chrisvoncsefalvay/vaers-outcomes huggingface dataset:
minor swelling & tenderness of left axillary lymph node; minor swelling & tenderness of left axillary lymph node; This is a spontaneous report from a contactable consumer (Patient). A 54-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EL3248, Expiration Date: not reported) via an unspecified route of administration in left arm on 21Apr2021 11:00 as 2nd dose, single dose for COVID-19 immunization. The patient previously took first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number EL3248, Expiration Date: not reported), via an unspecified route of administration, in left arm on 31Mar021 10:00AM at single dose for COVID-19 immunization. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Medical history included hypothyroidism, hypertension, osteoarthritis and asthma. Patient had known allergies to shellfish, bee venom, seasonal allergies, dust & mold.Concomitant medication(s) included within 2 weeks of vaccination, levothyroxine sodium (SYNTHROID); liothyronine sodium (CYTOMEL); lisinopril; budesonide, formoterol fumarate (SYMBICORT); diphenhydramine hydrochloride (BENADRYL). On 22Apr2021 19:00,The patient experienced minor swelling & tenderness of left axillary lymph node. AE resulted in doctor or other healthcare professional office/clinic visit. No treatment was given for the adverse event. The outcome of the events was resolved on 28Apr21 at 05:00.  No follow-up attempts are needed. No further information is expected.
I did not have an adverse reaction to the vaccine. I started pain in legs, and I thought it was pulled muscles. On 01/04/2023, I had difficulty breathing with chest pain and contacted my doctor. He got me admitted to the hospital immediately. They found blood clots in both legs and in both lungs. I was sent home after one day with blood thinner medication.
57 y/o male, with past medical history of Liver Transplant, damage to the Left Base of the Lung, Asthma, HTN, DM, Pneumonia (currently), Psych history (undisclosed), Induced Coma, Kidney and Liver Failure, who presents with dizziness and shortness of breath onset post vaccination. Patient states that this is his second dose in the two-dose series, received to the left arm. Patient states that after the first Pfizer vaccination he had some discomfort to the site, but no other reaction. NP and Paramedics at patient side. Patient legs were elevated and initial vital obtained. Patient was noted to be Hypoxic, oxygen saturation was 88-89% on RA. When asked if patient uses oxygen, he stated that yes but didn?t bring it here to the facility. Patient all other vitals within normal limits (132/73 BP, 85 P, 14 Resp). Patient noted to be Hyperglycemic at 242, patient states that he did not take his diabetes medication this am. At this time, patient was placed on 2 L of O2 by NC. Patient saturations did not improve (91%), so O2 increased to 4 L by NC with no improvement. Patient now discloses that he currently has a lung infection and is being treated with antibiotics, which he has started today. Patient states that he has pneumonia but that he was recently tested for Covid with a negative result (no documentation provided). It was determined by the NP that patient needed to be transported to the ER. Patient is unstable, hypoxic, hyperglycemic, currently being treated for lung infection and has an extensive medical history. Fire rescue arrived to site and also explained to patient that its in his best interest to be transported, patient refusing. Patient signed Against Medical Advice and patient was transported to his personal vehicle via stretcher. Due to patient refusing to be transported by Fire Rescue, the NP also had patient sign an AMA form for site. CNO and PM aware.
faint; Soreness at injection site; chills; lethargy; body aches; weakness; Hypotension; This is a spontaneous report from a contactable consumer (patient reported himself). A 62-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0178), via an unspecified route of administration, administered in Arm Left on 31May2021 at 10:15 AM (at the age of 62-year-old), as a single for covid-19 immunisation. The patient medical history included Coronary artery disease, CABG (Coronary artery bypass) surgery and hypertension. The patient had no known allergies. The patient received an unspecified concomitant medication within two weeks of vaccination. The patient previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0179), via an unspecified route of administration, administered in Arm Left on 10May2021at 10:00 AM, as a single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient did not have covid prior vaccination. The patient was not tested for covid-19 Since the vaccination. On 01Jun2021 at 09:00 AM, the patient experienced faint, soreness at injection site, chills, lethargy, body aches, weakness, and hypotension. Hypotension was continued to till the date. The patient visited physician office for the events. The treatment received for the adverse events was none. The patient was not resolved from all the events at the time of this report.  Information on Lot/Batch number was available. Additional information has been requested.
Smallpox vaccination 3/21/03.  On 03/25/03 - developed hives-like rash on face, neck, and torso - 03/27/03 Saw Infectious Disease MD and treated with topical steroids - Papules became confluent, lasted 10 days.  Intense itching.
Weakness, fever, muscle aches, runny nose, hoarseness, coughing, runny nose, itchy eyes, extremely tired.
Information has been received from a physician concerning a 12 year old female who on 03-APR-2008 was vaccinated intramuscularly with a 0.5 mL dose of GARDASIL (lot # not reported).  Concomitant therapy included Tdap and MENACTRA administered "at the same visit" on 03-APR-2008.  It was reported that as the patient started to leave the office she felt lightheaded.  She sat down and fainted and shortly "came around".  The physician reported that this occurred around 3:00 in the afternoon and the only thing the patient had consumed that day was a soda and a glass of milk.  The patient recovered and left the office.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/10/2008.  Initial and follow up information has been received from a physician and an unspecified reporter concerning a 12 year old female who on 03-APR-2008 was vaccinated intramuscularly in the upper left arm with a 0.5 mL first dose of GARDASIL (lot # 660389/1968U).  Concomitant therapy included MENACTRA administered "at the same visit" on 03-APR-2008.  Initially it was reported that as the patient started to leave the office she felt lightheaded.  She sat down and fainted and shortly "came around".  The physician reported that this occurred around 3:00 in the afternoon.  In follow up it was reported that the patient fainted for a few seconds, had no loss of consciousness, 10 minutes after the shots were given.  In follow up it was also reported that the shots were given at 5:10 pm and the adverse event onset was 5:15 pm.  The patient's blood pressure was 70/60 and the only thing the patient had consumed that day was a soda and a glass of milk.  The patient was given MEDIALYTE SOLUTION) and her blood pressure went up.  The patient recovered and left the office.
I went to the doctor for my check-up.  I had routine blood work to check A1C and fasting blood sugar. My A1C jumped from 5.5 to 5.9.  This was all in one year. The doctor suggested lifestyle changes to bring the numbers down. I have never had issues with my A1C in my past, until this vaccine. I am now  diagnosed with Pre-Diabetes.
Patient received the covid  vaccine on Sunday12/2020. He found out that his roommate tested positive for covid on 12/20/2020 when he got home. He started to have dry cough on 12/20 evening.  Had HAs but resolved 12/22. Still coughing. No fever/chills/bodyaches.
On day 7 arm began to itch.  On the 9th day, arm was swollen, red, and hot to the touch.  Spot is red approximately 6 inches in diameter at site of vaccination.  Arm ached.  Now on the 12th day, still aching but to a much lesser degree.  Swelling and redness have gone down.
Extreme fatigue started within hours and still continues 6 days later, fever of 101.1, headache, body aches, leg swelling, diarrhea, nausea. Most symptoms lasted 48 hrs. The diarrhea lasted 3 days and the fatigue is ongoing.
Exposed vaccine at 13 months, fever, vesicular papular rash trunk, head, arms and leg, itchy.
Very fast beating heart, irregular heartbeat taken to hospital via Ambulance?. diagnosed with A-fib and given cardiac medications
Answered page from RN pt. calling to reporting having reaction to vaccination recieved today at 2. Spoke with pt. on hold on phone. pt. stated "I came and got my shot at about 2 oclock and came back to work and after I got here and was here a little while and started getting a rash and my face feel slike my eyes are going to start swelling. I'm being monitoring by the Nurse practitioner here and she's got benadryl for me if I need it and I took Tylenol a little while ago I just wanted to let yall know" I advised pt. to follow instruction of the nurse practitioner who's monitoring her and pt added "I will" and expressed gratitude for speaking with her. I also encourage pt VAERS report. Pt "I will".
11:30 pm 9-28-21- fever,chills, nausea,vomiting, excruciating bone and muscle pain .  Called dr at 7am on 9-29-21- instructed to take ibuprofen q8h and benedryl q8h. Did seem to help a little.  9-30-21 felt better in am until about noon then fever-chills-nausea- vomiting resumed and throat started to feel tight. Went to er. Treated for allergic reaction possibly from vaccine. Treated with injections of solumedrol,  benadryl,zofran, epinephrine, and pepcid. 1 liter of iv fluids given. Labs showed high d dimer results. Cant do ct scan as im allergic to iodine contrast. Did nuclear scan and didnt see any clots. Cxr done showed no problem. Ekg showed abnormal rythmn after epi. Second ekg showed resolved. Sent home on pred for 5 days. 10-1-21 mouth ulcers appeared and legs are weak.
This spontaneous report was received from a nurse concerning an unspecified number of patients (demographics unknown). On unspecified dates since 25-AUG-2015, the patients were vaccinated with doses of VAQTA (Lot # L008665; expiration date: 10-FEB-2017, Lot # K008333; expiration date: 10-MAR-2017 and Lot# K011304; expiration date: 28-APR-2017) which were exposed to temperature outside of the recommended range. No adverse experience had been reported. This is one of several reports received from the same source. Additional information has been requested.
Site: Pain at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Mild, Additional Details: Patient had a few seconds of syncope after patient came back to consciousness she experienced difficulty breathing that was alleviated by taking off her mask. She was lighted head ed and nauseous while 911 came
not until 12 days later, swollen area and rash just below injection site.;  arm was hot to the touch.  Went to doctor who verified it was an adverse reaction and prescribed Methyprednisone 6 day.
DIZZINESS AND FALL; SCRAPED NECK AND BACK ON SHELF; TREATED WITH ANTIBIOTICS AND BANDAGES; PATIENT CLAIMED TO BE ALRIGHT AND WAS ABLE TO LEAVE AND MAKE IT HOME SAFELY.
Red popular area at site of injection extending 4" below site, itching at site of rash.
1/8/03 in the evening, pt experienced a fever of 102F-103F. Tylenol was given at 04:00. Fever increased to 105F and repeated Tylenol brought temperature down to 102F. Mild rash on face and trunk noted. Thursday 1/9/03, temperature "down" and rash has increased on face and trunk with increased itching. Saw MD and he Rx'd Benadryl. On 1/10/03, itching continues. No fever and improved appetite.
Swollen lymph node in left underarm started the day after the vaccine. Four days later (today 2/9/21), I have a rash (hives-looking) on my left upper arm where I received the vaccine. A couple of the bumps are raised. The swollen lymph node persists today after using warm compresses and antibiotic cream to the area.
soar arm for 2 weeks, including swollen the size of Oreo cookie diameter for 2 weeks. Hot, red and itching  at the injection site days 10-14 after the injection.  Constant headaches for 2 weeks and intermittent headaches up to to day including sinus pressure.  Dizziness last night for 5 minutes.
Day after injection noted pinkish/reddish area covering entire back from neck to waist, red splotches noted on chest and shoulders, itching on chest and shoulders. This lasted for 3 days. Used Benadryl tablets and cream.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMh significant for dyspnea, pulmonary fibrosis, AF, pacemaker, asthma, hyperlipidemia, aortic incompetence, chf, aortic valve stenosis, overweight, fibrosis of lungs, pulmonary hypertension. Deceased 4/30/2021. No cause of death noted, no notation regarding recent illness. Seen in March 26th for SOB upon waking up.
Headache, Fever, Rash, Palpitations, fatigue muscle soreness in injection site. Narrative:
This case was reported by a consumer (subject) and described the occurrence of possible hepatitis A in a male subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On March 2005, the subject received the 1st dose of TWINRIX (unknown details). In November 2006 and May 2007 the subject received 2nd dose and 3rd dose of TWINRIX (unknown details) and experienced drug dose administration interval too long. The subject was aware that his 2nd and 3rd doses of TWINRIX were delayed; however, he was told by the nurse at the time of administration that "it was still okay". In 2013, 8 years after vaccination with TWINRIX 1st dose, 7 years after vaccination with TWINRIX 2nd dose, and 6 years after vaccination with TWINRIX 3rd dose, the subject experienced possible hepatitis A, possible vaccination failure, and diarrhea. This case was assessed as medically serious by GSK. Relevant diagnostic tests were as follows: The subject reported that he "had a test in 2009 which showed that he was nonreactive for hepatitis A." In 2013, the subject "had blood work done at his doctor's office" and "the test showed he was immune to hepatitis B as expected and all test results were within range with one exception, his hepatitis A result now displays 'reactive' though there is no actual number included." At the time of reporting the events were unresolved.
Pregnancy; A spontaneous report (United States) was received from a healthcare professional concerning a 39 years old, female patient who received the vaccine during pregnancy/vaccine exposure during pregnancy.   The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included multivitamins.  On 11 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 011L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 11 Jan 2021, the patient was administered the vaccine during pregnancy.Patient wanted to report a first trimester pregnancy.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.  The event vaccine administered during pregnancy was considered resolved on 11 Jan 2021.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 39-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
I developed intermittent Bilat leg numbness on Jan 2nd and 3rd.  On Jan 4th the bilat lower leg numbness was constant all day and around 4 pm that same day I developed right forearm numbness. On Jan 5th the symptoms have seemed to  have resolved in my legs,  right forearm is still slightly numb. No weakness present just numbness.
This spontaneous report was received from a nurse, referring to an adult patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapy, drug and allergy history were not provided. On an unknown date,  the patient was mistakenly vaccinated with a pediatric dose of RECOMBIVAX HB (strength, dose number, dose, administration route, lot number and expiration date were not reported) for prophylaxis. No adverse effects were reported.
headaches; nausea; He received the third dose of the vaccine; This is a spontaneous report from a contactable other hcp (Nurse). A 74-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on an unspecified date (batch/lot number was not reported) as dose 3, single for covid-19 immunization (at the age of 74-years-old). Medical history included leukaemia (moderately immunocompromised with a history of leukemia) and moderately immunocompromised from unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received first and second doses of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, as single dose for COVID-19 immunization. It was reported that to the patient who was moderately immunocompromised with a history of leukemia, his haematologist recommended he receive the third dose of the Pfizer Covid-19 vaccine and he received the third dose last Wednesday on 25Aug2021 and on 26Aug2021 he started experiencing side effects of headaches and nausea and been having them ever since. Caller reports treating the patient with Tylenol. Caller asked were there any other treatment recommendations. Caller states "he was basically asking me if I had any medical advice, so I'll have him call his doctor and keep treating with Tylenol." The outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Patient received 3rd dose Pfizer-BioNTech COVID-19 monovalent instead of the Booster Pfizer-Bivalent vaccine in error.  No adverse effect noted.
9 days after shot I developed chronic spontaneous urticaria. Body covered in painfully itchy raised welts they appear all over body- scalp, legs, arm, face, crotch, hands. Everywhere. They feel hot and are unbearable itchy and debilitating- not able to go to work/ sleep/ shower/ do anything without this pain. I am on week 3 of symptoms even after a prednisone steroid. There is a social media support group with 900+ members all going through this.
REDNESS ON INJECTION SITE, 2" X 2.5", SLIGHTLY WARM TO TOUCH. NO SWELLING, NO PUSS, NO DRAINAGE. SLIGHT PAIN (AS USUAL) NO FEVER. RED-PATCH SIZE IS STABLE, NOT SHRINKING, NOT ENLARGED.
Shingles; left eye pain; pain on her head at the level of her eye; pain moving toward her ear; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th October 2019, the patient received the 1st dose of Shingrix. On 23rd October 2019, 7 days after receiving Shingrix, the patient experienced shingles, eye pain, headache and ear pain. The patient was treated with antivirals nos. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the eye pain, headache and ear pain were unknown.   It was unknown if the reporter considered the shingles, eye pain, headache and ear pain to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in right arm. 1 week after vaccination, patient had continuous painful left eye pain and she also had pain on her head at the level of her eye and then moving toward her ear. The patient saw a neurologist who diagnosed Shingles, she was on an antiviral at the time of reporting. The polymerase chain reaction test was negative but doctor still thought it was shingles. The reporter consent to follow up.
15 min after administration patient reported HA - feeling weak - some dizziness. 5 min after this reported shallow breathing and difficulty breathing. Treatment: 125mg SOLU-MEDROL IM and BENADRYL 50mg IM. Patient given prednisone 60mg x 3 days - instructed to take BENADRYL 25mg po Q 4-6 hrs for next 24h, ZANTAC 150mg BID x 3 day.
states felt ill & then got a rash mild on 9JUN98;rash started neck upper chest to arms & legs;lasted a couple of days;site of inj itchy & warm;
Acute tinnitus in right ear. Clogged feeling in right ear. Hearing disruption in right ear.
Patient develop cellulitis on her left upper arm when the PREVNAR-13 vaccine was administered. She was treated by her doctor with antibiotics (SEPTRA) for 7 days.
Initial unsolicited report received from a nurse on 03-Oct-2017. This case involves a female patient (age not reported) who was vaccinated with a dose of FLUZONE HD (batch number, expiry date, route and site of administration were not reported), on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced shortness of breath and a rash. The patient's laboratory data and corrective treatment were not reported. The event's outcome was not reported. List of documents held by sender: none.
No new AE; GARDASIL 9 was improperly stored and administered.; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. There was no information regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies.    From 09-MAR-2021 until 03-MAY-2021, doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) vaccines had multiple excursions.   On 31-MAR-2021, the patient was vaccinated with one dose of the improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # 1687290 with expiration date of 06-SEP-2022 for prophylaxis (dose, frequency, route of administration and anatomical location were not provided), which were stored at a temperature of 34.50 Fahrenheit degrees for 3.5 hours. No new adverse event.  Digital data logger was involved.  This is one of several reports from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687290; expirationdate: 06-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2105USA002246: US-009507513-2105USA002236: US-009507513-2105USA002270: