chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 4 weeks developed a severe DVT in right leg and multiple pulmonary emboli bilaterally in both lungs; Within 4 weeks developed a severe DVT in right leg and multiple pulmonary emboli bilaterally in both lungs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 27Dec2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 54 years for covid-19 immunisation. The patient's relevant medical history included: "Sleep apnoea syndrome" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: moderna (Prev dose product=COVID 19, Prev dose brand=Moderna, Prev dose brand unknown=False, Prev dose lot number=019B21A, Prev dose lot unknown=False, Prev dose administration date=09Apr2021, Prev dose number=2), administration date: 09Apr2021, when the patient was 53-year-old, for COVID-19 Immunization; moderna (Prev dose product=COVID 19, Prev dose brand=Moderna, Prev dose brand unknown=False, Prev dose lot number=03021A, Prev dose lot unknown=False, Prev dose administration date=12Mar2021, Prev dose number=1), administration date: 12Mar2021, when the patient was 53-year-old, for Covid-19 immunization. The following information was reported: PULMONARY EMBOLISM (hospitalization, disability, medically significant, life threatening), DEEP VEIN THROMBOSIS (hospitalization, disability, medically significant, life threatening) all with onset 26Jan2022, outcome "not recovered" and all described as "Within 4 weeks developed a severe DVT in right leg and multiple pulmonary emboli bilaterally in both lungs". The patient was hospitalized for pulmonary embolism, deep vein thrombosis (hospitalization duration: 7 day(s)). The events "within 4 weeks developed a severe dvt in right leg and multiple pulmonary emboli bilaterally in both lungs" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Feb2022) Negative. Therapeutic measures were taken as a result of pulmonary embolism, deep vein thrombosis.   Clinical course: Treated with Heparin by IV and Eliquest for up to 1 year. No covid prior vaccination. No known allergies.  No follow-up attempts are needed. No further information is expected.
Fever, chills, large swollen arm, patient fell down and hit head at 2:30am when walking dog.  Attributes the fall the the covid shot.
Information was received from a registered nurse, regarding unspecified patients (demographics not provided). The nurse reported that ROTATEQ; GARDASIL (case #1404USA000049); and PEDVAX HIB (case #1404USA010717) were potentially exposed to a 33F and a 24F recording, which she believed to be erroneous recordings of a digital Vaccines for Children (VFC) Thermometer, and have been administered to unspecified patients (dates of administration, lot numbers, dosages and route of administration not provided). The nurse reported that she believed that the thermometer that gave her the readings is inaccurate. She stated that her facility has a mercury thermometer that read temperatures that were in the recommended range. No adverse effect reported. Additional information has been requested.
SPLENIC VEIN BLOCKAGE; VACCINE-INDUCED THROMBOTIC THROMBOCYTOPENIA; This spontaneous report received from a patient through social media via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, frequency time 1 total was administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, (after taking the J&J vaccine) the patient was diagnosed with vaccine-induced thrombotic thrombocytopenia and was on blood thinner for life. The patient would be possibly facing a splenectomy in the near future since the splenic vein was completely blocked and it would not get any better. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from splenic vein blockage, and the outcome of vaccine-induced thrombotic thrombocytopenia was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211139590-Covid-19vaccinead26.cov2.s- splenic vein blockage-This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20211139590-Covid-19vaccinead26.cov2.s-vaccine-induced-thrombotic thrombocytopenia -This event(s) is labeled per RSI and is therefore considered potentially related.
Expired vaccine used/The vaccines was stored in freezer, we take out one to two vials and place in fridge each day as; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/The vaccines was stored in freezer, we take out one to two vials and place in fridge each day as) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/The vaccines was stored in freezer, we take out one to two vials and place in fridge each day as). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/The vaccines was stored in freezer, we take out one to two vials and place in fridge each day as) 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 information was provided.
Information has been received from a female pharmacist who developed shingles on 11 FEB 2007, two weeks after her daughter was vaccinated, on 30 JAN 2007, with varicella virus vaccine live (Oka/Merck). On 14 FEB 2007, the patient was seen medically for a mild episode. On an unspecified date the event resolved without complications. The patient sought unspecified medical attention from her physician. There was no product quality complaint. There were no lab diagnostic studies performed. Additional information has been requested.
PNEUMOVAX and flu shot given in left deltoid. Diagnosed with cellulitis, fever. Treated with Doxycycline Hyclate 100mg PO BID x 10 days.
Passed out 10 minutes after vaccination. I was driving, resulted in a car accident. The pharmacy did not have me wait after vaccination.
Insomnia for 1 week; This is a spontaneous report from a non-contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Sep2021 at 14:15 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included allergic to sulfa. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any vaccines within four weeks prior to vaccination. Concomitant medications were not reported. The patient previously took terbinafine (MANUFACTURER UNKNOWN) and experienced drug allergy. On 08Sep2021 at 01:30, the patient experienced insomnia for 1 week. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event insomnia for 1 week was resolved on 15Sep2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Full body itching. No hives, redness, warmth, or rash. 25mg PO Benadryl administered. Pt educated on the need to emergently come to emergency department if there is any noticeable change in status . Specifically: If patient starts to experience any respiratory issues, peri-oral itching or tingling, throat tingling, or if Benadryl does not alleviate itching.
The morning following vaccination, the patient experienced a worsening "high" fever, pain and swelling in the arm where she was injected. It was indicated that the patient had sought medical attention. The patient's experiences persisted for 10 days. Additional information has been requested.
soreness at injection site; Neck felt stiff; Flushed face/face felt hot; Flushed face/face felt hot; Felt "off"; "Off" feeling was a bit foggy-brained; weakness; Injection site swollen; This is a spontaneous report from a non-contactable consumer, the patient. A 63-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ERE737) via an unspecified route of administration on 01Apr2021 at 11.30 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medication. The patient had history of known allergies to insect bites (slight reaction to insect bites, no EPI pen needed/used). The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021, 20 minutes after vaccination, the patient experienced flushed face, face felt hot and felt off. That off feeling was a bit foggy-brained, weakness but was not so much that she had to stop what she was doing. Neck felt stiff about 30 minutes after vaccine. These symptoms lasted about an hour and Injection site was swollen for first 8 hours or so. Day after vaccination, only minor soreness at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcomes of flushed face, face felt hot, felt off, foggy-brained, weakness, neck felt stiff, Injection site swollen were recovered on 01Apr2021 and of the soreness at injection site was recovered on 02Apr2021.  No follow-up attempts are possible. No further information is expected.
Immediately after vaccination, discussed her history of emphysema and discussed the fitting of the N95 mask to her face for good protection.  A few minutes later, while under observation the client reported feeling dizzy  and having palpitations.  Her pulse was irregular with some very strong beats and some weaker; she was pale.   We assisted her to recline on a cot and recommended removal of the mask for increased fresh air, considering her symptoms.   She recovered well with the observation of other RN, who also found there were some concerns about her morning medication and hydration.   She was given water to drink.  She was held until she felt really well for 15 additional minutes, and then she headed off to Bible Study, (saying she felt well enough to go shopping) confirming that she had a cell phone with her and would stop driving immediately if she had any symptoms.    Called her at home at 3:30 pm and she reported having a very good day.    ( in review note that her vaccine appointment information requested reasonable accommodation "required a place to sit if standing for long periods is required", and she reported a prior history of a severe allergic reaction).   RN 5/11/22 3:45 pm. Pt reported that on the morning of 5/11/22, due to early morning dose of thyroid medication that she had nothing to eat or drink prior to vaccintion.  Pt also reports hisotry of insomnia averaging about 4 hours of sleep a night.   PHN 5/13/22 08:30
Client presented to receive Moderna Booster. Vaccinator was vaccinating client when syringe detached from needle while still in the arm. Some of the vaccine liquid leaked on patients arm while the rest of it stayed in syringe. stated that less than half of the dose had been injected. Client stated he wanted to be revaccinated with full dose. Vaccinatorrevaccinated client with Moderna booster.
Fever; chills; lethargy; body aches; headache that kicked in 12 hours; This is a spontaneous report from a contactable healthcare professional. A 29-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date not reported), via an unspecified route of administration in the left arm on 09Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to and post vaccination. Since the vaccination, the patient has not been tested for COVID-19. On 09Jan2021, the patient experienced fever, chills, lethargy, body aches, and headache that kicked in 12 hours after the vaccination and lasted for 24 hours. Clinical outcome of the events was recovered on an unspecified date.
Fatigue, body aches, head ache, chills. On 2/16/2021 at 8am. Low grade temp of 99.0 degrees
Presented to medical facility 8/13/21 for Moderna Covid-19 vaccine When asked if this was her first vaccine, she responded "yes" She also marked "no" to "Ever received a COVID-19 vaccine?" After administering the injection, she stated, "I guess you can't take that back, right?" She then stated that this was in fact her third COVID-19 Moderna vaccine and she just received a booster and felt bad about lying about  Notified Director of Health Services
Pt recv vax on 4/28/98; 30 min post vax pt exp fever, diarrhea, vomiting & headache
Pt recvd vax 21APR93 & exp h/a, nausea, dizziness, vomiting & a local react manifested by redness, swelling, heat & soreness;
12 hrs post 2nd vaccine-bad stomach ache 24 hrs post 2nd vaccine-bad muscle aches over entire body, nausea, headache, very tired  2 week post 2nd shot-still having bad body aches and still tired
pt recvd vax & w/in 24hrs p/vax pt exp a fever of 100;sx resolved w/in 24hrs;
Hives all over body, itchy skin all over body, redness all over body, swelling/welts all over body.
Immediately, post vax, the MMR in left upper arm, a 2"-3" area around the injection site became red and inflammed. Child observed about 20 minutes in clinic with no visible signs of a systemic reaction. Mom was advised to watch site and if not improved or if worsens in the next 24 hours, to see MD.
DIZZINESS NAUSEA VOMITING DIARRHEA HEADACHE AND FACIAL TINGLING FEELING NUMB AT TIMES FACIAL LT MILD MOUTH DROOP NOTED LT EYEBROW SLIGHTLY LESS ELEVATED ABLE TO SQUINT EYE OK   NEURO NEG ROMBERG NORMAL RAPID F-T-N GAIT NORMAL GOOD UE/LE STRENGHT   GOOD GRIP
Patient received third dose of Prevnar 13 at age 9 months, but it was too early since patient had received the second dose at 7 months old on 12/14/22. In this case, the patient must wait until 12 months of age to receive the third dose.
Acute onset of dizziness, nausea, later vomiting.  Started 0730 upon arising.  Last vomiting was about 12:45 (5 hours of duration) with residual nausea.  Went to the Emergency Department to rule out early signs of a stroke.   Tests (lab, chest xray, CT Brain, MRI Brain) were all negative.  I was discharged.  Perhaps this series of symptoms started from irritation in nerves in ears (problem I had in 2015). I had my first stroke (Lucunar pin point in Left hippocampus) that resulted in amnesia (inability to form new memories for a few hours).  THere were NO motor function changes and the only thing positive was the MRI.  This stroke  was 5.5 months after second Moderna.
Woke up with ringing in the left ear. Has continued now as ringing in my head.
vaccine given on 15 Aug 03, today 19 Aug 03 my upper left arm has a swollen area approximately 2 inches X 1 1/2 inches and firm, hot and sore to the touch and is sore to move.  Was told by PCP this was a moderate reaction, take motrin, use ice packs and if it's still this way in 2 weeks, make a follow-up appointment.  Was also told to keep an eye on any increased redness, this was unusual but not unheard of.
Arm  pain  both at injection site and also  ache throughout left arm. Pain was more intense on day after the injection. (Wednesday 03/31). By. Thursday, 04/01, the  pain was reduced and was very subtle.
expired dose administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported. On 01-Dec-2021 the vial was initially stored in the refrigerator and the vial did not undergo any temperature excursions. Some patients had reported flu-like symptoms after receiving the vaccination but the reporter did not have details on that.
Right hip pain without history of injury. Not able to walk starting 10/2 and 10/3. X-ray and lab test ruled out other causes. Diagnosed as Toxic Synovitis based on symptoms. Pain subsided 10/4.
Narrative: first dose moderna 9/3/21 second dose moderna 9/30/21 covid positive 12/17/21 Patient with hospitalization related to COVID 12/22/21-12/23/21
Information has been received from a physician concerning a 2 month old female who on 11-OCT-2007was vaccinated PO with her first 2.0 mL dose of RotaTeq vaccine. In 2007, the patient experienced a fever of 102.5 degrees Fahrenheit  and watery and frequent diarrhea. The patient was seen in the emergency room, but was not admitted to the hospital. Blood and urine studies were performed. Subsequently, the patient recovered. There was no product quality complaint. Additional information has been requested.
Redness, tenderness, swelling at left deltoid extending to autocubital/elbow regions within 24 hours of Pneumovax. Keflex, Benadryl and warm compresses.
Narrative:  84 year old male admitted on May 29 2022 with with worsening hallucinations. He was found to be COVID positive on June 7 2022 during routine surveillance screening and had mild hypoxia, cough, and wheezing. He had received Moderna vaccine x 3 on February 11 2021, March 11 2021, and December 7 2021. He was treated with remdesivir 200 mg IV x 1 then 100 mg daily x 4 days and methylprednisolone 20 mg IV q8h x 3 days and then dexamethasone 6 mg orally daily x 5 days. On June 8 2022 patient was noted to have an elevated D-dimer and found to have PE. He was noted to have clinical deterioration and went to comfort care on June 13 2022 and expired on June 15 2022.
Pt. had a reaction on the RD with the DTaP and MMR vaccine. The reaction is 50x60mm. The treatment is to apply heat.
Seized; This case was reported by a consumer via interactive digital media and described the occurrence of seizure in a 16-year-old male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   Co-suspect products included meningococcal A vaccine for an unknown indication.   In August 2020, the patient received Meningococcal B vaccine. On an unknown date, the patient started meningococcal A vaccine at an unknown dose and frequency. In August 2020, less than 2 weeks after receiving Meningococcal B vaccine, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure was unknown.   It was unknown if the reporter considered the seizure to be related to Meningococcal B vaccine.  Additional details were reported as follows: It was reported the patient received A and B last week from the date of reporting and seized in the parking lot on his way out of the office.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 09-AUG-2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) by a physician, for routine adult health maintenance and the intended purpose for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 20-DEC-2012, the patient was treated by a physician assistant for a vesicular outbreak, which was diagnosed as shingles. The patient was prescribed FAMVIR for management of her painful symptoms and chronic pain. The outcome of the events is unknown. 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. Additional information has been requested.
0.25 ml fluviron given.  Rec for 74 yrs.  No reaction.
Initially in the first 3-5 days sore arm, mild headache and upset stomach. 11 days later began itching all over. With itching getting welts and hives. Pressure sensitive. Improves with ice or cold compress. PCP recommended antihistamine and Pepcid AC which I have been taking for 3 days without significant relief. Anti itch cream temporarily helpful. Hydrocortisone cream tried once immediately made the hives worse.
PATIENT DEVELOPED VERY ITCHY URTICARIA - SMALL BUMPS BEHIND HIS ARMS, ON HIS BACK, TORSO, CHEEKS.
This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Lost Sense of Smell and Taste after the Second Shot) and AGEUSIA (Lost Sense of Taste after the Second Shot) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 041B21A) for COVID-19 vaccination. No Medical History information was reported. On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-May-2021, the patient experienced ANOSMIA (Lost Sense of Smell and Taste after the Second Shot) and AGEUSIA (Lost Sense of Taste after the Second Shot). At the time of the report, ANOSMIA (Lost Sense of Smell and Taste after the Second Shot) and AGEUSIA (Lost Sense of Taste after the Second Shot) was resolving. No concomitant medications was reported. No treatment information was not provided.