chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Large DVT in leg femoral popliteal; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date  (at the age of 74-years-old) as a single dose for COVID-19 immunisation. The patient medical history was none. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient previously received the first dose of BNT162b2 on 18Jan2021 at 12:00 (Lot Number: Unknown) for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient experienced large DVT in leg femoral popliteal without other cause on 24Mar2021, diagnosed 3-4 weeks after the 2nd vaccine.  The patient underwent lab tests and procedures which included PCR COVID test on 24Mar2021 (post vaccination), which was negative. Therapeutic measures included rivaroxaban (XARELTO) as a result of large DVT in leg femoral popliteal (deep vein thrombosis). The patient was recovering from the event, large DVT in leg femoral popliteal.   No follow up attempts are possible; Information about Lot and batch number could not be obtained.
Patient reported experiencing extreme fatigue (marked by  difficulty staying awake) and weeping welts at injection site
22 patients received expired Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (22 patients received expired Moderna Covid-19 vaccine) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    In April 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (22 patients received expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (22 patients received expired Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  It was reported that dose was administered to patient after 30-day Use by Date or after manufacturer date of expiry. The date the vial was initially stored in the refrigerator was unknown. It was also reported that the vial didn't undergo any temperature excursions.  In Apr-2022, the patient received second booster dose which was expired on 27-Mar-2022.  No treatment information was reported.
The evening of imm's - irritability, crying, increasing to unconsolable screaming for over 12 hours starting the next morning, seizure like activity x 1 - shaking, eye rolling, drooling approximately 19 hours after imm's. No fever. Hospitalized x 2 days for w/u of seizures in infant. 11/7/07-records received for DOS 10/23-10/25/07- DC DX: Possible seizures, developmental delay, infection ruled out. Day prior to admission she was noted by PCP to be mildly developmentally delayed in her gross motor functions. Not sitting up, rolling front to back only. Later same day became irritable, fussy and next afternoon whole body shaking and her eyes rolled up. Parents are poor historians as they are both diagnosed with MR and are delayed.
Received DTaP 7/31/07, 2-3 hrs after receiving DTaP (#4) presented with 2 discrete urticarial lesions on left cheek. Presented to Emergency Room, was given Benadryl and discharged.
She had a high fever; drowsiness; sore arm; headaches followed by a seizure.
Hives started on7/12/00. Seen on 7/14/00 and started on oral Benadryl.
(L) deltoid redness (L) upper arm swollen & red. Today decreased redness continued (L) upper arm swollen. TYLENOL, ice packs, CLARITIN.
After receiving the vaccine she had redness and swollen in her left eye. It started in the corner of her left eye then spreaded to her whole eye which has since then spreading to the right eye, with peeling of the skin.  Any exposer to sunlight irritates it. She also has a crusty nose with peeling skin. Have seen a eye doctor it is not pink eye.
NEUROPATHY IN FEET WAS WORSED; ARTHRITIS HE HED GOT WORSED; FELT WEAKNESS; This spontaneous report received from a patient concerned a 60 year old white and not Hispanic Latino male. The patient's height, and weight were not reported.  The patient's concurrent conditions included arthritis, and neuropathy in feet, and other pre-existing medical conditions included patient had no other underlying conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: unknown) dose was not reported, frequency one total, administered at left arm on 13-MAY-2021 for prophylactic vaccination.No concomitant medications were reported. After the vaccination, patient felt weakness on 14-May-2021 and on 15-May-2021 his arthritis had got worse and the neuropathy in his feet was worse. But the weakness he had noticed was more than anything. His weakness was steady throughout since he had received the shot  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt weakness, arthritis he hed got worsed, and neuropathy in feet was worsed. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210713986 - covid-19 vaccine ad26.cov2.s - Neuropathy in feet was worsed- 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).
Narrative:  COVID infections following completion of COVID vaccine series 01/06/21 COVID vaccine dose #1 01/28/21 COVID vaccine dose #2 02/16/21 Pt presents to ED reporting loose black stool for the past 3-4 days along with a headache; denies blood, nausea, vomiting, fever, or chills; labs and CT are unremarkable; discharged 07/03/21 Pt presents to ED reporting suicidal ideation; admitted to psych; COVID NEGATIVE 07/04/21 Pt reports he was not suicidal and occasionally feels overwhelmed and sad; denies continuous depressed mood/episodes; discharged home 07/30/21 Pt presents to screening reporting cough, fatigue, muscle pain; COVID POSITIVE 07/31/21 Pt presents to ED reporting chills, severe cough, watery diarrhea, moderate fatigue, fever, headache, and muscle pain that started 3-4 days ago; pt hemodynamically stable and treated with rx for acetaminophen; discharged home and instructed to quarantine; COVID POSITIVEE 08/01/21 Pt reports feeling better and symptoms of cough and diarrhea 08/02/2021 Pt reported productive cough, congestion, and runny nose 08/05/21 Pt reports feeling better and cough is nearly resolved
Contracted COVID-19; Contracted COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 16-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm; in Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm; and on 17Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm, all intramuscular for COVID-19 immunisation. The patient's relevant medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16May2022, outcome "recovered" and all described as "Contracted COVID-19". The patient underwent the following laboratory tests and procedures: COVID-19 PCR nasal swab: on 19May2022 (as reported) and was positive. Therapeutic measures were not taken as a result of drug ineffective or COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Administered first dose of Pfizer (5-11) at 12:04pm, at 12:09 was alerted that patient was having a reaction to the vaccine. She looked very pale and tired. EMT was called.
accidentally gave Quadracel instead of Pentacel/no AE; accidentally gave Quadracel to 15 months old instead of Pentacel/no AE; Initial information received on 24-Jun-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 months old female patient who was mistakenly vaccinated with DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot C5755AB, dosing details 0.5 ml, fourth dose and expiry date 10-JUL-2022) via intramuscular route in the left thigh unknown date for prophylactic vaccination(product administered to patient of inappropriate age) and  (wrong product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and HEPATITIS A VACCINE (HEPATITIS A).  It was an actual medication error case due to wrong vaccine administered and inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  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.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On an unspecified date the patient was vaccinated with a dose of RECOMBIVAX HB (lot#/batch# unspecified) dose, location, frequency and route unspecified, which was improperly stored, exposed to 1C for 24 hours. No known adverse effects. Additional information is not expected because the reporter would not be contacted.
pt recv vax 1APR96 & 26JUN97 pt presented to MD office w/less than 12 crusted lesions on arms, back, & chest;pt had broken out in rash approx;
I collapsed and fainted the morning after having the two vaccines. My husband observed that I was unresponsive for less than 30 seconds. When I woke up, I felt very sick. My blood pressure, usually around 100, shot up to over 200 and stayed high for several repeated tests. I became extremely nauseated and weak, but suffered no pain, no chest or arm pain, and no difficulty breathing. One reading of my Tropinin I level was high at 0.11 ng/mL but then reverted to normal range. My blood pressure, oxygen absorption, heart rate and other readings were normal. I was admitted overnight for observation and passed a stress test and other test.  I had slept very poorly the night before due to the pain in my arms from the two vaccines. I also had leg and ankle cramps many times throughout the night, which is rare for me. I felt fine when I first got up and was going through normal morning activities when I became faint and had to sit down. I passed out onto a table top and did not fall or hit my head.
The subject is a nursing student who received the flu shot during a simulated disaster drill type process.  He received the flu shot on 10/26/2006 at 1215.  At 1230 he returned to the clinic area stating that he was lightheaded and nauseated.  He also stated that his righ arm had a tight feeling and was numb and tingling.  At 1240 his face became very flushed and hot to the touch.  He did not have and respiratory distress.  The occupational health physician said to send him to the ED or give him an epi-pen.  He refused the ED so an epi-pen was provided and administered at 1300.  After about 15 to 20 min his face became less red and hot to the touch.  His lightheadedness and dizziness got better as well as the arm numbness and tingling.  His father picked him up and took hime to his regular doctor for follow-up since he had refused going to the ED.  He returned to school on 10/30/2006 with a full doctor's release with no restrictions.
Woke up at 9am 12/22/21 with a slitting headache , body and joint aches, upset stomach and chills. The headache got worse as the day went on?couldn?t sleep because my head was pounding so bad. Finally at 3 am I took a hot bath and was able to sleep.  Today I feel a little better sore and week and headache is a dull thud. Right arm really sore and real tender in the armpit.
Patient was vaccinated, moments later she had lost consciousness. Administering technician notified pharmacist immediately. When patient was approached she was regaining consciousness. Boyfriend said she was out for about 30 seconds. She vomited and moments later was feeling better. She was monitored until 9pm. Patients blood pressure was taken sporadically for about 1.5 hours with numbers ranging from 76/57, to 190/146. Last BP reading was 101/76.  She said she was well enough to go. Gave patient card and told her to call for any other AE or questions/comments. Patient stated she has a history of syncope, especially when in medical atmosphere.
Left side where COVID Bivale and Flu vaccine were given are very red and sore as expected.  However, across my left shoulder blade and up the side of the left side of my neck are experiencing excruciating discomfort.  I haven't done anything to strain or stress it.  May not be related to vaccines, but can't think of anything else to cause so much pain.  Maybe slept wrong?  I'm thinking, probably not;
24 h after shot - 4 lumps in lymph node under left arm. Pt note tired than usual. No problem with Flu shot in 2012. Swelling going down by 11/4/13. Completely gone by 11/16.
Skin beneath the bandaid became very red and raised.  The square are under the bandaid where the injection was given, was completely normal.
Dizziness the morning after the 2nd Vaccine administered on March 11, 2021, Dizziness (felling of head spinning) while trying to get out of bed on the morning of March 12, 2021, Also periodic feelings of head spinning with slight movements of my head. Today not as severe as day one. But, still lingers as of March 15, 2021.  (Today)
Swollen; redness, slightly swollen, and a small rash around injection site; redness, slightly swollen, and a small rash around injection site; redness, slightly swollen, and a small rash around injection site; Tiredness; rash from the face mask; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as Age: 77, Unit: Unspecified) received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history included tested positive for covid on 01Jul2020. The patient's concomitant medications were not reported. The patient received Covid 19 vaccine on 02Jan2021. In Jan2021, she experienced still swollen, redness, slightly swollen, and a small rash around injection site. She felt tiredness. She also got a rash from the face mask. She is calling to inquire if these side effects are common and how to treat. The outcome of the events tiredness and rash from the face mask was unknown, while for the other events was not recovered.  Information on the lot/batch number has been requested.
Patient stated that her reactions started on January 22, 2021 (10 days later) with symptoms of red, itchy area that had enlarged over next two days but started putting benadryl ointment on it and it went away.   Patient was not previously diagnosed with COVID-19 in the past.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The medical history of the patient included chicken pox. On 29-JAN-2015 the patient was inadvertently vaccinated with (Oka/Merck) VARIVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown) for an unknown indication instead of ZOSTAVAX. No concomitant medications were reported. No adverse events were reported. The action taken with (Oka/Merck) VARIVAX was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with (Oka/Merck) VARIVAX was unknown. No product quality issue was reported. Additional information has been requested.
Case number PHEH2014US020442, is an initial spontaneous report from a physician received on 08 OCT 2014. This report refers to a 3 years old female patient. Past medical history and concomitant medications were not reported. She was inadvertently vaccinated with FLUVIRVIN 2014/2015 (batch  number: unknown) intramuscularly on 07 OCT 2014. No adverse event was reported following the maladministration (inappropriate age at vaccine administration).
Become unaware of things going on around him, delirious, spiked a fever of 103.5, vomiting, twitching, constipated, temperature went back down to normal 2 days later, but continued the twitching and started slow blinking for a couple days. 3 days post vaccines he was very irritable spending most of the day/night fussing or crying.
fever of 102 and 103 even after 48hrs of the shot. and severe headache. Advil has no effect on headche, temp is breaking down after taking meds. but keeps coming back.
Pt report severe R arm pain that occurred approx 2 hours after receiving the IM injection on 3/1/22.  Then yesterday 3/2/22 she was sent home from work d/t feeling ill.   This morning 3/3/22 has had bouts of nausea and vomiting.
Shingles? 9 days after the vaccine. Antiviral tablets. I never had Chicken Pox.
The pt was diagnosed with atypical Guillain Barre syndrome. The mother did not pursue treatment as directed by MD. The mother states the child's problem is related to the injection. The pt also has difficulty walking.
Narrative: COVID infection following COVID vaccine series 01/23, Pfizer, dose #1 02/12, Pfizer, dose #2 09/03 pt cc cough, rhinorrhea, dyspnea, exposure: unknown 09/22 COVID swab, result: detected 09/22 CXR impression: Findings: Reticulonodular opacities are now noted projecting over the right midlung region new since previous examination. Negative for pneumothorax, airspace disease, atelectasis, effusions or edema. The heart size and configuration are normal. Mediastinum and pleural spaces are normal. No masses, nodules or adenopathy detected. The visualized bones are normal for the patient's age. Impression: Nonspecific reticulonodular opacities in the right midlung. Recommend CT scan to better evaluate 09/29 clinically resolved 10/07 CT Chest impression: The lungs demonstrate no consolidation, masses or effusions. There are ill-defined areas of groundglass in the dependent portions of the right lower lobe. The heart is mildly enlarged globally. Extensive coronary artery calcifications. There is no evidence of pericardial effusion. No significant pneumothorax. No significant mediastinal adenopathy or soft tissue mass. The visualized osseous structures show no lytic or blastic lesions. No acute osseous abnormality visualized. The visualized portions of the abdomen appear normal. Impression: 1. Patchy bilateral perihilar and lower viral infection (Covid 19). 2. Coronary artery disease. Cardiomegaly. 09/22 SARS-COV-2 Variant Sequencing result: pending.
Approximately 15 minutes after injection my heart started racing and I experienced extreme Lightheadedness.  I notified the nurse, who proceeded to take my pulse, then had me lie down.  Approximately 10 minutes later, it became very difficult to speak.  Although I could think, it became increasingly difficult to form words.  At that point they called Rapid response,  Over the next 20 minutes, it subsided, and I was able to think and speak coherently.  Then it started all over again.  I could think, but it was extremely difficult to keep my eyes open or to form words.  At that point I was taken to the Emergency Department, where they did a complete stroke assessment.
I received the last of my Gardasil vaccine March of 2009. Immediately after I broke out in a rash/hives on my body. I started experiencing headaches on a regular basis, back pain, shortness of breath, pvcs, palpitations, racing heart and severe depression. November of 2009 I started experiencing tingling and zaps and gyrations in my legs, feet, arms, and hands as well as head. I have muscle twitches, weakness, fatigue, shortness of breath, back pain. And now swollen lymph nodes although I have no knowledge of having had a cold or virus. Labs revealed a high level of arsenic in my body, and proteins in my blood.
Narrative:  Pt reported to nursing with 24 hours from 2nd moderna vaccine, exacerbation of existing Phempigus Vulgaris which was treated by non-clinic Dermatologist with Magic Mouthwash. Symptoms lasted approx.. 3 weeks.
Hospitalization for hyponatremia, COVID. Treated with dexamethasone, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
No adverse event happened. Read Tdap on 5/4/06 and 8/7/06.
Redness and swelling at injection site. Worst on 3/8 improving on 3/9. No evidence of infection.
This spontaneous report has been received from a physician, via immunization record from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 1804USA006650), concerning a 68-year-old male patient. On 13-APR-2005, the patient was vaccinated by a licensed practical nurse (LPN) with pneumococcal vaccine, polyvalent (23-valent) (reported as pneumococcal polysaccharide 23-valent (PPSV23) (CVX=33)) (manufacturer unknown) 0.5 milliliter administered Intramuscularly in left deltoid, as prophylaxis; on 09-DEC-2015, the patient was vaccinated by a registered nurse (RN) with pneumococcal vaccine, polyvalent (23-valent) (reported as pneumococcal polysaccharide 13 valent (PCV13) (CVX=133)) (manufacturer unknown) 0.5 milliliter administered Intramuscularly in left deltoid; and on 05-DEC-2016, the patient was vaccinated by a RN with pneumococcal 13 valent vaccine (reported as pneumococcal polysaccharide 23-valent (PPSV23) (CVX=33)) (manufacturer unknown) 0.5 milliliter administered Intramuscularly in right deltoid, as prophylaxis (strengths, lot numbers, and expiration dates for all 3 doses were not reported) (inappropriate schedule of product administration).; Sender's Comments:  US-009507513-1804USA006650: US-009507513-2112USA001567.
This spontaneous report as received from a physician via a field representative refers to a male patient in his late 30's or early 40's. The patient's medical history included cerebral palsy. On an unknown date, the patient was vaccinated with dose 1 of PNEUMOVAX23 (lot#, route, dose not reported). No concomitant medications were reported. On an unknown date, the patient developed a serious local reaction, his arm was severely swollen and he complained of pain. No hospitalization, no death was reported. Patient sought medical attention (unspecified). The outcome of arm severely swollen and complained of pain was unknown. Additional information has been requested.