chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have been having adverse reaction starting 5 hours after I received the injection and it continues to date:  3/3/21  5:30pm injection  10:30pm right arm from elbow to shoulder is spasming like crazy and does not stop until 2:30am. Left hamstring is excruciating pain. 3/4/21 until 3/7/21: Severe spasms on left side of my mid back and spasms all over body and face. Left hamstring still hurting severely.  Spasms and left hamstring hurting every day. I have to take Tylenol to keep the pain tolerable.  3/8/21 - 3/12/21:  Spasms throughout body and face continues but left hamstring stopped hurting. Now right Trapezious and Romboid killing me.  One day 1 was really dizzy for a short time but it passed. 3/13/21 - 3/18/21 - Spasms throughout body and face continue but right Trapezious and Romboid settle down. Now left mid back killing me. 3/18/21 - 3/21/21 - Spasms throughout the body and face continue. Now both calf muscles are very ichy.  Mid back pain has calmed down.  3/21/21 - 4/4/21 - Spasms throughough the body continues and has not stopped. My body is spasming day and night every day.
had took three shots, a booster and all for COVID-19 and is positive for COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (had took three shots, a booster and all for COVID-19 and is positive for COVID-19) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A, 002B21A and 013A21A) for COVID-19 prophylaxis.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) tablet for COVID-19.    No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) 3 dosage form twice a day. In July 2022, the patient experienced COVID-19 (had took three shots, a booster and all for COVID-19 and is positive for COVID-19). At the time of the report, COVID-19 (had took three shots, a booster and all for COVID-19 and is positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         The ethnicity was reported. No concomitant medications were reported. No treatment medications were reported.  Company comment: This spontaneous case concerns 80 years old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI of COVID-19 that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since event onset was not disclosed. On an unknown date, SARS-CoV-2 test was Positive. It was reported that patient received co-suspect NIRMATRELVIR, RITONAVIR (PAXLOVID) on unknown date. No further details on clinical course, other lab test results and treatment received were reported. The outcome of the event was reported as unknown. Current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns 80 years old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI of COVID-19 that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since event onset was not disclosed. On an unknown date, SARS-CoV-2 test was Positive. It was reported that patient received co-suspect NIRMATRELVIR, RITONAVIR (PAXLOVID) on unknown date. No further details on clinical course, other lab test results and treatment received were reported. The outcome of the event was reported as unknown. Current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
pt exp malaise/weakness temp r/t vax;also exp photophobia 1 day prior to adm;on day of adm pt became lightheaded & fell;proximal muscle weakness noted on PE;MRI of spine revealed compression of C3-4-GBS r/o;allergist felt rxn not d/t vax;
This spontaneous report was received from a nurse refers to 01-year-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 27-SEP-2017, the patient was vaccinated with improperly stored VAQTA lot # N008823, expiry date: 26-MAY-2018, and M-M-R II lot # M045392, expiry date: 17-NOV-2018; dosing details were not reported, both for prophylaxis. The lot# of M-M-R II was reconstituted with properly stored sterile diluent (MRK). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054.
After approx 28 hrs from vaccination, the lymph nodes in the right axillary area has become edematous and painful.  Pain and soreness at the injection site (Rt deltiod) approx 19 hrs after injection.
pharmacist administered Fluzone High-Dose, to a patient who had already received the vaccine with no reported adverse event; Initial information received on 24-Oct-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 65 years old female patient and pharmacist administered Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent], to the patient who had already received the vaccine 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 Elasomeran (Spikevax) for Prophylactic vaccination.  On 18-Oct-2023, the patient received 0.7 ml  of suspect Influenza Quadrival A-B High Dose Hv Vaccine (with an unknown formulation, expiry date and lot number) (Strength: Standard, Frequency: once) via intramuscular route in unknown administration site (UTR: abbreviation not possible) for prophylactic vaccination (Immunisation). On 23-Oct-2023 she also received same dose of the same vaccine .  On 23-Oct-2023, the pharmacist administered Influenza Quadrival A-B High Dose Hv Vaccine, to a patient who had already received the vaccine with no reported adverse event (extra dose administered) (latency: 5 days).  It was reported, Supervisor reporting that another pharmacist administered Fluzone High-Dose, to a patient who had already received the vaccine. This situation is reported as a medication error due to administering 2 Fluzone HD vaccines in a period of 5 days. The caller states that the patient had his first influenza Fluzone High-Dose on 18Oct2023 and then again on 23Oct2023. Caller is also inquiring if they should look for double the potential side effects.    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.
RASH - NO TX YET INJECTION SITE SWELLING AT 10 POST INJECTION
Tinnitus in both ears; Have odd sensations in the top and back of our head; 24/7 tinnitus is driving us downright mad; Odd sensations in the top and back of our head; This is a spontaneous report received a contactable consumer. This consumer reported similar events for two patients with the same product; this case is the second of two. A male of unspecified age received the first dose of BNT162b2 (solution for injection; batch/lot and expiry information not provided) as a single dose via an unspecified route on an unspecified date in Mar2021 for COVID-19 immunisation. There was no medical history, concomitant or past drug history reported. The consumer reported that about fifteen minutes or so after receiving the first dose of the Pfizer COVID vaccine the patient experienced new onset tinnitus in both ears. The consumer stated that the patent is also experiencing odd sensations in the top and back of his head. The cosumer exclaimed that the 24/7 tinnitus is driving him downright mad. The consumer reported the her and her husband received the second dose even though he is still experiencing side effects because he wanted to do his part and get vaccinated. The outcome of the events tinnitus in both ears, and odd sensations on the top and back of his head, was not recovered. The outcome of the event 24/7 tinnitus is driving him downright mad was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) :  PFIZER (Same reporter/product, similar event in different patient)
COVID Vaccine Breakthrough Case  J&J Dose 2/2/21 (1855194) COVID Positive 12/15/21  12/15/21: 58-year-old male with no past medical history except he has a chronic smoker.  He presented to the emergency room this morning complaining of worsening SOB and associated cough of 5 days duration.  He also complained of fever, nausea, occasional vomiting, generalized weakness and some myalgia.  Patient received 1 dose of Johnson and Johnson COVID vaccine on 12/02/2021. At the emergency room he was quite febrile with a temperature of 104.2° F and hypoxic currently requiring 3-4 L of oxygen with O2 saturation of 100% but on room air saturation is 88%.  Other vitals are normal.  The laboratory test is significant for mild hyponatremia with Na 132 and D-dimer of 0.77.  CT angiogram of the chest revealed no PE in the proximal vessels, mediastinal, bilateral hilar adenopathy and bilateral infiltrates right greater than left.  12/18/21: 58-year-old man who presented worsening shortness of breath, cough for 5 days duration.  In the emergency department he was noted to be febrile and hypoxic on room air, COVID-19 rapid antigen and PCR was subsequently positive.  Chest x-ray   And CT pulmonary angiogram demonstrated bilateral viral pneumonitis and ruled out pulmonary embolism.  was admitted to the hospitalist service where was started on anti-inflammatory agents, parenteral steroids and remdesivir with good effect.  Clinical response was favorable with resolution of hypoxia, improvement in shortness of breath and cough.  He has been successfully weaned to room air will be discharged today in stable medical condition to continue outpatient follow-up.
Patient received vaccine on 11/01/11 and had typical muscle soreness, which was resolved after 2 or 3 days.  The pain then came back on 11/10/11.  Pt reports muscle stiffness and pain in the same area as before.  Pt reports that pain is relieved by ibuprofen.  Pt reported having a cold a few days after vaccination that has since resolved.
Not sure if this was a reaction to vaccine or not?  3/4/2021 when I woke up to get out of bed, upon standing, I got a severe feeling of dizziness or vertigo that resulted in my legs giving out and me falling down.  I didn't get hurt but it felt like I almost passed out.  I fell backwards against a wall and slid down. I did not report this to my doctor previously listed.
REDNESS, ITCHING, SWELLING, WARM TO TOUCH, MILD FEVERS, TENDERNESS AND PAIN AT INJECTION SITE.
I was conducting a vaccine clinic at a local school. The patient was unhappy and apprehensive about getting the vaccine when she arrived. Patient finally agreed to get the vaccine and after I administered the vaccine she said she did not feel well and slumped over slightly. Her mother was by her side supporting her and talking her through it. She then put her head back and  was breathing heavily. She seemed to go in and out of consciousness initially. After a few seconds, she appeared a little dazed but alert within approximately 40 to 60 seconds. My technician got her a drink of water and  I offered to call 911 but patient's mother did not think it was necessary. Patient went back to her mother's office instead of going back to the classroom. We checked on the patient at the end of the clinic and she had gone home to rest. The clinic coordinator was asked to notify us if there was any additional concerns.
diarrhea; gas; severe abdominal cramping; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (severe abdominal cramping), DIARRHOEA (diarrhea) and FLATULENCE (gas) 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.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced ABDOMINAL PAIN (severe abdominal cramping). On an unknown date, the patient experienced DIARRHOEA (diarrhea) and FLATULENCE (gas). At the time of the report, ABDOMINAL PAIN (severe abdominal cramping), DIARRHOEA (diarrhea) and FLATULENCE (gas) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  The patient reported severe abdominal cramping, diarrhea and gas with grains and dairy. No information regarding corrective treatment was reported by the patient.
rash about 3 inches in diameter around injection site.  advised to use antihistamines (Claritin/Zyrtec/allegra) and hydrocortisone cream if needed.  they had Benadryl cream at home that the used.  also advised to remove bandaid in case that was precipitating rash.  son checked in with me later in the day to say the rash was resolving with no further issues
OCULAR HERPES; STROKE; shingles; Information has been received from a lawyer concerning a case in litigation and refers to a 67-year-old female patient. No information regarding the pt's medical history, concurrent conditions and concomitant medications was reported. On 30-JAN-2012, the pt was administered with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, vaccination site, lot # and expiry date were not specified) at the physician office for the long-term prevention of shingles and zoster-related conditions. On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider for injuries resulting from zoster vaccine live (ZOSTAVAX) use: ocular herpes and a stroke. As a result pf her receipt of zoster vaccine live (ZOSTAVAX), the pt was caused to suffer shingles in or about October 2012, including and all of it sequelae. As a result of her receipt of zoster vaccine live (ZOSTAVAX) , the pt has been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a direct and proximate result of zoster vaccine live (ZOSTAVAX)'s manufacturing defect, the pt suffered severe and permanent physical injuries, including but not limited to shingles, as well as other severe and permanent health consequences. The pt has endured substantial pain and suffering. The pt has incurred significant expenses for medical care and treatment, and will continue to incur such expenses in the future. The pt has lost past earnings and has suffered a loss of earning capacity. The pt  has suffered and would continue to suffer economic loss, and has otherwise been physically, emotionally and economically injured. The pt's injuries and damages ware permanent and would continue into the future.  The pt sought actual and punitive damages from the Company as alleged herein. the pt demanded judgment against Company for compensatory, treble, and punitive damages, together with interest, costs of suit, attorneys' fees, and all such other relief as the Court deems proper. The outcome of shingles was reported as not recovered. The outcome of ocular herpes and stroke was unknown. The causality was related.  The event of shingles was considered to be disabling. Upon internal review, the events of ocular herpes and stroke were determined to be medically significant.
weakness; chills; body ache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), CHILLS (chills) and PAIN (body ache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced ASTHENIA (weakness), CHILLS (chills) and PAIN (body ache). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, ASTHENIA (weakness), CHILLS (chills) and PAIN (body ache) was resolving.            No relevant concomitant medications were reported.  Action taken with mRNA-1273 in response to the events was not reported.
felt sick; Received second dose that had improper storage; dizzy/light headed; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (felt sick), PRODUCT STORAGE ERROR (Received second dose that had improper storage) and DIZZINESS (dizzy/light headed) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (felt sick), PRODUCT STORAGE ERROR (Received second dose that had improper storage) and DIZZINESS (dizzy/light headed). At the time of the report, VACCINATION COMPLICATION (felt sick), PRODUCT STORAGE ERROR (Received second dose that had improper storage) and DIZZINESS (dizzy/light headed) had resolved.            No treatment information was provided by the reporter. No Concomitant medicines were reported.
Flu-like symptoms, shakes/chills, hypertension, slow to respond to questions.
started severe nausea, 15 minutes, ice cold, shaking, chills, lasted 30 minutes, felt Shortness of breath,  arm pain, tachycardia, 1 hour total before felt better.  Overnight had night sweats, fever, fatigued, no wheezing, no meds taken by the morning felt back to normal.
The following day at work, about 15 hours following the vaccine began experiencing a global itching sensation on the skin.  Started at the breast area and migrated down to the belly, groin, buttocks, thighs over the next 7+ days.  On 12/31/21 a rash appeared on the chest directly below the neck area between the breasts.  The rash was itchy, no fluid was seeping from  it, and it was raised above the skin with little bumps. Self-treatment with benedryl, hydrating creams, and hydrocortisone cream without success.  Self-treatment was due to the doctor's office closed for the holidays.
pt had fever of 101.0 & a rash;rash covered face, inc extremities, abd & trunk area;sx appeared morning of 4MAY;parent took pt to regular MD;no tx other than APAP prescribed;dx MMR rxn;
Vaccine administered at 3 p.m., hives started showing up that evening.  Remained the same over the next 24 hours, worsened 48 hours later to cover entire trunk, face, and neck.  No improvement noted 10 days later.
Approximately 8 hours after receiving vaccine, patient complained of feeling very tired and weak with joint pain in all four extremities (L>R).  Pain had resolved in all extremities except left arm within 5 days.
2nd Pfizer vaccine was given on Thursday Jan. 7th around 1240pm.  That evening I experienced expected muscle aches, chills, headache, fatigue. The next evening, Jan 8th I experienced chest pain which felt like heartburn or gastritis (which I do not typically have)  in addition to the muscle aches, chills and headache returning. The morning of Jan 9th I woke up with a swollen face in addition to ongoing body aches, fatigue and headache and took 50mg of Benadryl and  went to urgent care for evaluation.
Patient broke out in rash on face, trunk and arms. Medicated with BENADRYL (5mL) and ORAPRED (5mL). Rash resolving. Patient referred to Allergy and Asthma for evaluation.
she had rash on the arm where she got the shot and the other arm as well/rash/Week after I got it; I broke out with rash; burning skin feeling; itching; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm on 26Jul2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date in 2021 for COVID-19 immunisation. The patient stated that a week after getting the second shot (Aug2021), she had a rash on the arm where she got the shot and the other arm as well. At first it had a burning skin feeling and was itching and was nothing serious. When she took Benadryl, those went away but the rash was still there. She said she never got rashes prior to receiving the vaccine. She asked how long this would last. She wanted to know if anybody have any idea how long will the rash last or what she can do about it. She is taking Benadryl and it is not itching or burning but it was still there. The outcome of the event rash was not recovered while the outcome of the rest of the events was recovered on an unspecified date. The reporter assessed the events as non-serious.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Began having fluttering, fast beating of my heart within a few days of injection. Finally went to Doctor as symptoms were not getting better. They are in the process of running tests. They performed an EKG in office, at that time the fluttering had stopped, the EKG was normal. The fluttering continues to come and go.
Approximately 20-30 minutes after receiving the vaccine, my tongue had minor swelling. The swelling sensation lasted for approximately and hour. My breathing and ability to swallow was not effected.
sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 28th December 2021, the patient received the 2nd dose of Shingles vaccine. In December 2021, less than a week after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had Shingles dose the day before reporting and feel fine but sore arm. The patient asked for exercise and to do normal pushups, light weights, long walk. It had been about 18 hours. The follow-up would not possible as no contact details were available.