chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This reaction has occurred twice since my first vaccination.  One at 9 days post vaccine and the other at 20 days post vaccine.   Sudden onset of a hot, swollen, mildly itchy red lacy rash over several areas of the body starting with the face. My face turned bright red and splotchy and was very hot. Then it spread to my neck and chest, then my arms, elbows, and hands, then to my stomach and thighs and butt. I took 2 Benadryl within ten minutes of each reaction starting and the rash slowly disappeared over the next 30 minutes after taking the medicine. No residual rash was left after the reaction.   The rash appeared on an empty stomach both times and without any environmental triggers. No other trigger has been identified.  No other bodily systems were involved in the reaction other than the skin.
Headache, Sedation, Myalgia, Arthralgia, Fever, NauseaVomiting, Chills Narrative:  Other Relevant History:
Started getting very tired and lethargic on the 27th. On the 28th non-responsive, temperature read 103, heart rate while at rest was 133. Diagnosed with flu. Right arm (pneumonia vaccine) began hurting so bad that I could not lift it. by 11/29/11 I had a red rash growing down my arm. My arm was extremely firm to the touch and approximately 10 degrees hotter than the rest of my body.
My chronic fatigue syndrome is extreme.  Medication is not helping it.  After having Covid 11/2020 I had a similar rolling bouts of severe CFS always proceeded by a headache lasting several days, but nothing as severe as the vaccine induced CFS.  Both episodes of CFS, after covid and the vaccine are significantly more severe than my normal baseline.
I am having EXTREME nausea and vomiting.  Can?t hold anything down.  And extreme fatigue.
I was diagnosed with Osteoporosis on January 4, 2023, and Breast Cance March 16. I am waiting for surgery which will be scheduled soon.
Delayed period (5+ days) ? currently day 33 of very consistent 28 day cycle
started with back pain. skin hurt to touch. then bad chills. bad fatigue. fever. stayed in bed for almost 24 hours straight. very weak.
pt recv vax & devel tenderness on site of inj, watery eyes, lightheaded;
This incident happen at Hospital Heart Institute. On November 9th at 853am, patient received her booster dose of Moderna vaccine in her left upper arm deltoid muscle. Patient notes initial she received the Pfizer vaccines for her 1st and 2nd dose with no reaction. Patient decided today to change her booster to Moderna. 13 minutes after the patient received her Moderna booster she started to complain of left upper chest warmness. Nurse took her blood pressure and it states 100/53, pulse 53. Patient then began to feel cold and clammy . 2 nurses help patient lay flat in ground with leg elevated on chair. Patient notes she feeling better the warm feeling in her left chest has gone away and the cold and clammy feeling has subsided. Patient then sat in chair and blood pressure increase to 122/84. 10 minute shad past and patient agained started t get the warm feeling in her left upper chest, cold and clammy. Patient was lower down to the floor with the help of 3 nurses. EMS was called and patient vital signs were stable patient just notes she does not feel well and needs to go to the hospital. Patient was transfer by Ambulance to the Hospital. No incident was not caused by unsafe condition or act.
She received her 2nd dose of COVID vaccines yesterday afternoon. This morning when she woke up she had a terrible headache, it felt like pressure her it was 10 out of 10.  Mom gave her 200 mg ibuprofen and it did not help her headache.  Mom also gave her 360 mg of Tylenol.  That did not help either.  She felt some nausea so mom gave her some Zofran, shortly after this she felt tired and threw up.  She has been drinking some chicken broth and water and sips of earl grey tea. These things came out with her vomiting. She did not have any head injury.  No fever, no neck pain, no sore throat.  Urine was clear this morning.  No problem with vision.  Headache is little bit better but still there.  Took Maxalt which has helped.
Patient said it exacerbated her multiple sclerosis symptoms. Entire left side went numb and couldn't walk without walker. Extreme dizziness also occurred. Symptoms started the night patient received the vaccine and were the worst the second day and then started subsiding 2 days after.
Guillain-Barre Syndrome. 3 doses of IVIG - Jan 2014. Still numb in hands, arms, legs, feet.
This spontaneous case was initially received on 02-Oct-2015. The case report was received from a(n) Health Professional and concerns a(n) patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 01-Oct-2015 - 01-Oct-2015, Batch no: not provided, Route of administration: not provided, Dose: 1 ml. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/events(s) and outcome: On 01-Oct-2015, after starting / treatment with AFLURIA the patient received a 1 ml dose of AFLURIA, instead of 0.5 ml/Overdose (non serious, outcome: Unknown). On an unknown date, after starting / treatment with AFLURIA the patient experienced Medication error (non serious, outcome: Unknown). Action taken: Details manually to be entered, Event treatment: Details manually to be entered, Rechallenge/Dechallenge information: Details manually to be entered. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate. Reporter's assessment: The reporter stated that all the patients seemed fine, and confirmed that none of the patients were pregnant. The 1 ml dose was due to clinical error, which did not confirm the dosage.
fully vaccinated (Pfizer, 2/18/21, 3/19/21), symptom onset 8/7/21
Shingles for 3rd time, even after vaccine/Suspected Vaccination Failure; Shingles for 3rd time; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case.                                        The age at vaccination was not reported. The patient had shingles for the 3rd time, even after getting Shingle vaccine.    This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
After 48 hrs turned red, hot, swollen, burning sensation. Over 2 inches long of redness.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult male patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, immediately after receiving SHINGRIX, the patient experienced injection site pain, injection site bruising and injection site discoloration. On an unknown date, the outcome of the injection site pain, injection site bruising and injection site discoloration were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site bruising and injection site discoloration to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient who is a healthcare professional. The age at vaccination was not reported. The patient experienced pain while receiving the SHINGRIX vaccine. The patient stated that, SHINGRIX vaccine was the most painful shot they ever received. The vaccine was administered by an experienced nurse so the patient did not felt that it was administration error that caused the pain. The patient experienced bruising (purplish or yellow) and pain which lasted 4 to 5 days after the injection. This event was reported to Medical Information by an inside sales representative.
This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 22-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline) during pregnancy. On 14 September 2011 the subject received unspecified dose of BOOSTRIX (.5 unknown, intramuscular). Her last menstrual period was on 10 February 2011 and estimated date of delivery is 11 December 2011. The subject was exposed to BOOSTRIX during third trimester. On 14 September 2011, at the time of vaccination with BOOSTRIX, the subject experienced vaccine exposure during pregnancy. On an unspecified date, LVIEF (left ventricular echogenic intracardiac focus) was performed indicating evidence of defect [prenatal screening test normal]. Relevant test results included ultrasound performed on 16 April 2011, 21 April 2011 and 21 July 2011: results not provided. On 30 June 2011: AFP (alpha-fetoprotein), results not provided. On an unspecified date The outcome of the pregnancy was unknown.
A couple hours after VARIVAX injection given patient had a 3" diameter raised, hot area at the injection site per mom's report. Dr. was paged and prescribed Zyrtec 10 mg daily. They used ice pack to the area which also helped resolve her symptoms. The itching subsided and patient was better on 1/29/2010.
I have developed a thyroglossal duct lesion, and nose bleeds. For the first time of my life, the middle of my throat has been feeling pain to the point that it is difficult for me to speak and impairing my daily activities. It?s also the first time I have blood coming out of my nose when I blow it. My neck catscan showed a thyroglossal duct lesion in the middle of my throat. I did have a mild sore throat which I felt in my glands, not in the middle, before getting the vaccine. I have also had a low grade fever for almost 3 weeks. I think people who have may have active infections should be warned to hold off on taking the vaccine.  I am not sure if there was a possible interaction with my steroid shot for my shoulder the week prior. I was advised to still take the vaccine.
4-5 pm her upper arm and axillary became tender and sore. 6-7 Neck area near "adams apple" became edematous. 8pm continued signs of swelling, back of tongue feeling thick, hard to swallow. 8:15 took 1 Benadryl 25mg and 2 ibuprofen 200mg. 8:40 took another Benadryl 25mg and called her family physician. 9:30pm c/o feeling like she had to clear her throat coughing, neck red and warm to touch.  Taken to ER.  Given solumedrol and Benadryl IV push, Temp 99.2.  Xray taken of neck region.
Chills; joint pain; muscle pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 21-year-old female patient (not pregnant) received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular (Left arm) on 22Dec2020 09:30 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  There were no other medications received within 2 weeks of vaccination. The patient experienced chills, joint pain, and muscle pain on 22Dec2020 (19:00). There was no treatment received for the adverse event. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was recovering. This case is non-serious.
in march 23rd 2021/ they gave a 3rd dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix on 05th August 2019) and Shingrix (received second dose of Shingrix on 21st October 2019).   On 23rd March 2021, the patient received the 3rd dose of Shingrix. On 23rd March 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter informed as per the records, the patient was given third dose and was discovered later that patient had 2 doses already but patient said it was false and requested another dose which led to extra dose administered. The patient did not receive any 4th dose of Shingrix. The reporter consented to follow up. This case has been linked with case ID US2021111558 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021111558:Same reporter
Patient reported having a very sore arm almost immediately after administration, a few hours later he started to have a general malaise feeling (mild fever, fatigue). During the night, around 2am, he reported waking up out of sleep with severe chills. He is feeling slightly better the following morning (today) but is still unwell.
When I got the vaccine I had a red spot about the size of a quarter.  Now it is the size of 2 fifty cent pieces side by side.  It is red, painful, itchy and has little bumps on the area.   It is hot to the touch.   -  I seen a, NP and she put me on an antibiotic.
This spontaneous report was received from a doctor of pharmacy via a company representative concerning a 62 year old female patient. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. On an unknown date, after the vaccination, the patient experienced a slightly elevated injection site reaction (unspecified) that was 6 inches in length. It was unspecified if the patient sought any medical attention. It was unspecified if any treatment was given or if any lab tests were performed. The patient was recovering from the event. The relatedness for the event was unknown for ZOSTAVAX. Additional information is not expected.
Atrial fibrillation; Was not feeling well; Warm sensation in chest; This is a spontaneous report from a contactable nurse (patient).  This 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot EJ 1685), intramuscular, on 21Dec2020 at 09:30 PM at single dose for COVID-19 immunisation. Vaccine location was left arm.  The patient was vaccinated at hospital, age at vaccination was 62-years-old. The patient received also varicella zoster vaccine RGE (CHO) (SHINGRIX) on 19Nov2020. Medical history included gastrooesophageal reflux disease (GERD) and high cholesterol. Concomitant medications included omeprazole, colestyramine (QUESTRAN), and vitamins. On 22Dec2020, the patient was not feeling well intermittently starting the day after the injection with warm sensation in chest that would go away until 31Dec2020 when the warm sensation of chest would not go away. The patient was sent for EKG that showed atrial fibrillation that she is now being treated for. The events resulted in doctor or other healthcare professional office/clinic visit. The events were reported as non-serious. Outcome of the events was unknown.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported atrial fibrillation and the administration of COVID 19 vaccine, BNT162B2. More information regarding the clinical course, the patient's underlying concurrent medical condition are required for the Company to make a more meaningful causality assessment.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, Agency, as appropriate.
Intended to give patient Varicella, Vaxcelis was given instead. No symptoms or adverse reaction observed. Vaccine schedule adjusted for future visits.
Patient became COVID-19 positive after being fully vaccinated. Patient is also not asymptomatic.
Information has been received regarding a case in litigation from a lawyer and a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2012, the patient, approximately 75 years old, was administered the ZOSTAVAX by a healthcare provider at a medical clinic (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a healthcare provider at a medical clinic for the following injury resulting from the ZOSTAVAX use: Shingles. The patient claims damages including: injury to self and economic losses. The outcome of the shingles was unknown. Additional information has been requested.
A nurse drawing up vaccine diluted several vials with 1.6ml diluent instead of 1.8ml. 6 doses were retrieved from vial following dilution. An unknown # of individuals received more concentrated dose. No doses lost. No adverse events witnessed in vaccine recipients.
On Thur., Jan. 31, 2007 the child received #5 dose of Dtap, #4 dose IPV, #1 dose of MMRV (had separate doses of MMR and Varicella at 1 year of age), #1 dose of Hepatitis A, and #4 dose of PCV7. The child took a 2 hour nap after receiving the immunizations.  When she woke up she complained of pain in both  legs. The morning of Thur., Feb. 1, the child developed a fever of 101 and  continued to complain of leg pain. That same morning the family flew out of State. The Mother noticed that the child's right leg (immunization area) had a circular area of swelling about 4 inches in diameter with a center of redness about the size of a silver dollar. The left leg(immunization area) had an area of swelling and redness about the size of a quarter with a bruise in the center. Both sites were warm to the touch. Mother states that  she treated her daughter with ice packs to the sites and administered  Tylenol, Ibuprofen and Benadry until she could get an appointment with a doctor. The Mother was instructed by the doctor to continue her treatment and return if the child developed increased pain, redness, swelling or if any red streaks occur. The fever resolved after 2 days. On Sunday, Feb. 4, the leg pain, redness and swelling started getting better  Today, Feb. 5. the leg pain has resloved. The swelling and  redness has decreased in the right leg. The left leg the swelling and redness has resolved except for a bruise.
This spontaneous report as received from a physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 25-APR-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mVls 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown, which was stored at -6.66 Celsius Degrees for 576 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
shingles hot deathly ill; This case was reported by a consumer via interactive digital media and described the occurrence of illness in a 60-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced illness. On an unknown date, the outcome of the illness was unknown.   It was unknown if the reporter considered the illness to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient's parent. The age at vaccination was not reported. The reporter reported his/her daughter had deadly ill side effect with Shingles shot. No contact details were available. The case had been linked with US2021AMR192577 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR192577:Original Case : US2021AMR179087
Face is still sore; This case was reported by a consumer via interactive digital media and described the occurrence of facial pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced facial pain. On an unknown date, the outcome of the facial pain was unknown.   It was unknown if the reporter considered the facial pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of shingrix and experienced face was still sore. The age group was not reported but it was selected as adult as per vaccine indication. The patient received shot of clovis, had no side effects. The information regarding consent to follow was not reported.
Patient developed significant muscle and joint aches on 3/12/2021. She also noticed swelling , redness and pain at the injection site. She experienced urinary frequency on 3/12/2021 that resolved within 24 hours. The muscle aches and pains slowly resolved over 48 hours. The injection site redness and pain has worsened since onset. She was treated on 3/15/2020 with oral antibiotics and topical steroid cream for the reaction at the injection site.
Chills, Body aches and joint pain, headache, fatigue.  Reddened area at the injection site approximately 6x3 inches. Site hard, hot and itchy.  Tylenol and fluids, hydrocortisone topically for the arm. Symptoms subsided in 2.5 days. Reddened rash like area on arm diminished in 1 week but still present.
Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients received doses of improperly stored (Oka/Merck) VARIVAX (lot# reported as 1015046, expiration date: 29-APR-2017, route and dose were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
itching and rash; This is a spontaneous report from a non-contactable nurse, the patient. A 38-year-old non-pregnant female patient received second dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: EP6955), via an unspecified route of administration in the left arm on 18Mar2021 at 8:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. The Patient did not have any allergies to medications, food, or other products. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: EN6200), via an unspecified route of administration in the left arm on 25Feb2021 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had not been tested for COVID-19 since the vaccination. On 18Mar2021 at 11:00, the patient experienced itching and rash. The patient did not receive treatment for the reported event. The clinical outcome of the itchy rash was recovered on an unknown date.  No follow-up attempts are needed. No further information is expected.