chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant concerning a 11 week old male patient with oxygen therapy since birth and a history of premature birth who on 12-JUN-2009 received ROTATEQ oral (lot # 662951/1432X) while he was in a lying position. Concomitant therapy included vitamins (unspecified) (POLY-VI-SOL). He "took the dose well" but when the mother was putting him in the car outside the office, she noticed his coloring was gray and he had stopped breathing. The mother returned him to the office and the physician gave him CPR. The patient's oxygen was "turned up" and the patient was observed for 3 hours in the office. Physician ordered an apnea monitoring to go to the patient's home. Subsequently, the patient recovered on 12-JUN-2009. The patient's "stopped breathing" was considered to be immediately life-threatening and other important medical events by the medical assistant. Follow up information had been received from the medical assistant indicated that the patient did not receive any concomitant vaccines when he received ROTATEQ. The medical assistant stated that the patient was born at approximately 24 or 25 weeks gestation. The patient was in the neonatal intensive care unit from his birth, 21-MAR-2009 to 11-JUN-2009. The patient was discharged from the hospital and sent home on oxygen, 1/8 liter/min. The medical assistant stated that approximately 3 minutes after the ROTATEQ was administered the patient stopped breathing. The physician performed CPR on the patient. The patient responded to CPR. The patient's oxygen was increased to 1 liter/minute. The patient was observed for 3 hours in the physician's office and was sent home on oxygen, 1/4 liter/minute and sent home with an Apnea Monitor. The patient had a follow-up visit with the physician on 16-JUN-2009. The medical assistant stated that the Apnea Monitor's alarm "never went off', (described as the baby was doing fine). The patient's weight was 5 Lbs 8 oz. The patient's next follow-up visit was scheduled for 22-JUN-2009. Additional information has been requested.  6/23/09 Medical records received DOS 6/12/09. Physical examination unremarkable. Patient stopped breathing shortly after vaccine administration. Mouth to mouth resusitation, 2 breaths, breathing restored. 02 administered.
swelling and irritation at the injection site; swelling and irritation at the injection site; This is a Spontaneous report from a contactable physician based on the information received by Pfizer from Merck & Co., Inc. (Case Number: 013999141). A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) on an unspecified date at single for immunisation .  The patient medical history and concomitant medications were not reported.  The patient experienced swelling and irritation at the injection site  on an unspecified date with outcome of unknown. No follow-up attempts are possible, information about batch number cannot be obtained.
Diagnosed with autoimmune hypothyroidism-Hashimotos on Jan 6, 2022.-Related to immune system Diagnosed with squamous cell skin cancer August 2022-Related to immune system. Diagnosed with shingles Nov 4, 2022 even though I've had 2 shingles vaccines-Related to immune system Cardiac symptoms-SOB, Chest Pain, erratic heart rate and BP, lightheadedness, facial numbness began in Spring of 2022 and intensified in June-September,  Diagnosed with SVT but all symptoms not explained.
Approximately 24 hours after inoculation my arms and legs went numb. It took approximately 24 hours for feeling to return.
10 days after patient received the vaccine patient had a fever of 101, diarrhea, slight head ache, achy joints, lack of appetite but recovered after 24 hours.
Pt had hives on rt arm and left lower leg; red eyes and flushed cheeks. Gave 1/2 tsp Benadryl PO; 30 min later redness decreasing. No redness or swelling at injection site. Unsure if child got into stingweed or stung by bee.
bodyaches (hips mostly), headache for first 18 hours then developed a fever >103.5 for the next 48 hours. Also developed moderate diarrhea on 09/26/2009 which continued through 09/28/2009.  Treated with tylenol and ibuprofen, fever did not go lower than 100.5 until the evening of 09/27/2009.
threw up approximately 45min; nausea; dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A 72-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 72 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: VOMITING (non-serious), outcome "unknown", described as "threw up approximately 45min"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness".  Additional information: My husband (also 72), who went with me and got the same vaccination at the same time and same place threw up approximately 45min. after the shot + felt nausea + dizziness for 1 or 2 days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient's husband had same vaccine with no problem.  Patient had no reaction after first dose. Patient received Hep A in last 3 months.  Patient is active, plays sports and not overweight.    Arm hurt at injection site right away but at about 10pm started to hurt more.  Patient felt tired and started to get headache by midnight.  Patient also felt achy so took 1 Excedrin.  Patient woke up at 6am and got vertigo when went down to pick up something.  Patient sat on bed but felt dizzy. Patient not as dizzy as before but head still spinning.  This morning patient is very nauseous and vomited this morning. Patient had bad headache all day--took Tylenol. Patient called pharmacist who specified vertigo is not normal so encouraged to report.   Patient spoke to relatives who a doctor/pharmacist to check in.   Recovery at 50%.   Patient does not feel like she would be able to drive safely.  Arm is doing better; arm is not as swollen or tender
Contracted COVID 19 on September 30; severe case with fever, chills, headaches, joint aches; diarrhea, etc.;  treated with PAXLOVID; tested negative after 6 days but tested positive the 7th day; relapse lasted 5 days; no further treatment during relapse; isolated for 5 days after testing negative; total of 3 weeks in bed and unable to do normal activities.
Fatigued 2-5 days, arm sore 2-4 days, Covid Arm big red circle at site of injection started 2 days after, red circle is getting bigger day 8
This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown ages and genders. On unknown dates, the patients received improperly stored dose of PROQUAD (Lot# L044055, Expiry date: 02-MAY-2017) (Lot# L046510, Expiry date: 19-MAY-2017) (Lot# L051101, Expiry date: 17-JUN-2017) (route of administration: subcutaneous) (incorrect product storage). No adverse effect reported. The outcome of the events was unknown. This is one of the two reports from the same reporter. Additional information has been requested.
This is a spontaneous report from two contactable consumers (one of them is the patient) from a Pfizer sponsored program. A 59-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EP534) via an unspecified route of administration, administered in Arm Left, at the age of 59-year-old, on 22Mar2021 08:30, as SINGLE DOSE for covid-19 immunization.  Medical history included three strokes, hypertension, diabetes mellitus. The patient had no additional Vaccines Administered on Same Date of the Pfizer Suspect and had no prior vaccinations within the last 4 weeks. Concomitant medications included metformin taken for diabetes mellitus (has been taking for many years) and losartan taken for hypertension since 2018 (has been taking for about 3 years).  On 09Apr2021, the patient was feeling bad and went to the hospital. There he was told that he has had three strokes in the past. The patient was told that one of the strokes was about a month ago (Mar2021). He went to the hospital three days ago. He was not admitted and was sent home. He went back again and was sent home. He was started on Plavix two days ago for stroke. The events required emergency room visit. The patient right now is working and travelling and he supposed to have the 2nd dose of the vaccine on 12Apr2021. He wants to know if he can take it late or what possible that he can do. Outcome of was feeling bad was unknown while the event stroke recovered in 2021 with sequelae.
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Around 5 minutes after administration, patient fell from a sitting position to the floor. I ran to his aide were I turned patient on his side and he was able to come to. Upon question with him and his father it is believed that through anxiety patient fainted and fell to the floor. We then called 911 and EMTs came to check patient to clear him to go home with his father. This was also upon his father's request.
At 11:00 patient came in our office for annual well exam and go MenB vaccine (1st) dose. Pt. called at 2:49 pm same day c/o feeling dizzy, nausea, shaky, lethargic and pale. Advised pt to hydrate and have a snack and rest. C/B in AM to check in.
About 20 minutes after the vaccine, I felt like my throat was swelling, like an asthma attack. It was not severe. This lasted for about 2 hours. Less than 24 hours later, I started having chest pain when I would breathe.
numbness & weakness in the lt upper extremity which happened p/having a Td in the lt arm because a puncture wound;
On the first day, it started with a dry and scratchy throat which continued into the next day. Fatigue started to set in as well and post-nasal drip. On the fourth day, I developed body aches and continued for another day or so. During this time, I was 26 weeks pregnant with an estimated due date of February 2023. I took an at-home COVID-19 test on 11/24/2022 which came back positive. I went to urgent care once I knew it was COVID-19, but they wouldn't do anything for me because I'm pregnant. I called my OB/GYN, she informed me to take TYLENOL and MUCINEX since they were the only safe drugs to take while pregnant.
itching to throat, ears, and lips that began 10 minutes after J&J Covid vaccine. Progressed to chest pain.
Severe swelling at injection site, Pediatric down past elbow, very hot and red. Saw MD 8-6-12, Rx's- Prednisone; KEFLEX; Hydroxyzine and VICODIN.
Per hospital report "Dr. order flulaval. Patient was given Fluad by RN. Staff member thought patient was over 65."
Developed shortness of breath and chest pressure on 3/25/2021.   Went to the emergency facility where EKG revealed a 3rd degree heart block.  Transported via EMS the same day where further cardiac workup was performed.   On 3/26/2021 I underwent implantation of a dual chamber cardiac pacemaker.  I was discharged home on 3/27/2021.
experiencing pain in his left side; Almost feels like a broken rib; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN (experiencing pain in his left side) and MUSCULOSKELETAL CHEST PAIN (Almost feels like a broken rib) in a male 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) UNK dosage form. On an unknown date, the patient experienced PAIN (experiencing pain in his left side) and MUSCULOSKELETAL CHEST PAIN (Almost feels like a broken rib). At the time of the report, PAIN (experiencing pain in his left side) and MUSCULOSKELETAL CHEST PAIN (Almost feels like a broken rib) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Chest pain chest tightness. Irregular heartbeat. Sharp pain in chest. Fast and hard beating. Feels like someone is sitting on my chest heavy and hard to breathe.
EE received AFLURIA 2012 flu vaccine into (L) deltoid at 6:10 AM, EE went home & went to bed. EE woke up at 2pm & (L) arm was swollen, sore & (L) 3rd, 4th, 5th digits numb.
Severe joint pain specifically in knees.  Required visit to orthopedist.  Could not diagnose.  At booster same chain of events occurred.  Identical replication
Headache: 2/10, global/ diffuse, responds to excedrin & getting, worse in the morning.  +R Foot went numb and the resolved. No tingling, weakness, or numbness, dysphagia, slurred speech, seizures, blurry vision.  Thirst: Very thirsty.  ALtered Mentation: Slower in responding, Having to really think before she speaks  Muscle Spasms  +hot flashes  no fever, chills, chest pain, or sob.  hyper-emotional (Sponteneous crying).
My nose started to bleed out/after I went to bed around 3:00 AM my nose started to bleed again; After the shot my injection site just started to bleed out a lot; I felt a little off after I received the shot; I noticed a old cut on my finger started to bleed a little; This is a spontaneous report from a contactable consumer (Patient) reporting himself. A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: FC3183) via an unspecified route of administration, administered in Arm Left on 28Aug2021 at 13:00 as DOSE 1, SINGLE (at the age of 34-year-old) for covid-19 immunisation. The patient's medical history was not reported. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). On 28Aug2021 at 13:30, after the shot injection site just started to bleed out a lot, patient felt a little off after he received the shot. Then about 30 minutes later nose started to bleed out. Patient noticed a old cut on finger started to bleed a little. Then after patient went to bed around 3:00 AM nose started to bleed again. The patient did not received the treatment for events. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
PT was pregnant was given Anthrax vaccine. G1 T 0 P0 A0 L0, EDD 01Feb2022. No adverse documented or reported my patient.
24-32hr p/vax pt had listlessness, sleepiness, emesis, whining, cold hands & feet;no fever;
2nd dose missed; little sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little sore arm) and PRODUCT DOSE OMISSION ISSUE (2nd dose missed) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concomitant products included BACLOFEN for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (little sore arm). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose missed). At the time of the report, PAIN IN EXTREMITY (little sore arm) and PRODUCT DOSE OMISSION ISSUE (2nd dose missed) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided.
This spontaneous report as received from a registered pharmacist refers to a 70 years old male patient. Approximately on November 2010 (reported as two years ago from the reported date), the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route were not reported). No concomitant medications were reported. On an unknown date, the patient saw his physician as he experienced symptoms consistent with "precursors of shingles". The patient sought medical attention (saw his physician) and treatment information was unspecified. The outcome of symptoms consistent with "precursors of shingles" was reported as not recovered. Additional information is not expected.
FEVER, WARM, SWOLLEN, TENDER AREA, WITH PAIN SHOOTING DOWN TO WRIST UNRELIEVED BY TYLENOL 8 HOUR TABS.
This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a 50-year-old female patient who received FLUARIX QUADRIVALENT (batch number L94EX, expiry date 30th June 2016). On 16th October 2015, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the report considered the pain in arm to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient experienced sore arm after vaccination. This case was created on follow up of case US2016019415 and was reported by the same reporter.
I have developed an uncomfortable ringing in my left ear . I received my Pfizer Covid booster vaccine. It is hard to read the lot # " 33025bd" or "3302SB0".
Started as mild swelling and headache.  Then fever 102.4 and aches.  Today 3/27/2021 very bad aches in bones and joints, swelling gone, temp 100.2   Extremely tired and ANY activity feels like I've ran a marathon.  Chills, mild sore throat.
Right after receiving the vaccine, his eyes began to roll in the back of his head and he passed out briefly.  He was seated so he did not fall to the ground.  He lost feeling in his legs and hands temporarily.  He also complained of ringing in his ears  and his watch indicated a low heart rate of 42bpm.  911 was called and they evaluated him.  His vitals at that point were stable and the patient's mother declined to take him to the hospital.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right 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: "IgA nephropathy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 from 30Jan2023 to 04Feb2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
I began the Anthrax series as an active duty member of the Air Force on 8/11/99. The 2nd on 8/25/99, 3rd on 9/8/99 and the 4th on 2/8/00. Symptoms of Crohn's dx'd in 4/00, began in 9/99.
Patient started with subjective fever and chills and was inconsolable despite mom giving TYLENOL in the evening after receiving the flu vaccine. Yesterday he refused to put pressure on his foot. Mom says he feels "warmer" than usual but not as high as the first night. Still not wanting to walk on it today but will walk some. She says the leg is swollen and red from the thigh down to his knee. Giving ADVIL. Other siblings have been fine with no reaction. Specifically no breathing problems. No history of egg allergy.
On the 31st of August I had fatigue, 102 fever and chills. It started that morning. This was the first COVID-19 bout I had. By lunchtime I went to urgent care and was given Paxlovid for 5 days from 8/31-9/4. It worked so well that it cleared everything up the next morning. The first night I was drenched from head to two at night, it went through the mattress. I soaking wet and my blood pressure was back to normal. And my blood pressure was going very high and my meds weren't working 2 days before I tested positive with COVID-19.  9/10 I went to the health center and I was positive again after being negative. I had a low grade fever and high pulse and sinus issues. I was told it was Paxlovid rebound. I was sick until 9/19 when I wound up in the hospital. I was given a steroid pack which helped with my sinuses. On the 19th I had a tayaccardia event and was admitted into the hospital for 3 days. I'm now on a heart monitor. My thyroid went down to 10.4 after being in the normal range for a long time.
Started low grade temperature, sore throat, diarrhea, body aches, headache, chills the day after injection Tylenol and Excedrin, symptoms resolved.
About a week after the injection, the site of the injection became red, swollen and itchy. It hurt to touch and eventually the red area increased to an oval about 3 inches at the highest and 2 inches across. It seems to be slowly resolving although it's still itchy and now more pink than red and still swollen. I have not sought medical care.
lost most of her taste; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as 60, unknown unit) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient lost most of her taste on an unspecified date with outcome of unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Stuffiness in ear (no pain, traveled to neck gland), diarrhea for a whole week (stomach pains, nausea, no vomiting) From start to finish lasted about 10 days
Within 3 hours of first vaccine, a small rash developed on right hand.  It became itchy with burning sensations as time went on.  Slowly throughout the next few days, more spots appeared on the right hand.  After the 2nd dose, the rash then appeared on the left hand.  These rashes have been on my hands since Nov 2021.  I experience flare ups at least once a week with no commonality in my environment.  Also, within a week after my second dose I was admitted to the ER with a migraine that could not be resolved.
Never returned for 2nd dose; This case was reported by a other health professional via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 16th September 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient never returned for 2nd dose after numerous attempts to reach them. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter needed to know if administered 2nd dose or restart series. The reporter consented to follow up. This case was linked with case US2021AMR219304, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR219300:same reporter
severe thrombocytopenia - admitted to hospital 4/30-5/1/21; readmitted 5/24
Symptoms: Random itchy outbreaks throughout body that come and go. Raised welts that are hot to the touch that come and go. These welts look like someone has scratched me. These welts are not related to itchy rash.