chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Vomiting
Clinical narrative: 12:00 PM loss of appetite, 2:00 low energy, 3:30 complaining of sore leg and acting lethargic, 4:00 fever, 5:00 PM vomited once, 5:30 gave Ibuprofen, 6:00 fever gone and energy slowly returning, appetite remained low the rest of the night.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site reaction, Rash erythematous, Rash maculo-papular, Scab
Clinical narrative: Erythematous maculopapular rash, followed by the appearance of clear vesicles that subsequently crusted over. Localized over injection area (right deltoid) in a dermatomal distribution consistend with cervical nerve root involvement.
Age: 5.0
Sex: F
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No known adverse reaction. Tdap was given to patient instead of a Dtap.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site pain
Clinical narrative: Area of induration 12 cm x 15 cm developed on upper left arm well below injection site, no itching, but tender. Worst day after injection, improving by 2nd day.
Age: 0.63
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 1.0
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Periarthritis
Clinical narrative: Adhesive capsulitis of left shoulder.
Age: 1.19
Sex: F
Vaccine: FLU3, HEPA, MMRV, PNC13
Symptoms: Injection site erythema, Injection site induration, Local reaction
Clinical narrative: Local reaction on Rt thigh of redness and firm area at injection site. Area is not warm to touch. Mom has treated with cold packs, and TYLENOL. Influenza and MMR/V given in Rt. leg/thigh.
Age: 0.91
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 0.92
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 0.64
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, Pyrexia
Clinical narrative: Fever 2 d after shot 101 x 1 day.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Pallor, Presyncope
Clinical narrative: This spontaneous report as received from a physician refers to a 13 year old female patient with non medical history. On an unspecified date in 2014 about 4-6 weeks ago the patient was vaccinated with dose 1 of GARDASIL (lot# was not reported). There was none concomitant medication. The patient became light headed, pale and looked like she was going to faint. The physician instructed the patient to sit down and the patient felt better a few minutes later. No treatment was given for the adverse event. No lab diagnosis study was performed. The patient sought medical attention in the office. The patient recovered the same day that GARDASIL was administered. The physician stated that the patient plans to continue with the GARDASIL series. The physician reported that the patient had not consumed an adequate amount of fluids before receiving GARDASIL vaccination. Additional information has been requested.
Age: 1.66
Sex: M
Vaccine: DTAP, FLU3, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Gait disturbance, Pain in extremity, Pyrexia
Clinical narrative: Low grade subjective fever x 2d. Difficulty walking secondary to leg pain x 2d.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Convulsion
Clinical narrative: Case number PHHY2013US000737 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 473340) website on 02 Jan 2013 with a follow up report received from the quality assurance department (QA reference number: 209087) on 23 Jan 2014. This report refers to an 89 year old female patient. The patient's current condition included syncope. The patient was vaccinated with FLUVIRIN (batch number: 1204101, expiry date: 31 May 2013) intramuscularly in the right arm on 27 Sep 2012. On an unknown date, after vaccination the patient developed numerous brief seizures. The patient visited the emergency room on an unknown date. The patient had not recovered at the time of report. The seriousness and causality of the event were not reported. The batch review report stated that based on the review performed, this product batch (1204101) was manufactured in accordance with the approved internal procedures and was in compliance with the cGMP requirements. Follow up received from the quality assurance department (QA reference number: 209087) on 23 Jan 2014: The expiry date and the batch review report were updated.
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Skin lesion
Clinical narrative: This spontaneous report as received from a Healthcare Professional refers to a male patient of unknown age. On 10-APR-2013 the patient was vaccinated with ZOSTAVAX, (lot # J000435, expiration date 10-APR-2014) in the left arm (dose and route unspecified). Concomitant medications were not reported. On approximately 11-APR-2013 (reported as 1-2 days after vaccine was given), the patient experienced raised lesion developed after vaccine was given. Patient described it starts out like a mosquito bite and itches then after he scratch it becomes raised has occurred frequently at least weekly then monthly. He is still experiencing this in his arms, back and head. Action taken with ZOSTAVAX was not reported. The outcome of the events was not recovered/not resolved, reported as still ongoing due that he is still experiencing this in his arms, back and head. Additional information has been requested.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Body temperature increased, Feeling abnormal, Irritability, Vomiting
Clinical narrative: Vaccines received 6/24/13 - received phone call 6/27 stating patient had been irritable, dazed, not playful, temp elevated 100, vomiting off and on this lasted 1 week per mom, was advised to return if symptoms persisted. Not rechecked in office.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Trismus
Clinical narrative: Case number PHHY2013US140390 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 503677) website on 03 Dec 2013 with a follow up information received from Quality Assurance department (QA reference number: 268977) on 05 Feb 2014. This report refers to a 25 year old male patient. His medical history included diabetes. He was vaccinated with FLUVIRIN (batch number: 1307701) intramuscularly into right arm on 13 Sep 2013. On the same day, after vaccination, he reported lock jaw. The outcome of the event was reported as complete recovery. No seriousness and causality was reported for the event. Based on the batch review performed, it was concluded that FLUVIRIN batch number 1307701 was manufactured in accordance with the approved internal procedures and in compliance with the cGMP requirements. Non-significant follow-up received from Quality Assurance Department (reference number: 268977) on 09 Dec 2013: Updated QA reference number only. Follow up information received from QA department on 05 Feb 2014: Updated batch review report.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site warmth, Nausea, Pyrexia, Vaccination site cellulitis
Clinical narrative: Case number PHHY2013US139969 is an initial spontaneous report received via vaccine adverse event reporting system (VAERS reference number: 503740) on 03 Dec 2013 with follow-up received from the quality assurance department (reference number: 268160) on 20 Jan 2014. This report refers to a 73 years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1307801) and PNEUMOVAX (other manufacturer, batch number: H012072); both vaccines administered intramuscularly in the right arm on 19 Sep 2013. On 19 Sep 2013, she developed nausea and fever. She also had redness and warmth at site and she went to emergency room. She was told that she had cellulitis at vaccination site. The outcome was reported as complete recovery. Based on the investigation performed. QA department stated that the FLUVIRIN (batch number: 1307801) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Non-significant follow-up received from the quality assurance department (reference number: 268160) on 05 Dec 2013: Updated reference number. Follow-up received from Quality Assurance Department (reference number: 268160) on 20 Jan 2014: Updated batch review report.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Cellulitis, Inflammation, Rash erythematous, Rash pruritic, Skin irritation
Clinical narrative: Case number PHHY2013US140108 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 504626) web site on 03 Dec 2013 with a follow up received from the quality assurance department (QA reference number: 268592) on 04 Feb 2014. This report refers to a 60 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 13412P, expiry date: 31 Mar 2014) intramuscularly in to the left arm along with ZOSTAVAX (other manufacturer, batch number: J003796) subcutaneously in to the left arm on 23 Sep 2013. On 25 Sep 2013, she was diagnosed with cellulitis by practitioner. She developed red inflamed rash radiating from just below shoulder to below elbow (approximately 8 inches by 4 inches) that was itchy, and she also experienced irritation. Reaction was caused by ZOSTAVAX vaccine, flu shot site was not affected. Final outcome of the events was reported as complete recovery on an undetermined date. No further information about causality and seriousness was reported. Based on the batch review performed, QA department concluded that this FLUVIRIN batch (13412P) was manufactured in accordance with the approved internal procedures and was in compliance with the cGMP requirements. Follow up received from the quality assurance department (QA reference number: 268592) on 04 Feb 2014: The expiry date and batch review report were updated.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site infection, Injection site warmth
Clinical narrative: Case number PHHY2013US140146 is an initial spontaneous report from a Vaccine Adverse Event Reporting System (reference number: 505771) received on 03 Dec 2013 with a follow up report received from the quality assurance department (QA reference number: 268625) on 29 Jan 2014. This report refers to a 51-year-old female patient. Her concurrent conditions included allergy to erythromycin base and penicillin. Concomitant medication included MICROGESTIN FE. She was vaccinated with FLUVIRIN (batch number: 1307601, expiry date: 31 Mar 2014) intramuscularly on left arm on an unknown date. On an unknown date, post vaccination, she experienced local skin infection, warmth and redness at site of injection 3 inches x 1.5 inches. She was given antibiotics BACTRIM and MEDROL dose pack. Outcome of the events was reported as condition unchanged as of 04 Oct 2013. Seriousness and causality of the events was not reported. The batch review report stated that based on the review performed, this batch (1307601) was manufactured in accordance with the approved internal procedures and was in compliance with the cGMP requirements. Follow up received from the quality assurance department (QA reference number: 268625) on 29 Jan 2014: The expiry date and the batch review report were reported.
Age: 62.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Urticaria
Clinical narrative: Case number PHHY2013US140145, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 506388) website on 03 Dec 2013 and a follow up received from Quality Assurance Department (QA, reference number: 268946) on 23 Jan 2014. This report refers to a 62-year-old female patient. Her medical history included allergy shots for multiple allergies. On 01 Oct 2013, she was vaccinated with FLUVIRIN (batch number: 1308401) intramuscularly in the right arm and ZOSTAVAX (batch number: J003796) subcutaneous in the left arm. On 03 Oct 2013, she experienced round, red, warm and whelp at injection site which was diagnosed as possible infection at site of injection as per the physician. The outcome of the events reported as not recovered. The seriousness and causality of the events were not reported. Based on the investigation performed, the QA department stated that, the FLUVIRIN (batch number: 1308401) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (QA, reference number: 268946) on 23 Jan 2014: Updated batch review report.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis
Clinical narrative: Case number PHHY2013US140487 is an initial spontaneous report from a physician via vaccine adverse event reporting system (reference number: 506565) received on 03 Dec 2013 with a follow up information received from Quality Assurance department (QA reference number: 268199) on 23 Jan 2014. This report refers to a 57 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1309301, expiry date: 30 Apr 2014) and PNEUMOVAX (other manufacturer, batch number: H022280) both intramuscularly on left arm (1 inch apart) on 05 Oct 2013. On an unknown date after vaccination, she experienced cellulitis where injections were given. She had a visit to emergency room due to this event. Outcome of the event was reported as condition unchanged as of 08 Oct 2013. Seriousness and causality of the events was not reported. Based on the batch review performed, it was concluded that FLUVIRIN batch number 1309301 was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow up information received from QA department on 23 Jan 2014: Updated batch review report.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Heart rate increased
Clinical narrative: Case number PHHY2013US140268, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 507615) website on 03 Dec 2013, with a follow up received from the QA department (reference number: 269939) on 05 Feb 2014. This report refers to a 63-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 1307701) intramuscularly in the arm on 11 Oct 2013 (at 12:30 pm). On the same day (at 3:30 pm), after vaccination she experienced increased heart rate, shortness of breath followed by dizziness. Patient went to emergency room where her vitals were monitored and no treatment was given but just was under observation. The outcome of the events reported as recovered. The seriousness and causality of the events were not reported. Based on the batch review, it was stated that the concerned FLUVIRIN batch number 1307701 was manufactured in accordance with approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Follow up received from the QA department (reference number: 269939) on 05 Feb 2014: Updated batch report.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Death, Malaise, Pharyngitis streptococcal
Clinical narrative: Case number PHHY2014US001339, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 509890) website on 06 Jan 2014 and a follow up received from Quality Assurance Department (reference number: 272795) on 04 Feb 2014. This report refers to a 46-year-old male patient. Concomitant medications included amoxicillin 500 mg and Nyquil Cold and Flu. He was vaccinated with FLUVIRIN (batch number: 13394P) intramuscularly in the left arm on 23 Oct 2013. On the same date, after vaccination he did not feel well. He went to the hospital with chest pain on 26 Oct 2013 and was diagnosed with strep throat. He was prescribed with medicine and sent home. The outcome of the events reported as not recovered. On 27 Oct 2013, the patient died (reason unknown). The seriousness and causality of the events were not reported. Based on the batch review performed, the QA department stated that, the FLUVIRIN (batch number: 13394P) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up received from the QA department (reference number: 272795) on 07 Jan 2014: Updated QA reference number. Follow-up received from Quality Assurance Department (reference number: 272795) on 04 Feb 2014: Updated batch review report.
Age: 38.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis
Clinical narrative: Case number PHHY2014US000817 is an initial spontaneous report from a physician via Vaccine Adverse Event Reporting System (VAERS reference number: 510149) website on 06 Jan 2014 and a follow up received from Quality Assurance Department (QA, reference number: 273075) on 04 Feb 2014. This case refers to a 38-year-old patient female patient. Her medical history was not reported. Concomitant medication included fluconazole. She was vaccinated with FLUVIRIN (batch number 1309201) and PNEUMOVAX (other manufacturer, batch number J004196) intramuscularly in her left arm on 20 Oct 2013. On 22 Oct 2013 after vaccination she had cellulitis at the injection site. Following the event the patient visited emergency room. The physician attributed event to vaccination. It was reported that symptoms appeared same day as vaccination and worsened over the next two days. The outcome of the events was reported as condition unchanged as of unknown date. The seriousness and causality assessment of the event was not reported. Based on the investigation performed, the QA department stated that, the FLUVIRIN (batch number: 1309201) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (QA, reference number: 273075) on 04 Feb 2014: Updated batch review report.
Age: 24.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Drug administered at inappropriate site, Injection site pain, Joint range of motion decreased, Pain in extremity
Clinical narrative: Recieved flu vaccine on Dec. 19, 2013 at 11 am with s/s starting at 1:30 pm to have aching, throbbing pain from shoulder to tips of fingers. S/S continued. 12/26/13 seen at urgent care. Called by urgent care on 12/27/13 and given RX for Naproxen, been taking since this time s/s in upper shoulder area, decreased ROM due to pain.
Age: 24.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Recieved flu vaccine on Dec. 19, 2013 at 11 am with s/s starting at 1:30 pm to have aching, throbbing pain from shoulder to tips of fingers. S/S continued. 12/26/13 seen at urgent care. Called by urgent care on 12/27/13 and given RX for Naproxen, been taking since this time s/s in upper shoulder area, decreased ROM due to pain.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Abdominal pain, Arthralgia, C-reactive protein, Full blood count normal, Headache
Clinical narrative: This spontaneous report was received from a physician referring to a 4 year old female patient.On 20-JAN-2011 the patient was vaccinated with M-M-R II dose 1 and on 17-JAN-2014, was vaccinated with M-M-R II [lot # J006955] dose 2, 0.5 ml, subcutaneous. In January 2014 (exact date unspecified) the patient experienced vasculitis, serum sickness, platelets and sedimentation rate slightly elevated, crp and liver function was slightly elevated. On 27-JAN-2014 the patient experienced fever that increased to 103 F. On 29-JAN-2014 the patient experienced generalised vascular deep to mild pink rash that was painful and itchy, 80% of her body was raised red and pruritic, stomach ache, achiness and pain in joints, mild to moderate conjunctivitis redness. The patient received the treatment with ibuprofen at home and IV fluids in the ER. The patient sought medical attention, contacted the physician and went to ER. There was no significant disability or incapacity, no hospitalization, the event was not life threatening and there was no PQC involved. The outcome of achiness and pain in joints was reported as not recovered/not resolved. For all the other events, the outcome  is reported as recovering/resolving. The causality of the events was unspecified. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Liver function test abnormal, Malaise, Pyrexia, Red blood cell sedimentation rate normal, Serum sickness-like reaction
Clinical narrative: This spontaneous report was received from a physician referring to a 4 year old female patient.On 20-JAN-2011 the patient was vaccinated with M-M-R II dose 1 and on 17-JAN-2014, was vaccinated with M-M-R II [lot # J006955] dose 2, 0.5 ml, subcutaneous. In January 2014 (exact date unspecified) the patient experienced vasculitis, serum sickness, platelets and sedimentation rate slightly elevated, crp and liver function was slightly elevated. On 27-JAN-2014 the patient experienced fever that increased to 103 F. On 29-JAN-2014 the patient experienced generalised vascular deep to mild pink rash that was painful and itchy, 80% of her body was raised red and pruritic, stomach ache, achiness and pain in joints, mild to moderate conjunctivitis redness. The patient received the treatment with ibuprofen at home and IV fluids in the ER. The patient sought medical attention, contacted the physician and went to ER. There was no significant disability or incapacity, no hospitalization, the event was not life threatening and there was no PQC involved. The outcome of achiness and pain in joints was reported as not recovered/not resolved. For all the other events, the outcome  is reported as recovering/resolving. The causality of the events was unspecified. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Urine analysis normal, Vasculitic rash
Clinical narrative: This spontaneous report was received from a physician referring to a 4 year old female patient.On 20-JAN-2011 the patient was vaccinated with M-M-R II dose 1 and on 17-JAN-2014, was vaccinated with M-M-R II [lot # J006955] dose 2, 0.5 ml, subcutaneous. In January 2014 (exact date unspecified) the patient experienced vasculitis, serum sickness, platelets and sedimentation rate slightly elevated, crp and liver function was slightly elevated. On 27-JAN-2014 the patient experienced fever that increased to 103 F. On 29-JAN-2014 the patient experienced generalised vascular deep to mild pink rash that was painful and itchy, 80% of her body was raised red and pruritic, stomach ache, achiness and pain in joints, mild to moderate conjunctivitis redness. The patient received the treatment with ibuprofen at home and IV fluids in the ER. The patient sought medical attention, contacted the physician and went to ER. There was no significant disability or incapacity, no hospitalization, the event was not life threatening and there was no PQC involved. The outcome of achiness and pain in joints was reported as not recovered/not resolved. For all the other events, the outcome  is reported as recovering/resolving. The causality of the events was unspecified. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Abdominal pain upper, Arthralgia, C-reactive protein increased, Conjunctival hyperaemia, Conjunctivitis
Clinical narrative: This spontaneous report was received from a physician referring to a 4 year old female patient.On 20-JAN-2011 the patient was vaccinated with M-M-R II dose 1 and on 17-JAN-2014, was vaccinated with M-M-R II [lot # J006955] dose 2, 0.5 ml, subcutaneous. In January 2014 (exact date unspecified) the patient experienced vasculitis, serum sickness, platelets and sedimentation rate slightly elevated, crp and liver function was slightly elevated. On 27-JAN-2014 the patient experienced fever that increased to 103 F. On 29-JAN-2014 the patient experienced generalised vascular deep to mild pink rash that was painful and itchy, 80% of her body was raised red and pruritic, stomach ache, achiness and pain in joints, mild to moderate conjunctivitis redness. The patient received the treatment with ibuprofen at home and IV fluids in the ER. The patient sought medical attention, contacted the physician and went to ER. There was no significant disability or incapacity, no hospitalization, the event was not life threatening and there was no PQC involved. The outcome of achiness and pain in joints was reported as not recovered/not resolved. For all the other events, the outcome  is reported as recovering/resolving. The causality of the events was unspecified. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Full blood count, Laboratory test, Liver function test abnormal, Pain, Platelet count increased
Clinical narrative: This spontaneous report was received from a physician referring to a 4 year old female patient.On 20-JAN-2011 the patient was vaccinated with M-M-R II dose 1 and on 17-JAN-2014, was vaccinated with M-M-R II [lot # J006955] dose 2, 0.5 ml, subcutaneous. In January 2014 (exact date unspecified) the patient experienced vasculitis, serum sickness, platelets and sedimentation rate slightly elevated, crp and liver function was slightly elevated. On 27-JAN-2014 the patient experienced fever that increased to 103 F. On 29-JAN-2014 the patient experienced generalised vascular deep to mild pink rash that was painful and itchy, 80% of her body was raised red and pruritic, stomach ache, achiness and pain in joints, mild to moderate conjunctivitis redness. The patient received the treatment with ibuprofen at home and IV fluids in the ER. The patient sought medical attention, contacted the physician and went to ER. There was no significant disability or incapacity, no hospitalization, the event was not life threatening and there was no PQC involved. The outcome of achiness and pain in joints was reported as not recovered/not resolved. For all the other events, the outcome  is reported as recovering/resolving. The causality of the events was unspecified. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Polymerase chain reaction, Pruritus, Pyrexia, Rash erythematous, Rash pruritic
Clinical narrative: This spontaneous report was received from a physician referring to a 4 year old female patient.On 20-JAN-2011 the patient was vaccinated with M-M-R II dose 1 and on 17-JAN-2014, was vaccinated with M-M-R II [lot # J006955] dose 2, 0.5 ml, subcutaneous. In January 2014 (exact date unspecified) the patient experienced vasculitis, serum sickness, platelets and sedimentation rate slightly elevated, crp and liver function was slightly elevated. On 27-JAN-2014 the patient experienced fever that increased to 103 F. On 29-JAN-2014 the patient experienced generalised vascular deep to mild pink rash that was painful and itchy, 80% of her body was raised red and pruritic, stomach ache, achiness and pain in joints, mild to moderate conjunctivitis redness. The patient received the treatment with ibuprofen at home and IV fluids in the ER. The patient sought medical attention, contacted the physician and went to ER. There was no significant disability or incapacity, no hospitalization, the event was not life threatening and there was no PQC involved. The outcome of achiness and pain in joints was reported as not recovered/not resolved. For all the other events, the outcome  is reported as recovering/resolving. The causality of the events was unspecified. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Red blood cell sedimentation rate increased, Serum sickness, Swelling, Urine analysis, Vasculitic rash
Clinical narrative: This spontaneous report was received from a physician referring to a 4 year old female patient.On 20-JAN-2011 the patient was vaccinated with M-M-R II dose 1 and on 17-JAN-2014, was vaccinated with M-M-R II [lot # J006955] dose 2, 0.5 ml, subcutaneous. In January 2014 (exact date unspecified) the patient experienced vasculitis, serum sickness, platelets and sedimentation rate slightly elevated, crp and liver function was slightly elevated. On 27-JAN-2014 the patient experienced fever that increased to 103 F. On 29-JAN-2014 the patient experienced generalised vascular deep to mild pink rash that was painful and itchy, 80% of her body was raised red and pruritic, stomach ache, achiness and pain in joints, mild to moderate conjunctivitis redness. The patient received the treatment with ibuprofen at home and IV fluids in the ER. The patient sought medical attention, contacted the physician and went to ER. There was no significant disability or incapacity, no hospitalization, the event was not life threatening and there was no PQC involved. The outcome of achiness and pain in joints was reported as not recovered/not resolved. For all the other events, the outcome  is reported as recovering/resolving. The causality of the events was unspecified. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Vasculitis, White blood cell count normal
Clinical narrative: This spontaneous report was received from a physician referring to a 4 year old female patient.On 20-JAN-2011 the patient was vaccinated with M-M-R II dose 1 and on 17-JAN-2014, was vaccinated with M-M-R II [lot # J006955] dose 2, 0.5 ml, subcutaneous. In January 2014 (exact date unspecified) the patient experienced vasculitis, serum sickness, platelets and sedimentation rate slightly elevated, crp and liver function was slightly elevated. On 27-JAN-2014 the patient experienced fever that increased to 103 F. On 29-JAN-2014 the patient experienced generalised vascular deep to mild pink rash that was painful and itchy, 80% of her body was raised red and pruritic, stomach ache, achiness and pain in joints, mild to moderate conjunctivitis redness. The patient received the treatment with ibuprofen at home and IV fluids in the ER. The patient sought medical attention, contacted the physician and went to ER. There was no significant disability or incapacity, no hospitalization, the event was not life threatening and there was no PQC involved. The outcome of achiness and pain in joints was reported as not recovered/not resolved. For all the other events, the outcome  is reported as recovering/resolving. The causality of the events was unspecified. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Abdominal pain upper, Arthralgia, Full blood count, Full blood count normal, Headache
Clinical narrative: This spontaneous report was received from a physician referring to a 4 year old female patient.On 20-JAN-2011 the patient was vaccinated with M-M-R II dose 1 and on 17-JAN-2014, was vaccinated with M-M-R II [lot # J006955] dose 2, 0.5 ml, subcutaneous. In January 2014 (exact date unspecified) the patient experienced vasculitis, serum sickness, platelets and sedimentation rate slightly elevated, crp and liver function was slightly elevated. On 27-JAN-2014 the patient experienced fever that increased to 103 F. On 29-JAN-2014 the patient experienced generalised vascular deep to mild pink rash that was painful and itchy, 80% of her body was raised red and pruritic, stomach ache, achiness and pain in joints, mild to moderate conjunctivitis redness. The patient received the treatment with ibuprofen at home and IV fluids in the ER. The patient sought medical attention, contacted the physician and went to ER. There was no significant disability or incapacity, no hospitalization, the event was not life threatening and there was no PQC involved. The outcome of achiness and pain in joints was reported as not recovered/not resolved. For all the other events, the outcome  is reported as recovering/resolving. The causality of the events was unspecified. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Hepatic enzyme increased, Pyrexia, Rash, Red blood cell sedimentation rate, Serum sickness-like reaction
Clinical narrative: This spontaneous report was received from a physician referring to a 4 year old female patient.On 20-JAN-2011 the patient was vaccinated with M-M-R II dose 1 and on 17-JAN-2014, was vaccinated with M-M-R II [lot # J006955] dose 2, 0.5 ml, subcutaneous. In January 2014 (exact date unspecified) the patient experienced vasculitis, serum sickness, platelets and sedimentation rate slightly elevated, crp and liver function was slightly elevated. On 27-JAN-2014 the patient experienced fever that increased to 103 F. On 29-JAN-2014 the patient experienced generalised vascular deep to mild pink rash that was painful and itchy, 80% of her body was raised red and pruritic, stomach ache, achiness and pain in joints, mild to moderate conjunctivitis redness. The patient received the treatment with ibuprofen at home and IV fluids in the ER. The patient sought medical attention, contacted the physician and went to ER. There was no significant disability or incapacity, no hospitalization, the event was not life threatening and there was no PQC involved. The outcome of achiness and pain in joints was reported as not recovered/not resolved. For all the other events, the outcome  is reported as recovering/resolving. The causality of the events was unspecified. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Arthralgia, Blood follicle stimulating hormone decreased, Blood luteinising hormone decreased, Blood parathyroid hormone decreased
Clinical narrative: In October 2013 I began to experience unexplained bruising, tenderness to touch, pain and erythema to the area where the bruises were located the bruises began on the bilateral arms near the wrists. My arms constantly ached and throbbed. All fingers on both hands are swollen daily. My hands also turn red, white, and blue. Mainly red and blue. My knuckles will be blue and hands and fingers red. Certain fingers are sore to bend and move and feel warm on the inside. On a daily basis I currently experience fatigue, tiredness, weakness of the legs and arms, lethargy, swelling to all fingers, and bilateral wrists, soreness, warmth red and blue discoloration, hot flashes and sweats, dizziness, pain, joint pain, arthralgia, numbness and tingling to the bilateral upper and lower extremities, rash, and vasculitis. I have been diagnosed with unspecified inflammatory polyarthropathy and unspecified diffuse connective tissue disease. I'm currently off of work due to this and have been off work since January 1 2013 because the symptoms became too severe to work. I haven't worked in 2 months.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Blood testosterone decreased, Complement factor decreased, Connective tissue disorder, Contusion, Cyanosis
Clinical narrative: In October 2013 I began to experience unexplained bruising, tenderness to touch, pain and erythema to the area where the bruises were located the bruises began on the bilateral arms near the wrists. My arms constantly ached and throbbed. All fingers on both hands are swollen daily. My hands also turn red, white, and blue. Mainly red and blue. My knuckles will be blue and hands and fingers red. Certain fingers are sore to bend and move and feel warm on the inside. On a daily basis I currently experience fatigue, tiredness, weakness of the legs and arms, lethargy, swelling to all fingers, and bilateral wrists, soreness, warmth red and blue discoloration, hot flashes and sweats, dizziness, pain, joint pain, arthralgia, numbness and tingling to the bilateral upper and lower extremities, rash, and vasculitis. I have been diagnosed with unspecified inflammatory polyarthropathy and unspecified diffuse connective tissue disease. I'm currently off of work due to this and have been off work since January 1 2013 because the symptoms became too severe to work. I haven't worked in 2 months.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Dehydroepiandrosterone decreased, Dizziness, Eosinophil count decreased, Erythema, Fatigue
Clinical narrative: In October 2013 I began to experience unexplained bruising, tenderness to touch, pain and erythema to the area where the bruises were located the bruises began on the bilateral arms near the wrists. My arms constantly ached and throbbed. All fingers on both hands are swollen daily. My hands also turn red, white, and blue. Mainly red and blue. My knuckles will be blue and hands and fingers red. Certain fingers are sore to bend and move and feel warm on the inside. On a daily basis I currently experience fatigue, tiredness, weakness of the legs and arms, lethargy, swelling to all fingers, and bilateral wrists, soreness, warmth red and blue discoloration, hot flashes and sweats, dizziness, pain, joint pain, arthralgia, numbness and tingling to the bilateral upper and lower extremities, rash, and vasculitis. I have been diagnosed with unspecified inflammatory polyarthropathy and unspecified diffuse connective tissue disease. I'm currently off of work due to this and have been off work since January 1 2013 because the symptoms became too severe to work. I haven't worked in 2 months.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling hot, Hot flush, Hyperhidrosis, Hypoaesthesia, Immunology test
Clinical narrative: In October 2013 I began to experience unexplained bruising, tenderness to touch, pain and erythema to the area where the bruises were located the bruises began on the bilateral arms near the wrists. My arms constantly ached and throbbed. All fingers on both hands are swollen daily. My hands also turn red, white, and blue. Mainly red and blue. My knuckles will be blue and hands and fingers red. Certain fingers are sore to bend and move and feel warm on the inside. On a daily basis I currently experience fatigue, tiredness, weakness of the legs and arms, lethargy, swelling to all fingers, and bilateral wrists, soreness, warmth red and blue discoloration, hot flashes and sweats, dizziness, pain, joint pain, arthralgia, numbness and tingling to the bilateral upper and lower extremities, rash, and vasculitis. I have been diagnosed with unspecified inflammatory polyarthropathy and unspecified diffuse connective tissue disease. I'm currently off of work due to this and have been off work since January 1 2013 because the symptoms became too severe to work. I haven't worked in 2 months.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Joint swelling, Lethargy, Local swelling, Lymphocyte count normal, Monocyte count decreased
Clinical narrative: In October 2013 I began to experience unexplained bruising, tenderness to touch, pain and erythema to the area where the bruises were located the bruises began on the bilateral arms near the wrists. My arms constantly ached and throbbed. All fingers on both hands are swollen daily. My hands also turn red, white, and blue. Mainly red and blue. My knuckles will be blue and hands and fingers red. Certain fingers are sore to bend and move and feel warm on the inside. On a daily basis I currently experience fatigue, tiredness, weakness of the legs and arms, lethargy, swelling to all fingers, and bilateral wrists, soreness, warmth red and blue discoloration, hot flashes and sweats, dizziness, pain, joint pain, arthralgia, numbness and tingling to the bilateral upper and lower extremities, rash, and vasculitis. I have been diagnosed with unspecified inflammatory polyarthropathy and unspecified diffuse connective tissue disease. I'm currently off of work due to this and have been off work since January 1 2013 because the symptoms became too severe to work. I haven't worked in 2 months.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Muscular weakness, Pain, Pain in extremity, Paraesthesia, Platelet count increased
Clinical narrative: In October 2013 I began to experience unexplained bruising, tenderness to touch, pain and erythema to the area where the bruises were located the bruises began on the bilateral arms near the wrists. My arms constantly ached and throbbed. All fingers on both hands are swollen daily. My hands also turn red, white, and blue. Mainly red and blue. My knuckles will be blue and hands and fingers red. Certain fingers are sore to bend and move and feel warm on the inside. On a daily basis I currently experience fatigue, tiredness, weakness of the legs and arms, lethargy, swelling to all fingers, and bilateral wrists, soreness, warmth red and blue discoloration, hot flashes and sweats, dizziness, pain, joint pain, arthralgia, numbness and tingling to the bilateral upper and lower extremities, rash, and vasculitis. I have been diagnosed with unspecified inflammatory polyarthropathy and unspecified diffuse connective tissue disease. I'm currently off of work due to this and have been off work since January 1 2013 because the symptoms became too severe to work. I haven't worked in 2 months.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Polyarthritis, Rash, Reverse tri-iodothyronine decreased, Skin discolouration, Tenderness
Clinical narrative: In October 2013 I began to experience unexplained bruising, tenderness to touch, pain and erythema to the area where the bruises were located the bruises began on the bilateral arms near the wrists. My arms constantly ached and throbbed. All fingers on both hands are swollen daily. My hands also turn red, white, and blue. Mainly red and blue. My knuckles will be blue and hands and fingers red. Certain fingers are sore to bend and move and feel warm on the inside. On a daily basis I currently experience fatigue, tiredness, weakness of the legs and arms, lethargy, swelling to all fingers, and bilateral wrists, soreness, warmth red and blue discoloration, hot flashes and sweats, dizziness, pain, joint pain, arthralgia, numbness and tingling to the bilateral upper and lower extremities, rash, and vasculitis. I have been diagnosed with unspecified inflammatory polyarthropathy and unspecified diffuse connective tissue disease. I'm currently off of work due to this and have been off work since January 1 2013 because the symptoms became too severe to work. I haven't worked in 2 months.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Vasculitis, White blood cell count increased
Clinical narrative: In October 2013 I began to experience unexplained bruising, tenderness to touch, pain and erythema to the area where the bruises were located the bruises began on the bilateral arms near the wrists. My arms constantly ached and throbbed. All fingers on both hands are swollen daily. My hands also turn red, white, and blue. Mainly red and blue. My knuckles will be blue and hands and fingers red. Certain fingers are sore to bend and move and feel warm on the inside. On a daily basis I currently experience fatigue, tiredness, weakness of the legs and arms, lethargy, swelling to all fingers, and bilateral wrists, soreness, warmth red and blue discoloration, hot flashes and sweats, dizziness, pain, joint pain, arthralgia, numbness and tingling to the bilateral upper and lower extremities, rash, and vasculitis. I have been diagnosed with unspecified inflammatory polyarthropathy and unspecified diffuse connective tissue disease. I'm currently off of work due to this and have been off work since January 1 2013 because the symptoms became too severe to work. I haven't worked in 2 months.
Age: 34.0
Sex: M
Vaccine: SMALL
Symptoms: Rash macular, Skin hyperpigmentation
Clinical narrative: Diffuse hyperpigmented macular rash about anterior abdomen without systemic symptoms.  Evaluated patient on 6Feb2014 and recommended observation.
Age: 1.34
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Hyperhidrosis, Paraesthesia, Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: One half hour after injections, pt was completely perspired. One hour later pt developed fever of 102 degrees ax. Fever reduced with alternating TYLENOL and ibuprofen a 3 hrs. Pt woke this am with prickly red rash all over body. Pt afebrile at visit. Mother advised to continue TYLENOL and ibuprofen. BENADRYL for rash prn.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Hypoaesthesia, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, tenderness at injection site, with numbness and tingling in the arm, one day after receiving vaccination. Burning in right flank area two days after receiving vaccination.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Redness, swelling, tenderness at injection site, with numbness and tingling in the arm, one day after receiving vaccination. Burning in right flank area two days after receiving vaccination.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Herpes zoster, Papule, Pruritus
Clinical narrative: This spontaneous report as received from a register nurse and a VZV questionnaire, concerning a 72 year old female patient. The patient's medical history included shingles and breast cancer with metastasis, diagnosed three years ago (in approximately January 2011) and none allergies. On Friday 24-JAN-2014, afternoon (also reported as within the last 3 years) the patient was vaccinated with ZOSTAVAX lot # J011549 expiration date 19-DEC-2014, 0.65 ml, subcutaneous in the left arm per Oncology specialist request. Concomitant therapies included XGEVA, amlodipine besylate, letrozole, furosemide, metoprolol, LANTUS SOLOSTAR, NOVOLOG Flex pen, hydrochlorothiazide (manufacturer unknown) and levothyroxine. The register nurse reported that on 25-JAN-2014, 24 hours of receiving ZOSTAVAX the patient developed a "fist sized rash on her back that looks like shingles". The reporter explained that the patient was vaccinated in the afternoon on Friday 24-JAN-2014 and in the afternoon of Sunday 25-JAN-2014 she had a spot on her back (reported as center of back) that was itching and slightly burning. Also the patient's husband stated had noticed redden area size of a fist. The rash was described as raised red papules, number of lesions approximately 20 of 4 x 4 inches, herpes zoster dermatome. The reporter explained that the patient went to see her doctor on 27-JAN-2014 and it looked like shingles. A sample was obtain  on 27-JAN-2014 from the skin papule. The patient was treated with ZOVIRAX 200 mg once daily for 5 days. At the time of the report the outcome was reported as recovered (in January 2014). The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the Merck vaccine strain. Additional information has been requested.