chrisvoncsefalvay/vaers-outcomes huggingface dataset:
04/06/2022 Vaccination 06/24/2022 Started to experience a tickle in throat 06/25/2022 Coughing, body aches, fatigue. No elevated temperature.  06/26/2022 Medication. Four days later, I felt better.
Pt recvd vax & exp immediate arm pain & it was unclear as to which dose of vax was given in which arm; less than 1 wk p/vax pt devel a white patch of depigmented skin on the deltoid; probably vitiligo; No further details were provided;
On 3 June my arm left forearm started to swell and there it was tight, I did hot and cold regiments thinking I injured it somehow, after the pain persisted I went to the my PCP and he ordered an ultrasound where it was discovered I had a DVT. This was 18 June. I received my second shot on 8 June. And last week I had the same symptoms, I contacted the hematologist and he ordered another ultra sound and now I have another DVT.
Since having the vaccination two weeks ago in my right arm, I have had chronic muscle aching mid-deltoid, moderate weakness and reduced range of motion of my upper arm.
Diarrhea; Vomiting; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), VOMITING (Vomiting), CHILLS (Chills) and FATIGUE (Fatigue) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), VOMITING (Vomiting), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, DIARRHOEA (Diarrhea), VOMITING (Vomiting), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up information received. Contain no new significant information. Only Contact details were updated.
severe chest pain, vomiting, shortness of breath, lethargy, swelling, redness and hardening around injection site. ER did and ekg in which results were ok. Symptoms also started to go away around this time (hour to hour and a half later) Redness, pain and hardness around injection site remained.
had arm soreness in her left arm from the injection; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that: A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), via an unspecified route of administration in left arm on 22Jan2021 8:00 at single dose for COVID-19 immunization. The patient medical history included Transient ischaemic attack (TIA) which was not ongoing.  The patient's concomitant medications were not reported.  The patient previously took 2 baby aspirin (162 mg) every evening and has done this for the past 15-20 years for Transient ischaemic attack. Received call from consumer regarding the Pfizer COVID vaccine. The reporter who asks if taking her regular regimen of 2 baby aspirin daily will interfere with the vaccine effectiveness. She had first covid vaccine dose Friday on 22Jan2021 at 8 am. She had no reaction other than a little soreness in her arm from the injection after getting the vaccine in Jan2021 and it went away in a couple of days. She just massaged her arm and it was fine. She reported that due to a history of TIA she took 2 baby aspirin every evening and has done this for the past 15-20 years. After getting her vaccine she was told that taking aspirin may interfere with the antibody response and she called today to ask if that was true and if she should take an antibody test. She was reading on some links yesterday about blood thinners. It kind of freaked her out. She took 2 baby aspirin daily and together it was 162 mg, which she has been taking for years. She used to get trans ischemic attacks and has not had any since she has been taking them. She took them at 6 pm, which she did the evening before she had the vaccine. She called to check, to see if taking 2 baby aspirin every day for the past 15 to 20 years would affect the vaccination that she got. She asked because she had someone telling her after getting the vaccine, oh you shouldn't have done that and so she called to check and to see if that was okay. She would be taking second dose on 12Feb2021. She would like to know if that reduced the effectiveness for her. She had not heard that anywhere previous or she would have stopped taking the aspirin 5 days prior. She was feeling fine. The outcome of the event 'arm soreness in her left arm from the injection' was recovered in Jan2021.   Information about lot and batch number has been requested.
BLOOD CLOTS IN LEGS; EYESIGHT TROUBLE; ARM SORENESS; TIREDNESS; WEAK; This spontaneous report received from a consumer concerned an elderly female. The patient's height, and weight were not reported. The patient's concurrent conditions included: cigarette smoker. The patient has no known drug allergies, has no history of drug abuse or illicit drug use and does not drink alcohol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clots in legs, eyesight trouble, arm soreness, tiredness, and weak. the reporter stated that the patient recently had a "procedure" for this issue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clots in legs, arm soreness, tiredness, weak, and eyesight trouble. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210800541.; Sender's Comments: V0: 20220254679- covid-19 vaccine ad26.cov2.s Blood clots in legs. 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). Therefore, this event(s) is considered unassessable.
Mild headache, feverish feeling but when I checked my temperature after work it was normal. I felt chills in the morning but it didn?t last long. I still feel a little feverish but the thermometer reads normal.
Onset of shingles symptoms approximately 2weeks after first dose. Rash on right chest and right middle back, head ache, chills, sore muscles, fatigue, light sensitivity, skin numbness. Rash has since blistered.
Itching and red spots at injection site. Redness is getting bigger. This was reported 6 days after injection.
Several years ago I got the shingles shot in October / got Inner shingles/ Suspected vaccination failure; got Inner shingles; Pain you can't scratch; Pain you can't scratch; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, between 2 and 4 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and pruritus. On an unknown date, the outcome of the vaccination failure, shingles, pain and pruritus were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and pruritus to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age group was not reported but was selected as adult as per vaccine indication. The age at vaccination was not reported. Several years before the reporting date, the patient got the shingles shot in October and got inner shingles in January.  The patient had never heard of inner shingles but patient's M.D. (Doctor of medicine) and a specialist confirmed.  The patient had pain that could not be scratched.  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting.
Shortness of breath and rushed to ER - they found massive blood clot in both lobes of my lungs.  No sign of Deep Vein Thrombosis - seems a mystery.  Almost fatal if not gotten to ER so quickly they said.  I was in the ICU from 4/7 - 4/10
No AE; Nurse reported on Sep 28, 2023, a two month old patient was accidently administered a dose of GARDASIL 9. Nurse stated no adverse events have been reported as of now, but she has still not called the patients parents. The patient was suppose to recei; Nurse reported on Sep 28, 2023, a two month old patient was accidently administered a dose of GARDASIL 9. Nurse stated no adverse events have been reported as of now, but she has still not called the patients parents.; The patient was suppose to receive Prevnar 13. Nurse stated the HCP who administered the product must have gotten the products confused because GARDASIL 9 was not ordered.; This spontaneous report was received from a nurse and refers to a 2-month-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 28-SEP-2023, the patient was accidently administered a dose of HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, once, valid lot #W014513, expiration date: 26-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided) (Wrong product administered) (Product administered to patient of inappropriate age). The patient was supposed to receive pneumococcal vaccine conj 13v (crm197) (PREVNAR 13). Nurse stated the healthcare provider (HCP) who administered the product must have gotten the products confused because HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not ordered (Product confusion). Nurse stated no adverse events have been reported as of now, but she had still not called the patients parents. No further information provided.
pt lives in a nursing home; had a positive COVID test on 1/11/22 in nursing home; placed on isolation; on O2 supplementation; DNR; pt passed away in the nursing home; per death certificate, the cause of death was COVID 19
mottle skin and welts; an unspecified illness; lab work done to determine immunity to chicken pox and was found to have low titers; mottle skin and welts; shingles rash; This spontaneous report was received from a nurse practitioner referring to a 3 years old male patient. The patient's drug reaction/allergies included several unspecified antibiotics and "Zith". The patient had no concomitant medications.  On an unknown date (reported as at 3 years old age), the patient received varicella virus vaccine live (oka/merck) (VARIVAX) with sterile diluent (MERCK STERILE DILUENT) (both dose, unit, lot#, and expiration date were not reported), subcutaneously for prophylaxis. A few days later, he developed a shingles rash and was treated with diphenhydramine hydrochloride (BENADRYL). The second dose of varicella virus vaccine live (oka/merck) (VARIVAX) was not given due to the shingles rash.  On an unspecified date, the patient also developed mottle skin and welts after taking azithromycin in elementary school for an unspecified illness. He had had similar skin reactions to several other unspecified antibiotics in his childhood. The reporter did not know any lot number or expiration information or the manufacturer of either product due to how long ago these reactions occurred. The patient had lab work done to determine immunity to chicken pox for his Program and was found to have low titers. In order to continue in his program, he would need another dose of varicella virus vaccine live (oka/merck) (VARIVAX). The outcome of all events was reported as recovered. The causality assessment was not provided.
Intense nausea and  vomiting; uncontrollable chills that lasted for hours; cold skin; weakness (unable to stand}; extreme exhaustion
Left arm is sore and feels weak, similar to the first 24 hours after I got the shot. But that went away until today.  The joint where my arm connects to shoulder hurts and the pain increases when pressure is applied or movement of the arm happens.
fever; discomfort as well as breathing; discomfort as well as breathing; he experiences a shortness of breath; This is a spontaneous report from a Pfizer sponsored program. This contactable male consumer (Patient) reported for himself that: A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unknown), via an unspecified route of administration on 22Apr2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 22Apr2021 after the vaccination, the patient experienced a shortness of breath. On an unspecified date, the patient experienced fever and discomfort as well as breathing. On an unspecified date, the patient underwent lab tests and procedures which included PCR test: unknown result (he was waiting for the result). It was reported that, patient had his 1st shot this 22Apr2021. He did some workout in the gym after taking it, then after getting home, he experiences a shortness of breath that was about 45mins, the day after which was Friday, he felt fever and discomfort as well as breathing. On the same day, he actually did a PCR test, and he was still waiting for the result. Patient was concerned if those experiences was from COVID-19 or from the vaccine. Unaddressed medical questions were not referred or forwarded to Medical Information. The outcome of events was reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
added a different diluent on the vaccine itself coming from a different manufacturer and not the diluent that comes with the vaccine, with no reported adverse event; Initial information received on 17-Mar-2022 regarding an unsolicited valid  non-serious case received from a other health professional via call center.  This case involves a 3 months old female patient who experienced different diluent on the vaccine itself coming from a different manufacturer and not the diluent that comes with the vaccine, with no reported adverse event while receiving vaccine HIB (PRP/T) Vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria vaccine toxoid, hepatitis b vaccine RHBSAG (Yeast), Pertussis vaccine acellular 3-component, Polio vaccine Inact 3V (VERO), Tetanus vaccine toxoid (Pediarix) for Prophylactic vaccination; and Pneumococcal vaccine conj 7V (CRM197) (Prevnar) for Prophylactic vaccination.  On 16-Mar-2022, the patient received 0.5 ml dose of suspect HIB (PRP/T) Vaccine unknown formulation, (batch lot UJ522AA expiry date unknown) via intramuscular route for immunization.  On an unknown date the patient developed a non-serious event added a different diluent on the vaccine itself coming from a different manufacturer and not the diluent that comes with the vaccine, with no reported adverse event (product preparation error) (unknown latency) following the administration of HIB (PRP/T) Vaccine.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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.
pt recv vax & was found to be pregnant;23JUN96 pt delivered by C-section a nl male 2mo premature;baby devel elevated bilirubin & was monitored in a high risk hosp;
This spontaneous report was received from a licensed practical nurse and refers to unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # M000442, expiry date: 31-MAR-2018, dose and route of administration were not reported). No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. Follow up information has been received on 08-MAY-2016 from the nurse and refers to 13 weeks old patient of unknown gender. Om 26-AUG-2016, the patient received improperly stored doses of RECOMBIVAX HB and ROTATEQ (orally, dose was not reported). This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012794: US-009507513-1608USA012916:
pt recv vax 22NOV98 & 24NOV98 noticed rash over chest;area large & itched ;physical exam WNL;
pt stated he had a head ache about 15 minutes after getting the vax but subsided quickly.  When he woke up the next morning he had tightness in his chest that last a while and then went away.  A couple of days later he had a dizzy spell which would come and go.  This lasted about 3 days.  He had another episode of tightness in his chest.  On 3/7/2021 he developed a red rash on his chest that had a hive in the middle of it that was itchy.  He started getting itchy spots on the top of his hands, fore arms, top of his ears, and the top of his head.   At this time he only has slight rash on his chest and shoulders that are not itching.
The patient c/o of pain, erythema, edema and cellulitis at injection site.
Kidney transplant on 4/11. Immediately after surgery severe R groin pain. Within 7 days, leg continued to swell, pain continued, and clots (DVT?s) were found via ultrasound in the R groin, R calf, L calf. Readmitted to the hospital where anticoagulant therapy found unsuccessful. Clots continued to grow. Pt was put on heparin. Pt has no history of blood clotting disorders.
Severe sharp pain from injection site up to shoulder to neck and also down to the elbow, to the wrist, to hand. Could not grasp and hold things with any weight in my left hand. Left armpit swollen and painful to any touch. Severe hip joint pain. Severe lower back pain. The injection site was red, swollen, warm, and itchy. I contacted my doctor's office, the nurse called me back and suggested heating paid, moist heat, bath soak, Tylenol since I'm allergic to NSAIDs. I had already tried all those plus ibuprofen. I took Tylenol pm to help try and sleep. It helps a little but not with pain. I am 10 days post Booster and still have hip joint pain and when I move my left wrist a certain way sharp pain into my fingers. I can now grasp and hold things with my left hand. You can still see where my injection site is but there is no pain, warmth, or itchiness. My lymph node in my armpit is not swollen and almost entirely pain-free. I have been extremely fatigued this entire time. I see my doctor for a physical and follow-up on 01/14/22.
Client received vaccine at 12:00pm after passing risk screening and completing consents at a vaccination clinic event at a local fire station. At 12:09pm, while client was sitting in the waiting area after vaccination as part of the recommended protocol to monitor for adverse events post-vaccination, she began feeling unwell. She started to walk toward the vaccination stations and was stumbling. Staff escorted her to a preassembled cot and had her lie down. The patient reported feeling "tingling" in her face, throat and lips and felt like her lips and tongue were swollen. There was no swelling visually apparent.  Staff called 911, and assessed patient, collected some vital signs (BP 140/90, pulse 83, O2 sats 100,%) and prepared epiniphrine auto injector pen. First responders who were in the fire station building arrived promptly. The patient continued to feel swelling in her throat, but no difficulty breathing . She appeared pale and weak but did not exhibit other signs of anaphylaxis. The healthcare team administered epinephrine in left deltoid. EMS arrived, and team gave report. Care was transferred to EMS. EMS transported patient to local hospital. Patient walked to ambulance without difficulty.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Additional Details: Per patient, she experienced a red/pink rash on arm around injection site.  Arm is rock hard, painful, and warm to touch.
Flu shot on Oct. 9th. Pain since the day after he got a shot. No pain the day of the shot. + flu shot in the past. No reaction ever. Woke the next am with pain. That was 6 weeks ago..Pain was at his AC joint. Has not been active since that day, just walking. Typically plays basketball but not that night. Iced the first week. Pain persists.  Seen by PA on 11/8/2019 - tx with heat, regular ibuprofen and ROM exercises.  Follow up appt on 11/22/2019 sx persist, but are resolving
Developed flu-like illness that was characterized by fatigue, weakness, anorexia, fever & sweats; Lab eval revealed liver func 1-1/2 to 2 times the upper normal limit; dx hepatitis;
Office visit notes Patient is a 32 y.o. male presenting on 8/4/2021 for Chest Pain   This am awoke with feeling of pressure in chest. Had first Pfizer vaccine two days ago in this office. No SOB. Has been working outside, using forklift to load and unload with no change in symptoms. No previous hx. No hx of CAD. Family hx - MGF deceased from MI in his 70s. PE alert NAD, Lungs clear, CV RRR without murmur. Left arm injection site - no erythema or swelling of site or left arm. EKG." written by Dr.  EKG was abnormal  Inferolateral ST-elevation  Patient was transported to the hospital via ambulance