chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Thirst
Clinical narrative: Received the SHINGRIX vaccine from my PCP and by 8 pm I was so tired and had to go to bed. Throughout the night I had major night sweats and then moments of freezing. At 3:30 am, I got up as I was super thirsty and my head was pounding. I took 1-Extra Strength TYLENOL and went back to bed where I continue to have both freezing and night sweats again. I finally dragged myself out of bed and was soaked. Around 11 am on 9/29/2018, my husband said I was breathing pretty hard and looked bad, felt my head and I was hot. Took my temperature and it was 102 F. I was now having a heaviness on my chest, severe headache and fever. Went to the local hospital where they first ruled out flu and pneumonia is but I remained with temperatures of both 102 and then 103F. HR greater than 120 and B/P greater than my normal 110/70's, stayed above 140/85 for hours. After review of testing they admitted to hospital for overnight to determine what other source could be causing all of the symptoms, fluids given along with TYLENOL and monitored until discharged on 10/1/2018. My first shingle shot back in April 2018 I only had a sore arm but none of the severe side effects this last time.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Laboratory test abnormal
Clinical narrative: Patient received SHINGRIX vaccine and was hospitalized the next day for cellulitis which she attributes to the injection she received.
Age: 45.0
Sex: F
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: FLUAD was mistakenly given to patient under 65.
Age: 75.0
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Burning sensation, Chills, Pyrexia, Vaccination site reaction
Clinical narrative: Reaction to SHINGRIX vaccine: fever, chills, burning very and painful joints.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: Syncope after vaccination.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: Several hours after receiving my second dose of the SHINGRIX vaccine, I experienced uncontrolled shivering for almost an hour. I might have sought medical help if it wasn't so late at night. The symptoms subsided and I had no further incidents or any longer term effects.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest X-ray normal, Erythema, Herpes zoster, Injected limb mobility decreased, Musculoskeletal chest pain
Clinical narrative: Burning and stabbing pains in ribs at left back at spine. Went to my primary physician on 9/10/18 but he found nothing. Went to clinic on 9/20/18 because pain was worse. They x-rayed my ribs on left side, but found no problems. The nurse practitioner mentioned that my symptoms were like those who had shingles but I had no rash. Went back to clinic on 10/25/18 and the N.P. said I had "Internal Shingles" and put me on Valacyclovir and gabapentin. She said I had most probably had it since 9-10-18, when I first complained. I got the original shingles shot (ZOSTAVAX) on 7/19/11 and had no adverse reaction. This SHINGRIX shot caused my arm to swell, turn very red, had fever, and I couldn't raise my left arm above my breast. These symptoms lasted 4 days. This was the 1st of two doses. Will not take the 2nd dose. I was told "Internal Shingles" is uncommon, which is why they could not diagnose me when I first gave them my pain symptoms. I had none of the typical "rash" that always indicates you have shingles.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Peripheral swelling, Pyrexia
Clinical narrative: Burning and stabbing pains in ribs at left back at spine. Went to my primary physician on 9/10/18 but he found nothing. Went to clinic on 9/20/18 because pain was worse. They x-rayed my ribs on left side, but found no problems. The nurse practitioner mentioned that my symptoms were like those who had shingles but I had no rash. Went back to clinic on 10/25/18 and the N.P. said I had "Internal Shingles" and put me on Valacyclovir and gabapentin. She said I had most probably had it since 9-10-18, when I first complained. I got the original shingles shot (ZOSTAVAX) on 7/19/11 and had no adverse reaction. This SHINGRIX shot caused my arm to swell, turn very red, had fever, and I couldn't raise my left arm above my breast. These symptoms lasted 4 days. This was the 1st of two doses. Will not take the 2nd dose. I was told "Internal Shingles" is uncommon, which is why they could not diagnose me when I first gave them my pain symptoms. I had none of the typical "rash" that always indicates you have shingles.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Lower deltoid site swelled up painful red itchy.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site cellulitis, Injection site swelling, Local reaction, Ultrasound scan
Clinical narrative: Localized reaction to flu shot treated as cellulitis. Left arm. Emergency visit copy attached. 10/4/18 Pt doing well per mother. She did not come for f/u. 9/28/2018, Swelling of the left arm, got flu shot. 12-year-old male with history of egg and mild allergy being evaluated in the emergency department for swelling of the left upper arm. He got his flu shot yesterday. In the night he noticed some swelling around the shot site. It was also hurting making him a little bit more increased which prompted the ED visit. He is able to move his arm well. Denies any drainage. Denies any fever. Denies any wheezing or difficulty breathing.
Age: 57.0
Sex: M
Vaccine: FLUC4
Symptoms: Adverse event following immunisation
Clinical narrative: Took the flu shot on Sept 30 2018 and developed either Bell palsy or GBS.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: On Sep 25 2018, patient received her first dose of Varicella vaccine. The next day, she developed swelling and redness lesion at injection site.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain in extremity
Clinical narrative: Received second shines shot on Friday, September 28th around noon. Woke up after midnight that night with a severe headache and chills. Did not have this reaction with the first shot in the series, only a very sore arm. Arm was not as sore with the second shot. I did receive the shots at two different pharmacy locations.
Age: 49.0
Sex: U
Vaccine: FLUX
Symptoms: Asthenia, Chills, Nausea, Vomiting
Clinical narrative: Got a flu shot injection at Hospital yesterday around 2 pm. Woke 6am today with nausea, vomiting and severe weakness,chills.
Age: 60.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Gene mutation, Influenza like illness, Lip swelling, Pharyngeal oedema, Pyrexia
Clinical narrative: Patient received both SHINGRIX and AFLURIA on the same day, different arms. Patient called later that evening stating he has flu like symptoms - body ache and fever, swollen lips, throat which disappeared right away. Pharmacist advised patient to take BENADRYL, TYLENOL or ADVIL and to go to the ER if any SOB or swollen throat appears again.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pyrexia, Rhinorrhoea
Clinical narrative: Fever, chills, runny nose.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Pt reports pain right above the elbow. It is affecting her range of motion. No swelling or redness. Arm looks totally normal.
Age: 0.17
Sex: F
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient accidentally received an influenza vaccine at her 2 month check up that was not ordered.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain
Clinical narrative: Pt received PNEUMOVAX 23 vaccine in the afternoon 10/02/2018. After the shot, Pt experienced discomfort at the injection site; took some ALEVE. Later afternoon the next day, 10/03/2018, tenderness and redness appeared, not at the injection site but around the injection area. Pt has been advised to consult with primary care doctor.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: (R) arm red, hot and swollen. Pt. tx with KEFLEX 250mg/5ml 7ml TID x 10 day.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Localized allergic reaction. Flu shot given 9/27/18 Rt thigh. Patient developed swelling 9/29/18 with erythema skin reported by mother. Seen 10/1/18 swelling site of shot, no erythema, no tenderness. Swelling and itching. Oral steroid given. F/U 10/4/18. Pt was started on prednisone/and BENADRYL. F/U in 2 days. 10/4/18 child doing well per mother. She cannot come for appt. Pt has previous H/O allergic rash to metals. Pt has previously received flu shot without any problem.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient reported that her left arm was very sore and became nearly immobile several hours after the vaccination. This lasted a few weeks. Today she reports her arm is still sore.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site pain, Pyrexia
Clinical narrative: Red spot on (R) cheek above injection site on (R) thigh, a week after 12 month shots. (R) thigh injection site red, hard, painful. Also runny nose, congestion, fever 100.8. Scattered red lesions on torso, face, legs. Advised to avoid contact with susceptible individuals and supportive care of varicella.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Respiratory tract congestion, Rhinorrhoea, Skin lesion
Clinical narrative: Red spot on (R) cheek above injection site on (R) thigh, a week after 12 month shots. (R) thigh injection site red, hard, painful. Also runny nose, congestion, fever 100.8. Scattered red lesions on torso, face, legs. Advised to avoid contact with susceptible individuals and supportive care of varicella.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: 9/25 Administered 1st Serie shot of the SHINGRIX vaccine. 2 days later I contracted shingles on left thigh and torso/hip are.
Age: 24.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Feeling hot, Hyperhidrosis, Pruritus, Rash
Clinical narrative: Sweating, itching, rash, heat wave.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: (L) arm has been sore and limited range of motion since flu shot was given on 9/7/18.
Age: 0.17
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Redness and induration Rt ant thigh at site of PREVNAR shot 1 day after shot.
Age: 25.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: LD, redness area, itching present, no open areas, swelling present, diphenhydramine 1% topical cream.
Age: 60.0
Sex: M
Vaccine: FLUA3
Symptoms: Injection site erythema
Clinical narrative: Redness present to LD - (start 10/3/18), no treatment, no swelling.
Age: 1.58
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: 1 cm nodule with overlying redness on Right anterior thigh. 0.5 cm nodule with overlying redness on Left anterior thigh.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Abdominal X-ray, Full blood count, Irritability, Pyrexia, Urine analysis
Clinical narrative: Pt. started with fuss, fever and continued to bc irritable thru the night. Woke with fever 101.4 and projectile vomiting. So mom brought child to be seen. MD ordered CBC, UA, Abd XRay.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Pt. started with fuss, fever and continued to bc irritable thru the night. Woke with fever 101.4 and projectile vomiting. So mom brought child to be seen. MD ordered CBC, UA, Abd XRay.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Rotator cuff syndrome
Clinical narrative: Possible tendonitis or bursitis of rotator cuff after AFLURIA QUAD Flu vaccine administration. Injection site may have been too high.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Impaired work ability, Influenza like illness, Pain
Clinical narrative: First shingle shot around 11:30 a.m. By 9:30 feeling very flu-like. Whole body ached chills. Was unable to go to work the next day.
Age: 1.25
Sex: F
Vaccine: FLU4, HEPA, MMRV
Symptoms: Rash
Clinical narrative: 2 hours after MMRV, Hep A and influenza vaccine developed rash on face.
Age: 15.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Gaze palsy, Malaise, Musculoskeletal stiffness, Pallor
Clinical narrative: 15 seconds after HPV/Flu vaccine given, Pt. didn't feel well and became pale, eyes rolled toward forehead, all 4 extremities became stiff. Nurse lowered her onto exam table then she immediately responded to her name. Pulse ox 100%, BP 111/68, HR 61.
Age: 24.0
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Shot received 10/1/18 - on 10/2/18 upon awaking - red raised area about 1 to 1 1/2 inches below injection site about 7-8 cm wraps around to bicep area - warm to touch - not itchy - saw a nurse practitioner - no meds prescribed - on 10/3/18 - pt self medicated with BENADRYL - cortisone cream - cool compresses - 10/4 - better this am subsiding some. No other symptom or c/o.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Oral pruritus, Pharyngeal oedema, Swollen tongue, Throat irritation
Clinical narrative: About 30 minutes after vaccine she felt like her tongue and throat were itchy and swollen. BENADRYL 25 mg po x 2. EPI 0.3 mg IM x 1.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Arthralgia, Erythema, Hypersensitivity, Pain in extremity, Urticaria
Clinical narrative: Two hours after shot my left elbow had severe pain which progressed to my hand. Went to clinic was told it was an allergic reaction returned to clinic next day with welts on and under left arm and severe pain and redness. Redness at the site and under my arm.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Arthralgia, Erythema, Hypersensitivity, Injection site erythema, Pain
Clinical narrative: Two hours after shot my left elbow had severe pain which progressed to my hand. Went to clinic was told it was an allergic reaction returned to clinic next day with welts on and under left arm and severe pain and redness. Redness at the site and under my arm.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain in extremity, Urticaria
Clinical narrative: Two hours after shot my left elbow had severe pain which progressed to my hand. Went to clinic was told it was an allergic reaction returned to clinic next day with welts on and under left arm and severe pain and redness. Redness at the site and under my arm.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of herpes simplex in a 67-year-old female patient who received SHINGRIX for prophylaxis. On 9th August 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 11th August 2018, 2 days after receiving SHINGRIX, the patient experienced herpes simplex. On an unknown date, the outcome of the herpes simplex was recovered/resolved. It was unknown if the reporter considered the herpes simplex to be related to SHINGRIX. Additional details were provided as follows: The patient had no history of herpes simplex lesions. The developed a lesion on her buttocks that was herpes simplex. This was diagnosed by the patient's husband who was a physician. In 2018, herpes simplex lesion resolved on its own without need for treatment. This case has been linked to US2018173524, reported by the same reporter.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes simplex
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of herpes simplex in a 67-year-old female patient who received SHINGRIX for prophylaxis. On 9th August 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 11th August 2018, 2 days after receiving SHINGRIX, the patient experienced herpes simplex. On an unknown date, the outcome of the herpes simplex was recovered/resolved. It was unknown if the reporter considered the herpes simplex to be related to SHINGRIX. Additional details were provided as follows: The patient had no history of herpes simplex lesions. The developed a lesion on her buttocks that was herpes simplex. This was diagnosed by the patient's husband who was a physician. In 2018, herpes simplex lesion resolved on its own without need for treatment. This case has been linked to US2018173524, reported by the same reporter.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Rash
Clinical narrative: Red, hot, hard, swollen, hives.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Feeling hot, Induration, Swelling, Urticaria
Clinical narrative: Red, hot, hard, swollen, hives.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Dizziness, Headache, Herpes zoster, Hyperaesthesia, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced shingles, influenza-like symptoms, blistery rash and itchy rash. On an unknown date, the outcome of the shingles, blistery rash and itchy rash were unknown and the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the shingles, influenza-like symptoms, blistery rash and itchy rash to be related to SHINGRIX. Additional information received as follows: The patient reported that recently she received the vaccine for the shingles and for the first 2 days after receiving vaccine, she had flu like symptoms but after that she got small rashes with blisters on her thighs and they itch instead of hurt, she was wondering if this was part of the reaction from the vaccine. The patient went to the physician and they said that it might be shingles but she had question if she could have the shingles from the dead virus vaccine. The patient had confirmed with the second position that she contracted shingles from vaccine. The patient allowed to contact her physician for the confirmation of this adverse event. The patient believed that this would be a customer complaint. She was not sure if she also contact the Food and Drug Administration to issue a field alert because the indications and side effects were not listed correctly. Additionally, the patient said that this had cost her 2 additional physician's appointments and cost of prescriptions and loss of time at work.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pyrexia, Rash, Rash macular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced shingles, influenza-like symptoms, blistery rash and itchy rash. On an unknown date, the outcome of the shingles, blistery rash and itchy rash were unknown and the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the shingles, influenza-like symptoms, blistery rash and itchy rash to be related to SHINGRIX. Additional information received as follows: The patient reported that recently she received the vaccine for the shingles and for the first 2 days after receiving vaccine, she had flu like symptoms but after that she got small rashes with blisters on her thighs and they itch instead of hurt, she was wondering if this was part of the reaction from the vaccine. The patient went to the physician and they said that it might be shingles but she had question if she could have the shingles from the dead virus vaccine. The patient had confirmed with the second position that she contracted shingles from vaccine. The patient allowed to contact her physician for the confirmation of this adverse event. The patient believed that this would be a customer complaint. She was not sure if she also contact the Food and Drug Administration to issue a field alert because the indications and side effects were not listed correctly. Additionally, the patient said that this had cost her 2 additional physician's appointments and cost of prescriptions and loss of time at work.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Dizziness, Formication, Headache, Herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced shingles, influenza-like symptoms, blistery rash and itchy rash. On an unknown date, the outcome of the shingles, blistery rash and itchy rash were unknown and the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the shingles, influenza-like symptoms, blistery rash and itchy rash to be related to SHINGRIX. Additional information received as follows: The patient reported that recently she received the vaccine for the shingles and for the first 2 days after receiving vaccine, she had flu like symptoms but after that she got small rashes with blisters on her thighs and they itch instead of hurt, she was wondering if this was part of the reaction from the vaccine. The patient went to the physician and they said that it might be shingles but she had question if she could have the shingles from the dead virus vaccine. The patient had confirmed with the second position that she contracted shingles from vaccine. The patient allowed to contact her physician for the confirmation of this adverse event. The patient believed that this would be a customer complaint. She was not sure if she also contact the Food and Drug Administration to issue a field alert because the indications and side effects were not listed correctly. Additionally, the patient said that this had cost her 2 additional physician's appointments and cost of prescriptions and loss of time at work.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced shingles, influenza-like symptoms, blistery rash and itchy rash. On an unknown date, the outcome of the shingles, blistery rash and itchy rash were unknown and the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the shingles, influenza-like symptoms, blistery rash and itchy rash to be related to SHINGRIX. Additional information received as follows: The patient reported that recently she received the vaccine for the shingles and for the first 2 days after receiving vaccine, she had flu like symptoms but after that she got small rashes with blisters on her thighs and they itch instead of hurt, she was wondering if this was part of the reaction from the vaccine. The patient went to the physician and they said that it might be shingles but she had question if she could have the shingles from the dead virus vaccine. The patient had confirmed with the second position that she contracted shingles from vaccine. The patient allowed to contact her physician for the confirmation of this adverse event. The patient believed that this would be a customer complaint. She was not sure if she also contact the Food and Drug Administration to issue a field alert because the indications and side effects were not listed correctly. Additionally, the patient said that this had cost her 2 additional physician's appointments and cost of prescriptions and loss of time at work.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Influenza like illness, Rash pruritic, Rash vesicular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced shingles, influenza-like symptoms, blistery rash and itchy rash. On an unknown date, the outcome of the shingles, blistery rash and itchy rash were unknown and the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the shingles, influenza-like symptoms, blistery rash and itchy rash to be related to SHINGRIX. Additional information received as follows: The patient reported that recently she received the vaccine for the shingles and for the first 2 days after receiving vaccine, she had flu like symptoms but after that she got small rashes with blisters on her thighs and they itch instead of hurt, she was wondering if this was part of the reaction from the vaccine. The patient went to the physician and they said that it might be shingles but she had question if she could have the shingles from the dead virus vaccine. The patient had confirmed with the second position that she contracted shingles from vaccine. The patient allowed to contact her physician for the confirmation of this adverse event. The patient believed that this would be a customer complaint. She was not sure if she also contact the Food and Drug Administration to issue a field alert because the indications and side effects were not listed correctly. Additionally, the patient said that this had cost her 2 additional physician's appointments and cost of prescriptions and loss of time at work.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Rash generalised, Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythropapular rash in a 60-year-old female patient who received SHINGRIX for prophylaxis. On 11th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 23rd September 2018, 12 days after receiving SHINGRIX, the patient experienced erythropapular rash. On an unknown date, the outcome of the erythropapular rash was unknown. It was unknown if the reporter considered the erythropapular rash to be related to SHINGRIX. Additional details were reported as follows: The patient developed red bumps on both of her upper arms and lower legs or calf area. The healthcare professional was reporting her own adverse event. The healthcare professional provided her work information, did not receive vaccine at work. Does not have vaccine information for this adverse event.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash papular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythropapular rash in a 60-year-old female patient who received SHINGRIX for prophylaxis. On 11th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 23rd September 2018, 12 days after receiving SHINGRIX, the patient experienced erythropapular rash. On an unknown date, the outcome of the erythropapular rash was unknown. It was unknown if the reporter considered the erythropapular rash to be related to SHINGRIX. Additional details were reported as follows: The patient developed red bumps on both of her upper arms and lower legs or calf area. The healthcare professional was reporting her own adverse event. The healthcare professional provided her work information, did not receive vaccine at work. Does not have vaccine information for this adverse event.
Age: 17.0
Sex: F
Vaccine: HPV9, HPV9, MNQ
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial information received on 19-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 17 years old female patient who was exposed to vaccine MENACTRA in context of drug exposure during pregnancy. The reported drug exposure during pregnancy occurred at unknown gestation period and the patient was exposed to MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE at 6 weeks of pregnancy, during first pregnancy trimester for MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. The date of last menstrual period was reported as 24-Jul-2018. The estimated due date is 30-Apr-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown number of previous pregnancy/ies. The patient's concomitant medications included GARDASIL 9 for Immunization (made by Merck). On 22-Aug-2018, the patient received a 0.5 ml first single dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5989AA; expiry date: 27-Aug-2019 via intramuscular route in the left deltoid. Relevant prenatal testing after exposure was not provided. No lab data reported. Final diagnosis was drug exposure during pregnancy. On 19-Sep-2018, the patient had a visit to ER/Physician. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Applicable for drug exposure during pregnancy. Additionally, at time of reporting, the pregnancy is still ongoing. The data has been collected prospectively; i.e. before the child was born.
Age: 17.0
Sex: F
Vaccine: HPV9, HPV9, MNQ
Symptoms: Exposure during pregnancy
Clinical narrative: Initial information received on 19-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 17 years old female patient who was exposed to vaccine MENACTRA in context of drug exposure during pregnancy. The reported drug exposure during pregnancy occurred at unknown gestation period and the patient was exposed to MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE at 6 weeks of pregnancy, during first pregnancy trimester for MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. The date of last menstrual period was reported as 24-Jul-2018. The estimated due date is 30-Apr-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown number of previous pregnancy/ies. The patient's concomitant medications included GARDASIL 9 for Immunization (made by Merck). On 22-Aug-2018, the patient received a 0.5 ml first single dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5989AA; expiry date: 27-Aug-2019 via intramuscular route in the left deltoid. Relevant prenatal testing after exposure was not provided. No lab data reported. Final diagnosis was drug exposure during pregnancy. On 19-Sep-2018, the patient had a visit to ER/Physician. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Applicable for drug exposure during pregnancy. Additionally, at time of reporting, the pregnancy is still ongoing. The data has been collected prospectively; i.e. before the child was born.
Age: 37.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Rash
Clinical narrative: This case was reported by a consumer and described the occurrence of generalized urticaria in a 37-year-old female patient who received FLUARIX QUADRIVALENT 2018-2019 season for prophylaxis. On 24th September 2018, the patient received FLUARIX QUADRIVALENT 2018-2019 season. On 24th September 2018, 2 hrs after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced generalized urticaria and pruritus. On 25th September 2018, the patient experienced ear swelling. The patient was treated with BENADRYL, Steroid (Not Specified) and antihistamine. On an unknown date, the outcome of the generalized urticaria, ear swelling and pruritus were unknown. It was unknown if the reporter considered the generalized urticaria, ear swelling and pruritus to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional information was reported as follows: This case was reported by the GSK employee. On 24th September 2018 Monday, the patient was vaccinated with a dose of FLUARIX at GlaxoSmithKline health services site. Two hours after vaccination with FLUARIX, the patient experienced hives on her hands and neck and got itchy. Within several hours after the same, the hives spread. On 25th September 2018, in the morning, the hives experienced by the patient were severe and were over whole body, also the patient experienced severe swelling on both the ears. The patient's personal physician advised her to take BENADRYL every six hours. The patient was put on Steroid taper and Antihistamine regimen by her physician to resolve the issues. The patient also stated that she would be happy to answer any questions related to the case.
Age: 37.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Ear swelling, Pruritus, Urticaria
Clinical narrative: This case was reported by a consumer and described the occurrence of generalized urticaria in a 37-year-old female patient who received FLUARIX QUADRIVALENT 2018-2019 season for prophylaxis. On 24th September 2018, the patient received FLUARIX QUADRIVALENT 2018-2019 season. On 24th September 2018, 2 hrs after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced generalized urticaria and pruritus. On 25th September 2018, the patient experienced ear swelling. The patient was treated with BENADRYL, Steroid (Not Specified) and antihistamine. On an unknown date, the outcome of the generalized urticaria, ear swelling and pruritus were unknown. It was unknown if the reporter considered the generalized urticaria, ear swelling and pruritus to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional information was reported as follows: This case was reported by the GSK employee. On 24th September 2018 Monday, the patient was vaccinated with a dose of FLUARIX at GlaxoSmithKline health services site. Two hours after vaccination with FLUARIX, the patient experienced hives on her hands and neck and got itchy. Within several hours after the same, the hives spread. On 25th September 2018, in the morning, the hives experienced by the patient were severe and were over whole body, also the patient experienced severe swelling on both the ears. The patient's personal physician advised her to take BENADRYL every six hours. The patient was put on Steroid taper and Antihistamine regimen by her physician to resolve the issues. The patient also stated that she would be happy to answer any questions related to the case.
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: Asthenia, Eye movement disorder, Fatigue, Headache, Loss of consciousness
Clinical narrative: My husband was driving me home and said that I passed out about 4 minutes after shot. Seized up for approximately 8 seconds and my eyes went to the back of my head. Threw up 4 times within 20 minutes of getting the shot. Throat got tight. Extreme weakness and fatigue starting only a few minutes after getting the vaccine and lasting all day. Got headache about 1 hour later but that subsided as the day went on.
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: Seizure, Throat tightness, Vomiting
Clinical narrative: My husband was driving me home and said that I passed out about 4 minutes after shot. Seized up for approximately 8 seconds and my eyes went to the back of my head. Threw up 4 times within 20 minutes of getting the shot. Throat got tight. Extreme weakness and fatigue starting only a few minutes after getting the vaccine and lasting all day. Got headache about 1 hour later but that subsided as the day went on.
Age: 1.08
Sex: F
Vaccine: MMRV
Symptoms: Pyrexia, Rash
Clinical narrative: Mild fever, rash.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Pain, Pyrexia
Clinical narrative: Fever, body aches, left hand felt numb.
Age: 26.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site urticaria
Clinical narrative: Hives around injection site.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Wheezing
Clinical narrative: PATIENT REFERS SHE BEGAN WITH WHEEZING AND DIFICULTY BREATHING AFTER VACCINE ADMINISTRATION.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Intestinal operation, Intussusception, X-ray
Clinical narrative: Intussusception diagnosed at surgical team. Reduced surgically on 10/3/18.
Age: 68.0
Sex: U
Vaccine: FLUA3, PPV
Symptoms: Chest pain, Chills, Erythema, Hyperhidrosis, Pain in extremity
Clinical narrative: Patient experienced swelling and redness approximately 2 hours after the vaccination. Later experienced chills and sweats and pain in the arm and chest. Redness and swelling lasted approximately 2 days after the vaccine. On 10/03/2018 reports feeling fine.
Age: 68.0
Sex: U
Vaccine: FLUA3, PPV
Symptoms: Swelling
Clinical narrative: Patient experienced swelling and redness approximately 2 hours after the vaccination. Later experienced chills and sweats and pain in the arm and chest. Redness and swelling lasted approximately 2 days after the vaccine. On 10/03/2018 reports feeling fine.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Anxiety, Crying, Depression, Immediate post-injection reaction, Mood swings
Clinical narrative: Uncontrollable crying, depression, anxiety, mood swings, and widespread pain immediately after. I developed psoriasis shortly after and have never had it before nor does my family have a history of psoriasis.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Psoriasis
Clinical narrative: Uncontrollable crying, depression, anxiety, mood swings, and widespread pain immediately after. I developed psoriasis shortly after and have never had it before nor does my family have a history of psoriasis.
Age: 66.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Injection site rash
Clinical narrative: Patient had rash around lower bicep area. It occurred below the injection site. Approximately 4x5".
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: The patient had localized swelling and redness to the left thigh.
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a Pharmacist, concerning a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with a dose of M-M-R II, via intramuscular route of administration, instead of subcutaneous, for prophylaxis (dose, anatomical location, lot number and expiration date were not reported) (Incorrect route of drug administration). No adverse effects were reported. No product quality complaint (PQC) was involved.  Follow-up information was received on 03-OCT-2018. On 03-OCT-2018, a phone call was made to the pharmacist. A pharmacy tech, who was there at the time the administration error happened, answered the call and she was able to provide that it happened with only one patient.  Follow-up information received from Pharmacist on 04-OCT-2018. It was confirmed that the patient was female, who was approximately between 40 to 60 years of age. It was reported that the administration error occurred at the end of May 2018, and it was the pharmacist first day back to work at the pharmacy after being on maternity leave. The pharmacist had asked her co-worker about the correct route, and she relied on what her coworker said. The pharmacist didn't realize that it was given incorrectly (given intramuscular instead of subcutaneously) until she contacted the company. The pharmacist "notified the patient after that about the incorrect route but the patient said she was fine, the patient had no complaints" or adverse reactions. A request was made for lot and expiration date information but she thought it might had been "returned and had since expired" since May 2018. The pharmacist was not able to provide any additional information.  This case was previously considered non-valid, but upon receipt of follow-up it was determined that the case is now valid as the patient identifiers were provided.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site swelling
Clinical narrative: Information has been received from a physician referring to a 33 years old female patient. The patient's concurrent condition, concomitant medication and medical history were not provided. On 04-SEP-2018 the patient was vaccinated with PNEUMOVAX 23 (strength, dose, frequency, route, lot # and expiration date were not provided)for prophylaxis at arm. The patient was also vaccinated with a previous dose of PNEUMOVAX 23 in approximately 2012 (reported as an unspecified date "5-6 years ago"). On 05-SEP-2018 the patient came into the office with redness on the whole arm of administration, swelling in the right side of the upper arm of administration and the swelling almost looked like a mass. The patient was in the office at the time of the report. The outcome of the events was reported as not recovered. The causality assessment was not provided.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Rash
Clinical narrative: Information has been received from a physician via a company representative referring to a 12 year old female patient. The patient's concurrent condition, concomitant medication, drug reactions/allergies or medical history were unknown. On an unknown date the patient was vaccinated with GARDASIL 9 (strength, dose detail, lot # and expiration date were unknown) intramuscular for prophylaxis (reported as Human Papilloma Virus (HPV) prevention) and VAQTA (strength, dose detail, route, lot # and expiration date were unknown) for prophylaxis.  One day after the administration, the patient experienced rash on back of her legs. The patient came back to the office on an unspecified date and diphenhydramine hydrochloride (BENADRYL) (reported as BENEDRYL) was prescribed for the rash. At the reporting time, the outcome of the event was reported as recovered. The causality between the event and suspect vaccines was not provided.
Sex: F
Vaccine: HPV9
Symptoms: Injected limb mobility decreased, Injection site induration, Injection site nodule, Injection site swelling
Clinical narrative: This spontaneous report was received from a physician and refers to a 21-year-old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 14-SEP-2018, the patient was vaccinated with GARDASIL 9 lot # R000303 with expiration date on 29-AUG-2020 (reported as 29-SEP-2020), intramuscularly in the left arm for prophylaxis (dose and frequency were not reported). On 03-SEP-2018, the patient woke up with a raised, hard knot, 3 centimeters in diameter, at the site of the injection, and it was difficult for the patient to lift her left arm. The patient sought medical attention and received treatment (unspecified). The outcome of the events was reported as recovering. The relatedness between the events and GARDASIL 9 was not reported.
Age: 10.0
Sex: F
Vaccine: FLUX, HPV9, MEN, TDAP
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a consumer refers to a 11-year-old female patient. The patient had no pertinent medical history and no drug reactions or allergies. However, it was reported that the patient experienced injection site pain after receiving an unspecified flu vaccine in the past. On 15-SEP-2017, the patient was vaccinated with GARDASIL 9 (exact dose, route of administration, lot number and expiration date were not provided) for prophylaxis. On 17-SEP-2018, the patient received GARDASIL 9 lot # N035955, intramuscular for prophylaxis. Other suspect therapies included an unspecified flu vaccine (dose and route not provided) given on the same day as a second dose of GARDASIL 9. Concomitant therapies included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid, meningococcal acyw polysaccharide vaccine and meningococcal polysaccharide vaccine (unspecified). It was reported that the GARDASIL 9 shot hurt when it was administered and the patient also experienced pain at the injection site afterwards. The patient's mother stated that she did not remember if her daughter experienced any pain after receiving her first dose of GARDASIL 9. She also noted that the patient was given the 2 dose regimen because of the patient's age, but the second dose was later than 12 months after the first one. Additionally, it was reported that the patient experienced injection site pain also where the flu vaccine was administered. The patient received an unspecified treatment for the event but no lab diagnostics were performed. She did not seek medical attention. The outcome of injection site pain was reported as recovering. The relatedness between the event and the suspect vaccines was not provided by the reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 27-SEP-2018, the patient was inadvertently vaccinated with a dose of expired VARIVAX lot # M033213, expiration date: 13-JUL-2018, subcutaneously, (dose was not provided) for prophylaxis. On that day, the patient also received sterile diluent. No adverse effect was reported.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a 15 year old female patient. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. Approximately in March 2018 (reported as 6 months ago), the patient received her first GARDASIL 9 for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported). On 28-SEP-2018, the patient was at the office to receive her second dose of GARDASIL 9 for prophylaxis, lot #R009614 and expiration date 30-NOV-2018 (strength, dose, frequency and route of administration were not reported) (inappropriate schedule of drug administration). No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, drug reactions and allergies were not reported. On 02-OCT-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # R011806 and expiration date: 23-APR-2020 (strength, dose, route of administration and anatomical location were not reported) indicated for prophylaxis which was reconstituted with sterile diluent (MERCK) (product storage error). No adverse effect was reported. Administered dose of vaccine experienced a temperature excursion of -14 degrees Celsius to -10 degrees Celsius (-11.9°C) for 1 hour and 27 minutes on unspecified date called by a data logger. There were no previous excursions reported.