chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It has a Big "knot" within under the skin.; HOT to the touch; Left arm has a BIG RED Circle; itchy; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 59267-1000-02. 6756961) via an unspecified route of administration in the left arm on 12May2021 at 11:00 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. The patient medical history was reported as none. The patient did not receive any other medication within two weeks of vaccination. The patient previously received first dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 59267-1000-03. 6752068) via an unspecified route of administration in the left arm on 21Apr2021 at 11:00 (at the age of 68-years-old) as a single dose for COVID-19 immunisation and also previously took tramadol (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13May2021 at 09:00, the patient had a big red circle (like the area was deeply sun-burned). It had a big knot under the skin. It was hot to the touch and itchy. It appeared next day, and was still there on the day of reporting. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events had a big red circle (like the area was deeply sun-burned), big knot under the skin (nodule), hot to the touch and itchy were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected  .
Pain in half of his head, like a headache,  after first vaccine; Pain in left arm, after first vaccine; This is a spontaneous report  received from a contactable consumer(patients wife). A 48-year-old male patient received the first dose of BNT162B2 (PFIZER VACCINE FOR COVID 19) via an unspecified route of administration on the left arm on 21Jul2021 at 17:00 (Batch/lot number:FA6780; Expiration Date: Unknown) at the age of 48-year-old as single dose for COVID-19 immunization. Medical history and concomitant medication were none. Investigation Assessment was none. Family Medical History Relevant to AEs was not provided. Because it was requested at the patient workplace thus the patient taking Pfizer vaccine for COVID-19. The patient was not related to a study or programme. Prior vaccination (within 4 weeks), the patient didn't received any other vaccinations. Relevant Test was none. History of all previous immunization with the Pfizer vaccine considered as suspect was none. AEs following prior vaccinations was none. On 22Jul2021 morning, the patient experienced pain in half of head, like a headache and pain in left arm. The events were ongoing. The reporter stated she needs some information because her husband went to work, and he experienced side effect. The reporter stated her husband didn't saw any one doctor at the clinic. The reporter wanted to known whether it would be better to call his doctor and whether this was normal and whether they could prescribe medication. The reporter stated that her husband was calling her asking for some medication for the pain, and she confirmed, that her husband hadn't taken any medication. The events didn't resulted in emergency room and physician office. The outcome of events was not recovered.
Initial information received on 13-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 15 months old female patient who received expired vaccine used with no known reported symptoms, while she received vaccine DAPTACEL. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MMR for Immunisation; PREVNAR 13 for Immunisation; and OKA/MERCK VARIVAX II for Immunisation. On 11-Sep-2018, the patient received 0.5 ml fourth dose of suspect DAPTACEL lot C5041BA, expiry date: 02 Sep 2018 via intramuscular route in the right thigh. It was an actual medication error due to expired vaccine used. It was reported that the patient did not had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Patient states he felt sick for 6 weeks after receiving his first dose of the SHINGRIX vaccine.
Information has been received from a registered nurse concerning two patients who were vaccinated with a dose of VARIVAX. Concomitant therapy included influenza virus vaccine (unspecified). The two patient developed anaphylactic reaction and were both sent to the emergency room for treatment. It was noted that the above information was on a fax that the office received from the another hospital. The two patients not patients from this office. No other information was available. Unspecified medical attention was sought. There was no product quality complaint. The event was considered an other medical event by the reporter. This is one report of several from the same source. Additional information has been requested.
Bed ridden; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BEDRIDDEN (non-serious), outcome "unknown", described as "Bed ridden".  Additional information: It was reported by the patient that "When are you guys going to fix the damage you have done with this vaccine my life has been hell for two years since getting the vaccine. I have been bed ridden. Doctors won't do anything to help fix. Fix the damage you have done this is ridiculous".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
No adverse event; Patient received 0.5 ml of a first dose of bivalent instead of monovalent; This spontaneous case was reported by a physician and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received 0.5 ml of a first dose of bivalent instead of monovalent) and NO ADVERSE EVENT (No adverse event) in a 26-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Oct-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 26-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received 0.5 ml of a first dose of bivalent instead of monovalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received 0.5 ml of a first dose of bivalent instead of monovalent) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received 0.5 ml of a first dose of bivalent instead of monovalent).    Concomitant drugs were not reported.  It was reported that physician received the bivalent shots from the state.   Treatment medications were not provided.
Rash around inj site and on buttocks. Treated with Benadryl.
Pain and swelling at injection site for 72 hours. Child claimed entire arm hurt. Reaction began within 2 hours, post vax. Treated with Tylenol.
arm became swollen to the elbow; Hurts at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm became swollen to the elbow) and INJECTION SITE PAIN (Hurts at injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012620A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PERIPHERAL SWELLING (arm became swollen to the elbow) and INJECTION SITE PAIN (Hurts at injection site). At the time of the report, PERIPHERAL SWELLING (arm became swollen to the elbow) and INJECTION SITE PAIN (Hurts at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
light headed and passed out aprox 3 hrs. after vaccine. Achy and very fatigued until following evening.  Had the same reaction with the first of the 2 shots 3 months prior to this one. That time it took aprox 12-14 hrs before passing out.
half asleep drinking a bottle; mom described small sz (shaking & trembling 5-10 sec);
Pt was have nausea, headache, redness and swelling to the location of injection. Symptoms developed later on in the afternoon and into the next morning.
About a half hour after receiving my vaccine I became very nauseous, my heart felt like I was having a heart attack and I became very short of breath. Sadly I have terrible chest pain still in my heart area
Major allergic reaction to the shot; Heat all over her body; Foggy head; Heavy right arm; Shooting pain under the breast; Left ear and face itching, itching spread all over body; Clogged ears; A spontaneous report was received from a 69-year old female consumer who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced major allergic reaction to the shot, heat all over her body, foggy head, heavy right arm, shooting pain under the breast, left ear and face itching, itching spread all over body and clogged ears.   The patient's medical history included asthma and anaphylactic shock with Sulfa medication. No relevant concomitant medications were reported.   The patient received the first of two planned doses of mRNA-1273, (Lot/Batch No. 031M20A) on 26-Feb-2021 intramuscularly in the right arm for prophylaxis of COVID-19 infection.    The patient reported after her first shot, she did stay in the office for 30 minutes and after she left within the hour after receiving the shot, she had a major allergic reaction. The patient felt heat all over her body, foggy head, right arm was heavy, shooting pain under breast, felt ear and face was itching. Then itching spread all over the body, and ears clogged up. As soon as itching spread, she took four Benadryl (diphenhydramine) 25mg each and used Dulera (mometasone-formoterol) asthma inhaler to prevent the reaction. She did not have a rash and did not have difficulty breathing because of the medicines that she took. The patient does not know if she can take the second shot because she fears having anaphylactic shock.   Treatment for the events included Benadryl 25mg Capsules.  Action taken with mRNA-1273 in response to the event was unknown.    The outcome of the events major allergic reaction to the shot, I fear having anaphylactic shock, heat all over her body, foggy head, heavy right arm, shooting pain under the breast, left ear and face itching, itching spread all over body and clogged ears were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Erythema to face and chest starting at 8:15pm, about 4 hours after injection. Took Benadryl at 8:30pm. Redness mostly resolved by 10:30pm
The patient was instructed to wait for 15 minutes and the patient started to have a headache with eye pain, swelling in hands, nausea, the systemic rash.
Breakthrough case admission after 2 vaccines Pfizer 4/22/21 Lot# Ew0172;  Pfizer 5/13/21 ER2613
Day after vaccines vomiting went to ER with mild dehydration. Sent home after ER returned 2 days later & admitted with moderate to severe hypotonia. Pt was lethargic & delay response. Pt. has hx of seizures.
Patient claims arm became weak on Saturday, Dec. 17, 2011, but not sore, just weakness.
Vaccination administered on 2/17/22 that had expired on 2/12/22.
Patient became very lightheaded and fell to the floor approximately 15 minutes after receiving the vaccine.  She did not completely lose consciousness and did not hit her head but was very confused and disoriented.  An ambulance was  called and the patient was taken to the hospital.
The patient is a 36 y.o. female with a past medical history notable for Hemolytic anemia on Rituxin monthly, Follows with Dr., chronic pain, depression, hypertension, migraines, sickle cell disorder, and thyroid disease who presents as a transfer from ER due to sickle cell crisis. Patient presented to ER with AMS, family reported finding patient unresponsive at home this am. Per record GCS was 5-7 when EMS arrived. Her sats were in the 60s. Patient was found to have a fentanyl patch which she is prescribed. She did not appear to be improving. She was subsequently intubated. She was somewhat difficult to oxygenate. Bronchoscopy showed copious edema bilaterally. Chest x-ray showed diffuse pulmonary edema. Her hemoglobin was found to be 4.9. She was noted to have some vaginal bleeding. Occult blood testing was positive. Per report patient's pulse bradied down into the 30s. It was unclear if she had a pulse so CPR was started. She quickly regained ROSC. Her heart rate improved to the 90s. She was given 1 unit of blood, started on propofol and epinephrine. Creatinine was 1.2. Potassium was 3.2, and it was replaced. WBC 10,Initial head CT scan was nondiagnostic due to limited patient cooperation. Repeat CT head was negative for acute abnormality. Patient was started on cefepime. She was transferred here for higher level of care. She is subsequently being transferred to another facility for further evaluation. On arrival here patient is intubated, sedated on propofol, in no distress. Vital signs stable. Patient tested positive for COVID-19. Started on Decadron and remdesivir. Critical care consulted. Has developed hypertriglyceridemia. Additionally, sputum culture growing MSSA consistent with superimposed MSSA pneumonia. Patient on cefepime. Patient had general worsening of her condition with worsening respiratory issues. On the night of 810, patient coded multiple times. Family visually made the decision to make patient DNR. Hemoglobin dropped consistent with acute chest syndrome. Lactic acid was greater than 18. Patient coded 1 more time and expired early this morning.
t102, frequent crying episodes, high pitched cry; sx lasted 2 days; seen by pvt MD who prescribed motrin;
PEEING BLOOD; This spontaneous report received from a consumer concerned a 56 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, batch number: Unk) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported. On 09-APR-2021, the subject experienced peeing blood. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from peeing blood. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
This spontaneous report was received from a healthcare worker via the company representative regarding an unspecified number of infant patients of unknown demographics. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients' were vaccinated with ROTATEQ, oral (dose, dose number, lot # and expiration date unknown). On unknown dates, unspecified number of patients "regurgitated or spit up" doses of ROTATEQ (infantile spitting up, incomplete dose administered) and these doses were repeated on unknown dates (Inappropriate schedule of vaccine administered). No product quality issue was involved. The outcome of infantile spitting up was unknown. Causality was not provided by the reporter. Additional information has been requested.
Her scalp was dry, Some dry patches on her face, Her forehead had dry skin, dry patch of skin on her chin; scalp peeling; Her scalp had been itching during that time, too; Stinging skin; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EL3302 and expiry date not reported), via an unspecified route of administration, administered in Arm Left on 02Mar2021 (at the age of 81-year-old), as dose 1, single, for COVID-19 immunisation. Medical history included high cholesterol for about 15 years which was inherited from family and was on a very low cholesterol pill that was a 10mg dose; high blood pressure for about 10 years and took a small dose of blood pressure medicine; seasonal allergies for most of her adult life and her seasonal allergies were acting up now, but that her seasonal allergies come and go and if she smelled someone's perfume, it would trigger something in her, but her reaction doesn't last long. She was hacking because something was in the air. The patient's concomitant medications were not reported. The patient had shingles shot 4 years ago. No additional vaccines administered on same date of the Pfizer suspect. Patient had no prior vaccinations within 4 weeks. On an unspecified date in Mar2021, since her first COVID-19 Vaccine shot, the patient experienced a dry scalp and dry facial skin which started about a month ago and it had been itching during that time. The patient got her hair shampooed once a week, on Saturdays, and her beautician noticed her dry scalp. The beautician told her it wasn't dandruff, but that her scalp skin was just flakey and started using a different shampoo (no other information) to wash her hair. On 27Mar2021, the patient shampooed her hair and noticed only a little patch of dry scalp skin left. The patient forehead had dry skin that had worsened since she first noticed it a month ago. The patient also had a dry patch of skin on her chin. The patient lived in a place with lot of wind lately, and that the wind could be a part of her dry scalp and dry facial skin. The patient used a Mary Kay brand facial cleanser, facial exfoliator, skin lotion, and night cream on her face and all the Mary Kay facial products she used were from the Mary Kay Time Wise product line. It was reported that, the Mary Kay Time Wise exfoliator was a new product for her. It was reported that, Mary Kay Time Wise facial lotion made her skin sting. The patient was scheduled for her regular blood work next week. The outcome for dry patches was not recovered; outcome of scalp peeling and stinging skin was unknown while the outcome for scalp itching was recovering. The patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EN6202 and expiry date not reported), via an unspecified route of administration, administered in Arm Left on 30Mar2021 (at the age of 81-year-old), as dose 2, single, for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a physician refers to an unknown number of patients of unknown age. On an unknown date, the patients were vaccinated with GARDASIL lot # M014929 27-MAY-2017, K010215, 05-MAY-2017, L040459 06-JUN-2017. Temperature excursion 46.6F for 30 minutes, 46.6F for 15mins, 46.3F for 15mins, 28.9F for 150 hours. No adverse effects were reported. Additional information has been requested.
About 30 minutes after the shot I developed bumps on the back of my tongue. It felt like something was stuck in the back of my throat like a popcorn kernel.  When I arrived home I took Benadryl. I also felt some leg pains and took some tylenol before bed. When I woke up the bumps on my tongue were gone, however I now felt dizzy and "off". I ended up going into work where I was given a negitve Covid test. Around 9:00am I started getting head to toe body aches and a headache. I felt exhausted and I didnt feel right. I ended up going home at 11:45. From 11:45-5:30pm, the muscle aches, headache, back/side/stomach cramps, and fatigue got worse. My temp ranged from 99.3-100.1 with Aleve and Ibuprofen in me.  I ended up going to sleep around 10pm where I had night sweats, and weird dreams. I woke up in the morning today 1/14 feeling like I had a slight headache, but for the most part I felt back to normal. I currently do not have any symptoms at 11:36am.
fatigue, weakness lower extremities, burning both feet, dysphagia, pain feet , legs, back, impaired gait, impaired balance. impaired ability to perform all ADL. Ringing ears. high risk falls due to balance issue.  started in April after second vaccination and is ongoing with current date.
This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 02-Aug-2018 by Seqirus from VAERS (VAERS ID: 744961), concerning a 19-year-old, adult female patient. The patient's historical condition included allergic rhinitis and the patient was allergic to sulpha drugs (since an unspecified date). On an unspecified date in 2009, the patient was administered influenza vaccine, (dose: unknown, route of administration, anatomical site, trade name, manufacturer, batch number and expiry date: not reported). On an unspecified date in 2009, 2 weeks after vaccination [as reported], the patient developed fever at a temperature between 101 to 104, body aches, upper and lower respiratory congestion, and cough which persisted for several weeks. The patient described these events as likely non-IgE mediated reactions to Influenza vaccination. At the time of the report, the outcome of the events was not reported. The reporter assessed the case as non-serious. This case was linked to 201803106 due to same patient and reporter.
Pfizer 1/18/21, 2/8/21. Positive on 2/26/22.
Seen in ER for febrile inc temp seizure next day after inject given day before. Lab work done - treated in ER & released home.
A non serious spontaneous case from a nurse involving Papular rash around eyes. The reporter causality is possibly related to FluMist. This case is submitted according to the VAERS safety surveillance accelerated reporting agreement with FluMist. A nurse practitioner reported that a 38 year old female patient experienced non pruritic papular rash around both eyes, back pain and maxillofacial edema, one day after she received FluMist on Oct 6 2005. No accompanying shortness of breath was noted. per the reporter, symptoms presented were not consistent with angioedema. She went back to the clinic ans was prescribed with oral Benadryl (Diphenhydramine), ranitidine, Motrin (ibuprofen) and Percocet (acetaminophen/oxycodone). Complete blood count and urinalysis were done, both of which were within normal. As of Oct 21 2005, the patient has completely recovered from adverse events reported. The reporter assessed the events as possibly related to FluMist.