chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After more than 24 hours my arm hurts; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (After more than 24 hours my arm hurts) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (After more than 24 hours my arm hurts). At the time of the report, VACCINATION SITE PAIN (After more than 24 hours my arm hurts) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age 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 PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.   Treatment information was not provided.   This case was linked to MOD-2021-338337 (Patient Link).
Itching at site of injection, also noted red blotching consistent with shape of band aid. Also approx 4x4 area upper left arm. PMD notified advised to give Benadryl 25 mg IM, irritation, inflammation resolved approx 20 min.
03/20/2021  upper left arm swollen,  arm sore to move. a slight headache. 03/21/2021 Woke up with sever sore left arm . Bad pain when rasing left arm .Had a hard time getting dressed. Still had a headache but it  was a little worse 03/22/2021 Headache gone, Left arm still a little sore , but much improved.
Patient had Pfizer COVID-19 vaccines on 5/27/2021 and 6/17/2021. On the evening of 06/18/2021 she started having headache with nausea and vomiting. Over that weekend she progressively got worse with slurred speech and then aphasia although she could still follow commands. She was then seen in the emergency department where she was then transferred to emergency department.  There she was noted to have deterioration in her neurologic exam with inability to follow commands. She was then transferred to Hospital where she became more obtunded and encephalopathic and was transferred to the.
No adverse effects- patient was given initial Pfizer dose instead of Pfizer Bivalent booster
Patient experienced a problem in her ears after getting 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of EAR DISORDER (Patient experienced a problem in her ears after getting 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EAR DISORDER (Patient experienced a problem in her ears after getting 2nd dose). At the time of the report, EAR DISORDER (Patient experienced a problem in her ears after getting 2nd dose) outcome was unknown.            No concomitant medications were reported.  Treatment information was not provided.
Abdominal Pain; ER - I had an ileus and every test done in the sun: Endoscopy; Diagnosed with me - possible upper bowel obstruction and thickening of the small bowel - severe abdominal pain and constipation Endoscopy; colonoscopy; three CAT SCANs with - two different contrasts IV and oral  and two with IV contrasts - biopsies of the small bowel; I went to the doctor yesterday - I have to leave work with severe abdominal pain and vomiting - have had every blood test, too. I am going to get a breath test for bacteria - drink something and then breathe into different tubes throughout the day; more stool specimens scheduled too. Irritated -stomach lining - when they did the endoscopy last month or the month before - that is when they saw it was irritated. Went to ER last week. Another time they said ileus was fine. Three or four ER visits all together so far. They just give me pain medication and send me home - they gave me Fentanyl  - through nasal or IV - that's all I have been able to take.  More blood work - scheduled as well. Treatment: bland diet - I've lost 20 minutes - 10 of it in a week because of I was throwing it what I ate. He ordered medication for me for when I get the abdominal pains - I haven't got it yet - it's for the spasms that are occurring when I get the pain. Still getting symptoms off and on - not linked to anything.
one week after receiving injection, right arm at injection site developed redness, rash, hot to touch, painful, itchy.
Patient went to the emergency room either 12/31/16 or 01/01/17, she is uncertain. She reported she was diagnosed with a urinary tract infection, low k+ and dehydration. And showed the MD her arm from the TDAP but the doctor did not remark on it.
Patient did not suffer any adverse reactions. MENACTRA was given on 9/24/18. The patient was not due for a dose.
1wk p/vax pt had chest & throat tightness;went to hosp ER 25OCT dx was sinus infect & also flu shot rxn;f/u MD appt w/Md on 10NOV;
Information has been received from a health professional concerning a 67 year old female with an allergy to latex, who on 10-DEC-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot # 663198/1419X). On an unspecified date the patient had numbness of her lips and a "weird taste" in her mouth. The patient had not recovered. Additional information has been requested.
1" hard area, pale center w/#" irregular red area, APAP PRN; used 1/2" needle;
Information has been received from a physician's assistant concerning a 20 year old male,  who was vaccinated with Hepatitis A virus vaccine inactivated 20 years ago. Subsequently, the patient started blinking the next day and continues to do so. The patient sought unspecified medical attention. Additional information has been requested. The reporter also reported on the patient's niece WEAS # 00120970.
Had the first Moderna Vaccine on February 11, 2021, on February 18, my left upper arm started itching and developed a rash under the injection site that today Feb. 19 is about 4 inches long and 2 inches wide.  It has an oval shape with a distinct border around it.  it feels hard and the skin feels tight at the rash area.
LEG CRAMPS; TIREDNESS; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 140 pounds, and height was 153 centimeters. The patient's past medical history included left ankle injury, and leg cramps, and concurrent conditions included seasonal allergy, social alcohol drinker, and non-smoker, and other pre-existing medical conditions included no drug abuse or illicit drug usage. history of taking birth control medication 40 years ago but she stopped it since then due to severe leg cramps. The patient experienced drug allergy when treated with morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. Concomitant medications included naproxen sodium. On 15-MAY-2021, the subject experienced leg cramps. On 15-MAY-2021, the subject experienced tiredness. The action taken with covid-19 vaccine a was not applicable. The patient recovered from leg cramps on 15-MAY-2021, and had not recovered from tiredness. This report was non-serious.
After receiving the 2nd Booster on 5/25... left arm very painful, then at about 48 hours after vaccine the left upper arm very swollen and painful, became erythematous with extending rash along lateral ram extending to antecubital area. Arm swelled to 3x normal size. Next morning swelling and red induration extended down to forearm. Tight swelling and painful.
Diarrhea; Fatigue; Joint Pain; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), FATIGUE (Fatigue), ARTHRALGIA (Joint Pain) and HEADACHE (Headaches) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), FATIGUE (Fatigue), ARTHRALGIA (Joint Pain) and HEADACHE (Headaches). On 11-Jan-2021, DIARRHOEA (Diarrhea), FATIGUE (Fatigue) and ARTHRALGIA (Joint Pain) had resolved. At the time of the report, HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications provided as blood pressure medication and various vitamins. No treatment details was provided.
Administration of vaccine was painful in left deltoid.  Arm remained sore that night after administration.  Pain in left shoulder has gotten prgressively worse each day since administration of vaccine to the point is very painful and has limited movement of left shoulder. No reddness, swelling or hot to touch at injection site.
Sharp abdominal pain after eating; Sweats; This case was reported by a pharmacist via call center representative and described the occurrence of abdominal pain in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number MY7JS, expiry date 30th April 2022) for prophylaxis.   On 7th May 2020, the patient received the 2nd dose of Shingrix. On 9th May 2020, 2 days after receiving Shingrix, the patient experienced abdominal pain and sweating. On an unknown date, the outcome of the abdominal pain and sweating were unknown.   It was unknown if the reporter considered the abdominal pain and sweating to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and two days later started to be experienced sharp abdominal pain and sweats after she eats. The reporter consented to follow up.
Arm pain-heavy feeling, painful when moving  Low grade fever 99.5 Moderate Body aches, especially low back
Breakthrough case admission after three vaccines;  Pfizer 2/26/21 Lot# EN6200;  Pfizer 3/17/21 Lot# EN6207;  Pfizer 11/19/21 Lot# 30145BA ;
Developed metallic taste in mouth  within 5 minutes of vaccine administration that persisted for 1 to 2 hours. Developed palpitations and flushing within 10 minutes of vaccine administration that resolved after 1 minute. Palpitations and flushing recurred along with development of burning sensation in distal extremities within 15 to 20 minutes of vaccine administration.  Palpitations were forceful and pronounced enough to cause chest tightness, lightheadedness, and weakness.   These symptoms resolved without intervention after less than 5 minutes.
5 Days following second vaccine I experienced heart palpitations and tachycardia that sent me to the ER. I am still dealing with these palpitations every single day. I?ve had a bunch of tests done and they can?t figure out what?s wrong. I?ve never had heart palpitations in my life until I got the second shot.
Expired vaccine was administered to patient. Expiration date: 02/21/2021. Date given: 06/24/2021
patient received undiluted vaccine (for a dose of approximately 20mcg rather than the intended 10mcg).  Parent was contacted on 7/21/22 after the error was discovered.  No adverse effects other than sore arm.
Soreness to his arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 29Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Soreness to his arm". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient woke up in the AM and left arm was red and swollen the size of a tennis ball with associated itching to site. Also had mild dizziness.
Approx 3 minutes after receiving the vaccine she became very anxious.  She started dry heaving into the trash can. She also has hypoglycemia and her BS was 100. She was able to calm herself down without medications. Her doctor told her next time to eat more before she goes.
passed out; couldn't move; threw up; joint pain; headache; hives; high fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Mar-2021 and was forwarded to Moderna on 24-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Urticaria (chronic hives for 16 years.) since an unknown date. Concomitant products included DOXEPIN, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), FEXOFENADINE HYDROCHLORIDE (ALLEGRA) and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jan-2021, the patient experienced PYREXIA (high fever). On 19-Feb-2021, the patient experienced URTICARIA (hives). On 19-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), MOVEMENT DISORDER (couldn't move), VOMITING (threw up), ARTHRALGIA (joint pain) and HEADACHE (headache). On 19-Mar-2021, LOSS OF CONSCIOUSNESS (passed out) had resolved. On 24-Mar-2021, MOVEMENT DISORDER (couldn't move), VOMITING (threw up), PYREXIA (high fever), ARTHRALGIA (joint pain) and HEADACHE (headache) had resolved. At the time of the report, URTICARIA (hives) outcome was unknown.            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.; Reporter's Comments: .; 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.
BREAKTHROUGH COVID INFECTION, TESTED POSITIVE ON 08/05/2021. FULLY VACCINATED ON 01/21/2021.
First adverse reaction was 01/23/2021 Fever of 103.0 Farenheit. Took tylenol 1000mg orally Second adverse reactio was on 1/24/2021 All over body hives. Treated with Benadryl 50mg  orally multiple doses. Third adverse reaction 1/25/2021 numbness and tingling in left arm. Continues and is getting worse.
26 hrs p/inject exp numbness & tingling in hands & feet & difficulty walking; wk of 7NOV had pain in legs, hand & feet-difficult going up steps; 22NOV states having difficulty keeping balance; lost 14lbs, difficulty swallowing; poss virus;
9 days post-injection have a raised, red welt, that is hot and itchy . Site is larger than a 50 cent piece and elongated
Swollen, red, left leg - swollen from hip to knee - 12 1/2 inch circumference mid leg, 11 inch circumference around knee.
I was diagnosed with invasive ductile carcinoma in the right breast on 1/30/2023. On 12/8/2022, I had undergone a routine mammogram, in which an abnormality was detected. On 1/18/2023, I underwent a follow-up mammogram and an ultrasound. I then underwent a biopsy on 1/25/2023. I got the results back on 1/30/2023, which is when I learned I had cancer. On 3/1/2023, I had a lumpectomy and a partial bilateral mastectomy. I am due to start chemotherapy in April 2023. I am also due to undergo 12 weekly treatments of paclitaxel. Every three weeks for a year, I will also be treated with HERCEPTIN. Four to six weeks following starting the paclitaxel, I will also be getting daily radiation treatments from Monday through Friday for three weeks. Following that, I will also be taking tamoxifen for five years. I have a family history of breast cancer, but I don't have the genetic component associated with breast cancer.
Pt. states that after receiving the 1st dose of Prevnar 13 01/13/2022, started experiencing symptoms that evening of swelling of the Lymphnoid underarm area in the Left arm. Feverish to the touch, "hard lump" has formed. No noted Primary visit/communications.
Took oral Typhoid vaccine prescribed by MD and picked up at Pharmacy. Woke today with facial swelling with pain. I consulted with State epidemiologist.
severe swelling in the arm, so bad it looked like cellulitis/ severe reaction; severe swelling in the arm, so bad it looked like cellulitis/ severe reaction; This spontaneous report was received from a female patient of unknown age who was reporting on herself. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 25-SEP-2018, she was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route of administration, anatomical location, strength, lot number and expiration date were not provided) for prophylaxis. The patient requested ingredients contained in pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) because on an unknown date in September 2018 she experienced severe swelling in the arm. The swelling looked so bad, like cellulitis. She sought for medical attention and informed her physician about this event, but also refused to inform if ant treatment was provided. The outcome of arm swelling looking like cellulitis was unknown.  The reporter did not provide a causal assessment between the mentioned events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). Upon internal review, cellulitis was determined to be medically significant.
Almost immediate reaction-Reports dizziness.  vision change, LOC, EARS ringing. Throat pain.  feeling "hot".
Vaccine administered 2/4@1030. Small grape sized lump noted to left armpit 2/5@0800.  By noon, lump had increased in size. The lump was the size of the palm of my hand. It is painful to touch. No redness or erythema noted.  Taking Tylenol and Motrin
13NOV95 pt exhibited lack of visual tracking & lack of blink on confrontation;11NOV95 sz (?) & septic workup done @ hosp;sepsis r/o;CSF pleiocytosis
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 at 16:30 as dose 5 (booster), single (Lot number: GH9702) at the age of 68 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing). Concomitant medication(s) included: DESVENLAFAXINE, start date: 01Nov2018. 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: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Report about covid treatment yes, Reporter type patient, vaccine received yes, other medication in 2weeks yes, Product COVID 19 Treatment start date 04Apr2023, stop date 09Apr2023. This is a notification generated from the regulatory system. As part of the simplification process, the following Complaint Records were classified as Product Use Attributes Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the 'One and Done' business process according to in PQS Q1215 and/or Q1252. Refer to the below table for details. Conclusion of Previously Completed Investigation The complaint for "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot GH9702. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Agency site concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.
Left upper arm swollen, extreme headache, nausea, chills - took extra strength Tylenol every 6 hours but very little relief
Muscle soreness; Arm tenderness; Headache; Fatigue; This is a spontaneous report from a non-contactable consumer (patient). A non-pregnant 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EL9267), via an unspecified route of administration, administered in left arm on 12Feb2021 at 15:00 (age at vaccination was 27-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history included known allergies to Cephalosporins and sulfas. Concomitant medications (other medications in two weeks) included desvenlafaxine succinate (PRISTIQ), ibuprofen and multivitamins (as reported); all from an unspecified date and unknown indication. The patient did not receive any other vaccine within 4 weeks. Prior to vaccination, the patient has not been diagnosed with COVID-19 and post vaccination, the patient has not been tested for COVID-19. The facility type where COVID-19 vaccine was administered was reported as hospital. On 12Feb2021, the patient experienced muscle soreness, arm tenderness, headache, and fatigue. It was reported that muscle soreness and arm tenderness lasted for 3 days. No therapeutic measures were taken as a result of the events. The outcome of the events muscle soreness and arm tenderness was recovered on 15Feb2021 while for headache and fatigue was recovered on Feb2021.  No follow-up attempts are possible. No further information is expected.