chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore throat that seemed to develop into a cold. Other symptoms went away after a few days but the sore throat and cough lasted 2 weeks.  Went to doctor when cough persisted for more than a week.  I seemed to feel better and tested negative for covid so  I went back to work.  Then felt worse again - and also continued to experience fatigue.  Feeling better by the end of November.
moderate, related, bilateral tinnitis, still ongoing with no diminishment in intensity, now 60 days post-vaccination
Mom noted nickel-sized dimple to left thigh approx. 3 weeks, post vax. Two nurses noted on 9/21/01, left thigh muscle scarring; muscle tissue appears separated. Child referred to doctor for follow-up.
Mild migraine with visual aura on 2/13 was followed by severe migraine on 2/14 with visual aura, nausea, hand/finger numbness. Onset of severe migraine symptoms began at 9:30 am 2/14 and subsided by about 3:30 pm. Treatment included excedrin, prednisone, ibuprofen, tramadol and oxycontin.
jaw pain; chest pain; severe pressure in his head.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW (jaw pain), CHEST PAIN (chest pain) and HEAD DISCOMFORT (severe pressure in his head.) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 026C21A) for COVID-19 vaccination.     no medical history was provided.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], AMLODIPINE and LOSARTAN for an unknown indication.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced PAIN IN JAW (jaw pain) (seriousness criteria hospitalization and medically significant), CHEST PAIN (chest pain) (seriousness criteria hospitalization and medically significant) and HEAD DISCOMFORT (severe pressure in his head.) (seriousness criteria hospitalization and medically significant). The patient was hospitalized until 26-May-2021 due to CHEST PAIN, HEAD DISCOMFORT and PAIN IN JAW. At the time of the report, PAIN IN JAW (jaw pain), CHEST PAIN (chest pain) and HEAD DISCOMFORT (severe pressure in his head.) outcome was unknown.            No treatment medication information was provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of events, a causal relationship cannot be excluded. However, patient's concomitant medication may suggest underlying cardiovascular risk factors that could be confounders. No further information is expected at this time.   This case was linked to MOD-2021-273538 (Patient Link).   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of events, a causal relationship cannot be excluded. However, patient's concomitant medication may suggest underlying cardiovascular risk factors that could be confounders. No further information is expected at this time.
On March 23, I became dizzy and developed hives. I have had hives and uncontrollable itching until now May 13. Hives and itching are finally disappearing.  I was dizzy  during week of March 23 only. I have never had hives or been dizzy after any vaccination  until now. I have not seen a doctor concerning this.  .
Cough, fever, fatigue,headache, stuffy nose. Treated with five days of Paxlovid.  Tested negative at 7 days. Second case of COVID  January 23, 2023 symptoms were worse. Also treated with Paxlovid. Tested negative quickly ( within 5 days) but had a severe residual cough that required steroids, inhalers?.and took more than a month to end. More severe fatigue?just starting to resolve March 21, 2023
Pt  noticed streaking in the arm the vaccine was given the morning after the vaccine. 10/1/23 telemedicine appointment looks bruised, and feels swollen and warm continued. Patient received two antibiotics to treat - sulfamethazole and rifampin.
This spontaneous report was received from medical assistant, concerning a patient of unknown age and gender. On 30-SEP-2014 the patient was vaccinated with (Oka/Merck) VARIVAX, subcutaneous (dose, lot # was unknown) instead of a dose ZOSTAVAX (dose and route was unknown) inadvertently. No adverse effects were reported. No product quality complaint (PQC) was involved. The outcome of the events was unknown. Additional information has been requested.
Approximately 4 hours following my second dose of Moderna, I began to feel ill.  7 hours later, I awoke at night with severe nausea and vomiting that lasted two hours and began again the following morning.  The following day, I experienced chills, fever (102 was the high) and fatigue.  I had a low grade grade fever, chills and fatigue for the following 24 hours.  I felt malaise for an additional three  days.  (symptoms lasted from 2/11 through  2/16).
2 days after receiving vaccines started having sharp, stabbing pain, and bruising in cervix area. Muscles ache and burn also inner thighs. No fever, no vaginal discharge. Still having discomfort 12 days afterwards. No sexually active.
Spontaneous abortion following covid booster. Was not aware at the time I was around 5-6 weeks pregnant. Bleeding started on Dec 14th, spotting continued on and off. Then on the 23rd I became very nauseated. I could not get out of bed or eat or drink all day. My husband discovered me passed out in the bathroom and called an ambulance. Pregnancy/miscarriage was confirmed, proceeded to pass large clots over the following days and bleeding/spotting continued until about 3 weeks from when it began on Dec. 14. 1 prior pregnancy in 2018 with no complications.
On 2/9 I had upper respiratory congestion in the evening. The congestion got worse on 2/10 and was mostly in sinuses.  Tested Positive 2/11 on an At HOME COVID-19 test. Saw Doctor who tested with a PCR COVID-19 test, also positive. Doctor proscribed Paxlovid and an albuterol inhaler. By 2/12 I felt better. By 2/14 I felt recovered.
Adverse Event/Reaction:  Symptoms including time of vaccination and onset time of symptoms:  Felt dizzy shortly after vaccine. Was driven over to the 30' lot. History of high BP. She had taken her BP in the am, BP was normal in the am.   History of allergy to green chiles with throat and tongue swelling   After about 10', she reported that she felt her tongue was swollen, she had minor speech difficulties and intermittent clearing of throat. Different speech pattern.   RRR not tachy, lungs clear, no clear swelling of tongue was observed, but speech pattern changed, and became less clear over time, after benadryl.   Vital Signs:  Time: BP: 201/106 P: 86 regular O2 Sats: 100  Labs/tests done: none  Medications given: Time: 11:42am Medication: Benadryl i.m. 50 mg in RD.    Outcome of the adverse event (if paramedic please list hospital taken to): 10' after benadryl. She reported improvement, however BP remained elevated and voice pattern was still abnormal. Because of the high blood pressure, epi was not provided and ambulance was called. Patient was a hospital patient, and was transported by EMS to Hospital for follow up care.  Per ED note- The patient has had resolved symptoms and is in no respiratory distress with stable vital signs. Hypertension has improved. The patient is going to be discharged with primary care physician follow-up. She has been given return precautions for any new or worsening symptoms.
I was having a little lightheadedness for about a week and a half probably started about December 8th or 9th, 2022. I have a blood pressure cuff at home and took it since I wasn't feeling well. It was 160/104. I made an appointment with doctor. I spoke with my doctor December 20th, 2022 who prescribed me a NORVASC. I took the first day and then on December 22nd, 2022.
Patient developed hives/redness on her arms after receiving her fist dose of COVID-19 vaccine.  Patient was given 25 mg of diphenhydramine po, and released home after extended observation period in the Vaccine Clinic.
Information has been received from a pharmacist concerning a female inpatient at his hospital who was given a dose of PNEUMOVAX 23 intravenously over the weekend and developed an injection site reaction. The patient was already an in-patient at the hospital when she was given the dose. The reaction did not prolonged her hospital stay and the patient had already been discharged. It was not known if the patient had received PNEUMOVAX 23 previously. The pharmacist did not have any details because he heard the information second-hand. The patient sought medical attention. No further information is available.
Maternal exposure during pregnancy, third trimester; Baby born with spinal cord tethering due to a lipomeningioma of sacrum.; Baby born with spinal cord tethering due to a lipomeningioma of sacrum; Booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the parent.  A neonate patient was exposed to bnt162b2 (BNT162B2), transplacental, administration date 23Oct2021 (Lot number: FF2588) as dose 3 (booster), single for covid-19 immunisation. The mother of the patient was 33 years old at the time of vaccination. The mother's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The mother was 36 weeks pregnant at the event onset. The mother's concomitant medications were not reported. The mother's past drug history included: Aspirin, reaction(s): "Known allergies: Aspirin", notes: Known allergies: Aspirin. The mother's vaccination history included: Bnt162b2 (Dose number: 1, Product: COVID 19, Brand: Pfizer, Lot number: El1284, vaccine location: Left arm), administration date: 10Jan2021, for COVID-19 Immunization; Bnt162b2 (Dose number: 2, Product: COVID 19, rand: Pfizer, Lot number: El 3247), administration date: 02Feb2021, for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset 23Oct2021, outcome "unknown", described as "Booster"; MATERNAL EXPOSURE DURING PREGNANCY (medically significant), outcome "unknown", described as "Maternal exposure during pregnancy, third trimester"; SPINAL MENINGIOMA BENIGN (congenital anomaly, medically significant) with onset 22Nov2021, outcome "not recovered", described as "Baby born with spinal cord tethering due to a lipomeningioma of sacrum."; SPINAL CORD INJURY (congenital anomaly) with onset 22Nov2021, outcome "not recovered", described as "Baby born with spinal cord tethering due to a lipomeningioma of sacrum".  Follow up information has been requested.; Sender's Comments: As per available information, the causal association between the event immunisation, MEDP, spinal meningioma benign and spinal cord injury and the suspect drug BNT162B2 cannot be excluded. 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : PFIZER INC-202101723580 Mother/baby case
I started feeling like I was having worse than usual asthma symptoms a week after my first dose. I would take albuterol but it did nothing to help. For the following 5 months I experienced pretty much constant fatigue, being easily winded, varying degrees of chest pain, fever if overly exerted, difficulty breathing, and elevated heart rate with no cause. After stopping all physical activity to try and recover, about 4 months after the first symptoms, I started to feel improvement. It has now been 11 months and the symptoms ebb and flow, worsened significantly for a bit after having covid, and again after catching a cold that was not covid. Though in that time I have been able to get back to some physical normalcy, I have definitely never been back to my old self. I still need to significantly reduce physical activity, am easily winded, experience high heart rate, and take much longer than I used to to recover from physical activity. All of the testing I got did not come back with anything to suggest what was happening. I would guess that that was the case because I wasn't able to get any heart scans until 5 months after the fact, when I had started to improve and was very well rested.
Physician recommended a lower than authorized dose of the Moderna Bivalent booster dose for an immunocompromised patient; No Adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Physician recommended a lower than authorized dose of the Moderna Bivalent booster dose for an immunocompromised patient) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Physician recommended a lower than authorized dose of the Moderna Bivalent booster dose for an immunocompromised patient) and NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Physician recommended a lower than authorized dose of the Moderna Bivalent booster dose for an immunocompromised patient) 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 ACCIDENTAL UNDERDOSE (Physician recommended a lower than authorized dose of the Moderna Bivalent booster dose for an immunocompromised patient).    Concomitant product use was not provided by the reporter.  A pharmacist reported about a patient whose physician recommended that the patient receive a lower/a lower than authorized dose of Moderna COVID-19 bivalent booster dose because the patient was immunocompromised.  Treatment information was not provided.   Reporter did not allow further contact
I contracted COVID19 1/10/2022 with symptoms of runny nose, congestion, sore throat. I was sick for about 4 days.
RN stat called for patient due to near syncopal episode after receiving the 1st dose of the Pfizer vaccine. With in 3 minutes of receiving vaccine at 1:28pm, patient became pale, diaphoretic, drowsy, ammonia used but patient did not loose consciousness. Ice pack placed to her neck, fan facing patient, legs elevated on chair and vitals assessed. BP checked and low. Patient became nauseous but no vomiting. Mother remained with patient. Patient rested, vitals repeated and stable, Dr.  cleared for discharge home.
Pt recv vax in 1/98; four day later pt exp alopecia; pt to dermatologist
Rash on arm- big red swollen itchy patch that started the day of the shot and has lasted almost two weeks
PFIZER COVID-19 EUA: fully vaccinated individual stated that she had allergy-like symptoms on 072721 that were not abnormal to her. She was at work on 072821, and by the end of the workday, she felt "abnormally cold and like she was abnormally crashing". She went to an outside clinic and tested + for covid-19.
This spontaneous report as received from a healthcare worker (who was also an office manager) via company representative refers to an unspecified patient of unknown age and gender. The healthcare worker heard from a friend that on an unknown date, the patient was vaccinated with a dose of GARDASIL, injection (lot#, expiration date, dose, strength and route not reported). The an unspecified patient experienced a seizure, on an unspecified date, after receipt of GARDASIL. The patient was not a patient of the office manager's facility. The outcome of seizure was unknown. It was unspecified if the patient sought medical attention. Upon internal review, seizure was considered to be medically significant. Additional information has been requested.
Chills; Severe Headache; Extreme fatigue and it lasted 36 hours.
Pt had flu shot 10/29/08 at 8:30AM, by 12:30pm she developed symptoms of headache, muscle aches, fever (101 6/0), fatigue.
very high fevers, hives, erratic behavior, black sunken eyes, red periorbital area, red face, then diarrhea x 1 week and 2 days
pt recvd vax & w/in 1wk p/vax exp a rash on both arms & back consisting of tiny raised bumps which were not itchy;they were blotchy on back;addl w/in the 1st wk p/vax;fatigue & stiff neck;seen by a dermatologist poss viral infect
Little growth around injection site; Injection site is red; Injection site is hard; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Little growth around injection site), VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE INDURATION (Injection site is hard) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012220A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-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 VACCINATION SITE MASS (Little growth around injection site), VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE INDURATION (Injection site is hard). At the time of the report, VACCINATION SITE MASS (Little growth around injection site), VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE INDURATION (Injection site is hard) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment for the events has been taken to alleviate it.    Reporter did not allow further contact
PATIENT FAINTED DURING IMMUNIZATION, NO TREATMENT, PATIENT WOKE UP IN 2 MINUTES AND REFUSED EPI-PEN AND AMBULANCE SERVICE
upset stomach/nausea, slight temp (more than 1 degree) headache, very tired, diarrhea, sore arm
Information was received on 27-JUN-2017 from a medical assistant via a company representative concerning a 4 month old female patient. The patient does not have any relevant medical history. Concomitant medications included PEDIARIX vaccine and the PREVNAR 13 vaccine (dates received not reported). The medical assistant reported that this 4 month old female was given GARDASIL 9 once, on 27-JUN-2017 for no indication. On 27-JUN-2017, the person administering the vaccine accidentally grabbed the wrong vial and administered GARDASIL 9 (lot M028323, expiration 26-SEP-2018) (dose, route and injection site not reported) to the 4 month old patient. The patient's relative laboratory data are unknown. As of 27-JUN-2017, the patient was given one dose of GARDASIL 9 and the outcome of receiving the GARDASIL 9 is unknown. No other information was reported. Additional information has been requested.
Fever, vomiting. Onset 12 hours after injection. Resolved within approximately 48 hours. Missed school.
severe pain in the arm where the patient received the injection; "red spot" at the site of injection; unable to move that arm; This spontaneous report as received from a pharmacist refers to a 68 year old male patient. The patient's concurrent conditions and medical history were not reported. The patient did not have any allergies. Concomitant therapies included atorvastatin, donepezil, meloxicam, icosapent ethyl (VASCEPA), meclizine, olmesartan medoxomil and pantoprazole.    On 04-FEB-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) intramuscular injection (lot # S024808 and expiration date: 02-JUN-2021; dose and frequency not reported) as prophylaxis.     Later on the same day, the patient developed severe pain in the arm where he received the injection (injection site pain) and he developed a "red spot" at the site of the injection (injection site erythema). Due to the severe pain, the patient was unable to move that arm (injected limb mobility decreased). The patient went to see a physician and received acetaminophen (TYLENOL) as treatment. The outcome of the events was reported as not recovered.   The reporter considered the events injection site pain, injected limb mobility decreased and injection site erythema to be serious due to disability.
Patient received second dose of Moderna and had an itchy mouth/jaw area for about five minutes until it subsided
ED to Hosp-Admission Discharged  8/27/2021 - 9/1/2021 (5 days) Hospital  Patient presents with ? Shortness of Breath ? Generalized Body Aches     1. COVID-19 viral infection?patient has been having diarrhea, generalized body aches fever and cough.  He is tested positive for COVID-19.  He was actually vaccinated 2 months ago.  Patient's oxygen saturation is fairly normal.  Patient will be admitted and given IV dexamethasone secondary to dyspnea.  He does not need to remdesivir or convalescent plasma at the moment.  His x-ray is somewhat atypical and that he has left basilar infiltrate.  However his procalcitonin level is also quite low.  We will hold off on antibiotics for now. 2. Diabetes mellitus type 2?continue with insulin protocol. 3. BPH?continue with tamsulosin and finasteride. 4. COPD?patient has a significant wheezes.  There is likely been exacerbated by his COVID-19 infection.  He will be on steroids.
Pt received vaccination at school three days later seen in ER with erythema/induration on the right thigh. Prescribed with Keflex. Follow-up on 10/15/2001. 8.5cm x 4.5cm faint erythema with induration.
received the Flublok vaccine subcutaneously instead of in the muscle, no adverse event; improper needle size, 25g 5/8th inches/ no adverse event; Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from an other health professional.  This case is linked to case 2019SA307015.  This case involves a male patient who received the INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV]subcutaneously instead of in the muscle (Incorrect route of product administration) (lot QFAA1910, Exp.date- 26-May-2020) via subcutaneous route in the deltoid nos on 30-Oct-2019  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapies were given.   It was a case of actual medication error due to Incorrect route of product administration and also a case of improper needle size, 25g 5/8th inches (Incorrect needle gauge used).  No symptoms reported following vaccination.  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.  Outcome was not applicable for the events.  No further information was reported.
Symptom Duration/Timing:  Since date: 03/31/2003 (11 days s/p Anthrax Vaccine #6);Approximate Time of onset 0430 hr : Symptom Location: Bil Ear Describe: Dizziness, tinnitus and bil ear pain Symptom Quality/Severity: Quality: dull ache  Severity: Pain 2/10; dizziness 9-10/10 Associated Signs and Symptoms: Bil ear pain, dizziness and tinnitus Modifying factors:   Exacerbating: None   Mitigating:  None  Prior Similar Symptoms: None