chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Bursitis, Pain in extremity
Clinical narrative: Patient received a flu vaccine at her workplace and shortly afterward began to have severe pain in her upper arm. She was diagnosed with bursitis in the Emergency Dept. Pain has not improved since. She does not remember the manufacturer or the lot number of her vaccine.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Crying, Dizziness, Fear
Clinical narrative: Crying; Scared; She felt dizziness; Blood pressure lying down 127/63, blood pressure standing 104/73; This report was identified from a line listing obtained on request by the company from the FDA under the Act (HA# 797721) on 26-SEP-2019, concerning a 11 year old female patient. The patient had no concomitant therapies.  She was allergic cefdinir (OMNICEF) (reported as OMNASEF). She had no other illnesses and chronic or long-standing health conditions at the time of vaccinations and had had not an adverse event following any previous vaccination.   On 22-JAN-2019 at 08:30, 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) intramuscularly, in the right arm (dose was not reported) (lot # N025429, expiration date was not reported, but upon internal validations established as 21-JUL-2020) administered for prophylaxis. She was also vaccinated with the sixth dose of diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid (BOOSTRIX) intramuscularly, in the left arm (lot # 7FX42, expiration date and dose were not reported) and with the first dose of meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) intramuscularly, in the right arm (lot # U5989AA, expiration date and dose were not reported).  During the vaccination, the patient was crying and scared. She felt dizziness after the last shot of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). The patient was lied down and within 5 minutes, dizziness went away and stated felt better. On an unspecified day in January 2019, the patient recovered from the remaining events. On an unspecified date in January 2019, the patient's blood pressure (BP) lying on exam table was 127/63 (no units reported), and while standing was 104/73 (no units reported).  The causal relationship between the events and the vaccines was not reported.  Follow up information has been received on 22-OCT-2019, from the healthcare professional who administered the vaccines. The patient's demographic information was updated. The reporter confirmed the expiration dates of the vaccines as: 17-OCT-2019 for diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid (BOOSTRIX) and 27-AUG-2019 for meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA). Meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) were administered in the right deltoid; Diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid (BOOSTRIX) was administered in the left deltoid. The patient did not receive treatment for the previously reported dizziness. The reporter considered the event dizziness to be related to the suspect therapies. The patient's blood pressure fluctuated from 127/63 (no units reported) to 104/73 (no units reported) on an unspecified date in January 2019. The outcome of this event and its causal relationship with the suspect vaccines was not reported.
Age: 13.0
Sex: M
Vaccine: FLUR4, FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 13-year-old male patient received a dose of Flublok, no AE; Initial information and additional information received on 15-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 13 years old male patient who received a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot number and expiry date not reported via intramuscular route in unknown administration site on 05-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to inappropriate age at vaccine administration.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Discomfort, Hypoaesthesia, Peripheral swelling
Clinical narrative: legs felt weak; legs felt heavy; fell down twice; pain in right thigh; Initial information received on 29-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age male patient who experienced legs felt weak (muscular weakness), legs felt heavy (limb discomfort), fell down twice (fall) and pain in right thigh (pain in extremity), while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history included surgery in Jul2019 to rectify pinched nerves in his back. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On 14-Oct-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in the left arm.  On an unknown date, the patient developed a non-serious legs felt weak (muscular weakness) and legs felt heavy (limb discomfort), one day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  On an unknown date, the patient developed a non-serious pain in right thigh (pain in extremity) and fell down twice (fall), unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  It was reported that within 2 days after vaccination, both of his legs felt weak and heavy. On the 3rd and 4th day after the injections his right leg gave out on him. One day his right leg gave out on him and the same day his left leg gave out on him which made him fall twice. Patient went to Neurologist and the Neurologist did an MRI and it was negative.   Relevant laboratory test results included: Magnetic resonance imaging:  [negative]  Final diagnosis was pain in right thigh, legs felt heavy and legs felt weak.   It was not reported if the patient received a corrective treatment.  The outcome of the events was reported as Unknown.  Information on the batch number was requested.
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Fall, Limb discomfort, Magnetic resonance imaging normal, Muscular weakness, Pain in extremity
Clinical narrative: legs felt weak; legs felt heavy; fell down twice; pain in right thigh; Initial information received on 29-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age male patient who experienced legs felt weak (muscular weakness), legs felt heavy (limb discomfort), fell down twice (fall) and pain in right thigh (pain in extremity), while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history included surgery in Jul2019 to rectify pinched nerves in his back. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On 14-Oct-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in the left arm.  On an unknown date, the patient developed a non-serious legs felt weak (muscular weakness) and legs felt heavy (limb discomfort), one day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  On an unknown date, the patient developed a non-serious pain in right thigh (pain in extremity) and fell down twice (fall), unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  It was reported that within 2 days after vaccination, both of his legs felt weak and heavy. On the 3rd and 4th day after the injections his right leg gave out on him. One day his right leg gave out on him and the same day his left leg gave out on him which made him fall twice. Patient went to Neurologist and the Neurologist did an MRI and it was negative.   Relevant laboratory test results included: Magnetic resonance imaging:  [negative]  Final diagnosis was pain in right thigh, legs felt heavy and legs felt weak.   It was not reported if the patient received a corrective treatment.  The outcome of the events was reported as Unknown.  Information on the batch number was requested.
Age: 8.0
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Large red area on upper Left arm, Swollen, warm and sensitive to touch. Red area was 5 1/2 inches long and 3 1/2 inches wide. Student stated the site itches. Used ice pack to site. Student visited school Nurse twice. Called father and informed student went home. (Saw School Nurse at 9:24 AM and 10:30 AM 10-30-2019)(notified Clinic 10-30-2019)
Age: 8.0
Sex: M
Vaccine: FLUC4, FLUC4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Large red area on upper Left arm, Swollen, warm and sensitive to touch. Red area was 5 1/2 inches long and 3 1/2 inches wide. Student stated the site itches. Used ice pack to site. Student visited school Nurse twice. Called father and informed student went home. (Saw School Nurse at 9:24 AM and 10:30 AM 10-30-2019)(notified Clinic 10-30-2019)
Age: 42.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Paraesthesia, Product administered at inappropriate site
Clinical narrative: Ms. received the flu vaccine in her (R) deltoid. During administration, she noted that the needle stopped, but was advanced deeper into her arm by the vaccine administrator. She immediately felt tingling in her lower (R) arm. Since the event, She continues to have (R) arm pain with lifting as well as ocassional numbness & tingling.
Age: 42.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Hypoaesthesia, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Ms. received the flu vaccine in her (R) deltoid. During administration, she noted that the needle stopped, but was advanced deeper into her arm by the vaccine administrator. She immediately felt tingling in her lower (R) arm. Since the event, She continues to have (R) arm pain with lifting as well as ocassional numbness & tingling.
Sex: M
Vaccine: PPV, PPV
Symptoms: Peripheral swelling, Rash
Clinical narrative: rash around the left upper arm; swelling started from left upper arm to forearm; swelling started from left upper arm to forearm; This spontaneous report as received from a pharmacist refers to a currently 84-years-old male patient.  The patient's medical history, concurrent conditions were not reported. Concomitant therapies included atorvastatin, metoprolol and latanoprost.     On 01-NOV-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # R012501, expiry date: 08-JAN-2020) via intramuscular route for prophylaxis. On an unknown date in 2019, the patient developed a rash around the left upper arm at the injection site with swelling starting from the left upper arm to the left forearm (peripheral swelling and Injection site swelling) . The outcome of injection site rash, Injection site swelling and peripheral swelling was reported as recovering/resolving. No further clarifying information provided. No product quality compliant (PQC). Causality was not reported.
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site rash, Injection site swelling, Peripheral swelling
Clinical narrative: rash around the left upper arm; swelling started from left upper arm to forearm; swelling started from left upper arm to forearm; This spontaneous report as received from a pharmacist refers to a currently 84-years-old male patient.  The patient's medical history, concurrent conditions were not reported. Concomitant therapies included atorvastatin, metoprolol and latanoprost.     On 01-NOV-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # R012501, expiry date: 08-JAN-2020) via intramuscular route for prophylaxis. On an unknown date in 2019, the patient developed a rash around the left upper arm at the injection site with swelling starting from the left upper arm to the left forearm (peripheral swelling and Injection site swelling) . The outcome of injection site rash, Injection site swelling and peripheral swelling was reported as recovering/resolving. No further clarifying information provided. No product quality compliant (PQC). Causality was not reported.
Age: 76.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Contusion, Dysphonia, Injection site pain, Joint range of motion decreased, Nasal congestion
Clinical narrative: 1. Shoulder pain when moving arm, lifting anything, or holding anything with significant weight that has not resolved yet.  2. Significant bruising at the injection site for 2 weeks. 3.  Loss of voice and continued hoarseness at this time.
Age: 76.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: 1. Shoulder pain when moving arm, lifting anything, or holding anything with significant weight that has not resolved yet.  2. Significant bruising at the injection site for 2 weeks. 3.  Loss of voice and continued hoarseness at this time.
Age: 76.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Aphonia, Arthritis, Dysphonia, Injection site bruising, Pain
Clinical narrative: 1. Shoulder pain when moving arm, lifting anything, or holding anything with significant weight that has not resolved yet.  2. Significant bruising at the injection site for 2 weeks. 3.  Loss of voice and continued hoarseness at this time.
Age: 76.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Weight bearing difficulty
Clinical narrative: 1. Shoulder pain when moving arm, lifting anything, or holding anything with significant weight that has not resolved yet.  2. Significant bruising at the injection site for 2 weeks. 3.  Loss of voice and continued hoarseness at this time.
Age: 64.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain in extremity, Peripheral swelling, Stomatitis
Clinical narrative: swelled arm, fingers swollen, severe pain, blister in mouth
Age: 64.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Oral mucosal blistering, Pain, Peripheral swelling
Clinical narrative: swelled arm, fingers swollen, severe pain, blister in mouth
Age: 72.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Headache, Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Patient called to report significant rash that extended from her injection site down to her elbow. Rash was red, swollen, warm to the touch, and very itchy. The patient also reported having a bad headache following the injection.
Age: 72.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Headache, Injection site rash, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Patient called to report significant rash that extended from her injection site down to her elbow. Rash was red, swollen, warm to the touch, and very itchy. The patient also reported having a bad headache following the injection.
Age: 72.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Patient called to report significant rash that extended from her injection site down to her elbow. Rash was red, swollen, warm to the touch, and very itchy. The patient also reported having a bad headache following the injection.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Fever, body ache, headache, fatigue.  Started the day after I took the vaccine, symptoms subsided the second day but returned the third day.
Age: 17.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Abdominal pain upper, Anxiety, Bladder pain, Cystitis interstitial, Cystoscopy abnormal
Clinical narrative: Patient received 3 shots of the HPV ( Gardasil ) Vaccine. Previously completely healthy girl with zero health issues, few days after receiving first dose her health rapidly deteriorated. Patient developed excruciating bladder pain, difficulty urinating, urgency to urinate, feeling of not being able to empty bladder, burning pain in bladder during urination and during regular daily activities as well. Suffered through 7 months of horrible pain. Finally diagnosed with Interstitial Cystitis. No cure, no medicine for this disease. Patient has been in constant pain for 3 years. Pain in both arms at the location where shots were given. This pain still exists today after 3 years. Electric-like shocks that start at the location where shots were given and theses shocks radiate down the arms.  Gravely disrupted menstrual cycle. Excruciating headaches. Highest level of anxiety (Diagnosed). Depression (Diagnosed). Excruciating stomach aches. Heart palpitations. Ear popping. Numbness and tingling in left side of face. Feeling of not being able to breathe. Feeling of something stuck in throat. Pain that randomly jumps from one site to others throughout the body. Patient had an adverse reaction 2-3 weeks after each shot; she developed a very painful, hard, red-purple, big bulge at the injection sites that lasted for weeks.
Age: 17.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Depression, Dyspnoea, Dysuria, Ear discomfort, Endoscopy upper gastrointestinal tract
Clinical narrative: Patient received 3 shots of the HPV ( Gardasil ) Vaccine. Previously completely healthy girl with zero health issues, few days after receiving first dose her health rapidly deteriorated. Patient developed excruciating bladder pain, difficulty urinating, urgency to urinate, feeling of not being able to empty bladder, burning pain in bladder during urination and during regular daily activities as well. Suffered through 7 months of horrible pain. Finally diagnosed with Interstitial Cystitis. No cure, no medicine for this disease. Patient has been in constant pain for 3 years. Pain in both arms at the location where shots were given. This pain still exists today after 3 years. Electric-like shocks that start at the location where shots were given and theses shocks radiate down the arms.  Gravely disrupted menstrual cycle. Excruciating headaches. Highest level of anxiety (Diagnosed). Depression (Diagnosed). Excruciating stomach aches. Heart palpitations. Ear popping. Numbness and tingling in left side of face. Feeling of not being able to breathe. Feeling of something stuck in throat. Pain that randomly jumps from one site to others throughout the body. Patient had an adverse reaction 2-3 weeks after each shot; she developed a very painful, hard, red-purple, big bulge at the injection sites that lasted for weeks.
Age: 17.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: General physical health deterioration, Headache, Hypoaesthesia, Injection site erythema, Injection site induration
Clinical narrative: Patient received 3 shots of the HPV ( Gardasil ) Vaccine. Previously completely healthy girl with zero health issues, few days after receiving first dose her health rapidly deteriorated. Patient developed excruciating bladder pain, difficulty urinating, urgency to urinate, feeling of not being able to empty bladder, burning pain in bladder during urination and during regular daily activities as well. Suffered through 7 months of horrible pain. Finally diagnosed with Interstitial Cystitis. No cure, no medicine for this disease. Patient has been in constant pain for 3 years. Pain in both arms at the location where shots were given. This pain still exists today after 3 years. Electric-like shocks that start at the location where shots were given and theses shocks radiate down the arms.  Gravely disrupted menstrual cycle. Excruciating headaches. Highest level of anxiety (Diagnosed). Depression (Diagnosed). Excruciating stomach aches. Heart palpitations. Ear popping. Numbness and tingling in left side of face. Feeling of not being able to breathe. Feeling of something stuck in throat. Pain that randomly jumps from one site to others throughout the body. Patient had an adverse reaction 2-3 weeks after each shot; she developed a very painful, hard, red-purple, big bulge at the injection sites that lasted for weeks.
Age: 17.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Injection site pain, Injection site swelling, Menstrual disorder, Micturition urgency, Pain
Clinical narrative: Patient received 3 shots of the HPV ( Gardasil ) Vaccine. Previously completely healthy girl with zero health issues, few days after receiving first dose her health rapidly deteriorated. Patient developed excruciating bladder pain, difficulty urinating, urgency to urinate, feeling of not being able to empty bladder, burning pain in bladder during urination and during regular daily activities as well. Suffered through 7 months of horrible pain. Finally diagnosed with Interstitial Cystitis. No cure, no medicine for this disease. Patient has been in constant pain for 3 years. Pain in both arms at the location where shots were given. This pain still exists today after 3 years. Electric-like shocks that start at the location where shots were given and theses shocks radiate down the arms.  Gravely disrupted menstrual cycle. Excruciating headaches. Highest level of anxiety (Diagnosed). Depression (Diagnosed). Excruciating stomach aches. Heart palpitations. Ear popping. Numbness and tingling in left side of face. Feeling of not being able to breathe. Feeling of something stuck in throat. Pain that randomly jumps from one site to others throughout the body. Patient had an adverse reaction 2-3 weeks after each shot; she developed a very painful, hard, red-purple, big bulge at the injection sites that lasted for weeks.
Age: 17.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Palpitations, Paraesthesia, Sensation of foreign body, Ultrasound uterus, Urinary retention
Clinical narrative: Patient received 3 shots of the HPV ( Gardasil ) Vaccine. Previously completely healthy girl with zero health issues, few days after receiving first dose her health rapidly deteriorated. Patient developed excruciating bladder pain, difficulty urinating, urgency to urinate, feeling of not being able to empty bladder, burning pain in bladder during urination and during regular daily activities as well. Suffered through 7 months of horrible pain. Finally diagnosed with Interstitial Cystitis. No cure, no medicine for this disease. Patient has been in constant pain for 3 years. Pain in both arms at the location where shots were given. This pain still exists today after 3 years. Electric-like shocks that start at the location where shots were given and theses shocks radiate down the arms.  Gravely disrupted menstrual cycle. Excruciating headaches. Highest level of anxiety (Diagnosed). Depression (Diagnosed). Excruciating stomach aches. Heart palpitations. Ear popping. Numbness and tingling in left side of face. Feeling of not being able to breathe. Feeling of something stuck in throat. Pain that randomly jumps from one site to others throughout the body. Patient had an adverse reaction 2-3 weeks after each shot; she developed a very painful, hard, red-purple, big bulge at the injection sites that lasted for weeks.
Age: 17.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Uterine pain
Clinical narrative: Patient received 3 shots of the HPV ( Gardasil ) Vaccine. Previously completely healthy girl with zero health issues, few days after receiving first dose her health rapidly deteriorated. Patient developed excruciating bladder pain, difficulty urinating, urgency to urinate, feeling of not being able to empty bladder, burning pain in bladder during urination and during regular daily activities as well. Suffered through 7 months of horrible pain. Finally diagnosed with Interstitial Cystitis. No cure, no medicine for this disease. Patient has been in constant pain for 3 years. Pain in both arms at the location where shots were given. This pain still exists today after 3 years. Electric-like shocks that start at the location where shots were given and theses shocks radiate down the arms.  Gravely disrupted menstrual cycle. Excruciating headaches. Highest level of anxiety (Diagnosed). Depression (Diagnosed). Excruciating stomach aches. Heart palpitations. Ear popping. Numbness and tingling in left side of face. Feeling of not being able to breathe. Feeling of something stuck in throat. Pain that randomly jumps from one site to others throughout the body. Patient had an adverse reaction 2-3 weeks after each shot; she developed a very painful, hard, red-purple, big bulge at the injection sites that lasted for weeks.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Insomnia, Myalgia
Clinical narrative: Chills, muscle aches, dizziness. Symptoms caused me to go to bed early that evening. I had some difficulty sleeping. Starting about 12 hours after the onset of symptoms, the symptoms slowly started to improve, and were essentially gone about 24 hours after onset.
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site reaction, Musculoskeletal stiffness, Poor quality sleep
Clinical narrative: Employee received Fluzone Quadrivalent flu vaccine on 10/18/2019 (2 ½ weeks ago). Employee has been experiencing left shoulder pain and stiffness since receiving the flu vaccine. He states the vaccine was given ?well above the deltoid?. He feels the vaccine went in the left shoulder joint space. He has been having ?significant pain and stiffness? in his left shoulder since the time of vaccination. Employee has limited ROM of his left shoulder. He cannot abduct his left arm past 30 degrees, he cannot flex past 45 degrees and he cannot extend his shoulder. He has limited internal and external rotation of his left shoulder due to the pain. He has been taking high doses of Ibuprofen and doing stretches without any improvement. He rates his pain as ?significant? especially at night. He is not sleeping well due to the pain. Employee was referred to Orthopedics for evaluation and treatment.
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered at inappropriate site
Clinical narrative: Employee received Fluzone Quadrivalent flu vaccine on 10/18/2019 (2 ½ weeks ago). Employee has been experiencing left shoulder pain and stiffness since receiving the flu vaccine. He states the vaccine was given ?well above the deltoid?. He feels the vaccine went in the left shoulder joint space. He has been having ?significant pain and stiffness? in his left shoulder since the time of vaccination. Employee has limited ROM of his left shoulder. He cannot abduct his left arm past 30 degrees, he cannot flex past 45 degrees and he cannot extend his shoulder. He has limited internal and external rotation of his left shoulder due to the pain. He has been taking high doses of Ibuprofen and doing stretches without any improvement. He rates his pain as ?significant? especially at night. He is not sleeping well due to the pain. Employee was referred to Orthopedics for evaluation and treatment.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Dermatitis, Periorbital swelling, Skin swelling, Swelling
Clinical narrative: Swelling around eyes and on neck (e.g., inflammation and swelling of the dermal tissues).
Age: 12.0
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse side effects.; a patient was administered an improperly stored MMRII vaccine.; This spontaneous report was received from a nurse referring to a 12 years old female patient. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.  On 30-SEP-2019, the patient was administered an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II)(lot # R028003, expiration date was 01-OCT-2020) subcutaneously for prophylaxis. The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) vaccine was stored in refrigerator that had gone out of range. The administered dose experienced a temperature excursion of 53.7 degree Fahrenheit for 6 hours 16 minutes. There were no previous temperature excursions. The temperature excursions were detected by a data logger. No adverse side effects.  Telephone call attempt on 16-OCT-2019 to obtain follow-up information was unsuccessful.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: the patient was administered an improperly stored dose of VARIVAX; no adverse effects; This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. There was no information about the patient's concurrent condition, concomitant medication and medical history provided.  On 24-SEP-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) injection (lot number S002874, expiration date not reported but upon internal validation established as 29-JAN-2021) for prophylaxis (exact dose and route of administration were not reported). The varicella virus vaccine live (oka/merck)(VARIVAX) was reconstituted in properly stored sterile diluent. No adverse effects were reported.  The vaccine experienced temperature excursion of 7.64 degree Fahrenheit for 20 minutes. The previous temperature excursion was 19.34 degree Fahrenheit for 34 minutes. The digital data logger was involved.
Sex: U
Vaccine: MMRV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient received improperly stored PROQUAD via intramuscular route; no adverse effects; The patient received improperly stored PROQUAD via intramuscular route; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concurrent conditions or drug reactions/allergies.    On 29-OCT-2019 the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), via intramuscular route (incorrect route of product administration), lot # S000621, expiration date 06-JUL-2020 for prophylaxis (dosage schedule and anatomical location were not provided) (product storage error). The vaccine was reconstituted with diluent MRK (lot number and expiration date were unknown by reporter). It was not specified if the diluent was stored properly. It was unknown by reporter the temperature excursion and time frame of the administered dose of  Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD). It was recorded by a data logger.  No adverse effects.
Sex: F
Vaccine: VARZOS
Symptoms: Contraindication to vaccination
Clinical narrative: ummunocompormised patient may receive the ZOSTAV AX vaccine; no adverse effects; This spontaneous report as received from a pharmacist referring to an over 80 years old (also reported as in 80's, roughly) female patient. The patient was immunocompromised and had none drug reactions/allergies. Information about concomitant medication was unknown by the reporter.   On an unknown date (also reported as in about 2 weeks), the patient may receive the  zoster vaccine live(ZOSTAVAX) (dose number, dose, anatomical location and route of administration, lot number and expiration date were unknown) for prophylaxis (circumstance or information capable of leading to medication error).
Age: 25.0
Sex: M
Vaccine: HPV9
Symptoms: Expired product administered, Injection site pain
Clinical narrative: a little pain while the GARDASIL 9 was being administered in his right arm, but the pain went away after the administration was complete.; administered an expired dose of GARDASIL 9; Information has been received from a nurse, referring to a 25 years old male patient. The patient had no medical history, concurrent condition or concomitant medications.      On 04-NOV-2019, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, strength, lot # R024264, expiration date 29-OCT-2019) intramuscularly in the right arm as his second dose in the series for routine vaccination (expired product administered).         On 04-NOV-2019, the patient experienced a little pain while the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was being administered, but the pain went away after the administration was completed. The patient did not seek for medical attention. No treatment was given for the events. No lab diagnostics/studies were performed. The causality between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and pain was not provided by the reporter.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; improperly stored vaccines; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was given regarding the patient's concurrent conditions, concomitant medications or medical history.  On 04-NOV-2019 or on 05-NOV-2019, the patient was vaccinated with an improper stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # S000352 with expiration 17-OCT-2021 for prophylaxis (dose and route of administration were not reported). The administered dose of the vaccine experienced a temperature excursion of lowest temperature below 36°F/2 degrees Celsius (1.3C) for 2 hours 18 minutes with no previous temperature excursion.  There was no adverse effect reported.  This call was because of a data logger.  This is one of two reports from the same reporter.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; A patient received an improperly stored ROTATEQ; Information has been received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On an unspecified date in November 2019 (reported as 04-NOV-2019 or 05-NOV-2019), patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally as prophylaxis (lot number S004253 expiration date in 21-OCT-2020) (dose and strength were not reported).  The rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was stored at a lowest temperature below 36 degrees Fahrenheit (°F)/ 2 degrees Celsius (°C) (1.3C) for the time frame of 2 hours and 18 minutes. There was no previous temperature excursion and the call was because of a data logger.  No adverse effects reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; improperly stored vaccines; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was given regarding the patient's concurrent conditions, concomitant medications or medical history.  On 04-NOV-2019 or on 05-NOV-2019, the patient was vaccinated with an improper stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot# S004253 with expiration date on 21-OCT-2020 per oral for prophylaxis (dose and route of administration were not reported). The administered dose of the vaccine experienced a temperature excursion of lowest temperature below 36°F/2 degrees Celsius (1.3C) for 2 hours 18 minutes with no previous temperature excursion.  There was no adverse effect reported.  This call was because of a data logger.  This is one of two reports from the same reporter.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect; patient was inadvertently administered GARDASIL 9 that was expired; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 04-NOV-2019 the patient was inadvertently vaccinated with expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection lot # N001533 expiry date 16-OCT-2019 for prophylaxis (dose and route were not reported) (Expired product administered). No adverse effect was reported.
Age: 68.0
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Feeling abnormal, Nasopharyngitis, Nausea
Clinical narrative: Feel a little under the weather; Sick to stomach; Queezy; Feels like has a cold; This case was reported by a consumer via call center representative and described the occurrence of feeling abnormal in a 68-year-old patient who received Herpes zoster (Shingrix) (batch number EG55L, expiry date unknown) for prophylaxis.   Previously administered products included Zostavax (received Zostavax 6 to 7 years ago from the time of reporting).   On 25th October 2019, the patient received the 1st dose of Shingrix (intramuscular). In October 2019, less than a week after receiving Shingrix, the patient experienced feeling abnormal, stomach discomfort, queasy and cold. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the feeling abnormal, stomach discomfort, queasy and cold were not recovered/not resolved.   It was unknown if the reporter considered the feeling abnormal, stomach discomfort, queasy and cold to be related to Shingrix.  Additional details were provided as follows: The patient experienced sick to stomach, queezy, felt like had cold and felt like under the weather. The patient asked whether it is common to feel a little under the weather after vaccination. The patient gave permission to contact healthcare provider.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Headache; Fever of 103 degrees; Muscle Aches; This case was reported by a nurse via call center representative and described the occurrence of headache in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced headache, fever and muscle pain. On an unknown date, the outcome of the headache, fever and muscle pain were recovered/resolved.   It was unknown if the reporter considered the headache, fever and muscle pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The age at vaccination was not reported, but it could be 61 or 62 years. The patient received Shingrix couple months before the date of reporting. The patient experienced short lived side effects such as fever, muscle aches and headache that resolved quickly.  The reporter did not ask if 1st dose of Shingrix was also administered at the same pharmacy as the 2nd dose. The reporter consented to follow up. For tolerance of 2nd dose of Shingrix refer case US2019195392.
Sex: U
Vaccine: UNK
Symptoms: Orbital oedema
Clinical narrative: Orbital edema on the left eye; This case was reported by a nurse and described the occurrence of orbital edema in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   On 25th October 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season. On 25th October 2019, less than a day after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced orbital edema (serious criteria GSK medically significant). The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the orbital edema was unknown.   It was unknown if the reporter considered the orbital edema to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient demographicdetails were not provided. The age at vaccination was not reported. On friday, the patient received Flu vaccine. On friday in the evening, the patient started to notice some orbital edema on the left eye, which increased in nature through the weekend. The patint received steroids as a treatment medication for orbital edema on the left eye. The patient was seen by provider in the afternoon of the day of reporting. No other visible symptoms.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction, Malaise
Clinical narrative: Feeling ill for a long time; Side Effects; This case was reported by a nurse and described the occurrence of feeling unwell in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.  On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced feeling unwell and adverse drug reaction. On an unknown date, the outcome of the feeling unwell and adverse drug reaction were unknown.   It was unknown if the reporter considered the feeling unwell and adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter inquired, whether anyone reading patient forums on the side effects from Shingrix. The reporter stated, she was scared by hearing about some people feeling ill for a long time due to Shingrix. The reporter heard from so many people that say that will not be getting the second shot due to the horrible side effects. The reporter consent to follow up. This is 2 of the 2 cases reported by the same reporter.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Incorrect route of product administration, Injection site reaction, Myalgia
Clinical narrative: Huge injection site reaction; She has felt horrible/felt awful; Pharmacy administered the shot subcutaneously in the back of the left arm; Vaccine administered at inappropriate site; Fever of 103 degrees; Muscle Aches; Headache; This case was reported by a nurse via call center representative and described the occurrence of headache in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received on 26th October 2019 and experienced fever, please refer case US2019AMR196003).   On 26th October 2019, the patient received the 2nd dose of Shingrix (subcutaneous). In October 2019, less than a week after receiving Shingrix, the patient experienced headache and muscle pain. On 26th October 2019, the patient experienced fever, injection site reaction, feels awful, wrong route of administration and vaccine administered at inappropriate site. On 28th October 2019, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the headache and injection site reaction were not recovered/not resolved and the outcome of the muscle pain was recovered/resolved and the outcome of the feels awful, wrong route of administration and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the headache, fever, muscle pain, injection site reaction and feels awful to be related to Shingrix.  Additional details were received as follows: The patient was been administered by Shingrix subcutaneously in the back of the left arm instead of intramuscularly in the deltoid, which led to wrong route of administration and vaccine administered at inappropriate site. She states that the back of her arm there was a huge injection site reaction. She states that with this injection she has felt horrible.  Later in the same day of vaccination, the patent experienced a fever of 103 degrees and felt awful.  She also experienced muscle aches and a bad headache. She said the headache was so terrible she couldn't get her head off the pillow.  On 28th October 2019, fever has stopped and the muscle aches have gone away but she still has a slight headache. She says the headache was much more vague at the time of reporting. She did not have the lot/exp of the injection. This case was linked with case US2019AMR196003, reported by the same reporter.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered at inappropriate site, Pyrexia
Clinical narrative: Huge injection site reaction; She has felt horrible/felt awful; Pharmacy administered the shot subcutaneously in the back of the left arm; Vaccine administered at inappropriate site; Fever of 103 degrees; Muscle Aches; Headache; This case was reported by a nurse via call center representative and described the occurrence of headache in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received on 26th October 2019 and experienced fever, please refer case US2019AMR196003).   On 26th October 2019, the patient received the 2nd dose of Shingrix (subcutaneous). In October 2019, less than a week after receiving Shingrix, the patient experienced headache and muscle pain. On 26th October 2019, the patient experienced fever, injection site reaction, feels awful, wrong route of administration and vaccine administered at inappropriate site. On 28th October 2019, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the headache and injection site reaction were not recovered/not resolved and the outcome of the muscle pain was recovered/resolved and the outcome of the feels awful, wrong route of administration and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the headache, fever, muscle pain, injection site reaction and feels awful to be related to Shingrix.  Additional details were received as follows: The patient was been administered by Shingrix subcutaneously in the back of the left arm instead of intramuscularly in the deltoid, which led to wrong route of administration and vaccine administered at inappropriate site. She states that the back of her arm there was a huge injection site reaction. She states that with this injection she has felt horrible.  Later in the same day of vaccination, the patent experienced a fever of 103 degrees and felt awful.  She also experienced muscle aches and a bad headache. She said the headache was so terrible she couldn't get her head off the pillow.  On 28th October 2019, fever has stopped and the muscle aches have gone away but she still has a slight headache. She says the headache was much more vague at the time of reporting. She did not have the lot/exp of the injection. This case was linked with case US2019AMR196003, reported by the same reporter.