chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Swelling, Urticaria
Clinical narrative: I received my first dose of covid vaccine on 02/26/21 at Hospital. I felt completely fine the following day just minor soreness which I expected. On 03/07/21, exactly 10 days post my vaccine I developed hives/welts on both hands, both elbows , both knees, and toes  that were elevated. I also developed some minor swelling but no fever, no pain just los of itchiness. I was given a vaccine of Medrol to calm down the sxs and seem to be doing okay.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm for a couple days; This case was reported by a consumer and described the occurrence of pain in arm in a 73-year-old male patient who received Herpes zoster (Shingrix) (batch number J454X, expiry date 4th October 2022) for prophylaxis.   On 28th January 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient for himself. The patient received Shingrix and had a sore arm for a couple days in the right arm. The reporter consented to follow up and granted permission for safety to follow up with consumer, as well as with pharmacist who administered the vaccine.  This case linked with US2021025175, US2021AMR025675 and US2021AMR025778, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021025175:same reporter US-GLAXOSMITHKLINE-US2021AMR025675:same reporter US-GLAXOSMITHKLINE-US2021AMR025778:
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Eye pain, Fatigue, Feeling abnormal, Headache, Memory impairment
Clinical narrative: Ache joints, neck, hip, back, headache, sore redish eyes. brain fog, memory problems, general sleepy feeling and tiredness. I've been feeling really good so this took me down it has been 6 days and I'm feeling better but still sluggish and feel a bit like lead in the blood.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Ocular hyperaemia, Pain
Clinical narrative: Ache joints, neck, hip, back, headache, sore redish eyes. brain fog, memory problems, general sleepy feeling and tiredness. I've been feeling really good so this took me down it has been 6 days and I'm feeling better but still sluggish and feel a bit like lead in the blood.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Fatigue, Musculoskeletal chest pain, Myalgia
Clinical narrative: Nausea, vomiting, muscle aches in both shoulders and in chest, chills, and tiredness. Event started about 5:15PM and symptoms subsided about 10:50PM the same day.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea, vomiting, muscle aches in both shoulders and in chest, chills, and tiredness. Event started about 5:15PM and symptoms subsided about 10:50PM the same day.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Myalgia, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, muscle aches in both shoulders and in chest, chills, and tiredness. Event started about 5:15PM and symptoms subsided about 10:50PM the same day.
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pruritus, Rash, Rash erythematous, Rash macular, Rash papular
Clinical narrative: Developed rash on forearms (3/4/21) which gradually worsened in scope and severity. By am of 3/5/21 rash was covering abdomen, chest, arms and buttocks.  By 3/6  the rash was present on thighs, knees, behind knees.  On 3/7 rash was present on face, top of head, throat and back.  Severe itching and burning accompanied rash.  The rash started out as patches of red raised areas that within 24 hours of emergence morphed into diffuse red splotches (appearance of severe sunburn).  Drs. Visit on 3/5 with injection of 120mg cortisone and direction to take benadryl up to 6 tabs/day.  No other body symptoms other than rash and itching/burning.  Call to Drs office 3/8 to report continuation of rash and he was instructed to take Zyrtec.  As of 1:59 pm today 3/9, the rash has improved on stomach, legs, buttocks but remains present in varying degrees on other parts of body.
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Skin burning sensation
Clinical narrative: Developed rash on forearms (3/4/21) which gradually worsened in scope and severity. By am of 3/5/21 rash was covering abdomen, chest, arms and buttocks.  By 3/6  the rash was present on thighs, knees, behind knees.  On 3/7 rash was present on face, top of head, throat and back.  Severe itching and burning accompanied rash.  The rash started out as patches of red raised areas that within 24 hours of emergence morphed into diffuse red splotches (appearance of severe sunburn).  Drs. Visit on 3/5 with injection of 120mg cortisone and direction to take benadryl up to 6 tabs/day.  No other body symptoms other than rash and itching/burning.  Call to Drs office 3/8 to report continuation of rash and he was instructed to take Zyrtec.  As of 1:59 pm today 3/9, the rash has improved on stomach, legs, buttocks but remains present in varying degrees on other parts of body.
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash erythematous, Rash macular, Rash papular, Rash pruritic, Urticaria
Clinical narrative: Developed rash on forearms (3/4/21) which gradually worsened in scope and severity. By am of 3/5/21 rash was covering abdomen, chest, arms and buttocks.  By 3/6  the rash was present on thighs, knees, behind knees.  On 3/7 rash was present on face, top of head, throat and back.  Severe itching and burning accompanied rash.  The rash started out as patches of red raised areas that within 24 hours of emergence morphed into diffuse red splotches (appearance of severe sunburn).  Drs. Visit on 3/5 with injection of 120mg cortisone and direction to take benadryl up to 6 tabs/day.  No other body symptoms other than rash and itching/burning.  Call to Drs office 3/8 to report continuation of rash and he was instructed to take Zyrtec.  As of 1:59 pm today 3/9, the rash has improved on stomach, legs, buttocks but remains present in varying degrees on other parts of body.
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: Developed rash on forearms (3/4/21) which gradually worsened in scope and severity. By am of 3/5/21 rash was covering abdomen, chest, arms and buttocks.  By 3/6  the rash was present on thighs, knees, behind knees.  On 3/7 rash was present on face, top of head, throat and back.  Severe itching and burning accompanied rash.  The rash started out as patches of red raised areas that within 24 hours of emergence morphed into diffuse red splotches (appearance of severe sunburn).  Drs. Visit on 3/5 with injection of 120mg cortisone and direction to take benadryl up to 6 tabs/day.  No other body symptoms other than rash and itching/burning.  Call to Drs office 3/8 to report continuation of rash and he was instructed to take Zyrtec.  As of 1:59 pm today 3/9, the rash has improved on stomach, legs, buttocks but remains present in varying degrees on other parts of body.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Nausea
Clinical narrative: Very bad headache beginning the night of the vaccine chills nausea dizziness Ibuprofen did not help with the headache.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain
Clinical narrative: A volunteer (vaccinator) who was being trained by a nurse injected the vaccine very high in the shoulder - approximately  1 inch below the acromion process. Pain in the area of the injection site and shoulder began 3 hours after the injection. Pain was exacerbated by active motion of the arm, especially abduction. The pain resolved over 48- 60 hours. There were no other symptoms from the vaccination- there was  no fever, fatigue, nausea, chills, adenopathy, etc. The concern is that the injection was clearly not in the proper location and I have questions about the efficacy of the 2nd dose that was administered and the efficacy of the overall vaccination series because of this. I contacted the Health Department and reported this. They instructed me to also submit it to Vaers.
Age: 1.08
Sex: M
Vaccine: FLU4, HEPA, MMRV, PNC13, VARCEL
Symptoms: No adverse event
Clinical narrative: No Current Symptoms
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Diarrhoea, Fatigue, Myalgia
Clinical narrative: Chills, fever, diareaha, muscle aches, nausea, loss of appetite fatigue,
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Chills, fever, diareaha, muscle aches, nausea, loss of appetite fatigue,
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Symptoms: generalized puritus Outcomes: monitored for 45 min and given PO Benadryl and resolved
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Skin warm
Clinical narrative: Left arm soreness for 3 days after the vaccine. This morning, 8 days after vaccination, my left deltoid is sore again and it's temperature is warmer than my right deltoid.
Age: 79.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Chills, low grade fever, aches
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Pyrexia
Clinical narrative: Fever and chills for 24 hrs, swollen lymph nodes in armpit of injection site still ongoing
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Decreased appetite, Dysstasia, Hypersomnia, Incontinence
Clinical narrative: He came home, laid down and went to sleep and slept all day long.  He had incontinence or urine, and could not put any weight on his legs, could not stand on his own and confused about what was going on.  His wife was able to get him up after pulling and tugging on him, and mentally confused.  He was able to go to the bathroom, and got him back to bed.  He had a urinary accident and slept until the evening.  She could tell he was better and walked with a walker.  She said the symptoms resembled a stroke, but he got better.   He did not take anything, did not want anything for the symptoms.  She does not think that he ate anything that night.  He says that he's fine  now.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: Herpes sine Herpete  involving C3 R side. I had the same thing 2 years ago documented by serology. I have had Shingrix vaccine. As this has occurred less than 2 weeks after 2nd vaccine dose I felt it should be reported
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pleurisy
Clinical narrative: Diffuse myalgias and joint pains including pleuritic chest onset approximately 36 hours after dose administered.  Resolved after another 24 hours.  Recurred again for < 24 hours and then resolved.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Syncope
Clinical narrative: Snycopal episode immediately following vaccination, patient was lowered to floor, BP slightly low at 92/40. Patient diaphoretic, brought to cot. Evaluated client after fifteen minutes, sent home via medical transport.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: woke up morning after vaccination and was experiencing dizziness after rising.  Still experiencing  dizzines today March 9, 2021
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site papule, Injection site warmth, Skin warm
Clinical narrative: I want to preface this by saying that I believe the vaccine was administered more posterior and superior than a IM injection into the deltoid should be. This was confirmed by other health providers. Approximately 1 week s/p vaccine dose 1, I was lifting weights around 8PM (bench press), when I noticed some sudden soreness/pain in my shoulder joint on my left side (5/10). I returned home and around 11PM my shoulder felt mildly pruritic and very warm to the touch. I noticed a nodule palpable under the skin, measuring approximately 1cm, and it was then that I realized that it was in the same location of my vaccination injection (I will include photos of injection site and reaction). The nodule continued to grow ~2cm, when I decided to call the advice nurse line, (I am a 2nd yr MD-PhD student). I was advised to take diphenhydramine and go to the ER if I felt anaphylactic reaction occurring, and they made me a morning appt with the NP at the clinic. The diphenhydramine seemed to stop the progression, however the following morning the 2cm nodule was still present and warm to the touch, but was no longer pruritic. The NP received photos and advised that I continue antihistamines - diphenhydramine at night and loratidine during the day for ~5 days. She did agree that the injection was not a proper deltoid injection. Over the course of 3 days the nodule disappeared. I had no issues with the second vaccination.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Listless, Pain
Clinical narrative: achey body  chills  listless no appetite for 10 hrs.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Pruritus, Rash
Clinical narrative: Since the first vaccination on 2/04/2021, I have had intense itching episodes whole body. I have had a rash on my hand mainly on my left side. These itching episodes have continued since the second vaccine on 3/3/2021.  I also had intense body and joint pain which began about 8 hours after the second Moderna injection which continued for 12 hours or so.  I understood that this was likely to occur however, after the intense pain and soreness subsided, I am concerned that the joint pain remains.  I am in hopes that is subsides soon. I was not experiencing joint pain like I am having now prior to the vaccine.  These things that I am experiencing have not led me to the doctor yet. I am in hopes that the itching and the joint pain will subside.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Overall aches, fatigue, fever and chills for which I took Aspirin 3X's across 24 hours. Initial symptoms lasted 12 hours. Since I was feeling fine by 9:00 the next morning (24 hours after the vaccination,) I resumed my usual busy Saturday morning-activites but by 12:00pm the symptoms had  returned. That is when I took the 3rd dose of Aspirin and slept for 3 hours. Sunday I was pretty much inactive. Since then I have felt fine (if more fatigued than usual.)
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Disorientation, Dizziness, Fatigue, Gait inability
Clinical narrative: Approximately 28 hours after receiving the vaccine, I became very dizzy, to the point that my head was spinning so fast I would pass out. When I would wake up, I was so nauseated that I tried to throw up but hadn't eaten anything, so I had dry heaves. I would wake up and repeat this process over and over. After about 6 hours the dizziness got better but I could not walk by myself as I was so wobbly and weak. My husband tried to get me to the car to take me to the ER but I couldn't stand up. I felt a little better the next day (Sunday) but was unable to keep anything down. I slept a lot as I felt exhausted. I was unable to work on Monday or Tuesday as I was still very disoriented. I would periodically had dizzy spells where I thought I was going to pass out, so when I went back to work on Wednesday, my husband drove me to work and picked me up. At work, when walking I still was very unsteady on my feet and kind of had to hold onto the wall to keep my balance. This stayed with me thru the next week. I felt better the following week and have not had any other issues.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Loss of consciousness, Nausea, Retching
Clinical narrative: Approximately 28 hours after receiving the vaccine, I became very dizzy, to the point that my head was spinning so fast I would pass out. When I would wake up, I was so nauseated that I tried to throw up but hadn't eaten anything, so I had dry heaves. I would wake up and repeat this process over and over. After about 6 hours the dizziness got better but I could not walk by myself as I was so wobbly and weak. My husband tried to get me to the car to take me to the ER but I couldn't stand up. I felt a little better the next day (Sunday) but was unable to keep anything down. I slept a lot as I felt exhausted. I was unable to work on Monday or Tuesday as I was still very disoriented. I would periodically had dizzy spells where I thought I was going to pass out, so when I went back to work on Wednesday, my husband drove me to work and picked me up. At work, when walking I still was very unsteady on my feet and kind of had to hold onto the wall to keep my balance. This stayed with me thru the next week. I felt better the following week and have not had any other issues.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea
Clinical narrative: Within 48 hours of receiving covid vaccine, patient started experiencing severe headaches, mild nausea, and moderate chills. patient had tried OTC medication to help with symptoms with little to no relief. Same reaction/symptoms happened after 2nd covid dose. Symptoms are still present as of 3/9/2021 and not getting any better.   2nd covid shot was  2/11/2021  LOT:016M20A
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Red rash on arm, spreading, warm to touch
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Herpes zoster, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Unsure if directly caused by vaccine, but wanted to report it just in case:  Left arm pain, numbness, tingling and  weaknesses started on Monday March 1, Rash on left hand and upper body began on Wed March 5, diagnosed with Shingles on Thursday March 6.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Dehydration, Incomplete course of vaccination, Injection site rash, Mobility decreased, Pyrexia
Clinical narrative: had a fever / had to go to the hospital.; couldn't barely move / had to go to the hospital.; was completed dehydrated /had to go to the hospital.; Rash at the injection site (Left arm) 6 inches long and 3 inches wide. / had to go to the hospital.; This case was reported by a consumer via call center representative and described the occurrence of fever in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 6th October 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fever (serious criteria hospitalization), mobility decreased (serious criteria hospitalization), dehydration (serious criteria hospitalization), injection site rash (serious criteria hospitalization) and incomplete course of vaccination. On an unknown date, the outcome of the fever, mobility decreased, dehydration, injection site rash and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the fever, mobility decreased, dehydration and injection site rash to be related to Shingrix.  Additional information was provided as follows: The case was reported by patient herself. The reporter was asking if Shingrix contain the Polyethylene glycol or polysorbate, due to being interested in COVID vaccine. The patient had to go to the hospital after receiving 1st dose of vaccine. The patient stated she was completely dehydrated and could not barely move also had a fever. She experienced rash at the injection site (Left arm) 6 inches long and 3 inches wide. The reporter was unable to provide vaccine details. The patient was advised not to get the Second shot of Shingrix The reporter consented to follow up.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Urticaria
Clinical narrative: Patient stated that she developed some hives on her neck after receiving the vaccine and about 2 weeks after vaccination began having stomach upset that she is still experiencing
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Condition aggravated
Clinical narrative: Got shot at 3:30pm by 10:30pm had symptoms of bell palsy (eye sagged)  On 3/6/21 eye and mouth sagged.  Went to emergency room, was given Prednisone 50mg, still having problems with eye and mouth.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Blood test, Cardiac monitoring, Cough, Electrocardiogram
Clinical narrative: Anaphylactic reaction-flushing, lump throat, cough onset within 10 minutes. InER 2hrs home on medication solumedrol, benadryl,pepcid, IV fluids
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Oxygen saturation, Sensation of foreign body
Clinical narrative: Anaphylactic reaction-flushing, lump throat, cough onset within 10 minutes. InER 2hrs home on medication solumedrol, benadryl,pepcid, IV fluids
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Improper Storage (temperature)
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Injection site pruritus, Peripheral swelling, Pyrexia
Clinical narrative: Fever - 100.1 afternoon of 3/5, fever 98.9 into 3/6 Headache - 3/5 and 3/6 Joint ache - 3/5 and 3/6 Arm swollen and itchy at injection site
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Palpitations, Taste disorder
Clinical narrative: pt stated that the morning after the covid vax she felt nauseated, fatigued, had chills, racing heart beat, strange taste in her mouth.  One week after getting the vax she still has all of these symptoms and has an appt w/ her PCP on 3/11/2021.  She states she feels like she did when she had carbon monoxide poisoning 3 years ago.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Chills, Fatigue, Headache, Hypersomnia
Clinical narrative: About 9 days after receiving the 1st shot  on 1/15/21  a rash appeared on my chest area. Raised bumps and non spreading. I have now received my second dose on 2/11/21 .Had reactions that occurred the next day of chills, muscle and body aches, slept for 14 hours, totally fatigued, headache on day 4 ran a fever and then symptoms decreased. except for the rash that has never went away.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pain, Pyrexia, Rash, Rash papular
Clinical narrative: About 9 days after receiving the 1st shot  on 1/15/21  a rash appeared on my chest area. Raised bumps and non spreading. I have now received my second dose on 2/11/21 .Had reactions that occurred the next day of chills, muscle and body aches, slept for 14 hours, totally fatigued, headache on day 4 ran a fever and then symptoms decreased. except for the rash that has never went away.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Rash erythematous
Clinical narrative: Day 9 after vaccine felt slight itchiness at vaccine site off & on during day; Day 10 after vaccine woke up to itchy red circular rash around vaccine site approximately 1 1/2"x2".  Day 11 after vaccine rash site increased to 2" x 2 1/2" & itchy around edges. Rash slightly lighter in color except around edge.  Day 12 after vaccine rash @ 2 1/2" x 2 12" but much lighter-pinkish- in color & very little itching.  Day 13 rash very light pink & no itching.  Day 14, rash hardly visible. No itching and each day after visibly disappearing.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Accidental underdose, Extra dose administered, Immediate post-injection reaction, Injection site haemorrhage, Syringe issue
Clinical narrative: syringe issue; white part around the plunger where you put your fingers (finger tip) flew off during administration; patient was bloodied.; did not receive a full Boostrix dose / was given another, full Boostrix dose.; This case was reported by a pharmacist via call center representative and described the occurrence of injection site hemorrhage in a 40-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 33AT7, expiry date 7th November 2022) for prophylaxis. This case was associated with a product complaint.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st March 2021, the patient received Boostrix (intramuscular) and Boostrix Pre-Filled Syringe Device. On 1st March 2021, immediately after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced injection site hemorrhage and accidental underdose. On an unknown date, the patient experienced syringe issue and pharmaceutical product complaint. On an unknown date, the outcome of the injection site hemorrhage, accidental underdose, syringe issue and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the injection site hemorrhage to be related to Boostrix and Boostrix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that the white part around the plunger where you put your fingers (finger tip) flew off during administration into male patient's deltoid. The white piece flew off across the room. The patient did not receive a full Boostrix dose due to the finger tip flying off, which led accidental underdose. Patient did not receive a full Boostrix dose due to the finger tip flying off and patient was bloodied. The patient was given another, full Boostrix dose. The reporter did not consent to followup.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Rash
Clinical narrative: Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: 10 hours after injection began running a fever of 102, chilling, achy, headache. Treated with tylenol and lasted about 5 hours. Felt very tired and achy for the next 12-14 hours. Returned to work two days after feeling fine.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Dysphagia, Flushing, Pharyngeal swelling
Clinical narrative: Approximately 20 minutes after receiving the 2nd covid vaccine pt reported feeling lightheaded and dizzy which progressed to flushed blotchy redness on chest and neck.  BP 190/104. Approx 3 minutes later pt reported feeling like throat was swelling and was having difficulty swallowing. Pt had premedicated with Benadryl 25mg po prior to arrival due to history on anaphylaxis to multiple other medications and foods. Benadryl 25mg po was administered and pt assisted to exam room. Pt began to be anxious and said swelling was getting worse. Epinephrine (1mg/ml) 0.5mg IM administered per standing order.Refused ambulance or transfer to ER at this time. Husband at side and said this has happened previously and she knows how to manage without the ER.  10 minutes after 1st dose of epinephrine a second dose of 0.5mg epinephrine administered due to continued swelling. PT was monitored in clinic. Left ambulatory with no resp distress or resp symptoms noted. Pt and husband refused EMS and ER. Instructed to follow-up with PCP and s/s to seek further treatment from ER.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: Approximately 20 minutes after receiving the 2nd covid vaccine pt reported feeling lightheaded and dizzy which progressed to flushed blotchy redness on chest and neck.  BP 190/104. Approx 3 minutes later pt reported feeling like throat was swelling and was having difficulty swallowing. Pt had premedicated with Benadryl 25mg po prior to arrival due to history on anaphylaxis to multiple other medications and foods. Benadryl 25mg po was administered and pt assisted to exam room. Pt began to be anxious and said swelling was getting worse. Epinephrine (1mg/ml) 0.5mg IM administered per standing order.Refused ambulance or transfer to ER at this time. Husband at side and said this has happened previously and she knows how to manage without the ER.  10 minutes after 1st dose of epinephrine a second dose of 0.5mg epinephrine administered due to continued swelling. PT was monitored in clinic. Left ambulatory with no resp distress or resp symptoms noted. Pt and husband refused EMS and ER. Instructed to follow-up with PCP and s/s to seek further treatment from ER.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Pruritus, Skin warm, Tenderness
Clinical narrative: 1/5/2021 vaccination; sore arm, tenderness 1/8/2021 symptoms subsided 1/12 itchy red hot. Continued to increase in size.  Started out as size of eraser and got as big a baseball. Prescribed steroids for the 2nd injection but I never took them.  1/17 started to dissipate  *2nd vaccination; fatigue.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Nasopharyngitis, Pyrexia
Clinical narrative: shivering, cold, feverish, muscle aches
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hyperhidrosis
Clinical narrative: Initial sweaty and short of breath with pulse of 126 and oxygen saturation of 99%; rapidly improved with stable vital signs
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Migraine, Rash
Clinical narrative: The next day, the patient reported shingles on the temple of her right side, moving to the forehead / toward the eye /  diagnosis of shingles; This case was reported by a consumer and described the occurrence of shingles in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included migraine headache.   On 25th February 2021, the patient received the 1st dose of Shingrix (intramuscular). On 26th February 2021, 1 days after receiving Shingrix, the patient experienced shingles. The patient was treated with antivirals nos (Anti-Viral Medicine (Nos)). On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information was provided as follows: The patient went to see her physician for a migraine headache. The physician gave her a dose of Shingrix as part of her annual exam. The next day after receiving vaccine, the patient reported shingles on the temple of her right side, moving to the forehead and toward the eye. The patient went to urgent care and a diagnosis of shingles was made. The patient was given anti-virals and discharged.  On 1st March 2021 Monday, the patient went to see an ophthalmologist, who confirmed shingles again, but noted it did not get into the eye. Steroid drops were prescribed and symptoms were still present till the time of reporting. Formulation of Shingrix was not known, nor the lot number. The patient required emergency visit. The reporter consented to follow up.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nasopharyngitis
Clinical narrative: Overly tired, cold, some shivers and a headache at the end  Took A Tylenol Cold & Head caplet in the afternoon and the symptoms started to ease up.  Felt normal at 3 am the next day except for the raging headache but that went away by 5 am.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Body aches and fatigue.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Influenza like illness, Pain
Clinical narrative: I had body aches, slight headache and felt drained of energy.  Flu like symptoms
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Body temperature, COVID-19, Coronavirus test positive
Clinical narrative: testing positive for COVID; Fever for 3 hours after the vaccine/ High temperature; Joint pain; Severe upper back pain; Headache; A spontaneous report was received from a nurse concerning a 44-year-old female patient who experienced fever for 3 hours after vaccination, headache, joint pain, and severe upper back pain.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included dulaglutide, metformin, empagliflozin, losartan, amlodipine, levothyroxine, simvastatin, allopurinol, estrogen, colchicine, calcium, zinc, multivitamin and vitamin C.  On 05 Jan 2021, the patient received mRNA-1273 (Lot number 026L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 05 Jan 2021, patient experienced fever for 3 hours after vaccination.  The patient also experienced headache, joint pain, and  severe upper back pain. The patient stated her temperature was high from 05 Jan 2021 until 09 Jan 2021 when it went down.  Treatment information was not provided.  Follow-up received on 21 Feb 2021, from the patient's husband, included that the patient tested positive for Covid-19 on 09 Jan 2021 and was hospitalized on 11 Jan 2021.  The patient never recovered from her symptoms and the patient died on 02 Feb 2021.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the events Coronavirus test positive was fatal and for headache, joint pain, severe upper back pain and temperature were unknown.  The cause of death was reported as Coronavirus test positive and autopsy details was unknown.; Reporter's Comments: This case concerns a 44-year-old female who was hospitalized with a serious unexpected event of COVID-19 with fatal outcome along with NS unexpected back pain and NS expected fever, headache, arthralgia. Event onset was 5 days after the first dose of mRNA-1273. Treatment not reported. Event outcomes fatal. Autopsy results unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Testing positive for COVID
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: testing positive for COVID; Fever for 3 hours after the vaccine/ High temperature; Joint pain; Severe upper back pain; Headache; A spontaneous report was received from a nurse concerning a 44-year-old female patient who experienced fever for 3 hours after vaccination, headache, joint pain, and severe upper back pain.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included dulaglutide, metformin, empagliflozin, losartan, amlodipine, levothyroxine, simvastatin, allopurinol, estrogen, colchicine, calcium, zinc, multivitamin and vitamin C.  On 05 Jan 2021, the patient received mRNA-1273 (Lot number 026L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 05 Jan 2021, patient experienced fever for 3 hours after vaccination.  The patient also experienced headache, joint pain, and  severe upper back pain. The patient stated her temperature was high from 05 Jan 2021 until 09 Jan 2021 when it went down.  Treatment information was not provided.  Follow-up received on 21 Feb 2021, from the patient's husband, included that the patient tested positive for Covid-19 on 09 Jan 2021 and was hospitalized on 11 Jan 2021.  The patient never recovered from her symptoms and the patient died on 02 Feb 2021.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the events Coronavirus test positive was fatal and for headache, joint pain, severe upper back pain and temperature were unknown.  The cause of death was reported as Coronavirus test positive and autopsy details was unknown.; Reporter's Comments: This case concerns a 44-year-old female who was hospitalized with a serious unexpected event of COVID-19 with fatal outcome along with NS unexpected back pain and NS expected fever, headache, arthralgia. Event onset was 5 days after the first dose of mRNA-1273. Treatment not reported. Event outcomes fatal. Autopsy results unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Testing positive for COVID
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Anaphylactic reaction
Clinical narrative: Other side effects; Anaphylaxis; Anaphylaxis; A spontaneous report was received from a nurse, concerning a 32-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced 2 episodes of anaphylaxis (onset: 28 Jan 2021 and 29 Jan 2021) and other unspecified side effects.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unspecified date patient took her first of two planned doses. On 28 Jan 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 028L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 28 Jan 2021, the patient experienced the event of anaphylaxis (life threatening), within 30minutes after the second dose of vaccine. Hence, she received epinephrine and her condition did not improve so received a second dose of the same, also was treated with diphenhydramine and oxygen and sent home. Next day, on 29 Jan 2021, the patient again went into anaphylaxis, hence, received another epinephrine and was also given with prednisone due to which patient got better and was stable today. But, however, she still having other side effects but not anaphylaxis. The patient's clinical history says that on Sunday night she continued to be symptomatic with vaccine side effects. The patient was confirmed to be not pregnant. Treatment for event other side effects were unknwon.  Action taken with mRNA-1273 in response to the events were not reported.   The outcome of events anaphylaxis (onset: 28 Jan 2021) and anaphylaxis (onset date: 29 Jan 2021) was resolved on 29 Jan 2021. The outcome of event other side effects was considered unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Diarrhoea
Clinical narrative: Diarrhea; A-afib; A spontaneous report was received from an 83-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced diarrhea followed by exacerbation of her A-fib (atrial fibrillation).    The patient's medical history included hypertrophic obstructive cardiomyopathy.  Concomitant product use was not provided.  On 25-Jan-2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (batch number 011M20A) for prophylaxis of COVID-19 infection.  On 01-Feb-2021 (reported a week later), the patient experienced persistent diarrhea.  She stated, "I believe it's affecting my heart" and that "she went into A-fib since having diarrhea."      Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was unknown.  The events of diarrhea and atrial fibrillation were not resolved at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Facial bones fracture, Fall, Hand fracture, Wrist fracture
Clinical narrative: Broke the bone of my eye socket (bottom part); Broke my right-hand wrist; Broke my right-hand wrist; I slipped outside while given food to birds; A spontaneous report was received from a consumer who was a 50- year-old female, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, slipped outside while giving food to birds(fall), broke her right-hand wrist (hand fracture; wrist fracture) and broke the bone of her eye (facial bone fracture).   The patient's medical history was not provided. Concomitant medications reported included lisinopril and vitamins.  On 30-JAN-2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot: 010M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 20-FEB-2021, patient reported that she slipped outside while giving food to birds.  She stated that she broke her right hand and wrist as well as the bottom part of her eye socket.  The patient was scheduled to receive the second dose of mRNA-1273 on 27-FEB-2021 and was unsure as to whether or not to get it due to the fact that she had recently received a Tetanus vaccine.  Treatment for the events  included a cast to the right upper extremity and a tetanus shot to the right arm on 20-FEB-2021.  Action taken with mRNA-1273 in response to the events was unknown.  At the time of this report, the events, slipped outside while giving food to birds(fall), broke her right-hand wrist (hand fracture; wrist fracture) and broke the bone of her eye (facial bone fracture), were considered recovering/resolving.; Reporter's Comments: This case concerns a 50 year old, female patient, who experienced a serious unexpected event of Facial bones fracture, hand fracture, wrist fracture, and fall, 22 day after receiving 1st dose of mRNA- 1273 (Lot# 010M20A). Based on the mechanism of action of mRNA-1273, the events are assessed as unlikely related to mRNA-1273. Further information has been requested.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Neck pain, Urinary tract infection
Clinical narrative: UTI; weakness; neck pain; A spontaneous report was received  from a healthcare professional concerning an 85-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced UTI (urinary tract infection), weakness (asthenia) and neck pain.  The patient's medical history was not provided.  Concomitant medications were not reported.  On 26-Jan-2021, the patient received the second of two planned doses of mRNA-1273 (LOT/BATCH: 029K20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 21-Feb-2021, the patient went to the hospital and was admitted for two days for UTI, weakness, and neck pain. Treatment for the events was not reported.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore action taken with the drug in response to the events is not applicable.   The outcome of the events, UTI, weakness and neck pain, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Erythema, Peripheral swelling, Pruritus
Clinical narrative: cellultis; left lower leg turned stop-light red; swollen; itchy; A spontaneous report was received from a consumer who was a 73-year-old, female patient who received Moderna's COVID-19 vaccine and who developed cellulitis, her left lower leg turned stop-light red, swollen and itchy.  The patient's past medical history included cellulitis.  No relevant concomitant medications were reported.   On 19-Feb-2021, approximately 2 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (LOT/BATCH: 016M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On the day of vaccination, the patient reported that her left lower leg turned stop-light red and that it became swollen and itchy. The patient was admitted to the hospital 20-Feb-2021 through 22-Feb-2021 where she was treated with intravenous vancomycin.   Treatment for the event included intravenous vancomycin.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, cellulitis, her left lower leg turned stop-light red, swollen and itchy,  was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Vaccination site pain
Clinical narrative: Unconscious; Felt a bit sore at the injection site; A spontaneous report was received from a consumer and healthcare facility staff member concerning a 69 years old, female patient who experienced little bit sore at the injection site, unconscious and passed away.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 22 Feb 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.   The patient experienced sore at the injection site and unconsciousness both since 22 Feb 2021. The husband of the patient performed CPR as instructed by 911 and EMT's and police performed medical procedure which included injections and electrical shock both on 22 Feb 2021. The patient died on 22 Feb 2021.  Treatment information was not provided.   The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The patient died on 22 Feb 2021. The cause of death was unknown. Plans for an autopsy were not provided.; Reporter's Comments: This is a case of death of a 59-year-old, female patient who experienced injection site sore and became unconscious on the same day after mRNA-1273 administration and subsequently expired. Although critical details such as the patient's medical history and actual cause of death is lacking, based on the current available information which shows a strong temporal association with the product use, thus, a causal relationship cannot be excluded. injection sore is consistent with product safety profile and cannot be excluded.; Reported Cause(s) of Death: Unknown cause of death