated headache,other symptoms immediately after vaccine and then developed "cellulitis like" symptoms at injection site.
Age: 17.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Respiratory tract congestion, Sepsis, Skin warm, Swelling, Tachycardia
Clinical narrative: Mom indicated headache,other symptoms immediately after vaccine and then developed "cellulitis like" symptoms at injection site.
Age: 17.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Urinary tract infection, Urine analysis abnormal, Vulvovaginal mycotic infection, White blood cell count increased
Clinical narrative: Mom indicated headache,other symptoms immediately after vaccine and then developed "cellulitis like" symptoms at injection site.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness and swelling at injection site measuring 10cm. Pt complained of pain at injection site
Age: 1.51
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Pertussis
Clinical narrative: This is one case out of a cumulative total of 233 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 28 August 2014. These 233 cases represent children who received 3 or more doses of Sanofi Pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report was received on 28 August 2014 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a four year-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received three doses of PENTACEL; dose one lot number C3607AA received on 26 May 2010, dose two lot number C3607AA received on 28 July 2010 and dose three lot number C3669AA received on 18 September 2010 and dose four of PENTACEL, lot number C4059AA on 07 October 2011 (routes and sites of administration for all doses were not reported). The subject developed a cough on 04 July 2014, approximately 32 months after the last dose. On 15 July 2014, the subject developed a paroxysmal cough. The subject also experienced apnea, post-tussive vomiting and sleep disturbance (onset dates not reported). Laboratory testing included positive PCR on 17 July 2014. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 17 July 2014 for five days. The subject was not hospitalized. At the time of final contact on 22 August 2014, the subject's cough was still persisting. The duration of the cough was reported at that time as 49 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.51
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: This is one case out of a cumulative total of 233 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 28 August 2014. These 233 cases represent children who received 3 or more doses of Sanofi Pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report was received on 28 August 2014 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a four year-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received three doses of PENTACEL; dose one lot number C3607AA received on 26 May 2010, dose two lot number C3607AA received on 28 July 2010 and dose three lot number C3669AA received on 18 September 2010 and dose four of PENTACEL, lot number C4059AA on 07 October 2011 (routes and sites of administration for all doses were not reported). The subject developed a cough on 04 July 2014, approximately 32 months after the last dose. On 15 July 2014, the subject developed a paroxysmal cough. The subject also experienced apnea, post-tussive vomiting and sleep disturbance (onset dates not reported). Laboratory testing included positive PCR on 17 July 2014. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 17 July 2014 for five days. The subject was not hospitalized. At the time of final contact on 22 August 2014, the subject's cough was still persisting. The duration of the cough was reported at that time as 49 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.02
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Erythema multiforme
Clinical narrative: erythema multiforme rash, progressed over 72 hours and then disappeared after 72 hours.
Age: 0.37
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Immediate post-injection reaction, Injection site rash, Rash
Clinical narrative: Rash on legs and trunk faded after a day
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Patient brief symptom of syncope.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Local swelling, Pain
Clinical narrative: Swollen arm and painful.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Asthenia, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Headache, fatigue, nausea, weakness and fever. I am writing this letter in regards to my patient. Patient was administered a GARDASIL immunization at the County Health Department on August 12, 2014. On August 13, 2014, patient came into the office showing symptoms of a reaction to the immunization. In my opinion, I do not feel that he needs to be administered this immunization again, due to the high risk of another reaction. If you have any questions, feel free to contact my office.
Age: 22.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Pyrexia
Clinical narrative: Patient called clinic stating he woke up feeling feverish, advised to take Tylenol and rest
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site rash, Pain, Papule, Pruritus, Rash generalised
Clinical narrative: Pt developed full body rash. Sx of itching and pain. Non vesicular papules. Pt seen for doctor's appt on 9/2/14 at 3:30 pm. Rash developed at admin site, spread to neck, down LA, then to the rest of body.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Chest pain, Feeling hot, Rash
Clinical narrative: Recieved the flu vaccine on 09/03/14 and then noticed rash to chest and upper abdomen upon awakening on 09/05/14. Also reports "achiness" to upper chest and upper back area. Relates feels like she was running a fever but was noted afebrile.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Patient reported that her left arm was "swollen (the size of a softball), red, and hot."
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Fall, Staring, Syncope
Clinical narrative: Pt had an episode of vasovagal syncope, fell to ground and was sitting up when mom got there but staring blankly and mumbled answers.  Pt was laid down and returned to normal after 3 minutes.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Hypoaesthesia, Loss of consciousness
Clinical narrative: Patient blacked out shortly after receiving vaccine for a few seconds.  Later reported numbness in the same arm while at football practice.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Acne, Paraesthesia, Tenderness
Clinical narrative: Tingling around right eye in temporal area and cheek bone.  Also across forehead.  Sore to touch.  1 pimple.  Tingling increasing to face and top of head by 9/5/14 and possibly around body.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Paraesthesia
Clinical narrative: Tingling around right eye in temporal area and cheek bone.  Also across forehead.  Sore to touch.  1 pimple.  Tingling increasing to face and top of head by 9/5/14 and possibly around body.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Injection site warmth, Rash erythematous
Clinical narrative: Red oval shaped, 2 inch rash on right arm below injection site. Warm to touch. Patient saw physician 09/04/14 in evening.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Abdominal pain, Amylase increased, Blood immunoglobulin A normal, Blood thyroid stimulating hormone normal, Full blood count normal
Clinical narrative: Presented to our office on 7/21/14 with a 3 day history of nausea and vomiting with abdominal pain. Labs were drawn and all were normal except for an elevated amylase (222) and lipase (354)
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Human chorionic gonadotropin negative, Laboratory test normal, Lipase increased, Magnetic resonance cholangiopancreatography, Nausea
Clinical narrative: Presented to our office on 7/21/14 with a 3 day history of nausea and vomiting with abdominal pain. Labs were drawn and all were normal except for an elevated amylase (222) and lipase (354)
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Red blood cell sedimentation rate normal, Thyroxine free normal, Ultrasound abdomen normal, Vomiting
Clinical narrative: Presented to our office on 7/21/14 with a 3 day history of nausea and vomiting with abdominal pain. Labs were drawn and all were normal except for an elevated amylase (222) and lipase (354)
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Rash
Clinical narrative: Rash on Chest
Age: 18.0
Sex: M
Vaccine: HPV4, VARCEL
Symptoms: Eyelid ptosis, VIIth nerve paralysis
Clinical narrative: Pt developed progressive facial drooping and ptosis on R side over the course of the day on 9/3/14. Seen at urgent care and treated for Bell's Palsy with oral acyclovir and prednisone.  Symptoms were approximately 50% improved within 24 hours.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site rash, Pruritus generalised
Clinical narrative: Itching over her body, and had localized rash at the site of the vaccine.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Feeling abnormal, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Client's left upper arm is red (blotchy), swollen, and tender to the touch. Client stated that he was not feeling good. He ate and felt better after. Client does not have a fever.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Rash macular
Clinical narrative: Client's left upper arm is red (blotchy), swollen, and tender to the touch. Client stated that he was not feeling good. He ate and felt better after. Client does not have a fever.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Dizziness, Dysphonia, Nausea, Pharyngeal oedema, Urticaria
Clinical narrative: Developed nausea, dizziness, hives, swollen throat, hoarse voice a few minutes after receiving vaccines. Kept for observation and given Benadryl.
Age: 1.28
Sex: M
Vaccine: DTAPIPVHIB, HEP, MMR, PNC13
Symptoms: Rash erythematous, Rash generalised, Rash macular
Clinical narrative: Patient had various small red dots/marks on face, neck and collarbone area. Were not inflamed or swollen. Slightly bumpy and not itchy. Symptoms increased following day and moved throughout the body to include the torso, groin/butt area, legs and back as well as back of neck and scalp. redness decreased gradually on the face but still prevalent elsewhere. Dr. visit was made that day with no treatment necessary as it was thought this was a belated reaction to the MMR vaccine. No other symptoms were found common after vaccinations. Follow up with Dr. in a couple of days to confirm decrease of blotches/red marks.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pyrexia
Clinical narrative: Chills, fever.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RVX
Symptoms: Crying, Diet refusal, Opisthotonus, Pyrexia, Screaming
Clinical narrative: Refusal to eat, screaming and crying inconsolably including high-pitched screaming, fever. Infant breastfed only 3 times on 08/29/2014 and 08/20/2014. She screamed and arched her back whenever offered the breast, where previously, even with a cold, she sought comfort in breastfeeding and ate regularly and predictably over 8-10 times over a 24 hour period. Extreme personality shift evidenced by the screaming and inconsolable crying and refusal to eat. Previous to receiving these vaccines, my child would wake smiling and giggling and never refused to eat or sleep nor was prone to prolonged crying or irritability. She was a notably easy-going, pleasant baby who now requires significant soothing before she will breastfeed. She was taken to an urgent care doctor on 08/30/2014 who found no signs of dehydration or infection and offered no explanation for her refusal to eat or irritable symptoms.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Drug dependence, Dysphoria, Suicidal ideation
Clinical narrative: Severe dysphoria, borderline suicidal ideation, and craving for euphorigenic drugs.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site erythema
Clinical narrative: Large area of redness and bruising at injection site.
Age: 1.65
Sex: F
Vaccine: HIBV
Symptoms: Blood test, Gait disturbance, X-ray
Clinical narrative: Limping for unknown reason.  Would not put pressure on foot.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Anger, Injected limb mobility decreased, Injection site pain, Irritability, Muscular weakness
Clinical narrative: Pain and soreness in left shoulder and arm area. Weakness in area surrounding shot administration. Limited range of motion. All of these lasted through next day and are improving. Noticeable mood problem of anger and irritability, same onset time and duration. This has resolved.
Age: 0.21
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abdominal X-ray, Intussusception, Ultrasound abdomen, Vomiting
Clinical narrative: Intussusception - fluoroscopically reduced. Presented with vomiting.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Cold sweat, Dizziness, Feeling hot, Pallor
Clinical narrative: Dizzy, pale, warm/clammy.
Age: 0.92
Sex: M
Vaccine: DTAP
Symptoms: Diarrhoea, Moaning, Vomiting
Clinical narrative: Groaning x 72 hours. Vomiting and diarrhea.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Injection site induration, Injection site warmth
Clinical narrative: 4cm x 6cm warm indurated rxn at site of DTaP vaccine.
Age: 58.0
Sex: F
Vaccine: FLUC3, VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Injection site reaction lasting approximately 1 week - painful, itching, and warm to touch. Was seen by PCP and prescribed cephalexin on 8/5/14. Affected area approximately 2" surrounding injection site.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Pain
Clinical narrative: Pt received vaccine 8/28. Presented to pharmacy 8/29 in PM - large, red, raised rash at injection site approx. 1 1/2 inches wide x 4 inches long. No fever. Painful and had gotten slightly worse.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Pt received vaccine 8/28. Presented to pharmacy 8/29 in PM - large, red, raised rash at injection site approx. 1 1/2 inches wide x 4 inches long. No fever. Painful and had gotten slightly worse.
Age: 0.52
Sex: U
Vaccine: DTAPHEPBIP, PNC13, RV1
Symptoms: Diarrhoea, Injection site erythema, Injection site oedema, Pyrexia
Clinical narrative: Infant administered KINRIX by previous pediatrician's office. Reaction to a subsequent vaccine series of erythema, at injection site, edema at injection site, fever, diarrhea.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV, VARCEL
Symptoms: Incorrect dose administered, Wrong drug administered
Clinical narrative: MMR+V administered, pt should have received MMR. Pt parent contacted and informed.
Age: 1.01
Sex: M
Vaccine: FLU3, HIBV, MMR
Symptoms: Pyrexia
Clinical narrative: Fever of 103.4 developed.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Red area measuring 6.25 inches by 7.5 inches, hot to touch, and swelling. No difficulty breathing or swallowing.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Erythema, edema, warmth, pain with palpation (L) upper arm.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (route and lot # not reported). The consumer reported that on an unknown date but even after vaccination, the patient experienced shingles every year. The outcome of shingles every year was unknown. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Vaccination site urticaria
Clinical narrative: Urticaria (approx. 1 inch lateral to site) close proximity of vaccine admin. (L) deltoid. BENADRYL PO given. Monitored in office x30 min.
Age: 6.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Dizziness, Dizziness postural, Fatigue
Clinical narrative: Dizziness and fatigue 15-20 minutes after administering vaccines HPV and Tdap. Took vitals/BP/pulse. Waited in office for 30 min. Called 911 after attempting to stand 2x, felt dizziness again.
Age: 1.02
Sex: M
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Differential white blood cell count, Petechiae, Platelet count decreased, Rash macular, Thrombocytopenia
Clinical narrative: Patient received MMR on 8-18-14. Patient came in to the office on 9-4-14 with faint erythematous maculopapular rash on abdomen, back and legs. On mid-abdomen and upper back there were a few petechiae. On 9-4-14 the patient was sent for a CBC with manual diff. Platelet count was 71,000. Dx: Thrombocytopenia. CBC will be repeated 9-11-14 and seen in office.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Oropharyngeal pain, Pharyngeal oedema, Pyrexia
Clinical narrative: Patient started showing signs of low grade fever, fatigue, sore throat with swelling a couple hours after receiving vaccine. About 10 hours after administration she took BENADRYL.
Age: 64.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient received typhoid vaccine on 09/03/14. Lot # K1200-1 Exp=04/15/16 Manufacturer=Sanofi Pasteur. On 09/05/14 she called stating her arm was sore from the shoulder down and she couldn't raise her arm. If the pain isn't better to follow up with doctor on Monday and if the pain is worse to go to the emergency room.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Injection site is swollen to size of pancake and itches at 48 hours after administration.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Expired drug administered
Clinical narrative: #2 MMR given - outdated vaccine used. Expir. date 5/17/14. Mother informed of options for titer or serology in 4 wks or another dose of MMR and states she will think about it and let me know. Mother was informed on 9-3-14 and states child seems fine.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Abnormal behaviour, Drooling, Febrile convulsion, Urinary incontinence
Clinical narrative: Patient was taken to ER for febrile seizure. Pt urinated on himself, was acting funny and drooling. Pt was treated in ER w/ fluids, TYLENOL and MOTRIN and then discharged.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Arthralgia, Erythema, Joint swelling, Lip swelling, Urticaria
Clinical narrative: Mom reports on 8/30/14, child woke up with swollen bottom lip, hives and severe painful, erythematous, swollen knees. She was seen in ER, was given IV BENADRYL and steroids, and a breathing tx apophylactically. DC with MEDROL pack. All S & S resolved except knee swelling and pain after 3-4 hours.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Exposure during pregnancy
Clinical narrative: Patient received a HepB vaccine without a valid order from physician.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Nausea, Pyrexia, Swelling face
Clinical narrative: Patient received FLUZONE High-Dose around noon today (9/5/2014). Her daughter called stating that she has fever (102 degrees F), chills, headache, and is nauseated. Her face is swollen. BP = 131/59. Daughter was advised to bring patient to the E.R.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMRV
Symptoms: Urticaria
Clinical narrative: Hives (generalized) began 2-3 hrs. after vaccines given. Responded to BENADRYL.
Age: 1.26
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Erythema, Urticaria
Clinical narrative: Given DTaP and Hib on 6-26-14 -> hives? Red spots on legs and some around mouth. Ate yogurt without berries? Hx milk allergy. Advised BENADRYL 2.5 ml q 6 hrs prn.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site nodule, Lymphadenopathy
Clinical narrative: 9-5-14 c/o of "knot" of (R) deltoid 1-2 days then swollen lymph gland near (R) collar bone 5-6 days post vaccine. T=98.9. No other systemic side effects.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Gait disturbance, Pain in extremity, Skin discolouration, Skin warm
Clinical narrative: 2 days after injection, b/l thigh pain. Walked with limp, resolved 7-10-14. Black and blue areas (R) thigh, warm to touch.
Age: 1.01
Sex: M
Vaccine: FLU3, MMRV, PNC13
Symptoms: Erythema, Papule, Pyrexia, Rash
Clinical narrative: Monomorphous erythematous papules to (L) side of body. Unilateral thoracic exanthema of childhood. As well as fever of 101-102 degrees.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 28-AUG-2014, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 5 mcg/0.5ml, (dose, route, thimerosal status, lot # and expired date were not reported). Concomitant therapy was not reported. No symptoms reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Abnormal behaviour, Headache
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 17 year old female patient with one medical history and drug allergies. On 22-AUG-2014 the patient was administered the first dose of GARDASIL (0.5 ml, intramuscular, lot not report) series on 22-AUG-2014. Patient was also administered MENACTRA on 22-AUG-2014 in the other arm. Nurse practitioner received a phone call from the patient's mother on an unspecified date. Patient's mother stated that her daughter, was experiencing a headache which began on 23-AUG-2014. The headache was described as pretty constant. Patient was described by her mother as able to function however she was not herself. Treatment recommended by nurse practitioner was ALEVE, eating and drinking liquids. Patient was scheduled for an appointment at the office of nurse practitioner on 28-AUG-2014. None lab diagnostics studies performed. The outcome of adverse events was not recovered. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Autism
Clinical narrative: This spontaneous report as received from a pharmacist via field representative refers to multiple unspecified patients of unknown age and unknown gender. The pharmacist reported that she had read an unspecified article which stated that multiple unspecified patients had developed autism after receiving MMR II before the age of 36 months. The outcome of the event was unknown. The causality of the events with MMR II was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 11-AUG-2014 the patient was vaccinated with an expired MMR II albumin status: HSA, (lot # H014989, expiration date: 10-AUG-2014, dose, units, route of administration, anatomical location were not reported). No adverse symptoms were reported. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a male patient of unknown age. The patient received the first dose of RECOMBIVAX HB (therapy type, dose, route, lot# and expiration date  were not reported) in November 2011, the second dose of RECOMBIVAX HB (therapy type, dose, route, lot# and expiration date were not reported) on 10-JAN-2012 and the third dose of RECOMBIVAX HB (therapy type, dose, route, lot# and expiration date were not reported) on 27-FEB-2012. The reporter stated that the patient "received the 3rd dose of RECOMBIVAX HB too quick, it was only 6 weeks after the 2nd". No adverse effects were reported. No PQC (product quality complaint) was involved. Additional information is not expected, because there is no consent for further contact.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, the patient was inadvertently vaccinated with a dose of ZOSTAVAX injection (dose, route of administration, indication, lot# and expiry date unspecified) instead of a dose of VARIVAX. No concomitant medications were reported. No adverse effects were reported. Additional information is not expected as the reporting pharmacist did not grant permission to contact with him.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a currently 85 year old female patient refers to herself. Patient's medical history, drug reactions or allergies were not reported. In approximately 2011, also reported as: "2-3 years ago" the patient was vaccinated with ZOSTAVAX (lot#, expiration date, dose, route of administration not reported). Concomitant medications were not reported. On an unknown date, also reported as: "about 6 months after getting vaccine" the patient developed shingles multiple times after receiving ZOSTAVAX. There were unspecified prescription and over the counter (OTC) medications given as a treatment for the event. The outcome of the event was reported as recovering/resolving (also reported that symptoms improved). The patient sought medical attention by office visit. The relatedness between the therapy with ZOSTAVAX and the reported event was not reported. Additional information has been requested.