chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Head swelling; soft stool that's broken up; lots of gas; unusual bowel movements; loose bowels; This spontaneous case was reported by a consumer and describes the occurrence of FAECES SOFT (soft stool that's broken up), FLATULENCE (lots of gas), BOWEL MOVEMENT IRREGULARITY (unusual bowel movements), DIARRHOEA (loose bowels) and SWELLING (Head swelling) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concomitant products included CARVEDILOL, TAMSULOSIN HYDROCHLORIDE (TAMULOSIN), FINASTERIDE and RIVAROXABAN (XARELTO) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced DIARRHOEA (loose bowels). On 22-Jan-2021, the patient experienced FAECES SOFT (soft stool that's broken up), FLATULENCE (lots of gas) and BOWEL MOVEMENT IRREGULARITY (unusual bowel movements). On an unknown date, the patient experienced SWELLING (Head swelling). At the time of the report, FAECES SOFT (soft stool that's broken up), FLATULENCE (lots of gas), BOWEL MOVEMENT IRREGULARITY (unusual bowel movements) and DIARRHOEA (loose bowels) outcome was unknown and SWELLING (Head swelling) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was Reported   This case was linked to MOD-2021-219795 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Concomitant medications were added; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Rash under both arms and in elbow 'crease'; This is a spontaneous report from a non-contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Jun2021 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis. Concomitant medication included mesalazine (MESALAMINE) taken within two weeks of vaccination. The patient previously took ciprofloxacin (CIPRO) and experienced drug allergy. The patient previously also received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Jun2021, the patient experienced rash under both arms and in elbow 'crease'. Therapeutic measures were not taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event rash under both arms and in elbow 'crease' was resolved on an unknown date in Jun2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I started to feel a stiff neck  and pain on the upper right part of my back about 4 hours after receiving the Pfizer vaccine on my right arm. I have continued to feel the problem with my neck for several days. When I called the doctor's office  I was told to take Tylenol for the pain.
This spontaneous case, initially received on 08-Sep-2016, was reported by a Non-Health Professional and concerns a(n) 80-year-old female patient. Weight: Not provided; Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA on 08-SEP-2016. Dose: 0.5 ml, Route of administration: Intramuscular. Batch number: 13049221A. No additional suspect drugs. Adverse reactions/events and outcomes: On 08-Sep-2016, the vaccine has been administered that had particles in the vials - no adverse event (outcome: unknown, special circumstances: poor quality drug administered).
A miscarriage took place; I experienced a significant release of tissue; This is a spontaneous report from a contactable consumer (patient). A 26-years-old female patient received bnt162b2 (BNT162B2, Brand: Pfizer, solution for injection, Lot Number: FA7485, expiry date not reported), via an unspecified route of administration, administered in right arm on 03Aug2021 (at the age of 26 years old as reported) as dose 2, single for covid-19 immunisation. Medical history included covid-19 (prior to vaccination) from an unknown date and unknown if ongoing. Patient had nasal swab on 31May2021 (unknown results). The patient had no known allergies and other medical history. The patient had no concomitant medications and no other medications in two weeks.  Patient received dose 1 of bnt162b2 (BNT162B2, Brand: Pfizer) on 26Jun2021 (Lot number: EW0181) on 26Jun2021 administered in the right arm as COVID-19 immunization (at the age of 26 years old as reported). It was reported that a miscarriage took place on 13Aug2021. Patient experienced a significant release of tissue, and went to three different OBGYN's, two of which confirmed that the photos she presented were a miscarriage. Patient did not know that she was pregnant yet. The patient was pregnant at the time of the vaccination and of the events reported. The events was reported as serious as results in death (fetus). The event resulted in doctor or other healthcare professional office/clinic visit. It was reported that no treatments were received. The events recovered with lasting effects on an unknown date in 2021. Follow-up attempts are completed. No further information is expected.
This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 28 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "crohns" (unspecified if ongoing); "Sulfa" (unspecified if ongoing), notes: known allergies: ibuprofen, sulfa. Concomitant medication(s) included: MERCAPTOPURINE; ALLOPURINOL. Past drug history included: Ibuprofen, reaction(s): "known allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (12May2022) Positive, notes: rebound from paxlovid. The patient received paxlovid as other medication within in 2weeks for treatment of COVID-19 the treatment start date was 03May2022 and treatment stop date was 08May2022. The patient received Mercaptopurine and allopurinol as other medication in 2weeks product. The adverse event rebound from paxlovid, the adverse event start date was reported as 12May2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
on 1/6/21, 9 days after 1st dose of moderna covid 19 vaccine, several inches below the injection site on my left arm began to feel tender to the touch, more firm than surrounding tissue, and warm. 2 days after these symptoms began they resolved (no longer firm tender or warm) but have been replaced by a large raised pink mark on my left arm in the same area that was previously tender warm and firm. the pink raised area has no discomfort.
Patient was standing for vaccine and passed out directly after receiving vaccine. She hit the back of her head after syncopal episode. She did come to after a few seconds. She was taken back to an observatory room. she state she is a little nauseous. She denies shortness of breath, blurred vision, dizziness. Mild headache. Patient stood and was not dizzy. Had her walk and did not have any problems. Family history of fainting.
Fever - Ibuprofen. Large local reaction at the site of Prevnar injection.
This spontaneous report was received from a licensed practical nurse referring to a 19 month old female patient. The patient's concomitant medication, historical and concurrent conditions were not reported. On 09-AUG-2018, the patient was vaccinated at a private doctor's office/hospital using public funds with an improperly stored dose of VARIVAX (lot # R002051, expiry date unknown) subcutaneously and VAQTA (lot #R003739, expiry date unknown) intramuscularly both for prophylaxis in the left thigh. No prescription drug treatment for the experience was required. Details of the temperature excursions were not reported. Data logger was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1808USA007644.
Pt reported 4 days of "high fever" starting the day of administration and also "several" episodes of a "trance like state". Lasting 1 minute with a strange feeling afterward and feeling very tired. Pt states that this has not reccurred for approximately 1 week as of 6-26-19.
Local: Pain and swelling - approx. 60 hrs. General: Myalgia, fatigue, shivering and gastrointestinal symptoms - approx. 36 hrs.
Heart Flutter - heart would rapidly flutter for several seconds then return to normal.  This could occur repeatedly for up to 60-90 minutes During Flutter - Lightheadedness and shortness of breath Chest pain Feeling of not being able to catch breath
Initial unsolicited report received from a consumer on 23-Feb-2016. This case involves a 66-year-old female patient, who was vaccinated with a dose of INFLUENZA VACCINE (Influenza virus vaccine whole) (batch number, dose, dose in series, route and administration was not reported) on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, after vaccination patient experienced neuropathy. Laboratory investigations were not reported. Patient had received LYRICA as a corrective treatment. At the time of this report patient was not recovered from the event. Documents held by sender: none.
Initial unsolicited misuse report received from a consumer on 4 May 2016. This case involves a 12-year-old female patient who was vaccinated with a dose of DAPTACEL instead of ADACEL intramuscularly in the right deltoid on 3 May 2016. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions were reported none and concomitant medications were not reported. On 3 May 2016. Same day following the vaccination, the patient had developed injection site lump (about 3 inches) which started swollen and sore to touch, patient stated that there was sore with arm movement. It was a case of wrong vaccine administered, inappropriate age at vaccine administration and product use in unapproved population. The patient's laboratory data and corrective treatment was not reported. The outcome of the event was reported as not recovered. List of documents held by sender: none.
I received the pneumonia vaccination on 10-29-07.When I arrived home a short time later my body began to ache all over, I developed a fever that increased from 99.1 to 101.7 over the next several hours. I was so weak that I had to lay down. I stayed in bed until 10-31. The soreness around the injection area was much more severe than stated for the "after effects", it is now 2 days later and my arm is still extremely sore.
Pt. reported pain, soreness on side of body (chest) and arm where vaccine was administered. Pain lasted approximately one week, but now they are feeling OK with no pain or discomfort.
No adverse event; HCP called to report a TE with PNEUMOVAX 23 PFS. The outcome was "not supported" for the excursion of 72 hours 0 minutes 0 seconds at 46.7F (47F).  The excursion was discovered upon looking at the data logs.  Data logger recorded a 46.7F temp on Marc; This spontaneous report was received from a consumer, referring to a 73-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 03-MAR-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), at a dose of 0.5 milliliter (ml) (strength, vaccination scheme, anatomical site of vaccination and route of administration were not reported; lot number W027449, expiration date reported and validated as 25-SEP-2024) as prophylaxis, that experienced a temperature excursion (product storage error). The outcome was "not supported" for the excursion of 72 hours 0 minutes 0 seconds at 46.7F (47F). The excursion was discovered upon looking at the data logs. Data logger recorded a 46.7F temperature on 03-MAR-2023 and did not record again until logging a 43F temperature on 06-MAR-2023. Worst case scenario of 46.7F was used for the full 72 hours of the weekend per direction of the Health Care Professional (HCP). No adverse effects were reported.  It was reported that the vaccine experienced a temperature excursion of 46.7F for 77 hours. There was no previous temperature excursion.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002750: US-009507513-2304USA002746:
When I first received the vaccination, my arm was sore and painful for about a week following. Since then I've had chronical body pains in my ankles and joints as well as dizziness. It took several months of convincing my doctor I'm not well to get it addressed, I was sent to a rheumatologist. She confirmed that I have Fibromyalgia which sent me through another round of testing. I don't have a lot of details as of yet.
Patient contracted COVID after being fully vaccinated Cough, fever, congestion, body aches, hypoxia
pt recvd vax; immed exp dizziness & n; these sxs were not tx & resolved in "a few" hrs;
Swollen lymph nodes throughout my entire body started first and chronic hives entire body followed.  I?ve been taking antihistamines every day for a month now. Tried  to stop taking it for one day and they come back full force.
DTaP accidentally administered x2 on same day on 1/12/13. Patient with fever 101 on 1/12/13 - 1/13/13.
it was a bit itchy; small bump that did not grow; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (it was a bit itchy) and VACCINATION SITE MASS (small bump that did not grow) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included LEVOTHYROXINE for an unknown indication.    On 30-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-2021, the patient experienced PRURITUS (it was a bit itchy) and VACCINATION SITE MASS (small bump that did not grow). On 13-Jul-2021, PRURITUS (it was a bit itchy) and VACCINATION SITE MASS (small bump that did not grow) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was reported.   This case was linked to MOD-2021-272121 (Patient Link).
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 34 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive; (02Jun2022) negative; (04Jun2022) positive; (07Jun2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Tested negative using rapid antigen test on 02Jun. Symptoms had resolved. Symptoms returned (runny nose, fatigue, chest pressure) on 04Jun. Rapid antigen tests have been positive 04Jun and 07Jun. Adverse event start date: 04Jun2022, If patient recovered: Recovering, If treatment ae: No (as reported). Anti viral details: Product: COVID 19 Treatment. Brand: Pfizer. Treatment start date: 26May2022. Treatment stop date: 06Jun2022. Indication: Treatment of COVID-19. Other medication in 2weeks: No.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Mom noticed left arm was very red and swollen, warm to the touch day after injection. Child stated it did not hurt. This office was able to evaluate the area. Child appeared in no distress. Area was very red, swollen, warm and somewhat hard to the touch. No lymphedema in armpit area.
This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and gender. Medical assistant reported that since 13-NOV-2014 patients have been administered ROTATEQ orally, (dose and lot numbers were not provided) that underwent a supported temperature excursion. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
The client reported discomfort in her R bicept since vaccination day. Around the 23rd of July, she also fell out of bed and landed on her R arm.  She reported extra pain since then.  She also developed chest pain when she walked up stairs or uses her arm more.  Her family brought her to an emergency room at another hospital on 7/28/2007.  Evaluation there showed ECG changes and she was admitted to further evaluate her chest pain with unstable angina and bicept discomfort.  An MRI was done.  See below findings. 8/24/07-records received-7/28/07-Presented to ED with intermittent chest pain, has had right shoulder pain for past week to day days. Right arm pain since vaccines received. Two days after vaccines adminsitered fell out of bed and landed on right arm, extra pain since then. Developed chest pain associated with this. When she goes up stair or uses her arm more she develops chest pain. No shortness of breath, no nausea or vomiting. Feels somewhat weak. This is chronic for patient. Supposedly scheduled in August for some CT angiogram. PE: right upper extremity slightly swollen in deltoid and humeral area, tenderness of glenohumeral joint. Difficulty raising arm above head.  No C/O chest pain in ED. Impression: right bicipital discomfort secondary to immunizations. Chest pain with unstable anginaEdema in deltoid musculature consistent with recent immunization. Small amount fluid in subacrominal/subdeltoid bursa, consistent with recent injury or burisitis. Multiple normal sized lymph nodes in right axilla which are increased in number. these are likely reactive.
This is a spontaneous report from a contactable physician. A 17-year-old patient of an unspecified ethnicity and gender received the first dose of TRUMENBA at single dose for immunisation. The medical history and concomitant medications were not reported. The patient received the first dose vaccination and had a fever of 103 degree F. Event outcome was unknown.
I am reporting on an odd syndrome that could be related to COVID-19 and the vaccination: a most acrid smell that I had never encountered before, and only once since then, 11 days after the second COVID shot. I was woken up by the smell and went around the house trying to find the source. The smell was strongest in the bedroom, and so I had to be the source, either a heightened and distorted sense of smell or passing gas while asleep. Possibly my gut is reacting to something COVID. I wanted you to have this information in case you collect statistics on such.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 14-MAY-2007 the patient was vaccinated with the first dose of GARDASIL (lot#, dose unspecified), intramuscularly. On 13-MAY-2009 and 20-DEC-2013, the patient received the second dose and third dose of GARDASIL (lot# and dose unspecified) intramuscularly, in respectively. No adverse event reported. Additional information has been requested.
VER RED SORE ARM WHERE INJECTION WAS GIVEN WITH ZOSTER SIZE OF GOLF BALL PER TC
UNSPECIFIED ADVERSE REACTIONS; This spontaneous report received other pharmaceutical company (Pfizer, Inc.) via online article 'The Covid-19 vaccines are highly effective, and the chance of an adverse reaction is rare', concerned multiple patients (unspecified number). The patients' weight, height, and medical history were not reported.  The patients received vaccination with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported 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 an unspecified date, the patients experienced unspecified adverse reactions and an unspecified vaccination site in the state of Iowa paused vaccinations.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient outcome for unspecified adverse reactions was not reported. This report was non-serious. This case, for same reporter, was linked to 20210415305
Information has been received from a physician concerning a 16 year old female who "about 2 months ago" in approximately. November 2006, was vaccinated, intramuscularly (IM), into the deltoid muscle with the first 0.5 ml, dose of Gardasil (yeast). "About 2 months ago". in approximately, November 2006, on the same day of  injection, the patient developed swelling at the site of injection. The patient reported that the swelling at the injection site subsided (date not reported). The patient sought unspecified medical attention. The patient received the 2nd dose recently without incident. The latter dose was administered (IM) in the thigh. Additional information has been requested.