chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: side effects started showing up about five hours after time of injection and some are still present currently. These side effects include injection site pain, tiredness, headache, joint pain, muscle pain, and chills. The side effects that are still present are injection site pain and joint pain.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: side effects started showing up about five hours after time of injection and some are still present currently. These side effects include injection site pain, tiredness, headache, joint pain, muscle pain, and chills. The side effects that are still present are injection site pain and joint pain.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatine, Blood creatine phosphokinase, Blood test, Chest pain, Electrocardiogram
Clinical narrative: Left Side Facial Numbness and Chest Pain
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, H1N1 influenza, Hypoaesthesia, Prothrombin time, Troponin
Clinical narrative: Left Side Facial Numbness and Chest Pain
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Uterine dilation and curettage, X-ray
Clinical narrative: Left Side Facial Numbness and Chest Pain
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pruritus, Injection site rash, Rash
Clinical narrative: Day 2-4 afterward I had lightning like pains in my head (sides) and a dull headache.  On 1/16 the injection site started itching terribly and kept me up at night, on 1/17 I had a rash on my upper left chest and torso and at the injection site.  The rash has continued just around the injection site .
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: patient reported Hands itching 20 minutes after vaccine was given  no other complaints  Patient monitored for 45 minutes  in total  Benadryl 25 mg cap x 1 dose given - resolved , discharged
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Injection site nodule, Lymphadenopathy
Clinical narrative: Muscle knot at location of shot developed 24 hours after receiving vaccine. 48 hours after shot developed bruising. 96 hours after shot arm pit has become swollen and swore. 96 hours till current date/time of 6 days later swelling and soreness to arm pit progressively getting worse.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspepsia, Headache
Clinical narrative: At about 1am the night following receiving the vaccine, I started getting a headache and indigestion. At about 1:30 I had diarrhea for the next 3 hours until I took an anti-diarrheal medication.  My wife and I ate the same food that day. She did not get sick. I haven't had diarrhea in years.  I had a lingering headache the following day.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram
Clinical narrative: very extreem chest pains to the point i thought i was having a heart attact and had to take my nitrowent to my PCP on 1/18/21 they did an EKG and said everything there is fine i am continuing having chest pains even today just alot less
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Malaise, Pyrexia
Clinical narrative: Upper left arm is red and swollen 8 days after shot. Was ill with fever yesterday.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Vaccinated on 1/5/21. On 1/11/21 at bedtime injection site started itching really bad. 1/12/21 injection site was red, firm, indurated, and itchy. Was seen by provider on 1/12/21, pictures were taken. Applied topical anti-itch cream and suggested over the counter Claritin. Topical cream helped a little. Had recheck appointment with provider on 1/13/21. Redness was decreased, not as itchy, was starting to resolve. Still is itchy if she bumps it but not red or swollen by 1/14/21.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Discomfort, Ear discomfort, Ear pain, Hypertension
Clinical narrative: 12/30- possible exposure to COVID (+) med student 1/5- tested negative  1/8- tested negative, went to clinic and was diagnosed with a head cold, BP elevated 1/9-1/10- had 100.1. fever, lethargic, high BP, lymph nodes swollen 1/12- BP uncontrolled, Increased metoprolol to 2 pills instead of 1 1/15- noticed pressure on L side of neck, temp higher on this side compared to right 1/17- L earache, decreased hearing, feels clogged, pain  intermittent
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, Lethargy, Lymphadenopathy, Nasopharyngitis, Pyrexia
Clinical narrative: 12/30- possible exposure to COVID (+) med student 1/5- tested negative  1/8- tested negative, went to clinic and was diagnosed with a head cold, BP elevated 1/9-1/10- had 100.1. fever, lethargic, high BP, lymph nodes swollen 1/12- BP uncontrolled, Increased metoprolol to 2 pills instead of 1 1/15- noticed pressure on L side of neck, temp higher on this side compared to right 1/17- L earache, decreased hearing, feels clogged, pain  intermittent
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Pruritus, Rash
Clinical narrative: Red burning, itchy rash on face.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA  Patient experienced severe chills the night of 1/17/2021 with a peak fever of 101.7*F the morning of 1/18/2021.. Patient also experienced fatigue and slept about 12 hours that Sunday and Monday. Non-pharmaceutical treatment consisted of plenty of fluids and bedrest. Pharmaceutical treatment consisted of the use of extended-release acetaminophen. The dose taken was 1300 mg every 8 hours which really helped  with the chills. This was the maximum dose per product label as to ensure a daily intake of less than 4 grams of acetaminophen.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Pain, Pyrexia
Clinical narrative: Fever to 101.8, chills, body aches, headache, malaise. Lasted about 12 hours.   Took Ibuprofen
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Nausea, Vertigo
Clinical narrative: Day after vaccination --brain fog, Dizzy. Friday 1/15/2021 6:30 head spinning, nausea; symptoms have not subsided
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Hypertension, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: numbness of the left arm, mouth, tongue,  throat, loss of vision, high blood pressure
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Injection site began itching, growing red, and warming approximately 6 days after receiving injection, progressing to a hard, hot induration with aching around the injection site and shoulder joint/neck. The hard red area has increased in size to about 2? diameter over 2 days.  Called PCP approximately 8 days after injection to see if symptoms warranted a visit - PCP advised that it was a common adverse reaction to the vaccine and recommended a hot compress if needed. Improvement seen approximately 9 days after, with almost complete resolution 14 days after receiving the vaccine.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Neck pain
Clinical narrative: Injection site began itching, growing red, and warming approximately 6 days after receiving injection, progressing to a hard, hot induration with aching around the injection site and shoulder joint/neck. The hard red area has increased in size to about 2? diameter over 2 days.  Called PCP approximately 8 days after injection to see if symptoms warranted a visit - PCP advised that it was a common adverse reaction to the vaccine and recommended a hot compress if needed. Improvement seen approximately 9 days after, with almost complete resolution 14 days after receiving the vaccine.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hallucination, Head discomfort, Headache
Clinical narrative: Instant arm soreness and numbness. Arm muscle pain from about 2pm until about 9pm. Developing fatigue and headache by 2. At 9pm started to have sever rigors and had to move to a bed. Rigors for several hours with fever coming and going. Mild hallucinations while in bed and severe sweating. Woke up with left eye not responding but still had vision. Headache only on left side of head with severe pressure. Right sight felt normal. Right eye normal. Seemed like mix between edema and slight bell's pallsy. Could still move left side mouth and forehead. Eye was not responsive. Eye resolved after 2 days. Return to 100% about 96 hours after dose.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypoaesthesia, Limb discomfort, Pain in extremity
Clinical narrative: Instant arm soreness and numbness. Arm muscle pain from about 2pm until about 9pm. Developing fatigue and headache by 2. At 9pm started to have sever rigors and had to move to a bed. Rigors for several hours with fever coming and going. Mild hallucinations while in bed and severe sweating. Woke up with left eye not responding but still had vision. Headache only on left side of head with severe pressure. Right sight felt normal. Right eye normal. Seemed like mix between edema and slight bell's pallsy. Could still move left side mouth and forehead. Eye was not responsive. Eye resolved after 2 days. Return to 100% about 96 hours after dose.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Feeling hot, Injection site pain
Clinical narrative: Roughly 2-3  minutes post injection as I was sitting in the designated waiting area, (as instructed by the nurse to sit there for 15 minutes post injection to assure no adverse effects) I began to get very short of breath, I felt that I had to take my mask off  to breath properly. ( I did not remove my mask)  My heart then started to race and I felt a warming, tingling feeling throughout my body.  I felt a little hot and light headed.  I stayed sitting in my chair, tried to take some deep breath, and everything went away.  This lasted about 30 to 60 seconds.  I did  NOT report this to anyone there, as I was unsure if I was actually having a reaction or not. Since it went away on it's own, I did NOT report it to anyone.  I stayed for about 15-20 minutes post injection and then  I left and drove home.  I did feel tired and my arm is sore at injection site, but other than that, no other effects.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Paraesthesia, Skin warm
Clinical narrative: Roughly 2-3  minutes post injection as I was sitting in the designated waiting area, (as instructed by the nurse to sit there for 15 minutes post injection to assure no adverse effects) I began to get very short of breath, I felt that I had to take my mask off  to breath properly. ( I did not remove my mask)  My heart then started to race and I felt a warming, tingling feeling throughout my body.  I felt a little hot and light headed.  I stayed sitting in my chair, tried to take some deep breath, and everything went away.  This lasted about 30 to 60 seconds.  I did  NOT report this to anyone there, as I was unsure if I was actually having a reaction or not. Since it went away on it's own, I did NOT report it to anyone.  I stayed for about 15-20 minutes post injection and then  I left and drove home.  I did feel tired and my arm is sore at injection site, but other than that, no other effects.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: On 12-24-2020 I started to have a metallic taste in my mouth and at 2:35pm I experienced rapid  heart beat with chest tightness. On the next day I  felt two places in body begin with hives and it grew with itchiness till the third day.  I had under-skin itchiness which grew  into hives. I did a telemedicine consult with a doctor who started me on Benadryl, for me to take it 3 times a day for Monday and Tuesday after Christmas (12-28-2020 and 12-29-2020).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: TICKLING IN THE LOWER LIP, WHICH IS SLIGHTLY INFLAMMED
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pallor, Palpitations
Clinical narrative: Patient experienced heart racing and felt the color from her face go pale. Patient was brought to EMS area. Vital signs monitored. Adverse feelings resolved within 15-20 minutes
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Palpitations
Clinical narrative: Very bad arm pain for 36 hrs. very bad  body aches for 36 hrs very bad joint pain for 36 hrs no energy for 36 hrs *Heart palpitations continuing to date
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site papule, Injection site pruritus, Injection site rash, Injection site reaction
Clinical narrative: Red, raised, extremely itchy rash on left upper arm x 2-3 days.  Rash resolved.  Intermittent itching persists.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: Redness around injection area. I marked the redness, next day redness is moving outside of the border.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Arm pit sore - to injection site, warm to touch, red area, tender to touch, swollen denies any fever Started on abx - cephalexin
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site pruritus, Malaise, Pyrexia
Clinical narrative: Fever up to 102; headache; severe malise; itching and redness at injection site - treated with Alleve, rest & fluids
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Myalgia, SARS-CoV-2 test negative
Clinical narrative: Developed myalgias on 1/12 which lasted until Friday and developed loss of sense of smell and taste on Tuesday which lasted until Thursday
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Sensation of foreign body
Clinical narrative: Patients states felt lump in throat, able to swallow, denied shortness of breath or difficulty in breathing. Able to manage secretions. , Respirations 24, heat rate 102, skin warn and dry. Diphenhydramine 50 mg IM left gluteus maximums. Monitored for 30 min. Husband arrived to escort home. Refused transport or advice to seek medical attention. States "I am a ER nurse, and I am OK now".  Respirations 18 heart rate 84. Patient left with husband following.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Glossodynia, Oral discomfort, Tongue discolouration, Tongue disorder
Clinical narrative: Tip and edge of tongue feels on fire, white scabs and very painful. No swelling occurred. I have not seen a Dr about this. I called the location of where I got the vaccine to see if I could speak to a Dr and they gave me a email to send questions.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling, Lymphadenopathy
Clinical narrative: red itchy swollen knot at vaccine site , ongoing  swollen lymph node in armpit
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Paraesthesia, Pyrexia
Clinical narrative: Started with fever of 101.3, aching all over-hurt to touch skin, extreme fatigue, headache all that started about 12 to 15 hours after injection was given and lasted about 12 hours. I'm not sure if this next part has anything to do with the vaccine but I have an IUD(birth control) and I have not had a mensal cycle in over 4 years and about 48 hours after my injection I started with a lite mensal cycle. It's just very strange that I have not had anything in over 4 years and started this after the vaccine and that's the only thing I have done or changed.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Pulse absent, Vomiting
Clinical narrative: On 1/13/2021,  resident had sudden emesis. Immediately following emesis he was noted without a pulse and pronounced deceased. No acute symptoms noted prior to this episode. Resident does have a significant cardiac history.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Feeling hot, Hypoaesthesia, Nausea
Clinical narrative: 3 days after shot starting getting nauseous and very hot. Then an hour later I started getting foggy and the top my head and forehead is numb.  I had a low grade fever that night and my body feels very heavy like it?s sleeping.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Pruritus, Rash, Skin warm
Clinical narrative: Six days after vaccination, itching, rash, area warm, slightly swollen. No treatment
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Left upper  arm rash with reaness which growing every day and itching
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Pyrexia, SARS-CoV-2 test, Skin warm
Clinical narrative: 12 hours after shot I got extreme chills and fever once fever broke I was dripping in sweat and very hot to touch this happened 3 times in the full 20 hours than ended around 10:30 pm Sunday than Monday at 4 pm had the chills and fever again this happened two times last fever was 9:30 pm
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site swelling, Lymphadenitis
Clinical narrative: lymphadenitis on axilla of injection site with swelling/ erythema into the L breast.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Fatigue, Pyrexia
Clinical narrative: received moderna covid 19 1/14/21 12 noon.  1600 hours developed severe sharp 7/10 peri umbilical abdominal pain that did not radiate, no associated signs/symptoms.  Pain persisted until 2300 hours, took one tab acetaminophen, went to sleep.  Upon arising in AM pain resolved. Has not recurred.  Upon arising did experiencing more typical side effects including fatigue and thought he had fever, no thermometer to check, these symptoms subsided over 1-2 days.  No recurrence of any above symptoms.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy, diagnosed by patient's physician on January 16, 2021.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Injection site erythema, Injection site pruritus, Injection site swelling, Lymphadenopathy
Clinical narrative: Axilla pain and swelling (lymph node), L arm/shoulder reaction at site and below with redness, itching and swelling. Present for 1 week after initiation of symptoms with 2-3 days of pain and swelling and then improved over 3-4 days after that.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: C/O felling numbness in the back of his head and some tingling in left arm. Seen By EMT. BP-131/91,76. O2 Sat 98%. TEl./EKG SR.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenitis
Clinical narrative: Left axillary and clavicle lymphadenopathy, large, painful, and erythematous
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site reaction, Injection site warmth
Clinical narrative: Injection site reaction. Started 1 week after injection. Redness, hot to touch, large hard spot underneath injection, itching, throbbing. 5cmx9cm area
Age: 65.0
Sex: M
Vaccine: ADEN_4_7
Symptoms: Unevaluable event
Clinical narrative: none
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Headache, Malaise, Pain, Rhinorrhoea
Clinical narrative: had most side effects listed for vaccine - headaches, body aches, cough, runny nose, malaise.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal distension, Condition aggravated, Fatigue, Gastrooesophageal reflux disease, Nausea
Clinical narrative: flare up of her acid reflux / reflux was really bad; flare up of her acid reflux / reflux was really bad / had silent reflux for several years but it has been well controlled in the last 6 months; Exhausted; Body aches; nausea; bloating; This case was reported by a consumer and described the occurrence of esophageal acid reflux in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included silent reflux.   On 28th November 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 29th November 2020, 1 days after receiving Shingrix, the patient experienced esophageal acid reflux, condition aggravated, exhaustion, general body pain, nausea and bloating. On an unknown date, the outcome of the esophageal acid reflux was not recovered/not resolved and the outcome of the condition aggravated, exhaustion, general body pain, nausea and bloating were unknown.   The reporter considered the esophageal acid reflux, condition aggravated, exhaustion, general body pain, nausea and bloating to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Patient has had silent reflux for several years but it has been well controlled in the last 6 months. Patient reported that she received the 2nd dose of Shingrix vaccine on Saturday 28th November 2020 and on sunday 29th November 2020 experienced flare up of her acid reflux in night and stated the reflux was really bad also patient was exhausted and had body aches with nausea and bloating. The reporter did not consent to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Vaccine positive rechallenge
Clinical narrative: flare up of her acid reflux / reflux was really bad; flare up of her acid reflux / reflux was really bad / had silent reflux for several years but it has been well controlled in the last 6 months; Exhausted; Body aches; nausea; bloating; This case was reported by a consumer and described the occurrence of esophageal acid reflux in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included silent reflux.   On 28th November 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 29th November 2020, 1 days after receiving Shingrix, the patient experienced esophageal acid reflux, condition aggravated, exhaustion, general body pain, nausea and bloating. On an unknown date, the outcome of the esophageal acid reflux was not recovered/not resolved and the outcome of the condition aggravated, exhaustion, general body pain, nausea and bloating were unknown.   The reporter considered the esophageal acid reflux, condition aggravated, exhaustion, general body pain, nausea and bloating to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Patient has had silent reflux for several years but it has been well controlled in the last 6 months. Patient reported that she received the 2nd dose of Shingrix vaccine on Saturday 28th November 2020 and on sunday 29th November 2020 experienced flare up of her acid reflux in night and stated the reflux was really bad also patient was exhausted and had body aches with nausea and bloating. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Blood pressure increased, Chills, Dehydration, Dizziness
Clinical narrative: vomiting; chills; dehydration; elevated blood pressure; slow heart beat; dizziness; shortness of breath; localized abdominal pain; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2020, the patient received the 1st dose of Shingrix (intramuscular). In July 2020, 2 days after receiving Shingrix, the patient experienced vomiting, chills, dehydration, increased blood pressure, heart rate decreased, abdominal pain localized, dizziness and shortness of breath. On an unknown date, the outcome of the vomiting, chills, dehydration, increased blood pressure, heart rate decreased, abdominal pain localized, dizziness and shortness of breath were recovered/resolved.   It was unknown if the reporter considered the vomiting, chills, dehydration, increased blood pressure, heart rate decreased, abdominal pain localized, dizziness and shortness of breath to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that the female patient received the 1st dose of Shingrix in July 2020, and 2 days after the vaccination patient experienced vomiting, chills, dehydration, elevated blood pressure, slow heart beat, which lasted 2- 3 days and resolved.         The patient reports localized abdominal pain, which lasted for 1 week and resolved. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Heart rate decreased, Vomiting
Clinical narrative: vomiting; chills; dehydration; elevated blood pressure; slow heart beat; dizziness; shortness of breath; localized abdominal pain; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2020, the patient received the 1st dose of Shingrix (intramuscular). In July 2020, 2 days after receiving Shingrix, the patient experienced vomiting, chills, dehydration, increased blood pressure, heart rate decreased, abdominal pain localized, dizziness and shortness of breath. On an unknown date, the outcome of the vomiting, chills, dehydration, increased blood pressure, heart rate decreased, abdominal pain localized, dizziness and shortness of breath were recovered/resolved.   It was unknown if the reporter considered the vomiting, chills, dehydration, increased blood pressure, heart rate decreased, abdominal pain localized, dizziness and shortness of breath to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that the female patient received the 1st dose of Shingrix in July 2020, and 2 days after the vaccination patient experienced vomiting, chills, dehydration, elevated blood pressure, slow heart beat, which lasted 2- 3 days and resolved.         The patient reports localized abdominal pain, which lasted for 1 week and resolved. The reporter consented to follow up.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Tiredness; This case was reported by a consumer and described the occurrence of tiredness in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st December 2020, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was unknown.   It was unknown if the reporter considered the tiredness to be related to Shingrix.  Additional details were provided as follows: It was reported that patient received the dose of Shingrix and experienced tiredness. The reporter consented to follow up.
Age: 0.08
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: inadvertently injected an 8.5 week old with BEXSERO; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 8-week-old male patient who received Men B NVS (Bexsero) (batch number ABXA93AA, expiry date 28th February 2022) 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.   On 3rd December 2020, the patient received Bexsero (intramuscular) .5 ml and Bexsero Pre-Filled Syringe Device. On 3rd December 2020, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   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 medical assistant mentioned that, she inadvertently injected an 8.5 week old with Bexsero instead of Hepatitis B in the left thigh, which led to wrong vaccine administered. No further information was provided. The reporter consented to follow up.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain
Clinical narrative: feeling fatigued; arm pain in the injected arm; This case was reported by a consumer and described the occurrence of fatigue in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included rib fracture. Concomitant products included codeine phosphate, paracetamol (Acetaminophen + Codeine).   On 21st December 2020, the patient received Shingrix (intramuscular). On 21st December 2020, 1 hr after receiving Shingrix, the patient experienced pain in arm. On 22nd December 2020, the patient experienced fatigue. On 23rd December 2020, the outcome of the fatigue and pain in arm were recovered/resolved.   It was unknown if the reporter considered the fatigue and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient reported for himself. The patient experienced arm pain in the injected arm.  The reporter did not consent to follow-up. The lot number was not available.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Erythema, Injection site pruritus, Pruritus, Tremor
Clinical narrative: Patient received first COVID vaccine given at 3:10 pm approximately. Patient monitored closely at approximately 3:40pm began experiencing itching on left arm by injection site and up in hairline. Noted red patches, no hives, Provider on site made aware of patient itching. No issues with breathing, swallowing able to talk in complete sentences. She was eating a snack and drinking juice without issue 3:45 pm itching both arms and upper back plus up in hairline, complained of chest being heavy. Provider assessed lung sounds lungs clear per provider 4pm this writer notes red patches under chin and on side of face, noted patient scratching their back. Checked shoulder areas hives noted. Provider over to assess. Adult Anaphylaxis Kit accessed and guidelines followed Per Provider, Dr, IM Benadryl given 25mg from Anaphylactic kit. Injection given in Right deltoid no issues noted. Per provider Epinephrine pen 0.3mg given in right upper thigh. Oxygen saturation is 99% and heart rate 121.  4:05pm Patient noted to be shaking she states "this is normally what happens after the Epi Pen" Blood pressure checked and was 121/71 4:15 shaking has subsided she states breathing better 4:17pm reported to RN that breathing normal and patient reports minimal itching. 4:20pm Provider spoke with patient advised to go home and rest Patient understands not recommended to have second shot. Patient was driven back to her work location by employer to get her vehicle. Provider cleared patient to drive home.  Patient symptoms had resolved speaking clearly with no issues
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Patient received first COVID vaccine given at 3:10 pm approximately. Patient monitored closely at approximately 3:40pm began experiencing itching on left arm by injection site and up in hairline. Noted red patches, no hives, Provider on site made aware of patient itching. No issues with breathing, swallowing able to talk in complete sentences. She was eating a snack and drinking juice without issue 3:45 pm itching both arms and upper back plus up in hairline, complained of chest being heavy. Provider assessed lung sounds lungs clear per provider 4pm this writer notes red patches under chin and on side of face, noted patient scratching their back. Checked shoulder areas hives noted. Provider over to assess. Adult Anaphylaxis Kit accessed and guidelines followed Per Provider, Dr, IM Benadryl given 25mg from Anaphylactic kit. Injection given in Right deltoid no issues noted. Per provider Epinephrine pen 0.3mg given in right upper thigh. Oxygen saturation is 99% and heart rate 121.  4:05pm Patient noted to be shaking she states "this is normally what happens after the Epi Pen" Blood pressure checked and was 121/71 4:15 shaking has subsided she states breathing better 4:17pm reported to RN that breathing normal and patient reports minimal itching. 4:20pm Provider spoke with patient advised to go home and rest Patient understands not recommended to have second shot. Patient was driven back to her work location by employer to get her vehicle. Provider cleared patient to drive home.  Patient symptoms had resolved speaking clearly with no issues
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Moderna COVID-19 vaccine  Received shot 8am on a Thursday morning. Friday at 3am  Began having chills about 16 hrs after injection and fever4 hours later of 102. Also had headache and leg pains. Fever lasted until 8am Saturday morning. Then just had fatigue for 2 days. I took Tylenol and ibuprofen alternating.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives, sore arm, fatigue
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Limb discomfort
Clinical narrative: the first couple of days just soreness in arm from elbow up the back of head. On Sunday 1/18 has a small rash on chest in the evening.  had a welp on wrist when I woke up still had small rash.  as the day went on the rash spread and became whelp from head down to top of legs.    when I got up at 12:30 am Tuesday morning due to itching I also had something like a hot flash and felt sick to my stomach.  I spoke with the doctor in the office on Monday.  was directed to take Benadryl at night and xyzal 5 mg in the morning.  also was given a Rx for triamcinolone acetonide cream USP 0.1%. which does help with the itch when it is applied.  the rash/hives are still spreading.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Urticaria
Clinical narrative: the first couple of days just soreness in arm from elbow up the back of head. On Sunday 1/18 has a small rash on chest in the evening.  had a welp on wrist when I woke up still had small rash.  as the day went on the rash spread and became whelp from head down to top of legs.    when I got up at 12:30 am Tuesday morning due to itching I also had something like a hot flash and felt sick to my stomach.  I spoke with the doctor in the office on Monday.  was directed to take Benadryl at night and xyzal 5 mg in the morning.  also was given a Rx for triamcinolone acetonide cream USP 0.1%. which does help with the itch when it is applied.  the rash/hives are still spreading.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Limb discomfort
Clinical narrative: Patient noticed hives developing in middle of chest Sunday(1/17/21) evening.  Next day (1/18/21) she presented at work (PCP office), and hives had spread throughout body, and patient did not feel well.  Pt was prescribed a prednisone taper, triamcinolone 0.1% cream, Xyzal and diphenhydramine to manage symptoms.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Urticaria
Clinical narrative: Patient noticed hives developing in middle of chest Sunday(1/17/21) evening.  Next day (1/18/21) she presented at work (PCP office), and hives had spread throughout body, and patient did not feel well.  Pt was prescribed a prednisone taper, triamcinolone 0.1% cream, Xyzal and diphenhydramine to manage symptoms.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Chills, Computerised tomogram, Dyspnoea
Clinical narrative: Started with severe chills, body aches and feverish. The. Slight leg pain which worsened with time , swelling on the right leg calf, warm to touch and difficulty breathing. Got hospitalized on 1/16 21 with multiple clots in my right leg and clot in the lung. Still in the hospital now.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Peripheral swelling, Pulmonary embolism, Pyrexia
Clinical narrative: Started with severe chills, body aches and feverish. The. Slight leg pain which worsened with time , swelling on the right leg calf, warm to touch and difficulty breathing. Got hospitalized on 1/16 21 with multiple clots in my right leg and clot in the lung. Still in the hospital now.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm, Thrombosis, Ultrasound scan
Clinical narrative: Started with severe chills, body aches and feverish. The. Slight leg pain which worsened with time , swelling on the right leg calf, warm to touch and difficulty breathing. Got hospitalized on 1/16 21 with multiple clots in my right leg and clot in the lung. Still in the hospital now.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: 30-40 minutes after the vaccine administration, began to have a decreased sensation to left side of face to include jaw, lip and tongue.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Received first dose of Moderna Covid-19 vaccine on Monday 01/11/21 @10;30 AM. Had fever and chills,102-104.9, severe myalgia, joint pains(felt like run over by the truck), transient mild headache, severe muscle ache both arms(worse on left upper arm at vaccine site), fatigue and malaise.  Before vaccination, I had taken Alkaseltser, Nyquil and Naproxen.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I started to get a painful rash on my left torso and at first thought it was a bug bite but then after 48 hrs it got worse and more painful and I realized it was shingles. I have never had shingles and I am healthy and young and so I thought it might be related to getting the vaccine- Maybe COVID vaccine induced it or made me susceptible.  I am nursing a 4 month old to give more information.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Injection site became very red, hot, hard and swollen, nine days after receiving the vaccine.  Applied ice off and on the entire day.  Made no difference. Saw a medical provider on 1/18/2021, have been put on Cephalexin 500 mg, once capsule by mouth three times a day for 10 days.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis
Clinical narrative: Cellulitis at injection site. Treatment: Keflex 500 mg QID x 7 days.  Site measures 13 cm x 9 cm. Warmth and erythema at site. worsening over 24 hours.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Vaccination site reaction
Clinical narrative: 3 cm redness at vaccination site
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: SIGNIFICANT UPPER LIP SWELLING 6 DAYS LATER
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Cardiac arrest, Chest discomfort, Headache, Heart rate irregular
Clinical narrative: She had the first dose of Pfizer vaccine at the Campus on Friday 1/15 at 4:30 pm. After the vaccine, she had no new symptoms or signs of vaccine reaction and MD friend reports that he checked her pulse which was not elevated from baseline. On 1/16,  she awakened and continued to feel at her recent baseline. However, in the early afternoon, she complained of  headache, nausea/epigastric pain, and chest heaviness. These apparently were not unusual symptoms for her to feel intermittently.  Per her niece, who has a home O2 sat device, her 02 sat that morning was 97 with a HR of 87 irregularly irregular. She was afebrile. (continue on page 2)
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pulseless electrical activity, Syncope
Clinical narrative: She had the first dose of Pfizer vaccine at the Campus on Friday 1/15 at 4:30 pm. After the vaccine, she had no new symptoms or signs of vaccine reaction and MD friend reports that he checked her pulse which was not elevated from baseline. On 1/16,  she awakened and continued to feel at her recent baseline. However, in the early afternoon, she complained of  headache, nausea/epigastric pain, and chest heaviness. These apparently were not unusual symptoms for her to feel intermittently.  Per her niece, who has a home O2 sat device, her 02 sat that morning was 97 with a HR of 87 irregularly irregular. She was afebrile. (continue on page 2)
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: More than 24 hours of Shivering, Excruciating  headache, muscle, articulations pain and mild  fever.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Rash
Clinical narrative: migraine and rash
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Intense headache and chills. Had a fever of 103 at it?s highest. Had to go to urgent care.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Chills, sore arm, fatigue, muscle pain, joint pain, headache
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Chills, sore arm, fatigue, muscle pain, joint pain, headache
Age: 72.0
Sex: M
Vaccine: UNK
Symptoms: Coccidioidomycosis, Lung lobectomy
Clinical narrative: a portion of upper right lobe removed, cause determined valley fever
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure abnormal, Decreased appetite, Fatigue, Headache
Clinical narrative: Pt had nausea after 2 hours and felt tired/heavy feeling.  Took Ibuprofen.    On day later, experienced more nausea and lack of appetite, and then had a terrible headache.  It got worse and she experienced neck stiffness and her blood pressure was 175/95 at 4pm on 1/8.  She rested and felt better about 24 hours later.  She felt normal again after a few days.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Nausea
Clinical narrative: Pt had nausea after 2 hours and felt tired/heavy feeling.  Took Ibuprofen.    On day later, experienced more nausea and lack of appetite, and then had a terrible headache.  It got worse and she experienced neck stiffness and her blood pressure was 175/95 at 4pm on 1/8.  She rested and felt better about 24 hours later.  She felt normal again after a few days.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site streaking, Injection site swelling, Injection site warmth
Clinical narrative: Sever swelling of the site of injection, red area growing down the arm. Pain, not sore but pain, hot to touch.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count normal, Injection site discomfort, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: woke up 9 days post injection to a sore arm, when I looked at the arm in the mirror there were 4 red marks, 1 the size of a quarter maybe a little larger and three more the size of finger prints.  The red marks were slightly warm to the touch.  Arm was a little sore, but not bad.  As the morning progressed the red marks got larger and my arm began swelling.  The temperature of the red area became warmer.  Slight discomfort, more discomfort when bending over and hanging arm.  I took aceteminophen and iced the arm.  When I removed the ice pack the area was still very warm to the touch.  As the day progressed and went into the Monday the red mark got bigger and my arm was more swollen.  I contact my primary care and he expressed concerns of cellulitis based on the progression and symptoms.  I had a cbc and he placed my on antibiotics.  My cbc came back completely normal.  I am continuing the antibiotics as precaution.  The evening of Monday, January 18 the arm was starting to signs of the inflammation reducing. Tuesday, January 19th the red mark is smaller and the arm is not as swollen ( I have only taken two doses of antibiotics as of this morning).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: woke up 9 days post injection to a sore arm, when I looked at the arm in the mirror there were 4 red marks, 1 the size of a quarter maybe a little larger and three more the size of finger prints.  The red marks were slightly warm to the touch.  Arm was a little sore, but not bad.  As the morning progressed the red marks got larger and my arm began swelling.  The temperature of the red area became warmer.  Slight discomfort, more discomfort when bending over and hanging arm.  I took aceteminophen and iced the arm.  When I removed the ice pack the area was still very warm to the touch.  As the day progressed and went into the Monday the red mark got bigger and my arm was more swollen.  I contact my primary care and he expressed concerns of cellulitis based on the progression and symptoms.  I had a cbc and he placed my on antibiotics.  My cbc came back completely normal.  I am continuing the antibiotics as precaution.  The evening of Monday, January 18 the arm was starting to signs of the inflammation reducing. Tuesday, January 19th the red mark is smaller and the arm is not as swollen ( I have only taken two doses of antibiotics as of this morning).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: Slight headache, body aches, fatigue, chills.  I felt OK the next morning.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Pruritis and rash on lips chest and lower extremities. No swelling or shortness of breath, given diphenhydramine 50 mg orally for 1 dose as per MD recommendation,
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Headache, Pain
Clinical narrative: Fatigue, headache, body aches and upset stomach
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased
Clinical narrative: Uncontrolled elevated BP ranging 192/102 on multiple readings.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: almost 2 weeks later.  rash, swelling, itching, soreness, pain at injection site,
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: 24 hours after my 2nd vaccine I had symptoms of severe fatigue and body aches. I had a low grade fever and headache. The following morning I had pain in my left axilla, low grade fever, headache and body aches. I left work early because of severe fatigue and was out the following day for symptoms due to covid vaccine.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness, tingling from ear to right arm at injection site. At ER complains of right cheek tightness and tingling continually down to right shot area.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: On January 14th around noon, my vaccination site started itching pretty badly.  By later afternoon, I could feel a couple small bumps (like mosquito bites) under my skin at that site.  By evening, the area was red and quite itchy.  I put Cortisone-10 cream on it to help with the itching.  By the morning of January 15th, the area was raised and my upper arm seemed a bit swollen.  Itching continued as well as redness and the area was hot to the touch.  One large lump under the skin.  Redness was about 2.5 inches round.  I called my vaccination location and they were worried about cellulitis so advised me to be seen by a doctor.  Saw CNP at medical clinic.  She diagnosed me with cellulitis  and gave a prescription of Cephalexin 500mg, 1 capsule four times a day for five days.  I asked about getting the second shot in the series and she stated that I could just do it in the other arm.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: I received vaccine on Monday 1/4, on Wednesday 1/6 started developing some symptoms (tongue felt funny and slight loss of taste), by Thursday morning 1/7 my lip was funny feeling as well and by Thursday evening right side of my face was droopy.  Saw my PCP on Friday and was diagnosed with Bells Palsy.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Body temperature increased, Chills, Insomnia, Myalgia
Clinical narrative: At midnight 1/17/2021I developed severe muscle aches, shivering, chills, and a temperature of 100 F. The pain in my left arm was so severe I could barely move it. This all persisted to the morning of 1/18/2021 after which it resolved. I was unable to sleep at all the nights of 1/16/2021 or 1/18/2021.