chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After getting the second dose of Pfizer vaccine on 1/28/2021, I smell smoke in the office or at home all the time and it also triggers me coughing. Even as of today, I am still smelling smoke on and off inside the office and home.
Patient experienced seizure within the first few minutes of receiving 1st dose of COVID19 Moderna vaccine. Seizure lasted only about 2 minutes and resolved on its own (without any medication). No head injury occurred. 911 was called and paramedics took patient to the hospital.
sudden bilateral weakness in legs - 5/25 - difficulty ambulating 5/26 inability to stand admitted to Hospital 5/26 from ER Lumbar Pnncture - 5/30 Guillain Barre syndrome IVIG infusions 5/31 - 5/4 Dexamethasone IV t.i.d.  Discharged 5/5
This case was reported by a healthcare professional and described the occurrence of arm cellulitis in a 21-month-old female subject who was vaccinated with Infanrix (GlaxoSmithKline) for prophylaxis. Concurrent vaccinations administered on 25 April 2007 included varicella virus vaccine (Merck); subcutaneous; right deltoid. On 25 April 2007, the subject received 4th dose of Infanrix (.5 mL, unknown, left deltoid). On 26 April 2007, one day after vaccination with Infanrix, the subject presented at the physician's office with swelling and redness in her left arm, which was diagnosed as cellulitis. This case was assessed as medically serious by GSK. The reporter also identified a product quality complaint, questioning whether there was a problem with the Infanrix lot number that was administered to the subject. It was unspecified if the subject received treatment for cellulitis. At the time of reporting the outcome of the events was unspecified. The healthcare professional considered the events were possibly related to vaccination with Infanrix.
Pentacel injection in which the diluent was mixed with sterile water instead of the 0.4% NACL solution; Initial information was received on 12-Dec-2019 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case involves a patient of an unknown age who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] in which the diluent was mixed with sterile water instead of the 0.4% NaCl solution.  Medical history, medical treatment, vaccination and family history were not provided.  On 12-Dec-2019, the patient received second dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ014ABA via intramuscular route.  It was a case of actual medication error due to wrong solution used in drug reconstitution.  The patient did not experience any other AE.  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.
After my second covid vaccine I started feeling muscle pain primarily starting in my back.  I went to Dr and he prescribed some muscle relaxers which did not help.  Then did physical therapist which did not help.  Then did MRI and went Orthopedic center and said it was normal.  Dr ordered several labs, all negative except for high inflammation levels.  Continued physical therapist and then went to Dr rheumatologist who ran additional labs with all negative except high inflammation.  He started me on steroids and lyrica.  Recently went to Dr and he ordered hydroxychloriquine.  To date have been in extreme body pain.  Also have done chiropractic and pilates with no relief.
Red, raised area on arm at site of immunization, started small and progressed to 3-4 in oval area on 11-3-13, itchy and hot to touch, recommended BENADRYL and follow up with MD.
lethargy; frequent urination; headaches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargy), POLLAKIURIA (frequent urination), HEADACHE (headaches) and PYREXIA (Fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LETHARGY (lethargy), POLLAKIURIA (frequent urination), HEADACHE (headaches) and PYREXIA (Fever). At the time of the report, LETHARGY (lethargy), POLLAKIURIA (frequent urination) and HEADACHE (headaches) outcome was unknown and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.9 (Inconclusive) 99.9.         Concomitant medications were not provided by the reporter.   Treatment information was not provided by the reporter.   This case was linked to MOD-2021-072630 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: No new information.
1245: Patient presented to clinic to receive Johnson & Johnson COVID-19 vaccine. Prior to administration, patient denied any allergies or allergic reactions to vaccines in the past. Vaccine was injected into left deltoid. After injection, patient told medical assistant "he was feeling woozy." Medical assistant informed nurse practitioner student and MD. Patient was instructed to continue waiting for 15 minutes post injection and lay down on exam table. After medical assistant left room, a loud thud was heard and staff entered exam room to find patient laying on floor, head down, with drops of blood on face. While attempting to stabilize patient, his muscles were tense and stiff to touch and patient was making slight jerking movements with eyes open. Patient no talking and unable to answer questions or follow commands. Staff attempted to lay patient down but patient resisted and requested to leave. Patient was unable to identify his name, date of birth, current place or time. Patient refused to sit. Staff unable to obtain vitals due to refusal. 1306: 911 called and patient was taken to emergency room.
ADVERSE EVENT(s): - Significant breathing difficulty and feeling as though the upper portion of my lungs don't receive any oxygen anymore  TREATMENT(s): 1. Used an oral inhaler for about a week 2. Performed more cardio and sprints 3. Breathing exercises  OUTCOME(s): 1. Did not notice a change in lungs and breathing 2. Did not fix the adverse event...  But noticed that my cardio became significantly worse post-vaccination 3. Did not fix the adverse event...  Felt like I had to force more air into my lungs in order to "stretch" the upper portion of my lungs each time
I contacted my doctor through the portal telling her I tested positive for COVID-19. She prescribed PAXLOVID. I started it that night. It was supposed to be five days of treatment, but I only took it for two and a half days. PAXLOVID made me feel worse. I couldn't eat or sleep. My symptoms were mild. I just felt tired. I also had a sore throat, congestion, and chills. The chills only lasted the first night. It took me two weeks before I tested negative for COVID-19 again.
Information has been received from a medical assistant concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL vaccine (yeast) (lot # not provided) and fainted in their office. The reporter did not elaborate whether the patient received GARDASIL vaccine (yeast) or not. Additional information has been requested.
Lots of site pain; a patch of hives distal to the site; shoulder muscles (rotator cuff) really sore; This is a spontaneous report from a contactable consumer (patient). A 21-years-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 25Jul2021 (age at the time of vaccination was 21-year-old) (Lot Number: FA7484) as dose 1, single for covid-19 immunization. Medical history included loose ligaments, multiple left shoulder subluxations, intermittent malt and gluten sensitivity, intermittent malt and gluten sensitivity, patient diagnosed with COVID-19 (Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination the patient had not tested for COVID-19. Concomitant medications included List of any other medications the patient received within 2 weeks of vaccination: flaxseed oil [linum usitatissimum seed oil] (FLAXSEED OIL); vit d [vitamin d nos] (VIT D); zinc; ascorbic acid (VIT C) taken for an unspecified indication, start and stop date were not reported.On 26Jul2021 07:00, the patient experienced Lots of site pain; a patch of hives distal to the site; shoulder muscles (rotator cuff) really sore. The patient was not Hospitalized Prolonged. The patient does not receive any treatment for AEs. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The most recent COVID-19 vaccine was administered in pharmacy or Drug Store. The outcome of events was recovering.  Follow-up attempts are completed. No further information is expected.
hips were hurting; having hard time getting up and down; Her arm is a little sore now; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6201, and Expiration date: Unknown), via an unspecified route of administration, administered in right arm on 22Feb2021 11:00 (at the age of 78-year-old) as dose 2, single for COVID-19 immunization. The patient medical history included heart condition, AFib (atrial fibrillation) had in last Jan2020 (on a blood thinner for that now), breast cancer, blood pressure, and sensitivity to medication (some medications do not agree with her). The other conditions were started about 8-9 years ago. In the left breast no investigation assessment was performed. Concomitant medications included apixaban (ELIQUIS) taken for AFib (atrial fibrillation) and ongoing, diltiazem hcl (DILTIAZEM HCL) taken to regulate her heart and ongoing, lisinopril (LISINOPRIL) taken for blood pressure and ongoing and hydralazine (HYDRALAZINE) taken for blood pressure and ongoing. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL3247, and Expiration date: Unknown), via an unspecified route of administration on 01Feb2021 (at the age of 78-year-old) as dose 1, single for COVID-19 immunization and she said that her arm was sore for like a day and a half, but she had no other reactions with the first vaccine. It was reported that, the patient had the second shot yesterday around 11:00 on 22Feb2021 and stated that around 14:00- 15:00 (3) her hips started hurting (hips were hurting) and got progressively worse. Then they hurt all night and have hurt ever since. She was "having hard time getting up and down". She said that she kept a hot water bottle on it. She said that it was hard to get up and down, especially off of the toilet. She took a Tylenol at 09:00 on 23Feb2021. She said that she has had no problem with her hip prior to this. The patient said that she last saw her physician last Thursday. She said that she felt her age today, but she usually did not. The pain in her hips had improved since she took a Tylenol. "She said that she does have a sensitivity to medication. She said that some medications do not agree with her". The patient said, on an unspecified date in 2021 "her arm is a little sore now", but it was her hip that was bothering her now. She said that she did not have any artificial hips or anything. "She said that she has all of her body parts". The outcome of event hips were hurting was reported as resolving. The outcome of the event "having hard time getting up and down" was reported as not recovered. The outcome of event "her arm is a little sore now" was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021225296 Same patient, different AE, different dose
Muscle aches all over her legs and back; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle aches all over her legs and back) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported. ).   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Muscle aches all over her legs and back). At the time of the report, MYALGIA (Muscle aches all over her legs and back) outcome was unknown.            Concomitant product use was not provided. Treatment information was not provided. The patient wants to know whether she can take extra-strength excedrin for the aches.
Esophageal problems; Esophageal problems/ruptured esophagus; Severe headache; Nausea; Bedridden; Dry Heaving; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RETCHING (Dry Heaving), OESOPHAGEAL DISCOMFORT (Esophageal problems), DIZZINESS (Esophageal problems/ruptured esophagus), BEDRIDDEN (Bedridden) and HEADACHE (Severe headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced RETCHING (Dry Heaving) and BEDRIDDEN (Bedridden). On 04-Mar-2021, the patient experienced DIZZINESS (Esophageal problems/ruptured esophagus), HEADACHE (Severe headache) and NAUSEA (Nausea). On 21-Apr-2021, the patient experienced OESOPHAGEAL DISCOMFORT (Esophageal problems). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (intravenous) for Adverse event, at a dose of UNK dosage form. On 27-Mar-2021, RETCHING (Dry Heaving), BEDRIDDEN (Bedridden), HEADACHE (Severe headache) and NAUSEA (Nausea) had resolved. At the time of the report, OESOPHAGEAL DISCOMFORT (Esophageal problems) had not resolved and DIZZINESS (Esophageal problems/ruptured esophagus) 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.   Concomitant product use included a pain killer for an unknown indication.  Treatment medication included IV Benadryl for headache and nausea medicine that did not work five days after onset of symptoms.  The patient was advised not to take the second dose of the Moderna COVID-19 Vaccine.  The patient reported to have an appointment with a gastroenterologist for the ongoing esophageal symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Additional information added to include updated reporter information and event outcomes.
1020: Patient was complaining of dizziness. When transporting patient to stretcher she was having weakness and shaking. Onsite NP and EMT assessed patient immediately. First BG reading read low, second reading read 29. Patient was immediately given a breakfast bar. Vitals were taken. BP 171/96, HR 116, 02 98%. EKG showed sinus tach. Patient stated she had not eaten this morning and she is a diabetic. Fire rescue was called. 1035: Second set of vitals were taken BG 89, BP 177/96, HR 120, O2 98%. 1045: Fire rescue arrived, assessed patient. BG was 179. Patient refused to be transported to the hospital. 1100:,  Patient agreed to no further medical intervention on our end.
Neck felt tired. After few days, felt itchy, then later that night showed redness.
Information has been received from an 82 year old female with blood pressure high and iodine allergy who on approximately 15-JUN-2010 and approximately 04-JUL-2010 was vaccinated subcutaneously with 0.65ml ZOSTAVAX (Merck) respectively. Concomitant therapy included warfarin, digoxin, metoprolol and CRESTOR. On approximately 04-JUL-2010 the patient noticed a rash on her right hip and it was itching her. No medical attention was sought and no laboratory test was performed. At the time of the report the patient had not recovered. Additional information has been requested.
I had a pain/stiff neck and pain up my head. It was sudden and really hurt. Like I had wrenched my neck. Then I developed some bumps on my scalp, kind of in a line from my hairline to the crown of my head. These itched and tingled and hurt. Then I developed patches of rash on the right side of my neck, in my hair line and a patch under my right ear on my jaw.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jan2021 at 13:15 as dose 1, single (Lot number: EL9261), in left arm, on 11Feb2021 at 13:15 as dose 2, single (Lot number: EL9264), in left arm and on 26Oct2021 at 13:15 as dose 3 (booster), single (Lot number: 30145BA) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "allergic to penvk" (unspecified if ongoing). Concomitant medication(s) included: DOXYCYCLINE, start date: Jan2020, stop date: 12Jul2022; LEVOTHYROXIN, start date: Jan1991, stop date: 12Jul2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jul2022) negative; (08Jul2022) negative; (11Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported that patient received vaccine and received covid treatment. It was reported that patient received other medication in 2 weeks. Patient received treatment with anti-viral for COVID 19 Treatment start on 02Jul2022 and stop on 06Jul2022 with lot number unknown. Adverse event Testing positive for COVID on 11Jul2022. Nasal congestion, cough as this was after testing negative (beginning on Wednesday, 06Jul2022 thru Friday, 08Jul2022). It was reported that adverse event start date on 12Jul2022 at 01:15 PM (not updated). Device time stamp on 12Jul2022.  No follow-up attempts are possible. No further information is expected.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE HYPOXEMIC RESPIRATORY FAILURE IDIOPATHIC CENTRAL SLEEP APNEA
No longer controlled epilepsy with daily seizures with auras and getting worse; This is a spontaneous case initially received from an other non-health professional on 19-Aug-2019, concerning a 59-year-old, male patient (race and ethnic group were not provided).   The patient's relevant medical history included epilepsy.  The patient's concomitant medications included Trileptal (Oxcarbazepine) and Depakote (Valproate semisodium).  On 11-Aug-2019, the patient was administered with Afluria QUAD (influenza vaccine, inactivated influenza virus egg split CSL, dose: 0,5 ml, route of administration: intramuscularly, anatomical location: deltoid, batch number, expiration date: not reported) for influenza prophylaxis.   On 12-Aug-2019 during morning, within 20 hours after vaccination, the patient started experiencing seizures with auras daily.  On 19-Aug-2019, the patient stated that his epilepsy had been controlled for 35 years and now it is no longer controlled and daily auras were getting worse. The patient also stated it has ruined his life and nothing in his life has changed except he had the injection. On the same day, the patient had appointment with his physician.   The outcome of no longer controlled epilepsy with daily seizures with auras and getting worse was not resolved.  Company comment: Day after administration of Afluria QUAD vaccine the patient began experiencing worsening of underlying epilepsy including associated daily auras. Temporal proximity to development of adverse event is suggestive for causal role of vaccine. Patient's concomitant medications included oxcarbazepine and valproate. Indication for use of these drugs was not specified, however these drugs are known anti-epileptics. Dosing of these drugs is unknown, however patient reported no other changes aside from vaccination. Causal role of Afluria QUAD in exacerbation of epilepsy cannot be excluded based on the available information, therefore this event is assessed as related.; Reporter's Comments: Day after administration of Afluria QUAD vaccine the patient began experiencing worsening of underlying epilepsy including associated daily auras. Temporal proximity to development of adverse event is suggestive for causal role of vaccine. Patient's concomitant medications included oxcarbazepine and valproate. Indication for use of these drugs was not specified, however these drugs are known anti-epileptics. Dosing of these drugs is unknown, however patient reported no other changes aside from vaccination. Causal role of Afluria QUAD in exacerbation of epilepsy cannot be excluded based on the available information, therefore this event is assessed as related.
At the time of the injection sharp pain across my back , then at about 5 mins after feelings of light headedness, progressing pain across my back, trouble feeling like I could get enough air in with breathing and dizziness and I tried to get to the floor to sit or lay  down but passed out. Then the next event I recall was a sharp pain in my thigh(apparently administered Eli pen) . I regained consciousness and was gasping andI was told I had been given a shot of epi.
Two swollen knots formed on the thigh - one at injection site and one within an inch. It took about a week and a half for the swelling and knots to subside fully.
I got rash on my arm where the vaccine is on my left arm they did the vaccine and it looks like a red little; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 24Mar2021 (Batch/Lot number was not reported) at single dose at arm left for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 04Mar2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. "Today" all of sudden the patient got rash on patient's arm where the vaccine was on patient's left arm they did the vaccine and it looked like a red little. The action taken in response to the event for BNT162B2 was not applicable. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.