chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 09-Nov-2018 regarding an unsolicited valid serious case received from a non-healthcare professional. This case involves a patient of unknown age and gender who experienced cardiac arrest, while he/she received vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a serious cardiac arrest, following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. Lab data was not reported. Final diagnosis was cardiac arrest. It was not reported if the patient received a corrective treatment. The outcome of event of cardiac arrest was not reported. Documents held by sender: none. Sender's Comments: Patient of unknown age and gender experienced cardiac arrest after vaccination.Time to onset is unknown. Moreover, further information including patient's medical history, concomitant medications, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information the role of vaccine cannot be assessed.
Had shingles, just took a shingle shot/Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 01-AUG-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient stated that he/she could write a book on shingles, he/she had them twice and the 2nd time, he/she had just taken a Shingle shot. The patient also stated that it must had caused him/her to get them the 2nd time around. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
my mom and my dad they were vaccinated and they caught COVID too; my mom and my dad they were vaccinated and they caught COVID too; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history included family history of neoplasm malignant (cancer) in father. The patient's concomitant medications were not reported. The patient called in seeking assistance with the medication Dilantin. During the call the patient stated that he was vaccinated with the Pfizer shot. He took his first dose and tested positive for COVID and his mom and dad were vaccinated and they caught COVID too. The patient stated that everything that he had read, it said the vaccination can't give you, you can't get COVID from being vaccinated. He stated that they were vaccinated the first time and they all came down with COVID, all tested positive. He stated that his dad's doctor told him he doesn't need to be vaccinated anymore because his dad has cancer, and he had read that Pfizer did not test the drug on cancer patient's, the vaccine. The patient stated that he heard from his doctor's office that they were not the only people that's getting vaccinated and then tested for COVID. They told him that they were probably already exposed to it, were doing fine and then went to take their shot and all of a sudden they started feeling bad and then they went to take the test and were positive. The patient stated that he was looking forward to going back to work as he had been off of work since the 15th of February. He couldn't go back to work until he tested Negative. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Covid relapse; Covid replase; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and on 04May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "Gastric Ulcer" (unspecified if ongoing); "High Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for hypertension, start date: 2012; HYDROCHLOROTHIAZIDE taken for hypertension, start date: 2017; PROTONIX [OMEPRAZOLE] taken for gastric ulcer, start date: 13Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Covid relapse"; COVID-19 (medically significant), outcome "unknown", described as "Covid replase". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Jul2022) Negative, notes: The antigen test was negative 04Jul2022 and 05Jul2022; (05Jul2022) Negative, notes: The antigen test was negative 04Jul2022 and 05Jul2022; (06Jul2022) Positive, notes: positive COVID antigen test on 06Jul2022 and 08Jul2022; (08Jul2022) Positive, notes: positive COVID antigen test on 06Jul2022 and 08Jul2022; (13Jul2022) Negative, notes: antigen test was negative on 13Jul2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The Relapse was documented by a positive COVID antigen test on 06Jul2022 and 08Jul2022. The antigen test was negative 04Jul2022 and 05Jul2022. Patient was asymptomatic on 05Jul2022 but became symptomatic on 06Jul2022. symptoms resolved and antigen test was negative on 13Jul2022. Patient was fully vaccinated and had 2 booster shots, all of which were Pfizer vaccine. The most recent booster was 04May2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided and known drug safety profile, the causality between the suspect drug  BNT162B2 in the occurrence of the event cannot be excluded.
10 days post shot, I got spontaneous awful intense hives and rashes that would move around my body. I had slash marks, itchiness, and irritation intensely for 3 days. Took antihistamines with no relief. Tried Benadryl, Centirizine, Allegra. Allegra helped a little bit, but the symptoms continued for months. It was debilitating and it certainly interfered with daily life. I've never had hives before previously, and no other factors in my life changed. The hives subsided a bit more after 5 months although the rashes never FULLY went away. Another intense flare up 10 days after my second Moderna booster. Dermatographism/skin writing is also present with the hives and rashes.
Fever -> 100.3, Fatigue, Sore arm of injection, Light soreness around body. Lasted around a day.
Starting approximately 10pm on the day of the vaccination, extreme pain in entire left arm to fingertips lasting 2 days. She could not lift the arm for 2 days. Then, tingling and numbness to fingertips for a week out. Currently still feels lingering pain in elbow and arm directly above and below that elbow.
dec grade fever x 2 days, then 2 hrs having t103; APAP given; mom states lt arm has redden knot where shot was given & welps around knot; also states this AM pt is breathing hard;
PATIENT GOT A SMALL RASH AROUND THE INJECTION SITE THE DAY AFTER VACCINE WAS GIVEN, BUT ON 6/12/18 WENT TO THE DOCTOR AS THE RASH HAD GOTTEN TO BE AROUND 5 INCHES WIDE AND WAS WARM TO THE TOUCH. PATIENT ALSO REPORTED HIVES ALL OVER HER BODY AND CHILLS.
3RD MODERNA COVID VACCINE GIVEN 9/24/21, #045C21A; pt brought from facility to ED via EMS with unresponsiveness and respiratory failure; NRB; was positive for COVID; O2 supplementation; IV steroids; DNR with limited therapies; high troponin level; pt found deceased in the hospital
Pt was given SHINGRIX SUB Q instead of IM. Pt experienced exact same side effects as IM. Pain, redness and swelling. GlaxoSmithKline was called about incident and they explained that they did test vaccine sub q and it is a valid dose just more painful then IM.
Patient was here today scheduled in the Covid clinic for his first Pfizer-BioNTech COVID-19 Vaccine injection. Injection was given 0.2mL into right thigh at approx 11:00am, I had entered vaccine info into computer, scheduled next appt and dad, the patient and other person were waiting their 15-20min. I had checked on them twice during their wait period and he was doing fine. At around the 20min mark, dad hollared for a nurse. When I entered the room, patient was in dads arms, feet on floor, color was pale/ grayish. I took Him and layed him on the exam room table. He was breathing and starting to move around some.  dad watched him until I grabbed stethascope and cuff.  His BP lying down was 100/62, 2 Providers came in to check on him. Dad said he had complained of his head and neck hurting and then feeling weak prior to passing out.  The Provider continued to assess patient, asked pt/dad questions, listened to lung sounds, etc.  When pt was sat up, his BP was 96/64. We gave him cool compress, and then an ice pack to apply to back of neck and a cup of cold water. After patient was feeling better he was able to go home and was advised to take it easy and relax the rest of the day. ( also Dad had mentioned earlier when I was in the room with them, that they live in/near forest/woods- They had removed a very small tick from between his toes within the last day or so) Pfizer- Covid- 6mo-4yr (Maroon top) Lot # FT9142 exp 9/7/22 Sodium Chloride 0.9% lot# 6024132  Exp 5/31/23 (2.2mL mixed with vial)  Vial opened and mixed at 7:57am on 7/7/22- good for 6 hours
Both eyes swelled and became itchy. 2 tsps of BENADRYL were administered.
Very swollen lymph nodes under left arm and on left neck; Dose number = 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Dec2021 15:30 (Lot number: FL3197) at the age of 26 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Bipolar disorder" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "PTSD" (unspecified if ongoing). Concomitant medication(s) included: LITHIUM; LEVOTHYROXINE; GABAPENTIN; MINOCYCLINE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0162, Location of injection: Arm Left, Vaccine Administration Time: 04:45 PM), administration date: 16Apr2021, when the patient was 25 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0173, Location of injection: Arm Left, Vaccine Administration Time: 04:45 PM), administration date: 07May2021, when the patient was 25 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 18Dec2021 15:30, outcome "unknown", described as "Dose number = 3"; LYMPHADENOPATHY (non-serious) with onset 19Dec2021 12:00, outcome "not recovered", described as "Very swollen lymph nodes under left arm and on left neck". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: No seriousness criteria. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and reported Event Very swollen lymph nodes under left arm and on left neck. Their was no covid diagnosed prior to vaccination and patient  was not tested for COVID-19 post vaccination.  No follow-up attempts are possible. No further information is expected.
Patient had no experienced any side effects; Vaccine given intramuscularly instead of subcutaneously; This spontaneous report was received from registered nurse referring to a 4 year old male patient of unknown gender. The information about patient's concurrent conditions, medical history, concomitant medications was not reported.   On 30-NOV-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA) or human serum albumin (HAS) (PROQUAD) 0.5 mL, intramuscularly for prophylaxis (incorrect route of product administration) (strength, vaccination scheme, anatomical location were not reported; lot number U002535 has been verified to be a valid lot number, expiration date was 24-JUL-2022). At the time, the patient had not experienced any adverse event (no adverse event). No product quality complaints (PQC) were reported.
herpes zoster; Information has been received on 09-APR-2019 from a lawyer regarding a case in litigation concerning a male patient (age unknown).  The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions.   In 2015, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine (lot# and route not specified) by a pharmacist.  On an unspecified date, the patient was treated by a physician  for herpes zoster as a result of vaccination with zoster vaccine live (ZOSTAVAX). The outcome was not provided.   Additional information has been requested.
5 minutes after vaccine I felt a sharp pain in the middle of my head like a headache and thought it would go away and i got dizzier and dizzier for about 25 minutes, I started getting hoarse in my voice, and my heart rate went up.
BLOOD CLOT; This spontaneous report received from a consumer via social media a company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. Patient was very healthy before vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced blood clot. The reporter stated that, "I know a lady got J&J did within a week from blood clot and was very healthy before she got it". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220220791-Covid-19 vaccine ad26.cov2.s-blood clot . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
bruise from first dose; This is a spontaneous report received from a contactable consumer reported for a female patient. The consumer reported on two patients one is husband and one is wife. Report 1 of 2. This is the report on the wife. This report was not related to a study or programme. A 27-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0217; Expiration Date: Sep2021), via an unspecified route of administration, administered in Arm Left on 04Jun2021 (at the age of 27-year-old), as single for covid-19 immunisation. Medical history included anaemia. Family medical history relevant to events was none. The patient concomitant medications were not reported. Additional Vaccines administered on Same date of the Pfizer Suspect was none. The patient did not receive other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The events following prior vaccinations were none. On 18Jun2021, the patient experienced bruise from the first dose. Reporter stated that patient had a bruise from the first dose, but it was starting to fade, it was non concerning. The event did not require a visit to emergency Room and Physician office. The relevant tests were none. Reporter stated that the patient was in the hospital recently, but it was for a panic attack due to a paperwork issue as far as the reporter know. The patient was resolving from the event at the time of this report.  Follow up needed, further information has been requested.; Sender's Comments: Linked Report(s) :PFIZER INC-2021810425 Same reporter/ drug, different patient/ AE
Body ache from injection site to top of head (48 Hrs). Headache (24 Hrs). Slight memory loss/cognitive ability (2 wks).
I did not have an adverse reaction to the vaccine. I began not feeling well on 01/29/2023 with a sore throat. I tested positive for COVID-19 on 01/30/2023. I had a sore throat, painful ears and a fever.  I contacted my doctor and got a prescription for Paxlovid.  I was nauseated and had the metallic taste in my mouth while taking Paxlovid.  As of today, I am feeling better but it did bring back my heart palpitations.
SEVERE LEG CRAMPS/MUSCLE PAIN, CHILLS, TRUNK RASH
Pt developed swelling, heat and erythema of arm. Treated with cold compresses and it resolved in 2 weeks.
COVID-19 confirmed by positive COVID-19 test; COVID-19; COVID-19 exposure; This is a spontaneous report from a contactable physician (patient). A non-pregnant 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: EK5730) on 21Dec2020 at 18:15 (at the age of 51-years-old) intramuscularly in the right arm and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: EL1283) on 15Jan2021 at 12:00 (at the age of 51-years-old) intramuscularly in the left arm, both as a single dose for COVID-19 immunization. Medical history was reported as none. It was reported that the patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications (other medications in two weeks) were reported as none. The patient did not receive any other vaccines within four weeks prior to the vaccination.The patient experienced COVID-19 exposure on 01Feb2021, COVID-19 confirmed by positive COVID-19 test and COVID-19, both on 06Feb2021. It was reported that the patient "had close contact with COVID-19 positive son on 01Feb21. Now the patient had tested positive for COVID-19 with mild symptoms. The patient became infected more than 2 weeks after the second dose was administered." The patient was tested for COVID-19 post vaccination on 06Feb2021 and was positive via a rapid antigen nasal swab. It was reported that the patient did not receive treatment for the adverse event. The clinical outcomes of the events COVID-19 confirmed by positive COVID-19 test and COVID-19 exposure were both recovering/resolving.; Sender's Comments: Based on the available information, a causal relationship between events Vaccination failure / COVID-19 and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE)  cannot be completely excluded.
TENDER, ITCHY, RED, WARM RASH ON BACK OF ARM -- ABOUT 4 QUARTERS IN SIZE.
Client inadvertently received the Moderna vaccine during an employee vaccine clinic. Client was not of eligible age for the Moderna vaccine and the age was not caught until post vaccination. Client monitored for 30 minutes post vaccination. No adverse signs and symptoms noted. Client was informed of the event and provided next step instructions.
Rash all over abdomen , hands and feet sever itching unable to sleep, Rash lasted about 10 days headache or a week body aches for a week , wheezing and had to use inhaler for the week   Took Allegra and medrol dos pak and hydrocortisone cream on rash , albuterol
Extreme vertigo, fell on bathroom floor when got out of bed. Vertigo lasted approx. 8 hrs.
Between 18DEC88 & JUN89 pt recvd 3 doses of Recombivax & did not convert; 31JAN92 recvd booster dose of Engerix-B in the evening felt poorly, devel joint pain, fever, malaise, chills; 1FEB92 to ER c/o sore throat, swollen glands, h/a;
found a deep blood clot.; my calf, foot, and knee swelled up by evening./It stayed swollen for a week; my calf, foot, and knee swelled up by evening./It stayed swollen for a week; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 61-years of age), dose 1 via an unspecified route of administration, administered in arm right on 17Mar2021 12:00 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included blood clot after a back fusion about 16 years ago (2005), and had a knee replacement 3 months before the vaccine (Dec2020). The patient's concomitant medications were not reported. The patient previously took ANCEF [cefazolin sodium] and had allergies; and oxacillin which the patient had allergies and hepatitis. The patient was not diagnosed with Covid prior to vaccination nor was he tested for covid since vaccination. The patient did not receive any other vaccine within 4 weeks prior to Covid vaccine.  It was reported that the day the patient received the first vaccine his calf, foot, and knee swelled up by evening. It stayed swollen for a week and he went to see his doctor. He did an ultrasound on his calf and found a deep blood clot. He was now on blood thinners. He mentioned that he had a knee replacement 3 months before the vaccine but it was progressing fine. Usually blood clots occur after surgery within a 2 week period. He had a blood clot after a back fusion about 16 years ago. He was reporting this because his doctor was not sure why he got the blood clot and it coincided with the vaccine.  The patient underwent lab tests and procedures which included ultrasound scan: found a deep blood clot  in Mar2021. The events started on 17Mar2021 18:30 with outcome of recovering. The events resulted to doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result the events with LOVANOX and PRADAXA.  Follow-up attempts are completed. No further information is expected.
Tdap vaccine that expired on 7/4/21 was given to patient on 7/7/21.  No adverse reaction noted.
Tonsillitis June 2nd, 2021  - Hospital ER - Labs and tests ran - Negative results for Strep, Hep, Abscess, Infections - Given Antibiotics Appointment made for ENT Specialist for mid July Around June 22nd, 2021 - Hospital ER - More Labs and tests ran because I had trouble breathing  - Negative results for all test. - Given Antibiotics Mid July, Saw ENT Doctor at hospital - Discuss negative test results, prescribed more antibiotics, talked about surgery. Swelling did not go down after 3rd course of antibiotics, tonsillectomy set for Sept 20, 2021 Tonsillectomy performed on Sept 20, 2021. In recovery.
Pt came in the office. Pt have reaction with MMR 30x29 mm induration, redness and pt complaining pain. Also, pt reacted on VARIVAX 21x21 mm redness no induration. Mom notice on 02/14/13.