chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH ( my arm swelled up huge, was all red, itchy, sore and fevered), VACCINATION SITE ERYTHEMA (my arm swelled up huge, was all red, itchy, sore and fevered), VACCINATION SITE PAIN (my arm swelled up huge, was all red, itchy, sore and fevered), VACCINATION SITE SWELLING (my arm swelled up huge, was all red, itchy, sore and fevered) and VACCINATION SITE PRURITUS (my arm swelled up huge, was all red, itchy, sore and fevered) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood cholesterol abnormal.Concomitant products included VITAMINS NOS for Vitamin supplementation, ATENOLOL for an unknown indication.On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced VACCINATION SITE WARMTH ( my arm swelled up huge, was all red, itchy, sore and fevered), VACCINATION SITE ERYTHEMA (my arm swelled up huge, was all red, itchy, sore and fevered), VACCINATION SITE PAIN (my arm swelled up huge, was all red, itchy, sore and fevered), VACCINATION SITE SWELLING (my arm swelled up huge, was all red, itchy, sore and fevered), VACCINATION SITE PRURITUS (my arm swelled up huge, was all red, itchy, sore and fevered) and BODY TEMPERATURE INCREASED (I had temperature for one night). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL N) for Pain in arm and Redness, at an unspecified dose and frequency. On 07-Aug-2021, BODY TEMPERATURE INCREASED (I had temperature for one night) had resolved. At the time of the report, VACCINATION SITE WARMTH ( my arm swelled up huge, was all red, itchy, sore and fevered), VACCINATION SITE SWELLING (my arm swelled up huge, was all red, itchy, sore and fevered) and VACCINATION SITE PRURITUS (my arm swelled up huge, was all red, itchy, sore and fevered) outcome was unknown and VACCINATION SITE ERYTHEMA (my arm swelled up huge, was all red, itchy, sore and fevered) and VACCINATION SITE PAIN (my arm swelled up huge, was all red, itchy, sore and fevered) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On 06-Aug-2021, Body temperature: high (High) Increased. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.Concomitant products also includes Cholesterol medication. Patient says she also used pain release cream for treatmeant
she had a rash with itching; she had a rash with itching; a lump, swelling, that lasted for about 4 to 5 days; a lump, swelling, that lasted for about 4 to 5 days; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown and expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 03Mar2021 at 11:15 as DOSE 1 (age at vaccination:74 years), SINGLE for covid-19 immunisation (Reason for no lot number: of Pfizer covid vaccine: Other: Provides lot number as EN62 OC or OR for the first vaccine. She is unsure because it is handwritten). Medical history included ongoing rheumatoid arthritis (Diagnosed 10 years ago, ongoing malignant melanoma (Diagnosed about 6 years ago. It is the most serious form of skin cancer), covid-19 from Jan2021 to an unknown date First week of January. Concomitant medications included levothyroxine sodium (SYNTHROID) (She has been taking it for 30 years. Took one the morning of the vaccination) and escitalopram oxalate (LEXAPRO) (Started taking this 20 years ago). The patient experienced she had a rash with itching, a lump, swelling, that lasted for about 4 to 5 days on 04Mar2021. The day after the first vaccine she had a rash with itching and a lump, swelling, that lasted for about 4 to 5 days, she recovered completely on an unknown date in Mar2021.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Celiac Disease; Dizziness occurred within a minute of getting the vaccine and lasted for an hour; This case was reported by a nurse via call center representative and described the occurrence of celiac disease in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number T29Y2, expiry date 8th April 2023) for prophylaxis.   On 8th December 2021, the patient received the 1st dose of Shingrix. On 8th December 2021, between 2 and 4 months after receiving Shingrix, the patient experienced dizziness. In March 2022, the patient experienced celiac disease (serious criteria GSK medically significant). On an unknown date, the outcome of the celiac disease was unknown and the outcome of the dizziness was recovered/resolved.   It was unknown if the reporter considered the celiac disease and dizziness to be related to Shingrix.     Additional Information: GSK Receipt Date: 1-Jun-2022 Reporter's Comments: The nurse practitioner (NP) stated that a patient was there for her 2nd dose of Shingrix and had dizziness after the first dose. The dizziness occurred within a minute of getting the vaccine and lasted for an hour. She was diagnosed with celiac disease in March 2022. The reporter consented to follow up via postal.
My arm started hurting immediately. Started having chills. At 8PM I took my temperature, it was up 2 degrees. The night of the 25th my arm was so swollen and inflamed and hot, painful, I could hardly get out of bed. At 2AM I finally got up and put ice bags on it and had a fever and was up for 3 hrs. Chilling with the fever. Went back to bed for awhile, then got up because my arm was so painful I couldn't lay there. I was still chilling and could tell my fever was going up. At 9:45 AM my temperature was 100.6. As 10:15 I felt worse and worse, so cold, nose icy cold, hands icy cold, I wrapped up in a blanket and put on my winter gloves to try to warm my hands. I checked my temperature at 10:15 and it was 101.7 (Oct 26). At 12:30 noon, I took a shower which brought my temp down to 99.4. At 1:30PM, it was 101.5. I called Dr office and told her nurse the way I felt and what had happened since receiving the shot. She said she would talk to the Dr and call me back. They called me back at 4:15 and told me the Dr said it was a reaction to the pneumonia vaccination and to take Tylenol to try to get the fever down . While waiting for the nurse to call at 3:25PM, my temp was 100.9. Then I checked it at 7PM and it was 100.7. Had chills all day. My arm was really swollen, red and hot. The redness extended to almost my elbow and 3/4 of the way around my arm. The shot was at the top of the shoulder. One of my daughters came in and got me some Tylenol. Took it and went to bed at 7:30PM temp at that time was 100.5. Went to sleep immediately and didn't awaken until 9:48PM and I was wet with sweat hair went also and confused. Then went back to bed and slept. Awakened at 4AM, Oct 27th, soggy with sweat and my temp was 96.8. My normal temp runs 97.3 to 97.6 the reason I know is because I check it every morning about the same time, also weighing myself. Was completely exhausted and felt lousy, couldn't eat.
Nauseated, light headed, hot, seeing "spots", felt very warm, and became pale, complained of "pressure in head" within 10 minutes of receiving vaccine. Patient did not eat before vaccination.  Patient placed in supine position and observed for 40 minutes and patient recovered from symptoms within 5 minutes of being laid down.  Patient given granola bar and water.  No complaints of shortness of breath or other untoward symptoms noted.  Patient felt "normal" after 40 minutes of observation.  Mom told to call back with any issues.  Provider and RN observed patient for recovery
had post injection pain at site for 1 day. next day develop pain at left jawline and under temple with some swelling, which improved by 12/28. Denied other reactions or ILI symptoms.
Mild case of hives to face, abdomen and legs. Benadryl given with improvement.
This case was reported by a nurse and described the occurrence of asthma in a 11-year-old female patient who received MENVEO (batch number M17031, expiry date 31st March 2019). On 23rd March 2016, the patient received the 1st dose of MENVEO .5 ml. On 24th March 2016, 1 days after receiving MENVEO, the patient experienced asthma, erythema of extremities, rash, inflammation and influenza-like symptoms. On an unknown date, the outcome of the asthma, erythema of extremities, rash, inflammation and influenza-like symptoms were unknown. It was unknown if the reported considered the asthma, erythema of extremities, rash, inflammation and influenza-like symptoms to be related to MENVEO. Additional details were provided as follows: The patient received MENVEO on left upper arm. The next day after vaccination, the patient appeared with the erythema on her arm, rash, internal inflammation, and very flu like symptoms and asthma. The reporter did not agree to follow up.
The patient received his flu vaccine injection in the upper left deltoid muscle between 10AM and 11AM on 11/6/05.  At the time of immunization he did not complain of pain.  Later that day he experienced sharp pain in the injection area when lifting it and has had continued pain since that time associated with lifting of the arm or going through a range of motion (eg., when applying deoderant he can only lift his arm to about 90 degrees-- he cannot lift his arm any further without pain.  He does not experience pain upon touching or pressing his arm, only upon lifting or moving in a range of motion. He has not seen a physician at this point (12/8/2005).
Adverse event started the morning of 3/10/21 around 08:00 am. Symptoms included headache, fatigue, brain fog, memory issues, feeling feverish, and itching on torso, arms, and legs . Symptoms seemed to improve over the next week or two before worsening again on 3/27/21 around 10:00 am. On the day of 3/27 /21 I experienced headaches, fatigue, brain fog, memory issues, muscle aches, diarrhea, and vision problems. Currently on 3/30/21 symptoms have improved but I am still experiencing dull headaches and brain fog, as well as itching on torso, arms and legs and some vision problems.   I have not seen a provider  for these issues but have an appointment scheduled for 3/31/21. Treatment includes ibuprofen as needed.
Patient came in to clinic for annual flu shot. Looked her up in our system to see if she had one. I see the date she got one but when i went to put it in she has had one in 10/06/2021. Patient got one today 1/04/22. called gaurdian to let her know. she states patient is doing fine. No adverse reactions.
i have pain in right side my back is chocked and pain goes to my leg, and front towards my urinary bladder area, i saw doc my pcp, went to Emergency, saw ortho got my US done, CAT scan and getting MRI done. Nothing found yet.
On the first day of the injection (1/14/2021) the left arm was sore and I felt tired. Towards evening and during the night I felt cold and hot at the same time - an intense burning/freezing sensation, but no sweating. On the first day after the injection (1/15/201) the arm was still sore and I still felt tired - burning/freezing sensation had ceased. On the second day after the injection (1/16/2021) the left arm was not sore and I felt better, but at 11:00 a.m. the vein in the left temple burst and bled until about 6:00 p.m. Continuous throbbing pain across the forehead the entire day. The  middle of the forehead is covered with red dots; the area near the left eye has a number of open, bloody lesions; the area below the temple (left cheek) is black and blue. There are also two bright red spots on my left knee - but no bleeding. Nausea was slight, but present during the entire day on Saturday and Sunday. Since the hospitals have Covid 19 patients and I do not have a car, I stayed home and rested in bed.  Today on Sunday (1/17/2021) I can sit up and walk around somewhat; the throbbing pain in the head has ceased. The lesions are still vivid red , but slowly forming a crust.  Will make contact with my doctor  on Monday, when the office is open.
Pt received both doses of the Moderna COVID-19 vaccine (on 3/5/2021 and 4/1/2021).  Tested positive for COVID on 8/13/2021  Admitted to an outside hospital  around 8/17/2021 with cough and shortness of breath, hypotension during dialysis.  Found to have COVID pneumonia in that ER.  Transferred to another Hospital on 8/20/2021 due to worsening oxygenation, afib, and RVR. Currently in ICU.
Varicella- information has been received from a registured nursed concering a 12 month old female who is a twin.  In may 2000 the patient was vaccinated with one dose of varicella virus vaccine live (site unknown) Ten days post vaccination, the patient devloped 10-15 or 50 vesicles and the next day had a full blown case of chickenpox and was broken out all over with hundreds of chickenpox indicating that the patient had already been unkowingly exposed by an active source.  Unspeicified medical attention was sought.  also reported was the patient's twin sister who was vaccinated and developed similar events (waes 00060277).
Information has been received from a consumer concerning her 17 year old daughter with an allergy to penicillin, latex and metals who on 17-MAR-2008 was vaccinated with a 0.5 mL first dose of GARDASIL (lot # not specified).  Concomitant therapy included vitamins (unspecified).  On 17-MAR-2008 the patient's mother reported that the patient almost fainted in the office after receiving the 1st dose.  The next day it was reported that the patient was sent home early from school and also didn't go to school on the next day, "which is unlike her daughter."  Also, it was reported that the patient felt like she was going to faint, and experienced anxiety, vaginal rash/itching, and developed a bruise at the injection site.  The patient sought medical attention at the physician's office.  The patient was reported to be recovering.  No product quality complaint was involved. The patient's mother also reported that her daughter had a "serious" allergic reaction to the vaccine that lasted about a week and her daughter had to go to see a physician again. No product quality complaint was involved. Additional information has been requested.
I26.92 SADDLE PULMONARY EMBOLISM 6/17/2021 PULMONARY EMBOLISM, UNSPECIFIED. I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 7/2/2021 PULMONARY EMBOLISM, UNSPECIFIED. I82.403 ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 6/12/2021 PULMONARY EMBOLISM, UNSPECIFIED. J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 6/12/2021 PULMONARY EMBOLISM, UNSPECIFIED. I26.92 SADDLE PULMONARY EMBOLISM 6/17/2021 CHRONIC LYMPHOID LEUKEMIA I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 7/2/2021 CHRONIC LYMPHOID LEUKEMIA I82.403 ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 6/12/2021 CHRONIC LYMPHOID LEUKEMIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 6/12/2021 CHRONIC LYMPHOID LEUKEMIA
I had extremely bad ?heart burn?-like feeling and chest tightening in the evening the second day. I am not prone to heart burn and never have it outside of being pregnant. (I am not.) It was on my right side under my ribs and got so bad I could hardly breathe. Antacid didn?t help. I went to bed propped up on pillows and woke up feeling much better.
Menstrual cycle became irregular, heavy, concerning enough for gynecological work-up that was ruled normal. No explanation for extreme change in menses other than recent COVID injection.
No Additional adverse reaction; Varivax and proquad the same day; This spontaneous report as received from a pharmacist refers to a 1 year old patient of unknow gender. Medical history, concurrent conditionss, and concomitant medication were not reported.  On 10-SEP-2020, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis and measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) for prophylaxis (Route, anatomical location, dose, lot number, and expiration date were not provided.)  The patient  did not excperienced additional adverse reaction.
Continuing lower back pain since two days after 2nd dose of the vaccine (2nd dose taken on February 8, 2021).
EXTREME SWOLLEN LYMPH NODES, LEFT AXILLA (LUMP VISIBLE TO NAKED EYE, APPROX 4" IN DIAMETER AND PAINFUL).  ONGOING.   BODY PAIN LASTING APPROX 2DAYS.
Nurse gave third dose after 15 minutes of her second dose; wife received 2 doses of vaccine within 15 minutes; bedridden; very sick on Tuesday, Wednesday and Thursday; throwing up/ puking; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (Nurse gave third dose after 15 minutes of her second dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (wife received 2 doses of vaccine within 15 minutes), BEDRIDDEN (bedridden), ILLNESS (very sick on Tuesday, Wednesday and Thursday) and VOMITING (throwing up/ puking) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced EXTRA DOSE ADMINISTERED (Nurse gave third dose after 15 minutes of her second dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (wife received 2 doses of vaccine within 15 minutes), BEDRIDDEN (bedridden), ILLNESS (very sick on Tuesday, Wednesday and Thursday) and VOMITING (throwing up/ puking). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, EXTRA DOSE ADMINISTERED (Nurse gave third dose after 15 minutes of her second dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (wife received 2 doses of vaccine within 15 minutes), BEDRIDDEN (bedridden), ILLNESS (very sick on Tuesday, Wednesday and Thursday) and VOMITING (throwing up/ puking) outcome was unknown. Not Provided          Other Treatment information included Fluids. Action taken with mRNA-1273 in response to the event was not applicable   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow up received on 16-APR-2021, contains Non- significant information. On 17-Apr-2021: Follow up received on 17-APR-2021, contains information about treatment, added patient information. On 24-May-2021: follow up received on 24-MAY-2021, contains non- significant information.
This case was forwarded by Crucell, No: CVAE-011-2012. An initial report was received from a health professional on 12.Mar.2012 and concerns a 19-year-old female patient who, on an unspecified date, received an administration of VIVOTIF (batch no: 3002227). It was noted that on 13.Feb.2012 the patient also received a hepatitis A. The patient's medical history and concomitant medication were not reported. On an unspecified date, at an unspecified time following the VIVOTIF administration, the patient experienced idiopathic thrombocytopenic purpura and weakness in the body. The patient consulted a neurologist and felt fine a week and a half later. No further information was available. At the time of reporting the patient was considered recovered. The case was considered non-serious. Follow-up information was received from a healthcare professional on 10.Dec.2012 who reported that the patient had slow but continued resolution of symptoms. By 5.5 weeks after the onset all symptoms except mild tingling in the feet had resolved. The patient returned for no further follow-up. It was noted that the onset of symptoms occurred 17 days after the hepatitis A vaccination and that the VIVOTIF had been taken 11-17 days prior to the onset of symptoms.
devel numbing & tingling sensation in lt hand only arm all right x/for some tenderness @ site of inject; 8JUL93 hand same now has tightness/numbness on lt side face & nose;
Patient reported red area (about 8.5" and wrapped around arm) that traveled down arm from injection site. Area was warm to touch and very sore. Patient refuses second dose based on reaction to this dose.
Two days after the first dose I started receiving sever hot and cold flashes.. the third day I receive joint and muscles aches  By Sunday . the muscle and Joint Aches stopped 01/04/2021 -01/05/2021 Hot and cold flashes started back
She developed Hives all over within a few hours and they lasted 2 days. Mom treated with tendril
Son-in-law left this RN a voicemail stating that his mother-in-law received the vaccine last Tuesday 3/16 and on Thursday 3/18 she went  into the hospital via ambulance as she had uncontrollable diarrhea, nausea and fevers. She is now in a nursing home.
2/17/21-Anaphylaxis-15:17pm (within 30 min waiting period post vaccine), throat scratchy, moved to assessment area, HR 100, labored resp, O2 6L NRmask initiated. (ct reports similar reaction as previous anaphylaxis). 15:22pm-911 called, HR 120, Epi 0.5ml admin. 15:37pm transfer via ambulance to hospital.  02/18/2021 evening, f/u call to client by PHN, throat still feels 'weird', ct reports had 2nd Epi in ambulance, 3rd Epi in ER, plus Benedryl gel, Ct then recalled had anaphylaxis reaction in past to bee sting had ER visit, tx w/ steroids at that time. PHN recommended ct talk with PCP re epi pen order.
Bell's Palsy, face twisted; Burning in the mouth; Lips swelling; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (Bell's Palsy, face twisted) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetes mellitus. Concomitant products included METFORMIN for Diabetes mellitus. On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced FACIAL PARALYSIS (Bell's Palsy, face twisted) (seriousness criterion medically significant), ORAL DISCOMFORT (Burning in the mouth) and LIP SWELLING (Lips swelling). At the time of the report, FACIAL PARALYSIS (Bell's Palsy, face twisted), ORAL DISCOMFORT (Burning in the mouth) and LIP SWELLING (Lips swelling) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  Company comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.