chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Near paralysis; immobility, nearly collapsed. difficulty swallowing, chewing, slurred speech. Incontinence, difficulty writing, headaches, neck pain, cognitive problems, emotional swings, eye pain, decreased hearing, Treatment: 12/20-3/20 PT, OT & Speech. Alternating IVIG & Steroids since late December 2020. 12 treatments of each, continuing. 11/13 - 1/21 great improvement. 1/21 - today plateaued, no improvement. At approximately 60 % of where she was prior to 8/27/20 event.
Ten days after administration complained of sharp pain at injection site. 11 days after - site painful, itching, and 2 1/2 in diameter red area.
Pt has been experiencing left side facial neuralgia.   Pt thought that it was from tooth pain and went to dentist and a specialist to determine where the pain is originating from.  They said it was not dental and the only other possibility she feels is the vaccine.
Bilateral Pulmonary Embolism from Deep Vein Thrombosis in right peroneal artery of right leg.   Symptom was shortness of breath.  Went to emergency room, hospitalized Tuesday June 1 through Thursday June 3 when I was released.  Treatment was loading dose of Eliqius - 10 mg twice a day.  Breathing began to improve within a couple of hours of first dose.  Upon release finished out loading dose as per discharge instructions.  Now on 5 mg Eliquis twice a day.  Doctors in hospital stated the DVT/PE was unprovoked.  Have followed up with primary care physician, hematologist, cardiologist and pulmonologist.
Immune thrombocytopenic purpura; ITP; acute bleeding and thrombocytopenia; uncontrollable bleeding that did not stop; This is a spontaneous report from a Pfizer-sponsored. A contactable physician (anesthesiologist) reported that an 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 25Mar2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 27Mar2021, the patient developed immune thrombocytopenic purpura (ITP) after getting or receiving the COVID-19 vaccine. The physician would like to know the protocol of that. The patient got his vaccination, on Thursday before the reporting (25Mar2021). And the patient was admitted to the hospital 48 hours later on Saturday (27Mar2021) with acute bleeding and thrombocytopenia. The patient went to the hospital with uncontrollable bleeding that did not stop. The physician was interested if the company had any internal protocol for treatment of ITP occurring acute onset after the Pfizer COVID-19 vaccine. The physician was trying to get some information to help some rheumatologist who can't seem to be finding things on the information on treating this. The physician was not here to blame anybody for it and from what he/she read, there are like 150 cases around the world with thrombocytopenia after the COVID-19 vaccine from totally different manufacturers (further clarification unknown). The physician had read a many couple case reports of different individual, people have tried for that but he/she was just interested if the company had any inhouse information for the treatment protocols for acute thrombocytopenia after the Pfizer COVID-19 vaccination. The outcome of the event was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.; Sender's Comments: Based on the information provided and temporal association, a possible causal relationship cannot be excluded between the suspect product BNT162B2 and the reported event Immune thrombocytopenic purpura. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
Information has been received from a physician concerning a 16 year old female who on 27-MAY-2010 was vaccinated intramuscularly with the first dose of GARDASIL (Lot # 666121/1778Y). On 21-SEP-2010, the patient was vaccinated with the second dose of GARDASIL (Lot # and route not reported). The physician reported that on 27-MAY-2010 20-30 minutes after the patient received the first dose she felt a tingling sensation in both legs greater in the right leg, also, on the same day the patient had hyperventilated because she is afraid of shots. She had recovered within 12-24 hours. On 21-SEP-2010, after the second dose was give 5-10 minutes the patient felt numbness and tingling in the right lower leg and upper posterior thigh. For the second dose that patient had not hyperventilated. She was monitored. The physician reported that on 22-SEP-2010 the symptoms were still present. The patient sought medical attention. Follow up information has been received from the physician who reported that the 17 year old (also reported as 16 year old) healthy student female with no illness at the time of vaccination and no know drug allergies, on 27-MAY-2010 was vaccinated into the left deltoid with the first dose of GARDASIL and on 21-SEP-2010 into the right deltoid with the second dose of GARDASIL (Lot # 666598/0786Z). The physician stated that on 27-MAY-2010 30 minutes after receiving the first dose, the patient experienced bilateral low extremity tingling and without neuro deficit, ED if patient hyperventilated. The event resolved within 12 to 24 hours. On 21-SEP-2010, 5 to 10 minutes after the patient received the second dose, the patient experienced left extremity tingling and without weakness. She did not hyperventilate. The symptoms resolved without sequela within 12 to 24 hours. Additional information is not expected.
About 10 minutes after vaccine shaking, wheezing, tightness in chest/throat, sweating and heat. Called EMS, they assessed patient, she started to recover, patient walked out about 30 minutes later with EMS assistance.
Approximately 2 minutues following injection, child fell out of chair and onto the floor. Child had involuntary muscle movements of upper extremities; eyes were rolling back; non-responsive for ~ 45 seconds. Upon regaining responsiveness child reported was disoriented and reported that her head hurt. A few hours following the event the child reported to her mother that following the injection she began to feel dizzy and had a headache.
Patient received ZOSTAVAX on 4-12-11. A day after he had rt. shoulder pain (had vaccine in RA) & then his hips hurt really bad. Went to Dr. - could be vaccine reaction/also thinks he could have polymyalgic rheumatica.
Chills Body aches Joint pain Fever of 105.9 F Elevated heart rate Elevated blood pressure
Stuffy nose; More sinuses problems; Sinus pressure; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Stuffy nose), SINUS DISORDER (More sinuses problems) and PARANASAL SINUS DISCOMFORT (Sinus pressure) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Nose congestion. Concomitant products included METOPROLOL and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (Stuffy nose), SINUS DISORDER (More sinuses problems) and PARANASAL SINUS DISCOMFORT (Sinus pressure). The patient was treated with FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, NASAL CONGESTION (Stuffy nose), SINUS DISORDER (More sinuses problems) and PARANASAL SINUS DISCOMFORT (Sinus pressure) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Medications include Cholesterol Medications, Flonase
Extensive hives, joint swelling; swelling over left eye.  I saw him on 4/26/21.  He had some minor hives.  I prescribed an epiPen, prednisone (40 mg daily), and benadryl (25 mg tid prn rash, hives).  He came back on 4/27/21.  He had more hives, swollen left upper eyelid, joint pain, difficulty walking because of hives on soles of feet.  He had no respiratory distress.  His chest was clear.  I admitted him on 4/27/21 to the Hospital.
Guest reported to Observation Staff that he was feeling "light-headed". No other symtpoms experiences by guest per his report. Guest offered and accepted water and juice. BP assessed: 122/74 at 1106 and 120/78 at 1115. Guest reports "I am feeling fine now." Guest offered additional 15 min observation. He declined.
8-9 hours after second vaccination started to experience extreme abdominal pain.  Could not sleep because of pain.  Was awake for nearly 30 hours because abdominal pain was so extreme.  Began to vomit approximately 10 hours after second vaccine.  Very frequent within first 24 hours, then developed vomiting and diarrhea at same time.  Had fever, confusion and fatigue in days following.  Woke up every night since vaccine (excluding first night of zero sleep) covered in sweat, feels like skin is on fire at times.  Today day five, still exhausted but seems to be improving.
I received the first Moderna shot at approximately 4:30pm on 12/23/2020. Around 9:30pm that evening, I began to feel fatigued and had a slight headache. I went to bed around10:15-10:30pm. Shortly after going to bed, my headache  worsened and I began having chills. I was a bit restless that night and just did not feel well. These symptoms lasted until about 8am the following morning, 12/24/2020. I was still fatigued and still had a headache, which had lessened in intensity. I no longer had chills. The fatigue wore off throughout the day, but I still had a slight headache. Later in the evening I again became fatigued and still had a slight headache. The following day, my headache subsided, and I was only tired once evening came around. My symptoms had completely dissipated by 12/26/2020.
Pt returned to office 4/26/06 in afternoon with red raised varigated rash approx 9cm vertical on right leg with adm. site approx 4.5 cm above distal rash. Rash ranging in width at 6.5cm to 1.5cm. Warm to touch.
(R) arm-pain and blotchy redness (deltoid area). Recommended ice application, oral diphenhydramine 25mg and Ibuprofen (OTC). If not better by 10/30/14 (AM) see doctor.
feels bad; felt body aches; stuff and real weak; feeling sick in her stomach; chills; low-grade fever; light headache/headache; Out of breath just a little; I am sick; difficult for her to breathe; This is a spontaneous report from a Pfizer sponsored program. This is a contactable consumer or other non hcp reported for herself. A 55-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EN6202) via an unspecified route of administration on 27Feb2021 (Age at Vaccination 55years old) as single dose for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing Verbatim: Bronchitis asthmatic, hypersensitivity from an unknown date and unknown if ongoing Verbatim: Allergy. Concomitant medication(s) included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); montelukast sodium (SINGULAIR); ibuprofen (MOTRIN [IBUPROFEN]); paracetamol (TYLENOL) all taken for an unspecified indication, start and stop date were not reported. In Feb2021 the patient experienced difficult for her to breathe, out of breath just a little, i am sick, on 27Feb2021 light headache/headache, on 28Feb2021 feeling sick in her stomach, chills, low-grade fever, felt body aches, stuff and real week, on 01Mar2021 feels bad. Clinical course reported as she was just wondering, she wants to make sure about taking the second vaccine. she just got her first one on Saturday of this week. She is having a reaction to it, it's not bad, she is sick really bad with a headache and sick on my stomach. Yesterday I was running low grade fever and just felt body aches and stuff and real week. When paraphrased the concern, patient stated, Yes, if I should because yesterday my breath (Incomplete sentence), because I have asthmatic bronchitis and I didn't get really bad about it, out of breath just a little yesterday not real bad. When confirmed if the vaccine is Pfizer's Covid 19 vaccine, consumer stated, "Yes ma'am I am teacher since then we haven't been going out since Saturday morning. Treatment: she started the Motrin and Tylenol; she has been taking back and forth. she started this Saturday like before her even got the shot, she had already started it. The patient under-went lab tests and procedures which included body temperature: low grade fever on 28Feb2021 Low grade fever. The clinical outcome of the event low-grade fever was recovered, another events light headache/headache, feels bad was not recovered other events was unknown.  No follow-up attempts are possible. No further information is expected.
Redness which has progressively increased in size to 3" x 6". Warm to touch. Swollen and lump approx size of dime. Is now more sore. Applying Icy Hot at night. No fever. Today -MD recommended ZYRTEC 10 mg 1/day w/daily recheck.
received an expired dose of daptacel with no reported adverse event; Initial information received on 27-Jun-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old female patient who received an expired dose of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis B Vaccine, Pneumococcal Vaccine Conj 7v (Crm197) (Prevnar) both for Prophylactic vaccination..  On 26-Jun-2023, the patient received expired dose 0.5 ml (dose 2) Once (1X) of suspect diphtheria-15/tetanus/5 AC pertussis vaccine, suspension for injection (strength not reported) (lot C5893AA; Expiration Date :21-Jun-2023) via intramuscular route in unknown administration site for Immunization with no reported adverse event (expired product administered) (latency; on same day) Caller reports that the first dose of the dtap series came from a combination from a combination vaccine.  Action taken : not applicable.  Outcome :  Unknown.   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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
chills, fatigue, cough, shortness of breath, chest pain, stomach cramps, hot sweats; change in smell
Patient received her booster on 9/11/2021 towards the end of her pregnancy, one month prior to delivery.  Five days after a vaginal delivery, patient suddenly developed life-threatening hemorrhage.  She required 5u PRBC, 4u FFP, 1 cryoprecipitate.  She underwent an emergent D&C, had a Bakri balloon placed, and bilateral uterine artery embolization.
Tingling and numbness in fingers on left hand and arm areas.  Double vision started in right side though has now progressed to left eye also.
Relapse of ITP.  Severe thrombocytopenia with symptoms of petechiae, mucosal purpura, bruising.
7/16/07 A.M. Received Td vaccine left deltoid 7/16/07 P.M. Noted pain in (L) arm, chills, aches; did not sleep well. 7/17/07: Noted red, raised area around shot site; aches chills at night continued; did not sleep well.  7/18/07: returned to health center; Temp= 101.3F.  Area around injection site 3" diam red, indurated, warm to touch.  Given Ibuprofen 600 mg. P.O.  7/18/07: returned to health center; Temp+ 98.8F.  Left upper arm swelling decreased, induration decreased.  No chills or aciness last night.  Slept well.  Denies any previous reaction to Td immunization.
Itchy arm; Rash at injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Feb-2021 and was forwarded to Moderna on 04-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy arm) and INJECTION SITE RASH (Rash at injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included No adverse event.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itchy arm) and INJECTION SITE RASH (Rash at injection site). At the time of the report, PRURITUS (Itchy arm) and INJECTION SITE RASH (Rash at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided. No Treatment history was provided.   This case was linked to MOD-2021-018087 (Patient Link).
I95.89 CHRONIC HYPOTENSION 5/4/2023 BULLOUS PEMPHIGOID
Patient received expired daptacel, no AE; Initial information received on 04-Nov-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 months old female patient who received an expired 0.5 ml dose of vaccine  DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL](lot number C5307AAand expiry date: 23-Oct-2019) via intramuscular route in left thigh on 25-Oct-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACT-HIB).  It was a case of actual medication error due to expired vaccine used.  At the time of reporting, 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 holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
More headache; On the left arm between the elbow and shoulder a very blue with circle bruise was noted; hot flushes; chills; very high fever around 103F; fatigue; cold/a little bit chilly; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold/a little bit chilly), HOT FLUSH (hot flushes), CHILLS (chills), FATIGUE (fatigue) and HEADACHE (More headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PARACETAMOL (TYLENOL 8 HOUR) for Headache, ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN MIGRAINE) for Migraine, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), CIMICIFUGA RACEMOSA ROOT, GLYCINE MAX EXTRACT (BLACK COHOSH & SOY ISOFLAVONES) and PANTOPRAZOLE for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced NASOPHARYNGITIS (cold/a little bit chilly) and FATIGUE (fatigue). On 03-Feb-2021, the patient experienced CHILLS (chills) and PYREXIA (very high fever around 103F). On 16-Feb-2021, the patient experienced HOT FLUSH (hot flushes). On 04-May-2021, the patient experienced HEADACHE (More headache) and CONTUSION (On the left arm between the elbow and shoulder a very blue with circle bruise was noted). At the time of the report, NASOPHARYNGITIS (cold/a little bit chilly), HOT FLUSH (hot flushes), CHILLS (chills), FATIGUE (fatigue), HEADACHE (More headache), PYREXIA (very high fever around 103F) and CONTUSION (On the left arm between the elbow and shoulder a very blue with circle bruise was noted) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details were :Took Tylenol for fever, icepack for headache and consulted Gynecologist for hot flushes and was prescribed with Black cohosh 540 mg capsule once a day   This case was linked to US-MODERNATX, INC.-MOD-2021-109635 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-109635:Original Case : MOD-2021-109635
pt died in sleep 14 days p/vax;no signs of illness prior to death;possible SIDS, possibly unrelated;
brand new allergic reactions to antibiotics, high PSA levels >36, high platelet counts over 700, high ferritin, low iron
A patient was administered an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other care professional via Medical Information (Reference number- 00360429) and transmitted to Sanofi on 16-Nov-2020.  This case is linked to cases 2020SA325400 and 2020SA326243 (same reporter).  This case involves a 34 year old male patient who was administered a dose of 0.5 ml DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot U6101AA, expiry: 23-Oct-2020) once via unknown route in unknown administration site for prophylactic vaccination on 05-Nov-2020 (Expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was a case of an actual medication error due to Expired vaccine used (latency same day).  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 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
At 20:30 on 1/14/08 child had a one minute episode of generalized body tremor, which self-resolved.  The child was febrile at the time.
Patient contracted COVID after being fully vaccinated Weakness, fatigue, congestion, cough, diarrhea
PATIENT WAS GIVEN TDAP NOT DTAP.  THIS IS NUMBER 4 IN SERIES. NO S/S OF ADVERSE REACTION. MD AWARE. MEDICAL DIRECTOR AWARE. NO HARM OR INJURY TO PATIENT.
According to father, patient had right sided seizure (jerking of hand and leg) on 12/13/02. Seen at ER; CBC, eletrolytes, CT head all normal. Patient seen by neurologist in ER. Received EEG which was done on 12/19/02. EEG NL; Patient stable.
Patient within 5-10' after receiving these immunization, loss tone, became pale, and dropped heart rate 60". - 3/29/06 Review of 3-page medical record lists diagnoses as anaphylactoid reaction secondary to immunizations. Vasovagal response.
A painful rash the size of your palm over the injection site. It spread out at about 5pm. Medicine has not helped the pain or the rash.