chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe nausea, fever at the highest at 40.9 C (~105F) for about 3 hours followed by chills/fever over night ~38C, head and joint aches. All nearly resolved now (3 pm 04/28) I am reporting this to add to statistics and help vaccine development. I am allowing this report to be shared with the vaccine manufacturer besides governmental health officials.
Within 12 hours of receiving the vaccine I developed sever flu-like symptoms - low grade fever, chills, body aches, extreme fatigue, runny nose
Paresthesia? - Patient feels heat emanating from torso and back, night more than day since vaccination.  Skin temperature over site 2 degrees warmer than forehead.
This spontaneous report was received from a registered nurse and refers to a patient of an unknown age and gender. There was no information about the patient's pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. The nurse reported that the patient was vaccinated with a dose of VARIVAX lot number: M039317, expiration date: 20-SEP-2018 (strength, anatomical location, dose, frequency, and route of administration were not provided) for prophylaxis, which was reconstituted with a sterile diluent, instead of a dose of ZOSTAVAX due to a human error. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Symptoms: c/o ?dizziness, palpitations, lightheadedness, feeling of a rush? Intervention: VS stable. Stayed an additional 15 minutes, total 30 min. Symptoms subsided.
3x4 inch patches of red rash inside both legs just above the ankles. Rash is smooth and doesn't itch. Got the shot at the fair around noon, noticed the rashes when I got home around 4:00pm.
Following day patient complained of earache in left ear and had a tactile fever. He started reporting to mom that he could not hear out of his left ear.
Refrigeration excursions identified; No adverse event; Poor quality product administered; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and NO ADVERSE EVENT (No adverse event) in a 26-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Sep-2022 at 12:52 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 21-Sep-2022 at 12:52 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered).    No concomitant medication was reported.  It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department made aware of the situation. The Nurse called for a clinic that she was assisting. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to Aug-2022.  Date vial moved from freezer to refrigerator was 07-Sep-2022.  No adverse reactions reported for the patient.  No treatment information was provided.
3 days after vaccination, either Tdap or influenza vaccine, both given in left deltoid, began to hurt in the muscular region. Still hurting almost x year. Was sent to get x-ray of left shoulder on 03/30/2015, showed "mild degenerative disease involving acromicroclavicular joint". Patient seen again today on 09/03/2015 by same provider who asked to report to VAERS.
93 y/o female, PMHx of HTN, hypothyroidism, and hyperlipidemia is admitted for hypoxia, weakness, diarrhea, and cough due to Covid-19 pneumonia on 7/16/21. Pt was started on Decadron and prophylactic Lovenox. Chest x-ray demonstrates multifocal interstitial and minimal groundglass opacity throughout both lungs. Pt discharged to home on 7/19/21.
no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 17-APR-2019, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # R024906 with expiration date 30-AUG-2020 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
Day after vaccination: extreme fatigue and headache 3 Days after vaccination: fatigue and headache still present, but now experiencing nausea
Pt was in 8/14/06, Pneumovax 23 booster given IM in right deltoid on 08/15/06. Developed a reddened area at site with decreased ROM to arm. Now redness has radiated lower down arm, no redness at injection site, area warm to touch and red. No firmness. Size 3"w x 6"l. Advised warm compresses, ibuprofen and monitoring no resp distress with event.
5 days after injection in left arm started itching and arm turned red and swelled .  Arm was hot and redness kept spreading .
My husband tested positive; My husband tested positive; This is a spontaneous report from a contactable consumer (patient's wife). This reporter reported similar events for 2 patients (herself and her husband), this report refers to the reporter's husband. A male patient of unspecified age received dose 1 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient tested positive for COVID-19. The patient's wife believed symptoms she had after she received BNT162B2 were due to COVID-19 because as about 8 days later the patient tested positive. The patient received dose 2 of BNT162B2 on an unspecified date and was feeling fine. The outcome of tested postiive for COVID-19 was unknown.  No follow up attempts are possible.  Information about lot number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021014336 Same product, different AE/patient
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2012, the patient was inoculated with ZOSTAVAX at a medical office as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unspecified date, the patient was treated at the same medical office for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was considered not resolved. Causality assessment was related. Additional information has been requested.
just a sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 22Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history included: "Cirrhosis From Hepatitis C" (unspecified if ongoing), notes: Hepatitis C She got this from a hospital 40 years ago; "Cirrhosis From Hepatitis C" (unspecified if ongoing), notes: she got cirrhosis.; "Car accident" (unspecified if ongoing), notes: She was in a car accident; "Encephalopathy" (ongoing), notes: Encephalopathy. Concomitant medication(s) included: XIFAXAN taken for encephalopathy, start date: 2020 (ongoing); ZINC; GENERLAC taken for hepatic cirrhosis; LACTULOSE taken for hepatic cirrhosis. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: EN6199, NDC/Expiry: Unknown, this is not on the CDC vaccine record card.), administration date: 06Mar2021, when the patient was 73-year-old, for COVID-19 immunization, reaction(s): "Just a sore arm"; BNT162b2 (DOSE 2, SINGLE, Lot: ER8733, NDC/Expiry: Unknown, this is not on the CDC vaccine record card., Administered at 14:00.), administration date: 30Mar2021, when the patient was 73-year-old, for COVID-19 immunization, reaction(s): "Just a sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 22Oct2021, outcome "recovered" (2021), described as "just a sore arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity. Additional information: patient reported she got hepatitis C  from a hospital 40 years ago. She was in a car accident and they didnt screen the blood for Hepatitis C, they didnt even know Hepatitis C existed yet. When she got this, it kind of messed up her liver, so she got cirrhosis.Theres too much ammonia that goes into the brain, messes your brain up. If not for Xifaxan and Generlac would probably be in a home, because ended up in hospital; couldnt figure out how to go to bathroom. She knew she had to go, couldnt figure out how to do it, didnt know own name or name of president.They just loaded her up with Generlac and that was about it. Xifaxan really, really helps, she wouldnt be able to function without it; It has to do with gut, kills bad bacteria, thats why it works. Patient did not take a dose of Xifaxan because nauseous, didnt want to be more nauseous. Generlac: If the pharmacy is out of this they will give her Lactulose instead since its the same. Tastes really sweet, if youre trying not to eat sugar, theres no sugar or corn syrup, its a good sugar fix.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300073682 same patient, different dose and event;
I received the vaccine shot on May 21st, 2021. Immediately after I received the vaccine, I felt a severe pain on my right shoulder where the vaccine was given and there were some blood that came out. I was told by the pharmacy agent to sit for a while to allow the pain to go away. I did a little few minutes after and I went home. I could still feel a pain in my arm for the following days like a soreness. Around June 4th or 6th, the pain became excruciating, especially at night even if was not moving my arm. The pain would come with numbness of the fingers of my right hand on and off, the numbness was felt especially early in the morning. There was bad days were i the pain was really severe around 10/10 and other days I was better. Overall it and on the day when the pain was really bad, i was very difficult for to do my activities of daily live such as dressing up, cooking, cleaning, carry object, taking a shower, in general I could not use lift or move my right hand/shoulder up or around. Around the summer of 2021 as the pain was still coming on and off, I saw a doctor who gave several injection of a pain medication called "Lipatolam". Later in summer 2021, early fall 2021, I started feeling pain in my right wrist accompany with rigidity and I could not move my right wrist around. I also, started feeling pain in left forearm and also especially a night even when my left forearm was at rest. I couldn't receive any other vaccine because i was scared of the symptoms. In december 2021 I got covid-19 for the second time and all my symptoms became worst. Today the pain is continue and consistant on both of my arm and and on my right wrist and do not go away. I'm taking Neurontin 300 mg 2 tabs a day and cyclobenzaprine 10 mg 1 day daily for the pain.
Given 0.3 ml of UNDILUTED pfizer vaccine.  Reported sore arm and a swollen lymph node
Patient broke out in a rash from head to toe. He went silent. He stopped babbling and trying to talk. He  would cry constantly and could not be soothed. I didn't know it was a reaction to the vaccine and a month later we moved away. It was only months ago I connected all the dots and got confirmation he was injured by vaccines. His diet has been changed, vitamins/supplements/enzymes have been added to his diet, and he started speech therapy.
Infant patient received a dose of PENTACEL and IPOL, the provider said he forgot that Polio is part of PENTACEL, with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a physician via Medical Information (MI) (Reference number-00573543) and transmitted to Sanofi on  22-Apr-2021.  This case is linked to case 2021SA138683.  This case involves a twin 2 months old male patient who were vaccinated with a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot R1F97 and expiry date 03-Oct-2021) once on 21-Apr-2021 and POLIOMYELITIS VACCINE (INACTIVATED) [IPOL] via unknown route in unknown administration site for prophylactic vaccination on an unknown date, Polio is part of PENTACEL; the provider looked at the box and packaging but was focused on looking at the HIB part that he did not focus on the IPV part, what issues might two doses of IPV cause (inappropriate schedule of product administration).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and HEPATITIS B VACCINE RHBSAG (YEAST) (ENGERIX B) for prophylactic vaccination.  This was an actual medication error case due to inappropriate schedule of product administration (latency was same day).   At the time of reporting, no adverse event reported.  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.
Approximately 21  hours after shot (9 AM on 8/12) baby became fussy, irritable, unconsolable for 8 hours was seen in the office by my partner no source seen for irritability episode lasted 8 hours then got better over next 12 hours.
Myalgia, NauseaVomiting, left sore arm, back pain,  Narrative:
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. The reporter stated that on an unknown date multiple unspecified patients were vaccinated with improperly stored PEDVAXHIB (dosing details were not reported) (therapy type: Digital Data Logger) (lot # K008679 with an expiry date of 05-MAR-2017), at a temperature of 51 F for a time frame of 5 years (Incorrect product storage). There was a previous temperature excursion reported for PEDVAXHIB at a temperature of 59 F for 29 hours. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports from the same reporter. Additional information has been requested.
Caller developed a tiny little area which is grayish somehow like a bruise on her left arm, on the same arm where she got the vaccine; Caller developed a tiny little area which is grayish somehow like a bruise on her left arm, on the same arm where she got the vaccine; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiry date: not provided), dose 2 via an unspecified route of administration, on 01Jun2021 at 07:30 (age at the time 75-year-old), as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiry date: not provided), dose 1 via an unspecified route of administration, on an unspecified route (age at the time 75-year-old), as single dose for COVID-19 immunization. On 01Jun2021, the patient experienced a tiny little area which was grayish somehow like a bruise on her left arm, on the same arm. It was reported that, she was just alarmed as what she had read on the vaccination sheet was just injection site redness and not that one like patient. The patient would like to know if there were reports like the side-effect she had experienced. The outcome of the events was unknown.  Information on lot/Batch number has been requested.
Pt arrived to receive the moderna vaccine, prior to administration pt was asked a series of questions with question 1 being have you ever received a covid vaccine in the past. Pt stated "No" At this time medication was prepped and given and pt waited 15 minutes with no issues noted. I was later putting the vaccine in WEBIZ and it noted pt received the Jansen vaccine 4/10/2021. I immediately contact pt to verify if in fact they had received this vaccine that was noted WEBIZ. Pt stated she had not received the vaccine and was not sure why is was noted. At this time I did reach out to discuss the above noted event. All information provided and waited for response back. Dr. was notified of the event and no other vaccine needed. did also speak with patient and they finally did admit to getting the vaccine and and that they had lied to and they had not received it because of the information that had been released about side effects of J&J vaccine after getting it. We are reporting event per request but no noted adverse effects noted.
This spontaneous report as received from dean of students office refers to 8 patients ranging from 18-21 years of age. On an unknown date the patients were vaccinated with two documented doses of M-M-R II (lot number not reported). No other concomitant medications were reported. It was reported that on an unknown date the mumps identified among students who were fully vaccinated with two doses of M-M-R II. It was reported that patients who may have recently visited its campus or who had close contact with a student or staff member to contact their doctor if they are exhibiting symptoms. The outcome of the event was not reported. The causality of the event was not reported. Additional information has been requested.
Information has been received from a newspaper article titled "Varicella Breaks Out Despite Double Vaccine Doses" from the Family Practice News, July 15, 2007, concerning a child who received a first dose of varicella virus vaccine live (Oka/Merck) on an unspecified date. It is reported that in the fall if 2006, the child had a mild outbreak of varicella, with less than 250 lesions. The rash lasted about 4 days. A positive IgM serum spot test was used as confirmation. It is unspecified if medical attention was sought. The outcome is recovered. Additional information is expected.