chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient tested positive for COVID at his nursing facility at an unknown date. Patient presented to ED for hypoxia, still inpatient.
Initial information received on 11-Mar-2019 regarding an unsolicited valid non-serious case received from Other health care professional. This case is linked to cases 2019SA071131, 2019SA071150, 2019SA071146, 2019SA071147, 2019SA071148, 2019SA071149, 2019SA071152, 2019SA071153, 2019SA071154, 2019SA071155 and 2019SA071156, same reporter. This case involves a 11 years old patient (gender unknown) who received vaccine FLUZONE HIGH DOSE instead of FLUZONE QUADRIVALENT. The patient's past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE prefilled syringes during the 2018- 2019 Flu Season, lot UJ043AB, expiry date 22-May-2019 via unknown route in unknown administration site instead of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported. It was an actual medication error due to wrong vaccine administered, overdose and inappropriate age at vaccine administration. It was reported that 11 years child patient was given accidentally the FLUZONE HD prefilled syringes instead of the FLUZONE QUADRIVALENT. The patient did not experience any adverse reaction after the injection. 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. List of documents held by sender- none.
Approximately four hours after receiving the HPV vaccine, pt began felling chills run up her leg and then travelled to the whole right side of her body. She then felt weak, got a headache and got chills over her whole body. Duration 1.5 hours.
Tongue began swelling, hives on tongue and face; treated with Pepcid, Solumedrol, Benadryl, Medrol dose pack.
Pt recvd DTP 15SEP92-Tempra given on arrival home, mom states pt crying, lethartic, not eating, low grade temp; t105, rt leg red & sore; mom called MD;
The following day after the shot, my neck tightened to the point where I could no longer work at my job.  The more I worked, the worse the pain became.  It feels like a  muscular pain.
Mom brought twins in today 11/23/10 for flu vaccine. Reports last time I immunized the twins 7/29/10, gave ea 5 shots x 3 days after this child experienced 1 episode of "very sleepy" mom had to shake her awake then was nauseous, vomited saliva. Twin did not have sx.
EE reports symptoms fever of 102.0 not going down with Ibuprofen,  joint and muscle pain, congestion and cough.  Treatment include Ibuprofen with no improvement. Referred  for COVID testing.
After initial 1 day symptoms of arm pain, headache, high resting heart rate, and fatigue abated (similar to second shot), different symptoms persisted:  1) Vertigo / feeling off balance, even when sitting - like sea sickness 2) Heart thumping or palpitations, and sometimes discomfort - feels like my heart is racing 3) Continued elevated heart rate - resting heart rate around 75 compared to 60 normally
pt had a synconpe event, hitting head and being unconcious for a few minutes in which the pharmacist almost gave him a adreniline.  911 was called. Pt was assessed by emt and patient declined to be taken to hospital.
Pain that started right after hepatitis A,B. Tested 3 times false-positive for HIV in May 2019.  May, 2019 - severe Knee pain, physical rehabilitation did not help, had days when I could not walk. Still active and never stopped March 2020 - severe bilateral wrist pain that is still active May 2020 - severe sacroiliac pain, June 2020 - bilateral sciatica that is active till now.  July 2020 - thumb pain.  April 2021 - severe IT band syndrome with sacroiliac pain that I lost ability to walk for a few days.  June 2021 - severe bilateral shoulder pain, that I can't move a mouse while using computer.  September 2021 was diagnosed with fibromyalgia.
Chills; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6198), via an unspecified route of administration in the left arm on 10Apr2021 at 09:30 (at the age of 68-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 10:00, the patient experienced chills and fatigue. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events chills and fatigue were resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
12/7/2022 Vaccine site reaction swelling 10/10cm, red/purple discoloration, low grade fever.  Apply ice/cold compress to site, Tylenol prn pain.  To clinic in AM if worsening. 12/8/2022 No change advised to call clinic or go ER if any problems.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 29Aug2020 at 14:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 09Sep2020 at 16:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 28Aug2021 at 16:00 as dose 3 (booster), single (Lot number: EP7533) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 10Jan2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulphonamided" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 05Jun2022 at 12:00, outcome "recovering" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical Course: No other medication in 2weeks. Anti-viral details, with product COVID 19 Treatment, brand was Paxlovid, treatment start date was 29May2022 and treatment stop date was 02Jun2022, indication was Treatment of COVID-19. Rebound after completing Paxlovid. No treatment for AE.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events: "Drug ineffective", "COVID-19" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Hands Swelling; Felt Tired; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Hands Swelling) and FATIGUE (Felt Tired) in a 59-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   In February 2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In 2022, the patient experienced PERIPHERAL SWELLING (Hands Swelling) and FATIGUE (Felt Tired). At the time of the report, PERIPHERAL SWELLING (Hands Swelling) and FATIGUE (Felt Tired) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Concomitant Drugs Not Reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. In 2022 Humira was really not helping. No treatment information was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medication was provided. On 30-MAY-2017, the patient was vaccinated with a dose of M-M-R II, lot # L015282 (dose and route of administration were not provided), which had expired on 30-APR-2017. The vaccine did not had had any temperature excursions prior to administration. No adverse symptoms were reported. Additional information has been requested.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2013, the patient was inoculated with ZOSTAVAX by a physician for routine adult health maintenance and the intended purpose for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. In 2013, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. Well along in 2013, the patient sought subsequent treatment from another physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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 unknown. Causality assessment was related. Additional information has been requested.
Flu-like symptoms; Aches/ Pain; Unable to eat/Anorexia; Feeling terrible; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN (Aches/ Pain), FEEDING DISORDER (Unable to eat/Anorexia) and FEELING ABNORMAL (Feeling terrible) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN (Aches/ Pain), FEEDING DISORDER (Unable to eat/Anorexia) and FEELING ABNORMAL (Feeling terrible). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN (Aches/ Pain), FEEDING DISORDER (Unable to eat/Anorexia) and FEELING ABNORMAL (Feeling terrible) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Products known to have been used by the patient, within two weeks prior to the event, included blood pressure medication, hypercholesterolemia medication and hyperlipidemia medication.  Treatment for the event included none.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Additional information received included reporter details.
product storage error due to refrigerator malfunction at lowest temperature of negative 26 degree celsius, no AE; Initial information received on 15-Oct-2021 regarding an unsolicited valid non-serious case received from other health care professional and consumer/non- health care professional via Agency (Under reference number 00814299).  This case involves a 60 years old female patient who was administered with the INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] that had a product storage error due to refrigerator malfunction at lowest temperature of negative 26 degree celsius (Product storage error).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No concomitant medication was given to patient.  On 11-Oct-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (Total, once, lot UJ725AA and expiry date 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to product storage error temperature too low.  Details of laboratory data were not provided.  It was reported "Practice Administrator calling in a temperature excursion for FLUBLOK. Excursion started on 10-Oct-2021 and ended on 11-Oct-2021, dose of the FLUBLOK was administered. Caller is inquiring if the products are still suitable for use and if not should they revaccinate?'  At time of reporting, no adverse event was reported, and the outcome was unknown for the reported event.  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.
red, swollen eyes, swollen nose, extremely congested, diff breathing, rash on torso;
03/06/2021 about 1 hour of the vaccine at 3:00PM, I had severe chills, severe joint pains, severe sweating. I was felling extremely cold, nausea and vertigo. I couldn't get out of bed and needed care for a week from my son, I couldn't eat. Severe fever 104 degree. I took Tylenol every six hours for 4 days. It didn't help much. I called my doctor they said they couldn't do anything I even called the hospital they said the same thing. After 7 days I started feeling better. It was very awful.
(A dose of expired vaccine should usually not be counted as valid and should be repeated. In general, doses of non-live (for example, inactivated, recombinant, or polysaccharide) vaccines may be repeated immediately. Repeat doses of most live vaccines should be given at least 4 weeks after the expired dose, because of the possibility that the vaccine antigen could still be viable. The above recommendation applies to live oral rotavirus vaccine, but with this caveat: the last dose of rotavirus vaccine should not be given to a child older than 8 months 0 days. Space a repeat dose less than 4 weeks if necessary to not exceed this maximum age.  If a capsule of expired live oral typhoid vaccine is taken, the entire 4-dose series should be repeated. There is no need to wait 4 weeks. As an alternative, a dose of the injected typhoid vaccine may be given.  Contact your immunization program and/or the vaccine manufacturer for specific guidance on revaccination. A manufacturer could recommend a "grace period" during which a dose of expired vaccine could still be counted.    ***Feedback about your experience with CDC-INFO is important to us and will help us continue to improve. Please rate your interaction by completing this short survey: No physical Symptoms reported. Recommended to repeat dose in 4 weeks.
I started to have bilateral joint paint. I developed Iritis, a lot of fatigue, and my TSH hormone blood value stayed elevated. I went to see my eye doctor for the Iritis. It was a lot of eye pain and my eye got very blood shot. After a couple of appointments, He thought it was suspect because I was experiencing it for a long period of time. He told me to go see my primary doctor. I do remember having extreme fatigue early on in the pandemic and because of that I had to use my inhaler very frequently. Then my primary doctor also thought my body reacted strongly to the vaccination because I might have had COVID-19. I was referred to rheumatologist and they did some test and showed that my body was in an autoimmune response. Some the blood values had decreased and have started to stabilize. I continue to have the bilateral joint pain and fatigue. I am currently experiencing another bout of the Iritis.
Mom states that infant had a 104 temp after shots in the middle of the night, treated with acet and fever was reduced. Infant was seen in our clinic and had a temp of 98.8 this am at visit.
Extreme pain approximately 4 hrs after injection.  Took tylenol. Pain subsided with only soreness
Information has been received from a physician concerning an 8 or 9 year male pt who in 1996 was vaccinated with a dose of varicella virus vaccine live. Subsequently the pt experienced breakthrough chickenpox. It was reported that the child was not seen in the office but the mother called and reported a fever of 100- 101 degrees F and about 10-12 lesions. The lesions began breaking out on 08/04/2004. The mother believed the child was exposed  to another child that had chicken pox about 12 days prior to breaking out. It was reported that no prescription medication was ordered, but the mother was told to use Benadryl for itch and acetaminophen (Tylenol) for the fever and calamine + camphor+ pramoxine Hcl ( Aveeno) bath if necessary. Th pt  was recovering. At the time of the report, the pt;s experience was considered to be another important event (OMIC). No additional information is available. Follow up clarification was received form the nurse who indicated that the pt experienced a very  mild case of chickenpox that was definitely not serious. The pt had 20-30 spots. She did confirm that the parent was instructed to use Benadryl for itch, Tylenol for fever and Aveeno Bath if necessary.  No additonal inoformation was available. Additional follow up indicated that the child was seen one time only for a mild case of breakthrough chicken pox. No work up was done and the chlid tolerated it well. He was not seen again in the office for any problems related to this DX. No additonal infomation was provided. Additional information is not expected. Another pt (WAES 0408USA00542) developed breakthrough chickenpox after vaccination with varicella virus vaccine live.
Severe Pain in right upper arm. Upper Biceps, (Swollen, Pain radiated down, upper Arm to wrist-to soulder, down to Front wrist, can't raise Arm up sense this, vaccine.
4 hrs. after inj., aching, chills, fatigue. 8 hrs. - rapid heart beat (127 bpm), vomiting, fever 100.8, labored breathing.
Patient felt dizzy, lightheaded, and weak after vaccine administration. Patient was placed in supine position with legs elevated for 20 minutes. Patient was able to ambulate without assistance after incident.
Heart palpitations, rapid heart beat, fever, vomiting the next morning. Rapid heart beat until the afternoon. Extreme tiredness.
I tested positive for COVID-19. I had flu-like symptoms, heavy body aches, runny nose, diarrhea, coughing, chills, sweats, and a 99.8 fever. I received a 5 day course of Paxlovid. I still have a bit of a cough and tiredness.
I tested positive on Friday 4/22/2022, started feeling like I had flu like symptoms as well as a headache, regional headache and it felt like sinus pressure on one side of my head only. Feeling very stuffed up, no cough initially, but felt like flu like symptoms that grew in severity the next few days. Severe fatigue, no appetite. Digestive issues as well, a lot of abdominal pain in lower abdomen. Bouts of diarrhea. Then I got really ill, had a temperature of 103+ degrees for 2 days. Fever finally broke and I had chills and sweats. I still have feelings where I'll suddenly perspire. Random chills and sweat breaks. Temperature has been normal but sensations of hot flashes. My oxygen saturation was lowest at 96. I lost my sense of taste and smell but it just starting to return to a degree. Yesterday was the first time I smelled something, then diminished and came back. I believe it's coming back but it will take some time. COVID moved to my chest, Health department nurse noted that it could be Delta variant. Had a lot of bronchial issues, and white viscus secretions. Still going on today. My heart rate during my sickest was 110 with the high temperature. Slowly and surely, you feel like you're improving, then you feel the symptoms coming back on. The one thing that I found that genuinely helped was Nyquil and Dayquil. Felt relatively normal for 3-4 hours then the symptoms would come back. Also used the nasal spray and had my c-pap machine to keep things relatively down in the nose, but everything seemed more bronchial. Still abdominal issues, unsure of how long this would persist. PCP noted to get Paxlovid and by day 3, if I didn't feel better to contact him again. PCP also noted that it could have been the Delta as well. PCP put me on Zithromax for 5 days and I finished my Paxlovid then took my last Zithromax the day after. The antibiotic did seem to make a difference. Main complaint about my chest, didn't find it difficult to breathe, but felt like my sternum was heavy and couldn't expand chest. Still in recovery but fatigue is the biggest factor over all and needing to go to the bathroom more than usual. But fatigue is the hardest thing to overcome at this point. Felt like without the booster, I would've been much sicker. Thankful for booster. For doctor's visit, they were via telehealth.