chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: FLUA4
Symptoms: Diarrhoea, Herpes zoster, Injection site pain, Nausea, Pain
Clinical narrative: On or about 10/12/2020, I developed a rash, middle of back, more painful than itchy. I thought it was an insect bite following yard work, so applied OTC hydrocortisone cream. Shortly thereafter, this rash grew, and a separate breakout occurred on my right front torso. I continue to use OTC hydrocortisone cream but it doesn't seem to help much. Currently, I have a series of painful rashes across my mid-section which appear to  be shingles breakout. None of the breakouts have cleared up; all are spreading slowly.  I had chicken pox as a child but have never had a previous shingles outbreak.  I will also note that I did experience typical side effects from the flu shot the day after vaccination: low-grade fever, body aches, mild diarrhea, nausea, mild soreness at injection site. Fever was gone in 1 day, other symptoms within 2 days.
Age: 65.0
Sex: F
Vaccine: FLUA4
Symptoms: Pyrexia, Rash, Rash pruritic
Clinical narrative: On or about 10/12/2020, I developed a rash, middle of back, more painful than itchy. I thought it was an insect bite following yard work, so applied OTC hydrocortisone cream. Shortly thereafter, this rash grew, and a separate breakout occurred on my right front torso. I continue to use OTC hydrocortisone cream but it doesn't seem to help much. Currently, I have a series of painful rashes across my mid-section which appear to  be shingles breakout. None of the breakouts have cleared up; all are spreading slowly.  I had chicken pox as a child but have never had a previous shingles outbreak.  I will also note that I did experience typical side effects from the flu shot the day after vaccination: low-grade fever, body aches, mild diarrhea, nausea, mild soreness at injection site. Fever was gone in 1 day, other symptoms within 2 days.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Limb discomfort, Pain, Paraesthesia
Clinical narrative: Numbness traveling down left arm to palm and fingers (left ring & pinkie finger).  Tingling, heavy feeling in palm and underside of arm.  Intermittent pain rated 5 out of 10.   Blood pressure was 98/54 and pulse was 67 which is normally where it runs.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Maternal exposure before pregnancy, Menstruation delayed
Clinical narrative: Patient was seen 8/12/2020 for a well child check up and vaccines. Patient was late for her period so pregnancy test was done in the office and was negative. The two vaccines listed above were administered. On 9/10/2020 patient was seen in urgent care and pregnancy test was positive at that time. Patient not currently experiencing any adverse effects.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Activated partial thromboplastin time, Blood lactic acid, Chest X-ray, Chills, Culture urine
Clinical narrative: 6:10 pm tired, sleepy, chills, trembling, teeth chattering, unable to talk normally. 09/04/22 arrived at ED 7:39 pm. Medication given in the ED. 11:48 pm Sodium Chloride 0.9 % IV solution, 1,000 mliv. 11:49 pm Acetaminophen. 9/5/20 1:45 am, discharged. 9/14/20, 2 pm f/u w/pcp.  Pt went to MC.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Differential white blood cell count, Fatigue, Full blood count, Metabolic function test, Platelet count
Clinical narrative: 6:10 pm tired, sleepy, chills, trembling, teeth chattering, unable to talk normally. 09/04/22 arrived at ED 7:39 pm. Medication given in the ED. 11:48 pm Sodium Chloride 0.9 % IV solution, 1,000 mliv. 11:49 pm Acetaminophen. 9/5/20 1:45 am, discharged. 9/14/20, 2 pm f/u w/pcp.  Pt went to MC.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Prothrombin time, SARS-CoV-2 test negative, Somnolence, Speech disorder, Tremor
Clinical narrative: 6:10 pm tired, sleepy, chills, trembling, teeth chattering, unable to talk normally. 09/04/22 arrived at ED 7:39 pm. Medication given in the ED. 11:48 pm Sodium Chloride 0.9 % IV solution, 1,000 mliv. 11:49 pm Acetaminophen. 9/5/20 1:45 am, discharged. 9/14/20, 2 pm f/u w/pcp.  Pt went to MC.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Urine analysis
Clinical narrative: 6:10 pm tired, sleepy, chills, trembling, teeth chattering, unable to talk normally. 09/04/22 arrived at ED 7:39 pm. Medication given in the ED. 11:48 pm Sodium Chloride 0.9 % IV solution, 1,000 mliv. 11:49 pm Acetaminophen. 9/5/20 1:45 am, discharged. 9/14/20, 2 pm f/u w/pcp.  Pt went to MC.
Age: 26.0
Sex: M
Vaccine: FLU4
Symptoms: Chest pain, Echocardiogram, Electrocardiogram, Myocardial oedema, Myocarditis
Clinical narrative: Pt admitted to hospital 20 days later with myopericarditis, + troponins, chest pain, pericardial effusion and myocardial fluid collection/swelling.
Age: 26.0
Sex: M
Vaccine: FLU4
Symptoms: Pericardial effusion, Troponin
Clinical narrative: Pt admitted to hospital 20 days later with myopericarditis, + troponins, chest pain, pericardial effusion and myocardial fluid collection/swelling.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Lethargy, Somnolence
Clinical narrative: SEVERE LETHARGY for almost 5 days.  I actually felt like i couldn't wake up in the mornings. Also, pain and redness at site of injection.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Adverse reaction, Injection site erythema, Injection site swelling, Pyrexia, Vomiting
Clinical narrative: Patient Woke up with localized reaction. There was redness and swelling at injection site. Patient Developed 100.5F fever but additionally had symptoms of vomiting. Patient not ill prior or at time of injection. He is the second patient with these same symptoms after receiving Flu Vaccine Lot#: UJ533AA
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Headache, Pain, Pyrexia, Tremor
Clinical narrative: severe headache, fever, body shakes, joint pain for 36 hours
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Peripheral swelling
Clinical narrative: RED SWOLLEN UNDER INJECTION SITE.
Age: 54.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Erythema, Injection site discolouration, Injection site vesicles, Pyrexia, Swelling
Clinical narrative: swelling, high fever, redness, raised purple blister at one injection site
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Lethargy
Clinical narrative: Headache, muscle pain, shivering, sweating, tiredness, lethargy. Confined to bed 14 hours, all symptoms did not resolve for 3 days. No fever or other symptoms.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Headache, muscle pain, shivering, sweating, tiredness, lethargy. Confined to bed 14 hours, all symptoms did not resolve for 3 days. No fever or other symptoms.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Neck pain, Pain in extremity, Rash macular, Skin reaction
Clinical narrative: Typical sore arm for first two days. On 10/22/2020 patient reports a red blotch close to bicep (not injection site), sore arm, sore neck, chills, no fever
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Lymphadenopathy, Nausea, Oropharyngeal pain
Clinical narrative: An hour after the injection of the flu shot, a sore throat developed. The next day, the lymph nodes in the neck are swollen. I've been getting the flu shot for at least 10 years and this is the first time I've had any type of reaction. Albeit mild, never had a sore throat from a flu shot before, especially to develop right after.  The next day I developed joint soreness (especially in my hip), and some feelings of nausea.  All symptoms are still present today.
Age: 28.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Headache, SARS-CoV-2 test, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: On 10/20 reports a "bump" on the site of the varicella vaccine, together with a rash that is the size of a quarter coupled with itchiness.   On 10/19 night time, had headache 6 out of 10, woke up on 10/20 still with headache; on 10/21, headache is 3 out of 10 that comes and goes.  No fever reported.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Erythema, Peripheral swelling, Skin warm
Clinical narrative: Swollen, red, hot upper arm
Age: 1.08
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event. Vaccine error reporting.
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Eye swelling, Ocular hyperaemia, Urticaria
Clinical narrative: Hives on neck face, ear.  Eyes purple & swollen shut.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Malaise, Nausea, Pyrexia, Vomiting
Clinical narrative: Patient started feeling ill same night and developed a fever of 100.7F he then developed symptoms of nausea and vomiting over night around 12am 10/21/2020. There was two episodes of vomiting but arm did not develop localized reaction. He is the first patient to present with these symptoms in our office after receiving Flu Vaccine Lot#: UJ533AA
Age: 71.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site bruising, Paraesthesia, Rash erythematous, Rash papular
Clinical narrative: Patient reported feeling tingling in the left arm. Raised red lumps about the size of a quarter where observed on both arms.  Some bruising at the injection site. Patient reported they started the day after the injection and were getting better several days later.  I advised the patient to take oral allergy medication and see her doctor the next day if symptoms did not improve.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dry throat, Dyspnoea, Eye discharge, Eye swelling
Clinical narrative: The patient received a vaccine in the Right deltoid at the High School clinic on Saturday, October 17. She stated that approximately 7 hours after she received her flu vaccine she developed swelling in her eye and face, discharge similar to pink eye, and a sore dry throat with slight difficulty breathing. When further asked she mentioned that she had body aches and chills. She denied having fever, nausea, vomiting, hives and denied having significant trouble breathing where she felt as though she needed medical attention. She and her husband did some research on the Internet and felt like she was developing ocular respiratory syndrome. She went to bed and slept through the night and woke with the only stickiness in the eyes remaining. She did not call her doctor, seek medical attention or call the helpline on Saturday or Sunday. I spoke with the patient on Tuesday, October 20 after she called the helpline to inquire if this was a "normal reaction" and if she could get a COVID vaccine when it was developed. On Tuesday, the patient denied all symptoms with the exception of slight pinkness in her eyes. She denied drainage. On Wednesday, October 21, the patient stated that all symptoms were gone, she felt back to normal and had made an appointment with her doctor next week to discuss future vaccinations. The patient stated that she has received the vaccine previously with no unusual reaction though it had been several years since she was last vaccinated.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Ocular hyperaemia, Oropharyngeal pain, Pain, Swelling face
Clinical narrative: The patient received a vaccine in the Right deltoid at the High School clinic on Saturday, October 17. She stated that approximately 7 hours after she received her flu vaccine she developed swelling in her eye and face, discharge similar to pink eye, and a sore dry throat with slight difficulty breathing. When further asked she mentioned that she had body aches and chills. She denied having fever, nausea, vomiting, hives and denied having significant trouble breathing where she felt as though she needed medical attention. She and her husband did some research on the Internet and felt like she was developing ocular respiratory syndrome. She went to bed and slept through the night and woke with the only stickiness in the eyes remaining. She did not call her doctor, seek medical attention or call the helpline on Saturday or Sunday. I spoke with the patient on Tuesday, October 20 after she called the helpline to inquire if this was a "normal reaction" and if she could get a COVID vaccine when it was developed. On Tuesday, the patient denied all symptoms with the exception of slight pinkness in her eyes. She denied drainage. On Wednesday, October 21, the patient stated that all symptoms were gone, she felt back to normal and had made an appointment with her doctor next week to discuss future vaccinations. The patient stated that she has received the vaccine previously with no unusual reaction though it had been several years since she was last vaccinated.
Age: 92.0
Sex: F
Vaccine: FLUA4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse reactions
Age: 6.0
Sex: F
Vaccine: FLUN4
Symptoms: Chest X-ray, Electrocardiogram, Laboratory test, Syncope
Clinical narrative: Brief syncopal episode the morning after receiving Flumist intranasal vaccine without injury or lasting effects.
Age: 4.0
Sex: F
Vaccine: DTAP, DTAPIPV, FLUA4, IPV, MMR, SMALL
Symptoms: Expired product administered
Clinical narrative: PT WAS GIVEN EXPIRED VACCINE
Age: 27.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Dysstasia, Hyperhidrosis, Immediate post-injection reaction, Injection site pain
Clinical narrative: Injection was administered too high in the arm, and not into the deltoid muscle. Experienced sharp pain at time of the injection, which appears to have been administered into the bursa. Immediately following, experienced vasovagal syncope, profuse sweating, dizziness, and inability to stand up. Vasovagal symptoms resolved within several minutes. At this time, full range of motion remains at the joint where injection was administered. Will continue to monitor.
Age: 27.0
Sex: F
Vaccine: HPV9
Symptoms: Product administered at inappropriate site, Syncope
Clinical narrative: Injection was administered too high in the arm, and not into the deltoid muscle. Experienced sharp pain at time of the injection, which appears to have been administered into the bursa. Immediately following, experienced vasovagal syncope, profuse sweating, dizziness, and inability to stand up. Vasovagal symptoms resolved within several minutes. At this time, full range of motion remains at the joint where injection was administered. Will continue to monitor.
Age: 1.42
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Erythema
Clinical narrative: localized erythema
Age: 94.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood pressure increased, Chills, Nausea, Tremor
Clinical narrative: Chills, shaking, nausea, throwing up, weak, blood pressure went up. Dr. gave pills for nausea and then she slept. Called Dr. on call for Dr.
Age: 94.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Chills, shaking, nausea, throwing up, weak, blood pressure went up. Dr. gave pills for nausea and then she slept. Called Dr. on call for Dr.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Rash erythematous, Rash pruritic
Clinical narrative: Patient is 4 weeks pregnant at time of vaccine. She received vaccine on 10/20/2020 at 11am. On Wednesday 10/21/2020 she began to have a rash break out on her body that was red and "itchy". Patient presented to clinic with rash on Thursday 10/22/2020. Physician's Assistant evaluated patient and determined it was necessary to provide patient with an antihistamine mediation as well as topical Benadryl.
Age: 0.58
Sex: M
Vaccine: RV1
Symptoms: Rash
Clinical narrative: Rash (macular rash all over the torso , back and limbs , sparing the soles and palms) -  Treated with benadryl as needed for itchiness .
Age: 42.0
Sex: F
Vaccine: UNK
Symptoms: Malaise, Migraine, Pruritus, Rash
Clinical narrative: It started with migraines and overall feeling of being unwell on 10/17/2020. On 10/20/2020 I broke out in a rash. It started on my arms then it travel throughout my body. The itch was uncontrollable. I spoke with my doctor's office on 10/21/2020 (provided them photos) and they asked I go to urgent care immediately.   I was told to take Claritin asap and was prescribed steroids.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Injection site reaction considering of swelling, burning pain, redness, malaise,  subjective chills
Age: 81.0
Sex: F
Vaccine: FLUR4
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site rash, Injection site reaction, Injection site swelling
Clinical narrative: Patient states that evening she developed swelling in her left arm from her shoulder to her elbow. Her elbow was swollen and stiff and states it was difficult to move her arm. She also states she had stabbing sharp pain in her left bicep when she attempted to move her arm. Her arm became hot to touch and she developed what she described as a "prickly rash" from her shoulder to her elbow. She felt ill all day the next day. She states the reaction and swelling cleared up within 4-5 days.
Age: 81.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site warmth, Joint stiffness, Malaise
Clinical narrative: Patient states that evening she developed swelling in her left arm from her shoulder to her elbow. Her elbow was swollen and stiff and states it was difficult to move her arm. She also states she had stabbing sharp pain in her left bicep when she attempted to move her arm. Her arm became hot to touch and she developed what she described as a "prickly rash" from her shoulder to her elbow. She felt ill all day the next day. She states the reaction and swelling cleared up within 4-5 days.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: The next mornin10/20/2020 after receiving the Fluzone vaccine she noticed his left thigh at the vaccine site was red, swollen and hot.  That night she marked a circle on his thigh where it was red, swollen and hot.  10/21/2020 the parents brought him in to the clinic to see the pediatrician and the red, swollen hot area measured 10-12 cm.  No streaks or weeping.  Dr. advised they apply cold packs to the area and give him Tylenol if he complained of pain.  At this time he was active and walking/running.  10/22/2020 10:30 AM his mother reports the area now is barely visible.
Age: 74.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was given flu vaccine in error  Patient had no adverse reaction to my knowledge
Age: 61.0
Sex: F
Vaccine: FLUR4
Symptoms: Cellulitis, Vaccine positive rechallenge
Clinical narrative: client stated she had cellulitis with previous Flublok vaccine in 2019 but PCP wanted to try once more to see if it wasn't an aberration or coincidence vs a true reaction/issue. vaccination was done at 10:41am on 10/12/2020.  advised client to call PCP and/or seek immediate medical attention should signs of cellulitis reoccur.   with clean hands and gloves cleaned site with circular motions going outward.  injected and placed clean bandage.  minimal bleeding evident after injection. client called me the next day stating that cellulitis did reappear post injection this year also and that client's PCP was aware and treating the issue. I did not get medications nor other treatment information at that time.
Age: 24.0
Sex: M
Vaccine: SMALL, TYP, UNK
Symptoms: Cardiomegaly, Magnetic resonance imaging heart, Pain, Pleuritic pain
Clinical narrative: 24 yo male hx pericarditis x1 in 2003, x2 in 2004. Received SPV Jan 20, 2005 as primary vaccinee. Reports sensation of severe 10/10 stabbing/ pressure like CP thay radiated to bilat arms - simialr to prior episodes of pericarditis but more severe. Sx started approx 2 weeks after vaccinationo. Sx worse with laying back and improved leaning forward. +Pleuritic. First documentation is ED day 83 post receipt where he was diagnosed with pericarditis and given NSAID with immediate relief. . In follow up he had recurrent bouts of CP requiring narcotics - sx resolved after 4 weeks. Has had  continue recurrent episode's through 2013. Sinnce then and been prescribed nsaid +/- colchicine. Labwork  to include cardiac enzymes from  FEB 15,16 & 24 2005 were found but no accompanying notes.
Age: 66.0
Sex: F
Vaccine: FLUA4
Symptoms: Arthralgia
Clinical narrative: Patient reported severe shoulder pain. Has a doctor's appointment scheduled for 10/22/20 in the afternoon for further evaluation.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Erythema, Peripheral swelling, Rash
Clinical narrative: Patient received second shingles vaccine on 10/17/20 and reported to pharmacy on 10/22/20 complaining of adverse reaction. Rash from wrist to injection site. Red, swollen, with small rash. Patient stated there were blisters on forearm rash that has since healed.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Feeling abnormal, Headache
Clinical narrative: Extreme fatigue (slept 29 of 30 hours);  all over body pain, major headache, intense shivering, horrible stomach pain and constant nauseousness.  Shot was given at 4:36pm; arm muscle soreness instantaneously.  Fatigue hit hard at 11pm same day. No idea what happened on day 2 as I was going through all the above symptoms and had mental fog.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pain
Clinical narrative: Extreme fatigue (slept 29 of 30 hours);  all over body pain, major headache, intense shivering, horrible stomach pain and constant nauseousness.  Shot was given at 4:36pm; arm muscle soreness instantaneously.  Fatigue hit hard at 11pm same day. No idea what happened on day 2 as I was going through all the above symptoms and had mental fog.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Papule, Pruritus, Scab
Clinical narrative: Patient reported to PCP office with erythematous raised papules, some crusting, on right side of chest PCP diagnosed as shingles. PCP recommended cool/wet compress and caladry lotion to help with the itching.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Balance disorder, Confusional state, Disorientation, Dizziness, Dysstasia
Clinical narrative: High Fever,  Muscle pain in right leg/inability to stand or walk/Inability to maintain balance, Difficulty voiding, Dizziness/Confusion/Disorientation, Rashes,
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dysuria, Gait inability, Myalgia, Pyrexia, Rash
Clinical narrative: High Fever,  Muscle pain in right leg/inability to stand or walk/Inability to maintain balance, Difficulty voiding, Dizziness/Confusion/Disorientation, Rashes,
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dyskinesia, Influenza like illness, Pyrexia
Clinical narrative: High Fever,  Muscle pain in right leg/inability to stand or walk/Inability to maintain balance, Difficulty voiding, Dizziness/Confusion/Disorientation, Rashes,
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: patient was adminstered flublok on left deltoid, shortly after about 1 hour patient noticed itchy, red, swolleness to administration site. the redness is spreading to her elbow
Age: 16.0
Sex: M
Vaccine: FLU4, HEPA, HPV9, MENB, MNQ
Symptoms: Syncope
Clinical narrative: fainting after administration of vaccines; instructed patient to put head between the knees, applied a cold compress to the back of the neck, gave patient water, symptoms improved after nursing interventions were implemented; obtained BP reading (114/92).
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Lymphadenopathy
Clinical narrative: Swelling to lymph noes within 2.5 hours after injection
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Nausea, Pain in extremity, Sleep disorder, Tinnitus
Clinical narrative: 10/21 Arm pain shoulder to hand requiring narcotic to sleep.  I have a very high pain tolerance.  I have never needed narcotic after orthopedic or dental surgery (2 weeks ago) or after c-section.  . 10/22 arm pain slightly better but nauseated, no vomiting.  Experiencing vertigo to point need to lay down frequently.  ringing in ears and severe general malaise,. (I am a nurse)
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: 10/21 Arm pain shoulder to hand requiring narcotic to sleep.  I have a very high pain tolerance.  I have never needed narcotic after orthopedic or dental surgery (2 weeks ago) or after c-section.  . 10/22 arm pain slightly better but nauseated, no vomiting.  Experiencing vertigo to point need to lay down frequently.  ringing in ears and severe general malaise,. (I am a nurse)
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Fear, Hyperhidrosis, Migraine, Musculoskeletal stiffness
Clinical narrative: Started with chills and sweating, then prg to upper left side ache (pt was afraid of the vax causing blood clots), then when pt went to walk and stand, her toes were hurting along with stiffness (like arthritis), along with slight headache and frequent urination every two hours. Headache then prg to migraine, pt took tylenol and then felt better next morning.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity, Pollakiuria
Clinical narrative: Started with chills and sweating, then prg to upper left side ache (pt was afraid of the vax causing blood clots), then when pt went to walk and stand, her toes were hurting along with stiffness (like arthritis), along with slight headache and frequent urination every two hours. Headache then prg to migraine, pt took tylenol and then felt better next morning.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Influenza like illness, Injection site pain, Insomnia
Clinical narrative: Sharp pains throughout body, unable to sleep. Feels like a flu, where everything just hurts. Pain in neck and occipital region, headache, pain at injection site, sore muscles throughout. Tired, groggy.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Neck pain, Pain, Somnolence
Clinical narrative: Sharp pains throughout body, unable to sleep. Feels like a flu, where everything just hurts. Pain in neck and occipital region, headache, pain at injection site, sore muscles throughout. Tired, groggy.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Cough, Fatigue, Headache, Myalgia
Clinical narrative: 10/20/2020 dull headache, slight nausea  10/21/2020 chills, sensitive skin, muscle aches, fatigue, some slight nausea and headache, slight cough
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Sensitive skin
Clinical narrative: 10/20/2020 dull headache, slight nausea  10/21/2020 chills, sensitive skin, muscle aches, fatigue, some slight nausea and headache, slight cough
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Electrocardiogram, Eye swelling, Lip swelling, Tachycardia
Clinical narrative: TACHYCARDIA, CHEST PAIN, WHEEZING, BOTH EYES SWOLLEN SHUT, UNCONTROLLABLE SHAKING, TONGUE ITCHING, LIPS SWOLLEN
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Tongue pruritus, Tremor, Wheezing
Clinical narrative: TACHYCARDIA, CHEST PAIN, WHEEZING, BOTH EYES SWOLLEN SHUT, UNCONTROLLABLE SHAKING, TONGUE ITCHING, LIPS SWOLLEN
Age: 51.0
Sex: M
Vaccine: FLUC4
Symptoms: Axillary pain, Lymph node pain, Lymphadenitis, Tenderness, Testicular pain
Clinical narrative: First influenza vaccine ever received. Symptoms started the day after vaccination. Swelling, pain, tenderness in left axilla and left testicle. No redness. No immobility of left arm. Treatment: ice to left testicle/groin QPM x 2 days with improvement/decreased sensitivity. Both areas still swollen and tender, but improving daily.
Age: 51.0
Sex: M
Vaccine: FLUC4
Symptoms: Testicular swelling
Clinical narrative: First influenza vaccine ever received. Symptoms started the day after vaccination. Swelling, pain, tenderness in left axilla and left testicle. No redness. No immobility of left arm. Treatment: ice to left testicle/groin QPM x 2 days with improvement/decreased sensitivity. Both areas still swollen and tender, but improving daily.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: daughter came to pharmcy and showed a picture of injection site being red and itchy
Sex: M
Vaccine: HEP, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE reported; temperature excursion; This spontaneous report was received from a medical assistant and refers to a 11-day-old male patient. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 28-SEP-2020, the patient was vaccinated with improperly stored hepatitis b vaccine (recombinant) (RECOMBIVAX HB) via intramuscular route of administration (lot# reported as R028259 which was verified to be non valid with expiration date 20-JUN-2021 lot was also reported as #R028529 verified to be valid, expiration date: 09-JUN-2021) (exact dose, dose number, route of administration and anatomical location were not reported) for prophylaxis. Other suspect therapies included improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) via oral route of administration (lot# 1660989 was confirmed to be valid, expiration date was reported as 20-JUN-2021 and 15-MAY-2021, but upon internal validation was established as 15-APR-2021) (exact dose, dose number, anatomical location were not reported) for prophylaxis. The temperature to which the vaccines were exposed was from 43.4 (low temperature, degrees not reported) to 60.4 (high temperature) degrees of Fahrenheit (F) and the time frame was reported as 665.83 hours (first date when the product was out of proper storage range was reported as 01-AUG-2020, but noone did not know about it until the reporting time). No previous temperature excursion was reported. A digital data logger was involved. No adverse symptoms were reported.
Age: 14.0
Sex: F
Vaccine: MMR, MMRV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: accidentally was given PROQUAD instead of the Varicella and MMR 11; for varicella virus vaccine live (oka/merck)(manufacturer unknown) vaccine but she accidentally was given measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S021619, expiry date: 09-JAN-2021; dose and route were not; accidentally was given PROQUAD instead of the Varicella and MMR 11; This spontaneous report was received from a physician concerning 14 years old female patient. No information regarding her concurrent condition, medical history or concomitant therapy was reported.      On 06-OCT-2020, the patient came in for her first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and also for varicella virus vaccine live (oka/merck)(manufacturer unknown) vaccine but she accidentally was given measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S021619, expiry date: 09-JAN-2021; dose and route were not reported) instead of the varicella virus vaccine live (oka/merck)(manufacturer unknown) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route and lot# were not reported) (product administered to patient of inappropriate age, inappropriate schedule of product administration and wrong product administered). The patient was observed for five minutes after the vaccines were administered and she then said she felt fine and left. She was not given a separate varicella virus vaccine live (oka/merck)( manufacturer unknown). The accidental measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) administration was discovered after the patient had gone home. As of 06-OCT-2020, the patient was fine after receiving both products. The vials were discarded.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: lnadvertenly adminstered expired vaccine; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions or allergies were not reported.  On 09-OCT-2020, the patient was vaccinated with second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (strength, frequency, dose and route of administration were not reported; lot # R028381, expiration date was reported as 03-OCT-2020) for prophylaxis. This was an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), which was inadvertently administered to the patient (expired product administered). No previous temperature excursions. The outcome of the event was unknown.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Pharmacist is reporting an MMRII given intramuscularly instead of subcutaneous.; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reaction or allergy and concomitant therapy was provided.  On 10-OCT-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (0.5 milliliter (ml), batch/lot# and expiration date were unknown, strength was not reported) intramuscularly instead of subcutaneously for prophylaxis (subcutaneous injection formulation administered by other route).
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion; This spontaneous report was received from a practice manager 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 16-SEP-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # R025726, expiration date: 26-MAY-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursions of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R025726; expirationdate: 26-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion; This spontaneous report was received from a practice manager 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 16-SEP-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # R025726, expiration date: 26-MAY-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursions of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R025726; expirationdate: 26-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:
Sex: U
Vaccine: HEP, HEP
Symptoms: Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manger and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 09-SEP-2020, the patient was vaccinated with improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot #S022584, expiration date: 31-OCT-2020, dose: 1 injection (exact dose, dose #, route of administration and anatomical location were not reported) for prophylaxis.  The temperature excursion took place on 04-AUG-2020 and was as follows: below 2 Celsius degree (C) (1.1 C) for 27 hours and 45 minutes and above 9 Celsius degrees (9 C) for 1 hour and 15 minutes. There were no previous excursions reported. The digital data logger was involved. No further adverse events (AE) or product quality complain (PQC) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: HEP, HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manger and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 10-SEP-2020, the patient was vaccinated with improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot #S022584, expiration date: 31-OCT-2020, dose: 1 injection (exact dose, dose #, route of administration and anatomical location were not reported) for prophylaxis.  The temperature excursion took place on 04-AUG-2020 and was as follows: below 2 Celsius degree (C) (1.1 C) for 27 hours and 45 minutes and above 9 Celsius degrees (9 C) for 1 hour and 15 minutes. There were no previous excursions reported. The digital data logger was involved. No further adverse events (AE) or product quality complain (PQC) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: HEP, HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager 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 15-SEP-2020, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB), 1 injection, lot # S022584, expiration date: 31-OCT-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursion of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: HEP, HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager 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 16-SEP-2020, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB), 1 injection, lot # S022584, expiration date: 31-OCT-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursion of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager 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 17-SEP-2020, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB), 1 injection, lot # S022584, expiration date: 31-OCT-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursion of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: HEP, HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager 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 18-SEP-2020, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB), 1 injection, lot # S022584, expiration date: 31-OCT-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursion of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: VAQTA adult dose administered post-expiry; This spontaneous report was received from a physician referring to an Adult female patient of unknown age. Information about medical history, concurrent conditions and concomitant therapies was not provided.       On 15-OCT-2020, the patient was vaccinated with post-expiry hepatitis a vaccine, inactivated (VAQTA) (1 dose, lot # S021449, expiration date 23-AUG-2020; strength and route were not reported) for prophylaxis (expired product administered).