chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My wife drove me to the hospital because I had a heart attack after receiving the 2nd dosage (suffered mild cardio inflection) which meant that there was a blockage in the left circumplex artery and I had to have an angioplasty (surgical stint). I was placed on Plavix for one year along with baby aspirin indefinitely. I spent one night in the hospital as a result of the adverse event and will be starting Cardiac rehab on June 12, 2021.
This is a spontaneous report from a contactable consumer. This consumer reported similar event for 3 patients. This is the first of 3 reports. A patient of unspecified age and gender received TRUMENBA via an unspecified route of administration on an unspecified date at single dose for immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, the patient experienced passing out. At the time of the report, the outcome of the event was unknown. The information on the batch number has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2018357772 similar report from same reporter; US-PFIZER INC-2018357773 similar report from same reporter.
Within 48 hours post vax, the baby died from SIDS in the ER department.
A 54 year old FEMALE who received Covid 19 vaccine today and c/o "lightheadedness  and puffy/itchy throat a few minutes after injection" while was on monitoring  area after vaccination.   Nursing note:11:16 I was told by co worker that patient was going to need  vitals, so I took vitals notes given to me: throat tingling/tightness, light headed, nausea,  allergic to aspirin      11:17 staff gave orders to RN to give Solumedrol (IM) to patient.  she took patient information to get medication      11:26 patient states "I'm feeling okay"      11:32 patient states "I'm feeling good"      11:37 RN gave patient solumedrol (IM) injection to patient on  left deltoid @11:38      11:42 patient states "my left arm hurts"      11:47 Patient states "my left arm is really hurting after that injection"  pain scale 10/10      11:50 staff states "I will be putting an order in for epi pen and to pick  up at pharmacy"
Woke up in the morning of Feb. 5/22 with excruciating pain in left arm. Went to hospital, did nothing. Pain continued for 7 days. Then realized I had no strength in arm. Basically a dead arm . Have seen a neurologist had 2 MRI s so far . He's thinking its Parsonage  Turner syndrome. I have muscle atrophy in both arms. Have been seeing  a physio therapist.
3/28/01 at 08:30, father called and stated that pt was complaining of itchy neck at bedtime and woke this AM with red spots all over his body, itching, no fever, no difficulty breathing. Advised to call his doctor. On 4/2/01, father returned calls. Child to ER on 3/30/01 and put on prednisone. Back to school on 4/2/01. Dx'd with hives.
Refridgeration excursions identified/undergone several temperature excursions; No adverse event; vaccines have undergone several temperature excursions and may have been administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/undergone several temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (vaccines have undergone several temperature excursions and may have been administered to patients) and NO ADVERSE EVENT (No adverse event) in a 65-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Sep-2022 at 11:47 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 16-Sep-2022 at 11:47 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (vaccines have undergone several temperature excursions and may have been administered to patients). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/undergone several temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (vaccines have undergone several temperature excursions and may have been administered to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/undergone several temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (vaccines have undergone several temperature excursions and may have been administered to patients).    No concomitant medication was provided.  It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation.   Reportedly, the nurse called for a clinic that she was assisting. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022.   It was unknown that the patient ever been diagnosed with or tested positive for COVID-19.  It was reported that no adverse reactions were reported to their knowledge for any patients.  Treatment medication was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-670034 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-670034:Same reporter
could not lift his left arm elbow higher than his shoulder; soft cough; spitting out flem; headache; swollen lymph nodes on both the right and left side of neck; painful injection site left arm; swollen injection site left arm; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (soft cough), PRODUCTIVE COUGH (spitting out flem), MOBILITY DECREASED (could not lift his left arm elbow higher than his shoulder), VACCINATION SITE PAIN (painful injection site left arm) and VACCINATION SITE SWELLING (swollen injection site left arm) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0748C21A E) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jul-2021, the patient experienced VACCINATION SITE PAIN (painful injection site left arm) and VACCINATION SITE SWELLING (swollen injection site left arm). On 05-Jul-2021, the patient experienced LYMPHADENOPATHY (swollen lymph nodes on both the right and left side of neck). On 08-Jul-2021, the patient experienced COUGH (soft cough), PRODUCTIVE COUGH (spitting out flem) and HEADACHE (headache). On an unknown date, the patient experienced MOBILITY DECREASED (could not lift his left arm elbow higher than his shoulder). On 04-Jul-2021, VACCINATION SITE PAIN (painful injection site left arm) and VACCINATION SITE SWELLING (swollen injection site left arm) had resolved. On 07-Jul-2021, LYMPHADENOPATHY (swollen lymph nodes on both the right and left side of neck) had resolved. At the time of the report, COUGH (soft cough), PRODUCTIVE COUGH (spitting out flem), MOBILITY DECREASED (could not lift his left arm elbow higher than his shoulder) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient  had received his Moderna Covid-19 vaccine at  Supermarket. Treatment information was not provided Concomitant medication were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Translation received on 09 Jul 2021 and does not contain any new information.
patient was nervous about getting the shot.  she said she felt dizzy and hot afterward.  she stayed an extra 30 minutes b/c she was nervous.  no noticeable side effects were seen.  just anxious.
(L) leg redness, warm, tenderness started 24 hours after immunizations and getting larger on 12/14 10 cm x 4 cm.
This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. Between 01-AUG-2018 and 06-AUG-2018, the patients were vaccinated with an improperly stored VARIVAX subcutaneosly, for prophylaxis, lot #N035940 and expiration date 18-DEC-2019 (strength, dose and frequency were not reported), which was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT). No adverse effects were reported. The temperatures of excursion were reported as 6°F to 14°F during a time frame of 1 hour and 15 minutes and 28.5°F during a time frame of 45 minutes. There was no previous temperature excursion reported. There was a digital data logger involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1808USA009440: US-009507513-1808USA009441: US-009507513-1808USA009442: US-009507513-1808USA009443: US-009507513-1808USA009444: US-009507513-1808USA009445: US-009507513-1808USA009446: US-009507513-1808USA003515:
Patient was speaking at age appropriate level and was saying 7 words: mama, dada, Nana, papa, yes, no, and (his grandparents' dog's name). 3 days after the vaccines all language stopped and did not return until 6 months later.  At that time he only said mama. We had to enroll him in speech, healthy start, and ABA services to get all his language back, which took 1.5 years for it to be age appropriate.
I received the Pfizer Bivalent COVID-19 booster on 10/13/2022. On 11/7/2022, I arrived at an outpatient surgical hospital to undergo hip replacement surgery. When I was hooked up to the heart monitor prior to getting an IV, the monitor indicated that I had atrial fibrillation. I had never had this problem before or any other cardiac issues. The surgery was immediately canceled, and I was told to go to an emergency room. When I got to the ER, another reading was done of my heart. I was still experiencing atrial fibrillation 12 hours after it was first detected. The ER doctor prescribed me a blood thinner, Eliquis, to prevent a stroke. I was then discharged and advised to see a cardiologist within a couple of days. Unfortunately, I was unable to see a cardiologist right away. On or about 11/10/2022, I saw my PCP, and he did not detect atrial fibrillation at that point. He did tell me, though, that I should see a cardiologist for further diagnosis. I saw a cardiologist on or about 11/16/2022. When the cardiologist examined me, I was in atrial fibrillation. I was diagnosed with periodic atrial fibrillation. It is intermittent, and since I have learned to detected it with a smart watch, I monitored my situation daily. The longest I have experienced atrial fibrillation since learning to monitor the condition has been 30 hours; the shortest duration was 21 hours. I can then go for up to a week with normal cardiac rhythm. At the time of this writing, I have gone for 2 full weeks at normal rhythm.
My boyfriend and I believe we were given the wrong flu vaccine at a pharmacy based on our paper work saying Fluzone. Fluzone is marked as approved for 65 and older only on the manufacture site however my boyfriends and I  who received the vaccine are both under 65. I am pharmacy technician at a different chain and the pharmacist at my store say it is not  approved for those under 65 which matches what I found on the CDC website. We are both having body aches the night of getting the vaccine. I am also experiencing muscle stiffness and tirdness.
pt had inj 11OCT94 on 17OCT94 was taken to clinic w/loss of appetite, fever of 104 ax (unk if treated w/meds); some diarrhea & a rash that started on the trunk of the body & moved out to limbs; pt mom is pregnant @ the time; also rhinorrhea
Diarrhea, Vomiting, itching (on legs, arms, and stomach with no visible rash) - patient called today to discuss, she said there were no signs of swelling on her face, mouth or throat - we discussed taking an antihistamine (she's allergic to benadryl) and monitoring, if she felt symptoms were worsening then she will seek medical treatment
Patient reports feeling dizzy, headache, lying in the chair where she was sitting. The patient is placed on a stretcher with her legs elevated. 10:37am patient gets up from the stretcher in the company of a legal guardian. Patient indicates that she feels well, does not have dizziness or headache. The patient removes herself from the medical office stable, oriented and ambulating with family company.
Large red oval shaped rash appeared on my arm where I got vaccinated, about 5 days after my 2nd dose of the Moderna covid vaccine. It's starting to itch a little bit.
This spontaneous report was received from a medical assistant and refers to unknown number of patients of unknown age and gender. The patients' medical history, concomitant therapies and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M037770, expiration date: 01-JUN-2019 and lot # N001533, expiration date: 16-OCT-2019 (dose and route of administration were not reported) for prophylaxis. Administered doses of vaccines experienced the temperature excursion of 48 degrees Fahrenheit for 5 minutes. Data logger was used to capture temperature excursions. There were no previous temperature excursions. There were no adverse effects reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Flush; Itching; felt like she was going to wet herself; This is a spontaneous report from a contactable consumer. A 58-year-old female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK5730 and Expiration Date: unknown), intramuscularly in the upper left arm on 22Dec2020 at 08:48 at 58-years-old at a single dose for COVID-19 immunization; which was received at a hospital. The patient stated the hospital had a line for employees to drive up and receive the vaccine, she was in her car when the vaccine was administered. Medical history included ongoing allergy to sulfates from an unknown date (diagnosed at least 20 years ago). The patient had an allergy to sulfates. The patient had a bad reaction to sulfamethoxazole and trimethoprim (BACTRIM) many years ago. The patient did not have the Lot and NDC numbers, or expiration date to provide. The patient stated the reaction was so bad she had to receive multiple injections because her throat was closing off and she had big hives. This occurred years ago. There were no concomitant medications.  The patient previously took sulfamethoxazole and trimethoprim (BACTRIM) and experienced bad reaction, throat was closing off and big hives from an unknown date to an unknown date. On 22Dec2020, the patient experienced: flush, itching, and felt like she was going to wet herself; all assessed as non-serious. The patient called about the COVID-19 vaccine. The patient was wondering if there was any sulfa in the vaccine. The patient had the vaccine on 22Dec2020, and she was fine for the first hour and then she became flush and started itching an hour later. The patient stated " you know when you get a CT scan and the contrast makes you feel warm down there", states she got that same feeling where she felt flush and where she was warm down there and she felt like she was going to wet herself. The patient stated, "the bladder feeling came on so harsh and fast." The patient took diphenhydramine hydrochloride (BENADRYL) for two days and she felt better. The patient later clarified that she recovered completely as of 25Dec2020. Therapeutic measures were taken as a result of flush and itching. The clinical outcome of the events, flush and itching, was recovered on 22Dec2020. The clinical outcome of the event, felt like she was going to wet herself, was unknown. There was no history of previous immunization with the Pfizer vaccine considered as a suspect. There were no additional vaccines administered on the same date of the Pfizer suspect. The events did not require a visit to an emergency room or physician office.  The patient did not receive any prior vaccinations within 4 weeks of the suspect vaccine.  There were no adverse events (AEs) following prior vaccinations.  There were no relevant tests performed.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 09-NOV-2015, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # J005067 with expiry date 17-JAN-2015; dose and route were not reported). No adverse effects were reported. Additional information has been requested.
Patient felt light headed, developed nausea, blurry vision and shakiness. Had some injection site swelling.
Flu shot made me sick as hell nrver take another one; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 10-Oct-2020.  This case was linked to case 2020SA294157.  This case involves an unknown demographics of patient who experienced flu shot made me sick as hell nrver take another one (illness), while he/she received vaccine INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE lot number not reported via unknown route.  On an unknown date, unknown latency after vaccination, the patient developed a non-serious flu shot made me sick as hell nrver take another one (illness).  It was not reported if the patient received a corrective treatment.  The outcome was Unknown.  No further relevant information was reported.
69-year-old male patient presents to express care with concerns about Covid vaccine on 3/4/2021.  Patient states the day after his Covid vaccine his left arm felt normal and he had normal energy levels.  The following day however, the patient developed fatigue and left arm pain.  Patient states his arm is extremely painful with any abduction or forward flexion at the shoulder joint, but today he has noted that the pain is starting to subside.  The pain does radiate towards his elbow.  He is also noted a "low-grade fever of 99.6" he states his appetite is also depressed but he continues to eat and drink.  Patient denies changes in urination, bowel movements, denies abdominal pain, night sweats, or chills.
Mother called 4-12-13 and said running fever of 104. Advised not typical reaction. Child needs to see MD.
Adverse Event/Product Complaint Information: Pharmacist reported that some patients reported feeling "sick", mild fever, fatigue for one day after receiving PREVNAR 13 but overall well tolerated. This is a spontaneous report from a contactable pharmacist and physician via a Pfizer sales representative. A patient of unspecified age (reported as "65 plus", Unit: unspecified) and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient reported feeling "sick", had mild fever and fatigue for one day on an unspecified date after receiving PREVNAR 13, but was overall well tolerated. The outcome of the events was unknown. Information regarding the batch number has been requested.
I woke up with a sore throat, slight cough, stuffy nose.  I contacted my doctor to be tested, even though the sore throat seemed like drainage.  My husband had cold symptoms too and felt worse.  We both got tested.  I was negative for the C. Virus but my husband tested positive.  I tested 6 days later when they released him and was still negative in my Covid test.
T-105 lt arm swollen 21FEB91; Not seen by md mom states she gave Tylenol & Ibuprofen q 3-4 hrs. Temp broke at MN. Was fully recovered in 24 hrs.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L038503, expiration date: 18-DEC-2017) (dose and route of administration were not reported). No adverse effects were noted in any patients. Administered doses of vaccines experienced the temperature excursion of 0.4 degrees Celsius for 89 hours and 5 minutes. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected, as there was no consent to contact with the reporter.
Seen in office 8/6/15 24 hour after pneumococcal 13 vaccine, pt reports having severe joint pain and fatigue. Pt noted some tingling in his hands upon awakening which was present prior to injection but worse since 7/28/15. Also when seen 8/15/15 c/o (R) arm and hand pain worse. (R) arm swelling also present.
on Friday 4/9, nine days after I got the first vaccine I have developed a itchy rash at the injection site. I did had a sore arm the two days after receiving the shot as well.
Vomiting, nausea, fever, chills, severe headache, muscle/joint pain, dizzy, confusion, brain fog,
no adverse effects reported; patient was vaccinated with one dose of improperly stored PROQUAD; This spontaneous report was received from an other health professional (Nurse) refers to a 6 year old patient. The patient's medical history and concurrent conditions were unknown. On 02-AUG-2019, the patient was vaccinated with improperly stored (product storage error) measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # r030803, expiration date: 22-APR-2020) of digital data logger therapy type (Strength and anatomical location were unknown) of 1 dosage form for prophylaxis which was reconstituted with properly stored sterile diluent(STERILE DILUENT). Concomitant therapies included sterile diluent(STERILE DILUENT) (lot and expiration date were unknown). No adverse events was reported. The vaccine was stored at a temperature of 6 degree fahrenheit to 14 degree fahrenheit for 24 hours. No product quality issue was reported.
Headache, Myalgia, Arthralgia, HYPERtension, tingling of joint and feet, back pain, anxiety, sweating,chills Narrative:
Shot administered at local pharmacy at 10:30 Sunday morning and went about may daily normal routine. Retired to bed at approximately 11:00 pm. At approximately 5:00 am I awoke to use the bathroom returned to bed and within minutes a rapid heartbeat developed followed by shortness of breath. I attempted to get up out of bed whereas my wife was coming around to assist me I then collapsed to the floor unconscious. My wife called 911 where EMT's assisted me to the ambulance and I was taken to the hospital ER and admitted for Observation