chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer. A 55-year-old female patient started to receive PREVNAR 13 on 11Jan2016 at 09:30 at single dose in right arm. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took erythromycin and experienced allergy. She had influenza vaccine in Oct2015, with no adverse event. After receiving the PREVNAR 13 vaccine, within an hour, she had what sounds like an allergic reaction. On 11Jan2016 (within one hour from vaccination) patient experienced swelling of throat and dizziness; on 11Jan2016 (within 6 hours from vaccination) she had fever, chills, shakes/ still shake intermittently; on 11Jan2016 (within 10 hours from vaccination) had dry cough; on 11Jan2016 (within 24 hours from vaccination) she had swelling of face, due to which was hospitalized; on11Jan2016 she had a hard time having a bowel movement after receiving the vaccine, which was unusual for her. She wanted to go but could not, she felt clogged up. On 12Jan2016 she had cramping of stomach, sick of stomach, discoloration urine and unbelievably stinky bowel movement with very different smell; she still feel different/did not feel normal as of 13Mar2016 and she was extremely tired from an unknown date. Patient had had two chest colds between 11Jan2016-01Apr2016. She stated she normally had chest cold every two-three years, and now she had 2 in 3 months which lasts weeks. She called her doctor when she started experiencing the side effects and she was told to take BENADRYL for swelling of throat, so she took it from 11Jan2016 to 14Jan2016. She had blood drawn on 11Jan2016, but has not received the results yet. She reported she will not be getting the pneumococcal 23 vaccine. Swelling of throat recovered on 11Feb2016; swelling of face and fever recovered on 15Jan2016; chills recovered on 14Jan2016; shakes/ still shake intermittently and feel different not recovered; dizziness recovered on 30Jan2016; cramping of stomach and sick of stomach recovered on 12Feb2016; dry cough recovered on 30Jan2016, then returned on 01Apr2016 and not recovered; discoloration urine recovered on 12Jan2016; difficulty having a bowel movement was recovering; unbelievably stinky bowel movement and extremely tired had unknown outcome; chest colds recovered in 2016. Follow-up (01Apr2016): New information received from a contactable consumer includes: event details/course, new events, seriousness.
Nausea and vomiting on 1/16/21 early morning and then noted at 9PM  with hives to back and neck area-has been afebrile, 1/17/21 temp=99.7 continues with nausea and hives, 1/18/21 Hives continue.
Vertigo Lightheadedness Chills Exhaustion Trouble sleeping Slight fever Muscle aches Injection site pain Headaches Nausea Swollen lymph nodes in shoulder, neck, and armpit
p/vax pt devel bells palsy w/right side weakness & facial pain. condition persists
I woke up on February 5th, 2021 with pain in my armpit area. The area was extremely tender and ached.  Upon looking at my arm, I noticed a rash at the injection that was a few inches spread across my upper arm.  Today, February 6th, the rash is still present, as is some achenes in my upper arm and armpit area.
Information has been received from a physician concerning a 22 year old female who on an unspecified date "thought she was vaccinated" with MMRII. The patient reported this in an employee screening. Labs for rubella and rubeola show "equivocal and negative titers". No adverse symptoms were reported. Additional information has been requested.
Information has been received from a physician concerning a patient who was vaccinated with ZOSTAVAX. "A few months later", the patient was diagnosed with shingles. He also saw a opthamologist fro evaluation. Shingles was fully resolved on 22-JUN-2007. Follow-up was received from a registered nurse (R.N). This is one of several reports from the same source. Additional information has been requested.
Possible allergic reaction on Rt arm, slightly red, slightly tender and warm to touch. Complains of pain when moving arm. KEFLEX 250mg TID x 10 days given 5/29/14.
Patient complained of large, red, painful lump in her arm (she pointed to her left arm but the vaccine had been given in the right) followed by a diffuse body rash.
fatigue; severe headache; light chills; This is a spontaneous report from a contactable consumer or other non health professional (Patient). A 21-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3248) dose 2, via an unspecified route of administration, administered in Arm Left on 02Feb2021 (at the age of 21-years-old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medication was not reported. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously received INFLUENZA vaccines within 4 weeks prior to the COVID vaccine in left arm on 07Jan2021 for immunisation. The patient previously took first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3248) via an unspecified route of administration, administered in Left arm on 13Jan2021 02:45 pm (at the age of 21-years-old) as single dose for covid-19 immunisation. The patient wouldn't consider this adverse, just the predicted side effects, fatigue, severe headache, light chills on 03Feb2021 at 06:00 am. The headache was continued 2 days after vaccination. The patient not received treatment for the adverse event. Since the vaccination, the patient was not tested for COVID-19. The reporter assessed the events as non serious. The outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
No adverse event; drug exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (drug exposure during pregnancy) and NO ADVERSE EVENT (No adverse event) in a 30-year-old female patient (gravida 2, para 1) who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 80777-0102-96) for COVID-19 prophylaxis.     Concurrent medical conditions included Pollen allergy, Dust allergy and Sulfonamide allergy (Sulfa allergy).    On 21-Sep-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. The patient's last menstrual period was on 22-Aug-2023 and the estimated date of delivery was 28-May-2024. On 21-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced EXPOSURE DURING PREGNANCY (drug exposure during pregnancy). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). The patient received mRNA-1273.815 (SPIKEVAX 2023-2024) beginning around the  fourth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. At the time of the report, EXPOSURE DURING PREGNANCY (drug exposure during pregnancy) had resolved and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPOSURE DURING PREGNANCY (drug exposure during pregnancy).    No Concomitant medications were reported.  EDC was reported as early June or late May 2024. This was her 2nd pregnancy. 1st baby was born on XX-Nov-2021. She was scheduled to have her 1st prenatal checkup in October. She had normal pregnancy so far. Her immunization details were: 1st dose on 22-Apr-2021, lot number 002C21A. 2nd dose on 20-May-2021, lot number 017C21A. 3rd dose on 18-Nov-2021, lot number FH8027.  No treatment medications were reported.; Reporter's Comments: This is a spontaneous case concerning a pregnant (4 weeks of gestation period) 30-year-old female patient, with no relevant medical history, who experienced exposure during pregnancy with no adverse events associated. A dose of SPIKEVAX 2023-2024 vaccine, given as a fourth dose of COVID vaccine schedule, was administered. No further clinical information was provided for medical reviewing. The benefit-risk relationship of the SPIKEVAX 2023-2024 vaccine is not affected by this report.
day 6 to 7 developed swelling,  warmth, pain, redness to the left upper arm, diameter about 6 inches which was expanding and tenderness in the axilla. Was treated as cellulitis as the symptoms developed nearly a week after the vaccination. Was prescribed Keflex twice daily for 10 days
No known adverse effects; an administered dose of VARlVAX underwent a temperature excursion prior to being administered to 1 patient on 06/16/2020; This spontaneous report was received from a nurse prescriber and refers to a patient of unknown age and gender. No information regarding patient's medical history, concomitant medications and concurrent conditions was provided.     On 16-JUN-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S024362, expiration date 06-AUG-2021 2019 (route of administration, dose and frequency were not reported) for prophylaxis. Digital Data logger was involved. The vaccine was stored at the temperature that was reported as from 10.8 degrees of F for 2 hours. There was no previous temperature excursion reported.  No known adverse effects reported.
Patient had tachycardia and was found to have elevated blood glucose up to 374. Glucose was normal earlier in the year when checked. Starting metformin and will monitor glucose.
COVID fingers; Painful itching; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (COVID fingers) and PRURITUS (Painful itching) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (COVID fingers) and PRURITUS (Painful itching). In 2021, PRURITUS (Painful itching) had resolved. At the time of the report, VACCINATION COMPLICATION (COVID fingers) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.  The patient had a reaction to the second dose of the vaccination. The patient experienced painful itching and did go away.
Red patch rash, Headache, swollen lymph nodes. Sent home for 1 week until rash disappeared. Dr diagnosed with Rubella.
pt recvd vax; pt cried & unconsolable p/ shot on way home (trip took 4 hr-nl 2hr)stopped several times;high pitched cry; took bottle, approx 5 hrs at home fussy, hard to console; gave apap q/ 3 hr;no fever
I was at my Doctor for a routine check up and upon listening to my heartbeat he heard a skipped beat, this was a neurologist. I went then to my Cardiologist who put me on a heart moniotor to be reviwed on 06JUN2023.
Information has been received from a physician concerning a 13 year old male who was vaccinated with the second dose of VARIVAX (Merck) (lot# 659726/1772U), standard dose, SQ on his left arm. There was no concomitant medication. Several days after the vaccination the patient developed chickenpox rash on the injection site of his left arm. He also had fever. The rash disappeared within 2 to 3 days after the appearance of rash. On an unspecified date the patient recovered from fever. The patient was seen by the physician. Additional information has been requested.
Left shoulder started clicking, dull nagging pain, limited mobility, pain when moving and lifting arm above head, muscle weakness. Left shoulder now feels like a rotator cuff injury
Presented on 7/5  2 months of intermittent dyspnea and chest pain. Patient states it all began about 2 weeks after his first Moderna covid vaccine at mid/end of April. He developed exertional chest pain that felt like a squeezing. He was recommended a stress test at that time, but didn't have health insurance and wanted to wait until he was covered. He was put on a 5 day course of prednisone, that seemed to improve his symptoms and he felt back to baseline and was able to proceed with the 2nd moderna vaccine in the middle of May. Shortly after that, he developed intermittent dyspnea on exertion and chest tightness. It was difficult to take a deep breath in, felt like something was grabbing him when he tried to take a full deep breath. This has been becoming more constant over the last 2 weeks. Today, he was outside moving a lawnmower when his symptoms significantly worsened. He felt lightheaded. His wife convinced him to go to clinic, where he got a CTA that showed an saddle PE.
rheumatoid arthritis which has flared up following vaccination.; This is a spontaneous report received from a contactable nurse (patient). A 61-year-old female patient received BNT162B2 (Pfizer BioNTech COVID-19 vaccine, Formulation: Solution for injection (batch/Lot number: unknown), via an unspecified route of administration on 26Feb2021 at single dose for COVID-19 immunization. Medical history included blindness. Concomitant medications was not reported. Her next dose was in 2 days. The patient reported that she was ok the first few days after vaccination then experienced side effects including joint pains, the patient had numerous autoimmune diseases, specifying one of the as rheumatoid arthritis which has flared up following vaccination. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of RA flare due to temporal relationship. However, the reported event may possibly represent intercurrent medical condition in this patient.   There is limited information provided in this report.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
28 hours post-blotchy redness & pain about 2" in diameter around site. 36 hours post- raised swelling, redness 3" redness & pain. 50 hours post-hard, very red, warm to the touch, significant swelling 5" of redness. 54 hours post-very hot, swollen, raised significantly, pain, unable to walk normally. 65 hours post-very hot, swollen, raised significantly, cellulitis appearance, 8-9" is diameter, pain, unable to walk normally-saw nurse practitioner in the urgent care-diagnosis of allergic reaction, was put on Prednisone (5 days), BENADRYL, and CLARITIN for 10 days. 90 post-swelling started to go down, still warm to the touch and less painful. 1 week post-swelling and less redness, cool to the touch but discoloration where the 8-9" of cellulitis appearing 1 mo post-continued discoloration, no swelling, no redness.
Chills sweats nausea fever body aches migraine from 7:30 pm on 4/9 until 10:30 pm 4/10 treated with Tylenol.   Continued to have migraine and body aches and nausea on 4/11-4/13 treating with Tylenol.  On 4/13 went to urgent care and had a covid test performed.  Doctor advised me to switch from Tylenol to Motrin.  Continued to experience headaches minor body aches until 4/15.  Covid results came back negative.  As of today 4/16 still have headache that  I am treating with Motrin
HAD SHOT 02-26-21 . HAVE REDNESS ON UPPER FRONT PART OF ARM
It was reported that a male patient received a YF and a TD vaccination on 21-Sep-2000. reportedly the patient developed throat swelling, was able to talk and breathe. Patient has tracheostomy, was allergies or immunosuppression. Follow up mailed correspondence received on 7/27/01 it was reported that the pt recovered from this experience. Additional responsible physician info was provided.
I had severe stomach cramping; 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 ABDOMINAL PAIN UPPER (I had severe stomach cramping) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (I had severe stomach cramping). At the time of the report, ABDOMINAL PAIN UPPER (I had severe stomach cramping) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were mentioned. No treatment details were reported.
Janssen Covid-19 Vaccine EUA. Symptoms started about 4-5 hours after injection. Headache and overall tiredness started on the first day. By the next morning 5/5/21, I was experiencing Muscle soreness, Joint pain, Headache. By the next evening, 24 hours after injection I was experiencing Extreme Muscle soreness and Joint pain, Piercing headaches, Fever, overall weakness and exhaustion. These symptoms continued on 5/6. By 5/7 the severity of the symptoms had lessened, But I continue to experience headaches, Muscle fatigue and weakness, and overall tiredness and an inability to feel well rested after sleep.
09/03/21 The patient presents with COVID-19 x2 days. Per nurse, pt who has Alzheimer's was brought in by EMS after staff at his living facility noted a pulse ox in the 80s and EMS was called, once pt arrived he was put on a 2 liter nasal canula and is now resting at 97%. HPI limited due to clinical condition.  The onset was 2  days ago.  The course/duration of symptoms is unknown.  The character of symptoms is COVID-19 symptoms.  The degree at onset was unknown.  The degree at present is unknown.  Risk factors consist of Alzheimer's.  Therapy today: none.  Associated symptoms: denies chest pain, denies abdominal pain, denies nausea, denies vomiting, denies shortness of breath, denies fever, denies chills, denies headache, denies dizziness and denies back pain.
(L) increased arm soreness, sl. redness resolved after 2 days, Dec 31st swelling redness @ site 1/2 dollar size. progressed to saucer size over weekend of 1/1 - 1/3 Less swelling, increased redness and size
Patient had high fever of 101.5 with body aches, headaches, rash all over body for 4days. Injured kidney and liver through lab test
This study case was received from the investigator on 27 August 2012. A 21-year-old male subject with no reported past medical history had received ACAM2000 (lot number, route, site and date of administration not reported) and an unspecified amount of time later was found to have on 14 July 2009 an elevated central laboratory Troponin level of 2.03 ng/ml and on 23 July 2009 a central laboratory Troponin level of <0.10 ng/ml. The date of recovery was reported as 23 July 2009. The subject also had a rapid Troponin I level on 14 July 2009 that was not within normal limits (positive). On 14 July 2009, the subject had a normal ECG reading. Also, the subject had experienced chest pain on 13 July 2009, which resolved on the same day. There was no other reported visit. The subject had no concomitant medications. No further information was available at the time of the report. The subject's outcome was recovered. According to the Investigator, the event of elevated central lab troponin was considered an other important event and possibly related. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Documents held by sender: medical records.
9 days after MMRV pt had onset of fever with no other symptoms. He had a seizure with fever on the second day of fever and went to the ED where he received IV hydration, blood work and a CXR. The chest xray was read as c/w pneumonia. His blood work was unremarkable and with previous hx of febrile seizure and his then normal sensorium he was discharged to home. He had a further 3 days of fever without cough or other symptoms. He broke out in a small macular rash generally on the day after the fever ended and the rash lasted for three days. He remained clinically well.
Burning sensation in back of shoulder; Shooting pain in my shoulder and in my left arm; Shoulder pain that moves into the back of his shoulder; Pain where they gave the shot; I have been experiencing discomfort.; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning sensation in back of shoulder), PAIN (Shooting pain in my shoulder and in my left arm), DISCOMFORT (I have been experiencing discomfort.), VACCINATION SITE PAIN (Pain where they gave the shot) and ARTHRALGIA (Shoulder pain that moves into the back of his shoulder) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011FZ1A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In October 2021, the patient experienced DISCOMFORT (I have been experiencing discomfort.). On 23-Oct-2021, the patient experienced VACCINATION SITE PAIN (Pain where they gave the shot). On 25-Oct-2021, the patient experienced BURNING SENSATION (Burning sensation in back of shoulder), PAIN (Shooting pain in my shoulder and in my left arm) and ARTHRALGIA (Shoulder pain that moves into the back of his shoulder). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, BURNING SENSATION (Burning sensation in back of shoulder), PAIN (Shooting pain in my shoulder and in my left arm), DISCOMFORT (I have been experiencing discomfort.), VACCINATION SITE PAIN (Pain where they gave the shot) and ARTHRALGIA (Shoulder pain that moves into the back of his shoulder) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported.
Breakthrough case admission after 2 vaccines Janssen 4/10/21 Lot# 042A21a;  3/10/22 Moderna NO LOT #;  LOT NUMBER IS NOT LISTED IN THE STATE DATABASE; PLEASE DO NOT SEND REQUEST FOR LOT NUMBER
Administered on right arm and  almost 24 hours the patient developed a large red spot with pain on the inside part of the arm.
Information has been received from a licensed practical nurse concerning a 10 year old male with no pertinent medical history and drug reactions/allergies who on 25-FEB-1999 was vaccinated with a first dose of VARIVAX (Merck) 0.5ml subcutaneous in his left arm. On 04-JUN-2008 the patient was vaccinated with a second dose of VARIVAX (Merck) (lot# 657106/1891U) 0.5ml subcutaneous in his left arm. There was no concomitant medication. There was no illness at time of vaccination. Immediately post vaccination on 04-JUN-2008 the patient developed hives around the injection site and itching at injection site. The symptoms lasted a few hours. The patient was monitored and recovered, no treatment. The patient sought medical attention in office. Nurse was requesting lot 1891U check to see if there have been other reports of this happening with this same lot number. This is one of several reports from the same source. Additional information is not expected.