chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Loss of personal independence in daily activities
Clinical narrative: I was overly tired. Around 8:30 pm I started to feel very tired. I rested for the night and woke up at my normal time 6:00am. I was still very tired when I woke. I ended back in bed at 9:30am till 2:30pm. Once I was up again I was still tired. I did complete daily activates as normal. Went to bed at my normal time 10:00pm Saturday night and woke 6 am Sunday. Felt great and well rested.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Oral herpes, Paraesthesia oral, Peripheral swelling
Clinical narrative: Left arm became very sore after about 8 hours after each dose. After the 2nd day after each injection, a wave of exhaustion hit me. About 10 days after the first injection, I felt a tingling in my lip and a cold sore erupted. Then another! I've never had 2 at the same time. One on the top lip and one on the bottom. I haven't had a cold sore in 15 years. I had my 2nd titer on February 3rd. On February 15th I had another eruption of another cold sore.  I didn't think the first recurrence of a cold sore was linked to the vaccine, but the timing of the 2nd one is beyond coincidental, which is why I'm reporting it. Abreva is not helping too much. I haven't had a herpes breakout since 2006.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, Sleep disorder
Clinical narrative: Woke up at 3:30 AM with Chills and fever of 99.9  had body aches took tylenol and when I woke up at 6:15 felt better  no fever since
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain
Clinical narrative: Moderate neck pain for over 72 hours. No relief from rest, towel neck roll, ibuprofen /tylenol/naproxen. Pain is present in base for head/neck area whenever I move my head slightly to the left or right, and then when I lower my chin.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Headache, Pain, Pyrexia
Clinical narrative: The next day, I experienced terrible body aches, slight headache, low grade fever (100.4), and the worst chills I?ve ever experienced in my life. Intense chills and teeth chattering that lasted about an hour. Felt like I couldn?t breathe/ catch my breath.  I was in bed all day, sleeping on and off.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain
Clinical narrative: C/O earache in temple area bilateral. Improved. BP 130/78
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Pain in extremity
Clinical narrative: pain in right leg calf & thigh  having trouble walking
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site swelling, Lymphadenopathy
Clinical narrative: injection site swelling, axillary swelling, headache, chills
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Nausea
Clinical narrative: Fever, Chills, joint and muscle ache, headache nausea. Fever through the night. Treated with ibuprofen fever came down by noon and chills and headache continued throughout the day. These symptoms started 2 days after the shot and have continued for 2 days and it is unknown at this time how many days the symptoms lasted.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever, Chills, joint and muscle ache, headache nausea. Fever through the night. Treated with ibuprofen fever came down by noon and chills and headache continued throughout the day. These symptoms started 2 days after the shot and have continued for 2 days and it is unknown at this time how many days the symptoms lasted.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pain, Vomiting
Clinical narrative: Several hours after vaccine #2, developed severe headache, myalgias and vomiting. Seen in ED on 2/3/21 and admitted to hospital for pain and nausea control.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Pain, Pain in extremity
Clinical narrative: Physician, patient's son, and husband standing at patient's side throughout event. Within 5 minutes of receiving the 2nd COVID 19 vaccine, the patient began to report that she was feeling sharp shooting pains in her legs, arms and chest. The patient reported feeling anxious prior to the injection. Within 6-7 min, the patient began to experience difficult breathing at which time 911 was called. The patient was given 1 dose of Epi and one dose of Benadryl IM, which eased severity of the symptoms. The patient's vital signs remained within normal limits until time of transport to local hospital.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Barium swallow, Cerebellar stroke, Computerised tomogram, Dizziness, Dysstasia
Clinical narrative: 4am  (1/29/2021) extreme sweating to the point of soaking the hair on head; extreme dizziness with vertigo and inability to stand up or walk straight leading to nausea and vomiting  11am( out of bed)  needed assistance to chair bc of vertigo and vision impairment; spent most of day seated; cont to require assistance with any walking  9pm  to bed  8am(1/30/2021) Wake up and all symptoms worse. Unable to walk without assistance and had a severe body lean to left. Husband called doc and they suggested calling 911 to get to ER ASAP  1130 Arrived at hospital ER and was subsequently diagnosed and admitted  with a cerebellar stroke
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Hyperhidrosis, Nausea, Posture abnormal, Vertigo
Clinical narrative: 4am  (1/29/2021) extreme sweating to the point of soaking the hair on head; extreme dizziness with vertigo and inability to stand up or walk straight leading to nausea and vomiting  11am( out of bed)  needed assistance to chair bc of vertigo and vision impairment; spent most of day seated; cont to require assistance with any walking  9pm  to bed  8am(1/30/2021) Wake up and all symptoms worse. Unable to walk without assistance and had a severe body lean to left. Husband called doc and they suggested calling 911 to get to ER ASAP  1130 Arrived at hospital ER and was subsequently diagnosed and admitted  with a cerebellar stroke
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment, Vomiting
Clinical narrative: 4am  (1/29/2021) extreme sweating to the point of soaking the hair on head; extreme dizziness with vertigo and inability to stand up or walk straight leading to nausea and vomiting  11am( out of bed)  needed assistance to chair bc of vertigo and vision impairment; spent most of day seated; cont to require assistance with any walking  9pm  to bed  8am(1/30/2021) Wake up and all symptoms worse. Unable to walk without assistance and had a severe body lean to left. Husband called doc and they suggested calling 911 to get to ER ASAP  1130 Arrived at hospital ER and was subsequently diagnosed and admitted  with a cerebellar stroke
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: Employee received Covid19 vaccine on 01/13/2021 at 8:30 am and at 9:30 am she began  having, pain and burning to her left arm at the sight of the vaccine.  Two days later she was unable to lift her left arm due to the severe pain which continues until now.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Neuralgic amyotrophy, Pain, Periarthritis
Clinical narrative: Frozen shoulder, nerve issues including numbness in pinky and right finger and middle two right toes which over weeks has progressed to sensitivity to touch and achy joint pain when used.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Sensitive skin, X-ray
Clinical narrative: Frozen shoulder, nerve issues including numbness in pinky and right finger and middle two right toes which over weeks has progressed to sensitivity to touch and achy joint pain when used.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Dizziness, Dyspnoea, Electrocardiogram
Clinical narrative: Developed nose bleed around 8am, took 18 minutes to completely stop (held pressure x8 min, then clot dislodged, held pressure again x10 min). Got lightheaded, heart rate increased to 120 bpm, felt palpitations, got I-watch and took EKG. Then felt stronger palpitations, had to sit down, 2nd EKG read 172bpm. 911 called, felt very dizzy, laid down in floor with legs up, pursed lip breathing. Ambulance arrived and had SBP of 100. HR in ambulance on way to hospital was around 120.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Heart rate increased, Palpitations, Pregnancy test, Urine analysis
Clinical narrative: Developed nose bleed around 8am, took 18 minutes to completely stop (held pressure x8 min, then clot dislodged, held pressure again x10 min). Got lightheaded, heart rate increased to 120 bpm, felt palpitations, got I-watch and took EKG. Then felt stronger palpitations, had to sit down, 2nd EKG read 172bpm. 911 called, felt very dizzy, laid down in floor with legs up, pursed lip breathing. Ambulance arrived and had SBP of 100. HR in ambulance on way to hospital was around 120.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count increased
Clinical narrative: Developed nose bleed around 8am, took 18 minutes to completely stop (held pressure x8 min, then clot dislodged, held pressure again x10 min). Got lightheaded, heart rate increased to 120 bpm, felt palpitations, got I-watch and took EKG. Then felt stronger palpitations, had to sit down, 2nd EKG read 172bpm. 911 called, felt very dizzy, laid down in floor with legs up, pursed lip breathing. Ambulance arrived and had SBP of 100. HR in ambulance on way to hospital was around 120.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Rash, Rash pruritic, Respiratory tract congestion
Clinical narrative: Rash above arm where shot was given that spread to my right neck, then spread to my chest, then up my left neck side. Congestion. Rash is itchy. Have tried taking benadryl and rash will not go away even after 2 weeks.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Incontinence, Pyrexia
Clinical narrative: sfever and incontinent during the fever.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: fever, aches, pain, headache
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vomiting
Clinical narrative: dizziness and vomiting for a period of about 2 hours on Saturday afternoon
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Death, Wheezing
Clinical narrative: He had rigors starting 6 pm the day after the vaccination. He was treated with one 500 mg tylenol. He had increased wheezing but did not complain of SOB. At 0400 the next morning, he died.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Headache, Hypoaesthesia, Insomnia, Nausea
Clinical narrative: 1.  Left side of face became partially numb while driving home from pharmacy-lasted 20-30 minutes.  2.  Insomnia returned as well as some nausea and pain left, back of head during the night.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: a loud ringing in my right ear that started 3 hours after shot and is still ringing the next day
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Rash, Rash pruritic, Throat irritation, Vaccine positive rechallenge
Clinical narrative: I received my first COVID Vaccine at the hospital I work at on 12/23/20. About 2 weeks after I developed a rash that looked unusual over my whole back. My throat was itching at times. The rash faded. I did not think it was from the vaccine due to being two weeks later. However, after my second dose 2-3 weeks later I developed the same exact rash but worse. I am on steroids and it helps slightly but not taking it completely away. It burns and itches. It has now moved to my right foot and left arm.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Swelling and itching at vaccine point on arm, similar to bug bite style reaction.  Appeared six to seven days after vaccination.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pharyngeal swelling
Clinical narrative: throat closing, peri-oral tingling, and erythema on chest
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Feeling warm (no fever), body ache, fatigue, left arm injection site - swelling, pain, warm.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Feeling warm (no fever), body ache, fatigue, left arm injection site - swelling, pain, warm.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Condition aggravated, Confusional state, Cough, Death
Clinical narrative: Received Pfizer 1/22/2021. RNA+ 2/4/2021. S/S SOB, cough, confusion. COVID assoc. resp. failure, stage 4 lung cancer, COPD, HTN, former smoker. patient in hospice  and died 2/10/2021.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypertension, Lung carcinoma cell type unspecified stage IV, Respiratory failure, SARS-CoV-2 test positive
Clinical narrative: Received Pfizer 1/22/2021. RNA+ 2/4/2021. S/S SOB, cough, confusion. COVID assoc. resp. failure, stage 4 lung cancer, COPD, HTN, former smoker. patient in hospice  and died 2/10/2021.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Eight days after receiving vaccination I noticed my right arm at the shot site  was itchy & felt a bit swollen.  Noticed it more the next day.  That evening, day nine after injection I looked at the area.  There was an approximate area 2?x4? that was light red, swollen, tender to touch & still itched.  Took an antihistamine & Tylenol.  Symptoms have slowly decreased. It is now twelve days after vaccination, there is still mild itchy feeling  in the site area & I have noticed the area that was reddish is now a yellow color.  It is similar to the coloring of an old bruise.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Severe hives from head to toe that persisted for 72 hours roughly 7 days post vaccine. Was given a steriod injection by my PCP which helped tremendously as well as a daily antihistamine
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: C/o stiff arm. Site ok. Given arm exercises and told to call PCP
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Pruritus, Rash
Clinical narrative: periodic rashes over body and all over itchy starting on day 4. also there has been sore joints and muscles and random fatigue.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Contusion, Erythema, Fatigue, Influenza like illness
Clinical narrative: Flu like symptoms, chills, left arm pain and bruising, right arm pain, fatigue, all in 24 hours after vaccine, all lasting 72 hours.  CoVid arm- large huge, hot to the touch, sore and bright red circle; began 7-10 days after vaccine administration and lasting 3 days before subsiding slowly.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Post-acute COVID-19 syndrome, Skin warm
Clinical narrative: Flu like symptoms, chills, left arm pain and bruising, right arm pain, fatigue, all in 24 hours after vaccine, all lasting 72 hours.  CoVid arm- large huge, hot to the touch, sore and bright red circle; began 7-10 days after vaccine administration and lasting 3 days before subsiding slowly.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Fatigue, Hypoaesthesia oral, Oral pruritus, Pallor
Clinical narrative: @09:35 pt reported with itchy/ numb mouth. BP 120/70 86 20 97% Started to feel very tired, pale in color, hands cold, difficulty finding words, pt speaking slowly. Placed into supine position. 0940 EMS notified 100/70 82 20 99% 0955 patient refused EMS transport to hospital. Remained in supine position and then sat in chair. 1026 color improved, denied numbness, c/o headache. Pt left @ 1045 color good, speaking clearly without difficulty. Denies complaints, amb. out of clinic.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral coldness, Slow speech
Clinical narrative: @09:35 pt reported with itchy/ numb mouth. BP 120/70 86 20 97% Started to feel very tired, pale in color, hands cold, difficulty finding words, pt speaking slowly. Placed into supine position. 0940 EMS notified 100/70 82 20 99% 0955 patient refused EMS transport to hospital. Remained in supine position and then sat in chair. 1026 color improved, denied numbness, c/o headache. Pt left @ 1045 color good, speaking clearly without difficulty. Denies complaints, amb. out of clinic.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Diarrhoea, Painful respiration
Clinical narrative: Sunday morning 2/14/21 - Mild Diarrhea from 4 AM till noon, and middle of mild to moderate chest pain when inhaling for a couple of hours and then it went away.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Sore arm, then swelling, hardening, redness & a lot of heat in upper arm in about a 5" circle around infection site that lasted about a week.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Post-acute COVID-19 syndrome, Rash erythematous
Clinical narrative: Covid arm red rash
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Influenza like illness, Malaise, Poor quality sleep
Clinical narrative: Starting about 14 hours after the injection my heart rate increased.  I slept poorly but didn't realize until I got up in the morning that my heart rate was off. I wear a fit watchand it told me my heart rate was above resting 97% of the night (its usually below resting 97% of the night). My heart rate increased to 140  when I got up in the morning. I called my doctor who told me what to do to try and reduce the bpm and when to go to the ER if needed.  I stayed in bed all day and laying down I was able to keep my bpm in the 90's (about 20 bpm higher than usual) I experienced the other expected flu like side effects and headache as well.  24 hours after the side effects started, they began to decrease and for the next 24 hours I felt only slightly ill and my bpm resting was about 10 bpm over my usual. The next day  (2/14/21) I felt 100% myself and my heart rate was back to normal.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Fainting, 11:30 PM
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: severe fatigue within 12 hours, continued 72 hours fever (100-102 degrees) within 24 hours, continued 24 hours headache within 12 hours, continued 72 hours muscle pain within 24 hours, continued 48 hours
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysphagia, Ear discomfort, Fatigue, Headache
Clinical narrative: Date and time adverse event started: #1 vaccine cause swelling and pain to injection arm several hours after shot then was better the next day, was itching. #2 vaccine on right arm but it almost immediately caused numbness and tingling to left arm, felt tired. ~2 hours after vaccine, felt generalized pain and exhaustion, headache started, then 2 hours later developed chills and shivering, T 99F, leg cramps, nausea, difficulty swallowing and speech garbled. Numbness, tingling, dysphagia and speech garbled eased up after about 24 hours. She took APAP and icepack to neck to ease headache. Stayed in bed most of the time, didn't sleep well. Headache subsided, continued to have chills and aches. Now has lingering fatigue, today has "ears on fire," chills and nauseous.   Brand and lot of vaccine: Pfizer#1lot FL9262, Pfizer#2lot EL9267 (caller stated it is hard to read)  Date and time of vaccination: (list both if they received both shots): #1 Pfizer Jan 23, 2021
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscle spasms, Nausea, Pain, Pain in extremity
Clinical narrative: Date and time adverse event started: #1 vaccine cause swelling and pain to injection arm several hours after shot then was better the next day, was itching. #2 vaccine on right arm but it almost immediately caused numbness and tingling to left arm, felt tired. ~2 hours after vaccine, felt generalized pain and exhaustion, headache started, then 2 hours later developed chills and shivering, T 99F, leg cramps, nausea, difficulty swallowing and speech garbled. Numbness, tingling, dysphagia and speech garbled eased up after about 24 hours. She took APAP and icepack to neck to ease headache. Stayed in bed most of the time, didn't sleep well. Headache subsided, continued to have chills and aches. Now has lingering fatigue, today has "ears on fire," chills and nauseous.   Brand and lot of vaccine: Pfizer#1lot FL9262, Pfizer#2lot EL9267 (caller stated it is hard to read)  Date and time of vaccination: (list both if they received both shots): #1 Pfizer Jan 23, 2021
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Peripheral swelling, Pruritus, Sleep disorder, Speech disorder
Clinical narrative: Date and time adverse event started: #1 vaccine cause swelling and pain to injection arm several hours after shot then was better the next day, was itching. #2 vaccine on right arm but it almost immediately caused numbness and tingling to left arm, felt tired. ~2 hours after vaccine, felt generalized pain and exhaustion, headache started, then 2 hours later developed chills and shivering, T 99F, leg cramps, nausea, difficulty swallowing and speech garbled. Numbness, tingling, dysphagia and speech garbled eased up after about 24 hours. She took APAP and icepack to neck to ease headache. Stayed in bed most of the time, didn't sleep well. Headache subsided, continued to have chills and aches. Now has lingering fatigue, today has "ears on fire," chills and nauseous.   Brand and lot of vaccine: Pfizer#1lot FL9262, Pfizer#2lot EL9267 (caller stated it is hard to read)  Date and time of vaccination: (list both if they received both shots): #1 Pfizer Jan 23, 2021
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Diarrhoea, Dizziness, Paraesthesia oral, Pharyngeal paraesthesia
Clinical narrative: Throat and tongue tingling and sensation of swelling, diarrhea and took benadryl.  At 8 hrs post vaccine got dizziness, throat swelling, anxiety, and had to use epipen. Went to hospital by ambulance and was further treated with prednisone and benadryl and Zofran.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Swollen tongue
Clinical narrative: Throat and tongue tingling and sensation of swelling, diarrhea and took benadryl.  At 8 hrs post vaccine got dizziness, throat swelling, anxiety, and had to use epipen. Went to hospital by ambulance and was further treated with prednisone and benadryl and Zofran.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site warmth, Rash erythematous, Rash pruritic
Clinical narrative: Warm Red rash started 6 days post injection.  rash was itchy and itch was relieved with benadryl.   Bilateral warm red rashes over deltoid muscle.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Headache, Hot flush, Loss of libido
Clinical narrative: Lingering headache for 6 days.  Hot flashes/night sweats and on-going chills.  Tiny mouth sores.  No appetite.  No libido.    All symptoms have lasted for 6 days.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Night sweats, Stomatitis
Clinical narrative: Lingering headache for 6 days.  Hot flashes/night sweats and on-going chills.  Tiny mouth sores.  No appetite.  No libido.    All symptoms have lasted for 6 days.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Injection site reaction, Malaise, Rash erythematous
Clinical narrative: Loss of appetite, fatigue, malaise. One week later, 01/21/21 raised, red, itchy, rash appeared at injection site, lasted until 01/25/21
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular, Rash pruritic
Clinical narrative: Loss of appetite, fatigue, malaise. One week later, 01/21/21 raised, red, itchy, rash appeared at injection site, lasted until 01/25/21
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Swelling face
Clinical narrative: Swelling and numbness in right side of face. Physician recommended icing and swelling went down after a day. Still have tingling sensation at times
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cold sweat, Fatigue, Head discomfort, Headache
Clinical narrative: Instantly after receiving the shot I felt pain my arm. On Thursday my arm was real sore and I started feeling bad. I felt tired, real weak, sleeping, wanting to sleep, fever, headache, pressure on my head, sweating, calmly feeling, cold sweats. As of today I started to feel a little better but I still have a grade fever. I have been taking Tylenol for it.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Malaise, Pain in extremity, Pyrexia, Somnolence
Clinical narrative: Instantly after receiving the shot I felt pain my arm. On Thursday my arm was real sore and I started feeling bad. I felt tired, real weak, sleeping, wanting to sleep, fever, headache, pressure on my head, sweating, calmly feeling, cold sweats. As of today I started to feel a little better but I still have a grade fever. I have been taking Tylenol for it.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: Had cold like symptoms off and on for 3 weeks. Around week 2 I started getting flare ups at the injection site which would turn red, hurt to the touch and eventually look like a hive with swelling. After a flare up, the next day I'd be very weak and tired with worsening cold/flu like symptoms with fever around 100.9-101. 3 weeks later I'm still experiencing flare ups at the injection site.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site urticaria, Nasopharyngitis, Pyrexia
Clinical narrative: Had cold like symptoms off and on for 3 weeks. Around week 2 I started getting flare ups at the injection site which would turn red, hurt to the touch and eventually look like a hive with swelling. After a flare up, the next day I'd be very weak and tired with worsening cold/flu like symptoms with fever around 100.9-101. 3 weeks later I'm still experiencing flare ups at the injection site.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Headache, Tinnitus, Vertigo
Clinical narrative: I woke up with ringing in my ears at 4 AM and this is ongoing at times. Seems like it may be the left ear. I also experienced headache, vertigo, chest heaviness, vertigo, and chills for 3 days  following the vaccine.  Still have the ringing.  I cancelled the 2nd vaccine.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Decreased appetite, Headache
Clinical narrative: Chills, fever (up to 103F), loss of taste and smell, nerve tingling under skin, loss of appetite, severe headache   Symptoms subsided by 2/7/2021
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Chills, fever (up to 103F), loss of taste and smell, nerve tingling under skin, loss of appetite, severe headache   Symptoms subsided by 2/7/2021
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Feeling abnormal, Feeling cold
Clinical narrative: Extreme shivering from being cold almost convulsive,fever, headache, nausea with dry heaves, fatigue. Arm was sore and slightly swollen. At about 4 hours after I smelled smoke and dirty dish rag smell. That didn't last. Other symptoms started 12 hours after given shot. It was immediate like turning on a light switch. I slept until 5:30 the next day, 2/3/2021. Was able to eat a bit of soup and went back to sleep until next morning. I was able to go to work on 2/4/2021 but experienced some weird brain fog and fatigue. On 2/5/2021 my arm had a large red ring around injection site and hives below it. I remained fatigued and lack of appetite for 4 days or so.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site urticaria, Nausea, Pain in extremity
Clinical narrative: Extreme shivering from being cold almost convulsive,fever, headache, nausea with dry heaves, fatigue. Arm was sore and slightly swollen. At about 4 hours after I smelled smoke and dirty dish rag smell. That didn't last. Other symptoms started 12 hours after given shot. It was immediate like turning on a light switch. I slept until 5:30 the next day, 2/3/2021. Was able to eat a bit of soup and went back to sleep until next morning. I was able to go to work on 2/4/2021 but experienced some weird brain fog and fatigue. On 2/5/2021 my arm had a large red ring around injection site and hives below it. I remained fatigued and lack of appetite for 4 days or so.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, Peripheral swelling, Pyrexia, Retching
Clinical narrative: Extreme shivering from being cold almost convulsive,fever, headache, nausea with dry heaves, fatigue. Arm was sore and slightly swollen. At about 4 hours after I smelled smoke and dirty dish rag smell. That didn't last. Other symptoms started 12 hours after given shot. It was immediate like turning on a light switch. I slept until 5:30 the next day, 2/3/2021. Was able to eat a bit of soup and went back to sleep until next morning. I was able to go to work on 2/4/2021 but experienced some weird brain fog and fatigue. On 2/5/2021 my arm had a large red ring around injection site and hives below it. I remained fatigued and lack of appetite for 4 days or so.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Pain, Pyrexia
Clinical narrative: On 2/3/21 at 2:30pm joint pain and body aches. Next morning 2/4/21 fever of 100.4F was recorded and continued body and joint aches. As of 2/16/21 patient continues with fatigue and joint pain
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Started as an itchy spot where injection site was. Within about 6 hrs of itchiness, tightness began, then swelling and redness. Area was hot and inflamed.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Skin tightness
Clinical narrative: Started as an itchy spot where injection site was. Within about 6 hrs of itchiness, tightness began, then swelling and redness. Area was hot and inflamed.
Sex: F
Vaccine: FLUX, HPV9
Symptoms: Exposure during pregnancy, Wrong product administered
Clinical narrative: No additional AE; A pregnant patient received a GARDASIL 9 vaccine; She was supposed to be receiving the flu vaccine; This spontaneous prospective pregnancy report as received from a registered nurse refers to a 32-year-old pregnant female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.      On 26-JAN-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), 0.5 milliliter, once (route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. She was supposed to be receiving the influenza virus vaccine (unspecified)  (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. The patient's gestation period was 9 weeks 4 days, the pregnancy outcome was pending, and the fetal outcome was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Incorrect storage of drug; No adverse event; This spontaneous report as received from an office manager refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 (units not reported), lot # T010311, expiration date 24-MAR-2022 (route was not reported) for prophylaxis. The temperature excursion was -9.51 C for 56 minutes due to data logger. A previous temperature excursion was not reported.       This is one of four reports received from the same source.; Sender's Comments:  US-009507513-2102USA005039: US-009507513-2102USA004947: US-009507513-2102USA004607:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; vaccine was improperly stored and administered; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 20-JAN-2021, the patient was vaccinated with improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 ml, lot # T011167, expiration date 27-MAY-2022 (dose number, vaccination site and route of administration were not provided) for prophylaxis.  Administered dose of vaccine was exposed to the temperature excursions of 35.7 degrees Fahrenheit for 1 hour and 30 minutes on 27-OCT-2020 and 30.2 degrees Fahrenheit for 1 hour and 30 minutes on 28-OCT-2020. There was a previous temperature excursion, 64.36 degrees Fahrenheit for 3 hours on 14-OCT-2020. Digital Data Logger was involved. No additional adverse events were reported.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Erythema of eyelid, Eye disorder, Eye swelling
Clinical narrative: Left eye was red / moved to the right eye; Left eye / raised / Moved to the right eye; blotchy area on her face; Red area on her eyelids; Rash itches / crept under the eye / and in the corner of her eyes on her right eye / eye rash got worse; Red / area on her face; chills; flu like symptoms; This case was reported by a consumer and described the occurrence of chills in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number ZJ432, expiry date 27th May 2022) for prophylaxis.   Concurrent medical conditions included penicillin allergy.   On 30th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 30th November 2020, less than a day after receiving Shingrix, the patient experienced chills and influenza-like symptoms. On an unknown date, the patient experienced eye red, eye swelling, skin blotches, erythema eyelid, itchy rash and red face. The patient was treated with acetic acid (Apple Cider Vinegar) and antifungals for topical use (Antifungal Cream). On 1st December 2020, the outcome of the chills and influenza-like symptoms were recovered/resolved. On an unknown date, the outcome of the eye red, eye swelling, skin blotches, erythema eyelid and red face were unknown and the outcome of the itchy rash was not recovered/not resolved.   It was unknown if the reporter considered the chills, influenza-like symptoms, eye red, eye swelling, skin blotches, erythema eyelid, itchy rash and red face to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient herself. The patient reported that, she received the 1st dose of Shingrix and that night she awoke with the worst chills and flu like symptoms ever that lasted one day. Within two days, her left eye was red and raised and then it moved to the right eye.  The patient went to a doctor and they said that it was not consistent with shingles.  The patient had not changed anything prior to getting the rash and within that week she had purchased new mascara and eyeliner.  The patient also experienced a red, blotchy area on her face but it looked different than the red area on her eyelids.  The rash itches in phases and it has crept under the eye (more so on the left eye) and in the corner of her eyes on her right eye.  The patient tried apple cider vinegar which helped a little and she received an antifungal cream that she just received today on the day of reporting. Her eye rash got worse and then spread to both eyes and has slowly resolved somewhat but it was still there.  The patient had a drug allergy to penicillin. The reporter consented to follow up.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Ocular hyperaemia, Rash, Rash macular, Rash pruritic
Clinical narrative: Left eye was red / moved to the right eye; Left eye / raised / Moved to the right eye; blotchy area on her face; Red area on her eyelids; Rash itches / crept under the eye / and in the corner of her eyes on her right eye / eye rash got worse; Red / area on her face; chills; flu like symptoms; This case was reported by a consumer and described the occurrence of chills in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number ZJ432, expiry date 27th May 2022) for prophylaxis.   Concurrent medical conditions included penicillin allergy.   On 30th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 30th November 2020, less than a day after receiving Shingrix, the patient experienced chills and influenza-like symptoms. On an unknown date, the patient experienced eye red, eye swelling, skin blotches, erythema eyelid, itchy rash and red face. The patient was treated with acetic acid (Apple Cider Vinegar) and antifungals for topical use (Antifungal Cream). On 1st December 2020, the outcome of the chills and influenza-like symptoms were recovered/resolved. On an unknown date, the outcome of the eye red, eye swelling, skin blotches, erythema eyelid and red face were unknown and the outcome of the itchy rash was not recovered/not resolved.   It was unknown if the reporter considered the chills, influenza-like symptoms, eye red, eye swelling, skin blotches, erythema eyelid, itchy rash and red face to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient herself. The patient reported that, she received the 1st dose of Shingrix and that night she awoke with the worst chills and flu like symptoms ever that lasted one day. Within two days, her left eye was red and raised and then it moved to the right eye.  The patient went to a doctor and they said that it was not consistent with shingles.  The patient had not changed anything prior to getting the rash and within that week she had purchased new mascara and eyeliner.  The patient also experienced a red, blotchy area on her face but it looked different than the red area on her eyelids.  The rash itches in phases and it has crept under the eye (more so on the left eye) and in the corner of her eyes on her right eye.  The patient tried apple cider vinegar which helped a little and she received an antifungal cream that she just received today on the day of reporting. Her eye rash got worse and then spread to both eyes and has slowly resolved somewhat but it was still there.  The patient had a drug allergy to penicillin. The reporter consented to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Discomfort, Headache, Influenza like illness, Insomnia
Clinical narrative: Patient is experiencing discomfort; Aches around her body / she is just achy; Slight headache; Fever; Chills with aches; Could not sleep; Having flu like symptoms; Feels like crap; This case was reported by a consumer via and described the occurrence of discomfort in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th January 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 13th January 2021, less than a day after receiving Shingrix, the patient experienced discomfort, general body pain, headache, fever, chills and insomnia. In January 2021, the patient experienced influenza-like symptoms and feeling unwell. On an unknown date, the outcome of the discomfort, general body pain, headache, fever, influenza-like symptoms and feeling unwell were not recovered/not resolved and the outcome of the chills was recovering/resolving and the outcome of the insomnia was unknown.   It was unknown if the reporter considered the discomfort, general body pain, headache, fever, chills, insomnia, influenza-like symptoms and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The patient had received the second dose of Shingrix and she was experiencing discomfort which included aches around her body, slight headache and fever which started on the night of before reporting date. The patient also had chills on the night of before reporting date with aches and she could not sleep. The chills were better on the day of reporting but she was just achy at the time of reporting. She described it as having flu like symptoms and she felt like crap.  The reporter consented to follow-up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: Patient is experiencing discomfort; Aches around her body / she is just achy; Slight headache; Fever; Chills with aches; Could not sleep; Having flu like symptoms; Feels like crap; This case was reported by a consumer via and described the occurrence of discomfort in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th January 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 13th January 2021, less than a day after receiving Shingrix, the patient experienced discomfort, general body pain, headache, fever, chills and insomnia. In January 2021, the patient experienced influenza-like symptoms and feeling unwell. On an unknown date, the outcome of the discomfort, general body pain, headache, fever, influenza-like symptoms and feeling unwell were not recovered/not resolved and the outcome of the chills was recovering/resolving and the outcome of the insomnia was unknown.   It was unknown if the reporter considered the discomfort, general body pain, headache, fever, chills, insomnia, influenza-like symptoms and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The patient had received the second dose of Shingrix and she was experiencing discomfort which included aches around her body, slight headache and fever which started on the night of before reporting date. The patient also had chills on the night of before reporting date with aches and she could not sleep. The chills were better on the day of reporting but she was just achy at the time of reporting. She described it as having flu like symptoms and she felt like crap.  The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: after the first dose of Shingrix a patient developed shingles; This case was reported by a pharmacist and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received the dose a few months ago from date of reporting. The reporter stated that the patient developed Shingles after the dose of Shingrix.  This episode of shingles was not as bad as her previous cases.  No other information was available.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature abnormal, Chills, Dizziness, Heart rate
Clinical narrative: Heart rate at 107; Stomach issue; Nausea; Chills; Passed out; Dizzy; Temperature; Hands were shaking; Sweating profusely; A spontaneous report was received from a consumer who is a 73 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, dizzy(dizziness), temperature(temperature abnormal), hands were shaking(tremors), passed out(loss of consciousness), sweating profusely(hyperhidrosis), nausea, heart rate at 107(heart rate increased) and stomach discomfort(abdominal discomfort).  The patient's medical history, as provided by the reporter included breast cancer.  No concomitant medications were reported.  On 22 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 029L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 22 Jan 2021, the patient experienced chills, dizzy, temperature, hands were shaking, passed out and sweating profusely. The treatment for the events included paracetamol.  On an unknown date, the patient experienced, nausea, heart rate at 107 heartbeats per minute and stomach discomfort.   The treatment for the events included paracetamol.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the events, chills, dizzy, temperature, hands were shaking, passed out, sweating profusely, nausea, heart rate at 107 and stomach discomfort was unknown.; Reporter's Comments: This case concerns a 73-year-old female patient, who experienced serious event of loss of consciousness and non-serious events of chills, dizziness, temperature abnormal, tremors, hyperhidrosis, nausea, heart rate increased, and abdominal discomfort. The reported events occurred on the same day after first dose of mRNA-1273, (lot # 029L20A) with the exception of nausea, heart rate increased, and abdominal discomfort which occurred at unknown date. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hyperhidrosis, Loss of consciousness, Nausea, SARS-CoV-2 test
Clinical narrative: Heart rate at 107; Stomach issue; Nausea; Chills; Passed out; Dizzy; Temperature; Hands were shaking; Sweating profusely; A spontaneous report was received from a consumer who is a 73 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, dizzy(dizziness), temperature(temperature abnormal), hands were shaking(tremors), passed out(loss of consciousness), sweating profusely(hyperhidrosis), nausea, heart rate at 107(heart rate increased) and stomach discomfort(abdominal discomfort).  The patient's medical history, as provided by the reporter included breast cancer.  No concomitant medications were reported.  On 22 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 029L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 22 Jan 2021, the patient experienced chills, dizzy, temperature, hands were shaking, passed out and sweating profusely. The treatment for the events included paracetamol.  On an unknown date, the patient experienced, nausea, heart rate at 107 heartbeats per minute and stomach discomfort.   The treatment for the events included paracetamol.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the events, chills, dizzy, temperature, hands were shaking, passed out, sweating profusely, nausea, heart rate at 107 and stomach discomfort was unknown.; Reporter's Comments: This case concerns a 73-year-old female patient, who experienced serious event of loss of consciousness and non-serious events of chills, dizziness, temperature abnormal, tremors, hyperhidrosis, nausea, heart rate increased, and abdominal discomfort. The reported events occurred on the same day after first dose of mRNA-1273, (lot # 029L20A) with the exception of nausea, heart rate increased, and abdominal discomfort which occurred at unknown date. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.