chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Nausea, emesis, lightheaded, dizzy - Provided self-care measures for about 30 minutes and symptoms subsided. Client left with family.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Nausea, Vomiting
Clinical narrative: EUA Phizer-BioNtech vaccine reaction. patient reported vomiting associated with nausea and abdominal discomfort s/p getting the covid
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Pyrexia, Tremor
Clinical narrative: 62 years old female called to report an adverse reaction after she received her first Pfizer dose on 03/18/2021 @1330. patient report that on 03/20/2021 @1030 she developed dizziness, lost balance, fever and shaking. patient denies any allergies. patient reported that she is taking Lyrica, Lamictal for facial nerve pain. and amitriptyline to help her sleep. patient was instructed to drink plenty of water and keeping hydrated to help with the dizziness, patient was instructed to take tylenol to help with the fever. patient was instructed to seek medical attention if the symptoms got worse.
Age: 85.0
Sex: F
Vaccine: UNK
Symptoms: Death, Diarrhoea, Myocardial infarction, Pain, Vomiting
Clinical narrative: Vomiting, diarrhea, body aches on 03/16/2021 Death on 03/18/21  Cause: ruptured myocardial infarction
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Electrocardiogram, Guillain-Barre syndrome, Hypoaesthesia, Magnetic resonance imaging
Clinical narrative: Right and left leg weakness, numbness,  diagnosed with Guillion Barre Syndrome hospitalized for 7 days
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: Right and left leg weakness, numbness,  diagnosed with Guillion Barre Syndrome hospitalized for 7 days
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Intense itching in upper arms within 24 hours of vaccine. Welts on arms and legs.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Severe tinnitus.  I had very mild occasional tinnitus before the vaccine. But after the vaccine. it's been constant 24/7 and very loud.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity, Peripheral swelling
Clinical narrative: Arm soreness, chills, fatigue, mild swelling of fingers briefly for about 30 min 4 hours after shot
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen Glands
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Throat irritation
Clinical narrative: throat scratchy and lips swelled at 2 hours after shot
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: headache, nausea, mild body aches 15 hours after administration; chills (without fever) and total body pain 18 hours after administration; fatigue
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Nausea
Clinical narrative: Debilitating fever, chills, extreme aches, headache, fatigue, nausea lasting 48 hours. Headache lasted about 5 daysand fatigue and brain fog has been ongoing for over a week. Originally took Tylenol, but it didn't touch the headache so switched to Aspirin, which helped briefly.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Debilitating fever, chills, extreme aches, headache, fatigue, nausea lasting 48 hours. Headache lasted about 5 daysand fatigue and brain fog has been ongoing for over a week. Originally took Tylenol, but it didn't touch the headache so switched to Aspirin, which helped briefly.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: He was found deceased in his home 7 days after receiving the 2nd vaccine,
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Exposure via skin contact, Syringe issue
Clinical narrative: Dr administered Covid vaccination. Needle on syringe leaked at attachment point and part of the vaccine was administered and part ran out down pt's arm.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Injection site cellulitis
Clinical narrative: This patient developed diarrhea the next day after her Moderna COVID vaccine and then about a week after her injection developed at least a moderate cellulitis to her left upper arm, expressed purulent fluid from the area. On 03/17 she was seen in the office for the above and for cellulitis to upper arm that warranted ATB/Keflex. She still plans on getting her second dose of the vaccine.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: Approximately 10 days after the vaccine, I had extreme joint inflammation from my shoulders down to my ankles.  It eventually passed after taking anti inflammatories for about 4 days.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose normal, Cold sweat, Dizziness, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Patient stated prior to vaccine he has a history of fainting after vaccination. About 1 minute after vaccination he became pale, clammy, and lightheaded. Spoke with patient while someone else retrieved an ice pack and water. About 2 minutes after vaccination patient became unconscious and upper body had seizure like activity. Patient was moved to the floor immediately regained consciousness. Event lasted approximately 15-20 seconds. After regaining consciousness, stated he felt better. Remained on the floor for about 5 minutes, EMS was called as precaution. EMS stated vital signs and blood sugar were stable. Patient refused transport to hospital. Instructed to follow up with PCP.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Pallor, Seizure
Clinical narrative: Patient stated prior to vaccine he has a history of fainting after vaccination. About 1 minute after vaccination he became pale, clammy, and lightheaded. Spoke with patient while someone else retrieved an ice pack and water. About 2 minutes after vaccination patient became unconscious and upper body had seizure like activity. Patient was moved to the floor immediately regained consciousness. Event lasted approximately 15-20 seconds. After regaining consciousness, stated he felt better. Remained on the floor for about 5 minutes, EMS was called as precaution. EMS stated vital signs and blood sugar were stable. Patient refused transport to hospital. Instructed to follow up with PCP.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Palpitations, Vision blurred
Clinical narrative: Following administration of vaccine client complained of blurry vision, a heavy arm and  that he felt his heart rate was pounding out of  his chest.  EMS and Dr on site.  Pulse 58,  Blood pressure 104/65 and 100% 02 saturation.  Client was reclined in his car seat until he started feeling better.  He reported reactions to previous vaccines but no elaboration. Released by Dr and advised to seek medical attention later if needed.  Client verbalized understanding.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Cheilitis, Chills, Headache, Lip swelling, Nausea
Clinical narrative: Upper lip swelling day after my second vaccine that is painful and significant. Swelling has not resolved with Benadryl that was suggested and remains significantly swollen and inflamed.  Right side of upper lip started swelling first and then it slowly spread to the left side of the upper lip. Bottom lip not impacted. No other signs of respiratory distress or rash. I did spike a fever exceeding 103.6 after the vaccine and had aches/chills/nausea/headache but these were all expected. The lip swelling has been the outlier.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Upper lip swelling day after my second vaccine that is painful and significant. Swelling has not resolved with Benadryl that was suggested and remains significantly swollen and inflamed.  Right side of upper lip started swelling first and then it slowly spread to the left side of the upper lip. Bottom lip not impacted. No other signs of respiratory distress or rash. I did spike a fever exceeding 103.6 after the vaccine and had aches/chills/nausea/headache but these were all expected. The lip swelling has been the outlier.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Severe headache, muscle aches, chills and fever over 100 degrees.  Effects started approximately 12 hours after the vaccine was administered and lasted roughly 36 hours.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever and chills
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Pt had nausea and she vomited. She also felt like she was going to pass out. She said she had not eaten anything prior to receiving the vaccine and she took dose of her amoxicillin without eating prior. She was given some apple juice and popcorn and reported feeling better after consuming it.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: Worsened tinnitus
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Impaired work ability, Nasal congestion
Clinical narrative: Received vaccine 3/19  and then woke up 3/20 with fatigue, chills, nausea, diarrhea, congestion. Pt's symptoms were improving as far as congestion, but fatigue was so severe that pt did not feel that she was able to drive herself around and has missed work as a result. Sx ongoing as of 3/23 at 9:30 am.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Dizziness, Musculoskeletal chest pain, Nausea
Clinical narrative: After only having the first dose (1 of 2):  extreme light headed, nausea, weakness, no balance, pain in upper right side ribs below arm pit, Received shot for nausea and stayed in bed all day - mostly better the next day and normal the following day.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death within 60 days of vaccination
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: fatigue, headache, aches & pains all over, chills, and fever.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Date and time of vaccination: (list both if they received both shots):   First dose: 02/20/2021 @01130, second dose: 03/19/2021 @01130 Brand and lot of vaccine:   Moderna LOT(M030M20A) (048A21A) patient reported that she developed a fever and arm sorness today (03/20/2021) @730.  instructed to take tylenol to help with the fever. patient was instructed to apply cold compress to help with the arm sorness. patient was instructed to seek medical attention if the symptoms got worse.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Heart rate increased, Nausea
Clinical narrative: Nausea, severe headache, dizziness, rapid heartbeat
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Dizziness, Fear of falling, Flushing
Clinical narrative: Within 3 minutes of vaccination, patient became extremely nauseated and flush. He reported chills, cold sweats, feeling faint and fear of falling if he were to get up from his chair. After 7  minutes, he reported starting to feel better. At 22 minutes after vaccination, he reported feeling well enough to drive home. He stated he was no longer feeling faint or nauseated.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Within 3 minutes of vaccination, patient became extremely nauseated and flush. He reported chills, cold sweats, feeling faint and fear of falling if he were to get up from his chair. After 7  minutes, he reported starting to feel better. At 22 minutes after vaccination, he reported feeling well enough to drive home. He stated he was no longer feeling faint or nauseated.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: I have had ringing/tinnitus in my left ear since 2/13/21.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: Tingling in the cheeks on both sides of the face. More minor tingling in lips and tongue.   Mostly resolved after  2 hours, though still felt around 6pm
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Approx 5 minutes after receiving the vaccine client started c/o severe breathing difficulty. Client carries an epi pen with her at all times. Albuterol given, Husband administered epi pen in her right thigh. she was placed on o2. she was monitored for 30 minutes and felt better and released to home with her husband. she did call her PCP which told her to take 2 doses of Benadryl that evening.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Received COVID vaccine 12/28/2021.  Later that day had COVID exposure at home.  +PCR for COVID but no symptoms.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Myalgia, Neck pain, Pain, Peripheral swelling
Clinical narrative: Shot given Saturday at 12:15. Pm. Immediately neck pain started. I assumed it was from looking at my phone while I waited for the 15 minute wait to be up, but the pain never stopped, but it did move around my body. Fever every evening starting the day after the shot. Searing muscular pain since shot, worsens when fever happens, and the pain is moving throughout my body. On Monday, It is day 3 after the shot and my arm is swelling more today than any other day. Advil 400mg every 4 hours, rest, and plenty of fluids.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Shot given Saturday at 12:15. Pm. Immediately neck pain started. I assumed it was from looking at my phone while I waited for the 15 minute wait to be up, but the pain never stopped, but it did move around my body. Fever every evening starting the day after the shot. Searing muscular pain since shot, worsens when fever happens, and the pain is moving throughout my body. On Monday, It is day 3 after the shot and my arm is swelling more today than any other day. Advil 400mg every 4 hours, rest, and plenty of fluids.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Fear of injection, Loss of consciousness, Syncope
Clinical narrative: Per EMS on site client "Passed Out"   Syncope for 30 seconds following vaccine.  Previous history of syncope with "shots" Anxious with 02 Saturation of 98% pulse 65  Blood pressure 96/66 at 16.55pm.  At 17.00 client stated she felt better with Blood pressure up to 101/71 and pulse 85..  Released by Dr after being reclined in her car seat and reporting she felt better.  Advised to seek medical attention later if needed.  Client verbalized understanding.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Pain in extremity, Skin warm
Clinical narrative: On day 8 post injection felt soreness to arm and warm to touch, also slightly swollen and red rash over upper arm where shot was given. Today is day 9 post injection with pain on touch and rash still visible as well as the swelling. Rash is flat red flushing type
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site rash, Pain in extremity, Skin warm
Clinical narrative: I had the 2nd vaccine on Friday night and had a headache and arm pain. I woke up on Saturday morning with arm pain again and a red, raised rash where my injection site was. about the size of a half dollar and it was warm to the tough  Arm pain went away by Sunday but the rash grew to about the size of a golf ball in diameter and it was egg shaped and became darker red.  Monday the rash did not grow anymore but was still warm to the touch and there was pain if I pushed on the rash. It was getting lighter in color.  Right now on Tuesday, rash has gotten even more lighter to just a pink/almost skin color, it has not grown in size.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Paraesthesia oral
Clinical narrative: My mouth felt like it was tingling and my upper lip swelled a bit.  I did not seek treatment anywhere. Observed for any changes and would have sought treatment if it had advanced. Lasted approx. 2 hours. Lip returned to normal size. Would not have submitted this report if I I was not due for second shot on April 16th. Concerned because have had allergic reactions to several medication in past NSAID very serious reaction and Lisinopril severe rash. Question - should I pre-medicate with benadryl prior to second injection?
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: Faint red rash on right and left arms. Maybe 5 or 6 roughly circular patches about 1 inch in diameter on each arm.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Breast pain, Injection site pain, Lethargy, Oropharyngeal pain
Clinical narrative: lethargy, low fever. swollen neck(both sides), painful arm and breast on same side of injection. sore throat
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: lethargy, low fever. swollen neck(both sides), painful arm and breast on same side of injection. sore throat
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Lymphadenopathy, Oropharyngeal pain
Clinical narrative: Swollen glans in neck and sore throat , on going pain at injection site in right arm
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Insomnia
Clinical narrative: injection site pain - lasted 3 days body/muscle aches - last 3 days chills - lasted about 12 hours fever - lasted about 24 hours headache - lasted about 36 hours nausea - lasted about 12 hours fatigue - 3 days insomnia - one night
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: injection site pain - lasted 3 days body/muscle aches - last 3 days chills - lasted about 12 hours fever - lasted about 24 hours headache - lasted about 36 hours nausea - lasted about 12 hours fatigue - 3 days insomnia - one night
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Injection site pain, Somnolence
Clinical narrative: Arm and vaccination site not sore until this morning, but tolerable. Felt very sleepy starting at around 5:30pm yesterday. Had a good night sleep but very tired and sleepy this morning. Low energy.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Hypoacusis, Nausea
Clinical narrative: 12 days following my second Moderna vaccination I woke with dizziness, increased tinnitus, decreased hearing, fever and chills, nausea, and headache. After 2 1/2 days, the fever and chills, headache, and nausea had subsided. The tinnitus is the same as it's been since 3/17 (meaning worse than it's been over the past several decades), dizziness is mostly okay, some hearing loss is still noticeable when I am speaking with people who are wearing masks.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tinnitus
Clinical narrative: 12 days following my second Moderna vaccination I woke with dizziness, increased tinnitus, decreased hearing, fever and chills, nausea, and headache. After 2 1/2 days, the fever and chills, headache, and nausea had subsided. The tinnitus is the same as it's been since 3/17 (meaning worse than it's been over the past several decades), dizziness is mostly okay, some hearing loss is still noticeable when I am speaking with people who are wearing masks.
Age: 63.0
Sex: M
Vaccine: UNK
Symptoms: Death
Clinical narrative: Death, reportedly occurred one week after receiving covid vaccine.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure increased, Headache
Clinical narrative: Elevated blood pressure, 160 despite doubling dose of BP medicine, after 2 weeks (March 5) Headache Extreme joint pain which lasted 1 week, has resolved Taking tylenol for pain
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus in right ear
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Parosmia, Taste disorder
Clinical narrative: I had an "off" taste when eating & drinking , plus a funny smell when being in our truck. However, I was the only person that could smell it. It was like an antiseptic smell & if you could imagine what that might taste like, that is the best way to describe the strange test I got while eating & drinking. This lasted about a week. Plus, my left arm where I received the injection was sore for about 2 - 3 days, but I suppose that's to be expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: I had an odd smell sensation of an electrical burning smell (like that of an electric stove). It happened twice in the 2-3 days after getting the vaccine.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Nervousness
Clinical narrative: Have felt shaky with muscle twitches since day 1.  I would describe as similar to being on a low dose of steroids'.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Pain, Paraesthesia
Clinical narrative: Started to feel tingling on right side of torso, two days latter had a visible outbreak of shingles on right side of torso with severe pain. Went on 1 week course of valACYclovir (1 g) while also taking Advil for pain. Pain has subsided and outbreak is clearing.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood potassium decreased, Blood test, Contusion, Electrocardiogram normal
Clinical narrative: Got the vaccine, on the first day within the first hour she started feeling itchy, tingling sensation above her eyebrow over the left eye.  Didn't stay long, but sensation of itching left her.  Then noticed a pin dot of a little red spot on the left side of the eye, temple area, itchy and then it went away.  That night the soreness started in the arm.  The next day the whole arm was sore, but she kept exercising it and moving it.  On the third day the arm was clearing up like she didn't get a shot.  Then, the left thigh had some achiness.  The right ankle was achy as well, didn't stay long.  She is still waking up with a rapid heart beat.  She has a FU APT for labs and revisit with her PCP in a month.    On Saturday, 3/20/17 and woke up with heart palpitations, which they continued until she went to the ER around 4:00 AM.  They checked her, did an EKG, ran labs and VS.  The labs came back and told her that her potassium was depleted, and gave her something to calm her down.  She went to the store on Sunday and got some potassium citrate to maintain herself until she could get to the Doctor on Monday.  They did give her potassium while she was in the ER.  She went to the doctor on Monday, and he started her on a prescription for potassium.  She also made an appointment with her nephrologist to make sure she was okay before she gets the 2nd vaccine since she only has one kidney.  She also has had a lot of bruising from the blood draws in the hospital.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Pain in extremity, Palpitations, Paraesthesia, Pruritus
Clinical narrative: Got the vaccine, on the first day within the first hour she started feeling itchy, tingling sensation above her eyebrow over the left eye.  Didn't stay long, but sensation of itching left her.  Then noticed a pin dot of a little red spot on the left side of the eye, temple area, itchy and then it went away.  That night the soreness started in the arm.  The next day the whole arm was sore, but she kept exercising it and moving it.  On the third day the arm was clearing up like she didn't get a shot.  Then, the left thigh had some achiness.  The right ankle was achy as well, didn't stay long.  She is still waking up with a rapid heart beat.  She has a FU APT for labs and revisit with her PCP in a month.    On Saturday, 3/20/17 and woke up with heart palpitations, which they continued until she went to the ER around 4:00 AM.  They checked her, did an EKG, ran labs and VS.  The labs came back and told her that her potassium was depleted, and gave her something to calm her down.  She went to the store on Sunday and got some potassium citrate to maintain herself until she could get to the Doctor on Monday.  They did give her potassium while she was in the ER.  She went to the doctor on Monday, and he started her on a prescription for potassium.  She also made an appointment with her nephrologist to make sure she was okay before she gets the 2nd vaccine since she only has one kidney.  She also has had a lot of bruising from the blood draws in the hospital.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Starting at 1:00am  3/22/21 I woke to have chills where I could not get warm.  The original soreness in my right arm had radiated to the side of my neck and down to my shoulder blade.  By 3:00am I had a fever of 101 and was feeling nauseous.  By morning  6:00am I was just sore all over my body with a light headache.  This  continued through out the day with feeling tired and groggy.  Went to bed at 930pm and awoke 630am 3/23/21 feeling sore on the arm and body aches but, much better.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neck pain, Pain, Pyrexia, Somnolence
Clinical narrative: Starting at 1:00am  3/22/21 I woke to have chills where I could not get warm.  The original soreness in my right arm had radiated to the side of my neck and down to my shoulder blade.  By 3:00am I had a fever of 101 and was feeling nauseous.  By morning  6:00am I was just sore all over my body with a light headache.  This  continued through out the day with feeling tired and groggy.  Went to bed at 930pm and awoke 630am 3/23/21 feeling sore on the arm and body aches but, much better.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fear of injection, Immediate post-injection reaction
Clinical narrative: history of aversion needles and lightheadedness, has recurrence of lightheadedness immediately after receiving the vaccination. No itching, shortness of breath, tongue swelling, facial swelling.
Age: 31.0
Sex: M
Vaccine: UNK
Symptoms: Headache, Injection site erythema, Injection site pain, Muscle tightness, Thirst
Clinical narrative: Very sore at injection site. All muscles tense. Very thirsty. Headache. Redness at injection site.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis, Nausea, Pruritus, Throat tightness
Clinical narrative: Nausea, flushed, sweaty, itching, throat tightness - Epi administered IM, Benadryl administered IM, Vitals taken. EMS in facility ready to transport client to ER but client deferred transfer.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Following vaccine and during observation client complained of being "light headed" and "dizzy" for a few minutes.  EMS and Dr on site and client reclined briefly in her car seat.  Blood pressure was 150/90  pulse 66 02 saturation 95%.  Client was alert and oriented and released when she was feeing better. Advised to seek medical attention later if needed.  Client stated she has her "life line" and was wearing it around her neck.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Pain
Clinical narrative: headache, body ache, chills, sweating
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Patient was observed post COVID-19 immunization for 30 minutes based on pre-vaccination screening. During the observation period, she experienced an adverse reaction with the following symptoms: loss of consciousness. Assessment: Time of assessment 1915. Alert and oriented. Actions taken: placed in wheelchair,  given water and crackers, VS BP-102/61, P-69, O2-100%, VS BP-124/89, P=87, O2=100. Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for minutes. Discharged home. Immunizations Administered: Name, Date, Dose, VIS Date, Route - Pfizer COVID-19 Vaccine 3/22/2021, 7:07 PM, 0.3 mL, 12/11/2020, Intramuscular, Manufacturer: Pfizer, Inc.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: redness, swelling, soreness, pruritic symptoms subsided,  for treatment patient applied cold compress to injection site and active ROM was initiated to left arm.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea
Clinical narrative: shortness of breath chest pain
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Lymphadenopathy
Clinical narrative: Underarm swelling, redness, and pain - in armpit and down inside of left arm. Starting  Saturday - started 1 day after injection and has gotten worse each day.
Sex: M
Vaccine: MENB
Symptoms: Erythema, Fatigue, Feeling hot, Headache, Injection site erythema
Clinical narrative: redness / inch below the injection site; heat / inch below the injection site; swelling about an inch below the injection site; pain at the site; fatigue; muscles aches; headache; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   In January 2021, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 3rd February 2021, 1 week after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced erythema, localized feeling of warmth and local swelling. On an unknown date, the patient experienced injection site pain, fatigue, muscle pain and headache. On an unknown date, the outcome of the injection site pain, fatigue, muscle pain and headache were recovered/resolved and the outcome of the erythema, localized feeling of warmth and local swelling were unknown.   It was unknown if the reporter considered the injection site pain, fatigue, muscle pain, headache, erythema, localized feeling of warmth and local swelling to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: The case was reported by patient's parent. In January 2021 a week before reporting, the patient received the 2nd dose of Bexsero. The patient had the usual side effects of pain at the site, fatigue, muscle aches and headache that resolved with 2 days.  On the day of reporting, the patient developed redness, heat and swelling about an inch below the injection site. The reporter wanted to know was it common.
Sex: M
Vaccine: MENB
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Myalgia, Swelling
Clinical narrative: redness / inch below the injection site; heat / inch below the injection site; swelling about an inch below the injection site; pain at the site; fatigue; muscles aches; headache; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   In January 2021, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 3rd February 2021, 1 week after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced erythema, localized feeling of warmth and local swelling. On an unknown date, the patient experienced injection site pain, fatigue, muscle pain and headache. On an unknown date, the outcome of the injection site pain, fatigue, muscle pain and headache were recovered/resolved and the outcome of the erythema, localized feeling of warmth and local swelling were unknown.   It was unknown if the reporter considered the injection site pain, fatigue, muscle pain, headache, erythema, localized feeling of warmth and local swelling to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: The case was reported by patient's parent. In January 2021 a week before reporting, the patient received the 2nd dose of Bexsero. The patient had the usual side effects of pain at the site, fatigue, muscle aches and headache that resolved with 2 days.  On the day of reporting, the patient developed redness, heat and swelling about an inch below the injection site. The reporter wanted to know was it common.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Chills, Cough, Headache
Clinical narrative: Intense symptoms bad headache; Intense symptoms / Chills and shaking and couldn't hold a cup to drink; Intense symptoms / Muscles / ached and were painful; Intense symptoms / Joints ached and were painful; Intense symptoms / Bilateral lower back pain; Intense symptoms / Cough; shaking/shaking and could not hold a cup to drink; This case was reported by a nurse via other manufacturer and described the occurrence of headache in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of headache (received 1st dose on an unknown date, refer case US2021AMR028691).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache, chills, muscle pain, joint pain, low back pain, cough and tremor. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the headache, chills, muscle pain, joint pain, low back pain, cough and tremor were unknown.   It was unknown if the reporter considered the headache, chills, muscle pain, joint pain, low back pain, cough and tremor to be related to Shingrix.  Additional details were provided as follows: The case reported by patient herself. The age at vaccination was not reported. The patient received shingrix and had intense symptoms of bad headache, chills, shaking and could not hold a cup to drink. The patient also experienced muscles and joints ache, painful bilateral lower back pain and cough. The events resolved but still had a dry cough and developed and odor, burning plastic and taste started to diminish.  Odor continued and no taste and pharyngitis.  No fever reported. The patient received Pfizer Biontech covid-19 vaccine and experienced bad headache, chills and shaking and could not hold a cup to drink, muscles and joints ached and were painful bilateral lower back pain and a cough.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR028691:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Oropharyngeal pain, Pharyngitis, Tremor
Clinical narrative: Intense symptoms bad headache; Intense symptoms / Chills and shaking and couldn't hold a cup to drink; Intense symptoms / Muscles / ached and were painful; Intense symptoms / Joints ached and were painful; Intense symptoms / Bilateral lower back pain; Intense symptoms / Cough; shaking/shaking and could not hold a cup to drink; This case was reported by a nurse via other manufacturer and described the occurrence of headache in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of headache (received 1st dose on an unknown date, refer case US2021AMR028691).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache, chills, muscle pain, joint pain, low back pain, cough and tremor. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the headache, chills, muscle pain, joint pain, low back pain, cough and tremor were unknown.   It was unknown if the reporter considered the headache, chills, muscle pain, joint pain, low back pain, cough and tremor to be related to Shingrix.  Additional details were provided as follows: The case reported by patient herself. The age at vaccination was not reported. The patient received shingrix and had intense symptoms of bad headache, chills, shaking and could not hold a cup to drink. The patient also experienced muscles and joints ache, painful bilateral lower back pain and cough. The events resolved but still had a dry cough and developed and odor, burning plastic and taste started to diminish.  Odor continued and no taste and pharyngitis.  No fever reported. The patient received Pfizer Biontech covid-19 vaccine and experienced bad headache, chills and shaking and could not hold a cup to drink, muscles and joints ached and were painful bilateral lower back pain and a cough.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR028691:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Tongue discomfort
Clinical narrative: sore arm; This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Keflex with an associated reaction of oral candidiasis, Biaxin with an associated reaction of rash, Sulpha with an associated reaction of myalgia and Morphine with an associated reaction of nausea. Concomitant products included esomeprazole magnesium (Nexium), gabapentin and estrogens conjugated (Premarin).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received Shingrix injection a couple of years before reporting and experienced sore arm. The patient received unspecified BioNTech COVID Vaccine. The patient got the Pfizer vaccine and was getting the second one on 21st February 2021. They did not get her the vaccine card. She just knew it was Pfizer BioNTech COVID vaccine. The unusual side effects she experienced were deep fissures in her tongue, sensitivity in her tongue, and sensitive pallet. She had a reddish sensitive pallet. She was spitting blood for 4 hours before she realized she had fissures in the tongue. She could not contribute it to anything except she had the vaccination. She noticed it 3 nights after the vaccine. The fissures could have been developing, but she did not examine it until it started bleeding. Her tongue was examined frequently during the year by her dentist and her doctor. She got the vaccine on 31st January 2021. The symptoms could have started between 31st January 2021 and she noticed the bleeding on 3rd February 2021. It was before six or so when she got the injection and she was spitting blood about 6PM on 3rd February 2021. The bleeding lasted for 4 hours and she was about to go to emergency room , but the bleeding stopped. She had not bled again. The fissures were not cleared. The entire tongue had groves they were deep. There were still fissures there. Her pallet was still sensitive but it was not bleeding. It was red and the doctor told to use a Q-tip to apply hydrogen peroxide. That was all she suggested. Some days the fissures seem more irritated. Her dentist looks at her tongue closely twice a year. She saw the dentist in December and saw her primary care doctor in January. All labs were good. She hopes this did not happen with the second dose. She would say her tongue was slightly swollen. It was not preventing her from breathing, but the swelling was from the fissures. She get rashes from medications. She did not take the medications anymore.  The reporter consented to follow up. For tolerance of 2nd dose of shingrix, refer case US2021AMR045165.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR045165:same patient
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Peripheral swelling, Product prescribing error, Pyrexia
Clinical narrative: I was in fever; you would have to wait for two weeks to get done; I had shingles shot back / So I waited almost a month; shingles shot swelled my arm; This case was reported by a consumer via other manufacturer and described the occurrence of swelling arm in a 68-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included Herpes zoster (Shingles vaccine).   In May 2020, the patient received the 2nd dose of Shingles vaccine. In May 2020, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced drug dose administration interval too short. On an unknown date, the patient experienced swelling arm, fever and drug schedule prescribing error. On an unknown date, the outcome of the swelling arm and fever were recovered/resolved and the outcome of the drug dose administration interval too short and drug schedule prescribing error were unknown.   It was unknown if the reporter considered the swelling arm and fever to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient herself. The age at vaccination was not reported. The patient was calling due to she had questions regarding side effects. The patient received the dose of Shingrix and experienced swelling in arm and fever.  The patient received Shingrix 1 month after the 1st dose and that the patient was indicated by the druggist to at least wait two weeks between doses, which led to shortening of the schedule and drug schedule prescribing error. The patient received the dose of Covid-19 vaccine on 4th February 2021 and experienced soreness in arm for one day. The soreness in arm was resolved till th time of reporting The batch number for covid-19 vaccine reported as EL3249. The patient would go for 2nd covid-19 vaccination on 25th February 2021 and for blood work on 10th.  Note:- As per narrative its not clear about after which dose patient had swelling in arm and fever so as per conservative approach latest dose considered as suspect and all the events linked with 2nd dose.
Sex: U
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Pain, Pain in extremity
Clinical narrative: arm soreness; pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and Shingrix at an unknown dose. On an unknown date, immediately after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm and pain. Shingrix was discontinued. On an unknown date, the outcome of the pain in arm and pain were unknown.   It was unknown if the reporter considered the pain in arm and pain to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination not reported. The age group has been selected as per vaccine specification. Reporter claims that he knows of 5 different people that did not get the second Shingrix shot because of arm soreness and pain. The soreness in arm and pain AEs came after the first dose of shingrix. This is 1 of 5 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021054377:same reporter US-GLAXOSMITHKLINE-US2021AMR055618:Original Case : US2021054379 US-GLAXOSMITHKLINE-US2021AMR055621:Original Case : US2021054379
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; Excruciating. Pain killers aren't working; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. The patient was treated with analgesic, nos (Pain Killer). On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: This case was reported by patient. The age at vaccination was not reported. The patient received 2 doses of shingles vaccine and got shingles right now on the inside not outside and stated it was excruciating. Pain killers were not working. The patient would not wish this even on people taking care of their country. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles and time to onset were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Nausea, Pyrexia
Clinical narrative: fever of 100.5 / fever of 100; i want to throw up / Nauseated; headache; weak; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on an unknown date.).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. In March 2021, less than a week after receiving Shingles vaccine, the patient experienced fever, nausea, headache and weakness. On an unknown date, the outcome of the fever, nausea, headache and weakness were unknown.   It was unknown if the reporter considered the fever, nausea, headache and weakness to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. On the day before the reporting date, the patient received 2nd dose of Shingles vaccine and experienced weakness, headache, nauseated and fever 100/100.5degree F. The patient stated that his/her stomach was not upset but he/she wanted to throw up. No further information reported.; Sender's Comments:  US-GLAXOSMITHKLINE-US2018218333:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I got the shingles shot and I still got shingles!; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient. The age at vaccination was not reported. The patient received the shingles shot and still got shingles. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown.