chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Ear ringing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Feb2021 11:00 (Lot number: EL9266) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (not ongoing); "High blood pressure" (not ongoing); "COVID-19", start date: 24Aug2020 (unspecified if ongoing); "tinnitus", start date: 2014 (unspecified if ongoing), notes: He had tinnitus 7 years ago, Over the past 7 years, he has experienced ear ringing off and on; "vegan", start date: 2017 (unspecified if ongoing); "allergies" (ongoing); "heart health" (ongoing); "vitamin supplementation" (ongoing). Concomitant medication(s) included: VIT D (ongoing); COQ-10 taken for cardiovascular event prophylaxis (ongoing); CLARITIN [LORATADINE] taken for hypersensitivity (ongoing). The following information was reported: TINNITUS (non-serious) with onset Feb2021, outcome "unknown", described as "Ear ringing".  Additional information: Patient was also taking an unspecified turmeric supplement 2 tablets a day by mouth and multivitamins 1 tablet by mouth daily for vitamin supplementation. He mentioned that he hasn't been vaccinated in years. Last vaccine he received was about 7 years ago, the one he got was the one for stepping on a rusty nail which hurt. It was also reported that he got the Pfizer vaccine 19 days ago 12Feb2021 and about a week (5-7 days) after receiving the vaccine, he developed ear ringing. He reported the ear ringing was nothing crazy or severe. He checked his blood pressure a few times and it was fine. Patient stated that he knew blood pressure can be a symptom. He also stated that if he was busy doing things, the ear ringing was unnoticed, but he did hear and feel it when he was quiet or going to bed. If he stops doing something, he can hear it. He mentioned he had tinnitus 7 years ago. Patient also mentioned he tested positive for COVID 24Aug2020 and he did not have ear ringing as a symptom. Over the past 7 years, he had experienced ear ringing off and on. He had not been to the doctor because it hasn't been an issue. Event also did not result to emergency room visit.  No follow-up attempts are possible. No further information is expected.
Based on additional information received on 07 December 2015, this case will be deleted as it is duplicate of 2015SA149927. Initial unsolicited report received from a pharmacist on 28 September 2015. This case involves two patients those were vaccinated with a dose of FLUZONE (batch number, dose, route and site of administration was not reported) on an unspecified date. Both patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the both patients experienced rash, very warm and tenderness. Lab data and corrective treatments were not reported. The outcome of events was unknown. Follow-up information received from a pharmacist on 07 December 2015. This case will be deleted as it is duplicate of 2015SA149927. List of documents held by sender: none.
This spontaneous report as received from a physician refers to a unspecified patients of unknown age and gender. The patient's medical history and current conditions were not provided. On an unknown dates, the patients were vaccinated with a doses of PROQUAD (Merck) (dose and route were not reported) lot # reported as K022444 expiration date 13-MAY-2016 that were improperly stored. The temperature excursion for the PROQUAD (Merck) was found to be supported with in-house stability data. Secondary suspects and concomitant therapies were not reported. No adverse symptom reported. Additional information has been requested. This is one of several reports received from the same reporter.
Swollen arm; Could not sleep for 2 days; not a usual reaction; Instead of getting tired, it was reverse/She wasn't so forgetful as before and had better memory./ she got her energy back and her head was clear; couldn't get comfortable, couldn't watch television, it bothered her; Aches; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), INSOMNIA (Could not sleep for 2 days), THERAPEUTIC RESPONSE UNEXPECTED (not a usual reaction; Instead of getting tired, it was reverse/She wasn't so forgetful as before and had better memory./ she got her energy back and her head was clear), FEELING ABNORMAL (couldn't get comfortable, couldn't watch television, it bothered her) and PAIN (Aches) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Loss of energy and COVID-19. Concurrent medical conditions included Allergy NOS. Concomitant products included VITAMINS NOS and ALLIUM SATIVUM, ARCTIUM LAPPA, ECHINACEA ANGUSTIFOLIA, HYDRASTIS CANADENSIS, TABEBUIA IMPETIGINOSA (HERBSTAT) for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced CHILLS (Chills). On an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen arm), INSOMNIA (Could not sleep for 2 days), THERAPEUTIC RESPONSE UNEXPECTED (not a usual reaction; Instead of getting tired, it was reverse/She wasn't so forgetful as before and had better memory./ she got her energy back and her head was clear), FEELING ABNORMAL (couldn't get comfortable, couldn't watch television, it bothered her), PAIN (Aches) and PYREXIA (Fever). On 08-Apr-2021, CHILLS (Chills) had resolved. At the time of the report, PERIPHERAL SWELLING (Swollen arm), INSOMNIA (Could not sleep for 2 days), THERAPEUTIC RESPONSE UNEXPECTED (not a usual reaction; Instead of getting tired, it was reverse/She wasn't so forgetful as before and had better memory./ she got her energy back and her head was clear), FEELING ABNORMAL (couldn't get comfortable, couldn't watch television, it bothered her), PAIN (Aches) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.5 (High) 100.5. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         No treatment medication was provided.   This case was linked to MOD-2021-370450 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow Up contains no new information. On 01-Nov-2021: Follow up received, new event and patient's historical condition added and the coding of aches changed to ache.
PATIENT STATED AFTER SHE GOT THE VACCINE SHE EXPERINECED FEVER AND FLU LIKE SYMPTOMS WHICH SHE WENT TO DR FOR IT AND IT WENT AWAY SOON THEN SHE WOKE UP WITH A REDNESS SPREADING FROM THE INJECTION SITE  DAWN HER ARM 6 DAYS AFTER SHE GOT THE VACCINE, IT WAS HOT TO TOUCH , RPH TOLD PATIENT TO GET SOME ORAL BENADRYL AND IF SHE IS NOT FEELING BETTER GO TO  SEE A DR, IT WAS SUNADY SO TOLD HER TO SEEK EMERGENCY CARE , SINCE PATINET STATED FEELS A LITTLE TIGHT IN HER TROUTH ALSO
Covid  vaccine (dose #1, Moderna) administered by RN on 3/11/21.  Pt presented on 3/16/21 with  sore left arm and palpable bump measuring  3.5x2cm cm.  Mild redness, slightly warm site; pt afebrile. Some body aches/chills, bruising/redness at injection side. Mild pain with palpation. Overall improved, but redness remains at injection site. Of note, vaccine was administered with 1" needle; pt is 292 lbs and 1.5" needle indicated.  Provider to follow-up again today, 3/18/21.
My COVID-19  symptoms started on 01/09/2023 in the mid morning.  I had mild aches and some cold types of symptoms. On 01/09/2023 I did a COVID-19 home test which was negative. I did another one on 01/10/2023 it was negative. I went to the urgent care in the late afternoon on 01/10/2023. They did COVID-19 test but it was negative. Even though I had a  negative COVID-19 test they diagnosed me as having COVID-19. They also did a Flu test which was negative on 01/10/2023.  They prescribe me with Paxlovid for 5 days and Cefdinir for fluids in my ear/ post nasal drip.  On 01/11/2023 I did a home COVID-19 test again this time it was positive. I tested negative for COVID-19 on 01/17/2023. I had a COVID-19 rebound case on 01/20/2023 I tested positive .  I had a runny nose, fever, congested, hard to breath. I didn't call my doctor this time I just took over the counter medications and treated the symptoms.  I tested negative on 01/26/2023.  As of today 02/02/2023 I am still recovering but not fully recovered yet.
Patient reported feeling light-headed and dizzy immediately following vaccine, then fainted in a sitting position in chair. Pharmacist and customer assisted unconscious patient into lying down position on floor and patient promptly awoke. Patient remained lying down for 10 minutes while pharmacist directly observed with emergency kit nearby. Patient reported feeling better and then was able to sit upright. She was given a bottle of water and sat for observation for a remaining 20 minutes, then felt comfortable exiting the pharmacy.
At 330 this morning I woke up with body aches, lymph glands in neck swollen and sore throat
achy by the third day have been having heart palpitations and feeling of heart murmur.; achy by the third day have been having heart palpitations and feeling of heart murmur.; achy by the third day have been having heart palpitations and feeling of heart murmur.; This is a spontaneous report received from a contactable Consumer (patient).  A 46-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 13Apr2021 11:00 (Lot number: EP6955) at the age of 46 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Pernicious anaemia" (unspecified if ongoing); "Sulfonamide" (unspecified if ongoing). Concomitant medications included: IRON; cyanocobalamin (B12); ZINC; folic acid (FOLATE); ascorbic acid (C); colecalciferol (D). Past drug history included: pethidine hydrochloride (DEMEROL), reaction: "known allergies: Demerol". Vaccination history included: BNT162B2, administration date: 23Mar2021, when the patient was 46 years old, for COVID-19 immunisation, reactions: "Shortness of breath", "Pressure chest". The following information was reported: PAIN (non-serious), PALPITATIONS (non-serious), CARDIAC MURMUR (non-serious) all with onset 16Apr2021 13:15, outcome "recovered with sequelae" and all described as "achy by the third day have been having heart palpitations and feeling of heart murmur.". The event "achy by the third day have been having heart palpitations and feeling of heart murmur.", "achy by the third day have been having heart palpitations and feeling of heart murmur." and "achy by the third day have been having heart palpitations and feeling of heart murmur." was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, palpitations, cardiac murmur. Additional information: the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Pre-vaccination and post-vaccination COVID tests were not performed.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021509430 Same drug/reporter/patient, different dose
went into anaphylaxis; This case was reported by a physician via sales rep and described the occurrence of anaphylaxis in a female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent (intramuscular). On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced anaphylaxis (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylaxis was unknown.   It was unknown if the reporter considered the anaphylaxis to be related to FluLaval Quadrivalent.  Additional information was provided as follows: The age at vaccination was not reported. The patient received a Flulaval injection and went into anaphylaxis. The patient went home but had to have someone sit with her. It was unknown if the patient recovered. The filed representative had no information for lot number of medication. The reporter consented to follow up.
Breakthrough COVID on 05/09/2022. My case was very mild. It was mostly a scratchy and running nose, fatigue, coughing and a little bit of sore throat. I started taking the Paxlovid for 5 days. I feel fine, I have good energy. I just have a little drainage but I have allergies in the summertime anyways. I quarantine for 8 days. If I have to go out I use a mask.
LATERAL ASPECT OF RIGHT ARM WITH 4.8 X 5 CM AREA INFLAMED WITH ERYTHEMA , INDURATED
mom states started w/a fever during late noc of 30OCT97; T102 mom gave APAP morning of 31OCT97 pt broke out in a heavy pronounced red rash over abd, back & face;mom took pt to MD on 3NOV97 for eval & to r/o strep or scarlet fever;no tx;
Pt developed red, swelled, warm, painful RLE at lower leg/ankle/foot less than 24 hours, near 12-18 hours after 2nd dose.
FELT LIKE LEGS WILL BUCKLE UNDER  HER WHEN GOING TO RESTROOM; HIVES; ITCHING; INSOMNIA; DOES NOT FEEL HERSELF; ANXIETY; DRY MOUTH DESPITE DRINKING A LOT  OF WATER AS DIRECTED; WEAKNESS; 24 HOUR FLU; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207a21a, and expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-MAY-2021, the subject experienced 24 hour flu. On 06-MAY-2021, the subject experienced dry mouth despite drinking a lot of water as directed. On 06-MAY-2021, the subject experienced weakness. On 07-MAY-2021, the subject experienced itching. On 07-MAY-2021, the subject experienced insomnia. On 07-MAY-2021, the subject experienced does not feel herself. On 07-MAY-2021, the subject experienced anxiety. On 07-MAY-2021, the subject experienced hives. On 08-MAY-2021, the subject experienced felt like legs will buckle under her when going to restroom. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from 24 hour flu on 08-MAY-2021, and insomnia, was recovering from hives, and felt like legs will buckle under her when going to restroom, and had not recovered from itching, anxiety, does not feel herself, dry mouth despite drinking a lot of water as directed, and weakness. This report was non-serious.
Patient said after about 15 minutes that his throat was swelling mildly. We asked him to wait an extra 15 minutes in which he said it was resolving. I offered him some  Benadryl, but he did not want one.  He said he has had it happen before but not as bad with food allergies. Not sure what is causing his food allergies.
Rash is sore, achy, itchy; bubbling sunburn effect,dry-looking; has a numb feeling; tingling feeling; Rash is sore, achy, stings. dry looking; extremely bad vomiting; fever; After second dose patient had a "bad reaction"; Four to six hours after the shot became sick for 2 days, really sick.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (After second dose patient had a "bad reaction"), ILLNESS (Four to six hours after the shot became sick for 2 days, really sick.), RASH PRURITIC (Rash is sore, achy, itchy), RASH ERYTHEMATOUS (bubbling sunburn effect,dry-looking) and HYPOAESTHESIA (has a numb feeling) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A and 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Seizure.   On 07-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (Four to six hours after the shot became sick for 2 days, really sick.). On an unknown date, the patient experienced VACCINATION COMPLICATION (After second dose patient had a "bad reaction"), RASH PRURITIC (Rash is sore, achy, itchy), RASH ERYTHEMATOUS (bubbling sunburn effect,dry-looking), HYPOAESTHESIA (has a numb feeling), PARAESTHESIA (tingling feeling), RASH (Rash is sore, achy, stings. dry looking), VOMITING (extremely bad vomiting) and PYREXIA (fever). The patient was treated with CORTISONE (topical) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (After second dose patient had a "bad reaction"), RASH ERYTHEMATOUS (bubbling sunburn effect,dry-looking), HYPOAESTHESIA (has a numb feeling), PARAESTHESIA (tingling feeling), VOMITING (extremely bad vomiting) and PYREXIA (fever) outcome was unknown, ILLNESS (Four to six hours after the shot became sick for 2 days, really sick.) had resolved and RASH PRURITIC (Rash is sore, achy, itchy) and RASH (Rash is sore, achy, stings. dry looking) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products included Seizure medication.   This case was linked to MOD-2021-355992.
Drug ineffective; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 30 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Post concussion syndrome" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Mar2023) Negative, notes: Took antigen tests and was negative on Monday; (21Mar2023) Negative, notes: Took antigen tests and was negative on Tuesday; (23Mar2023) positive, notes: tested again at home Thursday and was positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300128879 Same patient, different drug, different event;
Pt devel erythema & induration surrounding the inject site p/receiving Typhoid vax; This adverse event has previously been reported to FDA by the reporter;
2/11/21, Received shot on Thurs, no immediate side affects other than slight tingling on tip of tongue and upper lip, extremely small red spots on my right wrist and soreness of right arm near injection.  2/12/21. Friday evening. Fever, chills and headache. Continued numbness/tingles on my tongue and lips. Tongue only slightly swelled three times.  2 weeks following: Drug rash/hives continued to try to appear every evening daily right before I took another Zyrtec. Needle pricks or itchy on my skin. Continued tingling/numbness sensation on tip of tongue and around mouth. Allergist had me on three 24-hour antihistamines. 8am Allegra, 2pm Zyretec, 8pm Zyrtec. 3/12/21 - Drsuggested going down to 2 Zyrec's per day 8am and 8pm. Did and was fine except continued on/off tingles/numbness on my tongue. Also increased facial tingles and numbness. The pink splotches on skin only appeared late one evening and went away, no full blown drug rash or hives, just a few needle pricking sensations on arms. 3/23/21 - Decreased to 1 Zyrtec @ 8pm per allergist. I am still feeling continued face and tongue pricks, tingles, numbness. 4/4/21 - A little tongue swelling late evening along with tongue and face tingle sensations. Finally went away and started again on 4/5/21. I am still taking only 1 Zyrtec every evening @ 8pm. Still throughout the day I continue to suffer with face/nerve tingles, pricks, tightness on my entire face, chin and throat. Tip of tongue on/off numbness. Submitting as Drhas not sent VAERS my latest allergic reaction report so said I will submit. I am getting very nervous and worried that symptoms have not gone away at almost exactly 2 months after my 2nd shot.
Shortness of breath, chest tightness, chest pain, shooting pains in chest and head, excessive claminess, weakness in arms and legs, brain fog, extreme fatigue, extreme loss of stamina, pressure in chest when I bend over, constant dizziness and lightheadedness, elevated pounding heart rate, tightness in neck and jaw, weight loss.
Information has been received from a case in litigation concerning a female physician who on 03-SEP-1996, 11-NOV-1996 and 03-APR-1997 was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown). It was reported that in 1997 the patient experienced an "electric-like shock sensation going down (the) center of (her) back into both feet." The patient's symptoms continued to progress. In 1998 the patient was seen by a neurologist and subsequently was diagnosed with multiple sclerosis. The patient's outcome was not reported. Upon internal review multiple sclerosis is considered to be an other medical event. No further information was available. Follow-up information was received and stated that although the electric-shock sensation occurred in 1997 at the time it was not clear that the patient had multiple sclerosis. As the symptoms continued to progress it became clear that the symptoms that she was suffering from were a result of the disease. The petitioner argued that the statute of limitations should not be applied to her until after her diagnosis in 2003. The special master, however held that "the Act provides a window of three years from 'the first symptoms or manifestation of onset' to file a vaccine related claim" and that because the electric-shock sensation was proven to be a statutory manifestation, her petition, falls outside the realm of the statute of limitations. Upon internal review multiple sclerosis is considered to be an other medical event. No further information was available.
Varicella Vaccine 09/05/2000 Shingles Dx: 01/25/2005 No documented case of varicella illness, vaccine only.
11/19/2003: 13 month old status post allergic reaction to immunization associated symptoms hives and pruritis.  Hydro-steroid cream (+) all evaluating factor.  No known allergies.  Tx: Clartin 1mg/1mg every day.
pt recv vax 5FEB96 & 13MAR98 pt devel 232 lesions;
Patient experience a seizure less than 48 hours after dose 1 of Moderna COVID19 vaccine.  Patient was stable on medications and had no history of seizures in the previous 3+ months.