chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case, initially received from a pharmacist on 29-Jan-2018, concerning a 32-year-old adult male patient. The patient's medical history and concomitant medications were not reported. It was reported that, AFLURIA QUADRIVALENT (single opened MDV (multi-dose vial)) underwent temperature excursion (first excursion) at room temperature of 76-degree F for 30-40 minutes (not more than an hour). On 25-Jan-2018, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 00944611A and expiry date: 30-Jun-2018) which underwent temperature excursion. It was stated that, the patient did not experience any adverse events after the vaccination. The reporter assessed the events as non-serious. Non-significant follow up received on 06-Feb-2018: The reporter confirmed that, the patient did not experience any adverse events after the vaccination. The narrative was amended accordingly.
Initial unsolicited report received from a consumer on 23-Feb-2017. This case involves a female patient (onset age not reported) who was vaccinated with a dose of PNEUMOCOCCAL VACCINE (Pneumococcal) and TETANUS TOXOID (Tetanus Vaccine) (batch number, expiration date, dose, dose in series, route and site of administration were not reported for both the vaccines) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following vaccination the patient skin was gradually getting drier and did not notice it until the skin was split on her thumbs and a red hot welt at the injection site, it was burning, hot to the touch, and itched like crazy. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Allergy reaction rash, itching, hives body, chest, hands. Medical treatment with prednisone tablet 8/22/13.
It seems like i have had sinus trouble since i have received the vaccine?  I have post nasal drip, at night i wake at early morning hours with cough and sometimes sinus headache. I?m not sure it it is related to vaccine but i wanted to report. I?m wondering if others have experienced the same symptoms?
red mark about iron sized on her injection arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red mark about iron sized on her injection arm) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red mark about iron sized on her injection arm). At the time of the report, VACCINATION SITE ERYTHEMA (red mark about iron sized on her injection arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.
red; 2 inch round circle; has fever on the injection site (Temperature, it's hotter); sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SCAR (2 inch round circle), VACCINATION SITE WARMTH (has fever on the injection site (Temperature, it's hotter)), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PAIN (sore) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore). On 28-Jan-2021, the patient experienced VACCINATION SITE SCAR (2 inch round circle) and VACCINATION SITE WARMTH (has fever on the injection site (Temperature, it's hotter)). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red). On 19-Jan-2021, VACCINATION SITE PAIN (sore) had resolved. At the time of the report, VACCINATION SITE SCAR (2 inch round circle), VACCINATION SITE WARMTH (has fever on the injection site (Temperature, it's hotter)) and VACCINATION SITE ERYTHEMA (red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Covid vaccine monitoring documentation. PT admission 1/21/22 - 1/28/2022.   COVID-19, mRNA, LNP-S, PF, 100 mcg/ 0.5 mL dose (MODERNA) 03/31/2021 Lot 028A21A. COVID-19, mRNA, LNP-S, PF, 100 mcg/ 0.5 mL dose (MODERNA) 4/28/2021 Lot 002C21A.
Rash on my back, it is very itchy; Rash on my back, it is very itchy; This is a spontaneous report from a contactable consumer (patient herself).  A 47-year-old female received first dose of bnt162b2 (BNT162B2 also reported as Pfizer BioNTech Vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on Dec2020 at single dose (dose 1) for Covid-19 vaccination. The patient's medical history was not reported.  Concomitant medications included levothyroxine sodium (SYNTHROID) and vitamin D. The patient experienced rash on her back, it was very itchy on an unspecified date in Dec2020.  She reported that she took Benadryl but might not get any relief from it. She had lab work but it was more than 14 days ago, no results reported. The outcome of events not recovered.   Information on the Lot/Batch number has been requested.
Been having diarrhea everyday since August 1st. Thought it might be a side effect of the vaccine but I?m not sure. I tried researching diarrhea symptom two weeks after vaccine and couldn?t find any information. Felt like it would be better safe than sorry to report through this platform and potentially get some answers.
fever 101.2 at 2pm took 2 tylenol and it broke  Went to the urgent care Feb 8, on 14th ER treated her as a sepsis pt. and did a whole check up and was negative (WBC and platelets returned back normal) WBC on the 8th was 2.4 now WBC 02/14 5.82  platelets 1750, now 26200 02/14 Recommended: please see a doctor just to confirm otherwise I would still recommend you get the second dose of the vaccine benefits outweight the risk
39y.o. at 39w4d presenting to triage for scheduled repeat C-section. Birthed baby boy
Hearing a high pitch noise in my head  that will not go away.  Pointer finger on left arm is numb and tingles with movement or touch.  Both symptoms started on the afternoon of the 21st.  Both came on at the same time and were very noticeable together.
Pt received the Pfizer covid19 booster injection on 11/25/2022. Pt arrived to 11/28/2022 with swelling of the face and a rash on her face, ears, arms, legs, and abdomen. Dr. was contacted and ordered 50mg of Benadryl. A prescription for Medrol Dose Pack was also prescribed.  To note, patient also received IV contrast for a fistulagram the same day they received the vaccine. As of 11/30 patient still has rash.  On PO Medrol.
I have a large lump (axillary area)  in the armpit of my left arm which is the injection arm. I noticed it roughly two days after the 2nd injection. It was non painful at first, but now it is tender. It is roughly the size of an egg/golf ball. I also have tenderness on my chest  above my right breast but on the pectoralis muscle. Nothing in the right armpit. I also had aggressive itching at the injection site and a hard area and red welt.
Joint Ache at 2000 hours followed a small headache and fever followed shortly by extreme chills, shivering, and exhaustion at 2100 hours. Next morning fever and chills were gone, but headache, joint ache, sore arm, and exhaustion remains.
Pt presented to pharmacy on 4/1/22 to pick up refill of medication. Pharmacist informed pt he was due for 2nd shingrix vaccination.   Received 1st dose on 1/26/22 at Pharmacy by pharmacist intern.    Upon speaking with patient, pt states he had a bad reaction right after receiving 1st dose. States he had an immediate burning tingling sensation down his arm right after vaccination. Pt states had extreme pain later that evening. Pt also states he is limited by daily activities still with his right arm and still has arm soreness as of 4/1/22. Pt is hesitant to receive 2nd dose after having reaction with first dose.    Pharmacist is suspecting a nerve might have been hit during administration.
Fever 102 F, extreme irritability- x 24 to 48 hours and poor feeding.
Bumps around the injection site; Itching; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number 249DB, expiry date unknown) for prophylaxis.   On 23rd January 2020, the patient received Shingrix. On 28th January 2020, 5 days after receiving Shingrix, the patient experienced injection site swelling and pruritus. On an unknown date, the outcome of the injection site swelling and pruritus were unknown.   It was unknown if the reporter considered the injection site swelling and pruritus to be related to Shingrix.  Additional details were provided as follows: The patient developed bumps around the injection site and itching. The reporter consented to follow up.
03/09/2021  in the morning at 11:00AM I started getting little red dots on my feet to ankle. It looked like blood stuck on my feet. It's burning all the time. I still have it. shoe's hurt my feet. It look like my skin is burned in the inside. I went to my doctor she gave me steroids' for 8 weeks. It stopped the progressing but the pain is still here. If my feet hurt more than usual I take  aspirin.
Headache, Sedation, Myalgia, Arthralgia, Fever, Diarrhea & NauseaVomiting Narrative:
Redness below injection site; 2 inches wide and 3 inches long; Itchy shoulder; Shoulder soreness; A spontaneous report  was received from a consumer concerning a 68-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shoulder soreness/ arthralgia, itchy shoulder/ pruritus, redness belowinjection site/ vaccination site erythema.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 28 Jan 2021, prior to the onset of the events ,the patient received first of two planned doses of mRNA-1273 (Batch number: 038K20A) intramuscularly for prophylaxis of COVID-19 infection.  On 29 Jan 2021, approximately 1 day after vaccination, the patient experienced shoulder soreness that lasted for few days and subsided. On 03 Feb 2021, the patient experienced itchy shoulder and 2 days later, on 5 Feb 2021, the patient discovered that area was itchy and red. The affected area was below the injection site and it was 2 inches wide and 3 inches long. The patient reported that the itchiness was subsided and redness was still there.   Treatment for the events included Hydrocortisone, OTC Benadryl.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, shoulder soreness, itchy shoulder, were considered to be resolving at the time of report. the outcome of the event, redness below injection site, was considered not resolved at the time of report.
Runny nose, chest congestion, wet cough, fever of 102, rash at injection site and stomach.
Bleeding gums, blood clots in the nose, unexplained bruising, bleeding from the rectum.
Initial report received from a consumer on 08 November 2011. A female patient received an injection (route and site not reported) of ADACEL, sanofi pasteur Ltd. lot number not reported, on 27 October 2011. The patient's medical history includes supraventricular tachycardia (SVT) with a rapid heart rate for which she takes atenolol. She had no illness at the time of vaccination and had no other medications within 4 weeks of the ADACEL. The patient received the ADACEL as part of treatment for a cut on the leg at an Emergency Room. Since receiving the ADACEL, the patient has been having increased episodes of SVT and increased rapid heart rate. The patient was tired and had no energy. The patient stated that she has a cardiologist but has not seen him yet. The outcome was reported as not recovered. Documents held by sender: None.
On 3/1/21 a used vial of Pfizer vaccine was reconstituted again with sodium chloride, they were reconstituted in error and patient received diluent only immunization. The immunization administered that day was not effective in providing protection against COVID.   Patient did not have any adverse reaction to the sodium chloride and returned on 3/5/21 to receive the correct dosage of Pfizer vaccine.
Tested positive for COVID 19, I starting showing symptoms of the virus on 1/22/2021 and they only worsened by 1/23/2021 therefore i went to be tested and got a positive result for the virus on 1/25/2021.
Patient began to have a seizure within 6 minutes of vaccination. She also had symptoms of shortness of breath and tachycardia
Within 3 minutes of getting vaccine patient began to have itching, redness, and hive noted in area of injection site on Right Lateral Thigh area. Only MMR given in that leg. Benadryl (12.5mg/5ml) 4ml dose administered in office and observed. No worsening symptoms. Patient released and parent advised to monitor site and to call for worsening symptoms.
Feeling of needle pricking my skin in various places on my body (feet, legs, arms, chest, face, scalp, anus). After dose 1 and dose 2 the sensations were quite intense, but not frequent (1-2x per hour).  The sensations stopped after 4-5 months and I had none for two months.  The pricking sensations started again within hours of dose 3 (booster).  The intense/sharp sensations are less frequent (1-2x per hour) but there are additional slight pricking/stinging sensations all over my body much of the time.  Additionally, for the first few days after dose 3 (booster) I had sensations like a feather was lightly brushing my skin - all over my body.
Sore arm. Swelling in Neck and Jaw, rash on abdomen.
side effects; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.   Treatment information not provided.
I had the worst menstrual cramps of my life and chalked it up to PMS. I also had nausea.  The cramps lasted for six hours, nausea for an entire day. I didn't think anything of it except that my body has been "off' since. The cramps returned the next two months, and I've never had cramps that bad in my entire life. In early June, I experience my first bout of constipation which I didn't learn until July resulted in the development of SIBO in my small intestines. It took two rounds of AMOX/CLAV to clear the SIBO, but we've yet to identify the cause of my seemingly new gastrointestinal issues. I have been tested for Celiac's and sucrose deficiency (which came back positive). We'd do more tests, but I can't afford them right now. I get bloated after eating. I still have some issues passing stool. My stomach always feels like its churning.
Migraine headaches lasting 3 days. Beginning within 24 hrs after injection. Also c/o blurred vision. Pt did not see MD. Self medicated with Excedrin Migraine, 2 tabs q 4-6 hrs X 3 days.
Patient is fully vaccinated.  She was evaluated in urgent care and had a positive swab for COVID. She states that yesterday she started feeling fatigued and chills.  She states that she woke up this morning with a sore throat. She denies chest pain, shortness of breath, hemoptysis, lower extremity swelling, history of PE or DVT. vital signs are stable. CXR: No acute pulmonary process. Medications: Nirmatrelvir, ritonavir. No respiratory distress. Patient stable and discharged home.
Fever; shivering; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and CHILLS (shivering) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced PYREXIA (Fever) and CHILLS (shivering). At the time of the report, PYREXIA (Fever) and CHILLS (shivering) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This spontaneous report as received from a medical assistant refers to a 23 years old female patient. The patient was vaccinated with dose 1 and dose 2 GARDASIL when she was 15 years old. No other co-suspects were reported. No concomitant medications were reported. At the time of reporting she was 23 years old and wanted to have her third dose. No adverse symptoms were reported. Additional information has been requested.
intermittent urticarial react; rash was on face, chest, arms & legs w/pos dematographism;
1) Sore/weak upper arm started within 2 hours, lasted approx 24 hours 2) Menstruation delayed by approx 7 days (expected same day as shot, started one week later)
cluster of vesicles left post neck and left and neck X3DAYS(5/1/2021-5/4/2021) SX ARE STILL ONGOING--HAVE NOT RESOLVED
Within 72 hours of immunization developed fatigue and achiness. Generally appears in good health. Temp increased and slowly returned to normal in about 1 hour's time, with return to normal activity.
Second day after vaccination = 101.6 temperature, headache, very tired Third day after vaccination = 99.2 temperature, headache, still tired Fourth day after vaccination = normal temp, slight headache Fifth day after vaccination = normal day
Patient filled out consent form and verbally said she was here for her 2nd moderna vaccine and after the vaccine was given she gave vaccination record card to be filled out and it was noted the 1st vaccine was pfizer.   Patient waited 30 minutes in clinic to be monitored for adverse reactions but was feeling fine.  Advised to return to clinic or go to ER if she began to feel like she was having adverse reaction.
Patient says 2 days after receiving the vaccination the vaccination area swelled, reddened and began itching.  She applied alcohol to the area to soothe it and it reduced in size after 3 days.   It now looks reddened and slightly raised.
Performing a flu clinic for nursing facility, and  I did not realize that the age of patient wasn't determined prior to giving him the vaccine. He received the 65 and older Influenza vaccine and he was 64. I had been handed a Fluad 65 and older vaccine and that is what I gave him.  Patient has not had any adverse reactions from this however. He is happy and healthy.
Pt diagnosed with COVID-19 on 12/9/2020 (symptom onset 12/6). Had fully recovered and completed isolation period. Had vaccine on 12/27, developed fatigue, dry cough and mild SOB after that. Developed chest pain (substernal stabbing discomfort) on 12/28 and presented to ED on 12/29. Work up was benign. Pt discharge home that same night.
Received flu shot, began to feel "funny". Started to sit down & passed out. Called 911 & by the time they arrived (approximately 3-5 minutes) he had come to.
SCREAMING EPISODE LASTING 3 HRS FOLLOWING DTP/OPV IMMUNIZATION
Information has been received from a medical assistant concerning a 22 year old female with seasonal allergy who in approximately 2007, about 4 years ago, was vaccinated with the first and the second doses of GARDASIL at 0 and 2 months (dose, route and lot # not reported). Concomitant therapy included CLARITIN. The patient developed HPV "around October 2010". On 25-APR-2011 the patient administered the third dose of GARDASIL. The patient didn't seek medical attention. No treatment was given for the event. "Biopsy" was performed on unspecified location but the result was not reported. At the time of the report, the patient had not recovered. Additional information has been requested.
ADVERSE EVENT; This spontaneous report received from a health care professional concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 07-APR-2021, the subject experienced adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse event was not reported. This report was non-serious. This case, from the same reporter is linked.
Narrative: COVID infection following COVID vaccine series 01/08, Pfizer, dose #1 02/01, Pfizer, dose #2 08/03 COVD swab, result; detected non-Facility lab 08/17 pt cc: cough, loss of taste or smell exposure: unknown 08/17 COVID swab, result: detected 08/20 clinically resolved
About 5 minutes after receiving shock, heart started racing. Alerted medics on site, they took blood pressure and confirmed heart rate of about 140 bpm. Due to history of heart transplant, was transported to ED by ambulance from vaccination site.
After receiving the flu shot at 2 pm on Oct. 26, I woke the next morning with lower back pain from muscle spasms, slight fever (1 degre), and very low energy.   I find this significant only because my brother had the same symptoms 2 weeks earlier, especially the back spasms.  He was in such pain that he went to a chiropractor for an adjustment.
improperly stored administered ROTATEQ that was not supported; This spontaneous report was received from a customer (reported also as "other") and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 06-JUL-2023, the patient was vaccinated with improperly stored (Product storage error) dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 ml, administered orally, lot # reported and confirmed as: 1968385, expiration date reported and confirmed as: 22-MAY-2024 for prophylaxis. Temperature excursion details: 34.9 degree Fahrenheit for 6 hours 34 minutes (20-JUN-2023); 51.4 degree Fahrenheit for 7 hours 33 minutes (03-JUL-2023); 51.1 degree Fahrenheit for 24 hours (04-JUL-2023); 50.7 degree Fahrenheit for 9 hours 27 minutes (05-JUL-2023); no previous temperature excursion.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2307USA009292:Original Case # (no patients' identifiers)