chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Nose bled for about 5 minutes) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), PROBIOTICS NOS, OMEPRAZOLE and CLOMIPHENE [CLOMIFENE] for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced EPISTAXIS (Nose bled for about 5 minutes). At the time of the report, EPISTAXIS (Nose bled for about 5 minutes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
Fatigue. Headaches. Muscle aches. Finger numbness. Worst allergies ever. Watery eyes. Runny nose. Sinus pressure. Facial swelling. White of eyes gone ( more grey and red). Dark circles around eyes. Congestion. Wheezing. Scratchy throat. Sneezing. Deep lung sneezing. Deep lung coughing.
Lowered B/P, Itchy Throat, Rash, Swelling, Hand numbness
196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) 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.     No Medical History information was reported.    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) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) 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 UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    No concomitant drug information was provided. It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine. No treatment drug information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Follow up received wherein Narrative was updated.
Pt received vaccine in left deltoid  12:09 p.m. @ 12;25 pt reported feeling nauseated.  Given water and pt started coughing.  Reported feeling slightly SOB.  B/P 142/90. HR 87. Breath sounds slightly decreased on expiration.  Reports mild headache. Positive rhinorrhea. Given 50 mg Benadryl PO once @ 12:35 p.m.  No angioedema. 12:47 p.m. breath sounds clear.  Reports symptoms seem to be resolving.  Cough resolved.  Continued to monitor.  1300 much improved.  Denies any symptoms.  HR 68; B/P 122/80.  Instructed to f/u with PCP.    #  21 Below:   Evaluated by NP @ Vaccine Site
This spontaneous report was received from a nurse concerning a 50 year old patient (gender unknown). On 11-FEB-2015 the patient was vaccinated in error with a pediatric dose of VAQTA 25/0.5 (units not provided (lot # and route were not provided). No adverse experience had been reported. This is one of several reports received from the same source. Additional information has been requested.
patient received just the liquid component of this vaccine without ActHIB portion/no AE; Initial information received on 07-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 2 years old male patient who received only DTap and IPV component of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] without HIB component .(Product preparation issue )  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant therapy included Hepatitis A and influenza vaccines.   On 06-Feb-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot U6257AB via intramuscular route in the left thigh for prophylactic vaccination.  It was of actual medication error due to Inappropriate reconstitution technique.  It was unknown whether adverse event was noted or not.  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.
No problems after immunization until 11 days post.  Noticed "pimples" and pruritis at injection site size of a quarter.  No other symptoms, gradually subsided.
Doctor prescribe Hiberix to a 81 years old patient; Prescribe / to a 81 years old patient / having a anticipating splenectomy; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 81-year-old patient who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced inappropriate age at vaccine administration and product prescribing error. On an unknown date, the outcome of the inappropriate age at vaccine administration and product prescribing error were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The doctor prescribed Hiberix to a 81 years old patient because he or she was having a anticipating splenectomy, which led to inappropriate age at vaccine administration and product prescribing error. The reporter consented to follow up.
Received vaccine that morning, by night area was warm to touch and "hard feeling" was painful. The next day it was the same. By Friday had a rash on arm looked as if rash started at injection site and spread down and around upper and lower arm. Also, had rash on stomach, back and chest. Rash appeared to be red, raised areas. Started taking BENADRYL every 4-6 hours on Friday until Sunday before rash improved.
Headache Fever/chills Fatigue Pain at injection site Discomfort glands in left side neck
Severe head and neck pain, muscle aches, joint pain, chills, fever, upset stomach, extreme tiredness, redness, pain, and swelling at injection site. It lasted 2 full days. I took ADVIL, and literally slept for 18 hours the day after the injection. I did not see a medical professional as my husband is a physician, and took care of me. I knew it was a reaction to the vaccine, and I figured it would eventually go away. It did on 06/17/2018.
Information has been received from a physician concerning a 4 month old male who, "approximately two weeks ago," on approximately 01-Jan-2008, was vaccinated with a dose of Rotateq.  Subsequently in January 2008, the patient experienced bloody stools.  The patient was sent to the emergency room and was observed not to have had intussusception.  It was reported that the bloody stool was still being observed even two weeks thereafter, not as bad, but still happening.  It was not known if the patient would continue the series of Rotateq at the six month visit.  Upon internal review, the patient's bloody stools were considered to be other important medical events.  Additional information has been requested.
I exp a rash all over my body was itchy, discomfort and painful. I went to the ER twice was given Prednisone. I was prescribed triamcinolone acetonide by the Dermatologist took about 2 weeks to clear.
I was having side effects during the vaccine a headache and then nausea, throat soreness, face redness, neck redness, rash on chest. Pain in lower abdomen. Pressure around left ankle.
Right after injection patient developed red, raised, whelp. 1 hour after injection he began to run fever of 101.8. Mother brought him into ER. Was instructed to take BENADRYL and TYLENOL. He then developed diarrhea that lasted 8 hours.
This case was reported by a healthcare professional (nurse) and described the occurrence of pertussis in a 25-month-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline), dtpa vaccine (non-gsk). Concurrent vaccination included PEDVAXHIB (non-gsk); Merck; unknown; unknown given on 14 December 2010; MMR II (non-gsk); Merck; unknown; unknown given on 14 December 2010. On 14 December 2010 the subject received INFANRIX as the 4th dose in series (unknown route, right thigh). On an unspecified dates, prior to receiving INFANRIX, the subject received 1st dose, 2nd dose and 3rd of DTPa vaccine (Non-GSK) (details unknwon. In October 2011, at an unspecified time after vaccination with DTPa vaccine (Non-GSK), 10 months after vaccination with INFANRIX, the subject experienced choking and cough. On 01 November 2011 pertussis and vaccination failure were confirmed with positive test result. The healthcare professional considered the events were disabling and clinically significant (or requiring intervention). Relevant test results included pertussis identification test positive on 01 November 2011. The subject was treated with "respiratory" inhaler (Inhalers). 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 HEXA and DTPa vaccine (Non-GSK). This is two of three cases from this reporter. The office has noticed a recent outbreak of pertussis in their area. See A0955333A and A0955537A for details regarding other two cases.
Pt ran a fever, eyes rolled to back of head; went limp taken to ER dx sz 24 hrs p/recvd vax not hospitalized;
a patient received a dose of Fluzone which was stored at 0.7 Celsius for 25 hours and 24 minutes with no AE; Initial information received on 25-Jan-2021 regarding an unsolicited valid non-serious case received from the other health care professional (medical assistant) via agency (Reference number: 00444852).  This case involves a 4 years old female patient who received a 0.5 ml dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] that was stored at 0.7 Celsius for 25 hours and 24 minutes lot UJ477AA, Expiry date: 30-Jun-2021 via intramuscular route in unknown administration site on 15-Dec-2020 for prophylactic vaccination (Product storage error).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  It was an actual medication error due to incorrect product storage (latency: same day).  Reporter can be contacted by Sanofi: Yes, Potential Product technical complaint (PTC): No, Description: Call received from medical assistant (MA) reporting a temperature excursion of unknown cause. Caller reporting PENTACEL, IPOL, FLUZONE QUADRIVALENT Multi Dose Vials (MDVs) AND PREFILLED SYRINGES, MENACTRA, ADACEL, and DAPTACEL at 0.7C for 25 hours and 24 minutes. Caller reported opened IPOL MDVs and opened Fluzone Quadrivalent MDVs. Caller reporting excursion occurring in December 2020. Caller reporting 11 doses of Fluzone Quadrivalent MDVs were administered post excursion. Caller with question on viability of administered vaccines post excursion. Product used: Not Applicable.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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.
I woke up around 1 am with chills and a low grade fever. This continued for the next 12 hours. For the following 24 hours I developed intense body aches, fatigue, headache, and slight dizziness. Overall the side effects lasted around 48 hours after injection. After that initial period there have been only minor instestinal discomfort and tiredness.
Information has been received from nurse via a field representative referring to herself/himself of unknown age. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates within the last few weeks, the patient was vaccinated with VARIVAX (dose, route, lot # and expiration date were not reported) for prophylaxis. Other suspect therapies included M-M-R II (dose, route, lot # and expiration date were not reported), diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid and influenza virus vaccine (unspecified) (it was not specified if the vaccines listed previously were administered concomitantly or on separate dates). At unspecified time after the patient received vaccines, the patient developed a sporadic cough, fatigue, and feel hot without having a fever. The outcome of the events was unknown. The causality assessment was unknown. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date the patient was vaccinated with PEDVAXHIB (Strength, dose and anatomical location were not reported) of lot # R005116 with an expiry date of 28-NOV-2020 intramuscularly for prophylaxis. Other suspect therapy included sterile diluent. On an unknown date, the patient received a dose of PEDVAXHIB that had been further diluted with an unknown volume of sterile diluent. No adverse effects were reported in the patient. There was no product quality complaint associated with the report.
patient has numbess of right side of face and felt swelling of the tongue. airway did not close. site staff gave Benadryl 25mg
Myalgia CHILLS, SORE THIGHS Narrative:  Other Relevant History:
chest tightness starting 1 day after covid booster that has been stable x 6 days.  Mobic prescribed while awaiting results.
flu; so sick; Initial information was received on 27-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves patient (unknown demography) who had flu (influenza) and was sick (illness), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious had flu (influenza) and was "so sick" (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Small areas of skin blotching in the forearms and c/o feeling some pressure in chest when she walked and went away at rest. No tx needed.  O2 Sat remained above 98% on room air and denied any itching to skin anywhere.
Immed tremors, flushing, sweating, anxious. BP went from 130/90 at office visit to 196/108-112 on 3 separate checks. Blood sugar 101, O2 RA 98-99%. Pt did not eat in AM and reportedly off Atenolol and RELAFEN x 4 days.
I had a little tenderness in my arm after receiving the vaccine. I tested positive for COVID-19 on 03/30/2023. I had a scratchy throat, sore throat, headache and fatigue. After three years, I was really shocked that it was positive. We did travel prior for a family vacation. I contacted my provider, and I got a prescription for PAXLOVID. I tolerated the medication without any complications. I did have the metallic taste, but it wasn't too bad. As of today, I don't think my stamina is back up but it is improving.
vertigo; Fatigue; muscle pain; stomach cramps; Diarrhea; mucus from sinus; This is a spontaneous report from a contactable other Non- HCP. A 82-Year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EL9261) via unspecified route of administration in left arm on 06Feb2021 (at the age of 82-Year-old) for COVID-19 immunization. Medical history included diabetes, high blood pressure, overweight. The patient was not pregnant. Concomitant medication included ezetimibe 10 mg once daily; metformin 1000 mg twice daily; acetylsalicylic acid (ASPIRIN) 81 mg once daily; chromium picolinate, cinnamomum verum bark, colecalciferol (CINSULIN ADVANCED STRENGTH) (medications in two weeks). No other vaccine in four weeks. The patient previously took first dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EL1283) in left arm on 16Jan2021 for COVID-19 immunization. On 06Feb2021, patient experienced muscle pain, fatigue, stomach cramps and diarrhea, mucus from sinus, vertigo. No treatment was received for events. No COVID prior vaccination. Patient has not tested COVID post vaccination. The outcome of events was recovered.  No follow-up attempts are possible. No further information is expected.
Nausea and vomiting, died in her apartment 2-3 days after COVID-19 Moderna 2nd shot administered. On March 25, 2021, our daughter received her first COVID-19 Moderna vaccination. On April 22nd, she received her 2nd Moderna vaccination, and our daughter grew ill and died in her apartment alone 3 days later. On April 23rd she telephoned to Inform my husband and I that she was nauseous and vomiting, and that she Informed her doctor of her symptoms. She said, her doctor told her that her symptoms where normal and should subside within a few days. On April 26 at 2:27 pm she was pronounced dead and her body was transported to the coroners office. The doctor on staff, wrote the cause of death as Atherosclerotic Cardiovascular Disease. Considering the fact that she was fine prior to taking the COVID-19 vaccine, my husband and I questioned cause of death. How was/is he able to say for sure that the 2nd COVID-19 vaccination was not the/a contributing factor to her death, particularly withstanding the absence of chain of events leading up to her death? His response literally was "I've seen so many cases like this, and I know what they look like. I can just look at a patient and tell what the cause of death was." This is a major concern for us, how could he know for sure without knowing anything about our daughter's medical history? Our daughter was a young 52 aged female with no prior history of heart disease, and she was well, up until receiving the 2nd COVID vaccination. Our hearts are crushed, she took very good care of us. We are seniors, and she was a major part of our lives, she prepared our meals. went grocery shopping, visited a minimum of 4 times weekly...We loved her so and she loved us. Sincerely, parents of deceased
Pt had a DTaP, Hib Titer, IPV & Prevnar at 4 months office visit. Pt developed hives day after immunization - Treated with Benadryl. On 06/12/02, Pt had DTaP with no reaction. On 07/12/02 pt had a Comvax & hives developed again (Hibtiter allergy)
I had a daily headache for 2 months starting on October 5th 2021. My blood pressure also went up 30-40 points - from 110/70  (I was measuring my BP weekly for years before the shot) to 140 - 150/80-85. That lasted for 3 months. Also, the growth of my body hair and nails slowed down significantly right after the shot and still didn't come back to normal  (4.5 months after the shot).
After receiving a td vaccine (Tenivac/TDVAX) in my left arm at my physical exam, I developed pain in my left shoulder that radiates through my shoulder, down my upper arm, and pain in my upper left chest. I experience pain every time I lift my arm above my head, try to reach behind my back, and experience pain when sleeping on my left side. This pain has interfered with my every day living, and this pain has been constant since receiving this shot and has never subsided.  I visited my primary care physician's office on August 11, 2022 regarding these symptoms.
2/7/18 1241 baby flu 0.25 prefilled given IM lt thigh. 1252 Mom brings baby back noting 4 red, round areas behind lt ear. Rapidly spreads to torso, rt ear and facial swelling. VSS. 1254 Epi 1mg/ml 0.1cc admin. SQ rt thigh. EMS called. 1257 BENADRYL 50mg/ml 0.3cc admin. IM rt thigh. 1303 EMS arrive. VSS, Pt is alert and intermittently crying. Taken to hospital.
Hives on face began around 4:30pm, along with a headache. Hives spread to body. Symptoms resolved in about 3 hours after taking BENADRYL, taking a bath, and applying topical steroids.
High fever (102.5), soar throat, nausea, headache, congestion and mucus
No known adverse event.  Just too many doses and both Pfizer and Moderna.  Concerned she will seek out all brands
Dull throbbing on-off like a real small toothache, at times feels like something isn't right still. 2 months < later into Dec. 2015.
I developed red bloody looking places all over my right leg. They would come and fade away by 3rd day. Then the process would start again. Painless but a little swelling by the end of the day. I finally went to see my dr. I knew it had to be a reaction to the shot because there was nothing else that changed. You could see I was bleeding under my skin ,some places were real big and others were dots. We waited to see if it would stop on its own ..next appointment we tried low dose prednisone. It seemed to work good with very little break thru bleeding. When the prednisone ran out the bleeding places returned. The Dr has me on 5mg prednisone daily now and it works. I may have a few spots come thru a month. The blood never came thru my skin,it was always absorbed by the body if that makes sense.