chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Nightmare, Pain, Pain in extremity, Sleep disorder
Clinical narrative: I started to become very tired around 2:00 pm on Wednesday 12/30, with a mild/moderate headache. The fatigue and headache continued through the evening, and at around 7:30 pm I experienced stomachache and indigestion. I went to bed early at 9:00 pm, with the headache, stomachache, fatigue, and my arm feeling very sore. I slept very restlessly with horrible dreams, as if I were sick or had the flu. In the middle of the night, I'm not sure when, I woke up feeling very achy and sore and freezing cold. After using the bathroom, I passed out, and hit my head on the floor or wall, resulting in a bump/cut. My husband heard me fall and found me lying on the floor.  I kept repeating "help me" and "water", and he was thinking that I would likely need to go to a hospital. He elevated my legs, put an icepack on my head, and got me water, and I became more lucid and started to feel better. I took 2 ibuprofen and drank water, then was able to get back into bed. I was very very cold but at one point woke up sweating. I slept the rest of the night and woke up this morning at 7:00 am (12/31) feeling fine, aside from tiredness, with no temperature.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: Sore arm, fever over 100, headache
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Dyspnoea, Fatigue, Headache
Clinical narrative: Injection site was sore to touch for 3 days, left arm went numb and unable to use for 1-2 hours after vaccine was given. Nerve pain was radiating in the shoulder, neck, and back for at least 3 days after receiving vaccine. Shortness of breath, headache, and fatigue.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site pain, Mobility decreased, Neck pain, Neuralgia
Clinical narrative: Injection site was sore to touch for 3 days, left arm went numb and unable to use for 1-2 hours after vaccine was given. Nerve pain was radiating in the shoulder, neck, and back for at least 3 days after receiving vaccine. Shortness of breath, headache, and fatigue.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Injection site was sore to touch for 3 days, left arm went numb and unable to use for 1-2 hours after vaccine was given. Nerve pain was radiating in the shoulder, neck, and back for at least 3 days after receiving vaccine. Shortness of breath, headache, and fatigue.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Grip strength decreased, Paraesthesia, Peripheral swelling
Clinical narrative: Patient stated she woke up this morning with both hands are swollen to the point she needs to take off her rings.  Also she states she has "tingling' between each finger but it does affect her grip.  No discoloration noted.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Malaise, Pain, Pyrexia
Clinical narrative: Fever of 100.1-101°, malaise, body aches, pain at the injection site
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hypoaesthesia oral, Lymph node pain, Pain in jaw, Paraesthesia oral
Clinical narrative: Approximately 10 minutes post vaccination patient jaw and molar began throbbing. Tongue began to tingle and mouth became numb. Felt like the glands up to both ears began hurting. Developed headache encompassing full head. Patient reported symptoms to administrators on 12/31/2020.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Toothache
Clinical narrative: Approximately 10 minutes post vaccination patient jaw and molar began throbbing. Tongue began to tingle and mouth became numb. Felt like the glands up to both ears began hurting. Developed headache encompassing full head. Patient reported symptoms to administrators on 12/31/2020.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear pain, Facial pain, Headache, Hypoaesthesia oral, Pain
Clinical narrative: Approximately 10 minutes post vaccination patient jaw and molar began throbbing. Tongue began to tingle and mouth became numb. Felt like the glands up to both ears began hurting. Developed headache encompassing full head. Patient reported symptoms to administrators on 12/31/2020.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in jaw, Paraesthesia oral, Salivary gland pain, Stress, Toothache
Clinical narrative: Approximately 10 minutes post vaccination patient jaw and molar began throbbing. Tongue began to tingle and mouth became numb. Felt like the glands up to both ears began hurting. Developed headache encompassing full head. Patient reported symptoms to administrators on 12/31/2020.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hypoaesthesia oral, Lymph node pain, Pain in jaw, Paraesthesia oral
Clinical narrative: About 5-10 minutes after the injection my jaw and bottom molars started throbbing, then my tongue started tingling and around my mouth went numb as if I had received a novocaine injection. Next it moved up my glands to both ears giving me tremendous ear pain, then it moved over to the tops of my cheekbones right under my eyes. Lastly I got a horrible headache.  I did not tell anyone at the Event Center about the jaw and tooth pain since I thought it was due to stress from having the vaccine. It took a full half hour for all symptoms to happen, which at this time I was on the road headed home.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Toothache
Clinical narrative: About 5-10 minutes after the injection my jaw and bottom molars started throbbing, then my tongue started tingling and around my mouth went numb as if I had received a novocaine injection. Next it moved up my glands to both ears giving me tremendous ear pain, then it moved over to the tops of my cheekbones right under my eyes. Lastly I got a horrible headache.  I did not tell anyone at the Event Center about the jaw and tooth pain since I thought it was due to stress from having the vaccine. It took a full half hour for all symptoms to happen, which at this time I was on the road headed home.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear pain, Facial pain, Headache, Hypoaesthesia oral, Pain
Clinical narrative: About 5-10 minutes after the injection my jaw and bottom molars started throbbing, then my tongue started tingling and around my mouth went numb as if I had received a novocaine injection. Next it moved up my glands to both ears giving me tremendous ear pain, then it moved over to the tops of my cheekbones right under my eyes. Lastly I got a horrible headache.  I did not tell anyone at the Event Center about the jaw and tooth pain since I thought it was due to stress from having the vaccine. It took a full half hour for all symptoms to happen, which at this time I was on the road headed home.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in jaw, Paraesthesia oral, Salivary gland pain, Stress, Toothache
Clinical narrative: About 5-10 minutes after the injection my jaw and bottom molars started throbbing, then my tongue started tingling and around my mouth went numb as if I had received a novocaine injection. Next it moved up my glands to both ears giving me tremendous ear pain, then it moved over to the tops of my cheekbones right under my eyes. Lastly I got a horrible headache.  I did not tell anyone at the Event Center about the jaw and tooth pain since I thought it was due to stress from having the vaccine. It took a full half hour for all symptoms to happen, which at this time I was on the road headed home.
Age: 56.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: red, warm bump at the injection location for few days. low pain. 1.5 inch.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: 12/30/2020 loss of taste and smell, symptoms have not resolved
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nasal discomfort
Clinical narrative: Burning to nostrils after vaccine was administered
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Condition aggravated, Dry throat, Nasal discomfort
Clinical narrative: Burning to nostrils after vaccine was administered
Age: 58.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Nasal discomfort
Clinical narrative: burning in nose, anxiety, dry throat @ 0920 BP-120/84 R-20 P-119 O2-99
Age: 58.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Condition aggravated, Dry throat, Nasal discomfort
Clinical narrative: burning in nose, anxiety, dry throat @ 0920 BP-120/84 R-20 P-119 O2-99
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypoaesthesia, Pruritus, Urticaria
Clinical narrative: Large, red welt developed on right arm 8 days after vaccination administered. Welt is painless, but itchy and numb.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Area of injection was slightly pink a couple hours after injection. The next day it was slightly larger than quarter size bright pink area which stayed for a few days. It started to get better and darkened, appeared as a bruise until yesterday it became pink again, but now worse. It is now a raised red, much larger area. hot to the touch and very itchy.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia
Clinical narrative: Patient reported arrhythmia after administration of Covid vaccine. Monitored in vaccine clinic x 30 minutes and discharged.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Fever over 100, chills, nausea, headache, body aches for approx. 24 hrs.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: 7 Hrs after initial injection, severe body aches, severe headache, fatigue and weakness and next morning bad chills....lasted till approximately 3:30 pm the next day 12-30-2020. Some light headiness after that but other symptoms  abated after I slept the whole day. Fatigue appears to be an on-going issue sine my initial Covid-19 positive test at holiday.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersomnia, Pain
Clinical narrative: 7 Hrs after initial injection, severe body aches, severe headache, fatigue and weakness and next morning bad chills....lasted till approximately 3:30 pm the next day 12-30-2020. Some light headiness after that but other symptoms  abated after I slept the whole day. Fatigue appears to be an on-going issue sine my initial Covid-19 positive test at holiday.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth, Pallor, Vaccination complication
Clinical narrative: Area of erythema approx. 10cm x8cm with satellite are approx. 2 cm beyond the inner red area.   Warm to the touch, not raised, blanches easily.   Told to monitor and take claritin or allegra OTC.
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Anal rash, Blister, Diarrhoea, Extra dose administered, Skin irritation
Clinical narrative: listed on previous page
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Headache, Heart rate increased, Pain, Pyrexia
Clinical narrative: On day of vaccine administered at about 1100 patient started with headache.  At 1300 he began to have body aches and headache increased.  Fell asleep.  At 1900 his heart rate went to 147/min, fever of 103 F, cough, increased body aches, headaches, O2 sats 97% on RA.  Went to ER by squad.  Was given tylenol, robitussin by mouth.  Given 1 L of IVF, and IV Toradol.  Was told by ER doctor to quarantine for 14 days and that the vaccine "work up the COVID-19".
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: Injection site pain, tiredness, headache, muscle pain, joint pain, night sweats
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats
Clinical narrative: Injection site pain, tiredness, headache, muscle pain, joint pain, night sweats
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Musculoskeletal stiffness, Pain in extremity, Sleep disorder
Clinical narrative: Pt was given a pneumovax 23 shot yesterday and left pharmacy without issue. She called today to let me know about an hour after she received the shot, her arm was experiencing stiffness and pain that radiated down her arm. She described her arm as "hurting and am unable to lift it. I think you damaged my joint".  I apologized that she was experiencing discomfort and asked if she had tried to ice or treat it with otc Ibuprofen or any other type of pain remedy. She said her husband was an ER doctor and she had been icing it and took ibuprofen and something else her husband gave her last night to sleep since it was uncomfortable to lie on and affected her being able to sleep through the night. I thanked her for letting me know of her experience and assured her I would write up the incident and follow up with her in another day or so to see if her condition improved. I also asked her to contact me if anything worsened. At the time of our discussion, she stated the pain had not worsened since yesterday, but not improved either.
Age: 35.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Headache, Palpitations, Throat tightness, Wheezing
Clinical narrative: Wheezing, throat tightness, palpitations, headache, weakness
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site erythema, Injection site pain, Pain, Pain in extremity
Clinical narrative: Patients shot was 11:30,  Tuesday 12/ 29.  Complained of arm ache starting at 16:30. On 12/20 at 8:00, body aches started. Had chills at 19:00-21:00.  Took Aleve and went to bed.  Feels good today, 12/31, but arm is tender to the touch with a little red 2cm spot at injection site.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Localised infection
Clinical narrative: Local infection, redness
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Pain in extremity, Skin warm
Clinical narrative: Adverse Event 1. Burning hand pain on right. the right hand was warm to touch relative to left 40 minutes after injection.  Treatment: Median Nerve Glides, Improved 99% in 24hrs with a frequency of once a day.   Adverse Event 2. Burning anterior thigh pain on left 13hrs after injection. Femoral Nerve Glides, 85% improved in 3 days with a frequency of 2-5 times a day.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Confusional state, Fatigue, Lymphadenopathy
Clinical narrative: Swollen cervicla lymph nodes 2-4 hours post injection, chills, fever, severe muscle  and joint pain at 8-10 hours post injection,  muscle weakness, confusion, loss of bladder control, tiredness 20-48 hours post injection
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Myalgia, Pyrexia, Urinary incontinence
Clinical narrative: Swollen cervicla lymph nodes 2-4 hours post injection, chills, fever, severe muscle  and joint pain at 8-10 hours post injection,  muscle weakness, confusion, loss of bladder control, tiredness 20-48 hours post injection
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Tenderness
Clinical narrative: softball size swelling, redness,  tenderness to right arm.   The swelling occurred  1 week after my injection.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Myalgia, Rhinorrhoea
Clinical narrative: Runny nose, chills, muscle aches starting at 10 AM the next day. Worsening injection site pain rated 6/10 the day of vaccination, it hurts more than vaccines I?ve received in the past.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth, Lymph node pain
Clinical narrative: Axillary lymph node tenderness under right arm @ 6 days after first vaccine injection; in right arm.  Swollen and warm at injection site on right arm @ 8 days after first vaccine injection; in right arm.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue
Clinical narrative: Fatigue, chills, and faint feeling
Age: 24.0
Sex: F
Vaccine: MENB
Symptoms: Injection site rash, Rash, Rash pruritic
Clinical narrative: Pt state she had one dose of Men-   B,Bex 10/05/20 and next day noted worsening skin rash on her torso and    arms worse near the site of injection, no feverhives, HA,or SOB    reported but rash spreading and very uncorfortable because of    itchiness.    SKIN/BREAST:   multiples mildly elevated erythematous patchy, very itchy    lesion both arms and torso, more intense Left lateral upper    arm near the site of the immunization.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Hyperhidrosis, Paraesthesia, Pruritus, Urticaria
Clinical narrative: Hot Flashes Sweating Tingling sensation on scalp Wheezing itching Hives
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: Hot Flashes Sweating Tingling sensation on scalp Wheezing itching Hives
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram normal, Fatigue, Full blood count, Heart rate increased, Human chorionic gonadotropin
Clinical narrative: At 5pm on day of vaccine she noticed right arm soreness, which worsened and woke her from sleep; Noticed swollen lymph node in right axilla; Took 600mg ibuprofen and pain subsided; Felt fatigued in the morning, went to her physical therapy and during therapy developed nausea, elevated heart rate to 160-170's for 20 minutes, and near syncope - was seen in the ED, EKG and labs unremarkable
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test normal, Lymphadenopathy, Metabolic function test, Nausea, Pain in extremity
Clinical narrative: At 5pm on day of vaccine she noticed right arm soreness, which worsened and woke her from sleep; Noticed swollen lymph node in right axilla; Took 600mg ibuprofen and pain subsided; Felt fatigued in the morning, went to her physical therapy and during therapy developed nausea, elevated heart rate to 160-170's for 20 minutes, and near syncope - was seen in the ED, EKG and labs unremarkable
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope, Sleep disorder, Urine analysis
Clinical narrative: At 5pm on day of vaccine she noticed right arm soreness, which worsened and woke her from sleep; Noticed swollen lymph node in right axilla; Took 600mg ibuprofen and pain subsided; Felt fatigued in the morning, went to her physical therapy and during therapy developed nausea, elevated heart rate to 160-170's for 20 minutes, and near syncope - was seen in the ED, EKG and labs unremarkable
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness
Clinical narrative: "Felt clammy all over/ dizziness"
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Developed a fever of 102.1, chills, severe body aches, HA, After about 18 hours after vaccine. The high fevers lasted about 12 hours. symptons are slowly subsiding.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Urticaria
Clinical narrative: About 10 minutes after vaccination, patient reported noticing some red hives over skin on upper body, was not itchy. Felt a little woozy  Was offered diphenhydramine 50mg orally by the PA, which she accepted. After taking dose, hives ameliorated and she felt well. She went back to work with no further issues reported
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Received Covid Vaccine on 12/23/20 (Wednesday) and only had a sore arm for a few days. On Saturday the 26th started having headaches, from a scale of 1 to 10, the pain is at a 7. The headaches have not gone away and they have been at a 7th the entire time. Been taking Ibuprofen and switched to Tylenol (helped more with the headaches).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: delayed (beginning 7 days after injection) reaction of redness, mild itching, and mild pain at the injection site plus arm/shoulder pain on same side as injection
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Injection site erythema, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: Redness, warmth and swelling to left deltoid, Malaise, shakiness, increased blood pressure
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Redness, warmth and swelling to left deltoid, Malaise, shakiness, increased blood pressure
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Fatigue, Headache, Injection site pain, Nausea
Clinical narrative: Over the past 48 hours, on and off symptoms have been: Headache Nausea  Fatigue Muscle soreness (site of injection-back to normal now) Abdominal pain
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Back pain, Chills, Myalgia
Clinical narrative: Moderna COVID-19 vaccine EUA 12/29/20  5pm left arm sore  8pm stomach became upset  9pm muscle aches started,  chills, low grade fever at 99.8 continued all night   12/30/20  9am severe muscle aches and joint pain, skin tingling/ sensitive to touch and temperature.  Continued all day  12/31/20  8am sore left arm and sore back/spine
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Pyrexia, Tenderness
Clinical narrative: Moderna COVID-19 vaccine EUA 12/29/20  5pm left arm sore  8pm stomach became upset  9pm muscle aches started,  chills, low grade fever at 99.8 continued all night   12/30/20  9am severe muscle aches and joint pain, skin tingling/ sensitive to touch and temperature.  Continued all day  12/31/20  8am sore left arm and sore back/spine
Age: 3.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong patient received product
Clinical narrative: the patient has not had any side effects at this time; 3 year old patient was giving a GARDASIL 9 by accident it was suppose to be given to her 11 year old sister; 3 year old patient was giving a GARDASIL 9 by accident it was suppose to be given to her 11 year old sister; This spontaneous report was received from a registered nurse referring to a 3 year old female patient. The patient's pertinent medical history, concurrent conditions and concomitant medications were not provided.      On 14-DEC-2020, the patient was vaccinated, by accident, with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dose, route of administration, anatomical location, lot # and expiration were unknown) as it was supposed this vaccine should had been given to her 11 year old sister. However, patient had not had any side effects at reporting time but they would like to know if there was anything they need to look for or watch for.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: general aches / pain; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The age group was not reported but was selected as an adult as per the vaccine indication. The patient experienced general aches .  The patient asked to take a nonsteroidal pain medication.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site warmth, Urticaria
Clinical narrative: wheal near the injetion site / diameter of 3 x 3 inches.; had soreness / around the injection site; hot to touch in her left arm around the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th November 2020, the patient received the 1st dose of Shingrix. On 16th November 2020, less than a day after receiving Shingrix, the patient experienced injection site pain and injection site warmth. On 19th November 2020, the patient experienced wheals. On an unknown date, the outcome of the injection site pain, injection site warmth and wheals were unknown.   It was unknown if the reporter considered the injection site pain, injection site warmth and wheals to be related to Shingrix.  Additional details were provided as follows: The patient received the first dose of the Shingrix vaccine in her left arm and on the same day Monday, Tuesday and Wednesday the patient had soreness and hot to touch in her left arm around the injection site and then by Thursday on 19th November 2020, 3 days after vaccination the patient started to see one wheal near the injection site which had a diameter of 3 x 3 inches. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: mild pain at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix a couple weeks ago, and experienced mild pain at the injection site. Consumer declined to provide further information for Safety report. Limited information provided. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Mild pain; This case was reported by a consumer via call center representative and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Tetanus vaccine with an associated reaction of pain.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced mild pain that resolved in a day or two. The reporter reported pain from Shingrix vaccine was no worse than a tetanus shot that was administered ages ago. Consumer declined to provide any further information for Safety report. Limited information collected. The reporter consented to follow up. This case is linked to the case US2020239736, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020239736:Same reporter
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Soreness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The reporter is the spouse of the patient. The age at vaccination was not reported. The patient got his 1st dose of Shingrix Vaccine, reporter stated patient had soreness at the injection site for a couple of days.  No additional information was provided.  The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020239733:same reporter US-GLAXOSMITHKLINE-US2020231855:Same reporter. From FU1 deleted
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: sickest; Initial information regarding an unsolicited valid non-serious case was received from a consumer (patient) via social media on 17-Dec-2020.  This case involves a patient of an unknown demographics who was sickest (illness), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, past vaccinations, family history and concomitant medications were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sickest (illness), (non-serious event) (unknown latency) following the administration of INFLUENZA VACCINE.   No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome was unknown for the events.  There will be no information available on the batch number for this case.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Discomfort, Erythema, Flushing, Pruritus
Clinical narrative: 11 hours after injection started with a burning sensation in upper back then flushing feeling with intermittent itchy from head to toe but especially in upper back and arms. Could see light redness on arms and shoulders but no hives or raised rash. Took Benadryl 25mg at 11:30 pm and 2:30 am along with ice packs on arms when it got worse. Also had a pressure feeling in upper back when trying to lie down or lie back in recliner along with congestion in back of throat. Breathing was never compromised. I was finally able to lie down in bed at 4 am on 12/31/20.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: 11 hours after injection started with a burning sensation in upper back then flushing feeling with intermittent itchy from head to toe but especially in upper back and arms. Could see light redness on arms and shoulders but no hives or raised rash. Took Benadryl 25mg at 11:30 pm and 2:30 am along with ice packs on arms when it got worse. Also had a pressure feeling in upper back when trying to lie down or lie back in recliner along with congestion in back of throat. Breathing was never compromised. I was finally able to lie down in bed at 4 am on 12/31/20.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Localized swelling and redness at the injection site 6cmx5cm which started one week following the injection.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Presyncope
Clinical narrative: I had a presyncope 5-10 mins after COVID vacc #1 on 12/26/20. Required oral fluids and food. Then, was sick for the following 3 days with COVID symptoms, with another presyncopal episode on 12/27 and multiple COVID symptoms.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Chills, low-grade fever, headache, nausea & vomiting, body aches
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Chills, low-grade fever, headache, nausea & vomiting, body aches
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Syncope
Clinical narrative: Vaso-vagal episode after receiving vaccine
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Dyspnoea, Vomiting
Clinical narrative: pt received vaccine at covid clinic on 12/30 at approximately 3:30, pt vomited 4 minutes after receiving shot--dark brown vomit, staff reported pt had vomited night before. Per staff report pt became short of breath between 6 and 7 pm that night.  Pt had DNR on file.  pt passed away at approximately  10pm.  Staff reported pt was 14 + days post covid
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Migraine, Pain, Pain in extremity
Clinical narrative: the day she got the shot, her arm was hurting a lot had chills body aches felt warm Migraine
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Nausea
Clinical narrative: Headache, chills, nausea, weakness
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Chest discomfort, Electrocardiogram abnormal, Feeling abnormal, Palpitations
Clinical narrative: This patient is a 72 y.o. female presenting to the emergency department with a chief complaint of acute palpitations onset this afternoon. Patient works as a pediatrician and states that after work today she went to receive her COVID-19 vaccine. She reports that about 10 minutes after getting the vaccine, she began to develop a heavy sensation in her chest as well as palpitations. EMS at the vaccine site performed a field EKG which the patient observed to have isolated PVCs. They then obtained a full EKG that again showed isolated PVCs. At this time the patient's blood pressure was taken and recorded to be elevated at 160/110. This caused the patient concern as she has no prior cardiac history or history of hypertension. Patient notes her systolic pressure at baseline is usually 110-120. Following onset patient reached out to her husband's cardiologist, Dr. who recommended she present to the ED as he was unable to see her in his office. Upon arrival to the ED patient reports that the heavy sensation in her chest has resolved, but she still feels "off".
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Ventricular extrasystoles
Clinical narrative: This patient is a 72 y.o. female presenting to the emergency department with a chief complaint of acute palpitations onset this afternoon. Patient works as a pediatrician and states that after work today she went to receive her COVID-19 vaccine. She reports that about 10 minutes after getting the vaccine, she began to develop a heavy sensation in her chest as well as palpitations. EMS at the vaccine site performed a field EKG which the patient observed to have isolated PVCs. They then obtained a full EKG that again showed isolated PVCs. At this time the patient's blood pressure was taken and recorded to be elevated at 160/110. This caused the patient concern as she has no prior cardiac history or history of hypertension. Patient notes her systolic pressure at baseline is usually 110-120. Following onset patient reached out to her husband's cardiologist, Dr. who recommended she present to the ED as he was unable to see her in his office. Upon arrival to the ED patient reports that the heavy sensation in her chest has resolved, but she still feels "off".
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Impaired work ability, Myalgia
Clinical narrative: chills, severe muscle aches, headache and joint pain.  Missed work
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Chills, Dizziness, Dizziness postural, Fear
Clinical narrative: Woke up morning of 12/30  2 days after receiving the vaccine , approx 6am rolled over felt dizzy while in bed.  Got out of bed at approximately 6:30am and felt dizzy almost not balanced and felt like stumbling to the left when I stood upright.  I quickly squatted to floor felt my heart beat fast but for only seconds.  Didn?t feel like passing out but I was able to walk to the bathroom but Still felt like I was leaning to the left side.  My heart beat felt within normal range. The rest of the day I had brief episodes with dizziness but not as severe as when I got out of bed.  I I also developed a mild headache to my forehead the rest of the day and felt chilled but no fever.  By the end of the day I felt better the symptoms resolved. Today 12/31 I am feeling myself.  I am fearful of getting the next vaccine. I need someone to call me and give me answers if possible.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Headache, Heart rate increased
Clinical narrative: Woke up morning of 12/30  2 days after receiving the vaccine , approx 6am rolled over felt dizzy while in bed.  Got out of bed at approximately 6:30am and felt dizzy almost not balanced and felt like stumbling to the left when I stood upright.  I quickly squatted to floor felt my heart beat fast but for only seconds.  Didn?t feel like passing out but I was able to walk to the bathroom but Still felt like I was leaning to the left side.  My heart beat felt within normal range. The rest of the day I had brief episodes with dizziness but not as severe as when I got out of bed.  I I also developed a mild headache to my forehead the rest of the day and felt chilled but no fever.  By the end of the day I felt better the symptoms resolved. Today 12/31 I am feeling myself.  I am fearful of getting the next vaccine. I need someone to call me and give me answers if possible.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: 31hrs after receiving vaccine I developed chills, they lasted about 3 hrs, afebrile until 2hrs after the chills ended and temp was 100, took Tylenol , slept well, woke feeling fine Injection site  reddened and swollen, even on this day (day 4) and site itchy, warm  today
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth
Clinical narrative: 31hrs after receiving vaccine I developed chills, they lasted about 3 hrs, afebrile until 2hrs after the chills ended and temp was 100, took Tylenol , slept well, woke feeling fine Injection site  reddened and swollen, even on this day (day 4) and site itchy, warm  today
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Autoimmune disorder, Condition aggravated, Dizziness, Fatigue
Clinical narrative: So when I woke the next morning I was basically feeling like I had an auto immune flare, my neuropathy was on fire, headache, tired, exhausted, I basically felt really tired all day. The next day I felt a little bit better and went to work but around noon I felt nauseated and all the symptoms returned and they stayed that way until I contacted my rheumatologist. They prescribed me prednisone on the 21st. On the 22nd I felt a little better. On the 23rd I felt good. On the 24th as I was tapering off of the prednisone the symptoms started returning. Then I met with MD and she told me to continue with the prednisone at 5mg and also hydroxyzine for my nausea and an antihistamine. The nausea was the biggest symptom after the prednisone and I could not eat anything. Even 2 pieces of toast I would get nauseated, not throw up but severely nauseated. I could drink anything but not eat and it stayed like that for a long time. Went on a bland diet and with the visterol I could eat more and better and no just mild nausea and exhaustion, I am still pretty fatigued and my joint pain is still bothering me but not as much as the beginning. Also dizziness.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Feeding disorder, Headache, Nausea, Neuropathy peripheral
Clinical narrative: So when I woke the next morning I was basically feeling like I had an auto immune flare, my neuropathy was on fire, headache, tired, exhausted, I basically felt really tired all day. The next day I felt a little bit better and went to work but around noon I felt nauseated and all the symptoms returned and they stayed that way until I contacted my rheumatologist. They prescribed me prednisone on the 21st. On the 22nd I felt a little better. On the 23rd I felt good. On the 24th as I was tapering off of the prednisone the symptoms started returning. Then I met with MD and she told me to continue with the prednisone at 5mg and also hydroxyzine for my nausea and an antihistamine. The nausea was the biggest symptom after the prednisone and I could not eat anything. Even 2 pieces of toast I would get nauseated, not throw up but severely nauseated. I could drink anything but not eat and it stayed like that for a long time. Went on a bland diet and with the visterol I could eat more and better and no just mild nausea and exhaustion, I am still pretty fatigued and my joint pain is still bothering me but not as much as the beginning. Also dizziness.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Head discomfort, Sinus congestion
Clinical narrative: Complaints of dizziness and fullness to sinuses/head following vaccination, monitored for 35 minutes, no other symptoms, vital signs within normal limits.  Felt fine enough to leave. Provided vsafe.cdc.gov link and advised to call Work Health with any questions or present to ED with any worsening symptoms.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Dizziness, Fatigue, Flatulence
Clinical narrative: sore arm, woke up at 10:10 with severe stomach upset, and gas. took some tums and laid back down, then got up a few minutes later with nausea, tried to vomit however felt dissy/ fainted. got back in bed with fever/ chills, layed down for a few minutes and felt better. entire episode lasted about 20 minutes. woke up the next morning with nausea, and general tired feeling. this lasted for about 12 more hours.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia, Syncope
Clinical narrative: sore arm, woke up at 10:10 with severe stomach upset, and gas. took some tums and laid back down, then got up a few minutes later with nausea, tried to vomit however felt dissy/ fainted. got back in bed with fever/ chills, layed down for a few minutes and felt better. entire episode lasted about 20 minutes. woke up the next morning with nausea, and general tired feeling. this lasted for about 12 more hours.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Chest discomfort, Chills, Fatigue
Clinical narrative: I had my vaccine at 1230 pm on Monday Dec 28th. At approx 430am Tuesday am, I awoke with a bad stomach ache.  By 9am, i had uncontrollable chills, followed by body pain, stiffness, extreme weakness. By 11a, I had a temp of 103.3.  This lasted approx 8 hours. Fever broke and a bad headache, chest wall and mid back discomfort along with muscles twitching, leg cramping and fatigue. Dec. 31st, doing better, but still fatigue, weakness, muscle twitching, headache.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscle spasms, Muscle twitching, Musculoskeletal discomfort, Musculoskeletal stiffness
Clinical narrative: I had my vaccine at 1230 pm on Monday Dec 28th. At approx 430am Tuesday am, I awoke with a bad stomach ache.  By 9am, i had uncontrollable chills, followed by body pain, stiffness, extreme weakness. By 11a, I had a temp of 103.3.  This lasted approx 8 hours. Fever broke and a bad headache, chest wall and mid back discomfort along with muscles twitching, leg cramping and fatigue. Dec. 31st, doing better, but still fatigue, weakness, muscle twitching, headache.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: I had my vaccine at 1230 pm on Monday Dec 28th. At approx 430am Tuesday am, I awoke with a bad stomach ache.  By 9am, i had uncontrollable chills, followed by body pain, stiffness, extreme weakness. By 11a, I had a temp of 103.3.  This lasted approx 8 hours. Fever broke and a bad headache, chest wall and mid back discomfort along with muscles twitching, leg cramping and fatigue. Dec. 31st, doing better, but still fatigue, weakness, muscle twitching, headache.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dysphonia, Pulmonary congestion
Clinical narrative: Developed cough, raspy voice and chest congestion 24 hours after receiving vaccine.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Began with a fever that night, 102.4, fever and chills, achiness and headache. Took 2 motrin tablets. In the morning still running 100.6 with the same symptoms.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous, Swollen tongue
Clinical narrative: Vaccine was administered at hospital at 13:00. I felt a minor sting immediately at injection site. No other symptoms noted. Waited in auditorium for 15 minutes and was released to return to work.   @1500  noted pruritis to bilateral under arm area (near axila), no other symptoms noted. @1900 noted pruritis was increasing in intensity to bilateral arms, and began sreading to left antecubital area, bilateral anterior wrists,  neck,  and face along jawline. Noted pink rash to identified areas above also began to develop with increasing intensity in pruritis.  @2300 I took 15mL (37.5mg) of  Benadryll to alleviate symptoms, and fell asleep.   12/31/220: Woke up @0615  noted rash and pruritis had resolved. Noted slight swelling to tongue, which has now resolved as well.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Nausea, Pain
Clinical narrative: Chills, body aches, headache, nausea, sweating
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Pyrexia
Clinical narrative: Flu like symptoms for two days, Feverish, Extremely exhausted
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Condition aggravated, Headache, Rash, Urticaria
Clinical narrative: Sudden increase of asthma symptoms that required use of rescue inhaler. Hives appeared on right hand and hive rash appeared on both cheeks of face. Headache. Headache stared midday and continue to increase in severity till onset of asthma symptoms and hives/rash that started about 06:00pm and lasted for about 3 hours. Took rescue inhaler and dose of Benadryl.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Chills. Nausea vomiting. Muscle aches headache joint pain. Extremely exhausted.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Chills. Nausea vomiting. Muscle aches headache joint pain. Extremely exhausted.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: I received my vaccine on 12/23/20. My arm was a little sore for a couple of days and the injection site bruised a little. Seven days after the vaccine (12/30/20) I noticed my arm was itching just below the injection site. I now have a small, red, swollen square at/just below the injection site. It is about 2x2 inches in size. Warm to the touch.  It is not interfering with my daily activities, but is noticeable.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I received my vaccine on 12/23/20. My arm was a little sore for a couple of days and the injection site bruised a little. Seven days after the vaccine (12/30/20) I noticed my arm was itching just below the injection site. I now have a small, red, swollen square at/just below the injection site. It is about 2x2 inches in size. Warm to the touch.  It is not interfering with my daily activities, but is noticeable.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Respiratory tract congestion
Clinical narrative: Itching, Congestion
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pruritus, Rash
Clinical narrative: Full body rash with very intense itching. Joint pain, severe headache.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This individual was given the Covid-19 vaccine at on offsite clinic at the age of 15 when the vaccine is only approved for 16 and older. No adverse reaction reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Shingles on right upper back and right chest. Pain and widespread shingles rash. Prescribed Valacyclovir and Gabapentin.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Injection site erythema, Swollen tongue
Clinical narrative: Pt had vaccine on 12/22.  Reported redness at injection site on 12/31 (9 days later).  A few hours later, pt experienced swelling tongue and blisters.  Advised to take benadryl and declined ED visit.  Friend will monitor.