chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4, MENB
Symptoms: Rash, Tachycardia
Clinical narrative: Tachycardia; Rash; This case was reported by a physician via sales rep and described the occurrence of tachycardia in a child female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included GARDASIL for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero and GARDASIL. On an unknown date, 15 min after receiving Bexsero, the patient experienced tachycardia (serious criteria hospitalization) and rash (serious criteria hospitalization). The patient was treated with epinephrine. On an unknown date, the outcome of the tachycardia and rash were unknown.   It was unknown if the reporter considered the tachycardia and rash to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Bexsero and Gardasil on different arm at same time. After 15 minutes, the patient had rash and was tachycardiac. The patient was brought to hospital. The reporter consented for follow up.
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: Contusion, Immunoglobulin therapy, Platelet count decreased
Clinical narrative: platelets are still below 4K; Bruising; This case was reported by a physician via sales rep and described the occurrence of contusion in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Hepatitis A vaccine for prophylaxis.   On 23rd May 2019, the patient received Shingrix and Hepatitis A vaccine. On 23rd August 2019, 92 days after receiving Shingrix and Hepatitis A vaccine, the patient experienced contusion. On 24th August 2019, the patient experienced platelets decreased. The patient was treated with rituximab (Rituxan). On an unknown date, the outcome of the contusion and platelets decreased were unknown.   It was unknown if the reporter considered the contusion and platelets decreased to be related to Shingrix and Hepatitis A vaccine.  Additional details were provided as follows: The age at vaccination was not reported applicable for this report. The patient received Shingrix and went to dentist and developed bruising. The patient had intravenous immunoglobulin and steroids therapy. The off treatment down. The patient had platelet booster and rituximab (Rituxan) and still platelet was still below 4k.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Muscle pain; This case was reported by a consumer and described the occurrence of myalgia in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknwon date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced myalgia. On an unknown date, the outcome of the myalgia was unknown.   It was unknown if the reporter considered the myalgia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had muscle pain.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Inappropriate schedule of product administration, Nausea
Clinical narrative: Inappropriate Schedule of Vaccine; Tiredness; Nausea; Dizziness; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of fatigue (1st dose received on 1st July 2018, refer linked case US2019186011).   On 2nd June 2019, the patient received the 2nd dose of Shingrix. On 2nd June 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced tiredness, nausea and dizziness. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the tiredness, nausea and dizziness were recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the tiredness, nausea and dizziness to be related to Shingrix.  Additional information received were as follows: Less than 5 months after receiving Shingrix, the patient experienced tiredness, nausea and dizziness. The symptoms lasted a day. The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Feeling hot, Herpes zoster, Malaise, Pain, Rash
Clinical narrative: Shingles; Rash; Warm; Body aches; Malaise; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st October 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 2nd October 2019, 1 days after receiving Shingrix, the patient experienced feeling of warmth, general body pain and malaise. On 6th October 2019, the patient experienced rash. On 8th October 2019, the patient experienced shingles. On 3rd October 2019, the outcome of the feeling of warmth, general body pain and malaise were recovered/resolved. On an unknown date, the outcome of the shingles and rash were not recovered/not resolved.   It was unknown if the reporter considered the shingles, feeling of warmth, general body pain, malaise and rash to be related to Shingrix.  Additional details were provided as follows: The patient received the first dose of the Shingrix vaccine on the evening of Tuesday. The next day he had the following symptoms malaise, body aches, and felt warm. All symptoms resolved 3rd October 2019. On Sunday, 6th October 2019, he noted what he thought was a mosquito bite on the right side of his neck. On Monday, 7th October 2019, during the middle of the day, he noticed that he had a rash on the right side of his neck, right side of his chest, and upper right side of his back. On Tuesday 8th October 2019, he went to the urgent Care and was diagnosed with Shingles. In the late afternoon on Wednesday, 9th October 2019, he also went to his primary care physician and was again told he had shingles. The reporter consented to follow up.
Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash, Rash erythematous
Clinical narrative: Shingles; Rash; Warm; Body aches; Malaise; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st October 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 2nd October 2019, 1 days after receiving Shingrix, the patient experienced feeling of warmth, general body pain and malaise. On 6th October 2019, the patient experienced rash. On 8th October 2019, the patient experienced shingles. On 3rd October 2019, the outcome of the feeling of warmth, general body pain and malaise were recovered/resolved. On an unknown date, the outcome of the shingles and rash were not recovered/not resolved.   It was unknown if the reporter considered the shingles, feeling of warmth, general body pain, malaise and rash to be related to Shingrix.  Additional details were provided as follows: The patient received the first dose of the Shingrix vaccine on the evening of Tuesday. The next day he had the following symptoms malaise, body aches, and felt warm. All symptoms resolved 3rd October 2019. On Sunday, 6th October 2019, he noted what he thought was a mosquito bite on the right side of his neck. On Monday, 7th October 2019, during the middle of the day, he noticed that he had a rash on the right side of his neck, right side of his chest, and upper right side of his back. On Tuesday 8th October 2019, he went to the urgent Care and was diagnosed with Shingles. In the late afternoon on Wednesday, 9th October 2019, he also went to his primary care physician and was again told he had shingles. The reporter consented to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: circular, inguinal rash; suspicious for shingles rash; This case was reported by a other health professional via call center representative and described the occurrence of rash in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix. On 9th October 2019, less than 2 weeks after receiving Shingrix, the patient experienced rash and shingles. On an unknown date, the outcome of the rash and shingles were not recovered/not resolved.   It was unknown if the reporter considered the rash and shingles to be related to Shingrix.  Additional details were provided as follows: This case was reported by a physician assistant in a gynecology office. The patient received 1st dose of Shingrix approximately 2 weeks ago and presented today, at the day of reporting, with a circular, inguinal rash that developed on Wednesday 9th October 2019 and appeared to be suspicious for shingles rash. The outcome reported for all the events in the structured field of XML is recovering/resolving instead of not recovered/ not resolved (outcome uploaded).
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Ear pruritus, Immediate post-injection reaction, Pruritus
Clinical narrative: Itch / Itching started in his middle ear, and then spread to his back; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 9th September 2019, the patient received the 2nd dose of Shingrix. On 9th September 2019, immediately after receiving Shingrix, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was not recovered/not resolved.   It was unknown if the reporter considered the pruritus to be related to Shingrix.  Additional details were provided as follows: In July 2019, the patient received 1st dose of Shingrix and did not experience any events. Almost immediately after 2nd dose of Shingrix, the patient began to itch. The itching started in his middle ear and then spread to his back. At the time of report, the symptoms have not improved. The reporter consented to follow up.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Impaired work ability, Influenza like illness, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: flu like symptoms; stayed home from work one day; sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in July 2019 and had no reaction).   On 6th October 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 7th October 2019, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms and activities of daily living impaired. In October 2019, the patient experienced pain in arm. On 9th October 2019, the outcome of the pain in arm, influenza-like symptoms and activities of daily living impaired were recovered/resolved.   It was unknown if the reporter considered the pain in arm, influenza-like symptoms and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left deltoid and had a sore arm for 2-3 days. Sore arm resolved. She states he had flu-like symptoms and he stayed home from work one day and he woke up feeling fine. All symptoms have resolved. The reporter consented to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Chills, Erythema, Fatigue
Clinical narrative: hot to touch; hot to touch; red face; gets hot and then cold; face gets red and flushed; fever/feverish; chills; swelling injection site/swollen; flu like symptoms; ache joints; lethargy; tired; low energy; The injection site red; This case was reported by a consumer via call center representative and described the occurrence of fever in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th October 2019, the patient received Shingrix. On 13th October 2019, 1 days after receiving Shingrix, the patient experienced fever, chills, injection site swelling, influenza-like symptoms, joint pain, lethargy, tiredness and energy decreased. On 14th October 2019, the patient experienced red face, feeling hot and cold and facial flushing. In October 2019, the patient experienced injection site erythema. On an unknown date, the patient experienced feeling hot and injection site warmth. On an unknown date, the outcome of the fever, chills, injection site swelling, influenza-like symptoms, joint pain, lethargy, tiredness, energy decreased, red face, feeling hot and cold, facial flushing, feeling hot, injection site erythema and injection site warmth were unknown.   It was unknown if the reporter considered the fever, chills, injection site swelling, influenza-like symptoms, joint pain, lethargy, tiredness, energy decreased, red face, feeling hot and cold, facial flushing, feeling hot, injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The patient received shingrix and next day she developed fever, chills, swelling at the injection site, flu like symptoms, ache joints, lethargy, low energy and felt tired. At the time of reporting she went to work and her face would get red and flushed, she experiences a hot and then a cold feeling off and on. She reports that she was still feverish but has not taken her temperature.  The people had told her that she was burning up after touching her.  The injection site, left arm, was still red, swollen and hot to touch.  The reporter did not consent to follow up. The caller reported that she did not had a treating physician.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Feeling of body temperature change, Flushing, Influenza like illness, Injection site erythema
Clinical narrative: hot to touch; hot to touch; red face; gets hot and then cold; face gets red and flushed; fever/feverish; chills; swelling injection site/swollen; flu like symptoms; ache joints; lethargy; tired; low energy; The injection site red; This case was reported by a consumer via call center representative and described the occurrence of fever in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th October 2019, the patient received Shingrix. On 13th October 2019, 1 days after receiving Shingrix, the patient experienced fever, chills, injection site swelling, influenza-like symptoms, joint pain, lethargy, tiredness and energy decreased. On 14th October 2019, the patient experienced red face, feeling hot and cold and facial flushing. In October 2019, the patient experienced injection site erythema. On an unknown date, the patient experienced feeling hot and injection site warmth. On an unknown date, the outcome of the fever, chills, injection site swelling, influenza-like symptoms, joint pain, lethargy, tiredness, energy decreased, red face, feeling hot and cold, facial flushing, feeling hot, injection site erythema and injection site warmth were unknown.   It was unknown if the reporter considered the fever, chills, injection site swelling, influenza-like symptoms, joint pain, lethargy, tiredness, energy decreased, red face, feeling hot and cold, facial flushing, feeling hot, injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The patient received shingrix and next day she developed fever, chills, swelling at the injection site, flu like symptoms, ache joints, lethargy, low energy and felt tired. At the time of reporting she went to work and her face would get red and flushed, she experiences a hot and then a cold feeling off and on. She reports that she was still feverish but has not taken her temperature.  The people had told her that she was burning up after touching her.  The injection site, left arm, was still red, swollen and hot to touch.  The reporter did not consent to follow up. The caller reported that she did not had a treating physician.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Lethargy, Pyrexia, Skin warm
Clinical narrative: hot to touch; hot to touch; red face; gets hot and then cold; face gets red and flushed; fever/feverish; chills; swelling injection site/swollen; flu like symptoms; ache joints; lethargy; tired; low energy; The injection site red; This case was reported by a consumer via call center representative and described the occurrence of fever in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th October 2019, the patient received Shingrix. On 13th October 2019, 1 days after receiving Shingrix, the patient experienced fever, chills, injection site swelling, influenza-like symptoms, joint pain, lethargy, tiredness and energy decreased. On 14th October 2019, the patient experienced red face, feeling hot and cold and facial flushing. In October 2019, the patient experienced injection site erythema. On an unknown date, the patient experienced feeling hot and injection site warmth. On an unknown date, the outcome of the fever, chills, injection site swelling, influenza-like symptoms, joint pain, lethargy, tiredness, energy decreased, red face, feeling hot and cold, facial flushing, feeling hot, injection site erythema and injection site warmth were unknown.   It was unknown if the reporter considered the fever, chills, injection site swelling, influenza-like symptoms, joint pain, lethargy, tiredness, energy decreased, red face, feeling hot and cold, facial flushing, feeling hot, injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The patient received shingrix and next day she developed fever, chills, swelling at the injection site, flu like symptoms, ache joints, lethargy, low energy and felt tired. At the time of reporting she went to work and her face would get red and flushed, she experiences a hot and then a cold feeling off and on. She reports that she was still feverish but has not taken her temperature.  The people had told her that she was burning up after touching her.  The injection site, left arm, was still red, swollen and hot to touch.  The reporter did not consent to follow up. The caller reported that she did not had a treating physician.
Age: 60.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site warmth, Urticaria
Clinical narrative: INFLAMMATION, REDNESS, FIRM TO TOUCH AND WARMTH TO INJECTION SITE.  AFFECTED AREA APPROXIMATELY 3 INCHES IN DIAMETER. COMPLAINED OF URTICARIA RADIATING TO RIGHT SIDE OF NECK. NO SOB.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: red, warm, achy 3 inch circumference left deltoid
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Inflammation, Pain
Clinical narrative: inflammation, redness, pain
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash, Respiratory tract congestion, Throat irritation
Clinical narrative: Systemic reaction. Full body rash, congestion, itchy throat, full body itching
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Adverse drug reaction, Contusion, Endotracheal intubation, Fall, Gait inability
Clinical narrative: On July 25 afternoon felt weakness a couple of times in the left leg. About 7 PM started to feel pins and needles in feet and hands. About 9 PM went to emergency room, About 2 AM, July 26 was transferred. About 10 AM could not walk without walker and fell with walker, from then on could not walk. After MRI and spinal tap confirmed Guillain-Barre Syndrome, about 7 PM administered IVIG. Over the following 4 days administered the remaining 4 doses of IVIG. On August 1 received a vascular ultrasound on left arm because of severe bruising due to several two arm lifts instead of using Hoyer lift . On August 4 at 3 PM was admitted to ICU because breathing was compromised. While in ICU contracted pneumonia. After breathing tube was removed experienced a reaction to Risperdal with thickening of tongue and facial swelling. August 9 at 11:30 PM was removed from ICU to regular floor room. Was discharged on August 13, 2019 to Rehab Hospital. During my stay there worked on OT and PT.  Released from rehab hospital on September 8, 2019 (27 days)  to Outpatient Rehab. Currently still in rehab.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Intensive care, Lumbar puncture abnormal, Magnetic resonance imaging abnormal
Clinical narrative: On July 25 afternoon felt weakness a couple of times in the left leg. About 7 PM started to feel pins and needles in feet and hands. About 9 PM went to emergency room, About 2 AM, July 26 was transferred. About 10 AM could not walk without walker and fell with walker, from then on could not walk. After MRI and spinal tap confirmed Guillain-Barre Syndrome, about 7 PM administered IVIG. Over the following 4 days administered the remaining 4 doses of IVIG. On August 1 received a vascular ultrasound on left arm because of severe bruising due to several two arm lifts instead of using Hoyer lift . On August 4 at 3 PM was admitted to ICU because breathing was compromised. While in ICU contracted pneumonia. After breathing tube was removed experienced a reaction to Risperdal with thickening of tongue and facial swelling. August 9 at 11:30 PM was removed from ICU to regular floor room. Was discharged on August 13, 2019 to Rehab Hospital. During my stay there worked on OT and PT.  Released from rehab hospital on September 8, 2019 (27 days)  to Outpatient Rehab. Currently still in rehab.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Muscular weakness, Paraesthesia, Pneumonia, Respiration abnormal, Swelling face
Clinical narrative: On July 25 afternoon felt weakness a couple of times in the left leg. About 7 PM started to feel pins and needles in feet and hands. About 9 PM went to emergency room, About 2 AM, July 26 was transferred. About 10 AM could not walk without walker and fell with walker, from then on could not walk. After MRI and spinal tap confirmed Guillain-Barre Syndrome, about 7 PM administered IVIG. Over the following 4 days administered the remaining 4 doses of IVIG. On August 1 received a vascular ultrasound on left arm because of severe bruising due to several two arm lifts instead of using Hoyer lift . On August 4 at 3 PM was admitted to ICU because breathing was compromised. While in ICU contracted pneumonia. After breathing tube was removed experienced a reaction to Risperdal with thickening of tongue and facial swelling. August 9 at 11:30 PM was removed from ICU to regular floor room. Was discharged on August 13, 2019 to Rehab Hospital. During my stay there worked on OT and PT.  Released from rehab hospital on September 8, 2019 (27 days)  to Outpatient Rehab. Currently still in rehab.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Tongue disorder, Ultrasound Doppler, Walking aid user
Clinical narrative: On July 25 afternoon felt weakness a couple of times in the left leg. About 7 PM started to feel pins and needles in feet and hands. About 9 PM went to emergency room, About 2 AM, July 26 was transferred. About 10 AM could not walk without walker and fell with walker, from then on could not walk. After MRI and spinal tap confirmed Guillain-Barre Syndrome, about 7 PM administered IVIG. Over the following 4 days administered the remaining 4 doses of IVIG. On August 1 received a vascular ultrasound on left arm because of severe bruising due to several two arm lifts instead of using Hoyer lift . On August 4 at 3 PM was admitted to ICU because breathing was compromised. While in ICU contracted pneumonia. After breathing tube was removed experienced a reaction to Risperdal with thickening of tongue and facial swelling. August 9 at 11:30 PM was removed from ICU to regular floor room. Was discharged on August 13, 2019 to Rehab Hospital. During my stay there worked on OT and PT.  Released from rehab hospital on September 8, 2019 (27 days)  to Outpatient Rehab. Currently still in rehab.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Acute disseminated encephalomyelitis, Computerised tomogram head abnormal, Dysarthria, Magnetic resonance imaging brain abnormal, Paraesthesia
Clinical narrative: Symptoms: paraesthesias and slurred speech.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Vasculitis
Clinical narrative: Symptoms: paraesthesias and slurred speech.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Skin lesion, Urticaria
Clinical narrative: Patient reported urticaria and pruritic to staff 10/10/2019 around midnight, exam 10/09/2019 at 9 AM revealed pruritic urticaria along posterior neckline, R elbow, ventral R forearm, ventral L forearm, bilateral flanks, bilateral anterior and posterior thighs, anterior calves, and anterior surface of bilateral feet.  Received fexofenadine (Allegra) 180 mg PO as one time dose, along with famotidine (Pepcid) 40 mg PO as one time dose, combined with  diphenhydramine lotion topically QID PRN, and diphenhydramine 12.5 mg PO Q6 hrs PRN pruritis/urticaria.   10/10/2019 - Worsening of symptoms, urticaria wheals present at previous mentioned locations, Urticaria wheals have increased erythema and are now raised on anterior and posterior calves, but not coalescing.  Initiated fexofenadine (Allegra) 180 mg PO daily x 14 days, along with famotidine (Pepcid) 40 mg PO x 14 days. Continue to utilize diphenhydramine lotion topically QID PRN. Will increase diphenhydramine 12.5 mg PO Q 6 hrs PRN pruritis/urticaria to 25 mg PO Q 6 hrs PRN. 10/11/2019 - There are multiple coalescing erythematous lesions present along face/cheek, bilateral flanks, bilateral anterior and posterior thighs, anterior calves, and anterior surface of bilateral feet that are raised, but erythema has decreased significantly since 10/10/2019 exam.  Continue with fexofenadine (Allegra) 180 mg PO daily x 14 days (starting 10/10/2019), along with famotidine (Pepcid) 40 mg PO x 14 days, diphenhydramine lotion topically QID PRN, and diphenhydramine 25 mg PO Q 6 hrs PRN urticaria/pruritis. Will change hydroxyzine (Atarax) 50 mg PO BID PRN to hydroxyzine pamoate (Vistaril) 25 mg PO TID PRN. Will initiate triamcinolone (Kenalog) 0.5% ointment BID. Will add calamine lotion topically QID PRN. Will also add Cetaphil lotion for moisturization. 10/14/2019 - Visual exam of face reveals skin intact, normotemp, and color consistent with genetic background. Marked improvement from 10/11/2019 exam.  Continue with previously prescribed interventions.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: I am reporting this incident to VAERS because this patient was given Trumenba before knowing she tested positive for pregnancy. Patient gave no indication to possible pregnancy at appointment on 9/17/19. She came into the clinic to get started on birth control and this is why we ran a pregnancy test to ensure it was negative before prescribing  medication. In the meantime, patient was due for Trumenba and it was given during the appointment before pregnancy test was ran. This was realized after the fact. Patient has had no known side effects or problems to our knowledge. She is scheduled with the OB office, she would've been in her first trimester at the time of vaccine administration.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Immediate post-injection reaction, Injection site pain, Pain, Rotator cuff syndrome
Clinical narrative: Employee reports immediate pain with actual injection, followed by continuous shoulder joint pain, beginning 1/2 hour after injection, has continued, is exacerbated with certain arm movements.  NSAID trial ordered 10/15/19; re-evaluation appt. 10/23/19.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Dry mouth, Erythema, Lip swelling, Peripheral swelling, Pruritus
Clinical narrative: Employee received Fluzone Quadrivalent flu vaccine in her left Deltoid, on 10/08/2019 with no initial reaction. On 10/09/2019, she woke up with red, raised, itching bumps she thought was "bedbug bites" on her legs and abdomen. As the day progressed, she developed more "itching welts" all over her body, including her legs, ankles, arms, elbows, wrists, trunk, and abdomen. She took several doses of Benadryl for her symptoms without much relief. The following day, 10/10/2019, she felt her lips starting to swell and the welts had spread to her hands, knees, ankles, and neck, abdomen, back and buttock areas. Her throat was "scratchy" which she felt was due to dry mouth from taking multiple doses of Benadryl.   She had very mild swelling of her upper lip. Her hands/palms were mildly swollen and itching. She had no welts or itching or swelling at the flu vaccine injection site. No difficulty breathing or shortness of breath. No difficulty swallowing. No chest pain. No headache, no fever, no n/v/d, no runny nose, no itching or watering of eyes. No joint pain. No peeling skin.   She had recently completed two 10-day courses of Keflex and two 10-day courses of Bactrim for treatment of reoccurring vaginal abscesses. She had the vaginal abscess surgically removed on 09/09/2019 and then another abscess developed and she was started on Bactrim again. She finished the last course of Bactrim 10/6/2019.   On 10/10/2019 Employee presented to Clinic for an evaluation of her symptoms. She was sent to  Medical Center Emergency Room for treatment. In the Emergency room she was treated with a dose of Decadron and Pepcid which that resolved her lip swelling and reduced her urticaria. She was sent home with prescriptions for Benadryl 25mg by mouth every 6 hours as needed for itching up to 12 days, Pepcid 20mg by mouth 2 times a day for 5 days, and prednisone 60mg by mouth for 5 days and instructed to follow-up with her primary healthcare provider and possible referral to an allergist.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Rash pruritic, Swelling, Throat irritation, Urticaria
Clinical narrative: Employee received Fluzone Quadrivalent flu vaccine in her left Deltoid, on 10/08/2019 with no initial reaction. On 10/09/2019, she woke up with red, raised, itching bumps she thought was "bedbug bites" on her legs and abdomen. As the day progressed, she developed more "itching welts" all over her body, including her legs, ankles, arms, elbows, wrists, trunk, and abdomen. She took several doses of Benadryl for her symptoms without much relief. The following day, 10/10/2019, she felt her lips starting to swell and the welts had spread to her hands, knees, ankles, and neck, abdomen, back and buttock areas. Her throat was "scratchy" which she felt was due to dry mouth from taking multiple doses of Benadryl.   She had very mild swelling of her upper lip. Her hands/palms were mildly swollen and itching. She had no welts or itching or swelling at the flu vaccine injection site. No difficulty breathing or shortness of breath. No difficulty swallowing. No chest pain. No headache, no fever, no n/v/d, no runny nose, no itching or watering of eyes. No joint pain. No peeling skin.   She had recently completed two 10-day courses of Keflex and two 10-day courses of Bactrim for treatment of reoccurring vaginal abscesses. She had the vaginal abscess surgically removed on 09/09/2019 and then another abscess developed and she was started on Bactrim again. She finished the last course of Bactrim 10/6/2019.   On 10/10/2019 Employee presented to Clinic for an evaluation of her symptoms. She was sent to  Medical Center Emergency Room for treatment. In the Emergency room she was treated with a dose of Decadron and Pepcid which that resolved her lip swelling and reduced her urticaria. She was sent home with prescriptions for Benadryl 25mg by mouth every 6 hours as needed for itching up to 12 days, Pepcid 20mg by mouth 2 times a day for 5 days, and prednisone 60mg by mouth for 5 days and instructed to follow-up with her primary healthcare provider and possible referral to an allergist.
Age: 1.0
Sex: M
Vaccine: MMR, UNK, UNK
Symptoms: Rash, Rash erythematous, Rash papular
Clinical narrative: A light pink, smooth rash began on belly  approximately 9 days post vaccination. At approximately 12 days post vaccination, rash began to cover entire body. At 13 days post vaccination, the rash covered entire body, concentrated at the ear lobes, cheeks, and feet. The rash was also raised, similar to hives, and bright red.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: PT Stated never having reaction previously. PT was prepped w/alcohol and flu shot given in left UE via IM. PT had no reaction right away and stated he felt fine. PT left clinic and came back 35 min later stating his left arm was stinging only by forearm/hand, not at injection site. No rash/hive, Gave benedryl PO 25mg. PT left stating that he now felt fine. Steady on feet and calm. PT stated after benedryl that he did receive cortisone shots "recently" and he pulled out his arm for the flu clinic incorrectly.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Erythema, Injection site erythema, Injection site urticaria, Urticaria
Clinical narrative: About 15 min after imms, pt developed "red patches" on left thigh near to where vaccine was given and in the right side of the back of the neck. Red patches looked flat, irregular symmetry. Baby was alert, no crying, regular breathing.  Mom later described the "red patches" as hives on 9.26.19.  Unsure how long hives remained on baby's body d/t unable to reach mom via phone after incident.  No hospitalization was required. Baby's doing well.
Age: 66.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site haemorrhage, Injection site swelling
Clinical narrative: patient experienced excessive bleeding at injection site. estimated at 1-2ml. the patient also had swelling at the injection site under the skin
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Chills, Erythema, Exfoliative rash, Headache
Clinical narrative: Patient reports the following after the 2nd dose of Shingrix : muscle aches (generalized), redness/splotches on right arm (not limited to injection site however), headache, and shivering-- >these symptoms started on 10/3/19. Redness on arm went away after "several days" but a red sore appeared "halfway between knee and thigh of the right leg"; around 10/6/19 red spots appeared as well on left leg and that evening when she took a bath both legs really burned and itched badly. Since 10/6/19 the rash started spreading from knees up to "personal area" on both sides...rash looks red and very "thick/scaly". Primary complaint is that it "hurts/burns/itches", arm seems to be worse than legs at this point and this is her primary complaint.  Patient saw primary provider 10/15/19, thoughts were that this was a shingles rash (pt has had shingles twice in the past) or allergic reaction to something in the vaccine. She does have a latex allergy but the package insert states no latex is used in the rubber stopper. With the first dose patient remembers having a very sore arm starting a couple weeks after the shot and lasting for "several weeks"; no rash, just soreness with dose 1. Provider recommended topical Sarna as needed and Benadryl at bedtime to help with itching. Patient reports this has been helping a little but rash is still prevalent.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pruritus, Rash, Rash erythematous, Rash macular
Clinical narrative: Patient reports the following after the 2nd dose of Shingrix : muscle aches (generalized), redness/splotches on right arm (not limited to injection site however), headache, and shivering-- >these symptoms started on 10/3/19. Redness on arm went away after "several days" but a red sore appeared "halfway between knee and thigh of the right leg"; around 10/6/19 red spots appeared as well on left leg and that evening when she took a bath both legs really burned and itched badly. Since 10/6/19 the rash started spreading from knees up to "personal area" on both sides...rash looks red and very "thick/scaly". Primary complaint is that it "hurts/burns/itches", arm seems to be worse than legs at this point and this is her primary complaint.  Patient saw primary provider 10/15/19, thoughts were that this was a shingles rash (pt has had shingles twice in the past) or allergic reaction to something in the vaccine. She does have a latex allergy but the package insert states no latex is used in the rubber stopper. With the first dose patient remembers having a very sore arm starting a couple weeks after the shot and lasting for "several weeks"; no rash, just soreness with dose 1. Provider recommended topical Sarna as needed and Benadryl at bedtime to help with itching. Patient reports this has been helping a little but rash is still prevalent.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin ulcer
Clinical narrative: Patient reports the following after the 2nd dose of Shingrix : muscle aches (generalized), redness/splotches on right arm (not limited to injection site however), headache, and shivering-- >these symptoms started on 10/3/19. Redness on arm went away after "several days" but a red sore appeared "halfway between knee and thigh of the right leg"; around 10/6/19 red spots appeared as well on left leg and that evening when she took a bath both legs really burned and itched badly. Since 10/6/19 the rash started spreading from knees up to "personal area" on both sides...rash looks red and very "thick/scaly". Primary complaint is that it "hurts/burns/itches", arm seems to be worse than legs at this point and this is her primary complaint.  Patient saw primary provider 10/15/19, thoughts were that this was a shingles rash (pt has had shingles twice in the past) or allergic reaction to something in the vaccine. She does have a latex allergy but the package insert states no latex is used in the rubber stopper. With the first dose patient remembers having a very sore arm starting a couple weeks after the shot and lasting for "several weeks"; no rash, just soreness with dose 1. Provider recommended topical Sarna as needed and Benadryl at bedtime to help with itching. Patient reports this has been helping a little but rash is still prevalent.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Pain
Clinical narrative: severe area of induration 5x3.5 inches redness and pain
Age: 14.0
Sex: F
Vaccine: FLUC4
Symptoms: Feeling abnormal, Throat tightness
Clinical narrative: Reports around 1230 she started to not feel right; pt. Reports she feels like her throat is closing Treatment during the ER visit : diphenhydrAMINE (BENADRYL) 50 mg/mL injection   25 mg, Intravenous, NOW, Mon 10/14/19 at 1500, For 1 dose   Given 10/14/2019 3:15 PM EDT 25 mg      famotidine (PEPCID) 20 mg in iso-osmotic 50 mL premix IVPB   50 mL (20 mg), Intravenous, NOW, Mon 10/14/19 at 1500, For 1 dose   New Bag/New Syringe 10/14/2019 3:15 PM EDT 50 mL 100 mL/hr       methylPREDNISolone sod succ (SOLU-MEDROL) 125 mg/2 mL injection   125 mg, 2 mL, Intravenous, NOW, Mon 10/14/19 at 1600, For 1 dose   Given 10/14/2019 3:15 PM EDT 125 mg         NS bolus infusion 1,000 mL   1,000 mL, Intravenous, Administer over 120 Minutes, NOW, Mon 10/14/19 at 1500, For 1 dose   New Bag/New Syringe 10/14/2019 3:15 PM EDT 1,000 mL 500 mL/hr          Father given school notes. One rx for Prednisone sent to pharmacy. All above events was reported from the ER reports
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Crying, Seizure, Seizure anoxic
Clinical narrative: Patient was crying like she normally does when receiving shots and then she had what we later found out was a seizure. I called for the nurse to come back because I knew something was not right and she went to get the doctor. He took her O2 level for me and sent us home.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Induration, Tenderness
Clinical narrative: Redness, induration and tenderness
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient came in for a varicella vaccine, per system he didn't receive his 2nd varicella.  Per vaccine record patient had an MMRV on 02/27/15. No adverse reaction occurred, was given an extra varicella.
Age: 13.0
Sex: M
Vaccine: FLU3, HPV9
Symptoms: Erythema, Hyperaesthesia, Skin exfoliation, Swelling, Swelling face
Clinical narrative: Within minutes of the injections both arms got very red , his face and neck became very red and started to swell. I went and got the doctor he noticed my son appeared to have some sort of reaction and assured me he would be fine. We waited for about 30 min and left. My son developed ulcer like burns on his face and nose. We used  triple antibiotic ointment on them didn?t rub and only patted them dry kept them clean and as those started to heal after about 8 days his entire face and neck peeled leaving his skin very sensitive. During this time he required daily naps which is not something he ever does he felt very run down.
Age: 13.0
Sex: M
Vaccine: FLU3, HPV9
Symptoms: Ulcer
Clinical narrative: Within minutes of the injections both arms got very red , his face and neck became very red and started to swell. I went and got the doctor he noticed my son appeared to have some sort of reaction and assured me he would be fine. We waited for about 30 min and left. My son developed ulcer like burns on his face and nose. We used  triple antibiotic ointment on them didn?t rub and only patted them dry kept them clean and as those started to heal after about 8 days his entire face and neck peeled leaving his skin very sensitive. During this time he required daily naps which is not something he ever does he felt very run down.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Skin warm, Vaccination site swelling
Clinical narrative: L upper arm has been red and swollen at the vaccine site.  Erythema present when he returned to clinic on 10/16 to be checked.  Area 6'long x 3" wide.  Mild warmth to the touch.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; improperly stored doses of varivax; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies were not reported. The patient's concomitant medication included sterile diluent (Lot # n030413 and expiration date reported as 05-JUL-2020). On 28-JUL-2019, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, frequency were not reported, lot # s002874 has been verified to be a valid lot number for (varicella virus vaccine live (oka/merck)), expiration date reported as 29-JAN-2021) for prophylaxis (product storage error). Doses of suspect vaccine experienced the temperature excursion - 7.64 fahrenheit (-13.35 degree Celsius) for 20 minutes. It was reported that previous temperature excursion was present (19.34 F for 34 minutes). Data logger was involved. No adverse effects (adverse events) were reported. No product quality complaint was also reported. Outcome for the events was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia
Clinical narrative: Numbness; This case was reported by a pharmacist via call center representative and described the occurrence of numbness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced numbness. On an unknown date, the outcome of the numbness was unknown.   It was unknown if the reporter considered the numbness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but could be between 77 or 78 years. The reporter stated that the patient had numbness the following day after their first dose of Shingrix. The patient thought it was because the pharmacist gave it too hard. The reporter consented to follow up.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Overdose, Product administered to patient of inappropriate age
Clinical narrative: 63 year old male received Fluzone High Dose, no AE; 63 year old male received Fluzone High Dose, no AE; Initial information received on 02-Oct-2019 regarding an unsolicited valid non-serious case received from  healthcare professional (medical assistant).  This case involves a 63 years old male patient who received 0.5 ml dose of  vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ221AB, Exp. Date 01-Apr-2020 via intramuscular route in the right deltoid on 02-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to inappropriate age at vaccine administration.  It was also a case of overdose.  At the time of reporting, no adverse reactions were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: No adverse event, Product storage error
Clinical narrative: patient received a Flu shot from an extended shipment of Fluzone Quadrivalent/no AE; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a non-health care professional (office staff).  This case is linked to cases 2019SA271944, 2019SA278134, 2019SA278136, 2019SA278137, 2019SA278139, 2019SA278140, 2019SA278141, 2019SA278135 and 2019SA271944 (same reporter).  This case involves a patient of unknown demographics who received a dose of vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED from an extended shipment.  Patients past history and concomitant therapy was not reported.  On 27-Oct-2019, the patient received a dose from a multi-dose vial of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot: UJ254AC) expiry date: 30-Jun-2020, (no dosing details were reported).  It was of actual medication error case due to product storage error.  It was reported that patient received a Flu shot from an extended shipment of Fluzone Quadrivalent.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.