chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Dizziness, Dyspnoea, Generalised oedema, Pruritus, Wheezing
Clinical narrative: 17yr old female pt here for vaccines  Vaccines admin    After vaccine admin, pt reported severe itching.  Generalized edema noted.  No hives, no facial swelling, no tongue swelling.  Pt began to c/o dyspnea. Light insp wheezes auscultated upper airways.  No stridor. VSS (see below repeated measurements) Epi Pen admin left lateral quadricep by NP at 8:27am Medical assistant called 911 and contacted school  Writer admin Benadryl 50mg at 8:29am After a few min pt reported no dyspnea and less itching.  Less erythema noted.   VS 8:27AM  HR 74 O2 sat 99%RA 8:29AM  HR 87 BP 115/57 T98.1 8:36AM HR 92 BP 132/64 O2 sat 99%RA 8:44AM HR 87 BP 122/58 O2 sat 98%RA EMS arrived approx 20 min later IV started left AC and benadryl was admin by EMT.  Pt started to c/o dyspnea and dizziness.  EMT calmed down pt and transported to chair.   Patient transferred to Hospital at 9:12am. Sent referral letter and copy of record   Reaction presumed to be from MMR as per vaccine records this is 1st time dose.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Dyspnoea, Wheezing
Clinical narrative: 10 days after receiving the immunization, pt started to have labored breathing. I immediately began giving her Albuterol, and was giving her 2 puff every 2 hours for an entire day. I then brought her to her pulmonologist's office for an emergency appointment: she was wheezing, was given Albuterol which helped reduce the wheezing, so she was sent home & told to continue Albuterol as needed. Her breathing continued to be labored (visual pulling of both abdomen & neck) for over another day before symptoms subsided. Aside from difficulty breathing, there were no other symptoms.
Age: 29.0
Sex: M
Vaccine: FLU4, PPV, TDAP
Symptoms: Cellulitis, Feeling abnormal, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Two days after receiving  Boostrix in the right arm and Pneumovax-23 and Fluarix Quad (2019-2020) in the  left arm the patient experienced symptoms of feeling poorly, low grade fever, tenderness, swelling, warmth, and redness to left arm where Pneumonvax-23 and Fluarix Quad (2019-2020) were administered.  The patient was diagnosed with a vaccine reaction and likely uncomplicated cellulitis, prescribed antibiotics, and given instructions to return to clinic in two days if symptoms have progressed.  Two days  later (four days  after receiving vaccinations)  the patient stated some spread in redness but feels symptoms are resolving.
Age: 29.0
Sex: M
Vaccine: FLU4, PPV, TDAP
Symptoms: Pyrexia, Tenderness, Vaccination complication
Clinical narrative: Two days after receiving  Boostrix in the right arm and Pneumovax-23 and Fluarix Quad (2019-2020) in the  left arm the patient experienced symptoms of feeling poorly, low grade fever, tenderness, swelling, warmth, and redness to left arm where Pneumonvax-23 and Fluarix Quad (2019-2020) were administered.  The patient was diagnosed with a vaccine reaction and likely uncomplicated cellulitis, prescribed antibiotics, and given instructions to return to clinic in two days if symptoms have progressed.  Two days  later (four days  after receiving vaccinations)  the patient stated some spread in redness but feels symptoms are resolving.
Age: 15.0
Sex: F
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: an unspecified 15 year old female patient was administered a dose of PROQUAD; This spontaneous report was received from a nurse referring to a 15 year old female patient. No information was provided regarding the patient's medical history, previous drug reactions, allergies, and concurrent conditions.  On an usnpecified date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # S002924 with expiration date on 28-JUL-2020 for prophylaxis (strength, dose, anatomical location, and route of administration were not reported) reconstituted with sterile diluent (MERCK STERILE DILUENT) (product administered to patient of inappropriate age).
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No adverse events; 3rd dose administered 6 weeks after the 2nd dose; This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 06-MAY-2019, the patient was vaccinated with first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, schedule, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On 25-OCT-2019, the patient was vaccinated with second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and on 06-DEC-2019, the patient was vaccinated with third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strengths, doses, schedules, routes of administration, anatomical locations, lot # and expiration dates were not reported) both for prophylaxis (Inappropriate schedule of product administration).
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Erythema, Feeling hot, Hyperhidrosis, Nausea
Clinical narrative: presented to the ER due to the symptoms. The patient was experiencing chills, feeling hot, fever, shaking, sweating, swollen red arm, and tight throat. per chart note, he was given a ZPak and Keflex in the ER, with unknown dosing. The patient was suspected to have pneumonia in addition to the vaccine reaction. Does not appear that anything was administered in the ER for the vaccine adr. NauseaVomiting & chills, hot, fever, shaking, sweating, swollen red ARM, tight throat
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling, Pneumonia, Pyrexia, Throat tightness, Tremor
Clinical narrative: presented to the ER due to the symptoms. The patient was experiencing chills, feeling hot, fever, shaking, sweating, swollen red arm, and tight throat. per chart note, he was given a ZPak and Keflex in the ER, with unknown dosing. The patient was suspected to have pneumonia in addition to the vaccine reaction. Does not appear that anything was administered in the ER for the vaccine adr. NauseaVomiting & chills, hot, fever, shaking, sweating, swollen red ARM, tight throat
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: presented to the ER due to the symptoms. The patient was experiencing chills, feeling hot, fever, shaking, sweating, swollen red arm, and tight throat. per chart note, he was given a ZPak and Keflex in the ER, with unknown dosing. The patient was suspected to have pneumonia in addition to the vaccine reaction. Does not appear that anything was administered in the ER for the vaccine adr. NauseaVomiting & chills, hot, fever, shaking, sweating, swollen red ARM, tight throat
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Pain, Pain in extremity
Clinical narrative: Day 1- sore arm. Day 2&3- aches and chills. Day 4, 5 & 6- Diarrhea and stomach pain
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Injection site pain, Injection site paraesthesia, Paraesthesia
Clinical narrative: Patient reported she had soreness at injection site 12/11/19. On 12/14/19 she experienced numbness and tingling from her left neck to her left fingers. These sensations are still present.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia, Radicular pain
Clinical narrative: 12-3 2-10 C/o Tingling in her her left fingers that started approximately 30 minutes after the injection. She head a sound in her nice like a swishing while she was getting the injection. She was instructed to move her hand and arm and use heat. She  was advised to follow up with the nurse if she did not feel any better. 12-6-2019 patient called the Rn to report that she had gone to the ER because of the tingling . The ER gave her a dosepack of Prednisone and released her to home with no restrictions . The diadnosis was Radicular Pain. Patient has is not on extern and not in school. She was told to follow up with the nurse at the clinic. .
Age: 51.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Axillary pain, Fatigue, Injection site pain, Loss of personal independence in daily activities, Nausea
Clinical narrative: Aches and pains throughout body, severe fatigue, nausea. Moderate pain in right arm that extends into armpit which continues 3 days later.  Inability to do normal tasks - Friday evening and most of Saturday in bed. Aches and fatigue better by 12/15, pain in arm continues.
Age: 51.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Aches and pains throughout body, severe fatigue, nausea. Moderate pain in right arm that extends into armpit which continues 3 days later.  Inability to do normal tasks - Friday evening and most of Saturday in bed. Aches and fatigue better by 12/15, pain in arm continues.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Joint effusion, Joint range of motion decreased, Joint swelling, Pain, Peripheral swelling
Clinical narrative: Patient saw her primary care practitioner the day after receiving Prevnar 13 complaining of swelling/edema to joints, puffy hands, mild pain, mild limitation to range of motion, timing of 4-6 hours after vaccine administration. The nurse practitioner recommended the patient not get Pneumovax 23 in the future due to the joint swelling experienced after Prevnar 13. Patient was also prescribed a prednisone taper and chart notes the clinic would continue to monitor her closely.
Age: 25.0
Sex: M
Vaccine: FLUR4
Symptoms: Blood pressure decreased, Dizziness, Feeling abnormal, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Right after the patient got the shot he told the pharmacist on duty that he was feeling funny and dizzy. The pharmacist told him to put his feet up and gave him some water. He became unconscious and 911 was called. When EMS came they checked his blood pressure and it was very low. He regained consciousness and was back to normal. According to the father his son has had this reaction to the flu shot before because he is terrified of needles.  Patient had the option to go to the hospital with father or EMS and he chose not to go to hospital at all and he left with his father.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Fall, Head injury, Loss of consciousness, Neck pain
Clinical narrative: Patient was standing at the checkout desk, felt lightheaded and "tingling tongue" and passed out. Falling backwards and hitting her head.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Paraesthesia, Paraesthesia oral, Spinal X-ray normal
Clinical narrative: Patient was standing at the checkout desk, felt lightheaded and "tingling tongue" and passed out. Falling backwards and hitting her head.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Oedema peripheral, Rash erythematous, Skin mass
Clinical narrative: On day 7 after MMR vaccine client noticed a very small knot under the skin with a red rash. Last week 12/04/2019 she noticed that the knot got bigger to size of a quarter. On Sunday 12/08/2019 she noted swelling under armpit. 12/10/2019 went to see Dr @ Medical Clinic and was given dx of possible cellulitis and prescribed doxycycline 100mg twice a day X 7 days. Plams to return 12/18/2019 for follow up visit, if not better suppose to have some lab work done.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Chills, Headache, Myalgia, Pain
Clinical narrative: Headache, Myalgia, Tachycardia & GENERALIZED ACHES AND PAINS; SWELLING; abdominal pain, chills
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling, Tachycardia
Clinical narrative: Headache, Myalgia, Tachycardia & GENERALIZED ACHES AND PAINS; SWELLING; abdominal pain, chills
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Erythema, Pain in extremity, Pyrexia, Swelling
Clinical narrative: Left arm cellulitis, fever, placed on Keflex. Bactrim added, then IV infusions (ceftriaxone) X-ray done, ultrasound done (12/5) neg. swelling, erythema improved. Arm pain still present 12/9/19.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Ultrasound scan normal, X-ray normal
Clinical narrative: Left arm cellulitis, fever, placed on Keflex. Bactrim added, then IV infusions (ceftriaxone) X-ray done, ultrasound done (12/5) neg. swelling, erythema improved. Arm pain still present 12/9/19.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site nodule
Clinical narrative: Right upper arm was black and blue and had a knot at deltoid muscle
Age: 37.0
Sex: F
Vaccine: UNK
Symptoms: Eye pain, Feeling abnormal, Injection site pain, Musculoskeletal pain, Neck pain
Clinical narrative: Itching, the pain in shoulder, then shaking and brain zaps, the pain in whole left arm, then more shaken and brain zaps, then pain from left elbow to left side of neck progressing over seven days time. Pain in right eye.
Age: 37.0
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity, Pruritus, Tremor
Clinical narrative: Itching, the pain in shoulder, then shaking and brain zaps, the pain in whole left arm, then more shaken and brain zaps, then pain from left elbow to left side of neck progressing over seven days time. Pain in right eye.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Chest X-ray abnormal, Computerised tomogram abnormal, Dyspnoea, Eye swelling
Clinical narrative: After the flu shot I became short of breath, throat was tight, and I was developing hives on my chest and neck.  I took Benadryl 1 hour after the shot.  Over the course of the next few days I was seen several times in the er for anaphylactic reaction to the flu vaccine.  I was also seen in the dr office for the same symptoms.  My lips and eyes were swollen and throat was tight.  My oxygen levels were in the low 80'sat times.  On December 6th I was admitted to the hospital for difficulty breathing my oxygen level when I went in was 76.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling, Oxygen saturation decreased, Throat tightness, Urticaria, Vaccination complication
Clinical narrative: After the flu shot I became short of breath, throat was tight, and I was developing hives on my chest and neck.  I took Benadryl 1 hour after the shot.  Over the course of the next few days I was seen several times in the er for anaphylactic reaction to the flu vaccine.  I was also seen in the dr office for the same symptoms.  My lips and eyes were swollen and throat was tight.  My oxygen levels were in the low 80'sat times.  On December 6th I was admitted to the hospital for difficulty breathing my oxygen level when I went in was 76.
Age: 7.0
Sex: F
Vaccine: DTAP
Symptoms: C-reactive protein, Full blood count, Metabolic function test, Red blood cell sedimentation rate, Seizure
Clinical narrative: Seizure lasting >1 minute 6:45 AM while sleeping w/ Mom; witnessed by Mom. Vomited x 1 45 min after seizure. appeared normal in office
Age: 7.0
Sex: F
Vaccine: DTAP
Symptoms: Vomiting
Clinical narrative: Seizure lasting >1 minute 6:45 AM while sleeping w/ Mom; witnessed by Mom. Vomited x 1 45 min after seizure. appeared normal in office
Age: 45.0
Sex: M
Vaccine: FLU4, MMR
Symptoms: Lacrimation increased, Ocular hyperaemia, Throat irritation
Clinical narrative: 45 y/o male pt received MMR & Influenza on 16Oct19. Developed redness of eye, watering eyes, and itchy throat. Pt denied palpitations, throat swelling, SOB or dyspnea. Co-worker gave pt 50 mg of Benadryl prior to clinic arrival. Denies prior reaction to influenza/MMR vaccination or eggs.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test normal, Dehydration, Dizziness, Erythema, Fatigue
Clinical narrative: in order, Lightheaded Nausea, pain, Swelling, redness, Fever all over. tired. Dehydrated, all within 24 hours. Starting almost within an hour of injection. Primary Care Doctor on vacation so I went to the hospital ER. 2nd Shot not as bad, but did get pain and some swelling. A little bit of redness.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pyrexia, Swelling
Clinical narrative: in order, Lightheaded Nausea, pain, Swelling, redness, Fever all over. tired. Dehydrated, all within 24 hours. Starting almost within an hour of injection. Primary Care Doctor on vacation so I went to the hospital ER. 2nd Shot not as bad, but did get pain and some swelling. A little bit of redness.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: rash on torso and both forearms
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Severe chills, body aches and fatigue
Age: 45.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Amenorrhoea, Blood creatine phosphokinase increased, C-reactive protein increased, Dyspnoea, Dysstasia
Clinical narrative: Dose 1 (8/13/19): severe left arm pain x  3 days; sore throat x 1 day, general malaise x 3 days  Dose 2 (10/15/19): severe left arm pain/heaviness (unable to lift arm higher than shoulder level) x 5 days, minor arm/shoulder pain for 2d thereafter. On October 26, excruciating lower leg myalgias developed, limiting ability to stand/walk/lift legs x 7 days.  Myalgias were accompanied by severe left foot swelling, shortness of breath and postural tachycardia. Medical evaluation revealed CK levels 300 times the upper limit of normal, and elevated inflammatory markers.  Pulmonary embolism/DVT were ruled out. Patient was treated with a 5 day course of oral steroids, which tempered the pain/swelling.  Severe myalgias and foot swelling resolved within 5 days of completing oral steroid therapy. However, tachycardia and exercise intolerance persist (patient had no issues with tachycardia/exercise intolerance prior to vaccination with Gardasil), and are now accompanied by chronic fatigue.   Additionally, the patient's menstrual cycles abruptly ceased after receiving the first dose of Gardasil in August.  At the time of this form submission, patient is still experiencing amenorrhea, even though she is pre-menopausal. Prior to receiving the first dose of Gardasil, she had regular (monthly) menstrual cycles.
Age: 45.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Exercise tolerance decreased, Fatigue, Gait inability, Inflammatory marker increased, Injected limb mobility decreased
Clinical narrative: Dose 1 (8/13/19): severe left arm pain x  3 days; sore throat x 1 day, general malaise x 3 days  Dose 2 (10/15/19): severe left arm pain/heaviness (unable to lift arm higher than shoulder level) x 5 days, minor arm/shoulder pain for 2d thereafter. On October 26, excruciating lower leg myalgias developed, limiting ability to stand/walk/lift legs x 7 days.  Myalgias were accompanied by severe left foot swelling, shortness of breath and postural tachycardia. Medical evaluation revealed CK levels 300 times the upper limit of normal, and elevated inflammatory markers.  Pulmonary embolism/DVT were ruled out. Patient was treated with a 5 day course of oral steroids, which tempered the pain/swelling.  Severe myalgias and foot swelling resolved within 5 days of completing oral steroid therapy. However, tachycardia and exercise intolerance persist (patient had no issues with tachycardia/exercise intolerance prior to vaccination with Gardasil), and are now accompanied by chronic fatigue.   Additionally, the patient's menstrual cycles abruptly ceased after receiving the first dose of Gardasil in August.  At the time of this form submission, patient is still experiencing amenorrhea, even though she is pre-menopausal. Prior to receiving the first dose of Gardasil, she had regular (monthly) menstrual cycles.
Age: 45.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Limb discomfort, Malaise, Menopause, Mobility decreased, Musculoskeletal pain
Clinical narrative: Dose 1 (8/13/19): severe left arm pain x  3 days; sore throat x 1 day, general malaise x 3 days  Dose 2 (10/15/19): severe left arm pain/heaviness (unable to lift arm higher than shoulder level) x 5 days, minor arm/shoulder pain for 2d thereafter. On October 26, excruciating lower leg myalgias developed, limiting ability to stand/walk/lift legs x 7 days.  Myalgias were accompanied by severe left foot swelling, shortness of breath and postural tachycardia. Medical evaluation revealed CK levels 300 times the upper limit of normal, and elevated inflammatory markers.  Pulmonary embolism/DVT were ruled out. Patient was treated with a 5 day course of oral steroids, which tempered the pain/swelling.  Severe myalgias and foot swelling resolved within 5 days of completing oral steroid therapy. However, tachycardia and exercise intolerance persist (patient had no issues with tachycardia/exercise intolerance prior to vaccination with Gardasil), and are now accompanied by chronic fatigue.   Additionally, the patient's menstrual cycles abruptly ceased after receiving the first dose of Gardasil in August.  At the time of this form submission, patient is still experiencing amenorrhea, even though she is pre-menopausal. Prior to receiving the first dose of Gardasil, she had regular (monthly) menstrual cycles.
Age: 45.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Myalgia, Oropharyngeal pain, Pain in extremity, Peripheral swelling, Postural orthostatic tachycardia syndrome
Clinical narrative: Dose 1 (8/13/19): severe left arm pain x  3 days; sore throat x 1 day, general malaise x 3 days  Dose 2 (10/15/19): severe left arm pain/heaviness (unable to lift arm higher than shoulder level) x 5 days, minor arm/shoulder pain for 2d thereafter. On October 26, excruciating lower leg myalgias developed, limiting ability to stand/walk/lift legs x 7 days.  Myalgias were accompanied by severe left foot swelling, shortness of breath and postural tachycardia. Medical evaluation revealed CK levels 300 times the upper limit of normal, and elevated inflammatory markers.  Pulmonary embolism/DVT were ruled out. Patient was treated with a 5 day course of oral steroids, which tempered the pain/swelling.  Severe myalgias and foot swelling resolved within 5 days of completing oral steroid therapy. However, tachycardia and exercise intolerance persist (patient had no issues with tachycardia/exercise intolerance prior to vaccination with Gardasil), and are now accompanied by chronic fatigue.   Additionally, the patient's menstrual cycles abruptly ceased after receiving the first dose of Gardasil in August.  At the time of this form submission, patient is still experiencing amenorrhea, even though she is pre-menopausal. Prior to receiving the first dose of Gardasil, she had regular (monthly) menstrual cycles.
Age: 45.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Red blood cell sedimentation rate, Ultrasound Doppler normal, Ventilation/perfusion scan normal
Clinical narrative: Dose 1 (8/13/19): severe left arm pain x  3 days; sore throat x 1 day, general malaise x 3 days  Dose 2 (10/15/19): severe left arm pain/heaviness (unable to lift arm higher than shoulder level) x 5 days, minor arm/shoulder pain for 2d thereafter. On October 26, excruciating lower leg myalgias developed, limiting ability to stand/walk/lift legs x 7 days.  Myalgias were accompanied by severe left foot swelling, shortness of breath and postural tachycardia. Medical evaluation revealed CK levels 300 times the upper limit of normal, and elevated inflammatory markers.  Pulmonary embolism/DVT were ruled out. Patient was treated with a 5 day course of oral steroids, which tempered the pain/swelling.  Severe myalgias and foot swelling resolved within 5 days of completing oral steroid therapy. However, tachycardia and exercise intolerance persist (patient had no issues with tachycardia/exercise intolerance prior to vaccination with Gardasil), and are now accompanied by chronic fatigue.   Additionally, the patient's menstrual cycles abruptly ceased after receiving the first dose of Gardasil in August.  At the time of this form submission, patient is still experiencing amenorrhea, even though she is pre-menopausal. Prior to receiving the first dose of Gardasil, she had regular (monthly) menstrual cycles.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUC4, MMRV
Symptoms: Dyspnoea, Oral mucosal eruption, Oral mucosal erythema, Rash, Wheezing
Clinical narrative: Approx 3 min after injections, Redness noted around mouth of patient with sob and wheezing. Rash around mouth occurred almost immediately, with sob and wheezing approx. 30 minutes after.  Rash began to spread through out extremities.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; a patient was administered an improperly stored dose of VARlVAX; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information about medical history, concurrent conditions, drug reactions/allergies and concomitant therapies was not provided.    On 20-NOV-2019, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX)  (rHA (recombinant Human albumin)) (lot # S019581, expiration date 25-JUN-2021; strength, dose and route of administration were not reported) for prophylaxis (product storage error). Temperature excursion was -0.2 Celsius degrees for 2 hours 40 minutes. Previous temperature excursion was 4.25 Celsius degrees for 2 hours 40 minutes. No adverse effects were reported. Data logger was involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: the patient did not experience additional symptoms; a patient received unspecified dose in VAQTA immunization series that was improperly stored; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 07-NOV-2019, the patient received improperly stored hepatitis a vaccine, inactivated (VAQTA) injection (lot # S010727, expiry date: 26-JUL-2020) (exact dose and route of administration were not reported) for prophylaxis.  Storage temperature was 10.57 Celsius degree during the time frame of 15 minutes. Previous temperature excursion was 9.94 Celsius degrees for 15 minutes, 10.1 Celsius degrees for 15 minutes and 13.29 Celsius degrees for 45 minutes. The digital data logger was involved. The patient did not experienced additional symptoms.
Sex: M
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Emotional distress, Physical deconditioning
Clinical narrative: cerebrovascular accident; Information has been received from a lawyer, regarding a male patient of unknown age (gender not provided). The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not provided. In or around 16-MAY-2017, the patient was inoculated with a dose of Zoster Vaccine Live (ZOSTAVAX) (dose, frequency, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after, the patient pt suffered a cerebral vascular accident. As a direct and proximate result of vaccination, the patient symptoms had resulted in physical limitations not present prior to using the product. Patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her conditions. In addition, patient sustained severe and permanent injuries, serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of Cerebrovascular accident was not recovered. The lawyer considered the event to be related.  Upon internal review, the event cerebrovascular accident was considered medically significant.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Periorbital swelling, Rash
Clinical narrative: Rash throughout entire body with swelling around both eyes, approx. 1 hour after vaccination - mother gave Benadryl at home, no sob, no respiratory issues, Benadryl worked and rash and swelling went away by end of day.  Prior HPV vaccine, patient had rash throughout body - unsure what vaccine as patient was also given Menveo first time.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: Patient called the pharmacy this morning (12/16/2019) and stated that her lymph nodes on the side of her body that she received the vaccination are swollen.
Age: 1.75
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Within 24 hours of shot, shot site had a red bump. Redness spread within 48 hours. The red area was hard and warm to the touch. Redness was about 2 inches in radius going down from the shot site. Redness started to fade and is continuing to fade around 72 hour mark. Swelling/hardness is also decreasing.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Chills, Depressed level of consciousness, Dizziness, Hyperhidrosis
Clinical narrative: 10 hours after vaccines, I had not only a high fever with chills and excessive sweating, but such severe lightheadedness and weakness that I almost passed out. To avoid falling from fainting, I just laid down on the floor. Additionally, my arm was bright red, warm to touch and painful several inches below the injection site; this subsided 4 days after the vaccine.  A low grade fever, chills, sweating and weakness lasted for 3 days; treated with Tylenol and Advil. Please notes the that my husband had the same vaccines the day after me and he had almost all the same symptoms with dizziness, but not faintness. I wonder if this was related to the batch of vaccines we were given.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: 10 hours after vaccines, I had not only a high fever with chills and excessive sweating, but such severe lightheadedness and weakness that I almost passed out. To avoid falling from fainting, I just laid down on the floor. Additionally, my arm was bright red, warm to touch and painful several inches below the injection site; this subsided 4 days after the vaccine.  A low grade fever, chills, sweating and weakness lasted for 3 days; treated with Tylenol and Advil. Please notes the that my husband had the same vaccines the day after me and he had almost all the same symptoms with dizziness, but not faintness. I wonder if this was related to the batch of vaccines we were given.
Age: 58.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: pain, swelling, redness to right upper arm that is spreading
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: Shoulder pain when lifting or moving arm and when sleeping
Age: 33.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Discomfort, Hangover, Lymphadenopathy, Mumps antibody test negative, Parotid gland enlargement
Clinical narrative: I received the MMR as a child.  I wanted to get a booster to be on the safe side due to the localized outbreak.  Approx one week after receiving the booster vaccination, At 4am, I awoke with the left Submandibular Gland swollen.  No fever, no pain, felt fine other than a slight hangover from drinking 3 bourbon and cokes the night before.  Other than that, I felt fine.  The following day, the left Submandibular gland was still swollen, so I went to Hospital?s urgent care.  They tested for Mumps, and quarantined me for five days.  By Saturday the noticeable swelling was gone, and I felt slightly under the weather, but more annoyed that I was quarantined and missing out on the weekend.  By Sunday, I was feeling completely fine.  The only medicine taken during this time was My daily Triumeq.  I do not take any OTC medicine, unless it is direly needed.  Monday, I awoke with the left Parotid gland swollen about the size of a silver dollar.  It was noticeable and slightly discomfortable, but not painful.  On Tuesday the sweeping was still there, so I took 600mg on time of ibuprofen.  It didn?t seem to do anything for the swelling, so I didn?t take it again.  The swelling very gradually subsided, and by Friday it was not noticeable without me pointing it out.  By this past Saturday, there was slight swelling, but only noticeable to two doctors  that I just happened to meet out and about, and I was telling them about the experience.  After looking at my face, intrigued, they noticed the very slight swelling still, and told me that I should file this report and monitor myself for the next couple of weeks.
Age: 33.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Patient isolation
Clinical narrative: I received the MMR as a child.  I wanted to get a booster to be on the safe side due to the localized outbreak.  Approx one week after receiving the booster vaccination, At 4am, I awoke with the left Submandibular Gland swollen.  No fever, no pain, felt fine other than a slight hangover from drinking 3 bourbon and cokes the night before.  Other than that, I felt fine.  The following day, the left Submandibular gland was still swollen, so I went to Hospital?s urgent care.  They tested for Mumps, and quarantined me for five days.  By Saturday the noticeable swelling was gone, and I felt slightly under the weather, but more annoyed that I was quarantined and missing out on the weekend.  By Sunday, I was feeling completely fine.  The only medicine taken during this time was My daily Triumeq.  I do not take any OTC medicine, unless it is direly needed.  Monday, I awoke with the left Parotid gland swollen about the size of a silver dollar.  It was noticeable and slightly discomfortable, but not painful.  On Tuesday the sweeping was still there, so I took 600mg on time of ibuprofen.  It didn?t seem to do anything for the swelling, so I didn?t take it again.  The swelling very gradually subsided, and by Friday it was not noticeable without me pointing it out.  By this past Saturday, there was slight swelling, but only noticeable to two doctors  that I just happened to meet out and about, and I was telling them about the experience.  After looking at my face, intrigued, they noticed the very slight swelling still, and told me that I should file this report and monitor myself for the next couple of weeks.
Age: 17.0
Sex: F
Vaccine: FLU4, HPV9, PPV
Symptoms: Injection site cellulitis, Injection site erythema, Platelet count decreased, Pyrexia, Thrombocytopenia
Clinical narrative: FEVERS 102-104 FOR 3 DAYS, THROMBOCYTOPENIA TO LOW OF 64,000 ON 12/14/19 -> IMPROVED 105,000 ON 12/15/19, PROGRESSIVE (L) DELTOID ERYTHEMA. TREATED WITH CLINDAMYCIN FOR CELLULITIS
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Administration site pain, Impaired work ability
Clinical narrative: Persistent pain of L deltoid at administered site. Pt reports persistent pain to L deltoid for 2 month S/P Flu vaccine. Patient will need to go on temporary disability as he is unable to complete tasks at work due to pain.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Patient came back and said she had pain in the left arm where she got the shot. She said Flexeril  & Tramadol help with the pain. She's being treated by MD for this pain.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Chest discomfort, Dyspnoea, Heart rate increased, Pharyngeal swelling
Clinical narrative: 100' Fever, Throat swelled, difficult To breath heavy chest, fast heartbeat, weak Took Benadryl and felt better by 11:00pm pulse up to 127
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: 100' Fever, Throat swelled, difficult To breath heavy chest, fast heartbeat, weak Took Benadryl and felt better by 11:00pm pulse up to 127
Sex: F
Vaccine: MMR
Symptoms: Anaphylactic reaction
Clinical narrative: Unspecified patient had an unspecified anaphylactic reaction to an unknown vaccine on unspecified date; This spontaneous report was received from a nurse regarding an unspecified patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies and concomitant therapies were unknown by the reporter.   On unspecified date (reported as "in the past"), the patient was vaccinated with an unspecified therapy (MK-0000) (strength, dosage, frequency, indication, route of administration, lot number and expiration was not reported), and the patient had an unspecified anaphylactic reaction to an unknown vaccine. Also, the patient received sought medical attention, but details were unknown by the reporter.  The outcome of the event was reported as recovered. The causal relationship between the event and therapy unspecified (MK-0000) was not reported.   Upon internal review, the event anaphylactic reaction was considered to be medical significant.   Follow up information was received from a nurse on 12-DEC-2019, regarding a female patient.  On an unspecified date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dosage, frequency, indication, route of administration, lot number and expiration was not reported) for prophylaxis.     The patient (an employee) reported that her mother had verbalized to her that on an unknown date, when the patient was a child, she had experienced and anaphylactic reaction with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). No further information was received.   This case was previously considered to be non-valid as no patient identifier was reported and no specific Merck therapy was involved.
Sex: M
Vaccine: PPV
Symptoms: Cough, Injection site swelling, Lung disorder, Productive cough, Throat irritation
Clinical narrative: swelling at the injection site; his lung problems came back; cough,tickle and Increased phlegm; Increased phlegm; This spontaneous report was received from a pharmacist regarding a 79 year old male patient. The patient medical history included pneumonia and current condition included hypertension. Concomitant therapies included metoprolol 100 milligram, eliqius 5 milligram and furosemide 20 mg. On 13-NOV-2019, the patient was vaccinated with properly stored pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) via intramuscular, lot # S026366 with expiry date 17-SEP-2020, (strength, dose were not reported) for prophylaxis. This was first pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) vaccine that this pharmacy has administered to the patient. The reporter stated that on an unspecified date in November 2019, the patient developed swelling at the injection site which was recovered on an unspecified date in 2019(also reported lasted two weeks). The patient also complained on an unspecified date in 2019, that his lung problems came back (lung disorder), cough, tickle and increased phlegm (productive cough) which reminded him of when he has a pneumonia on an unspecified date in the past. The patient had no cancer, over dose, medical attention and product quality complaint. The outcome of productive cough, cough and lung disorder was reported as recovered on an unspecified date in 2019. The reporter considered injection site swelling, productive cough, cough and lung disorder to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23).
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; administered a dose of VARIVAX on 03-DEC-2019 that had been improperly stored; This spontaneous report was received from a physician refers to a male patient of unknown age. The patient's concurrent condition, pertinent medical history and drug reactions/allergies were unknown. The patient's concomitant therapy included sterile diluent. On 03-DEC-2019, the patient was inadvertently vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (therapy type: digital data logger) (lot # S005084 and expiration date 19-FEB-2021) (dose, route of administration, anatomical location unknown) for prophylaxis (Product storage error). It was reported that there were no adverse effects. The administered dose of the vaccine experienced a temperature excursion of 9.3 Fahrenheit degrees (°F) for 1 hour, as recorded by a data logger. The vaccines had no previous temperature excursion.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Neck pain, Pyrexia
Clinical narrative: arm is very sore where I got the shot; Chills; Fever; Headache; Neck is sore; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th November 2019, the patient received Shingrix. In November 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, chills, fever, headache and neck pain. On an unknown date, the outcome of the injection site pain, headache and neck pain were not recovered/not resolved and the outcome of the chills and fever were recovered/resolved.   It was unknown if the reporter considered the injection site pain, chills, fever, headache and neck pain to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and had chills, fever and neck was sore. The patient arm was very sore where received the vaccine. The reporter asked how long did side effects last. The reporter asked was there anything else can assist. The reporter was day 3 since fever and chills were gone but headache, sore neck was still hurting.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Several of the side effects; This case was reported by a consumer via call center representative and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd December 2019, the patient received Shingrix. In December 2019, less than a week after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was not recovered/not resolved.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not applicable for this report. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received shingrix and had several of the side effects. The patient was looking for medical advice.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Pain
Clinical narrative: tirenedd; Body pain; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th December 2019, the patient received Shingrix. In December 2019, less than a week after receiving Shingrix, the patient experienced tiredness and general body pain. On an unknown date, the outcome of the tiredness and general body pain were unknown.   It was unknown if the reporter considered the tiredness and general body pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The age group was selected as adult as per vaccine indication. The patient reported that the patient had the Shingrix shot yesterday and as indicated of tiredness and body pain.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: high fever at 101.5 degrees; intense shivering; a severe headache; 12 hours of extreme fatigue; This case was reported by a physician via call center representative and described the occurrence of fever in a 61-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included thyroxine sodium (Levothyroxine).   In December 2019, the patient received the 1st dose of Shingrix. In December 2019, 11 hrs after receiving Shingrix and an unknown time after starting Levothyroxine, the patient experienced fever, shivering, headache and fatigue. On an unknown date, the outcome of the fever, shivering, headache and fatigue were recovered/resolved.   The reporter considered the fever, shivering, headache and fatigue to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported but could be between 60 or 61 years. The patient experienced fever at 101.5 degrees, intense shivering, a severe headache and 12 hours of extreme fatigue. The entire reaction began 11 hours after the shot and ended 18 hours after that. The patient tried looking at the clinical trial results for Shingrix, but was not qualified to understand the information as presented.      Lab Comments: on an unknown date body temperature was recorded
Sex: M
Vaccine: VARZOS
Symptoms: Local reaction, Pain, Swelling, Vaccine positive rechallenge
Clinical narrative: pain; swelling; This case was reported by a other health professional via sales rep and described the occurrence of pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1st dose on an unknown date and experienced swelling and pain, refer case US2019AMR219517).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain and swelling. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain and swelling were recovered/resolved.   It was unknown if the reporter considered the pain and swelling to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix and had local reactions of pain and swelling. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm hurt; This case was reported by a consumer and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Post vaccination the patient's arm hurted for a week which was a known side effect. The patient inquired about how long after the first dose can symptoms still occur. The patient also asked if need get the second shot in the arm or was there a less painful place to get the injection. This case was linked to another case US2019AMR225800 reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm hurt; This case was reported by a consumer and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: This case was reported by the reporter for his sister. The age at vaccination was not reported. Post vaccination the patient's arm hurt which was a known side effect. This case was linked to another case US2019AMR225799 reported by the same reporter.