chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Pain in extremity, Skin exfoliation
Clinical narrative: Woke up this morning to my hands covered in rough, dead, peeling skin.  It doesn?t hurt much, but it?s really weird. I tried exfoliating and immediately using a moisturizer but it didn?t help at all. The flaking has gotten worse as the day has gone on.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chapped lips, Chills, Decreased appetite, Dizziness
Clinical narrative: The normal symptoms started in about 12 hours. Chills, but hot body, sleeping alot.  Achey bones, even skin. Nausea, headache, fever 102.  The second day was noticeably louder tinnitus, teeth hurt, inner ear weird feeling, no appetite,  103 temp.  3rd day was 103 temp, lightheaded, achey, 2 hives at the site but very large, warm and hard.  Lower back and neck were really warm. Suddenly small pits in part of my gum that continued to spread, even under my tongue. Very sore and burned with everything I ate or drank.  My body seemed to be very itchy at night.  Temp went down tho.  The 4th day, today was sore mouth, lips peeling and chapped, still lightheaded and arm site is sore and warm.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Feeling hot, Gingival disorder, Gingival pain, Glossodynia
Clinical narrative: The normal symptoms started in about 12 hours. Chills, but hot body, sleeping alot.  Achey bones, even skin. Nausea, headache, fever 102.  The second day was noticeably louder tinnitus, teeth hurt, inner ear weird feeling, no appetite,  103 temp.  3rd day was 103 temp, lightheaded, achey, 2 hives at the site but very large, warm and hard.  Lower back and neck were really warm. Suddenly small pits in part of my gum that continued to spread, even under my tongue. Very sore and burned with everything I ate or drank.  My body seemed to be very itchy at night.  Temp went down tho.  The 4th day, today was sore mouth, lips peeling and chapped, still lightheaded and arm site is sore and warm.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypersomnia, Injection site induration, Injection site urticaria, Injection site warmth
Clinical narrative: The normal symptoms started in about 12 hours. Chills, but hot body, sleeping alot.  Achey bones, even skin. Nausea, headache, fever 102.  The second day was noticeably louder tinnitus, teeth hurt, inner ear weird feeling, no appetite,  103 temp.  3rd day was 103 temp, lightheaded, achey, 2 hives at the site but very large, warm and hard.  Lower back and neck were really warm. Suddenly small pits in part of my gum that continued to spread, even under my tongue. Very sore and burned with everything I ate or drank.  My body seemed to be very itchy at night.  Temp went down tho.  The 4th day, today was sore mouth, lips peeling and chapped, still lightheaded and arm site is sore and warm.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Lip exfoliation, Nausea, Oral pain, Pruritus, Pyrexia
Clinical narrative: The normal symptoms started in about 12 hours. Chills, but hot body, sleeping alot.  Achey bones, even skin. Nausea, headache, fever 102.  The second day was noticeably louder tinnitus, teeth hurt, inner ear weird feeling, no appetite,  103 temp.  3rd day was 103 temp, lightheaded, achey, 2 hives at the site but very large, warm and hard.  Lower back and neck were really warm. Suddenly small pits in part of my gum that continued to spread, even under my tongue. Very sore and burned with everything I ate or drank.  My body seemed to be very itchy at night.  Temp went down tho.  The 4th day, today was sore mouth, lips peeling and chapped, still lightheaded and arm site is sore and warm.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm, Tinnitus, Tongue disorder, Toothache
Clinical narrative: The normal symptoms started in about 12 hours. Chills, but hot body, sleeping alot.  Achey bones, even skin. Nausea, headache, fever 102.  The second day was noticeably louder tinnitus, teeth hurt, inner ear weird feeling, no appetite,  103 temp.  3rd day was 103 temp, lightheaded, achey, 2 hives at the site but very large, warm and hard.  Lower back and neck were really warm. Suddenly small pits in part of my gum that continued to spread, even under my tongue. Very sore and burned with everything I ate or drank.  My body seemed to be very itchy at night.  Temp went down tho.  The 4th day, today was sore mouth, lips peeling and chapped, still lightheaded and arm site is sore and warm.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Malaise, Pain in extremity, Pyrexia
Clinical narrative: No appetite, malaise, Fever 102.3 starting at 12AM. Chills, very painful L arm.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests abnormal, Anti-thyroid antibody positive, Antinuclear antibody increased, Blood thyroid stimulating hormone, Deafness neurosensory
Clinical narrative: Acute unilateral (left) sensorineural hearing loss - 2 1/2 weeks after first covid 19 vaccine (moderna).  Documented moderate to severe hearing loss left ear by serial auditory testing.  Treated with approx 18 days of oral corticosteroids. hearing recovered by 2/18/21 follow up audiogram and visit.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral, Full blood count normal, Laboratory test, Magnetic resonance imaging head normal, Red blood cell sedimentation rate normal
Clinical narrative: Acute unilateral (left) sensorineural hearing loss - 2 1/2 weeks after first covid 19 vaccine (moderna).  Documented moderate to severe hearing loss left ear by serial auditory testing.  Treated with approx 18 days of oral corticosteroids. hearing recovered by 2/18/21 follow up audiogram and visit.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Lymphadenopathy, Muscle spasms, Pain, Paraesthesia
Clinical narrative: Since my 2nd dose of my Covid shot, I experienced an inflamed lymph node in my left armpit. It lasted about a week and eventually passed. But since that event, I have been experiencing sharp pains on the left side of my body (arms, legs, buttocks), such as shocks, tingling, and numbness in my extremities. If I lift my left arm up, I get the sensation the arm and hand is falling alseep. But it's not the normal falling asleep sensation, more of a shocking pain running to my hands. My buttocks/back thigh area is constantly cramping up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Cough, Diarrhoea, Dyspnoea
Clinical narrative: Severe pain in arm, swelling in arm, ongoing fever, allergic reaction (itching that benadryl doesn't help), throat swelling, trouble breathing, visible rash on entire arm, weakness, fatigue, coughing, burning nose and throat, nausea, abdominal pain, diarrhea
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain in extremity, Peripheral swelling, Pharyngeal swelling
Clinical narrative: Severe pain in arm, swelling in arm, ongoing fever, allergic reaction (itching that benadryl doesn't help), throat swelling, trouble breathing, visible rash on entire arm, weakness, fatigue, coughing, burning nose and throat, nausea, abdominal pain, diarrhea
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Rash, Throat irritation
Clinical narrative: Severe pain in arm, swelling in arm, ongoing fever, allergic reaction (itching that benadryl doesn't help), throat swelling, trouble breathing, visible rash on entire arm, weakness, fatigue, coughing, burning nose and throat, nausea, abdominal pain, diarrhea
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Fatigue, Heart rate increased, Influenza like illness
Clinical narrative: Pain at the left side of the heart coinciding with each heartbeat, then heartbeats accelerated to a very rapid beat lasting about 15 seconds the returning back to normal within milliseconds. Never experienced this my entire life, even after running 10 miles, 4 times weekly. Usual minor flu-like symptoms were also felt like dizziness, and then tiredness. Slept a lot on the day my heart rate went up.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Tenderness
Clinical narrative: lymph nodes on neck/collar bone swollen, tender and sore to touch.  Currently still swollen and tender
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Headache, Impaired work ability, Malaise
Clinical narrative: Very ill feeling started on the following morning from the vaccination. Joint and muscle ache, chills, headache, stomach ache and fever. The symptoms were severe on the first day, and they were gradually fainting during the next two days. Was unable to work on the next day following the vaccination.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Very ill feeling started on the following morning from the vaccination. Joint and muscle ache, chills, headache, stomach ache and fever. The symptoms were severe on the first day, and they were gradually fainting during the next two days. Was unable to work on the next day following the vaccination.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: Ankle ans lower leg swelling daily from 4/29- 5/20/21
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site pain, Injection site pruritus, Injection site swelling, Mobility decreased
Clinical narrative: The injection spot became swollen, red, itchy and heated. The pain was preventing normal arm movements. The symptoms started to fade on the 6th day after the vaccination.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: The injection spot became swollen, red, itchy and heated. The pain was preventing normal arm movements. The symptoms started to fade on the 6th day after the vaccination.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Pyrexia, Supraventricular extrasystoles, Ventricular extrasystoles
Clinical narrative: Noticed continual palpitations (pvc,pac) the night of the second dose.  Woke up with palpitations and mild fever (100.4) at 4am. Took 2 Tylenol went back to sleep. Palpitations and fever resolved within 36 hrs after vaccine.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: Day 44 of missed menstrual cycle. Before vaccine,  cycle was never later, nor missed.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Fatigue, Pain
Clinical narrative: 12 hours post vaccination, joint pain in hips and legs. 16 hours post vaccination chills and body aches.  Followed by fatigue, continued body aches and loss of appetite for about 36 hours
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Dry skin, Dysuria, Erythema, Paraesthesia
Clinical narrative: rash on face, back, shoulders, and stomach (dry, red, peeling skin--not itchy) extreme burning and stinging of urethra and vestibular tissues prickling of external vulvar tissues (labia majora and minora, perineum) swelling and redness of mans pubis and labia majora burning and stinging when urinating and deficating excoriated vulvar and vestibular tissues white, nonodorous vaginal discharge that comes back negative for every infection and virus
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Skin exfoliation, Swelling, Urethral pain, Vaginal discharge
Clinical narrative: rash on face, back, shoulders, and stomach (dry, red, peeling skin--not itchy) extreme burning and stinging of urethra and vestibular tissues prickling of external vulvar tissues (labia majora and minora, perineum) swelling and redness of mans pubis and labia majora burning and stinging when urinating and deficating excoriated vulvar and vestibular tissues white, nonodorous vaginal discharge that comes back negative for every infection and virus
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vestibular disorder
Clinical narrative: rash on face, back, shoulders, and stomach (dry, red, peeling skin--not itchy) extreme burning and stinging of urethra and vestibular tissues prickling of external vulvar tissues (labia majora and minora, perineum) swelling and redness of mans pubis and labia majora burning and stinging when urinating and deficating excoriated vulvar and vestibular tissues white, nonodorous vaginal discharge that comes back negative for every infection and virus
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest pain, Computerised tomogram, Dizziness, Electrocardiogram
Clinical narrative: 5/22/2021 - evening time, right side of body went numb, knee locked up, collapsed on floor, chest pain, could not move whole body for 30 seconds then couldnt move right side for another 10 minutes, last 10 minutes called 911, dizziness conscious whole time 5/23/2021 - Hospital said had TIA mini stroke, prescribed blood thinner, have to follow up with Dr
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fall, Hypoaesthesia, Joint lock, Mobility decreased, Transient ischaemic attack
Clinical narrative: 5/22/2021 - evening time, right side of body went numb, knee locked up, collapsed on floor, chest pain, could not move whole body for 30 seconds then couldnt move right side for another 10 minutes, last 10 minutes called 911, dizziness conscious whole time 5/23/2021 - Hospital said had TIA mini stroke, prescribed blood thinner, have to follow up with Dr
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blindness, Chest pain, Dizziness, Fall, Movement disorder
Clinical narrative: 5/22/2021 - evening time, right side of body went numb, knee locked up, collapsed on floor, chest pain, could not move whole body for 30 seconds then couldnt move right side for another 10 minutes, last 10 minutes called 911, dizziness conscious whole time 5/23/2021 - Hospital said had TIA mini stroke, prescribed blood thinner, have to follow up with Dr
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest pain, Computerised tomogram, Dizziness, Electrocardiogram
Clinical narrative: Lost vision, lost ability to move, collapsed on floor, one side of body regained movement, dizziness, chest pain
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fall, Hypoaesthesia, Joint lock, Mobility decreased, Transient ischaemic attack
Clinical narrative: Lost vision, lost ability to move, collapsed on floor, one side of body regained movement, dizziness, chest pain
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blindness, Chest pain, Dizziness, Fall, Movement disorder
Clinical narrative: Lost vision, lost ability to move, collapsed on floor, one side of body regained movement, dizziness, chest pain
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Hypoaesthesia, Oropharyngeal pain
Clinical narrative: PT STATES HE HAD HIS 2ND MODERNA COVID VACCINE ON 26 APRIL.  HE STATES AFTER ABOUT 15 MIN OF VACCINE HE STARTED TO HAVE HEADACHE AND SINCE THEN HE HAD DAILY HEADACHES.  PT STATES HE ALSO HAD FEVER, CHILLS, SORE THROAT 24 HOURS AFTER THE VACCINE THAT RESOLVED THE NEXT DAY.  NO HX OF HEADACHES PRIOR TO VACCINE.  PT STATES HE NORMALLY WAKES UP WITH HEADACHE AND HAS SOME MILD TO MODERATE HEADACHES THROUGHOUT THE DAY.  USUALLY A THROBBING /ACHE. HAS TRIED TYLENOL AND BABY ASA WITH MINIMAL IMPROVEMENT OF SYMPTOMS.  LAST WEEK ON 19-21 MAY HE HAD A POUNDING HEACHES ALL DAY AND THE MEDICATION DID NOT HELP AT ALL.  PT STATES HE HAD OFF/ON NUMBNESS IN HIS FINGERS/HANDS, BUT DID NOT PAY ATTENTION TO WHICH HAND/FINGERS.  NO LIGHT OR SOUND SENSITIVITY.  NO NAUSEA/VOMITING.  NO CHANGES IN VISION.  NO HX OF HEAD INJ/TRAUMA.  OCC LIGHTHEADED.  SLEEP: 7.5-8 HOURS/NIGHT, NO CAFF: NO COFF, ENERGY DRINKS, SODA, TEA, NO PREWORK SUPPLEMENT.  H20: 2-3 HYDOFLASK FILLED/DAY.  EXERCISE: 3 TIMES/WEEK- NO INCREASED HA SYMPTOMS OR WORSENING HEADACHES.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: PT STATES HE HAD HIS 2ND MODERNA COVID VACCINE ON 26 APRIL.  HE STATES AFTER ABOUT 15 MIN OF VACCINE HE STARTED TO HAVE HEADACHE AND SINCE THEN HE HAD DAILY HEADACHES.  PT STATES HE ALSO HAD FEVER, CHILLS, SORE THROAT 24 HOURS AFTER THE VACCINE THAT RESOLVED THE NEXT DAY.  NO HX OF HEADACHES PRIOR TO VACCINE.  PT STATES HE NORMALLY WAKES UP WITH HEADACHE AND HAS SOME MILD TO MODERATE HEADACHES THROUGHOUT THE DAY.  USUALLY A THROBBING /ACHE. HAS TRIED TYLENOL AND BABY ASA WITH MINIMAL IMPROVEMENT OF SYMPTOMS.  LAST WEEK ON 19-21 MAY HE HAD A POUNDING HEACHES ALL DAY AND THE MEDICATION DID NOT HELP AT ALL.  PT STATES HE HAD OFF/ON NUMBNESS IN HIS FINGERS/HANDS, BUT DID NOT PAY ATTENTION TO WHICH HAND/FINGERS.  NO LIGHT OR SOUND SENSITIVITY.  NO NAUSEA/VOMITING.  NO CHANGES IN VISION.  NO HX OF HEAD INJ/TRAUMA.  OCC LIGHTHEADED.  SLEEP: 7.5-8 HOURS/NIGHT, NO CAFF: NO COFF, ENERGY DRINKS, SODA, TEA, NO PREWORK SUPPLEMENT.  H20: 2-3 HYDOFLASK FILLED/DAY.  EXERCISE: 3 TIMES/WEEK- NO INCREASED HA SYMPTOMS OR WORSENING HEADACHES.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Disturbance in attention, Fatigue, Hypersomnia, Loss of personal independence in daily activities
Clinical narrative: I received my covid vax overseas, where i'm living. There's no where to report sinopharm side effects that I can find.   I have had SEVERE exhaustion for two weeks. Sleeping 9-12 hours per day. Can't do strenuous exercise, or physical activity. Can't concentrate very well. Can't see very well either, blurred vision. I did also have joint pain ,but that's mild compared to the fatigue.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred, Visual impairment
Clinical narrative: I received my covid vax overseas, where i'm living. There's no where to report sinopharm side effects that I can find.   I have had SEVERE exhaustion for two weeks. Sleeping 9-12 hours per day. Can't do strenuous exercise, or physical activity. Can't concentrate very well. Can't see very well either, blurred vision. I did also have joint pain ,but that's mild compared to the fatigue.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Chills, Dizziness, Fatigue, Headache
Clinical narrative: First 24 hours fever up to 101.5 nausea headache chills fatigue general body pains and aches. Then about 36 hours after injection dizziness and off balance, feeling like falling.  Fever has resolved but mild headache persists.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: First 24 hours fever up to 101.5 nausea headache chills fatigue general body pains and aches. Then about 36 hours after injection dizziness and off balance, feeling like falling.  Fever has resolved but mild headache persists.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Headache, Hypoaesthesia oral, Nausea
Clinical narrative: Day after vaccine I had extreme nausea and head ache. Following day my lips went numb. Woke up the next day to Bell?s palsy (ER diagnosed) steroids seem to be helping. Currently still taking them.
Age: 44.0
Sex: M
Vaccine: UNK
Symptoms: Herpes zoster
Clinical narrative: Developed shingles
Age: 0.17
Sex: M
Vaccine: PNC13
Symptoms: Bradycardia, Condition aggravated, Infantile apnoea, Oxygen saturation decreased
Clinical narrative: Infant experienced increased apnea, bradycardia, and desaturation requiring increased respiratory support.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: Chest pain (midsagittal), feeling similar to heartburn, pain felt midsagittal throughout chest, but especially immediately below heart. Diaphragm movements when breathing increased severity of pain. Symptoms subsided within 12 hours with use of Kwan Loong Pain Relieving Oil. Unlike heartburn, nothing worked to relieve pain immediately. This was in addition to known side-effects that were present including: fatigue, slight fever, headache, muscle pain, and soreness at injection site.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Chest pain (midsagittal), feeling similar to heartburn, pain felt midsagittal throughout chest, but especially immediately below heart. Diaphragm movements when breathing increased severity of pain. Symptoms subsided within 12 hours with use of Kwan Loong Pain Relieving Oil. Unlike heartburn, nothing worked to relieve pain immediately. This was in addition to known side-effects that were present including: fatigue, slight fever, headache, muscle pain, and soreness at injection site.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Activated partial thromboplastin time shortened, Anti-cyclic citrullinated peptide antibody negative, Antinuclear antibody negative
Clinical narrative: Petechiae to L leg and lower abdomen 1 day after vaccination. 1 week after vaccination pt developed epigastric abdominal pain and CT abdomen with impression of  "1. Right 18 cm small bowel segment of circumferential moderate thickening and inflammatory mesentery with concern for ischemic enteritis.  Additionally, consider possible inflammatory bowel or Crohn's disease.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein, Complement factor C3, Complement factor C4, Complement factor normal, Computerised tomogram abdomen abnormal
Clinical narrative: Petechiae to L leg and lower abdomen 1 day after vaccination. 1 week after vaccination pt developed epigastric abdominal pain and CT abdomen with impression of  "1. Right 18 cm small bowel segment of circumferential moderate thickening and inflammatory mesentery with concern for ischemic enteritis.  Additionally, consider possible inflammatory bowel or Crohn's disease.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer, Gastrointestinal wall thickening, International normalised ratio normal, Mesenteritis, Petechiae
Clinical narrative: Petechiae to L leg and lower abdomen 1 day after vaccination. 1 week after vaccination pt developed epigastric abdominal pain and CT abdomen with impression of  "1. Right 18 cm small bowel segment of circumferential moderate thickening and inflammatory mesentery with concern for ischemic enteritis.  Additionally, consider possible inflammatory bowel or Crohn's disease.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count normal, Prothrombin time normal, Rheumatoid factor negative, White blood cell disorder
Clinical narrative: Petechiae to L leg and lower abdomen 1 day after vaccination. 1 week after vaccination pt developed epigastric abdominal pain and CT abdomen with impression of  "1. Right 18 cm small bowel segment of circumferential moderate thickening and inflammatory mesentery with concern for ischemic enteritis.  Additionally, consider possible inflammatory bowel or Crohn's disease.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: ?Moderna COVID-19 Vaccine EUA?
Age: 0.17
Sex: M
Vaccine: PNC13
Symptoms: Apnoea, Bradycardia, Neonatal hypoxia
Clinical narrative: Infant had increased apnea,  bradycardia, and desaturation requiring increased respiratory support.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Conjunctivitis, Ophthalmological examination
Clinical narrative: Got the vaccine, woke up 48 hours later with pink eye that can?t be linked elsewhere.  It was a Sunday so I decided to wait until Monday to go to urgent care, and by Monday morning it was in both eyes. Prescribed erythromycin which seemed to clear it up.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Myalgia, Peripheral swelling
Clinical narrative: Side effects after getting the second shot: Fever 103.1, muscle pain, headache, chills, dizziness, swollen arm
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Side effects after getting the second shot: Fever 103.1, muscle pain, headache, chills, dizziness, swollen arm
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heavy menstrual bleeding, Migraine, Nausea
Clinical narrative: My period started the night after receiving the vaccine.  I slept Saturday and then Sunday evening felt very nauseas and headachy.  Sometimes I get bad migraines with heavy periods and this is the worst I've had in months.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Starting on Sat 5/22/21 @ 8pm began to get pain all over body. By midnight I was in SEVERE pain (9). I could not sit, stand or laydown without pain.  I took 3 Tylenol  500 mg tablets and 1 benedryl.  At 6am I took two more Tylenol 500 mg  tablets.  I paced the floor trying to endure the pain,  finally subsided @ 5am and I was finally able to lay down and get some sleep.   Currently, my left arm is red, hot, sore, itchy and swollen at the injection site (this happened with first shot also).   I feel weakness in both arms and some pain in my lower back.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site warmth, Muscular weakness, Pain
Clinical narrative: Starting on Sat 5/22/21 @ 8pm began to get pain all over body. By midnight I was in SEVERE pain (9). I could not sit, stand or laydown without pain.  I took 3 Tylenol  500 mg tablets and 1 benedryl.  At 6am I took two more Tylenol 500 mg  tablets.  I paced the floor trying to endure the pain,  finally subsided @ 5am and I was finally able to lay down and get some sleep.   Currently, my left arm is red, hot, sore, itchy and swollen at the injection site (this happened with first shot also).   I feel weakness in both arms and some pain in my lower back.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Feeling hot, Induration, Mass
Clinical narrative: Hard lump, redness, itching, pain, hot, chills No treatment  6 days till symptoms
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus
Clinical narrative: Hard lump, redness, itching, pain, hot, chills No treatment  6 days till symptoms
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: I began developing an itchy rash on day 10 similar to hives.  I still have it and it has increased from a small location to all over my body.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Child experienced a nose bleed from left nostril (blood was running out of the child's nostrils) on May 24, 2021 around 4:30 a.m.  Nose appeared swollen. Nose bleed lasted about 5 minutes. Parent used tissue to help stop nose bleed and sat child in an upward position. Child remained alert and normal throughout the process. Child has a history of occasional nose bleeds but has not experienced a nose bleed prior to this incident in over a year.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: About 2/3 days after, I have é be feeling dizzy/ vertigo when laying down or quickly getting out of bed for about 2 weeks now   I?m not sure if this is a side-effect from the vaccine but this feeling is new to me and my doctor suggested I report it in case there are others who feel this way.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Epistaxis
Clinical narrative: My son is rarely sick. He came home from college, just after a few weeks from receiving the vaccine with a terrible cough and an unusual nosebleed. Every time he blows his nose, it is bloody. Never in 19 years have I observed this. My son is a college athlete and is extremely strong and healthy. These symptoms do not seem to be going away. The bloody nose is the most unusual effect and we are concerned this is an inflammatory side effect.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site reaction, Pyrexia
Clinical narrative: Fever, headaches, chills, reaction at the spot of injection.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Audiogram, Deafness unilateral, Ear discomfort, Magnetic resonance imaging, Tinnitus
Clinical narrative: Left ear slight hearing loss, tinnitus and ear fullness. Right ear is also ringing but not as bad as the left. The ears both have a popping sensation and the left ear feels closed at times.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Decreased appetite, Discomfort, Fatigue, Flatulence
Clinical narrative: Extreme fatigue. Extreme gas. Left upper Abdominal pain. Nausea. Poor appetite. Feels similar to gastritis. Pain and discomfort wakes me up and disrupts daily activities. Onset 1-2 days after vaccination. Symptoms getting worse.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Nausea, Pain
Clinical narrative: Extreme fatigue. Extreme gas. Left upper Abdominal pain. Nausea. Poor appetite. Feels similar to gastritis. Pain and discomfort wakes me up and disrupts daily activities. Onset 1-2 days after vaccination. Symptoms getting worse.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Appendicitis, Decreased appetite, Full blood count
Clinical narrative: left vaccine site at 12:30, went to dinner at a local restaurant with family, no appetite, had some french fries, went home and c/o stomach ache.  Pain in lower right side 1/2 inch above her hip bone.  constant dull pain, not piercing.  Hurt when coughing.  no appetite the next day, vomited twice overnight.  went to ER at 2100 on Sunday (the next day) and was admitted.  CBC, UA, ultrasound , diagnosed with appendicitis.  admitted and scheduled for surgery.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Ultrasound scan, Urine analysis, Vomiting
Clinical narrative: left vaccine site at 12:30, went to dinner at a local restaurant with family, no appetite, had some french fries, went home and c/o stomach ache.  Pain in lower right side 1/2 inch above her hip bone.  constant dull pain, not piercing.  Hurt when coughing.  no appetite the next day, vomited twice overnight.  went to ER at 2100 on Sunday (the next day) and was admitted.  CBC, UA, ultrasound , diagnosed with appendicitis.  admitted and scheduled for surgery.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: When I woke up the morning following my shot in my left arm, my left leg, from the bottom of my knee down to the top of my foot, was numb. This continued for several weeks and is still somewhat present to this day. It never "hurt", but just felt numb to the touch. I was able to walk and do normal activities, but when resting or sitting/laying, it was very uncomfortable. Now, almost 6 weeks out, it has slowly started to go away, but can still feel the "numbness" from time to time.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Vomiting
Clinical narrative: 3am headache until 5pm, 11am vomiting 3 times, 12am vomiting 2 times. weakness. All the same day.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Dizziness, Feeling abnormal, Movement disorder
Clinical narrative: Five days after the second COVID dose I experienced what I thought was motion disturbances similar to a head concussion (week long symptoms) I had six months ago. When I looked into what brain fog was with the vaccine it was very evident that was what was going on. I actually did not realize how bad it was until much later when it cleared. Difficulty focusing and having to repeat processing events that has never happened before. Difficulty sitting and following conversation after an hour need to get up and leave. Still some motion dizziness when turning head fast or downward such as putting on shoes.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Breaking out in large hives on opposite arm  of first vaccination dose, several on leg and a few give spots on the face .
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Decreased appetite, Fatigue, Headache, Injection site reaction
Clinical narrative: Itchy red rash around injection site, headache, cold sweats, muscle cramping & aches overnight, overall lethargy & exhaustion, and loss of appetite.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Muscle spasms, Myalgia, Rash erythematous, Rash pruritic
Clinical narrative: Itchy red rash around injection site, headache, cold sweats, muscle cramping & aches overnight, overall lethargy & exhaustion, and loss of appetite.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Computerised tomogram thorax, Fibrin D dimer increased, Pulmonary embolism
Clinical narrative: Patient presented with chest pain and found to have bilateral pulmonary emboli. He was 2 weeks post 2nd dose of Moderna vaccine. He has personal history of cerebral venous sinus thrombosis and also has positive family history of DVT's (mom had 2 DVT's during pregnancies)
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Seizure, Syncope, Vomiting
Clinical narrative: Very high fever, 108, leading to passing out, convulsion then vomiting
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Feeling abnormal, Headache, Palpitations
Clinical narrative: heart palpitations chest pain dizzy headache  Feeling as if I was suffering the effects of "severe dehydration".  This all came on very sudden, as opposed to a slow onset if I was actually dehydrated.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Dysphonia, Dyspnoea, Laboratory test normal, Pregnancy test urine negative
Clinical narrative: The patient presented to hospital with anaphylaxis without clear precipitating cause, possibly secondary to Pfizer COVID 19 vaccine. She presented to hospital on 5/22 with a lacy rash over the entire body and a change in her voice with a sensation that she couldn't breathe. She was given several doses of epinephrine, and steroids and improved, and was admitted to medicine for observation.  She reported getting initially COVID-19 vaccine dose on 4/19/21. Thereafter had lacy rash over entire body for 3 days which she took as needed benadryl with improvement. After her second dose on 5/10/21 she initially had no symptoms. Approximately 6-7 days after her second dose lacy whole-body rash returned, worse than when she initially had it after first vaccine dose. She took benadryl several times but rash worsened. She had an odd sensation in her throat and noticed a change in the tone of her voice, and felt like she was having difficulty breathing. She presented to the emergency department.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, SARS-CoV-2 test negative, Throat irritation, White blood cell count increased
Clinical narrative: The patient presented to hospital with anaphylaxis without clear precipitating cause, possibly secondary to Pfizer COVID 19 vaccine. She presented to hospital on 5/22 with a lacy rash over the entire body and a change in her voice with a sensation that she couldn't breathe. She was given several doses of epinephrine, and steroids and improved, and was admitted to medicine for observation.  She reported getting initially COVID-19 vaccine dose on 4/19/21. Thereafter had lacy rash over entire body for 3 days which she took as needed benadryl with improvement. After her second dose on 5/10/21 she initially had no symptoms. Approximately 6-7 days after her second dose lacy whole-body rash returned, worse than when she initially had it after first vaccine dose. She took benadryl several times but rash worsened. She had an odd sensation in her throat and noticed a change in the tone of her voice, and felt like she was having difficulty breathing. She presented to the emergency department.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac flutter, Tachycardia
Clinical narrative: Tachycardia: 130-150 on ambulatory, 1-teens at rest. Occurred for both injections but worse with first dose. First dose required vagal maneuver for improvement of symptoms and discomfort related to heart ?fluttering? and tachycardia
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Headache, Hyperhidrosis, Immediate post-injection reaction, Lymph node pain
Clinical narrative: Fever 101 - 8 hours after shot Fever 100 - 24 hours after shot Pain in lymph nodes under left arm - 12 hours after shot Soreness in muscles near shoulder and knee - 8 hours after shot Headache - 6-8 hours after shot Sweats - 12 hours after shot Pain in arm - immediately after shot Dry mouth - 10 hours after shot
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Fever 101 - 8 hours after shot Fever 100 - 24 hours after shot Pain in lymph nodes under left arm - 12 hours after shot Soreness in muscles near shoulder and knee - 8 hours after shot Headache - 6-8 hours after shot Sweats - 12 hours after shot Pain in arm - immediately after shot Dry mouth - 10 hours after shot
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Medium
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA  Right hand was numbed (rated 2 on a 10-point scale).  Right arm was fine, only felt numbed in the hand. The symptom occurred almost immediately and lasted for about 10 hours.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient's parent filled out all forms with age 12 and acknowledged that patient was over age 12. After immunizing technician gave vaccine and pharmacist was processing, the error was caught that the patient is 4 days shy of 12 years old. Patient did not report any adverse effects.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Rash
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: patient had no reaction at injection site, but would not let me bypass. patient had rash on back of both legs following injection, still present. gave benedryl for second dose on 5/23/21 to see if it helps-Mild
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Dysuria, Fatigue, Malaise, Muscle fatigue, Muscle spasms
Clinical narrative: Muscle fatigue, pain, and spasms. General malaise and fatigue. Urethral spasms and burning. Symptoms lasted about 48 hrs and got better. I took IBU 600 mg x 2 doses
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Urethral spasm
Clinical narrative: Muscle fatigue, pain, and spasms. General malaise and fatigue. Urethral spasms and burning. Symptoms lasted about 48 hrs and got better. I took IBU 600 mg x 2 doses
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: Facial and neck swelling, started 30 min after vaccine and lasted 1 hour, took Benadryl  Extremity swelling, started 1 hour post shot and lasted 6-8 hours Less important sided effects- fatigue, arm soreness, nausea, diarrhea, headache- lasting 24-48 hours Hair is falling out in clumps
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling, Swelling face
Clinical narrative: Facial and neck swelling, started 30 min after vaccine and lasted 1 hour, took Benadryl  Extremity swelling, started 1 hour post shot and lasted 6-8 hours Less important sided effects- fatigue, arm soreness, nausea, diarrhea, headache- lasting 24-48 hours Hair is falling out in clumps
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Dyspnoea, Hypertension
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypertension-Medium, Additional Details: Patient witnessed shortness of breath a few minutes after receiving second moderna shot. She was monitored and did start to feel better a couple of minutes after that. Patient stated she feels she was anxious and she refused emergency medical attention/911 when offered . She was monitored for 30 minutes after incident and stated she felt fine before leaving. She will follow up with her prescriber
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: vaccine given to person under the age of 18
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear discomfort, Ear pain, Ear swelling, Vaccine positive rechallenge
Clinical narrative: 29 days after I received my first  Pfizer vaccine dose, I developed pain and  inflammation of the right eardrum and had to go to the doctor to get prescribed eardrops called Ciprofoxacin and used it for 7 days, after which the pain subsided but the plugged up ears and heaviness in that ear remains.  After I received my second vaccine dose 32 days later, my other left ear developed the same symptoms of ear pain/inflammation of my eardrum three days after receiving the second vaccine dose.  I used Ciprofloxacin in that ear as well and the pain went away but the fullness and plugged-in ears remain.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysgeusia, Injection site swelling, Nausea, Paraesthesia
Clinical narrative: 24 hours later, had extreme dizziness, nausea, pins and needles all through my body a metal taste in the mouth for 3 weeks after the injection. Exactly a week later at 8:40 pm my left arm at the injection site grew a bump at the same time my left upper eyelid blew up. My arm later developed a red patch for three days. Currently my eyelid is still healing.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Swelling of eyelid
Clinical narrative: 24 hours later, had extreme dizziness, nausea, pins and needles all through my body a metal taste in the mouth for 3 weeks after the injection. Exactly a week later at 8:40 pm my left arm at the injection site grew a bump at the same time my left upper eyelid blew up. My arm later developed a red patch for three days. Currently my eyelid is still healing.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine administered to a person under the age of 18
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing
Clinical narrative: Observed pt. sitting in a wheel chair with mom and EMT.  Pt. awake, alert, verbal, complaining of feeling flush after taking 1st dose of Pfizer vaccine@12:43pm.  Vitals taken by site EMT.  Vitals within normal range.  BP 114/72, O2Sat 100%.  12:55 pt. stated, "I'm feeling better now."  Pt. observed by staff for 30 min. before leaving to go home.  1:20pm pt. left vaccine site to go home with mom with no signs of acute distress.  Patient and parent educated by staff about Pfizer vaccine.  Verbalized understanding.
Age: 16.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event
Clinical narrative: no adverse event; dose of PROQUAD that had been administered to patient over the age of 12 years old; This spontaneous report as received from a medical assistant refers to a 16 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.   On 30-MAR-2021, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot# T021301 expiration date not reported, but upon internal validation established as 19-DEC-2021, for prophylaxis (strength, dose and route were not provided). No adverse event was reported.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AEs/no further information provided; expired vaccine fo ROTATEQ was administered to a patient; This spontaneous report has received from a nurse referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history, and drug reactions/allergies were not reported.  On 06-MAY-2021, the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2 mL orally for prophylaxis (lot# 1676324, expiration date was reported and validated as 21-APR-2021; formulation and strength were not reported) (expired product administered). The administered Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) had not undergone any temperature excursions. The administration of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was supported by the post expiry memo. No additional adverse event or further information was provided.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No further details provided, no further AEs reported; a patient was given an expired dose of MMR II vaccine; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.   On 07-MAY-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin) (M-M-R II) (1 injection, strength, route and anatomical location were not reported, lot # S013683, expiration date 05-MAY-2021) for prophylaxis (expired vaccine used). No further adverse event was reported.
Sex: U
Vaccine: HPV9, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No signs or symptoms reported; Excursions occured; This spontaneous report was received from an administrator referring to a patient (age and gender unspecified). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 11-APR-2021, the patient was vaccinated with an improperly stored dose of yeast)(GARDASIL 9) prefilled syringe, dose and frequency reported as 1 time dose with lot # T026168 (expiration date: 04-DEC-2022) or 1691180 (expiration date: 15-NOV-2022) for prophylaxis (dose and route of administration were not reported). The administered dose of the vaccine experienced a temperature excursion of  49 and 48 degrees Fahrenheit on 09-APR-2021 and on 23-APR-2021 respectively  for 1 hours/ 15minutes. It was not recorded by a data logger and not previous temperature excursion was reported. No signs or symptoms reported.  This is one of several 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: T026168; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No sings or symptoms reported; Temperature excursion; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.   On 09-APR-2021 and 23-APR-2021, a Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (lot # T035379 has been verified to be a valid lot number for Pneumococcal Vaccine, Polyvalent (23-valent), expiration date 31-MAY-2022) was exposed to a temperature of 49.0  48.7 Fahrenheit degrees respectively  for a time frame of 1 hours and 15 minutes cumulative.  On an unspecified day between 09-APR-2021 and 12-MAY-2021, the  patient was vaccinated with 1 single dose of  the previous mention Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength and administration route were not provided) (product storage error). No digital data logger was involved, non previous excursions were reports and no sing or symptoms were reported (no adverse event).  This case is linked with several same reporter cases. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T035379; expirationdate: 31-MAY-2022; deviceage and unit: 0 ; operatorofdevice: Unknown; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2105USA002866: US-009507513-2105USA002935: US-009507513-2105USA002937: US-009507513-2105USA002938: US-009507513-2105USA002939: US-009507513-2105USA002940: US-009507513-2105USA002941: US-009507513-2105USA002942: US-009507513-2105USA002934: US-009507513-2105USA002933: US-009507513-2105USA002936: US-009507513-2105USA002932: