chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient reports her arm has been sore since the day vaccine was administered (over a month ago).
Age: 29.0
Sex: M
Vaccine: TYP
Symptoms: Condition aggravated, Eczema
Clinical narrative: Had eczema flare. Patient' eczema is very sensitive to lactose/dairy.  Steroid cream resolves, did not need prednisone Rx he was given.
Age: 4.0
Sex: F
Vaccine: DTAP, HEP, HEPA, MMRV, VARCEL
Symptoms: Vomiting
Clinical narrative: Mother reported that on Saturday 10/26/19 pt vomited 1-2 times in the evening after receiving the vaccines an has not vomited since Saturday 10/26/19. Mother reports no other s/sx. Patient has not received any other vaccines other than the vaccines she received on 10/26/19
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: localized swelling to left leg, larger than softball size, rash urticarial patches on back and trunk - treatment was benadryl and ibuprofen. No Follow-up Needed as long as improving. 10/30/19 This is a 4 year old male that presents with concerns for reaction to vaccination. He was given his varicella, Kinrix and MMR vaccines 2 days ago. Mother noticed the night of his vaccines that he was developing some erythema and warmth around his left thigh where the vaccines had been administered. He had no other trouble breathing. He had no diarrhea or emesis. She gave some Motrin and let him relax overnight. In the morning he had a couple other areas of rash on his chest and back. He states that the area was itchy and kind of sore, so mother called out triage line and at the time he did not have any other symptoms. No fever, no work of breathing or anything like that, so they were recommended to give some more Motrin and to followup today. Today the area is slightly larger than she saw last night. She had outlined it the night before and it is still warm but the patient is not complaining of any soreness at this time. He does state that it is itchy. He is having no other symptoms today and the areas of rash that were on his abdomen and back appear to be improving. O: Temperature is 97.9. General: Patient is awake and alert sitting up on the clinic table in no acute distress. Eyes: PERR bilaterally without conjunctival injection. ENT: Bilateral tympanic membranes are clear of erythema or bulge. Tympanostomy tubes are in place. Nares are patent without rhinorrhea. Throat is clear of erythema or exudate. CV: Heart is regular rate and rhythm without murmurs, rubs or gallops. Respiratory: Lungs are clear to auscultation bilaterally without wheeze or crackle. Abdomen: If obese and soft and nontender with good bowel sounds in all 4 quadrants. Skin: On the left thigh surrounding the area of his previous vaccination there is an area of erythema and warmth. It is a large patch about 5 cm x 6 cm. It has an irregular border. It is slightly outside the line that mother marked last night. There is no tenderness to palpation of the area. It is nonfluctuant. There are no other rashes or lesions noted on his body. A/P: This appears to be a local reaction most likely to the varicella vaccine that was placed in that leg. As he did not have a previous reaction before and has no intention to have that vaccine again as he has gotten his 2, this is unlikely to happen again. I recommended that they do some Benadryl 12.5 mg every 6 hours as needed to see if that helps and this should help this go away. Strict return precautions were given regarding any fluctuance of the area, fevers or other symptoms. We will also report this to the vaccine registry.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Local reaction, Rash, Urticaria
Clinical narrative: localized swelling to left leg, larger than softball size, rash urticarial patches on back and trunk - treatment was benadryl and ibuprofen. No Follow-up Needed as long as improving. 10/30/19 This is a 4 year old male that presents with concerns for reaction to vaccination. He was given his varicella, Kinrix and MMR vaccines 2 days ago. Mother noticed the night of his vaccines that he was developing some erythema and warmth around his left thigh where the vaccines had been administered. He had no other trouble breathing. He had no diarrhea or emesis. She gave some Motrin and let him relax overnight. In the morning he had a couple other areas of rash on his chest and back. He states that the area was itchy and kind of sore, so mother called out triage line and at the time he did not have any other symptoms. No fever, no work of breathing or anything like that, so they were recommended to give some more Motrin and to followup today. Today the area is slightly larger than she saw last night. She had outlined it the night before and it is still warm but the patient is not complaining of any soreness at this time. He does state that it is itchy. He is having no other symptoms today and the areas of rash that were on his abdomen and back appear to be improving. O: Temperature is 97.9. General: Patient is awake and alert sitting up on the clinic table in no acute distress. Eyes: PERR bilaterally without conjunctival injection. ENT: Bilateral tympanic membranes are clear of erythema or bulge. Tympanostomy tubes are in place. Nares are patent without rhinorrhea. Throat is clear of erythema or exudate. CV: Heart is regular rate and rhythm without murmurs, rubs or gallops. Respiratory: Lungs are clear to auscultation bilaterally without wheeze or crackle. Abdomen: If obese and soft and nontender with good bowel sounds in all 4 quadrants. Skin: On the left thigh surrounding the area of his previous vaccination there is an area of erythema and warmth. It is a large patch about 5 cm x 6 cm. It has an irregular border. It is slightly outside the line that mother marked last night. There is no tenderness to palpation of the area. It is nonfluctuant. There are no other rashes or lesions noted on his body. A/P: This appears to be a local reaction most likely to the varicella vaccine that was placed in that leg. As he did not have a previous reaction before and has no intention to have that vaccine again as he has gotten his 2, this is unlikely to happen again. I recommended that they do some Benadryl 12.5 mg every 6 hours as needed to see if that helps and this should help this go away. Strict return precautions were given regarding any fluctuance of the area, fevers or other symptoms. We will also report this to the vaccine registry.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: The patient presents with complain on having erythematous area on Left upper arm following Tdap vaccination on 10/21/19. Additionally complains on having firmness, swelling, tenderness, and itching of the area. The patient noticed redness and swelling in the shoulder within 24 hrs but was hoping that is would resolve on its own. Treatment cephalexin (Keflex) 500mg 1 tab 4 times daily for 10 days triamcinolone (Kenalog) 40mg injection prednisone (Deltasone) 20mg 1 tab daily for 5 days
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Cyanosis, Loss of consciousness
Clinical narrative: Patient was administered first dose of SHINGRIX shot. She reported reactions to TDAP in past but no reactions to FLUAD or ZOSTAVAX. Patient tolerated shot in the shot room and was able to put on her coat unassisted and left the room. She was alert and conscious. She sat in front of pharmacy. Another pharmacist rushed to her aid and declared that she was unconscious and turning blue. I called 911. The other pharmacist stayed with the patient. After about a minute the patient was conscious but remained laying on the floor and regained her normal color and was breathing normal. She was wheeled off to the emergency department by paramedics.
Age: 0.67
Sex: F
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Mother requested pt. only be given .25ml of a 0.5ml immunization so that is what was given
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Full blood count normal, Limb mass, Pain in extremity, Peripheral swelling, Rash erythematous
Clinical narrative: 1 day after injection of PrevnaR 13 (R) arm pain, swollen mass. 3 day after developed warm, red rash. No CP, SOB or itch.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Skin warm
Clinical narrative: 1 day after injection of PrevnaR 13 (R) arm pain, swollen mass. 3 day after developed warm, red rash. No CP, SOB or itch.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives on face, arms, back & trunk
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Erythema, Eye disorder, Fatigue, Ocular hyperaemia
Clinical narrative: Within Three to Four Hours I Noticed My Eyes were Bothering me at work. I went to A Mirror - Both eyes were Bloodshot & Bright Red. I Then Developed wheezing & problems breathing My Face swelled and Turned Red I felt Tired & sore. I have never Previously had a reaction to the flu shot. I obtain one every year The only difference in my health since my last flu shot is a Low tolerance and allergic reaction to mold.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Swelling face, Wheezing
Clinical narrative: Within Three to Four Hours I Noticed My Eyes were Bothering me at work. I went to A Mirror - Both eyes were Bloodshot & Bright Red. I Then Developed wheezing & problems breathing My Face swelled and Turned Red I felt Tired & sore. I have never Previously had a reaction to the flu shot. I obtain one every year The only difference in my health since my last flu shot is a Low tolerance and allergic reaction to mold.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Condition aggravated, Injection site swelling
Clinical narrative: I got a flu shot 10/7/19. Approx 5 hours later I developed a large swollen area on my left deltoid area. The swelling continued to worsen. Progressed to what was diagnosed as a flare of my autoimmune disease
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Abscess sterile, Blood culture negative, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: erythema & Swelling & pain at (R) arm injection site. Pt admitted on 10-18-2019 & discharged on 10-19-2019 Diag: sterile abscess
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: White blood cell count increased
Clinical narrative: erythema & Swelling & pain at (R) arm injection site. Pt admitted on 10-18-2019 & discharged on 10-19-2019 Diag: sterile abscess
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus, Skin warm, Swelling
Clinical narrative: -Raised area and red along with warmth  -no fever, body aches or chills -itching within 3-5 min
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Ultrasound scan normal
Clinical narrative: ache in upper muscle of Left arm January 2018: ultrasound - no abnormality ache still occurs about 2 to 3 times a week Decided not to get 2nd shot.
Age: 15.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, VARCEL, HPV9, MNQ, TDAP, VARCEL
Symptoms: Fall, Unresponsive to stimuli
Clinical narrative: Staff notified nurse, upon arrival patient was in floor unresponsive for approx 30 seconds; This spontaneous report was received from a health care professional via Food and Drug Administration (FDA) (Agency # 798223) and referring to an approximately 15- year-old adolescent white female patient. It was unknown if the patient was pregnant at the time of vaccination. The patient's medical history and concurrent conditions were not reported. Patient's concomitant therapies included ethinyl estradiol, norgestimate (SPRINTEC). There was no known allergies to medications, food or other products. On 28-DEC-2018, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in the right arm via intramuscular route (strength and dose not reported) (lot number # R002345, expiration date not reported, but upon internal validation established as 16-NOV-2020) for prophylaxis. On the same day, the patient was also vaccinated with the  second dose of varicella virus vaccine live (oka/merck) (VARIVAX) in the left arm via subcutaneous route (strength and dose not reported) (lot number # R020650, expiration date not reported, but upon internal validation established as 18-JUL-2020) for prophylaxis. On the same day, the patient was also vaccinated with first dose of diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid (BOOSTRIX) in the right arm via intramuscular route (strength and dose not reported) (lot number # 2T923, expiration date not reported) and first dose of meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) in the left arm via intramuscular route (strength and dose not reported) (lot number # 2T923, expiration date not reported) for prophylaxis. On the same day (28-DEC-2018) after the vaccination, the patient ambulated to check out counter, staff notified nurse that upon arrival the patient was in floor unresponsive for approximately 30 seconds (unresponsive to stimuli). The patient then opened eyes questioning what had happened. On 28-DEC-2019, the patient was then physically examined Awake, Alert and Oriented (AAOX3), assisted patient to stand and ambulate to patient room. The patient then waited in physician's office approximately 30 minutes without any further episodes and did not come back with any voice concerns. The patient visited a physician /healthcare professional clinic for the event. The outcome of the event was unknown. The causality assessment was not provided.  Follow-up information has been received on 30-OCT-2019. A call was placed to the medical assistant on 30-OCT-2019, which was answered by receptionist. The call was transferred to medical assistant, who was unable to assist (did not feel comfortable sharing patient information on phone).
Age: 15.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, VARCEL, HPV9, MNQ, TDAP, VARCEL
Symptoms: Unresponsive to stimuli
Clinical narrative: Staff notified nurse, upon arrival patient was in floor unresponsive for approx 30 seconds; This spontaneous report was received from a health care professional via Food and Drug Administration (FDA) (Agency # 798223) and referring to an approximately 15- year-old adolescent white female patient. It was unknown if the patient was pregnant at the time of vaccination. The patient's medical history and concurrent conditions were not reported. Patient's concomitant therapies included ethinyl estradiol, norgestimate (SPRINTEC). There was no known allergies to medications, food or other products. On 28-DEC-2018, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in the right arm via intramuscular route (strength and dose not reported) (lot number # R002345, expiration date not reported, but upon internal validation established as 16-NOV-2020) for prophylaxis. On the same day, the patient was also vaccinated with the  second dose of varicella virus vaccine live (oka/merck) (VARIVAX) in the left arm via subcutaneous route (strength and dose not reported) (lot number # R020650, expiration date not reported, but upon internal validation established as 18-JUL-2020) for prophylaxis. On the same day, the patient was also vaccinated with first dose of diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid (BOOSTRIX) in the right arm via intramuscular route (strength and dose not reported) (lot number # 2T923, expiration date not reported) and first dose of meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) in the left arm via intramuscular route (strength and dose not reported) (lot number # 2T923, expiration date not reported) for prophylaxis. On the same day (28-DEC-2018) after the vaccination, the patient ambulated to check out counter, staff notified nurse that upon arrival the patient was in floor unresponsive for approximately 30 seconds (unresponsive to stimuli). The patient then opened eyes questioning what had happened. On 28-DEC-2019, the patient was then physically examined Awake, Alert and Oriented (AAOX3), assisted patient to stand and ambulate to patient room. The patient then waited in physician's office approximately 30 minutes without any further episodes and did not come back with any voice concerns. The patient visited a physician /healthcare professional clinic for the event. The outcome of the event was unknown. The causality assessment was not provided.  Follow-up information has been received on 30-OCT-2019. A call was placed to the medical assistant on 30-OCT-2019, which was answered by receptionist. The call was transferred to medical assistant, who was unable to assist (did not feel comfortable sharing patient information on phone).
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Crying, Dizziness, Fear
Clinical narrative: dizziness; scared; crying; BP standing 100/75; This report was identified from a line listing obtained on request by the Company from the FDA (Agency number 803485) under the Freedom of Information Act refers to a 11 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-FEB-2019 at 08:30, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R016127, expiration date not reported, but upon internal validation established as 22-MAR-2021 (dose not reported) via intramuscular route in the right arm for prophylaxis. On the same day, the patient was vaccinated with sixth dose of diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid (BOOSTRIX) lot # 9GM3R, expiration date not reported, (dose not reported) via intramuscular route in the left arm for prophylaxis and first dose of meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) lot # U6151AB, expiration date not reported, (dose not reported) via intramuscular route in the right arm for prophylaxis. On 26-FEB-2019 at 08:30, the patient was scared and crying during immunization. After that the patient felt dizziness and laid down on exam table for 3 to 5 minutes. The patient's blood pressure (BP) was 111/69 (unit not reported) when lying down, 117/61 (unit not reported) when sitting and 100/75 (unit not reported) when standing (blood pressure abnormal). The patient felt better and sat in waiting room for 10 minutes before leaving. It was also reported that "the patient seemed might have been scared and not experiencing dizziness". The outcome of fear, dizziness, crying and blood pressure abnormal was reported as resolved.   The causality assessment was not provided by the reporter.  Follow-up information was received from the Health Care Professional on 28-OCT-2019.  The patient's demographics were provided. The patient had no illness, allergies, birth defects or medical conditions.  Hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) were given on the right deltoid and diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid (BOOSTRIX) was given on the left deltoid. It was reported that the vaccine was resumed.  There was no temperature excursion as a result of a reading from a digital data logger.  The reporter considered dizziness to be related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid (BOOSTRIX) and meningococcal acyw conj vaccine (dip toxoid) (MENACTRA).
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Blood pressure abnormal, Crying, Dizziness, Fear
Clinical narrative: dizziness; scared; crying; BP standing 100/75; This report was identified from a line listing obtained on request by the Company from the FDA (Agency number 803485) under the Freedom of Information Act refers to a 11 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-FEB-2019 at 08:30, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R016127, expiration date not reported, but upon internal validation established as 22-MAR-2021 (dose not reported) via intramuscular route in the right arm for prophylaxis. On the same day, the patient was vaccinated with sixth dose of diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid (BOOSTRIX) lot # 9GM3R, expiration date not reported, (dose not reported) via intramuscular route in the left arm for prophylaxis and first dose of meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) lot # U6151AB, expiration date not reported, (dose not reported) via intramuscular route in the right arm for prophylaxis. On 26-FEB-2019 at 08:30, the patient was scared and crying during immunization. After that the patient felt dizziness and laid down on exam table for 3 to 5 minutes. The patient's blood pressure (BP) was 111/69 (unit not reported) when lying down, 117/61 (unit not reported) when sitting and 100/75 (unit not reported) when standing (blood pressure abnormal). The patient felt better and sat in waiting room for 10 minutes before leaving. It was also reported that "the patient seemed might have been scared and not experiencing dizziness". The outcome of fear, dizziness, crying and blood pressure abnormal was reported as resolved.   The causality assessment was not provided by the reporter.  Follow-up information was received from the Health Care Professional on 28-OCT-2019.  The patient's demographics were provided. The patient had no illness, allergies, birth defects or medical conditions.  Hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) were given on the right deltoid and diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid (BOOSTRIX) was given on the left deltoid. It was reported that the vaccine was resumed.  There was no temperature excursion as a result of a reading from a digital data logger.  The reporter considered dizziness to be related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid (BOOSTRIX) and meningococcal acyw conj vaccine (dip toxoid) (MENACTRA).
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP, FLU4, HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Red and swollen where Injection was given.; Red and swollen where Injection was given.; warm to the touch and painful when raising her arm; warm to the touch and painful when raising her arm; This spontaneous report was received from an other healthcare professional and refers to a 12-year-old non-pregnant female patient. Her concurrent condition included allergy to unspecified sulfa drugs. The patient's medical history included hives due to sulfa allergy. No medication was listed as taking at the time of injection.  On 12-FEB-2019, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly in the right arm for prophylaxis (lot number: R019469, expiration date was not reported but upon internal validation established as 10-APR-2021) (exact dose was not provided).  On the same day, the patient also received influenza virus split virion 4v vaccine inactivated (FLUARIX QUADRIVALENT) injected in the right arm, intramuscularly, lot number: 4H5PT, 1st dose of diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid (BOOSTRIX) lot number: 33T42 and of meningococcal acyw conj vaccine (crm197)(MENVEO) lot number: AMVA036A, both injected in the left arm, intramuscularly (exact dose, indication and expiration date were not provided).   On 13-FEB-2019, the patient experienced injection site redness and swollen. It was reported that it was warm to the touch and painful when she was raising her arm. Due to adverse events, the patient visited healthcare professional and as a treatment she received ice and ibuprofen recommended every 6 hours as needed.  The outcome of the events was unknown. The causality assessment was not provided.
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP, FLU4, HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Red and swollen where Injection was given.; Red and swollen where Injection was given.; warm to the touch and painful when raising her arm; warm to the touch and painful when raising her arm; This spontaneous report was received from an other healthcare professional and refers to a 12-year-old non-pregnant female patient. Her concurrent condition included allergy to unspecified sulfa drugs. The patient's medical history included hives due to sulfa allergy. No medication was listed as taking at the time of injection.  On 12-FEB-2019, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly in the right arm for prophylaxis (lot number: R019469, expiration date was not reported but upon internal validation established as 10-APR-2021) (exact dose was not provided).  On the same day, the patient also received influenza virus split virion 4v vaccine inactivated (FLUARIX QUADRIVALENT) injected in the right arm, intramuscularly, lot number: 4H5PT, 1st dose of diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid (BOOSTRIX) lot number: 33T42 and of meningococcal acyw conj vaccine (crm197)(MENVEO) lot number: AMVA036A, both injected in the left arm, intramuscularly (exact dose, indication and expiration date were not provided).   On 13-FEB-2019, the patient experienced injection site redness and swollen. It was reported that it was warm to the touch and painful when she was raising her arm. Due to adverse events, the patient visited healthcare professional and as a treatment she received ice and ibuprofen recommended every 6 hours as needed.  The outcome of the events was unknown. The causality assessment was not provided.
Age: 25.0
Sex: F
Vaccine: HEP, HPV9, PPV, HEP, HPV9, PPV
Symptoms: Cough, Dysphonia, Fatigue, Rhinorrhoea
Clinical narrative: Patient presents with C/O cough, runny nose, a raspy voice and fatigue; Patient presents with C/O cough, runny nose, a raspy voice and fatigue; Patient presents with C/O cough, runny nose, a raspy voice and fatigue; Patient presents with C/O cough, runny nose, a raspy voice and fatigue; This spontaneous report was received from a medical assistant and refers to a 25-year-old non-pregnant female patient. There was no information about the patient's concurrent condition, concomitant medication and medical history provided.  On 05-FEB-2019, the patient was vaccinated with first doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly in the left arm (lot number R024264, expiration date not reported but established as 29-OCT-2019), pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscularly in the left arm (lot number R007722, expiration date not reported but established as 10-MAR-2020) for prophylaxis (exact dose was not provided for both vaccines) and with hepatitis b virus vaccine rhbsag (yeast) (ENGERIX-B) intramuscularly in the right arm, lot number: 924TJ (exact dose, expiration date and indication were not reported).  On 06-FEB-2019, the patient experienced cough, fatigue, dysphonia and rhinorrhea. The patient visited her healthcare professional due to adverse events.  The outcome was unknown. The causality assessment was not provided.
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Biopsy skin, Chills, Erythema multiforme, Nausea, Pain in extremity
Clinical narrative: Erythema multiforme; This case was retrieved from a VAERS download on 23AUG2019.   A 23-year-old male patient was diagnosed with erythema multiforme (PT: Erythema multiforme), following the administration of BioThrax (anthrax vaccine adsorbed).  On 25JUN2019, the patient received BioThrax (dose 2). On 25JUN2019, several hour after receiving vaccine, rash developed on both of his lower extremities. On 26JUN2019, he visited the emergency department, where he was referred to the dermatology clinic. Then, biopsy was performed and was prescribed triamcinolone topically. Later, his rash continued to spread rapidly over his entire body, so he again visited to the emergency department on 28JUN2019. He also complained of nausea/ vomiting (N/V), subjective chills, itching, and pain in his feet. Finally, he was diagnosed with erythema multiforme. Outcome was unknown.  Laboratory test included Biopsy (results were pending).  Current illness, concomitant medication, patient's history/ allergy were reported to be none.  The reporter considered the event of erythema multiforme related to the vaccine.  Company Comments: The described event "erythema multiforme" is a known effect of Biothrax vaccine, temporal relationship is established, and therefore considered to be causally related to the administration of BioThrax.  Investigation into the event of erythema multiforme received on 18OCT2019: No increase in the number of reports for erythema multiforme have been detected; no trends have been identified.  Company Comment (after update received 18OCT2019): causal relationship remains unchanged: related to drug administration.
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Pruritus, Rash, Rash generalised, Vomiting
Clinical narrative: Erythema multiforme; This case was retrieved from a VAERS download on 23AUG2019.   A 23-year-old male patient was diagnosed with erythema multiforme (PT: Erythema multiforme), following the administration of BioThrax (anthrax vaccine adsorbed).  On 25JUN2019, the patient received BioThrax (dose 2). On 25JUN2019, several hour after receiving vaccine, rash developed on both of his lower extremities. On 26JUN2019, he visited the emergency department, where he was referred to the dermatology clinic. Then, biopsy was performed and was prescribed triamcinolone topically. Later, his rash continued to spread rapidly over his entire body, so he again visited to the emergency department on 28JUN2019. He also complained of nausea/ vomiting (N/V), subjective chills, itching, and pain in his feet. Finally, he was diagnosed with erythema multiforme. Outcome was unknown.  Laboratory test included Biopsy (results were pending).  Current illness, concomitant medication, patient's history/ allergy were reported to be none.  The reporter considered the event of erythema multiforme related to the vaccine.  Company Comments: The described event "erythema multiforme" is a known effect of Biothrax vaccine, temporal relationship is established, and therefore considered to be causally related to the administration of BioThrax.  Investigation into the event of erythema multiforme received on 18OCT2019: No increase in the number of reports for erythema multiforme have been detected; no trends have been identified.  Company Comment (after update received 18OCT2019): causal relationship remains unchanged: related to drug administration.
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Blister, Erythema multiforme
Clinical narrative: Erythema multiforme; This case was retrieved from a VAERS download on 23AUG2019.   A 23-year-old male patient was diagnosed with erythema multiforme (PT: Erythema multiforme), following the administration of BioThrax (anthrax vaccine adsorbed).  On 25JUN2019, the patient received BioThrax (dose 2). On 25JUN2019, several hour after receiving vaccine, rash developed on both of his lower extremities. On 26JUN2019, he visited the emergency department, where he was referred to the dermatology clinic. Then, biopsy was performed and was prescribed triamcinolone topically. Later, his rash continued to spread rapidly over his entire body, so he again visited to the emergency department on 28JUN2019. He also complained of nausea/ vomiting (N/V), subjective chills, itching, and pain in his feet. Finally, he was diagnosed with erythema multiforme. Outcome was unknown.  Laboratory test included Biopsy (results were pending).  Current illness, concomitant medication, patient's history/ allergy were reported to be none.  The reporter considered the event of erythema multiforme related to the vaccine.  Company Comments: The described event "erythema multiforme" is a known effect of Biothrax vaccine, temporal relationship is established, and therefore considered to be causally related to the administration of BioThrax.  Investigation into the event of erythema multiforme received on 18OCT2019: No increase in the number of reports for erythema multiforme have been detected; no trends have been identified.  Company Comment (after update received 18OCT2019): causal relationship remains unchanged: related to drug administration.
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Biopsy, Chills, Erythema multiforme, Nausea, Pain in extremity
Clinical narrative: Erythema multiforme; This case was retrieved from a VAERS download on 23AUG2019.   A 23-year-old male patient was diagnosed with erythema multiforme (PT: Erythema multiforme), following the administration of BioThrax (anthrax vaccine adsorbed).  On 25JUN2019, the patient received BioThrax (dose 2). On 25JUN2019, several hour after receiving vaccine, rash developed on both of his lower extremities. On 26JUN2019, he visited the emergency department, where he was referred to the dermatology clinic. Then, biopsy was performed and was prescribed triamcinolone topically. Later, his rash continued to spread rapidly over his entire body, so he again visited to the emergency department on 28JUN2019. He also complained of nausea/ vomiting (N/V), subjective chills, itching, and pain in his feet. Finally, he was diagnosed with erythema multiforme. Outcome was unknown.  Laboratory test included Biopsy (results were pending).  Current illness, concomitant medication, patient's history/ allergy were reported to be none.  The reporter considered the event of erythema multiforme related to the vaccine.  Company Comments: The described event "erythema multiforme" is a known effect of Biothrax vaccine, temporal relationship is established, and therefore considered to be causally related to the administration of BioThrax.  Investigation into the event of erythema multiforme received on 18OCT2019: No increase in the number of reports for erythema multiforme have been detected; no trends have been identified.  Company Comment (after update received 18OCT2019): causal relationship remains unchanged: related to drug administration.
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Pruritus, Rash, Vomiting
Clinical narrative: Erythema multiforme; This case was retrieved from a VAERS download on 23AUG2019.   A 23-year-old male patient was diagnosed with erythema multiforme (PT: Erythema multiforme), following the administration of BioThrax (anthrax vaccine adsorbed).  On 25JUN2019, the patient received BioThrax (dose 2). On 25JUN2019, several hour after receiving vaccine, rash developed on both of his lower extremities. On 26JUN2019, he visited the emergency department, where he was referred to the dermatology clinic. Then, biopsy was performed and was prescribed triamcinolone topically. Later, his rash continued to spread rapidly over his entire body, so he again visited to the emergency department on 28JUN2019. He also complained of nausea/ vomiting (N/V), subjective chills, itching, and pain in his feet. Finally, he was diagnosed with erythema multiforme. Outcome was unknown.  Laboratory test included Biopsy (results were pending).  Current illness, concomitant medication, patient's history/ allergy were reported to be none.  The reporter considered the event of erythema multiforme related to the vaccine.  Company Comments: The described event "erythema multiforme" is a known effect of Biothrax vaccine, temporal relationship is established, and therefore considered to be causally related to the administration of BioThrax.  Investigation into the event of erythema multiforme received on 18OCT2019: No increase in the number of reports for erythema multiforme have been detected; no trends have been identified.  Company Comment (after update received 18OCT2019): causal relationship remains unchanged: related to drug administration.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dyskinesia, Gynaecological examination normal, Muscle contractions involuntary, Muscle spasms, Muscle twitching
Clinical narrative: Muscle spasms and twitches began mid April came on strong all over entire body. Patient saw neurologist who diagnosed her with Benign fasciculation syndrome. Patient states symptoms have been improving and is not on any medication for treatment.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Parasite stool test negative
Clinical narrative: Muscle spasms and twitches began mid April came on strong all over entire body. Patient saw neurologist who diagnosed her with Benign fasciculation syndrome. Patient states symptoms have been improving and is not on any medication for treatment.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Muscle contractions involuntary, Muscle spasms, Muscle twitching
Clinical narrative: Muscle spasms and twitches began mid April came on strong all over entire body. Patient saw neurologist who diagnosed her with Benign fasciculation syndrome. Patient states symptoms have been improving and is not on any medication for treatment.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, SMALL
Symptoms: Chest discomfort, Computerised tomogram, Echocardiogram normal, Electrocardiogram, Laboratory test
Clinical narrative: MYOCARDITIS, EXERTIONAL DYSPNEA, CHEST PAIN
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, SMALL
Symptoms: Tachycardia
Clinical narrative: MYOCARDITIS, EXERTIONAL DYSPNEA, CHEST PAIN
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, SMALL
Symptoms: Chest pain, Dyspnoea exertional, Electrocardiogram T wave inversion, Myocarditis, Troponin increased
Clinical narrative: MYOCARDITIS, EXERTIONAL DYSPNEA, CHEST PAIN
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Redness below the deltoid muscle; swelling below the deltoid muscle; itching below the deltoid muscle; This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number EG55L, expiry date 7th December 2021) for prophylaxis.   On 17th October 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 18th October 2019, 1 days after receiving Shingrix, the patient experienced erythema of extremities, swelling arm and itchy upper limbs. On an unknown date, the outcome of the erythema of extremities, swelling arm and itchy upper limbs were not recovered/not resolved.   It was unknown if the reporter considered the erythema of extremities, swelling arm and itchy upper limbs to be related to Shingrix.  Additional details were provided as follows: The registered pharmacist stated that the patient received their second dose of Shingrix on left deltoid an experienced severe redness, swelling and itching below the deltoid muscle (below the injection site, not at the injection site) following Shingrix administration. The pharmacist stated that administering pharmacist insists they administered in the deltoid muscle of the arm but patient is now questioning if it was received in the deltoid muscle. The reporter was consented to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Redness below the deltoid muscle; swelling below the deltoid muscle; itching below the deltoid muscle; This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number EG55L, expiry date 7th December 2021) for prophylaxis.   On 17th October 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 18th October 2019, 1 days after receiving Shingrix, the patient experienced erythema of extremities, swelling arm and itchy upper limbs. On an unknown date, the outcome of the erythema of extremities, swelling arm and itchy upper limbs were not recovered/not resolved.   It was unknown if the reporter considered the erythema of extremities, swelling arm and itchy upper limbs to be related to Shingrix.  Additional details were provided as follows: The registered pharmacist stated that the patient received their second dose of Shingrix on left deltoid an experienced severe redness, swelling and itching below the deltoid muscle (below the injection site, not at the injection site) following Shingrix administration. The pharmacist stated that administering pharmacist insists they administered in the deltoid muscle of the arm but patient is now questioning if it was received in the deltoid muscle. The reporter was consented to follow up.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Tingling down the arm, all the way down to his fingers on the left arm; This case was reported by a consumer via call center representative and described the occurrence of tingling in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 7th October 2019, less than a day after receiving Shingrix, the patient experienced tingling. On an unknown date, the outcome of the tingling was not recovered/not resolved.   It was unknown if the reporter considered the tingling to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. He experienced tingling down the arm, all the way down to his fingers on the left arm. The patient stated, even after two weeks, it was not improved. The patient consented to follow up and agreed to receive letter asking for healthcare professional contact.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Paraesthesia
Clinical narrative: Tingling down the arm, all the way down to his fingers on the left arm; This case was reported by a consumer via call center representative and described the occurrence of tingling in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 7th October 2019, less than a day after receiving Shingrix, the patient experienced tingling. On an unknown date, the outcome of the tingling was not recovered/not resolved.   It was unknown if the reporter considered the tingling to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. He experienced tingling down the arm, all the way down to his fingers on the left arm. The patient stated, even after two weeks, it was not improved. The patient consented to follow up and agreed to receive letter asking for healthcare professional contact.
Age: 27.0
Sex: F
Vaccine: ADEN_4_7, ANTH, FLU4, HEP, MENB, MMR, TYP, UNK, UNK, YF
Symptoms: Rash, Rash erythematous, Rash vesicular
Clinical narrative: I had a rash from chin to the chest that was red, blistered looking, and angry looking
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site cellulitis, Injection site erythema, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: customer reported a lump, redness, heat, severe pain at site of injection. went to urgent care and was diagnosed with cellulitis of upper left arm and was prescribed bactrim DS
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site inflammation, Injection site mass, Product administered at inappropriate site
Clinical narrative: states was given too low on the arm. into SubQ not im. redness inflammation a lump at site of injection
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Irregular cells with HPV type 16 infection; This spontaneous report was received from a consumer (patient's mother) referred to her 24-year old daughter. The patient had no medical history, concurrent conditions, drug reaction/allergies and concomitant medications. On 05-MAY-2010, the patient was vaccinated with first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) lot # 0317Y (invalid lot #) (dose, route, expiration date were not reported) for prophylaxis. On 05-JUL-2010, the patient was vaccinated with second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) lot # 1377Y and expiry date 29-JUN-2012. On 11-NOV-2010, the patient was vaccinated with third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) lot # 0331Z and expiry date 20-NOV-2012. Approximately on 02-OCT-2019 (reported as 2 weeks ago), a pap smear test was performed that found irregular cells with human papillomavirus (HPV) type 16 infection. The patient did not receive any treatment for the adverse event. The outcome of the event was not resolved. The reporter did not provide any causality assessment.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Blood test, Cellulitis, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: The patient experienced inject site swelling, redness, warmth, pain, unable to lift the arm, and was diagnosed with Cellulitis after receiving the PNEUMOVAX 23 vaccine; This spontaneous report was received from a 68 years old female patient regarding on herself with high cholesterol. The patient was allergic to aspirin. The concomitant medication was unknown.  On 06-SEP-2018, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (route unknown, in upper arm, one shot; lot # and expiration date were not reported) for pneumonia (prophylaxis).  On the same day, the patient experienced inject site swelling, redness, warmth, pain, unable to lift the arm, and was diagnosed with cellulitis after receiving the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vaccine. Patient was hospitalized for 3 days on 09-SEP-2018. The patient treated with alprazolam (ATARAX), intravenous of antibiotics (unspecified). The patient sought for medical attention. Blood work was performed (result was not provided). The patient was recovered on 04-OCT-2018. The causality assessment was not provided.   Upon internal review, cellulitis was determined to be medically significant.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: The patient experienced inject site swelling, redness, warmth, pain, unable to lift the arm, and was diagnosed with Cellulitis after receiving the PNEUMOVAX 23 vaccine; This spontaneous report was received from a 68 years old female patient regarding on herself with high cholesterol. The patient was allergic to aspirin. The concomitant medication was unknown.  On 06-SEP-2018, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (route unknown, in upper arm, one shot; lot # and expiration date were not reported) for pneumonia (prophylaxis).  On the same day, the patient experienced inject site swelling, redness, warmth, pain, unable to lift the arm, and was diagnosed with cellulitis after receiving the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vaccine. Patient was hospitalized for 3 days on 09-SEP-2018. The patient treated with alprazolam (ATARAX), intravenous of antibiotics (unspecified). The patient sought for medical attention. Blood work was performed (result was not provided). The patient was recovered on 04-OCT-2018. The causality assessment was not provided.   Upon internal review, cellulitis was determined to be medically significant.