chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injury, Nausea, Pyrexia, Skin laceration, Syncope
Clinical narrative: 10 hours after my shot, I had a sudden wave of severe nausea, dizziness, and heat and fainted. I slammed my face on the bathroom floor and broke my nose (among other cuts and bruises). After I fainted, the symptoms were gone except for the injuries from fainting and a slight fever and minor queasiness the next 2 days.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site pruritus, Lymphadenopathy
Clinical narrative: Reported delayed localized vaccine reaction after 1st  Moderna dose on 1/1/2021. (large area of erythema ) with Mild systemic symptoms (malaise, fatigue).- seen in ED 1/8/2021 Tested negative for Covid on 1/8.  Per MAR, was given second vaccine 1/28/2021.   Attempt to reach her to discuss outcome. Phone @ not taking messages.   No VAERS completed. : patient is a 33 y.o. female who presents with redness to her L deltoid erythema and enlarged axillary lymph nodes 2 days ago and erythema at the injection site of her COVID vaccine since yesterday. She had the COVID vaccine to the left deltoid on 1/1/21. She has had injection site pain, but no redness - but she is having some itching. She had had fatigue, malaise for the past week. She has taken OTC tylenol and ibuprofen, but has not taken Benadryl. She called the hotline and they wanted her to be evaluated and possibly tested for COVID.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, SARS-CoV-2 test negative
Clinical narrative: Reported delayed localized vaccine reaction after 1st  Moderna dose on 1/1/2021. (large area of erythema ) with Mild systemic symptoms (malaise, fatigue).- seen in ED 1/8/2021 Tested negative for Covid on 1/8.  Per MAR, was given second vaccine 1/28/2021.   Attempt to reach her to discuss outcome. Phone @ not taking messages.   No VAERS completed. : patient is a 33 y.o. female who presents with redness to her L deltoid erythema and enlarged axillary lymph nodes 2 days ago and erythema at the injection site of her COVID vaccine since yesterday. She had the COVID vaccine to the left deltoid on 1/1/21. She has had injection site pain, but no redness - but she is having some itching. She had had fatigue, malaise for the past week. She has taken OTC tylenol and ibuprofen, but has not taken Benadryl. She called the hotline and they wanted her to be evaluated and possibly tested for COVID.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose normal, Blood thyroid stimulating hormone, Burning sensation, Feeling cold, Flank pain
Clinical narrative: Developed acute-onset, sharp right pelvic/groin pain radiating to right groin and flank the day after receiving first Pfizer COVID vaccine.   Non-contrast CT abd/pelv revealed right ovarian cyst which resolved on follow-up vaginal ultrasound 1 week later.  Within about 2 days, the sharp pain progressed to burning neuropathic-type pain across the pelvic/pubic region and down bilateral inner thighs to knee level.  Pain was constant.  After 10-14 days, the pain transitioned from burning sensation to sensation of feeling cold (both on skin and deep tissues) that would feel normal to the touch.  It is symmetric on both sides and begins at the level of umbilicus and involves both groins and medial thighs. Symptoms worsen with sitting or standing up for prolonged periods of time (and become more noticeable/bothersome) and as the day progresses.  About 2 weeks later, the severe burning pain progressed to include bilateral buttocks and outer thighs as well.  MRI brain/cervical/thoracic/lumbar spine largely normal (tarlov cysts S2-S3, small left disc protrusion C5-C6).  CBC, BMP, TSH, B12, B6, lyme titer, ESR normal.  Currently being treated with gabapentin 300mg TID.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count normal, Groin pain, Magnetic resonance imaging, Magnetic resonance imaging head normal, Metabolic function test
Clinical narrative: Developed acute-onset, sharp right pelvic/groin pain radiating to right groin and flank the day after receiving first Pfizer COVID vaccine.   Non-contrast CT abd/pelv revealed right ovarian cyst which resolved on follow-up vaginal ultrasound 1 week later.  Within about 2 days, the sharp pain progressed to burning neuropathic-type pain across the pelvic/pubic region and down bilateral inner thighs to knee level.  Pain was constant.  After 10-14 days, the pain transitioned from burning sensation to sensation of feeling cold (both on skin and deep tissues) that would feel normal to the touch.  It is symmetric on both sides and begins at the level of umbilicus and involves both groins and medial thighs. Symptoms worsen with sitting or standing up for prolonged periods of time (and become more noticeable/bothersome) and as the day progresses.  About 2 weeks later, the severe burning pain progressed to include bilateral buttocks and outer thighs as well.  MRI brain/cervical/thoracic/lumbar spine largely normal (tarlov cysts S2-S3, small left disc protrusion C5-C6).  CBC, BMP, TSH, B12, B6, lyme titer, ESR normal.  Currently being treated with gabapentin 300mg TID.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Pelvic pain, Red blood cell sedimentation rate normal, Urine analysis, Vitamin B12 normal
Clinical narrative: Developed acute-onset, sharp right pelvic/groin pain radiating to right groin and flank the day after receiving first Pfizer COVID vaccine.   Non-contrast CT abd/pelv revealed right ovarian cyst which resolved on follow-up vaginal ultrasound 1 week later.  Within about 2 days, the sharp pain progressed to burning neuropathic-type pain across the pelvic/pubic region and down bilateral inner thighs to knee level.  Pain was constant.  After 10-14 days, the pain transitioned from burning sensation to sensation of feeling cold (both on skin and deep tissues) that would feel normal to the touch.  It is symmetric on both sides and begins at the level of umbilicus and involves both groins and medial thighs. Symptoms worsen with sitting or standing up for prolonged periods of time (and become more noticeable/bothersome) and as the day progresses.  About 2 weeks later, the severe burning pain progressed to include bilateral buttocks and outer thighs as well.  MRI brain/cervical/thoracic/lumbar spine largely normal (tarlov cysts S2-S3, small left disc protrusion C5-C6).  CBC, BMP, TSH, B12, B6, lyme titer, ESR normal.  Currently being treated with gabapentin 300mg TID.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vitamin B6 normal
Clinical narrative: Developed acute-onset, sharp right pelvic/groin pain radiating to right groin and flank the day after receiving first Pfizer COVID vaccine.   Non-contrast CT abd/pelv revealed right ovarian cyst which resolved on follow-up vaginal ultrasound 1 week later.  Within about 2 days, the sharp pain progressed to burning neuropathic-type pain across the pelvic/pubic region and down bilateral inner thighs to knee level.  Pain was constant.  After 10-14 days, the pain transitioned from burning sensation to sensation of feeling cold (both on skin and deep tissues) that would feel normal to the touch.  It is symmetric on both sides and begins at the level of umbilicus and involves both groins and medial thighs. Symptoms worsen with sitting or standing up for prolonged periods of time (and become more noticeable/bothersome) and as the day progresses.  About 2 weeks later, the severe burning pain progressed to include bilateral buttocks and outer thighs as well.  MRI brain/cervical/thoracic/lumbar spine largely normal (tarlov cysts S2-S3, small left disc protrusion C5-C6).  CBC, BMP, TSH, B12, B6, lyme titer, ESR normal.  Currently being treated with gabapentin 300mg TID.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Skin warm
Clinical narrative: Itching and large rash around the injection area (right arm) that is hot when touched.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling of body temperature change, Headache, Pain
Clinical narrative: Had extreme soarness throughout entire body. Bad headache Chills  Hot and cold episodes
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: vaccine taken on right arm on Wednesday 4/7/21 at 12:30 pm -symptoms began at 3am in the morning with a swelling 5cm by 3.5 cm at the site that was painful firm and hot to the touch, I was also febrile (temp not taken) with chills, sweating and body aches.  The swelling has persisted until Sunday 4/11/21 and I went to urgent care and was prescribed cephalexin. The fever lasted until the Saturday morning and was self treated with over the counter Tylenol.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: vaccine taken on right arm on Wednesday 4/7/21 at 12:30 pm -symptoms began at 3am in the morning with a swelling 5cm by 3.5 cm at the site that was painful firm and hot to the touch, I was also febrile (temp not taken) with chills, sweating and body aches.  The swelling has persisted until Sunday 4/11/21 and I went to urgent care and was prescribed cephalexin. The fever lasted until the Saturday morning and was self treated with over the counter Tylenol.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Tinnitus, Vertigo
Clinical narrative: Vertigo off and on yesterday.  Loud tinnitus in left ear last night for 3 hours until subsiding.  Woke me from sleep.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Migraine, Nausea, Pain, Pyrexia
Clinical narrative: About 5pm I started feeling nauseous,  beginning to throw up everything for the next two days I tried to eat or drink. I had a fever of 102 along with a horrible migraine,  body aches having to leave work up to two days after the shot to go home and sleep.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Vomiting
Clinical narrative: About 5pm I started feeling nauseous,  beginning to throw up everything for the next two days I tried to eat or drink. I had a fever of 102 along with a horrible migraine,  body aches having to leave work up to two days after the shot to go home and sleep.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Low grade fever for 12 hours Chills for 24 hours  Tiredness 36 hours  Upper left arm swollen and hot to the touch
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site swelling, Pruritus, Skin warm
Clinical narrative: Arm with injection site swelled and turned dark red and hot to the touch. Stayed this way for 30 hours. It occurred to me it could be an allergy, so I chewed a children's Benadryl. Started going down within minutes. Had to continue Benadryl for another 24 hours. Then super itchy; still warmer than normal to touch.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: Chills with uncontrollable shaking (took 3 blankets and a heating pad to stop), nausea, vomiting (blood sugar was in normal range throughout reaction), body aches, significant fatigue, headache
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: Chills with uncontrollable shaking (took 3 blankets and a heating pad to stop), nausea, vomiting (blood sugar was in normal range throughout reaction), body aches, significant fatigue, headache
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Delay of reaction approximately 4-5 days "COVID" arm, redness, heat, swelling, rash, itching to are of the injection site.  Now two weeks post-injection still some redness, heat, axillary area swelling, and trapezius stiffness, and sore
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: Delay of reaction approximately 4-5 days "COVID" arm, redness, heat, swelling, rash, itching to are of the injection site.  Now two weeks post-injection still some redness, heat, axillary area swelling, and trapezius stiffness, and sore
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity, Paraesthesia oral, Pyrexia
Clinical narrative: Within two hour head felt "off"  Like I was there but I was not.  Lips felt tingly.  Very nauseous feeling.  By the evening I had very bad headache and fever of 100.4.  During the night I had a pain running up my left arm up to my neck.  The next day very achy, still h ad headache and fever.  Was taking Tylenol every 6 house. By bedtime that night fever was 99.  When I woke up on Sunday morning fever was gone and so was the achy and nauseous feeling.  Headache gone also.  Arm still sore but that is to be expected
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Heavy nosebleed upon waking in the morning. First occurence ever. Blood pouring from nose, and down back of throat causing gagging. Duration 20 minutes or so. Applied pressure to nose, eventually stopped.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Rash, Rash pruritic, Vomiting
Clinical narrative: First was a continuing headache that started Saturday..  it worsened slowly.  Then, a Rash  appeared in inner arm opposite the shot arm between the elbow and armpit in the evening.  It was itchy.  At 5 AM the next morning - I started vomiting...  After 5 bouts of that about 3 hours apart, it stopped at 9 PM.  The rash had faded but did not leave until Friday evening , finishing with an itchy spot around the elbow.  - Had chicken pox as a child ..... - Did not experience congestion or diarrhea.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: Shoulder pain and limited range of motion.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Headache, Nausea, Nervousness
Clinical narrative: Fever and body aches beginning around 5pm, 7 hours after the vaccine. Nausea hit at 10pm and lasted until the next morning. I threw up 4 times throughout the night. I have red splotches all over my face from broken blood vessels I think. They are all around my eyes, but also on the rest of my face and neck. Fever of 100.4. Had a headache and was shaky all night. The next two days I have been fatigued.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Rash macular, Vomiting
Clinical narrative: Fever and body aches beginning around 5pm, 7 hours after the vaccine. Nausea hit at 10pm and lasted until the next morning. I threw up 4 times throughout the night. I have red splotches all over my face from broken blood vessels I think. They are all around my eyes, but also on the rest of my face and neck. Fever of 100.4. Had a headache and was shaky all night. The next two days I have been fatigued.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Pain in extremity
Clinical narrative: Rash at site of injection about 5 in in diameter. Red and itchy. Showed up about a week after shot and still present today 4/11/2021 but refusing in size and itch.  Also arm very painful for 3 days after injection from shoulder to elbow.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Fever, chills, headache, fatigue, nausea -- all for about 24 hours before easing
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Experienced chills after dinner
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Impaired driving ability, Vertigo
Clinical narrative: Severe vertigo, almost lost consciousness while driving dizziness
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: Severe upper arm, and shoulder pain. Flu like symptoms
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Deafness unilateral, Fatigue, Influenza like illness, Photosensitivity reaction, Somnolence
Clinical narrative: Severe upper arm, and shoulder pain. Flu like symptoms
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Severe upper arm, and shoulder pain. Flu like symptoms
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Immediate post-injection reaction, Nausea, Pain, Pyrexia
Clinical narrative: Severe pain as vaccine was administered, persisting for about 10 minutes. This was followed by low grade fever, chills, and mild body aches at about 11pm. There was also intermittent nausea in the evening. Body aches continued into the following day.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: syncope
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Computerised tomogram, Dyspnoea, Thrombosis
Clinical narrative: Shortness of breath and chest pain began on Wednesday  02/10/2021 (2 days after vaccine given), Breathing and chest pain severe enough to go to Emergency Room  on Saturday 02/13/2021 ( 5 days after vaccine given).   CT scan in Hospital showed  blood clotting in both lungs. Was kept overnight in hospital and released  on 02/14/2021 with prescription for Eliquis (blood thinner).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Fatigue, Lymphadenopathy, Pain
Clinical narrative: Tiredness started on 4/8/21 at approximately 2:00 pm.  Chills and body aches started on 4/8/21 at approximately 5:00 pm. Swelling and soreness of the lymph nodes in the right armpit started during the night of 4/8/21.  It is currently 1:55 pm on 4/11/21, at this reporting. The lymph nodes are still swollen and sore.  All other side effects were gone as of 4:00 pm on 4/9/21.  I have been taking Ibuprofen regularly for the pain and swelling.  Swelling has gone down slightly.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dysgeusia, Fatigue, Headache, Myalgia
Clinical narrative: 5 minutes after vaccine there was dizziness which passed after 10 minutes   30 minutes after vaccine there was headache, arm pain, muscle pain all over, fatigue, low grade fever, and sense of taste was altered. A constant metallic taste was in mouth and nothing (mints, brushing teeth, drinking water, etc.) removed it. Metallic taste resolved after 24 hours. Other symptoms lasted about 36 hours.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pyrexia, Taste disorder
Clinical narrative: 5 minutes after vaccine there was dizziness which passed after 10 minutes   30 minutes after vaccine there was headache, arm pain, muscle pain all over, fatigue, low grade fever, and sense of taste was altered. A constant metallic taste was in mouth and nothing (mints, brushing teeth, drinking water, etc.) removed it. Metallic taste resolved after 24 hours. Other symptoms lasted about 36 hours.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dysgeusia, Fatigue, Pain
Clinical narrative: 5 minutes after vaccine there was dizziness which passed after 10 minutes   30 minutes after vaccine there was headache, arm pain, muscle pain all over, fatigue, low grade fever, and sense of taste was altered. A constant metallic taste was in mouth and nothing (mints, brushing teeth, drinking water, etc.) removed it. Metallic taste resolved after 24 hours. Other symptoms lasted about 36 hours.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site warmth, Rash erythematous, Rash macular
Clinical narrative: Large erythematous, warm, itchy, macular rash around injection site. Noticed 1 week after injection but believes it was present prior to this.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: PATIENT EXPERIENCED SYNCOPE 15 TO 20 MINUTES AFTER SHOT WAS ADMINISTERED.  HELD AND COMFORTED UNTIL CONSCIOUSNESS WAS REGAINED.  OBSERVED FOR  ADDITIONAL 30 MINUTES BEFORE PATIENT LEFT AT HER OWN WILL
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site haemorrhage, Injection site reaction
Clinical narrative: bleeding at the injection site followed by bruising that is still visible on day 12.  I have had routine blood draws in the two weeks previous with no bruising.  No bleeding or bruising issues.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: Rash on upper arm where the injection was received.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: On friday night 4/9, pt started to have swelling and redness on arm with soreness. pt presented today with same symptom with warm to touch. Pt marked arm with sharpie to determine if spreading was occurring. in about 3 hours time, the redness spread about 3/4" out of the sharpie marked area with further discomfort felt by they patient. the pt will see medical evaluation and further care if needed.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Muscle twitching, Musculoskeletal stiffness, Pallor, Seizure
Clinical narrative: "Asyncope followed by apparent seizure activity. Palor, stiffness with jerking motion of muscles to extremities. Pt. lost conciousness multiple times (2 to 3). Patient was transported to hospital via EMS
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: "Asyncope followed by apparent seizure activity. Palor, stiffness with jerking motion of muscles to extremities. Pt. lost conciousness multiple times (2 to 3). Patient was transported to hospital via EMS
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Red, swollen at site. Chills, fever, and body aches starting 8 hours after and continued for 24 hours.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Gait inability, Headache, Injected limb mobility decreased
Clinical narrative: 8 hrs after vaccine (5:30 pm): chills, headache. 2 extra strength tylenol at 5:30 pm and 11:30 pm. Still headache and chills. 18 hrs after vaccine (3 am): could not move right arm (very little use in arm from ms) and could not walk. Legs would move only slightly without assistance. Arm and legs were better and functioning by 5 pm (14 hrs  later),  Continued to take extra strength tylenol because of temp through Wednesday, April 7
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Nausea, Pruritus
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Nausea-Medium
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives, treating with prednisone 4/11/2021
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Considerable headache and body aches throughout entire body.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Confusional state, Dizziness, Fatigue, Injection site pain
Clinical narrative: Injection site pain and swelling within 2 hours Fever of approximately 101 degrees within 12 hours, lasting 24 hours Severe body aches, beginning 10-12 hours after shot, lasting 24 hours Intermittent sharp, shooting pain in various joints and muscles, lasting about 36 hours Dizziness, mental confusion, fatigue, beginning within 12 hours, lasting 24-36 hours
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Myalgia, Pain, Pyrexia
Clinical narrative: Injection site pain and swelling within 2 hours Fever of approximately 101 degrees within 12 hours, lasting 24 hours Severe body aches, beginning 10-12 hours after shot, lasting 24 hours Intermittent sharp, shooting pain in various joints and muscles, lasting about 36 hours Dizziness, mental confusion, fatigue, beginning within 12 hours, lasting 24-36 hours
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Glossodynia
Clinical narrative: Sore at the tip of the tongue as if having a mouth ulcer.  Though, there is no visible mouth ulcer on  the tongue.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Injection site urticaria
Clinical narrative: COVID arm - allergic reaction/hive at injection site
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain, Pyrexia
Clinical narrative: Janssen COVID-19 Vaccine EUA. Fever over 103 for several hours, reduced slightly by Tylenol, aches, muscle pain, severe headache. After about 8 hours, fever continually varied between 99 and 101 for 12 hours, continued headache, diminishing muscle pain and aches. Very tired for next 24 hours as headache and fever dissipated.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Injection site pain, Myalgia
Clinical narrative: Pain at injection site, arthralgia, myalgia, fatigue, fever, chills
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Pain at injection site, arthralgia, myalgia, fatigue, fever, chills
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: covid arm (erythema, warmth, tenderness)
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Disorientation, Dizziness
Clinical narrative: Patient experienced dizziness.  Patient was a bit disoriented.   Patient was observed and given some food (potato chips) and water.  Symptoms resolved.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Nausea
Clinical narrative: Slight sorness in arm after shot. 7hrs after vax fever of 102 sustained for 12hrs, severe chills, slight headache. The following day 4/10/21 no fever, slight headache,  exhaustion, and loss of appetite. At 48hrs mark mild nausea and mild headache but, feeling much better.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Slight sorness in arm after shot. 7hrs after vax fever of 102 sustained for 12hrs, severe chills, slight headache. The following day 4/10/21 no fever, slight headache,  exhaustion, and loss of appetite. At 48hrs mark mild nausea and mild headache but, feeling much better.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Facial paralysis, Feeling abnormal, Movement disorder
Clinical narrative: 8 hours later , I had 101 fever , shivers , nausea and full on body aches . Since feeling so bad , next day I had a thc gummy to help with pain . That night , I could not move my legs ... a paralysis feeling went from feet to face . Half of my fave was crooked and I could barely talk .
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Paralysis, Speech disorder
Clinical narrative: 8 hours later , I had 101 fever , shivers , nausea and full on body aches . Since feeling so bad , next day I had a thc gummy to help with pain . That night , I could not move my legs ... a paralysis feeling went from feet to face . Half of my fave was crooked and I could barely talk .
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased, Pain
Clinical narrative: At 7am Saturday - 1 degree above normal temp, body aches.  Saturday evening - 2 degrees above normal temp, continued body aches. Sunday - continued body aches and weakness.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Hives/rash for 3 days all Over body. Treated with Claritin.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Chills, Injection site pain, Musculoskeletal pain
Clinical narrative: Dose 1: Soreness at injection site. Dose 2: Soreness at injection site, - 12 hours: Soreness at injection site, achiness in lower back, shoulders and butt - 24 hours: Soreness at injection site, achiness in lower back, shoulders and butt, fever of 100.4 degrees F - 32 hours: Soreness at injection site, achiness in lower back, shoulders and butt, chills lasting about 1.5 hours with shaking
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Dose 1: Soreness at injection site. Dose 2: Soreness at injection site, - 12 hours: Soreness at injection site, achiness in lower back, shoulders and butt - 24 hours: Soreness at injection site, achiness in lower back, shoulders and butt, fever of 100.4 degrees F - 32 hours: Soreness at injection site, achiness in lower back, shoulders and butt, chills lasting about 1.5 hours with shaking
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Migraine, Nausea
Clinical narrative: Chills began 8 days after 2nd vaccine.  With both vaccine did get headache, migraine, fatigue within the 1st few days.  Although, after 2nd vaccine on day 8 began chills and low grade fever, fatigue, nausea, and headache has continued.   Earlier in the week had a migraine.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Chills began 8 days after 2nd vaccine.  With both vaccine did get headache, migraine, fatigue within the 1st few days.  Although, after 2nd vaccine on day 8 began chills and low grade fever, fatigue, nausea, and headache has continued.   Earlier in the week had a migraine.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: sore arm began 2 hours after injection, chills began 9 hours after injection -  woke with body aches, fever, headache - Covid Arm began following day - hot, painful and swollen - no relief yet Hives started morning of Day 3
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: sore arm began 2 hours after injection, chills began 9 hours after injection -  woke with body aches, fever, headache - Covid Arm began following day - hot, painful and swollen - no relief yet Hives started morning of Day 3
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Epistaxis, Fall, Head injury, Headache
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Headache-Mild, Additional Details: after taking the vaccine, patient was walking towards the waiting area to wait for 15 minutes but fell down on the floor and hit his nose and it started bleeding.  i evaluated the patient and gave him water and washed him up.  patient told me he was feeling a lot better.  he was having a headache from the impact of his head hitting the floor when he fell but he feels better otherwise.  i kept the patient here for an extra hour to make sure the patient is ok otherwise and gave him water.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal injury
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Headache-Mild, Additional Details: after taking the vaccine, patient was walking towards the waiting area to wait for 15 minutes but fell down on the floor and hit his nose and it started bleeding.  i evaluated the patient and gave him water and washed him up.  patient told me he was feeling a lot better.  he was having a headache from the impact of his head hitting the floor when he fell but he feels better otherwise.  i kept the patient here for an extra hour to make sure the patient is ok otherwise and gave him water.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: A couple of weeks after my covid 19 shot, I had soreness at the injection site.  After a week I took some Advil several times but the soreness did not go away.  While the soreness is less severe today, it is still very noticeable even without my rubbing at the site of the injection.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Headache, Pyrexia
Clinical narrative: Developed severe chills, fever (102.2), headache, joint aches
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Pneumonia
Clinical narrative: Developed severe chills, fever (102.2), headache, joint aches
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: Janssen COVID-19 Vaccine EUA
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: while using 1 ml/25 g / 1 inch needle  syringe NDC number 1370310161 that was sent to us we draw a full dose from  a single vial of Janssen the vaccine vial and it was administered to the patient. No harm or side effects was reported to the pharmacy until the reporting time.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Fatigue, Irritability, Tremor
Clinical narrative: Severe hand tremors, weakness in legs, fatigue, irritability-ongoing since right after the second shot.  1 incident of vomiting.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Severe hand tremors, weakness in legs, fatigue, irritability-ongoing since right after the second shot.  1 incident of vomiting.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Systemic: Allergic: Anaphylaxis-Severe
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Somnolence, Tenderness
Clinical narrative: Headache, drowsiness , nausea, soreness, fatigue
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Myalgia, Pain, Pain in extremity, Palpitations
Clinical narrative: i started to have severe muscle pain in my thighs/legs , shooting pain throughout my legs and lower back. My heart was racing majority of the night , upwards of 100 at all times.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Injection site pruritus, Injection site swelling, Pain
Clinical narrative: Fever, chills, and aches for 2 days, and several days later (beginning at 7 days after vaccination), pain, itchiness, and swelling at vaccination site.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever, chills, and aches for 2 days, and several days later (beginning at 7 days after vaccination), pain, itchiness, and swelling at vaccination site.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose normal, Syncope
Clinical narrative: Patient experienced vasovagal syncope 5 minutes after receiving her vaccine. She woke up immediately after smelling alcohol and elevating her feet above chest level. 911 was called and was present within minutes and patient was taken to ER where she was monitored for 3 hours. She reported she had stable blood pressure, HR, and blood sugar. She was discharged after 3 hours of observation and is feeling well the next day.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Injection site erythema
Clinical narrative: Site: Redness at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium
Age: 30.0
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: patient that had 3 doses as a child and their record showed that they had another dose at age 30 because of job requirements. This patient never followed up with a 2nd or 3rd dose after the dose at age 30; This spontaneous report was received from a health case business professional referring to a 30 year old patient of unknown gender.   When the patient a child, had 3 doses of hepatitis b vaccine (recombinant)(RECOMBIVAX HB). No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.      On an unknown date, when the patient was 30 year old, was vaccinated with another dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) because of job requirements (dose, route of administration, lot number and expiration date were not reported), however, the vaccine dosing was outside of recommendations from prescribing information (PI), because this patient never followed up with a second or third dose after the first one, as there was no clear direction on this (inappropriate schedule of product administration). Now the patient was back because she/he was needing a booster for another job.   The health case business professional stated "employers had requirements for employees to have Hepatitis B vaccines if it was a high risk job and doctors were doing different things that did not necessarily follow the guidelines of the vaccine manufacturer or the Centers for Disease Control and Prevention (CDC). Information should be readily available about proper vaccination guidelines". The reporter had contacted the CDC and they were unable to give any information related to different vaccination schedules.; Sender's Comments:  US-009507513-2104USA002079:
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product preparation error
Clinical narrative: No additional AE details were available; Caller states they gave VARlVAX with 0.9% sodium chloride instead of the sterile diluent.; This spontaneous report was received from a physician referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not provided.  On 26-MAR-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) as prophylaxis (route of administration and anatomical location were not provided; dose, vaccination scheme frequency, lot number and expiration date were unknown by the reporter), however, the reporter stated that they gave varicella virus vaccine live (oka/merck) (VARIVAX) with 0.9% sodium chloride instead of the sterile diluent (product preparation error). No adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Herpes zoster/vesicular eruption; This spontaneous report regarding a potential litigation was received from a physician regarding a patient of unknown age and gender. The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) indicated for shingles vaccine (prophylaxis) (route of administration, vaccination scheme, dose, lot number, and expiration date were not provided).   On an unknown date, the physician reported that the patient who received Zoster Vaccine Live (ZOSTAVAX) (reported as shingles vaccine) developed herpes zoster afterwards. The physician stated he did not want to provided any further information since this was a legal case but said the vesicular eruption (herpes zoster), had resolved.   The outcome of the event herpes zoster was reported as resolved.  The causality assessment between the event herpes zoster and therapy with Zoster Vaccine Live (ZOSTAVAX) was not provided.
Sex: U
Vaccine: MMRV
Symptoms: Wrong product administered
Clinical narrative: patient who was inadvertently administered PROQUAD instead of the intended MMRll; He is unaware of any further adverse event/No additional adverse events; This spontaneous report was received from a registered nurse via company representative referring to a currently 15-year-old patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was inadvertently administered Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD)(rHA) 0,5 milliliter, for prophylaxis (vaccination scheme, route and anatomical location of administration were not provided) (lot number T030761 has been verified to be a valid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), expiration date not reported, but upon internal validation established as 08-MAR-2022) instead of the intended Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (Wrong product administered). The reporter was unaware of any further adverse event. No additional adverse events were reported.
Age: 1.5
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Nurse calling to report administration of expired vaccine MMR II; No additional adverse events reported as a result of the administration of the  expired vaccine; This spontaneous report was received from a Nurse referring to a patient 18-months-old , unknown gender, Information regarding the patient`s pertinent medical history, current condition, drug reactions/allergies and concomitant medication was not provided.   On 26-MAR-2021, the patient was vaccinated with a expired Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II), lot number S007813 and expiration date 14-MAR-2021 0.5 ml (single dose),for prophylaxis,(vaccination scheme and anatomical location were not provide)  No additional adverse events were reported as result of the vaccine administration. No prior temperature excursions were reported for the suspect therapy.
Age: 73.0
Sex: U
Vaccine: VARZOS
Symptoms: Uveitis
Clinical narrative: Uveitis; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a elderly patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 05-JUN-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). On an unknown date, reported as subsequent to the vaccination, the patient was treated for uveitis. The outcome of uveitis was not reported. The reporter considered uveitis to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, uveitis was determined to be medically significant events.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Medical assistant reported a temperature excursion which was administered to the patient; This spontaneous report was received from a medical assistant concerning, a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications and previous drug reactions or allergies.     On 01-APR-2021 the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA), 1 dosage form (lot number T013546 which was verified to be a valid lot number, expiration date reported and upon internal validation established as 28-OCT-2021), as prophylaxis (frequency, route of administration, anatomical location and vaccination scheme were not reported) (product storage error). The administered vaccine experienced a temperature excursion above 9 degree Celsius (°C) (9.3C) during a time frame of 0 hours 46 minutes and 0 seconds, as recorded by data logger. There was no previous temperature excursion. No adverse events were reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013546; expirationdate: 28-OCT-2021; 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; Sender's Comments:  US-009507513-2104USA001385: US-009507513-2104USA001384: US-009507513-2104USA001383: US-009507513-2104USA001386: US-009507513-2104USA001382:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Medical assistant reported a temperature excursion which was administered to the patient; This spontaneous report was received from a medical assistant concerning, a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications and previous drug reactions or allergies.     On 01-APR-2021 the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA), 1 dosage form (lot number T013546 which was verified to be a valid lot number, expiration date reported and upon internal validation established as 28-OCT-2021), as prophylaxis (frequency, route of administration, anatomical location and vaccination scheme were not reported) (product storage error). The administered vaccine experienced a temperature excursion above 9 degree Celsius (°C) (9.3C) during a time frame of 0 hours 46 minutes and 0 seconds, as recorded by data logger. There was no previous temperature excursion. No adverse events were reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: T013546; expirationdate: 28-OCT-2021; 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; Sender's Comments:  US-009507513-2104USA001375: US-009507513-2104USA001385: US-009507513-2104USA001384: US-009507513-2104USA001383: US-009507513-2104USA001386:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: no adverse event; Medical assistant reported a temperature excursion which was administered to the patient; This spontaneous report was received from a medical assistant concerning, a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications and previous drug reactions or allergies.     On 03-APR-2021 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 dosage form (lot number T024831 which was verified to be a valid lot number, expiration date reported and upon internal validation established as 18-NOV-2022), as prophylaxis (frequency, route of administration, anatomical location and vaccination scheme were not reported) (product storage error). The administered vaccine experienced a temperature excursion above 9 degree Celsius (°C) (9.3C) during a time frame of 0 hours 46 minutes and 0 seconds, as recorded by data logger. There was no previous temperature excursion. No adverse events were 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: T024831; expirationdate: 18-NOV-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; Sender's Comments:  US-009507513-2104USA001382: US-009507513-2104USA001375: US-009507513-2104USA001385: US-009507513-2104USA001384: US-009507513-2104USA001386: