chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient developed shortness of breath and nocturnal cough about 2 weeks after the second Moderna dose.  Symptoms got progressively worse.  He got medical attention on 6/25 and was initially thought to have GERD.  ED evaluation 7/5 was unrevealing.  Then felt to be possibly asthma/COPD.  Finally diagnosed with non-ischemic cardiomyopathy and rapid afib on 7/15.  Then suffered embolic stroke despite anticoagulation on 7/21.  He suffers hemiplegia, global aphasia.  Then had embolism to his R leg which required AKA to treat.
Information regarding PREVNAR 13 was received from a healthcare professional regarding a 2 year old female patient who experienced hives. The patient received a dose on 14 Sep 2010. The patient's concurrent illness includes drug hypersensitivity (Penicillin). Concomitant medications were not reported. The patient experienced  hives on 14 Sep 2010. As of 16 Sep 2010, the outcome for hives was unknown. No additional information was available at the time of this report.
Pt received MMR vaccine on 1/30/07. Mom stated child broke out with a rash on the night of 01/31/07. Brought child to office on 02/01/07 with urticarial rash all over.
After receiving the PPD, TD and varicella patient became quite pale. She was assisted in putting her head down between her knees. After about 5-10 seconds she lifted her head, good color had returned and she appeared alert. She was placed on an exam table for the fourth (MMR) injection. She was alert and responding appropriately. Within seconds of giving the MMR she developed a tonic seizure, arched neck, very stiff, clenched jaw and her color went from very pale to cyanotic. Attempted to establish and airway by pulling on lower jaw. Was able to open her jaw just enough for her to take one breath. She then started clonic movement and lost bladder control. She again became cyanotic. The entire episode lasted about 60-90 seconds. 911 was called. She finally relaxed and regained consciousness. BP 110/72 P.80 R.20. 911 arrived a few minutes later, checked Vital signs again and did a blood sugar. She was advised to go to ER because she has no history of seizure. She refused because of lack of health insurance.
Ist shot: the only symptom was minor soreness. Went away on day 2.   2nd shot: On about the 2nd day, started itching and redness, with noticeably hotter skin temperature (like an infection was present) which got worse on day 3 and onward.  Now, on day 6 there is a 3 inch red band on my left arm at the shot site and it is still warmer than the right arm and redness is obvious.  I took photos on day 6 showing the difference in the two arms redness.  Would be happy to share the photos.
PNEUMOVAX given 11/4/15. 11/5/15 fever 101.1 felt "blah". Went to ER. VS stable other than fever. Was discharged. Fever 103.7 on 11/6/15. Taking LEVAQUIN. Coughing up milky white phlegm.
Vaccine given had been moved from freezer to fridge on 10/18/2023, to be used by 11/18/2023. The vaccine was given to this patient one day after the use by date. The event was discovered by pharmacy staff on 11/20/2023. No harm was done to the patient, pharmacy staff have contacted Moderna to determine if the vaccine given was viable or if the patient should receive an additional vaccine.
After receiving vaccine, she started stating she was very tired. ON SITE EMS/Physican responded. VITAL BELOW. SHE REFUSED ADDITIONAL EVALUATION AND CARE, AND LEFT
Severe local reaction. Swelling and erythema of the right arm from shoulder to elbow. Fever.
T 97.3 F. Patient is a 52 year old woman traveling to a foreign country on a mission for one week. Denies allergies. Patient administered yellow fever vaccine and within seconds developed a 3x4 cm urticarial lesion with associated pruritus. No respiratory involvement. Resolution after 30 minutes no therapy administered.
Approximatley5 minutes after the first vaccine dose, I experienced a slight numbing of the throat and minor difficulty swollwing. Breathing never seemed to be compromised. Symptoms last for about 1 hour.
Bilateral leg weakness. progression of weakness occurred, and lumbar puncture was performed, Diagnosis of Guillain Barre
Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hives on chest-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-Medium
11 yo came in for 2nd Pfizer dose of her primary series. She was given the Pfizer bivalent dose.  No symptoms or any reactions.  Just needed to report. Vials look identical and was mistaken for primary series.
02/27/2021 -received vaccine #1. 03/01/2021 - began to have chest tightness. All through March I felt bad with symptoms of muscle aches, headaches, shortness of breath, loss of appetite, nausea. By the middle of March I felt so bad that on the 17th I had a covid test, which turned out negative. On the 20th I had nausea and vomiting and a fever of 101 to 102 degrees. I received instructions to use ondansetron for the Nausea/vomiting and Tylenol for the fever. On the 22nd I had a virtual with the nurse practitioner; she determined I had a GI virus and was not in need of anything further. I felt better on the 25th & 26th and decided to get vaccine #2 on the 03/27/2021. On the night of the 27th I went to the ER for worsening shortness of breath and chest pain, especially with deep inspiration, and nausea/vomiting. I was admitted to medical center with a (later) diagnosis of Bilateral Pleural Effusion. I was started on antibiotics and received multiple tests including x-rays, blood tests, cardiac function,Ct scan with contrast, images from nuclear med and more. A thoracentesis was done to drain a pocket of fluid in the left lower pleura - 700cc was removed and sent to the lab. Between the blood work and the pleura fluid it was determined that I had Systemic Lupus. I had no other acute s/s of Lupus although the Cutaneous Lupus had been diagnosed for many years.
A non-serious report of administration of expired FLUMIST was received for a health care professional concerning a 20-year-old male.  The patient's medical history and concomitant medications were not reported.  On 06-Oct-2008, FLUMIST was given via nasal administration by an immunization health technician.  The vaccine was found to be expired when a nurse in the same clinic noted that the lot number of the administered FLUMIST (expiration date 24-Mar-2008) was different from the lot number of the other supply of FLUMIST with expiration date of 25-Dec-2008.  The expired lot of FLUMIST was given to 17 adult individuals including this patient.  There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired.  Additional information received on 07-Nov-2008 and incorporated into the narrative:  no adverse events reported.  Additional information received 09-Apr-2009: product complaint investigation results.
This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. The patient was not a pregnant. No medical history and current conditions were reported. On 01-APR-2015 the patient was vaccinated with ZOSTAVAX (As per the prescribing information, injection) for prevention of shingles. No concomitant medications were reported. On an unknown date the patient experienced lump at the injection site. Sought medical attention, contacted the pharmacist. No product quality complaint was involved. The outcome of lump at the injection site was unknown. The reporter causality was not provided. No further information was reported. Additional information has been requested.
Fever about 10 hours after vaccination, hot flashes, chills, headache, muscle pain mostly in arm. This continued through the next evening as well
Pt had swelling in lt arm w/redness & warm to touch begining 22FEB92 then on 24FEB92 rt arm began to swell & redness & warm to touch; no fever noted & no other distress;
Within 24 hrs of receiving vaccination, pt. had T-103,severe headache.48 hrs later had a grand-mal seizure & respiratory arrest.  Dxed as having herpes encephalitis.(culture negative)
Two weeks after the shot, on 4/18 I began experiencing fevers and fatigue. The fever broke on 4/22 after experiencing headaches, excessive sweating, and fatigue for 4 days.
Patient received shot at approximately 3pm 9/10/09 and started feeling ill in the evening. He has suffered chills and numbing of the lips, and has also felt warm or "feverish" & suspected allergy and prescribed Benadryl. Patient said he felt much better after a half-hour. He took one tablet. 09/11/09.
Body aches, tired, fever, irregular heart beat (irregular heart beat came on two days after shot), headaches, chest pressure.
Intense migraine, lasting for multiple days. Subsided briefly then recurred. Still occurring over 9 days after vaccination. Limited abatement of symptoms with Excedrin,  ice packs to the forehead, and total reduction in stimuli (laying in a dark and silent room for days).  Firmness and soreness still at the injection site over 9 days after administration of vaccine.
positive for COVID-19; positive for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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 included: "cholesterol" (unspecified if ongoing), notes: on cholesterol medication. The patient took concomitant medications which included unspecified cholesterol medication. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Dec2022, outcome "unknown" and all described as "positive for COVID-19". The event "positive for covid-19" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Dec2022) Positive, notes: Saturday, 17Dec2022, her husband (patient) was positive for COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid (start date: 17Dec2022 at night and completed on an unspecified date).  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
unexpected bowel movement; This spontaneous case was reported by a consumer and describes the occurrence of BOWEL MOVEMENT IRREGULARITY (unexpected bowel movement) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included GERD, COPD and Pneumonectomy (Lung removed). Concomitant products included OMEPRAZOLE for an unknown indication.    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 BOWEL MOVEMENT IRREGULARITY (unexpected bowel movement). At the time of the report, BOWEL MOVEMENT IRREGULARITY (unexpected bowel movement) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
alopecia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), reporting the same event under the same product for 6 patients. This is one of 6 reports.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Single, unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Single, unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 3 (Booster), Single, unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 4 (Booster), Single, unknown manufacturer), for Covid-19 immunization. The following information was reported: ALOPECIA (non-serious), outcome "unknown".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300354114 same reporter/product/event, different patient;US-PFIZER INC-202300355044 same reporter/product/event, different patient;US-PFIZER INC-202300355045 same reporter/product/event, different patient;US-PFIZER INC-202300355046 same reporter/product/event, different patient;US-PFIZER INC-202300355043 same reporter/product/event, different patient;
Patient called to report itching and swelling near injection site 3 days after immunization, determined to be annoying but not severe, recommended that she take the antihistamine she had on hand and report to doctor if she felt it was necessary or if it got worse or spread, followed up with patient at 6pm, no progression of symptoms, but has not gone away yet.
Fatigue; Her "stomach feels like there's a knife",; She feels like she's "about to die", "I feel awful".; Wasn't feeling well; She "can't stand up straight", she's not been out of the house since Tuesday; Not eating; Vomiting; has Arm pain; Can't get up hardly; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (at the age of 54-year-old) (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 on an unspecified date for covid-19 immunisation and she was sick pretty bad too. The patient reported that she received the second dose of the vaccine on Tuesday and she felt like she was "about to die" and felt awful in 2021. She was not transferred to Safety since she wasn't feeling well. She stated since the second dose, she cannot stand up straight, she had not been out of the house since Tuesday, she was not eating, was vomiting, fatigue, her stomach felt like there was a knife, has arm pain, and she can't get up hardly. She was referred to her healthcare provider. Outcome of events was unknown.  Information about lot/batch number has been requested.
At 8PM the same day she received the H1N1 vaccine, patient began to have a sore throat and headache and her heart felt like it was racing.  She went to the ER the next morning. ER papers state she also complained of fatigue and nausea. ER doctor did not feel the symptoms were from the H1N1 shot.  Patient was hospitalized for 3 days. Discharge diagnosis was Atrial Fibrillation with Rapid Ventricular Response.  After discharge, patient reports she developed a fever (the evening of 2/10/10). She had had no fever prior to this.  Other symptoms are gone and she is on new cardiac meds.
1st dose 2-3years ago, 2nd not yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 2 to 3 years ago prior to the reporting).   On an unknown date, the patient did not receive 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 Information: GSK Receipt Date: 24-OCT-2022 Reporter's Comment: The reporter was the patient's husband. The patient was at home at the time of the reporting, but she did not come on the phone. The pharmacy where the shot was administered to the patient that the record was archived in that the patient had yet to receive the 2nd dose of Shingrix vaccine. The detail was reported for 1st dose. The reporter indicated that the patient gave consent to the follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. This case had been linked with US2022153129 by same reporter for different patient.; Sender's Comments:  US-GSK-US2022153129:Same reporter
Diarrhea; Dizziness; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), DIZZINESS (Dizziness) and ASTHENIA (Weakness) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     Concomitant products included OMEGA-3 [OMEGA-3 NOS] for Product used for unknown indication, METFORMIN, ATORVASTATIN, LISINOPRIL, TAMSULOSIN, OMEPRAZOLE, ZINC, VITAMIN C [ASCORBIC ACID] and COLECALCIFEROL (VITAMIN D3) for an unknown indication.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2021, the patient experienced DIARRHOEA (Diarrhea), DIZZINESS (Dizziness) and ASTHENIA (Weakness). At the time of the report, DIARRHOEA (Diarrhea), DIZZINESS (Dizziness) and ASTHENIA (Weakness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
This spontaneous report as received from a pharmacist via company representative refers to a male patient of unknown age. On an unknown date in the past the patient was vaccinated with ZOSTAVAX. No concomitant medications were reported. On an unknown date, years later, the patient experienced shingles. It was reported as mild case of shingles, just a little itchy. It was reported that the patient received unspecified antiviral medication at the time the event occurred. The outcome of mild case of shingles, just a little itchy is unknown. Additional information has been requested.
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 16-JAN-2012 at 7:30 and on 17-JAN-2012 at 7:30, ZOSTAVAX (Lot # 671141/1267AA) was exposed to -8 degrees C for an estimated total time out of range of 14 hours. On 01-MAR-2012 at 7:30, ZOSTAVAX (Lot # 671141/1267AA) was exposed to -14 degrees C for an estimated total time out of range of 10.5 hours and on 03-MAR-2012 at 11:30 it was exposed to -12 degrees C for an estimated total time out of range of 4 hours. On 06-MAR-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # 671141/1267AA, expiration date 05-NOV-2012) (dose and route of administration were not provided). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
Clients parent reports client developed red localized reaction past receiving immunization on 11/10/08. Redness began on 11/12/08 Rt. arm- mildly between deltoid & elbow, No swelling, pain or discharge. Redness 2 1/2 inches wide,  2 inches - long. MMR given RA SQ.
Pt returned to the pharmacy and states that she felt like she was having a reaction. Her hands were extremely red and shaky. She stated that her hands and legs were numb and tingling.  She was also breathing fast. She sat down and administered her EPIPEN that she brought with her.  She sat down for about 5 minutes.  She stated that she felt a lot better. She stated she was going to the emergency room which was across the street. She refused EMS .
Patient had lip swelling on the left side (same side the shot was administered) and a headache. She has received flu shots in previous years with no reaction.
Around midnight I began experiencing body aches that woke me up and prevented me from sleeping.  I took my temperature and had a fever of 101.1.  I took tylenol.  I had the same sypmtoms the following day and continued to take tylenol 325 mg until around dinnertime when the aches and fever diminished and then were gone. I also have a red, warm, itcy patch around the site of the injection.
HEADACHE; INJECTION SITE SORENESS; This spontaneous report received from a consumer concerned a 73 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced injection site soreness. On 07-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 08-APR-2021, and had not recovered from injection site soreness. This report was non-serious.
Red/swollen and warm to touch. Painful to touch. Red rash from vaccination site down to elbow. NO FEVER.
This spontaneous report as received from a healthcare worker refers to an unspecified patients of unknown age and unknown gender. On an unknown date, the unspecified number of patients were vaccinated with doses of improperly stored ROTATEQ (dose and frequency not reported). No adverse experiences reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
extreme fatigue since 3/9/21 Caller reports she received a call from someone from med center the day she received her vaccine on 3/9/21 stating she had been given a "stronger dose" of vaccine and they called to see if she was feeling ok. She reports that day she felt tired, but no other sx. Today she still reports extreme fatigue 6 days post vaccination. Recommend caller contact PCP as fatigue maybe r/t something other than vaccine given hx of DM and HTN. Pt agreeable.
Flushing and swelling of the ear on the side of the vaccination.  Pt states that had never happened before. No other regional symptoms.  Pt took ibuprofen and it resolved within an hour or 2.
Rashes/Hives started on the my left hand on the date of vaccination, about 30mins after vaccine administration. Then today, Dec 25, 2020 I have rashes on both forearms that are itchy.
large rash on neck area initially; rash spread to back and legs; hives on arm of injection in the middle of the night Took Benadryl which seemed to clear it up but rash came back in morning.  Threw up in morning.   Went to urgent care.  No respiratory issues and rashes cleared up.  Instructed to monitor and continue Benadryl as needed.  If hives come back and Benadryl does not clear it up then go to urgent care or ER.  Benadryl did seem to work but rashes continued for several days.
Total body tremulousness, suddenly started shivering all over, dropping things in my hand. Lasted 30-45 minutes. Although the event was shocking, I did have previous commitments which I completed although I did not feel great during the next few hours. Just a vague feeling of being unwell. (Perhaps concern about what had just happened). I returned home, looked up side effects of SHINGRIX and felt reassured that the neurological event was an adverse reaction to the vaccine. The next day and since I was fine.