chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling and severe tenderness in under eye area where injectable fillers were placed 3 months earlier
This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 17-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported.
fever; Pain from Covid arm; chills; Covid arm; This is a spontaneous report received from a contactable consumer (patient) reported for herself. A 36-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EL9621), via an unspecified route of administration, administered in arm right on 29Jan2021 as single dose for COVID-19 immunization. Medical history included back pain ongoing since 2009 and had back surgery, pneumonia and heart surgery. Concomitant medication included hydrocodone from 2012 and ongoing and morphine from 2015 to ongoing; both for back pain. As per ADR description, Caller reported that the first dose of the Covid-19 vaccine was fine. Caller reported that everything went the way it was supposed to. Caller reported that she had the Covid arm and a little bit of fever and stuff.  Covid arm - first dose: Caller reported that the Covid arm began about 6 hours after she received the injection on 29Jan2021. Caller reported that the pain lasted for about 3 days. Caller reported that her arm hurt and she couldn't sleep on that side. Little bit of chills - first dose: Caller reported that she experienced a little bit of chills on 29Jan2021 and just went to bed early. Caller reported that the next day, 30Jan2021, she felt fine except for her arm. Caller reported that she received her Covid-19 vaccine early in the morning and the chills began around 5 in the evening on 29Jan2021. Caller reported that she was fine the next day on 30Jan2021 like nothing had happened except for her arm.  First dose: Administration date: 29Jan2021; Lot Number: EL9261; Anatomical Location: Right arm Caller reported that her right arm was so sore that she couldn't sleep on it following the first dose of the Covid-19 vaccine. she's had pneumonia in her past life and she has had heart surgery, so she doesn't want to get Covid-19. Caller reported that she totally believes in the Covid-19 vaccine, but she never thought that she would be the one calling Pfizer after the fact. Caller reported that she was informed that before the Covid-19 vaccine, don't take any pain medicine. Caller reported that she followed all of the rules and didn't take any before receiving the Covid-19 vaccine. Caller reported that she didn't take any aspirin following the Covid-19 vaccine because she didn't want it to interfere with her immune system. Caller reported that she didn't take any pain medication for 4 days after the Covid- 19 vaccine to make sure that her immune system would interact with the vaccine naturally. Caller reported that she did not take pain medication before and for 4 days after she received both doses of the Covid-19 vaccine. The clinical outcome of the events was resolved on 30Jan2021.  No follow-up attempts are possible. No further information is expected.
pt recv vax 10APR96 in AM & mom reported pt running temp of 104.5 R;temp controlled w/APAP & advil
This spontaneous report was received from a healthcare worker referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with GARDASIL 9 (dose and route were not reported), lot # M037770 and expiry date: 01-JUN-2019 for prophylaxis. The vaccine was exposed to temperature of 47 to 77 Fahrenheit for 510 minutes. There was a previous temperature excursion of 47 to 77 Fahrenheit for 6 hours. No adverse effects and no product quality complaint (PQC) was reported. No further information provided. This is one of the several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA007237: US-009507513-1707USA007238: US-009507513-1707USA007239.
Muscle pain, myalgia following "recent" Anthrax and Smallpox vaccinations.
Acute pancreatitis - Plan to likely go home and return in one week for OP lap chole due to effient   07/16/21 lipase is 403, patient wants to go home and come back if we have to wait a week due to effient. Awaiting recs from GI and Cardiology. No longer any abdominal pain. Will stay on ASA through surgery per GI. Will restart effient or plavix a few days  Post surgery. Cardio rec restart statin the night before surgery, restart zetia now,  Dc home today and surgery planned for Wednesday. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Sore throat, aches, hive rash on upper back and neck and chest area.
numbness at end of tongue; dizziness; increased oral secretions; This is a spontaneous report from a contactable pharmacist. A 50-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), intramuscular on 22Dec2020 at single dose for Covid-19 immunisation. Patient was not pregnant. The patient medical history was not reported. Concomitant medication included meclizine, ondansetron (ZOFRAN), famotidine. The patient was admitted to emergency room (ER) post-vaccine administration for numbness at end of tongue, increased oral secretions and dizziness on 22Dec2020. She was given Benadryl and Pepcid, monitored for 3 hours before discharge from ER. Patient still experiencing same symptoms 1 week later per follow-up (29Dec2020). This case was reported as non-serious. The outcome of events was unknown.
Moderna COVID?19 Vaccine EUA  Dr. received Covid-19 vaccine on January 11, 2021 in his office.  Dr. reported complaints of abdominal discomfort to his staff starting on January 13 or 14th. Pain and condition worsened. By January 19th, running fever 103.9 F, oral. Labs showed elevated white count. On January 20th, follow up labs and KUB done. Elevated white count and Appendicits diagnosed. Also on January 20th, emergency consult done and emergency surgery done to remove appendix.   Reports of Appendicitis noted on follow-up research. Even though reports stated unknow correlations between Covid-19 vaccine and Appendicitis, VAERS report done as precaution.
Spontaneous abortion at 11 weeks of gestation; This spontaneous case was received on 10-Aug-2021 from other health professional  and concerned a 42-year-old female patient, of body weight: 108 lbs, height: 61 inches and body mass index (BMI): 20.4.  The patient had no relevant medical history. The patient's concomitant medications included Vitafol One (ascorbic acid, betacarotene, colecalciferol, cupric oxide, cyanocobalamin, folic acid, iron polysaccharide complex, magnesium oxide, nicotinamide, omega-3 fatty acids, potassium iodide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide) for healthy pregnancy.  The patient's obstetrical history included two previous pregnancies, with one elective abortion and one ectopic pregnancy. The patient had no history of offspring with major congenital malformation (MCM) and no maternal or paternal history with MCMs. The patient did not use tobacco, alcohol or illicit drugs during pregnancy.   The patient's last menstrual period (LMP) date was reported as 27-Dec-2020. The type of pregnancy was singleton. The estimated delivery date (EDD) was reported as 03-Oct-2021 and corrected estimated date of delivery (CEDD) was not reported.  On 03-Oct-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; dose, indication, route of administration and anatomical location: not reported). The batch number reported was P100239705.  No pregnancy complications were noted, and no prenatal tests were performed.   On 14-Mar-2021, five months and 11 days after receiving Afluria Quadrivalent, at 11 weeks of gestation, the patient had spontaneous abortion.   The outcome of the event spontaneous abortion was not reported.  The reporter did not provide a causality assessment to Afluria Quadrivalent.  The event of 'spontaneous abortion' was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company Comment:  Spontaneous abortion was reported in a 42-year-old female patient five months after vaccination with the suspect product Afluria Quadrivalent. No pregnancy complications were noted, and no prenatal tests were performed. Information regarding autopsy and possible aetiology for the reported event have not been provided. Patients age confounds causality since the risk of spontaneous abortions significantly increases by age. Based on implausible temporal relationship and presented confounder, causality is assessed as not related.; Sender's Comments: Spontaneous abortion was reported in a 42-year-old female patient five months after vaccination with the suspect product Afluria Quadrivalent. No pregnancy complications were noted, and no prenatal tests were performed. Information regarding autopsy and possible aetiology for the reported event have not been provided. Patients age confounds causality since the risk of spontaneous abortions significantly increases by age. Based on implausible temporal relationship and presented confounder, causality is assessed as not related.
Arm (injection site) is swollen (size of half an orange); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Arm (injection site) is swollen (size of half an orange)) 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 25-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced VACCINATION SITE SWELLING (Arm (injection site) is swollen (size of half an orange)). At the time of the report, VACCINATION SITE SWELLING (Arm (injection site) is swollen (size of half an orange)) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 14-AUG-2014, the patient was inoculated with ZOSTAVAX in his right deltoid for routine health maintenance and for the prevention of shingles (lot # and dose not provided). The vaccine was given by a Medical Assistant at his primary care physician's office. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 23-AUG-2014, the patient was diagnosed with paresthesia. On or about 15-SEP-2014, the patient was treated by his primary care physician and diagnosed with Guillain-Barre Syndrome and "post-traumatic syndrome."  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, pain and suffering, and other damages. Upon internal review, Guillain-Barre Syndrome was considered medically significant. Additional information has been requested.
It just came on like cold, congestion, and cough. Then it went into runny nose and voice loss. The voice loss lasted over a month. The cough eventually tapered off. The congestion lasted about 10 days.
Child had varivax 07/18/1997 was diagnosed with shingles 08/01/2003.
Hep A # 2 was given prior to recommended 6 mos interval for booster. The patient is stable. The mother is aware of incorrect administration.
Fever - initial Temp 100.3. Headache, neck pain, fatigue. Symptoms lasted 4-5 days. No other obvious source for the symptoms.
Tired; Mildly nauseated; Mild headache that migrated around my head and face; 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 female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Apr2021 11:00 (Lot number: EW0162) at the age of 45 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "adhesives" (unspecified if ongoing). Concomitant medication(s) included: CYMBALTA; CLARITIN-D. Past drug history included: Vicodin for known allergy: Vicodin, notes: Vicodin and adhesives. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer-BioNTech, lot number=ER8737,, lot unknown=False,, administration date=08Apr2021,, dose number=1,, vaccine location=Left arm), administration date: 08Apr2021, when the patient was 45 years old, for covid-19 immunisation.  The following information was reported: HEADACHE (non-serious) with onset 30Apr2021 05:00, outcome "recovered", described as "mild headache that migrated around my head and face"; FATIGUE (non-serious), outcome "recovered", described as "tired"; NAUSEA (non-serious), outcome "recovered", described as "mildly nauseated". Therapeutic measures were taken as a result of headache, fatigue, nausea.  Additional information: It was reported that, the patient did not receive other vaccine in four weeks. The patient not tested for covid post vaccination. It was reported that the patient had mild headache that migrated around my head and face and came and went. It was reported that it lasted a couple days. The patient was also very tired and mildly nauseated  No follow-up attempts are possible. No further information is expected.
Redness, swelling where shot was given, headache, nausea, body aches, sore joints.
Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Received Pfizer Vaccine on 02/22/21 and 3/15/21. Covid + 1/23/22. Presented to ED 1/23/22 with SOB, cough, fever, chills, and general malaise/dizziness x 4days. Placed on Airvo then escalated to NIV. Labs significant for glucose 387, Na 128, AGMA, Hgb 16.2. CXR with multifocal opacities. Respiratory status required intubation on 1/25/22. On 2/3 episode of unstable SVT refractory to adenosine, required defibrillation six times. Transitioned to DNR. Treated with remdesivir, solumedrol, and cefepime. Expired 02/07/22.
Very sick on next day, 11/10.  Vomited and nausea.  Headache.  Developed a rash on my face on my cheeks.  Spent most of the day in bed. No appetite.  On 11/11 feeling better but still not back to 100%.
Patient hospitalized from until discharge on 12/13/2021.  Symptoms started 11/27.  Patient reported a positive test but hospital was unable to locate the result and retested the patient on 12/9/2021 with a positive result.  Admitted with hypoxia.  Discharged home with home O2 and home care.
On 3/22/2023, I had quite a bit of coughing and a low-grade fever. I then developed a sore throat that had a sharpness whenever I swallowed. I also had the sniffles. I took two home antigen tests, and they both yielded a positive result. I called my doctor's office, and they scheduled a telehealth visit with their NP at 4:00 PM that day. The NP prescribed Paxlovid, which I began taking that evening. I had no side effects from the Paxlovid. The COVID-19 symptoms were like those with a cold with a sore throat. The fever went away pretty quickly. I isolated and worked from home; I had adequate energy for work. I took another home antigen test on 3/28/2023 and got a negative result, and I got another negative result on 3/30/2023. On 4/3/2023, I tested myself again and got a positive result. I saw my NP earlier today, and he thought it might have been a rebound or just a result of a residual trace of the virus. He advised me to wear a mask and to be cautious when I interact with others.
Patient reported lightheadedness, bump on top lip, and " lump in throat" that started 30 min after vaccine administration at other facility.
After vax, awoke w/ quarter-sized rash on L thigh. Inc to cover approx 2/3 of the L thigh, measured 10x8cm, red swollen, warm. Given abx (Ceftin) empirically for possible cellulitis.
On 03/29/06, patient presented to the immunization clinic in the am for Tdap and pneumococcal as per ordered by Her Dr. On 3/30/2006 pt had appt with her doctor for other reasons. Pt was sent to immunization appt to all out VAERS form. Per pt. Doctor prescription. PCN and was told to apply ice to shot site to decrease swelling. Per pt about 6:00pm she c/o stiffness and soreness (scale of 1-10 per pt pain rates 7) where pneumococcal was given. SQ site was warm to the touch and measured 64 x 69cm, no other complaints from pt.
some sort of tear between her bowels and her urination tract; has come down with shingles/it is dawning on her that it is pain from the shingles; This is a spontaneous report from a contactable consumer, the patient's husband.   An 80-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198), via an unspecified route of administration in the right arm on 20Feb2021 (at the age of 80-years-old) as a single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. The patient received the first dose of BNT162b2 (Lot Number: FL9265) at the age of 80-years-old, administered in the right arm on 30Jan2021 for COVID-19 immunisation. In 2021, the patient experienced some sort of tear between her bowels and her urination tract and shingles. The clinical course was as follows: The patient came down with shingles. It was unknown the date the shingles began for the patient as shingles was not suspected at first.  It could have started maybe 2-3 weeks after the second dose. Then, as of 03May2021, the patient was hospitalized for some sort of tear between her bowels and her urination tract which required an unspecified operation to be performed the same day.  At the time of the report, the patient was still in the hospital and the patient was in quite a bit of pain. It was assumed the pain was part of the operation. However, it was dawning on her that it was pain from the shingles and was worse than before. The clinical outcome of the shingles was not recovered, while that of the tear between her bowels and her urination tract was unknown.   Amendment: This follow-up report is being submitted to allow appropriate reporting to health authorities.
I?m writing to see if this is common or been seen in others. I was supposed to start my period on January 18-20 and it?s the 29th and still have not started. I?m not pregnant. Is this common? I?m not sure if it?s a side effect but I thought I should report if it is, and maybe to gain some knowledge if it is.
A few hours after 2nd Pfizer injection began feeling weak an feverish.  At around  11:00 the next morning I began seeing a flicker effect in the center of the left eye vision.   This flicker grew worse and eventually turned into a Chromatic aberration across the center of vision.  Then after a couple of days the vision started to fade in a washed out brown effect.   Called ophthalmologist  and made appointment.   Two days latter I could not see the fingers on my own hand.  Called Ophthalmologist and they got me in immediately.
headache, localized pain/swelling/erythema at injection site with swelling into anterior lateral chest and under left axilla. Symptoms persisting past 3 days, slow to improve. treatment: Tylenol and Ibuprofen PRN
Pfizer-BioNTech COVID-19 Vaccine  within 1-2 post vaccine administration started to experience tingling of throat (needle like feeling and some neck tightness). Symptoms started to disappear after 10 min and went completely away after 30 min
Vaccine was placed in refrigerator on 17-Feb-2022, expired product date on 01-Apr- 2022, administration date on 05-Apr-2022.; 21 patients administered with expired vaccines/25 Patients Identifiers Update for Safety; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines/25 Patients Identifiers Update for Safety) and PRODUCT STORAGE ERROR (Vaccine was placed in refrigerator on 17-Feb-2022, expired product date on 01-Apr- 2022, administration date on 05-Apr-2022.) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines/25 Patients Identifiers Update for Safety). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was placed in refrigerator on 17-Feb-2022, expired product date on 01-Apr- 2022, administration date on 05-Apr-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines/25 Patients Identifiers Update for Safety) and PRODUCT STORAGE ERROR (Vaccine was placed in refrigerator on 17-Feb-2022, expired product date on 01-Apr- 2022, administration date on 05-Apr-2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Date the vial was initially stored in the refrigerator on  17-Feb-2022. The vial did not undergo any temperature excursions.  It was reported that no patients had come out with adverse events.  The treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Follow-up received contains non significant information.
Headache; fever; chills; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (fever), CHILLS (chills) and ARTHRALGIA (joint pain) 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 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced HEADACHE (Headache), PYREXIA (fever), CHILLS (chills) and ARTHRALGIA (joint pain). At the time of the report, HEADACHE (Headache), PYREXIA (fever), CHILLS (chills) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
9-9-09 - Pt received 3rd GARDASIL vaccination approximately equal to 1:10pm. Approx. 4 hours later, began to "feel funny" and was making "non-lucid statements" while at work. Went home to bed. Woke 9/10/09 approximately equal to 1:00am with headache, mild shortness of breath and low grade fever (100.9). Left arm sore. Advised to go to ER - Pt triaged at ER, waited "4.5 hr" and left prior to being seen by MD. 9-11-09 - Pt reports feeling better. 9-15-09 - Fu call to pt, states "feeling fine". No further complaints.