chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Erythema, Inflammation, Joint swelling, Neck pain
Clinical narrative: I had the typical sore arm and headache on 8/28-8/29 which resolved within 2-3 days.  I then began to experience severe pain in different areas of my body. Since September 6, 2019 to present, I have been experiencing SEVERE debilitating joint pain/ redness and swelling in both hands,  joints and fingers,.....   I developed neck,   jaw and teeth  pain which required a visit to the dentist. He ruled out any dental issues. The pain spread to both hips, knees, and big toes.  I have tried  ice, heat, Aleve as well as topical anesthetics. None have resolved the pain.  I am scheduled to see the director of Immunology and Rhumatology at the Clinic.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Peripheral swelling, Toothache
Clinical narrative: I had the typical sore arm and headache on 8/28-8/29 which resolved within 2-3 days.  I then began to experience severe pain in different areas of my body. Since September 6, 2019 to present, I have been experiencing SEVERE debilitating joint pain/ redness and swelling in both hands,  joints and fingers,.....   I developed neck,   jaw and teeth  pain which required a visit to the dentist. He ruled out any dental issues. The pain spread to both hips, knees, and big toes.  I have tried  ice, heat, Aleve as well as topical anesthetics. None have resolved the pain.  I am scheduled to see the director of Immunology and Rhumatology at the Clinic.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Erythema, Headache, Joint swelling, Neck pain
Clinical narrative: I had the typical sore arm and headache on 8/28-8/29 which resolved within 2-3 days.  I then began to experience severe pain in different areas of my body. Since September 6, 2019 to present, I have been experiencing SEVERE debilitating joint pain/ redness and swelling in both hands,  joints and fingers,.....   I developed neck,   jaw and teeth  pain which required a visit to the dentist. He ruled out any dental issues. The pain spread to both hips, knees, and big toes.  I have tried  ice, heat, Aleve as well as topical anesthetics. None have resolved the pain.  I am scheduled to see the director of Immunology and Rhumatology at the Clinic.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pain in extremity, Pain in jaw, Peripheral swelling, Toothache
Clinical narrative: I had the typical sore arm and headache on 8/28-8/29 which resolved within 2-3 days.  I then began to experience severe pain in different areas of my body. Since September 6, 2019 to present, I have been experiencing SEVERE debilitating joint pain/ redness and swelling in both hands,  joints and fingers,.....   I developed neck,   jaw and teeth  pain which required a visit to the dentist. He ruled out any dental issues. The pain spread to both hips, knees, and big toes.  I have tried  ice, heat, Aleve as well as topical anesthetics. None have resolved the pain.  I am scheduled to see the director of Immunology and Rhumatology at the Clinic.
Age: 64.0
Sex: F
Vaccine: VARZOS, FLUC3, VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling in the left arm; Rash left arm; Left arm was also warm to the touch; Redness in left arm; Severe Headache; Pain in left arm / injection site pain; Fever; Flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUCELVAX QUADRIVALENT) for prophylaxis.   On 21st September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and FLUCELVAX QUADRIVALENT. On 21st September 2019, less than an hour after receiving Shingrix, the patient experienced headache, pain in arm, fever and influenza-like symptoms. On 26th September 2019, the patient experienced extensive swelling of vaccinated limb, rash, injection site warmth and injection site erythema. The patient was treated with prednisone, antibiotics nos and naproxen. On an unknown date, the outcome of the extensive swelling of vaccinated limb, headache, pain in arm, fever, influenza-like symptoms and injection site warmth were recovered/resolved and the outcome of the rash and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, headache, pain in arm, fever, influenza-like symptoms, rash, injection site warmth and injection site erythema to be related to Shingrix.  Additional information received were as follows: The patient received Flucelvax Quadrivalent in the right arm. The patient received Shingrix on the left arm. Within 1 hour of receiving Shingrix vaccine, the patient experienced severe headache, injection site pain, left arm pain, fever and flu like symptoms. Five days after receiving Shingrix, the patient experienced redness and swelling in the left arm. The patient stated that this area on the left arm was also warm to the touch and was approximately 5 by 7 inches in size, which led to extensive swelling of vaccinated limb. The patient stated that the area expanded from the injection site down to the elbow. 5 days after receiving Shingrix, the patient stated that she developed a rash on the left arm. The patient stated that she went to urgent care and was prescribed prednisone, antibiotics and naproxen. The reporter consented to follow up. Emergency room visit required. The caller did not provide any additional details. It was unknown if the reporter considered the headache, pain in arm, fever, influenza-like symptoms, rash, skin warm, erythema of extremities and extensive swelling of vaccinated limb to be related to Flucelvax Quadrivalent.
Age: 64.0
Sex: F
Vaccine: VARZOS, FLUC3, VARZOS
Symptoms: Injection site warmth, Pain, Pyrexia
Clinical narrative: Swelling in the left arm; Rash left arm; Left arm was also warm to the touch; Redness in left arm; Severe Headache; Pain in left arm / injection site pain; Fever; Flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUCELVAX QUADRIVALENT) for prophylaxis.   On 21st September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and FLUCELVAX QUADRIVALENT. On 21st September 2019, less than an hour after receiving Shingrix, the patient experienced headache, pain in arm, fever and influenza-like symptoms. On 26th September 2019, the patient experienced extensive swelling of vaccinated limb, rash, injection site warmth and injection site erythema. The patient was treated with prednisone, antibiotics nos and naproxen. On an unknown date, the outcome of the extensive swelling of vaccinated limb, headache, pain in arm, fever, influenza-like symptoms and injection site warmth were recovered/resolved and the outcome of the rash and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, headache, pain in arm, fever, influenza-like symptoms, rash, injection site warmth and injection site erythema to be related to Shingrix.  Additional information received were as follows: The patient received Flucelvax Quadrivalent in the right arm. The patient received Shingrix on the left arm. Within 1 hour of receiving Shingrix vaccine, the patient experienced severe headache, injection site pain, left arm pain, fever and flu like symptoms. Five days after receiving Shingrix, the patient experienced redness and swelling in the left arm. The patient stated that this area on the left arm was also warm to the touch and was approximately 5 by 7 inches in size, which led to extensive swelling of vaccinated limb. The patient stated that the area expanded from the injection site down to the elbow. 5 days after receiving Shingrix, the patient stated that she developed a rash on the left arm. The patient stated that she went to urgent care and was prescribed prednisone, antibiotics and naproxen. The reporter consented to follow up. Emergency room visit required. The caller did not provide any additional details. It was unknown if the reporter considered the headache, pain in arm, fever, influenza-like symptoms, rash, skin warm, erythema of extremities and extensive swelling of vaccinated limb to be related to Flucelvax Quadrivalent.
Age: 64.0
Sex: F
Vaccine: VARZOS, FLUC3, VARZOS
Symptoms: Extensive swelling of vaccinated limb, Headache, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: Swelling in the left arm; Rash left arm; Left arm was also warm to the touch; Redness in left arm; Severe Headache; Pain in left arm / injection site pain; Fever; Flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUCELVAX QUADRIVALENT) for prophylaxis.   On 21st September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and FLUCELVAX QUADRIVALENT. On 21st September 2019, less than an hour after receiving Shingrix, the patient experienced headache, pain in arm, fever and influenza-like symptoms. On 26th September 2019, the patient experienced extensive swelling of vaccinated limb, rash, injection site warmth and injection site erythema. The patient was treated with prednisone, antibiotics nos and naproxen. On an unknown date, the outcome of the extensive swelling of vaccinated limb, headache, pain in arm, fever, influenza-like symptoms and injection site warmth were recovered/resolved and the outcome of the rash and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, headache, pain in arm, fever, influenza-like symptoms, rash, injection site warmth and injection site erythema to be related to Shingrix.  Additional information received were as follows: The patient received Flucelvax Quadrivalent in the right arm. The patient received Shingrix on the left arm. Within 1 hour of receiving Shingrix vaccine, the patient experienced severe headache, injection site pain, left arm pain, fever and flu like symptoms. Five days after receiving Shingrix, the patient experienced redness and swelling in the left arm. The patient stated that this area on the left arm was also warm to the touch and was approximately 5 by 7 inches in size, which led to extensive swelling of vaccinated limb. The patient stated that the area expanded from the injection site down to the elbow. 5 days after receiving Shingrix, the patient stated that she developed a rash on the left arm. The patient stated that she went to urgent care and was prescribed prednisone, antibiotics and naproxen. The reporter consented to follow up. Emergency room visit required. The caller did not provide any additional details. It was unknown if the reporter considered the headache, pain in arm, fever, influenza-like symptoms, rash, skin warm, erythema of extremities and extensive swelling of vaccinated limb to be related to Flucelvax Quadrivalent.
Age: 64.0
Sex: F
Vaccine: VARZOS, FLUC3, VARZOS
Symptoms: Injection site warmth, Pain in extremity, Pyrexia, Rash
Clinical narrative: Swelling in the left arm; Rash left arm; Left arm was also warm to the touch; Redness in left arm; Severe Headache; Pain in left arm / injection site pain; Fever; Flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUCELVAX QUADRIVALENT) for prophylaxis.   On 21st September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and FLUCELVAX QUADRIVALENT. On 21st September 2019, less than an hour after receiving Shingrix, the patient experienced headache, pain in arm, fever and influenza-like symptoms. On 26th September 2019, the patient experienced extensive swelling of vaccinated limb, rash, injection site warmth and injection site erythema. The patient was treated with prednisone, antibiotics nos and naproxen. On an unknown date, the outcome of the extensive swelling of vaccinated limb, headache, pain in arm, fever, influenza-like symptoms and injection site warmth were recovered/resolved and the outcome of the rash and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, headache, pain in arm, fever, influenza-like symptoms, rash, injection site warmth and injection site erythema to be related to Shingrix.  Additional information received were as follows: The patient received Flucelvax Quadrivalent in the right arm. The patient received Shingrix on the left arm. Within 1 hour of receiving Shingrix vaccine, the patient experienced severe headache, injection site pain, left arm pain, fever and flu like symptoms. Five days after receiving Shingrix, the patient experienced redness and swelling in the left arm. The patient stated that this area on the left arm was also warm to the touch and was approximately 5 by 7 inches in size, which led to extensive swelling of vaccinated limb. The patient stated that the area expanded from the injection site down to the elbow. 5 days after receiving Shingrix, the patient stated that she developed a rash on the left arm. The patient stated that she went to urgent care and was prescribed prednisone, antibiotics and naproxen. The reporter consented to follow up. Emergency room visit required. The caller did not provide any additional details. It was unknown if the reporter considered the headache, pain in arm, fever, influenza-like symptoms, rash, skin warm, erythema of extremities and extensive swelling of vaccinated limb to be related to Flucelvax Quadrivalent.
Age: 44.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Hypoaesthesia, Injection site pain, Musculoskeletal stiffness
Clinical narrative: Numbness in his face; Stiffness in his neck and facial/cheek area; This case was reported by a nurse and described the occurrence of numbness facial in a 44-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On 1st October 2019, the patient received Influenza vaccine Quadrivalent unspecified season. On 1st October 2019, 30 min after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced numbness facial and stiffness. On an unknown date, the outcome of the numbness facial was recovered/resolved and the outcome of the stiffness was not recovered/not resolved.   It was unknown if the reporter considered the numbness facial and stiffness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The patient did not have known medical history or allergies to medications or food. The patient received Flu Vaccine, about 30 minutes after administration he noted numbness in his face.  The patient was advised to return to clinic if problem persisted or became worse.  The patient reported back to clinic on the reporting date stating the symptoms were mild at first, then encompassing both sides of his face or cheek area.  The patient states on the reporting date all numbness was gone but he feels a stiffness in his neck and facial or cheek area.
Age: 44.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Hypoaesthesia, Musculoskeletal stiffness
Clinical narrative: Numbness in his face; Stiffness in his neck and facial/cheek area; This case was reported by a nurse and described the occurrence of numbness facial in a 44-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On 1st October 2019, the patient received Influenza vaccine Quadrivalent unspecified season. On 1st October 2019, 30 min after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced numbness facial and stiffness. On an unknown date, the outcome of the numbness facial was recovered/resolved and the outcome of the stiffness was not recovered/not resolved.   It was unknown if the reporter considered the numbness facial and stiffness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The patient did not have known medical history or allergies to medications or food. The patient received Flu Vaccine, about 30 minutes after administration he noted numbness in his face.  The patient was advised to return to clinic if problem persisted or became worse.  The patient reported back to clinic on the reporting date stating the symptoms were mild at first, then encompassing both sides of his face or cheek area.  The patient states on the reporting date all numbness was gone but he feels a stiffness in his neck and facial or cheek area.
Sex: M
Vaccine: PPV, PPV
Symptoms: Extra dose administered, Peripheral swelling, Wrong product administered
Clinical narrative: injection site swelling; infection; This spontaneous report was received from a pharmacist concerning a 65 year old male patient. The patient's concomitant medications included unspecified topical creams, unspecified specialty medications,  gabapentin, testosterone, mirtazapine, oxycodone and doxycycline monohydrate. The patient's drug reactions/allergies included penicillin. The patient's pertinent medical history was unknown by reporter. On an unspecified date in September 2018, also reported as (about one year ago), the patient received the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), via intramuscular as it was instructed by his physician due to other health conditions (prophylaxis) (dosage schedule, anatomical location, lot number and expiration date were not reported).   On an unspecified date in August 2019, also reported as (for the past month and a half), the patient developed an unspecified infection and he was treated with doxycycline monohydrate.  On 29-SEP-2019, also reported as (one year after the first dose), the patient was vaccinated with the second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), via intramuscular, lot number S021740, expiration date 25-MAR-2021 as it was instructed by his physician due to other health conditions (prophylaxis) (dosage schedule and anatomical location were not reported). On the same date, the patient experienced swelling in the arm at the injection site (injection site swelling) which got worse throughout the day.  On 30-SEP-2019, the injection site swelling got worse.  On 01-OCT-2019, the swelling started getting better.  The patient did not receive treatment for the injection site swelling. Additionally he did not sought medical attention and none laboratory diagnostics/studies were performed. The outcome of the events was recovering. The causal relationship between the events injection site swelling and infection and therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Sex: M
Vaccine: PPV, PPV
Symptoms: Infection, Injection site swelling
Clinical narrative: injection site swelling; infection; This spontaneous report was received from a pharmacist concerning a 65 year old male patient. The patient's concomitant medications included unspecified topical creams, unspecified specialty medications,  gabapentin, testosterone, mirtazapine, oxycodone and doxycycline monohydrate. The patient's drug reactions/allergies included penicillin. The patient's pertinent medical history was unknown by reporter. On an unspecified date in September 2018, also reported as (about one year ago), the patient received the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), via intramuscular as it was instructed by his physician due to other health conditions (prophylaxis) (dosage schedule, anatomical location, lot number and expiration date were not reported).   On an unspecified date in August 2019, also reported as (for the past month and a half), the patient developed an unspecified infection and he was treated with doxycycline monohydrate.  On 29-SEP-2019, also reported as (one year after the first dose), the patient was vaccinated with the second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), via intramuscular, lot number S021740, expiration date 25-MAR-2021 as it was instructed by his physician due to other health conditions (prophylaxis) (dosage schedule and anatomical location were not reported). On the same date, the patient experienced swelling in the arm at the injection site (injection site swelling) which got worse throughout the day.  On 30-SEP-2019, the injection site swelling got worse.  On 01-OCT-2019, the swelling started getting better.  The patient did not receive treatment for the injection site swelling. Additionally he did not sought medical attention and none laboratory diagnostics/studies were performed. The outcome of the events was recovering. The causal relationship between the events injection site swelling and infection and therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Furuncle, Injection site erythema, Localised infection
Clinical narrative: PUS / BOIL; PINK; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pustule in a 80-year-old male patient who received Herpes zoster (Shingrix) (batch number 5KK99, expiry date unknown) for prophylaxis.   On 18th September 2019, the patient received the 1st dose of Shingrix. In September 2019, less than a day after receiving Shingrix, the patient experienced injection site pustule and injection site discoloration. On an unknown date, the outcome of the injection site pustule and injection site discoloration were unknown.   It was unknown if the reporter considered the injection site pustule and injection site discoloration to be related to Shingrix.  Additional information received were as follows: Within 24 hours pt. experienced a pus filled boil on left arm at the injection site. On 3rd October 2019, the patient went to pharmacy and reported the reaction. The site was dry but pink. The healthcare professional would like to know if he should receive the 2nd dose. The reporter consented to follow up.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site discolouration, Injection site pustule
Clinical narrative: PUS / BOIL; PINK; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pustule in a 80-year-old male patient who received Herpes zoster (Shingrix) (batch number 5KK99, expiry date unknown) for prophylaxis.   On 18th September 2019, the patient received the 1st dose of Shingrix. In September 2019, less than a day after receiving Shingrix, the patient experienced injection site pustule and injection site discoloration. On an unknown date, the outcome of the injection site pustule and injection site discoloration were unknown.   It was unknown if the reporter considered the injection site pustule and injection site discoloration to be related to Shingrix.  Additional information received were as follows: Within 24 hours pt. experienced a pus filled boil on left arm at the injection site. On 3rd October 2019, the patient went to pharmacy and reported the reaction. The site was dry but pink. The healthcare professional would like to know if he should receive the 2nd dose. The reporter consented to follow up.
Age: 65.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Dyspnoea, Lip swelling, Throat tightness, Tremor
Clinical narrative: Noticed mild throat constriction about 4:30.  Lips began swelling about 6:30, shaking began, eyes tearing shortly thereafter.  Took a Benedryl pill, shaking increased, and after calling an insurance company nurse line, took an ambulance to hospital.  There, vomiting and fainting began and violent shaking continued. Hospital administered epinephrine shot and fluids, and conditions improved.
Age: 65.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Lacrimation increased, Lip swelling, Syncope, Tremor, Vomiting
Clinical narrative: Noticed mild throat constriction about 4:30.  Lips began swelling about 6:30, shaking began, eyes tearing shortly thereafter.  Took a Benedryl pill, shaking increased, and after calling an insurance company nurse line, took an ambulance to hospital.  There, vomiting and fainting began and violent shaking continued. Hospital administered epinephrine shot and fluids, and conditions improved.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV, VARZOS, FLU3, PNC13, VARZOS
Symptoms: Dizziness, Erythema, Fatigue, Feeling abnormal, Hyperhidrosis
Clinical narrative: Patient experienced body fever, body ache, swelling of the arms, tenderness on the arms; blood pressure dropped down to 80/40.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV, VARZOS, FLU3, PNC13, VARZOS
Symptoms: Laboratory test, Malaise, Peripheral swelling, Skin warm, Syncope
Clinical narrative: Patient experienced body fever, body ache, swelling of the arms, tenderness on the arms; blood pressure dropped down to 80/40.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV, VARZOS, FLU3, PNC13, VARZOS
Symptoms: Blood pressure decreased, Pain, Peripheral swelling, Pyrexia, Tenderness
Clinical narrative: Patient experienced body fever, body ache, swelling of the arms, tenderness on the arms; blood pressure dropped down to 80/40.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Cyanosis, Respiratory arrest, Somnolence, Unresponsive to stimuli
Clinical narrative: Seizure lasting 2 minutes. Child stopped breathing and turned blue. Called 911. Was sleepy and unresponsive for the next 20 minutes. Taken in ambulance to emergency hospital where by then all vitals were normal. Discharged after a couple of hours. Waiting to see a neurologist for follow-up.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Bronchitis, Chest X-ray, Chest discomfort, Cough, Dehydration
Clinical narrative: The morning after the flu shot I got up I was a key from head to toe I pushed on and I went to church and got sick while in church I started to feel shaky my head started to ache my vision was impaired I immediately got home my chest started to feel tight my throat started to hurt my nose started to run my eyes started to hurt my face hurt my ears hurt my whole body ached    It was as if I had had the flu and I have had the flu before I'm a school teacher I get it all the time.  I went to my doctor she gave me a prescription for antibiotic because my ears and my throat are sore that was on Thursday the following Saturday I was so sick and dehydrated I went to clinic I received a breathing treatment and additional medication for coughing and to help clear my chest.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Ear pain, Facial pain, Headache, Influenza like illness, Malaise
Clinical narrative: The morning after the flu shot I got up I was a key from head to toe I pushed on and I went to church and got sick while in church I started to feel shaky my head started to ache my vision was impaired I immediately got home my chest started to feel tight my throat started to hurt my nose started to run my eyes started to hurt my face hurt my ears hurt my whole body ached    It was as if I had had the flu and I have had the flu before I'm a school teacher I get it all the time.  I went to my doctor she gave me a prescription for antibiotic because my ears and my throat are sore that was on Thursday the following Saturday I was so sick and dehydrated I went to clinic I received a breathing treatment and additional medication for coughing and to help clear my chest.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Nasal congestion, Nervousness, Oropharyngeal pain, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: The morning after the flu shot I got up I was a key from head to toe I pushed on and I went to church and got sick while in church I started to feel shaky my head started to ache my vision was impaired I immediately got home my chest started to feel tight my throat started to hurt my nose started to run my eyes started to hurt my face hurt my ears hurt my whole body ached    It was as if I had had the flu and I have had the flu before I'm a school teacher I get it all the time.  I went to my doctor she gave me a prescription for antibiotic because my ears and my throat are sore that was on Thursday the following Saturday I was so sick and dehydrated I went to clinic I received a breathing treatment and additional medication for coughing and to help clear my chest.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination complication, Visual impairment
Clinical narrative: The morning after the flu shot I got up I was a key from head to toe I pushed on and I went to church and got sick while in church I started to feel shaky my head started to ache my vision was impaired I immediately got home my chest started to feel tight my throat started to hurt my nose started to run my eyes started to hurt my face hurt my ears hurt my whole body ached    It was as if I had had the flu and I have had the flu before I'm a school teacher I get it all the time.  I went to my doctor she gave me a prescription for antibiotic because my ears and my throat are sore that was on Thursday the following Saturday I was so sick and dehydrated I went to clinic I received a breathing treatment and additional medication for coughing and to help clear my chest.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Dyspnoea, Erythema, Fatigue, Feeling abnormal
Clinical narrative: Beginning within 30 minutes of injection Facial swelling and redness, blood shot eyes,  fever day 1 100.4. Symptoms progressed to patient gasping for air while asleep bedtime. Complaints of difficulty catching her breathe. Being ?too uncomfortable to sleep?. Complaints of body aches not feeling right.  Day 2 temp 99.2 with Tylenol and ibuprofen. Continued complaints of difficulty breathing, complaints of not feeling right body aches and pains, random rashes/hives developed. Fatigue and mood changes. Insomnia.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Insomnia, Mood altered, Ocular hyperaemia, Pain, Pyrexia
Clinical narrative: Beginning within 30 minutes of injection Facial swelling and redness, blood shot eyes,  fever day 1 100.4. Symptoms progressed to patient gasping for air while asleep bedtime. Complaints of difficulty catching her breathe. Being ?too uncomfortable to sleep?. Complaints of body aches not feeling right.  Day 2 temp 99.2 with Tylenol and ibuprofen. Continued complaints of difficulty breathing, complaints of not feeling right body aches and pains, random rashes/hives developed. Fatigue and mood changes. Insomnia.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Swelling face, Urticaria
Clinical narrative: Beginning within 30 minutes of injection Facial swelling and redness, blood shot eyes,  fever day 1 100.4. Symptoms progressed to patient gasping for air while asleep bedtime. Complaints of difficulty catching her breathe. Being ?too uncomfortable to sleep?. Complaints of body aches not feeling right.  Day 2 temp 99.2 with Tylenol and ibuprofen. Continued complaints of difficulty breathing, complaints of not feeling right body aches and pains, random rashes/hives developed. Fatigue and mood changes. Insomnia.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: 3 days after receiving the flu vaccine developed hives on wrist, elbow, forearm and right shoulder of arm that flu vaccine was given in. Took Benadryl improved
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: large, round, red, warm, and itchy at site of injection. (4 in circ?)
Sex: U
Vaccine: HPV9, MMR, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: multiple doses of improperly stored Gardasil 9, MMR II and Rotateq were administered; no adverse effects reported in any patients; This spontaneous report was received from an office manager, referring to multiple unspecified patients (age and gender not provided). The patients' medical history and concurrent conditions were not disclosed. Concomitant therapies included sterile diluent (STERILE DILUENT).     On an unknown date, the patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R027577 and expiration date 23-JUN-2021, lot # R028978 and expiration date 23-JUN-2021), for prophylaxis (strength, dose, frequency, anatomical injection site, route of administration were not disclosed).  Other suspect therapies included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # R027997 and expiration date 01-OCT-2020, lot # R024910 and expiration date 30-AUG-2020, lot # R025335 and expiration date 06-APR-2020; for all lot # therapy type was rha), for prophylaxis (strength, dose, frequency, anatomical injection site, route of administration were not disclosed); and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R027272 and expiration date 07-JUN-2020, administered orally for prophylaxis (strength, dose and frequency were not disclosed).   The office manager also reported that on unspecified dates, since 22-MAR-2019, 4 more doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R028978 and expiration date 23-JUN-2021), that were improperly stored, were administered; as well as 3 more doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R027272 and expiration date 07-JUN-2020).  The specific lot number administered to each patient was unknown by the reporter.  Administered dose of vaccine experienced the temperature excursion of above 47 degrees Fahrenheit (also reported as 57.06 degrees Fahrenheit) for 1 hour and 19 minutes; and it was also noted that they underwent a previous temperature excursion of above degrees Fahrenheit (also reported as 57.87 degrees Fahrenheit) for 3 hours. The office manager reported that the cumulative time frame of the temperature excursion was 5 hours 33 minutes.  It was reported that sterile diluent used to reconstitute measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) did not undergo a temperature excursion.  At the time of this report, there were no adverse events reported. Digital data logger was involved.  Follow up information has been received on 09-OCT-2019, informing that all telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; A patient received improperly stored PROQUAD; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient. No information regarding the patient's concurrent conditions, medical history and concomitant medications was reported. On 12-SEP-2019, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA), lot #S002494, expiration date: 23-JUL-2020 (exact dose, frequency, route and site of administration were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. The vaccine experienced a temperature excursion between 6 to 14 degrees Fahrenheit (F) (10.2 F, multiple) for 50 minutes. There was no previous temperature excursion reported. Digital data logger was involved to capture the temperature excursion. No adverse effect was reported.  This is one of 14 reports received from the same reporter.; Sender's Comments:  US-009507513-1909USA005231: US-009507513-1909USA005525: US-009507513-1909USA005365: US-009507513-1909USA005424: US-009507513-1909USA005375: US-009507513-1909USA005139: US-009507513-1909USA005134: US-009507513-1909USA005129: US-009507513-1909USA005124: US-009507513-1909USA005119: US-009507513-1909USA005078: US-009507513-1909USA005220: US-009507513-1909USA005223:
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: The patient developed unspecified swelling at the injection site; This spontaneous report was received from a registered nurse regarding a 70 years old female patient. The patient's concurrent conditions included hypertension, migraine and cataract. The patient had no concomitant medications and no drug reactions/allergies.  On 12-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S021740, expiration date: 25-MAR-2021, dose and unit not reported) intramuscularly for prophylaxis.  On 13-SEP-2019, the patient developed unspecified swelling at the injection site and was treated by the physician with diphenhydramine hydrochloride (BENADRYL) 25 mg intramuscularly and diphenhydramine hydrochloride (BENADRYL) 25 mg by mouth when necessary. No lab diagnostics/studies were performed. The outcome of the event was not recovered.   The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the event was not provided.
Age: 13.0
Sex: U
Vaccine: HPV4, HPV9
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products, No adverse event
Clinical narrative: no adverse effects reported; The nurse midwife reports that on 01-JUL-2015, a female patient recieved her first dose of GARDASIL(lot and expiration unknown by reporter).The patient came back on 16-SEP-2016 for her second dose and GARDASILl 9 was administered.; The nurse midwife reports that on 01-JUL-2015, a female patient recieved her first dose of GARDASIL(lot and expiration unknown by reporter).The patient came back on 16-SEP-2016 for her second dose and GARDASILl 9 was administered.; The nurse midwife reports that on 01-JUL-2015, a female patient recieved her first dose of GARDASIL(lot and expiration unknown by reporter).The patient came back on 16-SEP-2016 for her second dose and GARDASILl 9 was administered.; This spontaneous report was received from a midwife referring to a patient of unknown gender and currently 17 years of age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 01-JUL-2015, the patient was vaccinated with first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb vaccine (GARDASIL) (strength, dose, lot\batch#, expiry date not reported) for prophylaxis. On 16-SEP-2016, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose not reported), lot# L036301, expiry date: 20-DEC-2017 for prophylaxis (inappropriate schedule of vaccine administration, wrong product administered, interchange of vaccine products). There were no adverse effects reported (No adverse event). There was no product quality complaint.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects; the patient received the first dose of GARDASIL 9 on an unspecified date 8 months ago and the second dose on 28-SEP-2019; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug reactions or allergies were not reported.  On an unspecified date in January 2019 (reported as 8 months ago), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, lot #, expiration date, route of administration and anatomical location were not provided) and on 28-SEP-2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # N019104, expiration date: 02-MAR-2020) (dose, route of administration and anatomical location were not provided) (inappropriate schedule of product administration). No adverse effects were reported.
Sex: U
Vaccine: MMRV, UNK
Symptoms: No adverse event, Product preparation error
Clinical narrative: no adverse effect; Proquad was inadvertently reconstituted with 0.4% sterile saline instead of sterlie diluent; This spontaneous report was received from a nurse referring to a 4 year-old patient of unknown gender. The patient's concurrent condition, medical history, drug reactions/allergies and concomitant therapy were not reported. On 01-OCT-2019, the patient was about to be vaccinated with one dosage form of properly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength not reported) (therapy type Rha) (lot No. S003866 has been verified to be a valid lot number for [measles, mumps, rubella and varicella (oka-merck) virus vaccine live], expiration date reported as 08-AUG-2020, but upon internal validation established as 08-AUG-2024) was inadvertently reconstituted with properly stored 0.4% sterile saline (lot # U6338AA with expiration date of 20-AUG-2021) (dose not reported) (anatomical location and route not reported) instead of sterile diluent for prophylaxis (wrong solution used in drug reconstitution). No adverse effects were reported. No product quality complaint (PQC) was associated with this report.
Sex: M
Vaccine: PPV
Symptoms: Computerised tomogram normal, Eye pain, Facial paralysis, Pupils unequal
Clinical narrative: facial drooping symptoms similar to Bell's Palsy on an unspecified side of the face; moderate to severe pain behind his left eye; unequal pupils-one is a 2 and 1 is a 3; This spontaneous report has been received from a pharmacist referring to a 51 years old male patient. The patient had no pertinent medical history or concomitant medications. Drug reaction or allergies included diphenhydramine hydrochloride (BENADRYL) allergy. Concurrent condition included hospitalization (reported as inpatient).  On 30-SEP-2019, during hospitalization, he was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscularly (lot #, expiration date and dose were not provided) for prophylaxis.   On the morning of 01-OCT-2019, the patient woke up experiencing moderate to severe pain behind his left eye (eye pain), facial drooping symptoms similar to Bell's Palsy on an unspecified side of the face (facial paralysis) and unequal pupils-one was a 2 and 1 was a 3 (unspecified test). Medical attention was sought. There was no intervention to prevent serious criteria. On the same day, a non-contrast computed tomography (CT) (unspecified body part) was performed with a negative result. He was being treated with amoxicillin 1440 mg every 8 hours orally, erythromycin ophthalmic ointment 4 times a day and methylprednisolone sodium succinate (SOLU-MEDROL) 125 mg intramuscularly-one time dose, and prednisone 60 mg daily. The events were not resolved.  The causality between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the events was not provided.  Upon internal review, facial paralysis was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been received from a lawyer referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not reported.  In 2017, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were unknown) for long-term prevention of shingles and zoster-related conditions.   On an unknown date, the patient experienced shingles. The patient did not recover from the event. The patient received treatment. As per the reporter, the patient has and will continue suffer significant medical and related expenses as result of the injury which costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies. The patient was hospitalized due to the event on an unknown date.   The reporter considered the event was related to Zoster Vaccine Live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not reported.  On or about 12-NOV-2015, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were unknown) for the long-term prevention of shingles and/or zoster-related conditions.   On an unknown date, the patient experienced shingles. The patient did not recover from the event. The patient received treatment. As per the reporter, the patient has and will continue suffer significant medical and related expenses as result of the injury which costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies. The patient was hospitalized due to the event on an unknown date.  The reporter considered the event was related to Zoster Vaccine Live (ZOSTAVAX).
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Decreased appetite, Dizziness, Lethargy, Pyrexia, Syncope
Clinical narrative: patient fainted; become dizzy; his vitals dropped as well; mild fevers; loss of appetite; lethargic; This spontaneous report was received from a physician and refers to a approximately 16-years-old male patient. The patient's drug reactions or allergies, medical history and concomitant medications were not reported.     On an unknown date in December 2018, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot#, expiration date, dose and route of administration were not reported) as prophylaxis. He had mild fevers, loss of appetite and was lethargic for the following 4 days. On an unknown date, he recovered from that events.  On 26-FEB-2019 at 15:10, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot#, expiration date and dose were not reported) administered in the left arm as prophylaxis. On that day, he become dizzy and fainted. He was monitored for about 20 minutes afterward because his vitals dropped as well. At the reporting time, he was doing better and on an unknown date in 2019, he recovered from the events. However, reporter was worried about the patient's 3rd dose and whether he should have it because the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) "dose not bode well" with him.  The relatedness between all events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.  Upon internal review, the syncope was determined to be medically significant.