chrisvoncsefalvay/vaers-outcomes huggingface dataset:
prednisone worsened her symptoms; Hearing loss; manstasis; Tinnitus; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of METASTASIS (Metastasis), DEAFNESS (Hearing loss), TINNITUS (Tinnitus), VOMITING (Vomiting), and CONDITION AGGRAVATED (prednisone worsened her symptoms) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.    Co-suspect product included non-company product PREDNISONE for an unknown indication.    No medical history reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started PREDNISONE (unknown route) 40 mg once a day. On 25JAN2021 and she was experiencing hearing loss, tinnitus, menstasis, and vomiting. During the time when her symptoms started happening, she had no idea what was going on. Patient has through three emergency room visits and two hospitalizations because of her symptoms. Her doctor prescribed her medications to treat her vomiting. She reported that prednisone worsened her symptoms.On 26-Jan-2021, the patient experienced ILL-DEFINED DISORDER (Manstasis) (seriousness criteria hospitalization and medically significant), DEAFNESS (Hearing loss) (seriousness criteria hospitalization and medically significant), TINNITUS (Tinnitus) (seriousness criterion hospitalization), and VOMITING (Vomiting) (seriousness criterion hospitalization). On an unknown date, the patient experienced CONDITION AGGRAVATED (prednisone worsened her symptoms) (seriousness criterion hospitalization). The patient was treated with MECLIZINE [MECLOZINE] for Adverse event, at a dose of 1 dosage form; ONDANSETRON (ZOFRAN [ONDANSETRON]) for Adverse event, at a dose of 1 dosage form; METOCLOPRAMIDE (REGLAN [METOCLOPRAMIDE]) for Adverse event, at a dose of 1 dosage form; PROMETHAZINE (PHENERGAN [PROMETHAZINE]) for Adverse event, at a dose of 1 dosage form; LORAZEPAM (ATIVAN) for Adverse event, at a dose of 1 dosage form; Physical therapy for Metastasis; Physical therapy for Deafness; Physical therapy for Tinnitus and Physical therapy (Therapy helping her with her balance) for Vestibular neuronitis. At the time of the report, ILL-DEFINED DISORDER (Manstasis), DEAFNESS (Hearing loss), TINNITUS (Tinnitus), VOMITING (Vomiting), and CONDITION AGGRAVATED (prednisone worsened her symptoms) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient had through three emergency room visits and two hospitalizations because of her symptoms. The patient stopped taking Ativan because she heard the medication can worsen her symptoms.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start  date of the events, a causal relationship cannot be excluded. Further information has been requested. Patient medical history may provide alterative justification for the vents occurrence.
After getting the injection I felt tingling in my mouth and a jolt of energy/ felt like my heart was racing. This subsided after a minute or so. I went home and rested all day. The next day I woke up with a sore throat. The following day I had a bad sinus headache with dizziness  and my sore throat got worse. The third day my headache and sore throat continued so I made a tele health appt. because I thought I had a sinus infection. Got prescribed antibiotics.  The headache persisted but the sore throat went  away.  I got COVID antigen tested at work on9/6  and it was negative . lost my taste and smell 9/8 and 9/9. I was then again antigen tested and pcr tested and my results were negative. headache has not gone away and it?s been 9 days since vaccinated.
Immediate reactions. A few hours after the vaccine I could not lift my arm from the pain.  Injection site red, hot and very sore.  Next day light headed, nauseous and vomiting.  Body aches.  Five days later I could lift my arm but sore and now have hard lumps (3).  I am extremely itchy especially on my right side and my scalp near my neck, my neck and shoulder.  The itching is sharp pain and irritated skin.  The sharp itching pain wakes me two to three times while I'm trying to sleep.  I can't sleep well at all.  I also have a severe stabbing pain at injection site at random times.  I'm very tired and not feeling good at all.  I called my primary care Dr office and they were not interested in speaking to me about this since they did not administer the vaccine.  They told me to go to the pharmacy where I received the vaccination.
Red splotches on my chest back and legs that still persist today (November 18. the splotches are not painful nor do they itch. Splotches are smooth to the touch
Moderna vaccine dose leaked from syringe-patient didn't get entire dose; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (Moderna vaccine dose leaked from syringe-patient didn't get entire dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced UNDERDOSE (Moderna vaccine dose leaked from syringe-patient didn't get entire dose). At the time of the report, UNDERDOSE (Moderna vaccine dose leaked from syringe-patient didn't get entire dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. The treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: Follow up received on 7-APR-2021 and contains Non significant information. On 08-Apr-2021: Follow up received on 8-APR-2021 and contains non significant information.; Reporter's Comments: This report refers to a case of underdose, for mRNA-1273, lot # unknown, with no associated AEs.
Pt. came in for her yearly influenza vaccine and on review of screening questions mentioned she had a reaction localized to her left arm last year after receiving the flu vaccine which was given at the clinic. Pt. noticed the redness, swelling, tenderness the next morning on 10/9/14 but did not report it or have it evaluated or treated. Pt. reports it lasted about 1 week and went away on its own. Pt. took a picture of the reaction with her phone and was able to show me the reaction.
Patient got shot 8/29, 8/30 arm was very warm to touch and started to bruise. It isn't as sore today 9/2 and bruise has gone down patient said. patient stopped in and reported today 9/2/14.
Started coughing and horse voice 30 minutes after vaccination, taken to emergency room in severe respiratory failure due to anaphylactic shock from flu vaccine.
Post vax, the pt developed pain and soreness of arm. On exam, the arm revealed swelling and bruising with tenderness and decreased mobility. Due to the persistence of discomfort, bruising, and warmth with swelling, antibiotics were given with full resolution.
Patient called today and stated that she developed a rash on her chest  that reminded her of the chickenpox.  She stated that it appeared on the 9th or 10th of this month.  It does not itch but is slightly tender.  It has not gotten and worse or better since then.
gums bleed; Top and bottoms gums swelled; blisters; Oral lessons started about 6 weeks after vaccination; This spontaneous case was reported by an other health care professional and describes the occurrence of GINGIVAL BLEEDING (gums bleed) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced ORAL DISORDER (Oral lessons started about 6 weeks after vaccination). On an unknown date, the patient experienced GINGIVAL BLEEDING (gums bleed) (seriousness criterion medically significant), GINGIVAL SWELLING (Top and bottoms gums swelled) and BLISTER (blisters). At the time of the report, GINGIVAL BLEEDING (gums bleed), GINGIVAL SWELLING (Top and bottoms gums swelled), ORAL DISORDER (Oral lessons started about 6 weeks after vaccination) and BLISTER (blisters) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took blood pressure medications as concomitant medication. No treatment information was provided by the reporter.  Company comment This case concerns a 77-year-old female subject who experienced the serious events of gingival bleeding, and non-serious events of gingival swelling, oral disorder, blisters, and scratches . The events occurred approximately 2 months 2 weeks after the first dose, and 1 month 2 weeks  after the second dose of Spikevax. The rechallenge was not applicable as the patient had already completed the 2 recommended doses of the vaccine. Causality was not provided by the reporter. The benefit-risk relationship of the vaccine is not affected by this report. Based on medical review of the available data, the case has been assessed as non-serious.   This case was linked to MOD-2021-319711 (Patient Link).; Sender's Comments: This case concerns a 77-year-old female subject who experienced the serious events of gingival bleeding, and non-serious events of gingival swelling, oral disorder, blisters, and scratches . The events occurred approximately 2 months 2 weeks after the first dose, and 1 month 2 weeks  after the second dose of Spikevax. The rechallenge was not applicable as the patient had already completed the 2 recommended doses of the vaccine. Causality was not provided by the reporter. The benefit-risk relationship of the vaccine is not affected by this report. Based on medical review of the available data, the case has been assessed as non-serious.
dry cough and throat; Post nasal drainage; She has had trouble of falling; dry cough and throat; Interstitial lung disease; broken hip; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4446716-00.  An 85-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HIP FRACTURE (medically significant) with onset 2022, outcome "recovering", described as "broken hip"; INTERSTITIAL LUNG DISEASE (medically significant), outcome "not recovered"; DRY THROAT (medically significant), outcome "recovering", UPPER-AIRWAY COUGH SYNDROME (medically significant), outcome "unknown" and all described as "Post nasal drainage"; FALL (medically significant), outcome "recovering", described as "She has had trouble of falling"; COUGH (non-serious), outcome "unknown", described as "dry cough and throat". The action taken for adalimumab was unknown.  clinical information:On unknown dates, the patient experienced interstitial lung disease, joint pain, dry throat, falling and postnasal drainage. In 2022, the patient experienced broken hip, Pfizer BioNTech COVID-19 Vaccine (Tozinameran) was also considered suspect. The patient had dry cough and throat due to Postnasal drainage. Rheumatoid arthritis has impacted her Interstitial lung disease. She had trouble of falling and broken her hip over five to six months ago. The last booster caused nausea and joint pain. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's assessment of the causal relationship of "interstitial lung disease", "broken hip", "dry cough and throat", "post nasal drainage" and "she has had trouble of falling" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely 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.
Woke up the first night  with body aches and fever. The next day felt nauseous with vomiting and body aches. Day 3 still had some body aches. Day 4 the pt returned to feeling normal.
Started to feel itchy all over. Welts and hives began to surface anywhere I would itch.  Used benedryl,  Allegra , and steroid cream. Lasted for 1.5 weeks and would only calm down with antihistamines.
Wheezing, coughing, trouble breathing, swelling of the lips and tongue, numbness of the lips and tongue
dizzy; could not walk without holding to an object; felt the need to relax and little tired; headachy; muscle aches; chills; little tired; patient received third shot within minutes of receiving second shot; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), GAIT DISTURBANCE (could not walk without holding to an object), RESTLESSNESS (felt the need to relax and little tired), ACCIDENTAL OVERDOSE (patient received third shot within minutes of receiving second shot) and HEADACHE (headachy) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included APIXABAN (ELIQUIS), CARVEDILOL and ROSUVASTATIN for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced ACCIDENTAL OVERDOSE (patient received third shot within minutes of receiving second shot). On an unknown date, the patient experienced DIZZINESS (dizzy), GAIT DISTURBANCE (could not walk without holding to an object), RESTLESSNESS (felt the need to relax and little tired), HEADACHE (headachy), MYALGIA (muscle aches), CHILLS (chills) and FATIGUE (little tired). On 26-Feb-2021, ACCIDENTAL OVERDOSE (patient received third shot within minutes of receiving second shot) had resolved. At the time of the report, DIZZINESS (dizzy), GAIT DISTURBANCE (could not walk without holding to an object), RESTLESSNESS (felt the need to relax and little tired), HEADACHE (headachy), MYALGIA (muscle aches) and CHILLS (chills) was resolving and FATIGUE (little tired) outcome was unknown.            No treatment medication was reported by patient.  Within a few minutes of receiving second shot, patient received a third shot of the Moderna vaccine. Patient said this was a confusion made by the nurse. Right away, he didn't experience any symptoms. However, when his night shift started, patient felt headachy, dizzy, had muscle aches, chills, could not walk without holding to an object, and felt the need to relax. His shift ended at 7 o'clock in the morning, and when he went to bed and woke up around noon, he felt much better. Patient felt a little tired, but nothing compared to what he experienced before.
VOMITED FOR ABOUT 8 HOURS; A VERY HIGH FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced vomited for about 8 hours, and a very high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomited for about 8 hours, and a very high fever. This report was non-serious.
Pt presented today for a flu immunization. She is accompanied by her mother and two younger brothers. All three received the Fluzone quadrivalent vaccine (NDC 49281-0633-15; LOT: UJ457AA; EXP: 6/30/21) provided by the program. She was seated.   Four minutes after administration pt stated "I don't feel good" and became unconscious. She then began seizing w/posturing and convulsions. RN was in the rm, called for assistance, and began seizure management. MD came into the room within 30 seconds and assisted with management. EMS was called.   Pt was tonic-clonic for ~45 seconds, and post-ictal for ~10 minutes. RN and MD stayed with the pt until she left via ambulance to hospital.   EMS obtained a BP of 93/56, BG of 84. Pt was A&Ox4 when EMS arrived. She only complained of fatigue.   Pt was able to walk unassisted to the ambulance and left the clinic in good condition.
Moderna COVID-19 Vaccine EUA Symptoms: slight fever, deep muscle and joint ache, painful headache, slight diarrhea near the end of symptoms, tenderness and 4 to 5 cm in diameter of redness at the injection site and an area of rash on upper chest.
Temp of 104F; Coughed uncontrollably 1-2hrs;
Patient with SIDS event after shots. Unsure if shots related or if coincidence. Autopsy reportedly (-).
Near syncope episode (pale, diaphoretic, nauseous) 8 minutes after the injection.
Initial case was received on 20 October 2010 from a healthcare professional. A 57 year old female patient received on 19 October 2010 an intramuscular right deltoid injection of FLUZONE (lot number UH223AB). On 19 November 2010 the patient experienced weakness, lethargy and her "arm to lip feels numb, like NOVOCAINE". She was not seen by a healthcare professional, but was going to call physician. No pre-existing medical conditions, allergies or concomitant medications were reported. The patient had not recovered. Follow-up information was received by a health care professional on 06 December 2010. The patient was advised by her physician not to worry unless she has trouble breathing or swelling in the throat. The pharmacist advised the patient to take BENADRYL which helped with the symptoms. The patient felt completely fine the morning of 21 October 2010 when she woke up. The patient had no illness at the time of vaccination and no other vaccinations within 4 weeks of the FLUZONE. The patient had no prior adverse events following prior vaccinations. The outcome was reported as recovered. Documents held by sender: None.
Headache lasting >4 days.  Possible autoimmune reaction (similar to what patient experiences during prior remicaide treatments) sores on face/trunk/legs.  Brain fog including difficulty with speaking.  Fatigue and extreme exhaustion, which occurred with 1st and 2nd dose.
had shingles 5 times; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient itself. The age at vaccination was not reported. The age group of patient was not reported however was captured as an adult as per vaccine indication. The patient had Shingles 5 times after 1st shot. The patient would not take 2nd shot.
Left arm muscle myalgia onset date of immunization continues deep arm muscle soreness and point tenderness at injection site.
Patient did not have a adverse reaction. I am reporting due to vaccine error of expiration. It was 2 days past expiration date.
Sore arm that first occurred a couple minutes after. Fever a couple hours later (100) and nausea
26OCT t103.2, swollen glands along jaw line-improved no sx 28OCT to MD 29OCT URI pt on ATB;
Pfizer covid vaccine was administered on day 33 of refrigeration, which is past the limit of 31 days provided by manufacturer. Pt was offered revaccination but said he is okay with administered dose at the moment. Proper labelling of vaccines has been enforced.
4 CM BY 4 CM ERYTHEMIC, RAISED RASH ON LEFT THIGH < 2 MM NEXT TO MMR INJECTION SITE. PT ASYMPTOMATIC, NO RX GIVEN.
got vaccine and got 2nd one 2 weeks later; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too short in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time after receiving SHINGRIX, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The reporter was patient's wife. The age at vaccination was not reported. The patient received 2nd dose of  Shingrix vaccine two weeks later after receiving 1st dose, which led to shortening of the recommended interval between vaccine doses. The reporter received first one and was told to get her second one in 3 to 6 months.  Someone made a mistake. The reporter asked which one was right. No other information was provided.
This spontaneous report as received from a healthcare worker also reported a nurse assistant refers to group of patients of unknown demographics. Information about patients' medical histories was not provided. On 13-JAN-2015, the patients were vaccinated with VARIVAX (Merck) (dose, frequency, indication and lot # were not specified) which was improperly stored. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Left arm redness and edema where Varicella vaccine was given. Erythematous and edematous 16 x 14cm area, warm to touch.