chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence, Tremor, X-ray
Clinical narrative: 3/24/2021 11am vaccination A couple hours later, I went back to work. I started feeling pains in my neck and feeling 'off'. The pain went to my hands, achy, and numbness radiated to feet. Felt awful driving home. Four hours, my body felt like 'hit by a baseball bat'. I did take some Tylenol and Ibuprofen. I went to bed, started to get chills with heating pad, felt like I just needed to sleep. My husband kept me hydrated. It hurt in my neck.  My temp was between 103-104. Included shaking, chills, sweats, fatigue.  A few days later, pain from shoulder to my neck. Past weekend, I went to see my chiropractor as I couldn't make pain go away, unless I lifted my arms. This is the only time I have ever seen a chiropractor and saw them a total of 8 times. They wanted me to go to 12 but it was 'getting expensive'.  *pretty much gone away *COVID +, Jan 2021
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute myocardial infarction, Dizziness
Clinical narrative: Patient presented to the ED and was subsequently hospitalized several times within 6 weeks of receiving COVID vaccination. Dates include: 2/24/21, 3/2/21, 4/17/21. Patient presented to the ED on 4/29/21 with NSTEMI and 5/7/21 with dizziness.
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiopathy, Chronic obstructive pulmonary disease, Coronary artery disease
Clinical narrative: Patient presented to the ED and was subsequently hospitalized several times within 6 weeks of receiving COVID vaccination. Dates include: 2/24/21, 3/2/21, 4/17/21. Patient presented to the ED on 4/29/21 with NSTEMI and 5/7/21 with dizziness.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Hearing ringing sounds in right ear. About from 4/15/21 to now continously.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Fatigue, Headache
Clinical narrative: Full body chills, extreme body aches (specifically in back, neck and joints), site injection soreness, headache, night sweats and fatigue. Symptoms got better with 800 mg ibuprofen, but returned. Woke up 2nd day with same symptoms. Treated again with 800 mg ibuprofen. Reporting this on Day 2.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Neck pain, Night sweats, Pain
Clinical narrative: Full body chills, extreme body aches (specifically in back, neck and joints), site injection soreness, headache, night sweats and fatigue. Symptoms got better with 800 mg ibuprofen, but returned. Woke up 2nd day with same symptoms. Treated again with 800 mg ibuprofen. Reporting this on Day 2.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, General physical health deterioration, Lethargy, Magnetic resonance imaging head normal, Mental status changes
Clinical narrative: Approximately 2 weeks after receiving vaccination, patient developed confusion and lethargy. He presented to the hospital where he was found to be febrile. Alteration mental status continued to worsen, and then had a generalized seizure.  Patient was empirically treated for possible meningoencephalitis but diagnosis is not confirmed.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Seizure
Clinical narrative: Approximately 2 weeks after receiving vaccination, patient developed confusion and lethargy. He presented to the hospital where he was found to be febrile. Alteration mental status continued to worsen, and then had a generalized seizure.  Patient was empirically treated for possible meningoencephalitis but diagnosis is not confirmed.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Fall, Hyperhidrosis, Syncope
Clinical narrative: Syncopal Episode  Vital Signs: BP 92/64 HR 60 Resp 14 O2Sat 98%  Skin Signs: Clammy, diaphoretic  Circulation: Cap refill 4-5 sec  Respiratory: Breath sound clear bilaterally  Initial Treatment: Patient received vaccine, fell to syncope - responsive after 5 seconds. Patient hit concrete floor with a loud sound. Patient awake after 5 seconds. A/Ox5 Patient moved to L lateral position with manual spinal check.  11:50 AM  Vital Signs: BP 99/60 HR 78 Resp 18 O2Sat 97%  Skin Signs: Diaphoretic  Circulation: Cap refill <2sec  Respiratory: Breath sound clear bilaterally  Follow up Treatment: EMS on scene. Patient assessed by EMS. Spine cleared by EMS. Patient moved to superior posterior. Patient refused further transport to hospital.  12:00 PM  Patient discharged home, escorted by EMS and significant other.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Seizure
Clinical narrative: Patient received vaccine and while walking around the store began to feel lightheaded/dizzy and fainted. Her parent caught her and brought her to the ground where she began to have a seizure. Paramedics were called and took over care of the patient. She was conscious and breathing after her seizure
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Occupational exposure to product
Clinical narrative: swirled in between fingers/ No evidence of leakage in package; Product got on her hand; Product got on her hand; This case was reported by a pharmacist via call center representative and described the occurrence of occupational exposure while preparing product for administration in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 4B53D, expiry date 10th October 2022) for prophylaxis. This case was associated with a product complaint.   On 17th May 2021, the patient received Shingrix. On 17th May 2021, unknown after receiving Shingrix, the patient experienced occupational exposure while preparing product for administration and exposure via skin contact. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the occupational exposure while preparing product for administration, exposure via skin contact and pharmaceutical product complaint were unknown.  Additional details were provided as follows: Age at vaccination was not applicable for this report. It was reported that the defect discovered while reconstituting. The reporter stated health care professional swirled in between fingers and unknown amount of air injected in vial, prior to turning upside to withdraw .The vial was held upside down. The product got on her hand, which led to occupational exposure while administering product and exposure via skin contact. No product was administered. The preparer was an experienced user. Rubber stopper/metallic skirt did not become loose on vial before handling. Flip-off cap was removed by HCP.  No evidence of leakage in package. The reporter failed to ask for picture.  The reporter did not consent to follow-up.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, COVID-19, Cough, Fatigue, Pyrexia
Clinical narrative: cough fever fatique loss of taste
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: cough fever fatique loss of taste
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Lymphadenopathy
Clinical narrative: after 1st and 2nd doses of shot - my L armpit lymph nodes swelled and became tender and painful.  After 1st dose the pain subsided after 3 or so days; wasn't too bad just uncomfortable.  After the 2nd dose the lymph nodes swelled even more than the first time and there was a constant pain/discomfort that lasted for several days with no relief from tylenol and mild temp relief from hot compresses.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose normal, Fall, Feeling hot, Head injury, Loss of consciousness
Clinical narrative: Patient received the Janssen vaccine.  Less than 1 minute after receiving the vaccine,  passed out and had seizure like activity for 10 sec.  When he fell, his hit the right side of his head.  When he came to, he knew where he was.  Ambulance was called, he refused to go to the hospital.  BP was 138/78 and pulse was in the 60's.  Leading up to passing out,  reported that he felt warm, then passed out.  After waking up and coming to, he was feeling better.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure like phenomena
Clinical narrative: Patient received the Janssen vaccine.  Less than 1 minute after receiving the vaccine,  passed out and had seizure like activity for 10 sec.  When he fell, his hit the right side of his head.  When he came to, he knew where he was.  Ambulance was called, he refused to go to the hospital.  BP was 138/78 and pulse was in the 60's.  Leading up to passing out,  reported that he felt warm, then passed out.  After waking up and coming to, he was feeling better.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Vaginal haemorrhage
Clinical narrative: headache, body pains, spotting blood
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: PT REPORTS DIZZINESS AND LIGHT HEADED. PT STATED THAT HE DID NOT EAT BEFORE COMING. CRACKERS AND COLD WATER WAS OFFERED AND PATIENT FELT BETTER AFTER 15MINUTES
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Seizure
Clinical narrative: Pt has experienced seizure events and amnesia. She is continuing to undergo extensive evaluations. Events started around April 22, 2021.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Abscess of eyelid, Subcutaneous abscess
Clinical narrative: pt noticed an abscess on his left chest about 3 days after vaccine. a day or two later another abscess on his right upper eyelid.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Not sure at the time of the call /  if the diluent vials were administered to patients; Not sure at the time of the call /  if the diluent vials were administered to patients; package doses unit missing; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in in an unspecified number of patients who received Herpes zoster (Shingrix) (batch number 7Y359, expiry date 15th November 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication, inappropriate dose of vaccine administered and pharmaceutical product complaint. On an unknown date, the outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and pharmaceutical product complaint were unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist had a Shingrix box which was only with 3 lyophilized vials and no diluent vials. The reporter was not sure at the time of the call if the box came that way or if the diluent vials were administered to patients, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No further information was provided at the time of the call. The reporter consented to follow up by telephone.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase normal, Anion gap decreased, Aspartate aminotransferase normal, Basophil count decreased, Basophil percentage
Clinical narrative: Received Pfizer 2nd dose on 3/28/21 --chills, body aches, in bed for 2 days straight --body aches resolved after 6 weeks (began after first shot) --chills began after 2nd shot and resolved after about 2 weeks --no fever Now sleeping 10 hours/night Fatigue is gradually improving but still --interfering with her ability to function --feels different from fatigue related to Parsonage and depression  Treated for staph infection of left axilla on 4/13 that began a week before (a week after 2nd Covid-19 vaccine)
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Blood albumin increased, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium normal, Blood chloride normal
Clinical narrative: Received Pfizer 2nd dose on 3/28/21 --chills, body aches, in bed for 2 days straight --body aches resolved after 6 weeks (began after first shot) --chills began after 2nd shot and resolved after about 2 weeks --no fever Now sleeping 10 hours/night Fatigue is gradually improving but still --interfering with her ability to function --feels different from fatigue related to Parsonage and depression  Treated for staph infection of left axilla on 4/13 that began a week before (a week after 2nd Covid-19 vaccine)
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatinine decreased, Blood glucose normal, Blood potassium normal, Blood sodium normal, Blood thyroid stimulating hormone normal
Clinical narrative: Received Pfizer 2nd dose on 3/28/21 --chills, body aches, in bed for 2 days straight --body aches resolved after 6 weeks (began after first shot) --chills began after 2nd shot and resolved after about 2 weeks --no fever Now sleeping 10 hours/night Fatigue is gradually improving but still --interfering with her ability to function --feels different from fatigue related to Parsonage and depression  Treated for staph infection of left axilla on 4/13 that began a week before (a week after 2nd Covid-19 vaccine)
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urea normal, Carbon dioxide normal, Chills, Eosinophil count decreased, Eosinophil percentage
Clinical narrative: Received Pfizer 2nd dose on 3/28/21 --chills, body aches, in bed for 2 days straight --body aches resolved after 6 weeks (began after first shot) --chills began after 2nd shot and resolved after about 2 weeks --no fever Now sleeping 10 hours/night Fatigue is gradually improving but still --interfering with her ability to function --feels different from fatigue related to Parsonage and depression  Treated for staph infection of left axilla on 4/13 that began a week before (a week after 2nd Covid-19 vaccine)
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Full blood count, Glomerular filtration rate, Haematocrit normal, Haemoglobin normal
Clinical narrative: Received Pfizer 2nd dose on 3/28/21 --chills, body aches, in bed for 2 days straight --body aches resolved after 6 weeks (began after first shot) --chills began after 2nd shot and resolved after about 2 weeks --no fever Now sleeping 10 hours/night Fatigue is gradually improving but still --interfering with her ability to function --feels different from fatigue related to Parsonage and depression  Treated for staph infection of left axilla on 4/13 that began a week before (a week after 2nd Covid-19 vaccine)
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Immature granulocyte count, Loss of personal independence in daily activities, Lymphocyte count normal, Lymphocyte percentage decreased, Mean cell haemoglobin
Clinical narrative: Received Pfizer 2nd dose on 3/28/21 --chills, body aches, in bed for 2 days straight --body aches resolved after 6 weeks (began after first shot) --chills began after 2nd shot and resolved after about 2 weeks --no fever Now sleeping 10 hours/night Fatigue is gradually improving but still --interfering with her ability to function --feels different from fatigue related to Parsonage and depression  Treated for staph infection of left axilla on 4/13 that began a week before (a week after 2nd Covid-19 vaccine)
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Mean cell haemoglobin concentration normal, Mean cell volume normal, Mean platelet volume normal, Metabolic function test, Monocyte count decreased
Clinical narrative: Received Pfizer 2nd dose on 3/28/21 --chills, body aches, in bed for 2 days straight --body aches resolved after 6 weeks (began after first shot) --chills began after 2nd shot and resolved after about 2 weeks --no fever Now sleeping 10 hours/night Fatigue is gradually improving but still --interfering with her ability to function --feels different from fatigue related to Parsonage and depression  Treated for staph infection of left axilla on 4/13 that began a week before (a week after 2nd Covid-19 vaccine)
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Monocyte percentage, Neutrophil count increased, Neutrophil percentage increased, Pain, Platelet count normal
Clinical narrative: Received Pfizer 2nd dose on 3/28/21 --chills, body aches, in bed for 2 days straight --body aches resolved after 6 weeks (began after first shot) --chills began after 2nd shot and resolved after about 2 weeks --no fever Now sleeping 10 hours/night Fatigue is gradually improving but still --interfering with her ability to function --feels different from fatigue related to Parsonage and depression  Treated for staph infection of left axilla on 4/13 that began a week before (a week after 2nd Covid-19 vaccine)
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Protein total normal, Red blood cell count normal, Red cell distribution width increased, Serum ferritin normal, Staphylococcal infection
Clinical narrative: Received Pfizer 2nd dose on 3/28/21 --chills, body aches, in bed for 2 days straight --body aches resolved after 6 weeks (began after first shot) --chills began after 2nd shot and resolved after about 2 weeks --no fever Now sleeping 10 hours/night Fatigue is gradually improving but still --interfering with her ability to function --feels different from fatigue related to Parsonage and depression  Treated for staph infection of left axilla on 4/13 that began a week before (a week after 2nd Covid-19 vaccine)
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Thyroxine free normal, Tri-iodothyronine free normal, White blood cell count increased
Clinical narrative: Received Pfizer 2nd dose on 3/28/21 --chills, body aches, in bed for 2 days straight --body aches resolved after 6 weeks (began after first shot) --chills began after 2nd shot and resolved after about 2 weeks --no fever Now sleeping 10 hours/night Fatigue is gradually improving but still --interfering with her ability to function --feels different from fatigue related to Parsonage and depression  Treated for staph infection of left axilla on 4/13 that began a week before (a week after 2nd Covid-19 vaccine)
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Anti-cyclic citrullinated peptide antibody, Antinuclear antibody, Arthralgia, Asthenia, Blood test abnormal
Clinical narrative: About 8-10 hours after the vaccine started feeling very sick. Fever reached 101.8 and had joint pains in hands, feet, wrists, and ankles along with full-body aches. Felt better after about 30 hours, but on day 5 post-vaccination started having painful joints in my hands, feet and some in wrists and ankles, and also in the elbows and knees. Saw a doctor and did blood work for inflammatory markers. Some came back elevated, so followed up with additional blood week a couple of weeks later. Got a referral to a rheumatologist who said that it might be RA, but too soon to diagnose and he said I had a good chance of it resolving with time.  I never had joint pain prior to the vaccine. It has been nearly 12 weeks now and I am still suffering from intense, debilitating joint pain, mostly in the hands and feet.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein, Full blood count, Inflammatory marker increased, Malaise, Metabolic function test
Clinical narrative: About 8-10 hours after the vaccine started feeling very sick. Fever reached 101.8 and had joint pains in hands, feet, wrists, and ankles along with full-body aches. Felt better after about 30 hours, but on day 5 post-vaccination started having painful joints in my hands, feet and some in wrists and ankles, and also in the elbows and knees. Saw a doctor and did blood work for inflammatory markers. Some came back elevated, so followed up with additional blood week a couple of weeks later. Got a referral to a rheumatologist who said that it might be RA, but too soon to diagnose and he said I had a good chance of it resolving with time.  I never had joint pain prior to the vaccine. It has been nearly 12 weeks now and I am still suffering from intense, debilitating joint pain, mostly in the hands and feet.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Red blood cell sedimentation rate, Rheumatoid factor
Clinical narrative: About 8-10 hours after the vaccine started feeling very sick. Fever reached 101.8 and had joint pains in hands, feet, wrists, and ankles along with full-body aches. Felt better after about 30 hours, but on day 5 post-vaccination started having painful joints in my hands, feet and some in wrists and ankles, and also in the elbows and knees. Saw a doctor and did blood work for inflammatory markers. Some came back elevated, so followed up with additional blood week a couple of weeks later. Got a referral to a rheumatologist who said that it might be RA, but too soon to diagnose and he said I had a good chance of it resolving with time.  I never had joint pain prior to the vaccine. It has been nearly 12 weeks now and I am still suffering from intense, debilitating joint pain, mostly in the hands and feet.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: 8PM PT. STARTED BREAKING OUT WITH HIVES, HAVING SEVERE ITCHING, CALL PLACE TO OFFICE (OFFICE HOURS CLOSED) S/W DR., ADVISED TO MEDICATE WITH BENADRYL. ONLY HAD TO BE MEDICATED ONCE.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Fatigue, Feeling abnormal, Feeling drunk, Influenza like illness
Clinical narrative: The first vaccine on 4/2/2021, I developed light vertigo a day or so afterwards.   I felt off kilter and tipsy.  It was not the super dizzy kind of vertigo.  I initially did not associate it with the vaccine as I have had periodic episodes in the past but it has been some time since the last episode.  I had some tiredness and started to not feel well the day of the 1st shot.  I received the 2nd shot on 5/1/2021.  I developed tiredness and light flu symptoms.  My right arm also hurt.  No big deal.  But the day or so afterwards, I developed vertigo that persisted for 5 plus days. (This was not dizziness or anything immediately after the shot.)  The vertigo for me is waking up and I am off kilter and feels like I have had a few beers.  The first day was not great but proceeded to get better.  I would usually have it worse in the morning and it would get better throughout the day.  I would feel less drunk,tipsy and less off kilter as time progressed.  I was able to see my ENT, Dr, on 5/20/21 though I am mostly recovered.  I think I am just predisposed to this and something in the vaccine triggered this response in my system.   Nonetheless, I am very thankful for the vaccine but wanted to report it in the event that it helps to understand how the vaccine may impact some people. I have no other effects and feel great.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Pain in extremity, Vertigo
Clinical narrative: The first vaccine on 4/2/2021, I developed light vertigo a day or so afterwards.   I felt off kilter and tipsy.  It was not the super dizzy kind of vertigo.  I initially did not associate it with the vaccine as I have had periodic episodes in the past but it has been some time since the last episode.  I had some tiredness and started to not feel well the day of the 1st shot.  I received the 2nd shot on 5/1/2021.  I developed tiredness and light flu symptoms.  My right arm also hurt.  No big deal.  But the day or so afterwards, I developed vertigo that persisted for 5 plus days. (This was not dizziness or anything immediately after the shot.)  The vertigo for me is waking up and I am off kilter and feels like I have had a few beers.  The first day was not great but proceeded to get better.  I would usually have it worse in the morning and it would get better throughout the day.  I would feel less drunk,tipsy and less off kilter as time progressed.  I was able to see my ENT, Dr, on 5/20/21 though I am mostly recovered.  I think I am just predisposed to this and something in the vaccine triggered this response in my system.   Nonetheless, I am very thankful for the vaccine but wanted to report it in the event that it helps to understand how the vaccine may impact some people. I have no other effects and feel great.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: 103 fever, severe headache and chills, body ache, fatigue, nausea and dizziness.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: 103 fever, severe headache and chills, body ache, fatigue, nausea and dizziness.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Fatigue, Pain in extremity, Rhinorrhoea
Clinical narrative: 1st night: mild cough, sneezing, runny nose, tiredness, sore arm and shoulder. - Slept all day. 2nd day: sneezing, runny nose, sore arm.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: 1st night: mild cough, sneezing, runny nose, tiredness, sore arm and shoulder. - Slept all day. 2nd day: sneezing, runny nose, sore arm.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: Pt received Pfizer for dose 2 instead of Moderna. No side effects noted
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dizziness, Fatigue, Headache, Nasal congestion
Clinical narrative: Sinus congestion/sore throat/cough/headache/fatigue/lightheadedness 2 hrs post vaccine. Given supportive medication to manage symptoms
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Sinus congestion/sore throat/cough/headache/fatigue/lightheadedness 2 hrs post vaccine. Given supportive medication to manage symptoms
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site swelling
Clinical narrative: Patient with localized swelling to injection site less than one minute after vaccine administration.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose / in January 2020 / has not received dose two; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in January 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that the patient who was in her late sixties received 1st dose of Shingrix on January2020 and did not receive 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Memory impairment, Pain
Clinical narrative: HEADACHES, ACHINESS, STINGING (NEUROPATHY) BODY ACHES, FOGGY HEADED, MEMORY ISSUES
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site cellulitis, Injection site rash, Injection site warmth
Clinical narrative: Patient received shot and believed that technique on vaccination was inappropriate causing patient to develop SSTI (cellulitis). Patient saw red rash that was very warm to touch on arm at injection site.  Patient went to urgent care and given oral antibiotics (Keflex) for infection on arm.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Injection site pain, Malaise, Nausea
Clinical narrative: Pt had vasovagal reaction and emesis immediately post vaccine admin. NO ALLERGY to vaccine. Okay to receive 2nd dose.  At 1:37PM, 6 min post receiving vaccine, patient told mom that he felt lightheaded and was having pain at injection site left arm. Rn assessed immediately and pt reported feeling "sick".  He drank few sips of water. MD called to bedside. I assessed pt at 1:39PM, pt sitting chair, elevated his legs onto the footrests of wheelchair sitting in front of pt.  +Facial and lip pallor,  and   complaining of nausea followed by 1 episode NBNB emesis consisting of what he ate for lunch 1 hour prior. Pt immediately reported feeling better post emesis. Lips appeared pink. Pt brought to triage area, lay supine on stretcher with legs elevated. Nausea and "lightheaded" sensation resolved prior to lying down. BP improved post emesis from 75/39 to 84/46 at 1:48 PM. Stayed lying down for 5 minutes after which time pt wanted to sit up.  Upon sitting BP and HR increased 96/64 and 69, stable with no nausea or lightheadedness, only remaining  sx "slightly weak". drank 12 oz apple juice and ate 2 graham crackers without any further emesis or symptoms. Observed for 15 more minutes and was ambulating without return of symptoms, discharged home with mom and brother with instructions to seek medical care if symptoms return.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Presyncope, Vomiting
Clinical narrative: Pt had vasovagal reaction and emesis immediately post vaccine admin. NO ALLERGY to vaccine. Okay to receive 2nd dose.  At 1:37PM, 6 min post receiving vaccine, patient told mom that he felt lightheaded and was having pain at injection site left arm. Rn assessed immediately and pt reported feeling "sick".  He drank few sips of water. MD called to bedside. I assessed pt at 1:39PM, pt sitting chair, elevated his legs onto the footrests of wheelchair sitting in front of pt.  +Facial and lip pallor,  and   complaining of nausea followed by 1 episode NBNB emesis consisting of what he ate for lunch 1 hour prior. Pt immediately reported feeling better post emesis. Lips appeared pink. Pt brought to triage area, lay supine on stretcher with legs elevated. Nausea and "lightheaded" sensation resolved prior to lying down. BP improved post emesis from 75/39 to 84/46 at 1:48 PM. Stayed lying down for 5 minutes after which time pt wanted to sit up.  Upon sitting BP and HR increased 96/64 and 69, stable with no nausea or lightheadedness, only remaining  sx "slightly weak". drank 12 oz apple juice and ate 2 graham crackers without any further emesis or symptoms. Observed for 15 more minutes and was ambulating without return of symptoms, discharged home with mom and brother with instructions to seek medical care if symptoms return.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysmenorrhoea, Headache, Heavy menstrual bleeding, Nausea
Clinical narrative: Severe headache, nausea, chills, fever, and throwing up. For 48 hours.   Also, next menstrual period after 2nd dose was extremely painful and long.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Severe headache, nausea, chills, fever, and throwing up. For 48 hours.   Also, next menstrual period after 2nd dose was extremely painful and long.
Age: 13.0
Sex: M
Vaccine: HEP, IPV
Symptoms: Cough, Extra dose administered, Headache, Somnolence
Clinical narrative: Patient received 5 total doses of IPV (polio vaccine) on 4/29/2021; usual dose is 0.5 mL but patient received 2.5 mL.  This was noted on 5/5/21.   The family was contacted and was informed on 5/5/21.   Patient's symptoms following included  headache, croupy cough, increased sleepiness .
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus.  Continuous, severity varies
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: patient went to doctor 5-20-21 complaining of sore right arm she states from first vaccine given on 4-19-21. patient says sharp pain and radiates to hand. patient was given 2nd shot on 5-17-21 and had no complaints of problem with  first immunization.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: PT REPORTED NUMBNES AND TINGLIN IN HER LEFT HAN. IMMEDIATELY AFTER VACCINATION. SHE RECEIVED VACINE IN HER l ARM. SHE PROCEEDED TO STRETCH HER HAND AND APPLY COLD  TO THE AREA AND REPORTED IMPROVEMENT IN SYMPTOMS. PT WAS INSTRUCTED AND THAT SHE COULD LEAVE THE SITE ONCE THE SYMPTOMS IMPROVES AND RESOLVED
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: did not receive the second / shot and 9 months have passed since the first dose; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 14th August 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The nurse reported that the patient did not received 2nd dose which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Feeling cold, Headache
Clinical narrative: Around noon I started to feel extremely tired and by 2 PM I had severe chills and a headache and felt really weak.  It is very warm today and I feel so cold despite that.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Vital signs measurement
Clinical narrative: C/O dizziness and headache  Vital Signs: BP 119/79 HR 66 Resp 15 O2Sat 98%  Skin Signs: Warm and dry  Circulation: Cap refill <2sec  Initial Treatment: Patient sitting on floor and continues to C/O dizziness. No increase in S/S  Notes:  Parents instructed to follow up with PCP and to seek medical care if symptoms increase. Parents verbalized understanding. Home with parents.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Hyperhidrosis, Nausea, Pallor
Clinical narrative: Immediately after vaccination patient became nauseous, diaphoretic, weak, pale and then brief ?LOC  HR66 Pulse Ox 98 BP 1  78/58 BP 2  100/70
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hip fracture
Clinical narrative: Patient had first injection on 3/31/21, and on 4/14/21 patient presented to the ED and was subsequently hospitalized for closed right hip fracture. Patient had second injection on 5/15/21, and on 5/18/21 patient presented to the ED and was subsequently hospitalized for shortness of breath.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Gait disturbance
Clinical narrative: Joints are very painful.  My shoulders hurt and rec cortisone shot and doing  pt.  My knees I was hoping it would go away but m y knees are very sore. They started hurting the night after the shot. I could barely walk. That night.  They started to get somewhat better with rest and Wishing it would go away but it is not. So I have an apt for my knees now   This is crazy. I use to walk everyday for 3-4 miles and I can?t barely make it to a car or down the steps.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pt received Pfizer for dose 2 instead of Moderna.   no side effects reported.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Feeling cold, Syncope
Clinical narrative: Patient fainted after vaccination while he was seated during the 15 minute observation window.  Patient quickly recovered (less than 1 minute) but was feeling cold and clammy.  Patient was given water to rehydrate and stay seated for observation; Pt did not require EMS to be called as he recovered quickly on his own.  Patient left with his friends when he recovered. A follow-up phone call to the patient was made a few hours after vaccination and patient was doing well.  Patient instructed to rest up and contact MD if needed.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received 3 doses Dose 1: 03/10/21 Lot EN6205 Dose 2: 03/16/21 Lot 003A21A
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient had 1st Moderna vaccine on 5/1/21 and after 9 days, the injection site started itching, swelling, red, and warm to touch. I recommended taking Benadryl and to contact her doctor. The patient contacted her doctor with a picture of the injection site. The doctor prescribed triamcinolone cream.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Discomfort, Dysphonia, Headache, Hot flush
Clinical narrative: My left shoulder is bigger than the right, slowly the center of my head behind my nose I started having a pulsating sensation and I told my doctors and couldn't put it together and my voice changed, and I get hot flashes and I've not had a hot flash in 15 years. Now I've progressively gotten pressure in my head and it's getting worse and worse going down back of my head into my spine. I had an MRI done yesterday. I'm in so much pain in my head now.  2nd dose vaccine was taken 1/27/2021
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Swelling
Clinical narrative: My left shoulder is bigger than the right, slowly the center of my head behind my nose I started having a pulsating sensation and I told my doctors and couldn't put it together and my voice changed, and I get hot flashes and I've not had a hot flash in 15 years. Now I've progressively gotten pressure in my head and it's getting worse and worse going down back of my head into my spine. I had an MRI done yesterday. I'm in so much pain in my head now.  2nd dose vaccine was taken 1/27/2021
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Facial pain, Fatigue, Inappropriate schedule of product administration, Myalgia
Clinical narrative: febrile/fever; chills; muscle-ache; Drug dose administration interval too long; sever fatigue; pain / in the eyes and between eyes; redness in the eyes and between eyes; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number AP545, expiry date 25th January 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on 6th November 2020).   On 14th May 2021, the patient received the 2nd dose of Shingrix. On 14th May 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. In May 2021, the patient experienced fever, chills, muscle pain, fatigue, facial pain and eye red. In May 2021, the outcome of the fever, chills and muscle pain were recovered/resolved. On an unknown date, the outcome of the fatigue, facial pain and eye red were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the fever, chills, muscle pain, fatigue, facial pain and eye red to be related to Shingrix.  Additional details were provided as follow: The patient received 2nd dose of Shingrix and experienced fever, chills, muscle pain, fatigue, pain in and between eye and redness in and between eye. The patient received 2nd dose of Shingrix, more than the recommended interval, which led to lengthening of vaccination schedule. The patient was currently experiencing sever fatigue, pain and redness in the eyes and between eyes.  The reporter consented to follow up
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Ocular hyperaemia, Pyrexia
Clinical narrative: febrile/fever; chills; muscle-ache; Drug dose administration interval too long; sever fatigue; pain / in the eyes and between eyes; redness in the eyes and between eyes; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number AP545, expiry date 25th January 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on 6th November 2020).   On 14th May 2021, the patient received the 2nd dose of Shingrix. On 14th May 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. In May 2021, the patient experienced fever, chills, muscle pain, fatigue, facial pain and eye red. In May 2021, the outcome of the fever, chills and muscle pain were recovered/resolved. On an unknown date, the outcome of the fatigue, facial pain and eye red were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the fever, chills, muscle pain, fatigue, facial pain and eye red to be related to Shingrix.  Additional details were provided as follow: The patient received 2nd dose of Shingrix and experienced fever, chills, muscle pain, fatigue, pain in and between eye and redness in and between eye. The patient received 2nd dose of Shingrix, more than the recommended interval, which led to lengthening of vaccination schedule. The patient was currently experiencing sever fatigue, pain and redness in the eyes and between eyes.  The reporter consented to follow up
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Fatigue, Feeling abnormal, Haemoptysis, Intensive care
Clinical narrative: 5-19-21 Patient self-reported to  that 8 days after receiving his first dose of Moderna (3/18/21), he began coughing up blood, was taken to the hospital, transferred to the ICU with thrombosis. He states he was in the ICU for 6 days. He then received second dose on 04/09/21 and was ill for 5 days again. States he currently remains fatigued, short of breath and "just not himself." Patient is concerned that the blood clots were related to his COVID Vaccines.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Malaise, Thrombosis
Clinical narrative: 5-19-21 Patient self-reported to  that 8 days after receiving his first dose of Moderna (3/18/21), he began coughing up blood, was taken to the hospital, transferred to the ICU with thrombosis. He states he was in the ICU for 6 days. He then received second dose on 04/09/21 and was ill for 5 days again. States he currently remains fatigued, short of breath and "just not himself." Patient is concerned that the blood clots were related to his COVID Vaccines.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: REPORTS LIGHT HEADED FOR A FEW SECOND AND WAS FINE AFTER DRINKING WATER
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Carotid artery stenosis
Clinical narrative: Patient hospitalized within 6 weeks of receiving COVID vaccination for stenosis of right carotid artery.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pt received Pfizer for dose 2 instead of Moderna.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Petechiae
Clinical narrative: 11:50 am Moderna administered 11:53 and @ 30 seconds  am it was noted that patient had  multiple small red dots all over her arms and hands. No apparent respiratory distress or difficulty, no nausea, no dizziness. Patient stated they felt " normal" other than the spots. The RN who administered the vaccine did not recall noting the red dots on the patient prior to vaccine administration. At 11:55 am out of caution, the patient was transferred via wheelchair with two registered nurse escorts' to the facility emergency room. Clinical assessment did not indicate the need for administration of injectable epinephrine nor Benadryl ( but these were sent with escorting RN's).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Lip ulceration, Mouth ulceration, Mucosal ulceration
Clinical narrative: Developed sores (Ulcer) in both nostrils, mouth and lip exactly 1 week after receiving first shot.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: patient received the adjuvant part of Shingrix only (without reconstitution with powder vial); patient received the adjuvant part of Shingrix only (without reconstitution with powder vial); This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 86-year-old male patient who received Herpes zoster (Shingrix) (batch number 5XP9M, expiry date unknown) for prophylaxis.   On 17th May 2021, the patient received the 1st dose of Shingrix. On 17th May 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient received only the adjuvant part of Shingrix (without reconstitution with powder vial), which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  The reporter did not consent to follow up. The reported batch number (5XP9M) belonged to adjuvant part of Shingrix.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Decreased appetite
Clinical narrative: DID NOT EAT
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: DID NOT EAT
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: at 2:55pm pt. c/o dizziness and lightheadedness.  pt assisted to gurney and placed in supine position with BLE elevated. pt offered fluids vs monitored vitals t-97.7 BP: 93/68 RR-17 o2 SAT 99%RA. pt reported hx of dizziness with needlestick.  vitals- BP: 90/68 P-73 RR-19 o2 SAT 99%RA  patient verbalized relief from symptoms noted with no dizziness an light headedness as reported by pt. zero change LOC Zero SOB alert and verbally responsive.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Rash pruritic, Skin warm
Clinical narrative: Fever was the main thing. I developed a rash on the arm  - on the left arm - on the 19th of January with a fever. Doctor's visit on 21st. Treatment was ice. The fever went away. The rash was all the way down to my elbow and it lasted  four days- through the weekend. It itchy and hot.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Cough, Dyspnoea, Nasal congestion, Oropharyngeal pain
Clinical narrative: Disclaimer: I was diagnosed with COVID in December 2020. This may be the reason why my symptoms were out of the ordinary.  The first shot gave me a mild chills and pretty bad body pain, however, the second shot gave me a sore throat, nasal congestion, chest congestion,  wet cough, body pain, and shortness of breath. In order to tally out a second exposure to Coronavirus, I got tested twice and was negative. These adverse symptoms started 4 hours after the 2nd vaccine and are still the same intensity. I?m taking mucinex and anti histamines but nothing has been helping much. I?m on my 6th day now.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Respiratory tract congestion, SARS-CoV-2 test negative
Clinical narrative: Disclaimer: I was diagnosed with COVID in December 2020. This may be the reason why my symptoms were out of the ordinary.  The first shot gave me a mild chills and pretty bad body pain, however, the second shot gave me a sore throat, nasal congestion, chest congestion,  wet cough, body pain, and shortness of breath. In order to tally out a second exposure to Coronavirus, I got tested twice and was negative. These adverse symptoms started 4 hours after the 2nd vaccine and are still the same intensity. I?m taking mucinex and anti histamines but nothing has been helping much. I?m on my 6th day now.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: There is no adverse event. This is reported due to administration error. First dose Moderna COVID vaccine was given on 4/17/21, but the 2nd dose Moderna COVID vaccine was given 1 day too early on 5/10/21 (i.e. 23 days after 1st dose). Minimum frequency between 1st and 2nd Moderna dose is 24 days.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests normal, Tinnitus
Clinical narrative: Tinnitus - constant ringing in ears
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Pt received Pfizer for dose 2 instead of Moderna.