chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Rash, swelling, pain and itching at injection site.
Age: 78.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Injection site pain, Injection site rash
Clinical narrative: RASH AT INJECTION SITE. INJECTION SITE SORENESS. NUMBNESS IN ARM.
Age: 73.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Local swelling, Tenderness, Urticaria
Clinical narrative: Local swelling, erythema, tenderness, followed by refractory urticaria.
Age: 73.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Peripheral swelling, Pruritus, Scratch, Sleep disorder, Urticaria
Clinical narrative: Local swelling, erythema, tenderness, followed by refractory urticaria.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Fatigue, Myalgia
Clinical narrative: I was unusually fatigued for the rest of the day after getting the vaccine on 04/01/2016. The following day, 04/02/2016, I had muscle aches from the time I got up in the morning. Aches got worse until I took two ibuprofen around 12 PM.  Now it is about 4 PM and the only ache remaining is in my upper back/shoulders.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Cardiac arrest, Hyporesponsive to stimuli, Resuscitation
Clinical narrative: Patient found by Mom poorly responsive. EMS called and arrived and able to resuscitate patient with multiple rounds of CPR and epinephrine.  Patient brought to outlying ER then transferred to another Hospital with diagnosis of cardiac arrest.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Autism, Blood aluminium increased, Blood heavy metal increased, Metal poisoning
Clinical narrative: Autism.
Age: 0.36
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Autism, Blood aluminium increased, Blood heavy metal test, Ear infection, Immune system disorder
Clinical narrative: Weak immune sys, Sickness, ear infections, sleep issues, sensory issues, autism.
Age: 0.36
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Malaise, Metal poisoning, Sensory disturbance, Sleep disorder
Clinical narrative: Weak immune sys, Sickness, ear infections, sleep issues, sensory issues, autism.
Age: 1.55
Sex: M
Vaccine: HBHEPB
Symptoms: Computerised tomogram, Dysstasia, Endotracheal intubation, Fatigue, Lethargy
Clinical narrative: Baby woke up 3 more times in the early morning total of 5 times, saying ouch, ouch, ouch. I checked for temperature, there was no fever. Sleeping in and out by 6:50am baby was in so much pain and could barley stand up, lethargic and only wanted me to hold him. I called the dr. they said give him a bath to ease the pain and some TYLENOL this was on Friday at now 8:30am. I did what they said, within the hour he was feeling a little better so I took him to childcare at 11:00am, when I picked him up he had a rash, hives up and down his face and was lethargic again. I knew something was wrong. Went home spoke to husband, I called the Dr. they were on lunch, I said if they don't answer within the hour we are going to emergency. we laid him down because he started fading in and out, it was very unlike him but we thought from the meds he was tired. 20 mins later our nanny ran down and said the baby is having a seizure! We didn't know how long within the 20mins, he was in seizure we called ambulance, he had been seizing at that time 7-10mins and begin to lose consciousness. The paramedics said his breath was slowing down after they gave him VERSED to stop the seizure. by the time he got to the hospital they needed to incubate him. The welts looked like burns. (hives). MRI and Cat scan were done. We now know he has a preexisting condition and will not take to the vaccines.
Age: 1.55
Sex: M
Vaccine: HBHEPB
Symptoms: Loss of consciousness, Nuclear magnetic resonance imaging, Pain, Rash, Respiratory rate decreased
Clinical narrative: Baby woke up 3 more times in the early morning total of 5 times, saying ouch, ouch, ouch. I checked for temperature, there was no fever. Sleeping in and out by 6:50am baby was in so much pain and could barley stand up, lethargic and only wanted me to hold him. I called the dr. they said give him a bath to ease the pain and some TYLENOL this was on Friday at now 8:30am. I did what they said, within the hour he was feeling a little better so I took him to childcare at 11:00am, when I picked him up he had a rash, hives up and down his face and was lethargic again. I knew something was wrong. Went home spoke to husband, I called the Dr. they were on lunch, I said if they don't answer within the hour we are going to emergency. we laid him down because he started fading in and out, it was very unlike him but we thought from the meds he was tired. 20 mins later our nanny ran down and said the baby is having a seizure! We didn't know how long within the 20mins, he was in seizure we called ambulance, he had been seizing at that time 7-10mins and begin to lose consciousness. The paramedics said his breath was slowing down after they gave him VERSED to stop the seizure. by the time he got to the hospital they needed to incubate him. The welts looked like burns. (hives). MRI and Cat scan were done. We now know he has a preexisting condition and will not take to the vaccines.
Age: 1.55
Sex: M
Vaccine: HBHEPB
Symptoms: Seizure, Urticaria
Clinical narrative: Baby woke up 3 more times in the early morning total of 5 times, saying ouch, ouch, ouch. I checked for temperature, there was no fever. Sleeping in and out by 6:50am baby was in so much pain and could barley stand up, lethargic and only wanted me to hold him. I called the dr. they said give him a bath to ease the pain and some TYLENOL this was on Friday at now 8:30am. I did what they said, within the hour he was feeling a little better so I took him to childcare at 11:00am, when I picked him up he had a rash, hives up and down his face and was lethargic again. I knew something was wrong. Went home spoke to husband, I called the Dr. they were on lunch, I said if they don't answer within the hour we are going to emergency. we laid him down because he started fading in and out, it was very unlike him but we thought from the meds he was tired. 20 mins later our nanny ran down and said the baby is having a seizure! We didn't know how long within the 20mins, he was in seizure we called ambulance, he had been seizing at that time 7-10mins and begin to lose consciousness. The paramedics said his breath was slowing down after they gave him VERSED to stop the seizure. by the time he got to the hospital they needed to incubate him. The welts looked like burns. (hives). MRI and Cat scan were done. We now know he has a preexisting condition and will not take to the vaccines.
Age: 0.51
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Anxiety, Autism, Blood aluminium increased, Dyspraxia, Metal poisoning
Clinical narrative: Spd, dyspraxia, non verbal, autism, anxiety.
Age: 0.51
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Schizotypal personality disorder, Speech disorder
Clinical narrative: Spd, dyspraxia, non verbal, autism, anxiety.
Age: 1.05
Sex: M
Vaccine: MMR
Symptoms: Anxiety, Autism, Blood aluminium increased, Developmental delay, Metal poisoning
Clinical narrative: Sensory processing disorder, Autism, Non verbal, Anxiety, Developmental delay.
Age: 1.05
Sex: M
Vaccine: MMR
Symptoms: Sensory integrative dysfunction, Unresponsive to stimuli
Clinical narrative: Sensory processing disorder, Autism, Non verbal, Anxiety, Developmental delay.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC
Symptoms: Anxiety, Autism, Blood heavy metal test, Dyspraxia, Psychiatric evaluation
Clinical narrative: Classic non verbal autism. Sensory processing disorder. Dyspraxia. Severe anxiety. Vmrc and speech diagnosis.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC
Symptoms: Sensory integrative dysfunction, Speech disorder
Clinical narrative: Classic non verbal autism. Sensory processing disorder. Dyspraxia. Severe anxiety. Vmrc and speech diagnosis.
Age: 0.36
Sex: M
Vaccine: 6VAX-F, RVX
Symptoms: Urticaria
Clinical narrative: Hives all over.
Age: 9.0
Sex: F
Vaccine: JEV1, RAB, TYP
Symptoms: Nausea, Pyrexia, Rash pruritic, Urticaria, Vomiting
Clinical narrative: Rash (diffuse, urticaria-type, pruritus) treated w/BENADRYL and prednisolone. Fever (102) treated w/TYLENOL. Nausea/vomiting (1x).
Age: 6.0
Sex: M
Vaccine: JEV1, RAB, TYP
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Rash (diffuse, urticarial-type, pruritus) treated w/BENADRYL and prednisolone.
Age: 47.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Intervertebral disc protrusion, Mobility decreased, Myalgia, Nuclear magnetic resonance imaging spinal abnormal
Clinical narrative: 47 yo former employee of the urgent care where she initially presented with this complaint came in 3-4 days after receiving Tdap vaccine to R deltoid. On the same day, she began experiencing localized pain at injection site. The next day, the pain had spread to her R trapezius muscle and prevented her from turning her head. The next day, her pain had spread to her ipsilateral rhomboids and rotator cuff muscles. She denied any specific muscle weakness but had pain with active and passive motion of her arm, preventing arm abduction past 90 degrees. Should could not turn her head on exam and would rotate in her chair to speak. She had pain on palpation of affected muscles. She had no fevers. She had no IV drug abuse. She had no previous complaints of radiculopathy or neck trauma. She did not have chronic pain issues.
Age: 47.0
Sex: M
Vaccine: TDAP
Symptoms: Pain
Clinical narrative: 47 yo former employee of the urgent care where she initially presented with this complaint came in 3-4 days after receiving Tdap vaccine to R deltoid. On the same day, she began experiencing localized pain at injection site. The next day, the pain had spread to her R trapezius muscle and prevented her from turning her head. The next day, her pain had spread to her ipsilateral rhomboids and rotator cuff muscles. She denied any specific muscle weakness but had pain with active and passive motion of her arm, preventing arm abduction past 90 degrees. Should could not turn her head on exam and would rotate in her chair to speak. She had pain on palpation of affected muscles. She had no fevers. She had no IV drug abuse. She had no previous complaints of radiculopathy or neck trauma. She did not have chronic pain issues.
Age: 60.0
Sex: F
Vaccine: UNK
Symptoms: Axillary pain, Injection site erythema, Injection site swelling, Injection site warmth, Local swelling
Clinical narrative: Redness, slight swelling, and warm to touch to the injected area (right arm). 04/03/2016 - the redness area is about 3cm diameter. Right armpit started have pain on 04/02/2016. Right armpit pain increased and swelling continued on 04/03/2016.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ, VARCEL
Symptoms: Syncope
Clinical narrative: Began to exit mobile clinic setting within 5 minutes of receiving three vaccines- syncope onset at 3:57PM.
Age: 14.0
Sex: F
Vaccine: TD
Symptoms: Alopecia
Clinical narrative: All of patient's hair fell out.
Age: 44.0
Sex: M
Vaccine: TD
Symptoms: Asthenia, Chills, Decreased appetite, Dysgeusia, Hallucination
Clinical narrative: Nausea, Weakness, Headache, Hallucinating, Loss of appetite, Metallic taste in mouth and Chills & Fever.
Age: 44.0
Sex: M
Vaccine: TD
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Nausea, Weakness, Headache, Hallucinating, Loss of appetite, Metallic taste in mouth and Chills & Fever.
Age: 1.27
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Irritability, Urticaria, Vomiting
Clinical narrative: Severe vomiting, irritabile. Woke up the following morning with hives on his face and legs. Doctor advised 3/4 tablespoon of Benadryl and to come into the office if symptoms persist.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Muscular weakness, Musculoskeletal pain, Neck pain
Clinical narrative: Patient reported difficulty lifting arm where vaccine was administered. Also, soreness, and weak feeling in hand, shoulder and back of neck, and some numbness in her right hand. Symptoms got worse one week later when she got the typhoid vaccine (administered at another facility), but have since gotten better. (still feeling some soreness and weakness in arm).
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient reported difficulty lifting arm where vaccine was administered. Also, soreness, and weak feeling in hand, shoulder and back of neck, and some numbness in her right hand. Symptoms got worse one week later when she got the typhoid vaccine (administered at another facility), but have since gotten better. (still feeling some soreness and weakness in arm).
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: REDNESS, SWELLING AND ITCHING OVER BICEP AREA OF ARM. PATIENT REPORTED SYMPTOMS STARTED SEVERAL HOURS AFTER THE SHOT AND REPORTED TO PHARMACY THE NEXT DAY WITH MILDER SYMPTOMS. THE PHARMACIST CALLED PATIENT ON THE SECOND DAY AFTER THE SHOT AND PATIENT REPORTED THE SAME SYMPTOMS BUT THAT THEY WERE STARTING TO GO AWAY. THE PATIENT HAS NOT TAKEN ANY MEDICATIONS FOR THE PROBLEM BUT SHE SAID SHE MAY TAKE A BENADRYL FOR THE ITCHING.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Dyspnoea, Hypersensitivity, Rash, Urticaria
Clinical narrative: After receiving a second anthrax vaccine, I suffered a severe allergic reaction that required hospitalization. The symptoms included skin rashes, hives and difficulty breathing. I will provide more details after receiving my records.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site warmth
Clinical narrative: Pt reported SE on 3/17/16: site of inj red (golf ball size), warm to touch, with hard ball feeling at site of inj.
Age: 0.18
Sex: F
Vaccine: DPP, DTAPHEPBIP, IPV, RVX
Symptoms: Abnormal behaviour, Diarrhoea
Clinical narrative: Shirking for no known reason 5-7 days and diarrhea for 10 days.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Burning sensation, Hypoaesthesia, Paraesthesia
Clinical narrative: Patient describes intermittent numbness/burning/tingling since receiving the vaccine in September.
Age: 1.03
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site rash
Clinical narrative: Day 11 post vaccines - rash on L thigh. Day 12 post vaccines - rash enlarging. RX Clindamycin for possible cellulitis.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Administration site pain, Administration site swelling, Administration site warmth
Clinical narrative: Administration site swelled and was very hot. Also stated that it was very painful.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Arm swollen,, down to elbow, red for > 4 days.
Age: 45.0
Sex: M
Vaccine: PPV
Symptoms: Abdominal pain, Diarrhoea, Dizziness, Nausea, Pruritus
Clinical narrative: Dizziness and urticaria pruritus. Diphenhydramine 50 mg once.
Age: 45.0
Sex: M
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Dizziness and urticaria pruritus. Diphenhydramine 50 mg once.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Arm swollen from injection site, which traveled down to elbow, red > 4 days.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Abdominal pain, Blood thyroid stimulating hormone, Differential white blood cell count, Full blood count, Headache
Clinical narrative: This spontaneous report was received from a Registered Nurse, concerning a currently 12 year old female patient. The patient's medical history included painful joints that awaken her at night. The patient did not have any concurrent conditions, drug reactions or allergies. On 20-JAN-2016, the patient was vaccinated with GARDASIL 9 Lot # L020015 expiry date 16-AUG-2017, (strength, dose number, anatomical location and route of administration were not provided). It was confirmed that the patient was not vaccinated with GARDASIL. On 23-MAR-2016, the patient was again vaccinated with GARDASIL 9. (Strength, dose number, anatomical location and route of administration were not provided). The patient did not take any concomitant medication. On 24-MAR-2016, the patient experienced leg pain, abdominal pain and also developed fever 101.3F, headache and sore throat. On the same date, the patient sought medical attention. A complete blood count (CBC) and thyroid stimulating hormone (TSH) were performed and showed normal results. Additionally, was performed a comprehensive metabolic panel (CMP) which showed an elevated serum glucose of 112 (units not provided) and a low calcium level. Also a strep test and a rapid flu test were completed, and they showed a negative result. Therefore, the patient was diagnosed with acute pharyngitis and hypersensitivity to GARDASIL 9. The patient received treatment TYLENOL. There was no product quality complaint involved. The outcome of the events was not provided. The relatedness between vaccination with GARDASIL 9 and abdominal pain, leg pain and acute pharyngitis was not reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Influenza virus test, Metabolic function test, Oropharyngeal pain, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous report was received from a Registered Nurse, concerning a currently 12 year old female patient. The patient's medical history included painful joints that awaken her at night. The patient did not have any concurrent conditions, drug reactions or allergies. On 20-JAN-2016, the patient was vaccinated with GARDASIL 9 Lot # L020015 expiry date 16-AUG-2017, (strength, dose number, anatomical location and route of administration were not provided). It was confirmed that the patient was not vaccinated with GARDASIL. On 23-MAR-2016, the patient was again vaccinated with GARDASIL 9. (Strength, dose number, anatomical location and route of administration were not provided). The patient did not take any concomitant medication. On 24-MAR-2016, the patient experienced leg pain, abdominal pain and also developed fever 101.3F, headache and sore throat. On the same date, the patient sought medical attention. A complete blood count (CBC) and thyroid stimulating hormone (TSH) were performed and showed normal results. Additionally, was performed a comprehensive metabolic panel (CMP) which showed an elevated serum glucose of 112 (units not provided) and a low calcium level. Also a strep test and a rapid flu test were completed, and they showed a negative result. Therefore, the patient was diagnosed with acute pharyngitis and hypersensitivity to GARDASIL 9. The patient received treatment TYLENOL. There was no product quality complaint involved. The outcome of the events was not provided. The relatedness between vaccination with GARDASIL 9 and abdominal pain, leg pain and acute pharyngitis was not reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Streptococcus test
Clinical narrative: This spontaneous report was received from a Registered Nurse, concerning a currently 12 year old female patient. The patient's medical history included painful joints that awaken her at night. The patient did not have any concurrent conditions, drug reactions or allergies. On 20-JAN-2016, the patient was vaccinated with GARDASIL 9 Lot # L020015 expiry date 16-AUG-2017, (strength, dose number, anatomical location and route of administration were not provided). It was confirmed that the patient was not vaccinated with GARDASIL. On 23-MAR-2016, the patient was again vaccinated with GARDASIL 9. (Strength, dose number, anatomical location and route of administration were not provided). The patient did not take any concomitant medication. On 24-MAR-2016, the patient experienced leg pain, abdominal pain and also developed fever 101.3F, headache and sore throat. On the same date, the patient sought medical attention. A complete blood count (CBC) and thyroid stimulating hormone (TSH) were performed and showed normal results. Additionally, was performed a comprehensive metabolic panel (CMP) which showed an elevated serum glucose of 112 (units not provided) and a low calcium level. Also a strep test and a rapid flu test were completed, and they showed a negative result. Therefore, the patient was diagnosed with acute pharyngitis and hypersensitivity to GARDASIL 9. The patient received treatment TYLENOL. There was no product quality complaint involved. The outcome of the events was not provided. The relatedness between vaccination with GARDASIL 9 and abdominal pain, leg pain and acute pharyngitis was not reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Abdominal pain, Blood calcium decreased, Blood glucose normal, Blood thyroid stimulating hormone normal, Drug hypersensitivity
Clinical narrative: This spontaneous report was received from a Registered Nurse, concerning a currently 12 year old female patient. The patient's medical history included painful joints that awaken her at night. The patient did not have any concurrent conditions, drug reactions or allergies. On 20-JAN-2016, the patient was vaccinated with GARDASIL 9 Lot # L020015 expiry date 16-AUG-2017, (strength, dose number, anatomical location and route of administration were not provided). It was confirmed that the patient was not vaccinated with GARDASIL. On 23-MAR-2016, the patient was again vaccinated with GARDASIL 9. (Strength, dose number, anatomical location and route of administration were not provided). The patient did not take any concomitant medication. On 24-MAR-2016, the patient experienced leg pain, abdominal pain and also developed fever 101.3F, headache and sore throat. On the same date, the patient sought medical attention. A complete blood count (CBC) and thyroid stimulating hormone (TSH) were performed and showed normal results. Additionally, was performed a comprehensive metabolic panel (CMP) which showed an elevated serum glucose of 112 (units not provided) and a low calcium level. Also a strep test and a rapid flu test were completed, and they showed a negative result. Therefore, the patient was diagnosed with acute pharyngitis and hypersensitivity to GARDASIL 9. The patient received treatment TYLENOL. There was no product quality complaint involved. The outcome of the events was not provided. The relatedness between vaccination with GARDASIL 9 and abdominal pain, leg pain and acute pharyngitis was not reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Full blood count normal, Headache, Influenza virus test negative, Oropharyngeal pain, Pain in extremity
Clinical narrative: This spontaneous report was received from a Registered Nurse, concerning a currently 12 year old female patient. The patient's medical history included painful joints that awaken her at night. The patient did not have any concurrent conditions, drug reactions or allergies. On 20-JAN-2016, the patient was vaccinated with GARDASIL 9 Lot # L020015 expiry date 16-AUG-2017, (strength, dose number, anatomical location and route of administration were not provided). It was confirmed that the patient was not vaccinated with GARDASIL. On 23-MAR-2016, the patient was again vaccinated with GARDASIL 9. (Strength, dose number, anatomical location and route of administration were not provided). The patient did not take any concomitant medication. On 24-MAR-2016, the patient experienced leg pain, abdominal pain and also developed fever 101.3F, headache and sore throat. On the same date, the patient sought medical attention. A complete blood count (CBC) and thyroid stimulating hormone (TSH) were performed and showed normal results. Additionally, was performed a comprehensive metabolic panel (CMP) which showed an elevated serum glucose of 112 (units not provided) and a low calcium level. Also a strep test and a rapid flu test were completed, and they showed a negative result. Therefore, the patient was diagnosed with acute pharyngitis and hypersensitivity to GARDASIL 9. The patient received treatment TYLENOL. There was no product quality complaint involved. The outcome of the events was not provided. The relatedness between vaccination with GARDASIL 9 and abdominal pain, leg pain and acute pharyngitis was not reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Pharyngitis, Pyrexia, Streptococcus test negative
Clinical narrative: This spontaneous report was received from a Registered Nurse, concerning a currently 12 year old female patient. The patient's medical history included painful joints that awaken her at night. The patient did not have any concurrent conditions, drug reactions or allergies. On 20-JAN-2016, the patient was vaccinated with GARDASIL 9 Lot # L020015 expiry date 16-AUG-2017, (strength, dose number, anatomical location and route of administration were not provided). It was confirmed that the patient was not vaccinated with GARDASIL. On 23-MAR-2016, the patient was again vaccinated with GARDASIL 9. (Strength, dose number, anatomical location and route of administration were not provided). The patient did not take any concomitant medication. On 24-MAR-2016, the patient experienced leg pain, abdominal pain and also developed fever 101.3F, headache and sore throat. On the same date, the patient sought medical attention. A complete blood count (CBC) and thyroid stimulating hormone (TSH) were performed and showed normal results. Additionally, was performed a comprehensive metabolic panel (CMP) which showed an elevated serum glucose of 112 (units not provided) and a low calcium level. Also a strep test and a rapid flu test were completed, and they showed a negative result. Therefore, the patient was diagnosed with acute pharyngitis and hypersensitivity to GARDASIL 9. The patient received treatment TYLENOL. There was no product quality complaint involved. The outcome of the events was not provided. The relatedness between vaccination with GARDASIL 9 and abdominal pain, leg pain and acute pharyngitis was not reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Cough, Dyspnoea, Glossodynia, Rhinorrhoea, Wheezing
Clinical narrative: This spontaneous report was received from a healthcare worker and a physician referring to a 4 year old male patient. The patient's concurrent conditions included a possible allergy to gelatin. The patient did not have pertinent medical history. On 31-MAR-2016, the patient was vaccinated with M-M-R II lot # L012480, expiry date 10-APR-2017, in the left arm (dose, dose number and route were not reported). Also, on the same date he received a VARIVAX (Merck) lot # L026405, expiry date 15-JUL-2017, in the left arm (dose, dose number and route were not reported); and KINRIX (reported as KINREX) in the right arm (lot number, expiry date, dose, dose number and route were not reported). The patient was not taking concomitant medications. On the same date, after 5 minutes of the administration of M-M-R II, the patient experienced an itchy tongue to hacking cough, grabbing at the throat, discharge from the nose and rales in chest. It was reported that the patient was sent to the hospital and received a treatment with unspecified oral steroids, BENADRYL and EPIPEN. No product quality complain was involved. At the time of this report, the outcome of hypersensitivity was unknown. The reporter did not provide a causality assessment between the hypersensitivity and the M-M-R II or the VARIVAX (Merck). Upon internal review, the experienced hypersensitivity was considered as medically significant, as it was treated with epinephrine hydrochloride. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Cough, Hypersensitivity, Rales, Rhinorrhoea, Throat tightness
Clinical narrative: This spontaneous report was received from a healthcare worker and a physician referring to a 4 year old male patient. The patient's concurrent conditions included a possible allergy to gelatin. The patient did not have pertinent medical history. On 31-MAR-2016, the patient was vaccinated with M-M-R II lot # L012480, expiry date 10-APR-2017, in the left arm (dose, dose number and route were not reported). Also, on the same date he received a VARIVAX (Merck) lot # L026405, expiry date 15-JUL-2017, in the left arm (dose, dose number and route were not reported); and KINRIX (reported as KINREX) in the right arm (lot number, expiry date, dose, dose number and route were not reported). The patient was not taking concomitant medications. On the same date, after 5 minutes of the administration of M-M-R II, the patient experienced an itchy tongue to hacking cough, grabbing at the throat, discharge from the nose and rales in chest. It was reported that the patient was sent to the hospital and received a treatment with unspecified oral steroids, BENADRYL and EPIPEN. No product quality complain was involved. At the time of this report, the outcome of hypersensitivity was unknown. The reporter did not provide a causality assessment between the hypersensitivity and the M-M-R II or the VARIVAX (Merck). Upon internal review, the experienced hypersensitivity was considered as medically significant, as it was treated with epinephrine hydrochloride. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Tongue pruritus
Clinical narrative: This spontaneous report was received from a healthcare worker and a physician referring to a 4 year old male patient. The patient's concurrent conditions included a possible allergy to gelatin. The patient did not have pertinent medical history. On 31-MAR-2016, the patient was vaccinated with M-M-R II lot # L012480, expiry date 10-APR-2017, in the left arm (dose, dose number and route were not reported). Also, on the same date he received a VARIVAX (Merck) lot # L026405, expiry date 15-JUL-2017, in the left arm (dose, dose number and route were not reported); and KINRIX (reported as KINREX) in the right arm (lot number, expiry date, dose, dose number and route were not reported). The patient was not taking concomitant medications. On the same date, after 5 minutes of the administration of M-M-R II, the patient experienced an itchy tongue to hacking cough, grabbing at the throat, discharge from the nose and rales in chest. It was reported that the patient was sent to the hospital and received a treatment with unspecified oral steroids, BENADRYL and EPIPEN. No product quality complain was involved. At the time of this report, the outcome of hypersensitivity was unknown. The reporter did not provide a causality assessment between the hypersensitivity and the M-M-R II or the VARIVAX (Merck). Upon internal review, the experienced hypersensitivity was considered as medically significant, as it was treated with epinephrine hydrochloride. Additional information has been requested.
Age: 29.0
Sex: M
Vaccine: HPV4
Symptoms: Autoimmune hypothyroidism, Burning sensation, Pain, Paraesthesia
Clinical narrative: The night of my shot I experienced extreme burning in my whole body, as well as pain and tingling. This lasted for 2 days.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PPV
Symptoms: Adverse reaction, Decreased appetite, Fatigue, Lethargy, Muscle twitching
Clinical narrative: By the end of the same day my daughter experienced negative reaction to her vaccines. She was extremely tired and lethargic. She had a fever and was twitchy for 2 days. Complete loss of appetite and a rash.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PPV
Symptoms: Pyrexia, Rash
Clinical narrative: By the end of the same day my daughter experienced negative reaction to her vaccines. She was extremely tired and lethargic. She had a fever and was twitchy for 2 days. Complete loss of appetite and a rash.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: REDNESS AT INJECTION SITE (1.5 INCH x 3 INCHES), WARMTH.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 4-year-old male patient who received KINRIX (batch number 2A947, expiry date 20th October 2017). On 3rd March 2016, the patient received KINRIX (intramuscular) .5 ml. On 3rd March 2016, less than a day after receiving KINRIX, the patient experienced injection site pain and injection site lump. On an unknown date, the outcome of the injection site pain and injection site lump were not recovered/not resolved. The reporter considered the injection site pain and injection site lump to be possibly related to KINRIX. Additional details provided as follows: The patient experienced pain at the injection site with movement, since then the patient's mother noticed a lump at the injection site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Injection site mass, Injection site pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 4-year-old male patient who received KINRIX (batch number 2A947, expiry date 20th October 2017). On 3rd March 2016, the patient received KINRIX (intramuscular) .5 ml. On 3rd March 2016, less than a day after receiving KINRIX, the patient experienced injection site pain and injection site lump. On an unknown date, the outcome of the injection site pain and injection site lump were not recovered/not resolved. The reporter considered the injection site pain and injection site lump to be possibly related to KINRIX. Additional details provided as follows: The patient experienced pain at the injection site with movement, since then the patient's mother noticed a lump at the injection site.
Age: 65.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Burning sensation, Hyperaesthesia, Musculoskeletal pain, Pain, Paraesthesia
Clinical narrative: Within 4 to 5 hours from receiving the PREVNAR 13 vaccine I started having torso pain, (from shoulder blades to lower waistline, front, back, and sides). Feeling needles sticking me, burning sensation in the waistline, knife stabbing feeling in shoulder blades, nothing could touch my torso because it caused pain.
Age: 65.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Abdominal pain, Back pain, Chronic inflammatory demyelinating polyradiculoneuropathy, Computerised tomogram abdomen normal, Drug dependence
Clinical narrative: Within 4 to 5 hours from receiving the PREVNAR 13 vaccine I started having torso pain, (from shoulder blades to lower waistline, front, back, and sides). Feeling needles sticking me, burning sensation in the waistline, knife stabbing feeling in shoulder blades, nothing could touch my torso because it caused pain.
Age: 65.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Gait disturbance, Lumbar puncture abnormal, Musculoskeletal pain, Nuclear magnetic resonance imaging brain, Pain in extremity
Clinical narrative: Within 4 to 5 hours from receiving the PREVNAR 13 vaccine I started having torso pain, (from shoulder blades to lower waistline, front, back, and sides). Feeling needles sticking me, burning sensation in the waistline, knife stabbing feeling in shoulder blades, nothing could touch my torso because it caused pain.
Age: 22.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site warmth, Oedema, Pyrexia, Swelling
Clinical narrative: Tenderness, edema, fever s/p vaccination with TDAP. Lt upper arm. Swelling generalized. Erythema and warmth extended 2" diameter around injection site and extended medially down to middle of upper arm.
Age: 22.0
Sex: M
Vaccine: TDAP
Symptoms: Tenderness
Clinical narrative: Tenderness, edema, fever s/p vaccination with TDAP. Lt upper arm. Swelling generalized. Erythema and warmth extended 2" diameter around injection site and extended medially down to middle of upper arm.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging normal, Pain in extremity
Clinical narrative: Patient stated did not hurt at all when she received the vaccine. However, the next morning (10-9-15) she had severe pain in the arm. She stated she has had pain in the left arm since the vaccine and has not improved. She said it is an 8 out of 10 during the day and pain 10 out of 10 at night. Her doctor has had her doing exercises for the arm which had not helped. She had an MRI on week of 3-28-16, which did not show any issues.
Age: 4.0
Sex: F
Vaccine: MMRV, TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: BOOSTRIX was given instead of KINRIX. Manufacturer was contacted. No adverse reaction or problem. Pt mom was called and informed. Asked to bring child in for the polio vaccine which was not in BOOSTRIX.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Raised area where vaccine was given, skin was warm to touch, tender, and pt was achy. Pt denied any fever or throat swelling. Pt developed Rxn on 3-30-2016/given steroid injection. 4/4/16 attempted to reach parent to check status. No answer.
Age: 61.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Asthenia, Injected limb mobility decreased, Injection site pain, Insomnia, Nuclear magnetic resonance imaging
Clinical narrative: I received a flu vaccine on 10/20/15 in my left shoulder. On 10/21/15 the left shoulder was very painful, limited mobility and lost strength. Sleepless night on 10/21/15 so went to urgent care 10/22/15.
Age: 61.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: X-ray
Clinical narrative: I received a flu vaccine on 10/20/15 in my left shoulder. On 10/21/15 the left shoulder was very painful, limited mobility and lost strength. Sleepless night on 10/21/15 so went to urgent care 10/22/15.
Age: 61.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Asthenia, Injection site pain, Insomnia, Mobility decreased, Nuclear magnetic resonance imaging
Clinical narrative: I received a flu vaccine on 10/20/15 in my left shoulder. On 10/21/15 the left shoulder was very painful, limited mobility and lost strength. Sleepless night on 10/21/15 so went to urgent care 10/22/15.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Patient developed hives covering entire body 24 hrs after receiving Tdap, MENACTRA, and GARDASIL 9.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Constipation, Diarrhoea, Fatigue
Clinical narrative: Patient reports he received the PREVNAR 13 on a Monday and had a "fairly significant" reaction he believes. Reports constipation and diarrhea, chills/fatigue and was "on the couch all week". Patient reports he was back to normal except for fatigue by Friday.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: This spontaneous report as received from a reporter refers to a 16-year-old male patient as a part of a market research agency. On an unknown date in July 2012 the patient was vaccinated with quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb. vaccine (manufacturer unknown) (reported as HPV vaccine) (lot # not reported) dosing details unspecified. No concomitant medications were reported. On an unknown date in July 2012 the patient experienced shot hurt, pain in the arm. The reported events were resolving at the time of this report. This is a corrected report. The suspect therapy has been changed to human papillomavirus (types 6, 11, 16, 18) recomb. vaccine (manufacturer unknown) (reported as HPV vaccine) V501 GARDASIL. Additional information is not expected.
Age: 6.0
Sex: F
Vaccine: MMRV
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report was received from a physician refers to a 6 year old female patient. The medical history, concurrent medications and concomitant medications were not reported. On 20-MAR-2014, the patient was vaccinated with PROQUAD (Merck), lot# was not reported. On 08-MAR-2011, the patient was vaccinated with VARIVAX (Merck) lot# was not reported. Approximately on 06-MAR-2016, (reported as 5 days ago) the patient developed 8 painful varicella like lesions on the back of her back. The outcome of was reported as not recovered/not resolved. The patient sought medical attention. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Left arm became itchy, red, tender and hard at site. Pt was instructed to use ice packs and take Tylenol.  These symptoms continued for 48 hours.
Age: 0.54
Sex: F
Vaccine: DTAPH, PNC13, RVX
Symptoms: Hyperhidrosis, Irritability, Pallor, Skin warm, Vomiting
Clinical narrative: Patient had been fussier this day, at around 1p she began to look pale and vomited.  It was different and more than regular spit up.  She nursed a little more and vomited again.  She fell asleep on my chest and felt warm although I didn't take her temp, she was unusually sweaty.  She woke up around 2p and had two instances of vomiting a bile like substance.  Then her color appeared back to normal and she ate and slept per her usual for the rest of the day and Sunday.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Aphasia, Noninfective encephalitis, Optic neuritis, Seizure, Visual impairment
Clinical narrative: This spontaneous report as received from a pharmacist (patient's father) via company field representative refers to a 12 years old female patient. The patient's medical history and concurrent conditions were none. On an unspecified date in July-2015 the patient had received her second dose of GARDASIL, lot # and expiry date was not reported. The patient had received unspecified concomitant medications. On an unspecified date in July-2015, the patient experienced visual disturbances (disability) and optic neuritis (disability). Therapy with GARDASIL was discontinued on an unspecified date in July-2015. Later in December-2015, she had chronic seizures (disability). Recently, on an unspecified date, she was diagnosed with inflammation of the left hemisphere of her brain (disability) and she could not speak (disability). The GARDASIL was not reintroduced. The outcome of the events were reported as not recovered. Upon internal review the events cannot speak, chronic seizures and inflammation of the left hemisphere of her brain were considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to unspecified patients of unknown gender and age. Information regarding patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not provided. On unknown dates, these patients were vaccinated with improperly stored doses of PROQUAD (Merck) (therapy type: RHA, lot # L046509, expiry date: 17-MAY-2017; lot # L045676, expiry date: 09-MAY-2017; lot # L051099, expiry date: 17-JUN-2017). The vaccine underwent a temperature excursion of 21.4 degrees Fahrenheit within the time frame of 24 hours. M-M-R II appeared on the product list, however no doses of the vaccine were administered to the patients. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent conditions, medical history or allergy/drug reactions were reported. On 28-MAR-2016, the patient was vaccinated with expired dose of RECOMBIVAX HB (strength, dose and frequency were not reported) lot # J006511, expiry date: 28-JAN-2016. Concomitant medications were not provided. No adverse effects were reported. No further information was provided. The outcome of expired product administered and no adverse event were unknown. Product quality complaint was not filed. Additional information has been requested.
Age: 1.05
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Product name confusion
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to a 12-month-old patient. The patient's medical history was not reported. On 14-MAR-2016, the patient was vaccinated with a dose of PROQUAD (rHA) (lot number L046507, expiration date 17-MAY-2017) and a dose of VARIVAX (Merck) (lot number L041207, expiration date 20-OCT-2017) during the same visit due to product confusion (also considered as overdose). The reporter stated that the PROQUAD (Merck) was mistaken for M-M-R II which was the intended product.  Dose and route of administration were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning multiple unspecified patients (demographics unknown). The patient's pertinent medical history and concurrent conditions were not provided. On multiple unspecified dates, the patients were administered improperly stored doses of RECOMBIVAX HB (Lot # L025738 expiration date: 14-AUG-2017) (route not provided). The patients' concomitant medications were not provided. No adverse effects were reported. It was reported the following temperature excursion for the administered vaccines: 34.2 degrees F for 9 days (216 hours). No previous temperature excursion was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Pt was given wrong hepatitis vaccine than what was ordered. Pt has not had any adverse reaction.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Hepatitis B test negative
Clinical narrative: This spontaneous report as received from a physician assistant refers to a 18 year old non-pregnant female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On unknown dates (also reported as in patient's childhood), the patient received a full vaccination series with RECOMBIVAX HB (route and site of administration, lot # and expiry dates were not provided). On an unknown date (also reported as unspecified recent date), the patient tested negative for titers for Hepatitis B. The reporter was not able at the time of reporting to provide the dates of administration or the lot numbers and expiration dates of the doses. The physician assistant stated that the patient was healthy and she did not experience any medical difficulties. Because the physician assistant was not able to specify the name of the vaccine the patient received, RECOMBIVAX HB was assumed product. The outcome of the event was unknown. The relatedness between the event and suspect therapy was not provided. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Diarrhoea, Skin warm, Swelling
Clinical narrative: (R) arm hot to touch. Swollen. Diarrhea x 5-6 QD x 2 days.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cough, Dyspnoea, Lacrimation increased, Rhinorrhoea, Swelling face
Clinical narrative: Coughing, watery eyes, runny nose, SOB, face swelling. Tx - EPI Shot/O2/BENADRYL/Breathing Tx/Steroid.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning multiple unspecified patients (demographics unknown). The patient's pertinent medical history and concurrent conditions were not provided. On multiple unspecified dates, the patients were administered improperly stored doses of GARDASIL 9 (Lot # L024993 expiration date: 17-OCT-2017) (route not provided). The patient's concomitant medications were not provided. No adverse effects were reported. It was reported the following temperature excursion for the administered vaccines: 34/2 degrees F for 9 days (216 hours). No previous temperature excursion was reported. This is one of several reports received from the same source. Additional information has been requested.