chrisvoncsefalvay/vaers-outcomes huggingface dataset:
neurologic side effects; cardiac and respiratory complications; cardiac and respiratory complications; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on (03Nov2023), this case now contains all required information to be considered valid.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: RESPIRATORY DISORDER (medically significant), CARDIAC DISORDER (medically significant) all with onset 2022, outcome "unknown" and all described as "cardiac and respiratory complications"; NERVOUS SYSTEM DISORDER (medically significant) with onset 2022, outcome "unknown", described as "neurologic side effects". Therapeutic measures were taken as a result of nervous system disorder, respiratory disorder, cardiac disorder. Within 48 hours the patient experienced neurologic side effects, to be followed by cardiac and respiratory complications. After 5 months of treatment the patient was able to stop medication and return to full normal activity.   The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided, and a temporal association, a causal association between reported events and suspect  bnt162b2, bnt162b2 omi ba.4-5 cannot be excluded.This impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Previous, all menstrual cycles were approximately 30 days (very heavy bleeding). In July I had a very light period and I have not had any period since then. I just saw the obgyn Dec 22 and started taking a 12 day dose of a progesterone medication. I also just received my Pfizer booster on 12/23
Swelling of arm, pain, rash as well as swelling of her throat. ER 6/28.Tx with ?? and Benadryl. Treated with Keflex 500 mg QID for 1 week begining 6/30.
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a six-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 20-Nov-2011. The patient received expired FLUMIST on 23-Nov-2011. The patient received a repeat dose. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. The reporter stated that the patient did not experience any late occurring adverse events.
Covid-19; Covid-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6203), in right arm, on 18Mar2021 as dose 2, single (Lot number: EN6207), in right arm and on 08Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 64 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "type 2 diabetes" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN, start date: Jan2012; BASAGLAR, start date: Jan2014; OZEMPIC, start date: Jan2018; JARDIANCE, start date: Jan2016; RAMIPRIL, start date: Jan2012; ROSUVASTATIN, start date: Jan2017.   The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Apr2022, outcome "unknown" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05May2022) Negative; (10May2022) Positive; (29Apr2022) Positive. Therapeutic measures were taken as a result of covid-19.   Clinical information: The patient had no known allergies. The patient had Rebound Covid Infection. The patient tested positive with symptoms 29Apr2022. The patient started and complied with 5-day course of Paxlovid for treatment of COVID-19 through 03May2022. Symptoms resolved antigen test negative on 05May2022. Developed URI symptoms on 09May2022. Antigen test positive on 10May2022.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events Vaccination failure and COVID-19 which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available.
throwing up, high white blood cell count, raspatory arrest, cardiac arrest, un able to destabilize,  death do to organ failure
Pt complained of severe headache for 2 days. Seen by MD and was hospitalized.
Patient came to pharmacy for first Moderna immunization, nervous about getting the vaccine. Patient instructed to wait near pharmacy for 15 minutes. 15 minutes after injection, patient reported sore shoulder, neck pain and side of throat "felt swollen." She did not have itching or swelling of face, lips or tongue. No trouble breathing. No trouble swallowing. Patient did not have hives. No indication of an anaphylactic reaction. Patient seemed nervous still. Patient asked to wait additional 15 minutes to see if a reaction would develop. No change in symptoms. Patient instructed to seek emergency help if symptoms worsen, do not go away, or if an anaphylactic reaction develops. Patient called pharmacy on 11/11/2021 to report additional symptoms to pharmacy she had after getting the vaccine: Continued pain in shoulder, "left throat swelling" (received vaccine in right arm), severe muscle pain in calves, nausea, loss of appetite, chronic diarrhea and extreme fatigue for 2 weeks. Patient claimed she had no reaction to a vaccine in the past. Patient said she visited her doctor and doctor told her not to get another COVID-19 vaccine.
stated that her husband has asthma, less well controlled; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Jan2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient has asthma, less well controlled on an unspecified date with outcome of unknown. It stated that he was fine.  Information on the Batch/Lot number has been requested.
Information has been received from a health professional concerning a patient who was vaccinated with a dose of VARIVAX (Merck) (lot number, injection site and route not reported).  Subsequently the patient experienced post vaccination rash.  A physician sent a sample to the report's lab for PCR testing to determine if the patient's rash was caused by the vaccine strain of VARICELLA or wild type VARICELLA.  The reporter would not disclose what VARICELLA vaccine was used in the patient or any information regarding the patient or the physician.  No further information is available.
Patient was brought in to office visit by grandmother. Medical assistant reviewed shot record on file and electronic record and determined child was missing vaccines. She asked grandmother if she happened to have an additional vaccine record because according to our records on file child was in need of vaccines. Grandmother stated she didn't have any other record and authorized MA to administer vaccines. Once vaccines were administered grandmother found the shot record and upon reviewing shot record the medical assistant found that the child had already previously received Kinrix and Proquad.
This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. No medical history, concurrent conditions or concomitant therapies were reported. On unknown dates in 2010, the patient was vaccinated with two doses of GARDASIL (lot #, expiration date, dose, route of administration and anatomical  location were not reported). On an unknown date, the patient received the third dose of GARDASIL 9 (lot #, expiration date, dose, route of administration and anatomical location were not reported) because GARDASIL was not available. No adverse symptoms were reported. Additional information has been requested.
Pt was given the wrong vaccine. Pt was given MENACTRA. She was to receive Hep A.
Developed hives on facial cheeks within a few hours of receiving IZ's. As of next day has intermittent hives increasing on arms, legs, chest and face.
This is a spontaneous report from a contactable Physician. An 80-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced allergy "pneumonia vaccination" on an unspecified date with outcome of unknown. Pfizer is a Marketing Authorization Holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) has submitted the same report to the regulatory authorities.
Face flushed, Itching started on right arm, Went back of neck and head, then down her body. Itching More severe on upper torso than legs. Mother took child to ER. Child received Benadryl.
sore arm; achy; not feeling well (flu like); not feeling well (flu like); swollen arm; no appetite; headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; PAIN (non-serious), outcome "unknown", described as "achy"; INFLUENZA LIKE ILLNESS (non-serious), MALAISE (non-serious), outcome "unknown" and all described as "not feeling well (flu like)"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swollen arm"; DECREASED APPETITE (non-serious), outcome "unknown", described as "no appetite"; HEADACHE (non-serious), outcome "unknown", described as "headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Cellulitis appeared less than 12 hrs after vaccination- redness, swelling about the size of golf ball. Patient called about 5 days later reporting and reported to office 8 days after event with continued erythema, heat and underlying fluctuation about 3.5cm in width. Reports improved and no longer painful.
Pt recvd 1st & 2nd dose of hep B vax on 14JAN91 & 11FEB91.P/ 1st dose pt exp tachycardia,tingling in chest.P/ 2nd dose pt exp tachycardia,flushed,ht feeling in chst,difficulty breathing,malaise,lethargy,pain,swelling @ inject site & itching
-swelling (5" x 3") red, sore for 7 days - chills and temperature 2/2/2021 starting at 4:00 p.m. and lasting  approximately 12 hrs.  Temperature 101.2 reduced with Ibuprofen
Vaccine exposure during pregnancy; Soreness at injection site; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) and VACCINATION SITE PAIN (Soreness at injection site) in a 36-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 06-Sep-2021. On 23-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) and VACCINATION SITE PAIN (Soreness at injection site). On 23-Dec-2020, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, VACCINATION SITE PAIN (Soreness at injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Concomitant medication use was not provided.  Patient reported date of last menstrual period was unknown but also reported it was in November 2020.  No Treatment information was provided.  This is a case of product exposure during pregnancy with an associated adverse event of vaccination site pain in the mother. Based on temporal association a causal relationship cannot be excluded. For the event transposition of the great vessels a case for the unborn fetus has been requested to be opened.; Sender's Comments: This is a case of product exposure during pregnancy with an associated adverse event of vaccination site pain in the mother. Based on temporal association a causal relationship cannot be excluded. For the event transposition of the great vessels a case for the unborn fetus has been requested to be opened.
loss of sense of smell; fatigue; mild diarrhea; This is a spontaneous report from Pfizer sponsored program via a contactable consumer (patient). A female patient of an unspecified age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 22Jan2021 (Batch/Lot number was not reported; Reason for no lot number: Patient unwilling to complete the report) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient got the COVID vaccine last Friday on 22Jan2021. The Patient had been having different side effects. Today on 29Jan2021 she had lost the sense of smell. She was not feeling bad. She wanted to know if she needs to take next steps. On 29Jan2021, experienced loss of sense of smell and on an unknown date in 2021 experienced fatigue, and mild diarrhea. The outcome of all events was unknown.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
36 hours of extreme fatigue (sleeping for 12 hours a day). On 04/25/2021, body aches started and lasted for about 6-8 hours
Severe pain at injection site on left shoulder.  Inability to lift shoulder more than approximately 4 inches.  The next day, aches all over body, chills, fatigue, headache, muscle and joint pain throughout the body
~ 5 minutes after vaccination, became diaphoretic, c/o light headedness,skin color appeared grey.  States he hadn't eaten since breakfast (now 2:30 pm).  Had just been doing hard work outdoors in the heat.  Took water, raisins & crackers with relief. BP 130/80 after snack. Observed for 20 minutes.  Called at home at 5pm, "feeling fine" per mom.
Dizziness; Diarrhea; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), DIARRHOEA (Diarrhea) and NAUSEA (Nausea) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced DIZZINESS (Dizziness), DIARRHOEA (Diarrhea) and NAUSEA (Nausea). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness), DIARRHOEA (Diarrhea) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Patient positive for COVID-19 on 3/13/21 after completing vaccination. She was asymptomatic.
My friend stated he felt like he had COVID-19 all over again.  Aches in the bones.... fatigue.....    Made him feel like a truck hit him just like it did when he had COVID.  These side effects only lasted for 1 day.
Headache, fever, chills, sore throat, weak muscle, nausea, whole body ache.
Overnight I felt very cold, chills then very hott.; Overnight I felt very cold, chills then very hott.; weak; heavy; sluggish; This is a spontaneous report from a contactable consumer. A 34-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 02Mar2021 09:30 (Lot Number: Unknown, at the age of 34-years-old) as single dose for covid-19 immunisation. Allergies to medications, food, or other products was none. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in unknown site on an unknown date (Lot Number: Unknown) as single dose for covid-19 immunisation. The patients concomitant medications were not reported. The patient overnight felt very cold, chills then very hot, weak, heavy, sluggish on an unspecified date. The outcome of the events was unknown.  Follow-up attempts are needed. Information on the lot/batch number has been requested.
Temp 102, uncontrollable chills, tachycardia one day after injection lasted all day and night into hospital stay
I had arm pain, aches, tired and vomited a few time. I felt weird all over. I had pain in my upper abdomen, legs and lower back. Chills and anxiety. On 2/8, I had a tele visit with my doctor. I took Tylenol as instructed to make sure that I didn't develop a fever. My doctor said that it could be from the vaccine. My left leg and foot were swollen on 2/13, so I called my doctor again and he sent me for a Doppler to check for a blood clot. I saw him on 2/15 in person. I have lower back pain and weakness in my legs at times, but it doesn't prevent me from doing anything. They feel heavy, especially if I walk for an extended period of time.
Initial pregnancy report received from a healthcare professional on 02 July 2013. A 32-year-old female patient had received intramuscularly first dose of ADACEL vaccine (Lot number: L44617AA and site of administration was not reported) on 02 July 2013. The patient had no significant medical history, no known allergy and had no serious reaction to previous vaccination. The patient had not received any vaccinations in last four weeks and has no history of taking Prednisone, cortisone, steroids nor any anticancer drugs. The patient had not received transfusions of any blood or blood products. The patient received vaccine during pregnancy. The patient's last menstrual period date was 24 November 2012 and estimated date of delivery was reported as "26 February 2013". The patient did not experience any serious adverse event. The patient's outcome was unknown. Documents held by sender: none.
In no particular order. Diarrhea. Heart palpitations. Shortness of breath. Mental fog. Bizarre dreams. Fatigue. Chills. Head to toe body pain especially in areas of previous injuries. Swollen lymph's in neck. Irritability. Depression. I had many of the same side effects after 2nd vaccination though more intense.
The patient presented to the emergency department for manic behavior and was incidentally found to be COVID positive.
This case was reported by a healthcare professional (medical assistant) and described the occurrence of viral influenza in at least 5 subjects of unspecified age and gender who were vaccinated with FLULAVAL (GlaxoSmithKline). Beginning in September 2013 the subjects received 1st dose of FLULAVAL (.5 ml, unknown route, left arm). The medical assistant could "recall at least 5 patients, mix of male and female (unknown numbers of each sex) that received the FLULAVAL Trivalent." Specific details were not known. The medical assistant reported that the office "only had one lot number" of FLULAVAL Trivalent. Within months of vaccination with FLULAVAL, specific dates not reported, the subjects experienced viral influenza and vaccination failure. Per the reporter, "various" subjects "are coming back into the office with the flu." The medical assistant reported that other subjects "that received the FLUARIX Quadrivalent at their office have not returned to the office with the flu." This case was assessed as medically serious by GSK. At the time of reporting the events were unresolved.
Exactly one week after the 2nd shot, patient was at a track meet and suddenly had a sharp pain in his chest.  It hurt when he inhaled, and he didn't compete.  He has never experienced this kind of chest pain before.  We thought it was an allergic reaction (hayfever?) because it seemed harder to breathe, so we gave him a benadryl and later went home.  He was tired and took a long nap.  Later he felt better.  But it was scary.  I think he underreported how he felt, to not alarm us parents.  He admits this now. There's not logical cause other than the vaccine ( no new foods, medications, experiences).  However, he didn't have any other notable side effects from the 1st or 2nd dose, except tiredness and arm soreness the first days.
Rashes, itching, finger swollen on right hand, fill swollen up in ears little bit tightness in chest. Developed after 2 days.
patient is reporting rash. Sent in pictures. Patient has small vesicular bumps on leg and back.
Anaphylactic shock; Numb lips; numb and cold hands; numb and cold hands; This is a spontaneous report from a contactable consumer (parent). A 35-year-old female patient received BNT162B2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at the age of 35 years old as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on an unspecified date. Immediately after the shot, the patient had numb and cold hands on an unspecified date. It improved and the patient was released. When the patient got home, she had anaphylactic shock and had numb lips, this started about 1.5 hours after the shot (unspecified date). The patient called and went to the hospital. The patient was treated with Benadryl. Outcome of numb and cold hands was recovering, while other events were unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Patient is a physician resident who reported Left axillary lyphadenopathy on 12/23/20 (2 days after receiving Pfizer COVID vaccine on 12/21/20). It was very mild and resolved within 1 day.  On 1/4/21, she noticed L axillary lymphadenopathy returned. On 1/5/21, it had spread to her right axillary lymph node.  It continued to worsen until Friday 1/8/21 when she reported to me and our physician to inquire about possible deferment of vaccination.  She still has swelling and tenderness at both axillary lymph nodes today 1/11/21. Severity is moderate in that it is painful, but not debilitating.
After the second vaccine on April 11 the trigeminal neuralgia including electric shocks in the face, headache became unbearable. I had to call emergency and request appointment with neurologist  asap. Dr. prescribed Tegretol and Baclofen. I have been on these meds ever since and my GP also prescribed  Amitriptyline.