chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 45 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 12Apr2021 as dose 2, single (Lot number: CW0151), in left arm and on 15Nov2021 as dose 3 (booster), single (Lot number: FH8030), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "I have had environmental allergies (pollen, dust, mold, etc) since childhood." (unspecified if ongoing); "I have had environmental allergies (pollen, dust, mold, etc) since childhood." (unspecified if ongoing); "I have had environmental allergies (pollen, dust, mold, etc) since childhood." (unspecified if ongoing); "I have had environmental allergies (pollen, dust, mold, etc) since childhood." (unspecified if ongoing); "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (20Feb2023) Negative. Therapeutic measures, Paxlovid from 12Feb2023 to 16Feb2023, were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Local redness and swelling on site. Tender and hard subcutaneous tissue. No other symptoms. Prescribed Motrin and told to soak area in warm water by doctor.
A report was received from a health care professional on 11/19/03 concerning a female vaccinee more than 65 years old who experienced sniffles, cough, fever, and sore throat within 1 week after receiving Fluvirin on approximately 11/6/03. On an unspecified date, within one week after vaccination, the vaccinee experienced sniffles, cough, fever, and sore throat. Results of a chest x-ray taken on an unspecified date were negative. The outcome of the event was reported as unknown. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
At about 15 hours after receiving a Pfizer's COVID-19 Booster shot, the patient had full body aches, a bad headache and dizziness.
Patient got PNEUMOVAX 23 in (R) arm 11/16. He called pharmacy 11/17 reporting severe swelling of (R) arm. Instructed him to go to his mD and follow up w/ VS.
I just wrote all this and the website timed out and deleted it all. ARGH!!! Starting over... I noted that the injection was very high up on my arm, and that it hurt more than the flu vaccine I had a month or two ago, and more than the J&J vaccine did. Not terrible, but I felt it more. But the soreness quickly got pretty bad. Around 9:30 I noted I could hardly move my left arm around much without significant, wincing pain. That night I didn't sleep well. Thursday I woke up early and tired, and my arm had very limited range of motion and it has stayed that way. Thur night I again didn't sleep that well and woke up early and tired. I lay in bed and googled shoulder pain after vaccine, and learned about SIRVA. It sounded exactly like my symptoms. I have a very slender, runner's build and for whatever reason I think they injected it into the bursa or some other area of my arm, and not the deltoid muscle. My arm can be down at my side with no pain. I can type this with both hands, with maybe a 1 on the pain scale, close to nothing. That's because the angle of my shoulder is pretty close to the angle of rest. But if I try to reach up for something, I can't go past my hair with my hand. And going across my body, I can't go more than 2" past my right bicep with my left hand. It hurts to get dressed and undressed. It's hard to put on or take off my hat or face covering when I go outside or back inside. I'd say I have about 30-35% of normal range of motion in my left arm/shoulder.
Fever 1 day after shots; temperature max 102.4 for 3 days. Blanching erythema on chest and abdomen for 3 days. Mild diarrhea, mild cough and watery eyes.
felt a little tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt a little tired) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Sulfa allergy) and Food allergy.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced FATIGUE (felt a little tired). At the time of the report, FATIGUE (felt a little tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-068488 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068488:Dose-2
INFORMATION TAKEN FROM WEDSS...Patient received the COVID-19 vaccine on 3/17.  On 4/14 the patient began experiencing symptoms of COVID-19 which included fever, shortness of breath, cough, chills and congestion.  Patient went in for testing on 4/19 with results coming back positive.
Two minutes after shot, I felt a flush go through me and felt tingly. My heart rate increased and lasted several minutes.
Fever, lost feeling of face, tingling in hands and feet, severe vertigo, difficulty breathing, body aches, severe headache, nausea, loss of vision, vomiting, confusion. Symptoms were most severe for 36 hours although still currently have many of them.
intense fatigue; low fever; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0185) via an unspecified route of administration on 18Jun2021 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. The patient had not reported any other health issue. The patient did not have any allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unspecified date in Jun2021, the patient experienced intense fatigue and low fever for over one month since second dose. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. On 23Jun2021, the patient underwent nasal swab test and the result was negative. The clinical outcome of the events intense fatigue and low fever was not recovered at the time of this report.
Severe pain at injection site and surrounding muscle tissue. Arm extremely sore and warm to the touch. Arm felt numb and tingly a few times. Ran fever and had chills on 11/11/11. Site still very sore on 11/12/11 and firm to the touch.
As soon as first half of intranasal FLUMIST administered, patient moderate nosebleed. Suspect scab came off/picks nose.
Burning sensation, difficult to swallow, dizziness, redness in the chest, deep pain in the puncture area, iron flavor,
This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Influenza A) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 029L20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included VITAMIN C [ASCORBIC ACID] and VITAMIN E [VITAMIN E NOS] for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA (Influenza A). At the time of the report, INFLUENZA (Influenza A) outcome was unknown.            No treatment medication was provided.  The patient would like to know when can he take his Moderna booster dose.
A report was received from a health care professional on 10/25/2002, concerning approximately 100 vaccinees of unknown demography who experienced injection site reaction an unknown time after receiving the Fluviring vaccine during October 2002. During October 2002, the reporter observed anecdotally a higher than ususal incidence of local reactions(warmth and redness) at the injection site. The clinic has administered Fluvirin vaccine to approximately 2000 adult patients since 10/01/2002. The reporter suspected that approximately 100 vaccinees were affected with the adverse event. The events were reported as resolved. The reporter has assessed the relationship of the vaccine to the events as probable.
NO APPETITE; GENERAL MALAISE; HEADACHE; EXTREMELY TIRED; NOT FEELING WELL; This spontaneous report received from a patient concerned a 71 year old female. The patient's weight was 110 pounds, and height was 61 inches. The patient's concurrent conditions included: sulfa allergy (Bactrim). The patient was previously treated with covid-19 vaccine ad26. cov2. s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: 23-AUG-2021) dose was not reported, 1 total administered on 06-MAR-2021,10:00 for prophylactic vaccination. (Dose number in series 1). Patient did not experienced any adverse reaction after vaccination.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, expiry: 07-MAR-2022) dose was not reported,1 total administered on 10-NOV-2021 to left arm for prophylactic vaccination (Dose number in series 2). No concomitant medications were reported.  On 10-NOV-2021 patient became extremely tired by afternoon, and she was not feeling well by night. On 11-DEC-2021 (next morning), she had no appetite at all and desperately not well (Dose number in series 2). This continued for the next 24 hours with general malaise, headache, for which patient took Benadryl and Tylenol every six hours and increased oral fluids to wash it out of system. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from no appetite, not feeling well, general malaise, extremely tired, and headache on NOV-2021. This report was non-serious. This case is associated with product quality complaint: 90000207091.
I had my J&J COVID vaccine on Monday 3.8.21 On Monday night I developed a fever of 103 which lasted all night despite Advil and Tylenol.  I had diarrhea, injection site pain and severe shaking.  On 3.11.21 I have developed a very red swollen injection site which is large and extremely painful to the touch.  My fever did go away at around 3AM on 3.11.21 but still have the body aches.  This was not listed in my possible side effects this far out and some side effects were not even listed in my hand out
I lost hearing in my right ear on April 24th, 10 days after my 2nd Pfizer vaccine. I went to urgent care, then saw Dr on April 27th. The cause of the problem and the urgency to correct it were not clear at the time. Unfortunately I had to wait 2 months to see an ENT who properly diagnosed the problem as Sensorineural Hearing Loss. I was prescribed a course of treatment with Prednisone, but this did not recover any hearing .  I have permanently lost almost all the hearing in my right ear.
MODERNA COVID 19 vaccination applied around 2:30 pm  that later after more or less 30 minutes from the application of vaccine started to feel breathing difficulty, mild cough and presented reddish discoloration on facial region. Patient also attempted to talk and her voice was almost gone. Patient was taken to the acute room by MA who applied the vaccine and  providers were notified about the emergency (3:00 pm aprox) , patient  was placed on semi Fowler position ( unable to tolerate complete supine position) due to  worsening of breathing difficulty; vital signs were taken,   O2 sat: 98%, pulse: : 74 X minute; BP: 150/90 Hg mm; oxygen applied through nasal cannula 4 L/min; patient referred also that she felt  that her  forehead was swollen and that she had blurry vision; reddish discoloration was observed on her face. 3:05 PM patient received epinephrine shot (0.5 mL IM STAT) on the lateral aspect of her left thigh; called rescue (around 3:07 PM) . After a minute of Epinephrine application patient refers feeling that she was breathing better. At 3:15 PM BP was taken again reporting 160/90 Hg mm; pulse was 82; reddish on face disappeared. Patient referred feeling improving not only regarding breathing but also on facial swelling sensation and also referred that her vision was not blurry anymore. Patient continue on oxygen source and around 3:18  pm rescue arrived. Rescue checked on patient and asked her if she wanted to go to the Hospital and patient answered : "No, I don't want to go to the Hospital". Patient signed  a refusal of treatment form, remained a few minutes more with oxygen, Oxygen was removed and saturation was assessed again reporting 98%; patient refers feeling well. Patient was accompanied by employee to the door and was picked up by relative and gone from the center. Patient left the Center feeling completely fine, denied difficulty breathing, CP, or any other symptoms.
numbness and paraesthesia right side of face with facial drooping at the corner of left side of mouth. Pain at injection site.
On February 21st of 2008 I received my first hpv and first hepatitis b vaccines and was told to come back in one month for my 2nd hepatiits b shot and then the following month I'd receive my 2nd hpv shot. So on the 27th of March I recieved what I though to be my second hepatitis b shot. With in days I had dropped into a very bad depression. I was crying all the time, could hardly function and had no idea what was causing all of this. I wanted to die and I didn't know why it got so bad I started to call help lines and tried to decide if I should see about getting some medical help. It was the worst I have ever felt in my life, I felt completely out of control. Finally after about 3 weeks of what I can only describe as hell, I started to feel a little better, then I received a bill I was being charged for my 2nd hpv shot not my 2nd hepatitis b! After talking to my mother and putting dates and everything together I believe that my deep depression was soley caused by receiving my 2nd hpv shot a month sooner than I'd expected. We immediatly made an appointment with the clinic to discuss there huge error. They refused to admit any mistake on their part due to that fact that the recommended time inbetween dosing on the hpv serious had change. They would only admit that they should have also given me the 2nd hepitis b shot as well as the 2nd hpv shot I'd received. No one told me that day that the plan had changed that I would be recieving the 2nd hpv shot a month sooner than planned. Not only do I think the clinic was inapt in their communicating my course of treatment but I believe that the 2nd hpv shot sent me into at least 3 weeks of severe depression that with out the help and support of my family and a close friend I don't know if I'd have made it through on my own. After thinking about everything I feel it is my responsiblitiy to tell you the reaction that I had from my 2nd shot, in hopes that maybe others have come forward and it will stop anyone else in the futre from suffering the same horrible side effect.I had decided not to continue the series and get the 3rd shot as I do not have any confidence left in series. I don't believe that it has been studied enough and will not risk having another adverse reaction as I did to the last one. I hope that if I am not the only one that has come foward with this reaction that it is taken very seriously. It may not have resulted in my death or caused any long term effects that I have become aware of but it was a severe reaction one that I was never warned or advised could happen, had I known it was a possible side effect I would never had agreed to the series in the first place.
Vaccine Were correct ones , but the mistake was that the vaccine where from the wrong stock instead of the private which patient has private insurance.
Vaccines may have been administered after excursion; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received HAV (Havrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis, HBV (Engerix B) for prophylaxis and Flu Seasonal QIV (FluLaval Quadrivalent) for prophylaxis.   On an unknown date, the patient received Havrix, Boostrix, Engerix B and FluLaval Quadrivalent. On an unknown date, unknown after receiving Havrix, Boostrix, Engerix B and FluLaval Quadrivalent, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 12-Sep-2022 Reporter's comment: The pharmacy director stated that vaccines Havrix, Boostrix, Engerix-B and Flualval were exposed to above recommended temperatures for months.  The pharmacy director stated that they were exposed to a max temperature of 48.59 F and were above 47 F for at least a month.  The vaccines might had been administered, but investigation was ongoing. No further details are available at this time.  The reporter consent to follow up. Additional Supportive Information: The vaccines were exposed to a max temperature above recommended temperature, which led to incorrect storage of drug.
Vaccinated at 8:55am, Per Nurse Practitioner note patient started experiencing itching upper chest, medicated with Benadryl P.O., started with throat itching, medicated with Benadryl IM,  EPI IM, EMS called, placed on O2, diminished breath sounds bases, slight  stridor, EPI IM,  Solumedrol IM,  EMS transported to local ED.  Patient called NP later in day and said she was admitted to the hospital.
menquadfi vaccine was given to a patient under the age of 2 with no reported AE; Initial information received  on 10-Mar-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 7 months old of an unknown gender and reporter reported Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] vaccine was given to a patient under the age of 2 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 Pneumococcal Vaccine Conj 13v (Crm197) (Prevnar 13) For Immunisation; Hib Vaccine Conj (Tet Tox) (Acthib) for Immunisation; and Diphtheria Vaccine Toxoid, Hepatitis B Vaccine Rhbsag (Yeast), Pertussis Vaccine Acellular 3-Component, Polio Vaccine Inact 3v (Vero), Tetanus Vaccine Toxoid (Pediarix) for Immunisation.  On 09-Mar-2023, the patient received 0.25 ml of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine Solution for injection (lot number: U7447AC, Expiry date: 20-Sep-2024, Strength: Standard, Frequency: Once) via intramuscular route in the right thigh for Immunization.  On 09-Mar-2023, the patient was given Meningococcal A-C-Y-W135 (T Conj) Vaccine was given to a patient under the age of 2 with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  It was reported, MENQUADFI vaccine was given to a patient under the age of 2. They are wondering what to look for as far as any adverse reactions.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (menquadfi vaccine was given to a patient under the age of 2 with no reported AE).  At time of reporting, the outcome was Unknown for the event menquadfi vaccine was given to a patient under the age of 2 with no reported ae.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.
After the shot the following day I experinced a climbing blood sugar  going above my Dexcom sensor measure of 400 mg/dL.  On 10/17/2022 ambulance was called and took me to ED.  In ED for day and ICU 3 days.   attached lab results from 10/17/2022.
Adolescent was vaccinated with TWINRIX, an adult vaccine, instead of the pediatric Hepatitis A and Hepatitis B. No adverse reaction noted by patient.
Pfizer-BioNTech COVID-19 Vaccine EUA: Patient was hospitalized with pericarditis and treated with colchicine. Patient was discharged medically stable.
***********COVID BREAK THROGH CASE ************* May 18 I started having a sore throat and some cough but no fever. That lasted for two days I tested on Wednesday (negative) and Friday (positive). The symptoms continued I still have a sore throat and coughing. I started getting headaches on Sunday and that lasted until Thursday along with sore throat and ring in my ears.
Severe headache 11 hours after vaccine. Soreness down back and neck and arm. Pt put ice on arm, back and head and too Ibuprofen and Tramadol. Symptoms resolved after 2-3 hours.
About 3 minutes after vaccine administration child was sitting in chair, became pale, said her vision was turning gray and lost some control of her head. Legs were raised, no loss of consciousness. Recovered in 1 min.