chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tested positive for Covid- 19; Tested positive for Covid- 19; Mild congestion; Janssen dose number in serious 1/BNT162 dose number in serious 2; Janssen dose number in serious 1/BNT162 dose number in serious 2; This is a spontaneous report received from contactable reporters (Consumer or other non HCP). Other Case identifier(s): 20211260954 (Janssen).  A female patient received BNT162B2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 2 (booster), single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Janssen covid-19 vaccine (Dose number: 1), administration date: Apr2021, for Covid-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), IMMUNISATION (medically significant) all with onset Dec2021, outcome "unknown" and all described as "Janssen dose number in serious 1/BNT162 dose number in serious 2"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Dec2021, outcome "unknown" and all described as "Tested positive for Covid- 19"; NASAL CONGESTION (medically significant) with onset 24Dec2021, outcome "unknown", described as "Mild congestion". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Dec2021) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry) in a 63-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  The vial did not undergo any temperature excursions. Total of 173 doses were given from LOT 070H21A. It was reported that the date vial initially stored in refrigerator was unknown.  Treatment medication was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non Significant  follow up was received.
Syncope.  Pt fainted and fell on Left side.  Had small elbow abrasion. No Bleeding.  Pt denies hitting head.  No swelling noted.  HR stead 80-100, RR 18.  BP 128/82 -- > 110/65 -- > 112/74.  Pt symptoms resolved.  Pt stable and released from the vaccination site.
CHILL; NOT FEELING WELL/KEPT FEELING WORST; FEVER; This spontaneous report received from a consumer concerned a female of unspecified age. 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 (dose series 1) (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, start therapy date was not reported (received at 11:15 AM in spring) for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  After vaccination at around 4 PM, she started not feeling well. At  7 PM that day , she started having fever (unspecified temperature) and kept feeling worse. Throughout the night she had alternating fever and chill until 4 AM the next day. At 4 AM, fever started subsiding but for the next 5 days she did not feel well at all (dose series 1). On an unspecified date, the patient received booster dose of non-company Covid-19 vaccine (dose series 2 ,  unspecified manufacturer) and  stated it was not as bad as the Janssen vaccine that she received. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and the outcome of chill and not feeling well/kept feeling worst was not reported. This report was non-serious.
p/ pt recv vax that same night pt devel high fever lasting approx 2-3 days. treated w/advil
I received the COVID vaccine 1st dose on Sat, Oct. 16th, 2021 at 5:45pm and at first the only side effect was a sore arm the next day. But, yesterday, Tues, Oct. 19, 2021 about 6:30pm I suddenly felt like my lungs were filling up with fluid and I started coughing really deep and hard. It felt like I had fluid stuck in my lungs and couldn't get it out. It also felt like my airway was tight and it was slightly hard to breath. It came on so suddenly and I didn't know what was going on so I began to drink water to try to help with the cough and kept standing and stretching my chest in hopes of helping with whatever was happening. After about 45 minutes, I was able to keep the coughing under control. About 3 hours after symptom began the fluid filled lungs feeling started to decrease in pressure and intensity. I then went to bed. I then went to sleep. Woke up Wed, Oct. 20, 2021 at 6:30am and my throat was sore (I'm assuming from the deep coughing yesterday) and I had a slight cough where some mucus was being discharged. My lungs still feel a little tight and I have a slight feeling of the need to cough (Wed. Oct. 20, 2021 at 9:00am) but I feel like I'm starting to feel a little better.  I just wanted to share what I feel to be a side effect of the vaccine I received in case anyone else has experienced the same thing.
shingles; body aches; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), FATIGUE (fatigue) and HERPES ZOSTER (shingles) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 038K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concurrent medical conditions included Cholesterol, Diabetes, Enlarged prostate and Hypertension. Concomitant products included ATORVASTATIN for Cholesterol, METFORMIN for Diabetes, TAMSULOSIN for Enlarged prostate, VALSARTAN for Hypertension, ACETYLSALICYLIC ACID (BABY ASPIRIN) and OMEPRAZOLE for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 07-Feb-2021, the patient experienced HERPES ZOSTER (shingles). In February 2021, the patient experienced MYALGIA (body aches) and FATIGUE (fatigue). At the time of the report, MYALGIA (body aches), FATIGUE (fatigue) and HERPES ZOSTER (shingles) outcome was unknown.            No treatment details were provided.
Raised area of skin, reddish in color, hot to touch, 3cm in diameter, very sensitive to touch, pain upon any contact with objects or breeze lasting 10 days, sensitive to touch for an additional 7 days, but less painful, not hot, then reduced in size, returned to normal color, but still hard tissue at injection site 1 month later. Red rash appeared within 8 hours of injection spreading from injection site over the next 4 days to reach, pink in color, sensitive to touch, measured 10 cm tall by 16 cm in width, remained visible for 10 days and then faded over next 7 days to normal skin color. Burning sensation in shoulders, elbows, knees worse with movement starting 6 hours after injection lasting another 18 hours and then disappeared immediately (24 hours post vaccine). Areas of itching on body starting on back below shoulder blade on left side, spreading to shoulders, arms, waist, torso, neck, face and thighs beginning 24 hours after injection. Red raised blemishes developed over these areas sparsely spaced, raised, hard, itchy, extremely painful when scratched. One on back of arm formed a pustule that was extremely painful if touched. Day 5 visited the doctor about reaction, told to watch and see if symptoms worsened. Symptoms remained the same for the next 5 days and then began to subside. Raised bumps on face, neck, and arms still visible 3 weeks post injection, finally resolving around 4 weeks.
5days p/vax pt devel vomit, diarrhea, fever; hosp w/fever & dec appetite; hosp w/ fever & dec po intake; disch & hosp again-vomit; disch & hosp w/weight dec; barium enema performed, dx intussusception.
Thready pulse and found unconscious five minutes post vaccination, wrists were flexed with tonic movements, patient was incontinent with urine and had loss of consciousness for 5-6 minutes; had second seizure two minutes after the first one ended, it was brief and lasted for approximately 30 seconds.
Information has been received from a registered nurse, concerning a 20 year old female who on approximately 16-APR-2007 was vaccinated with the first dose, IM in the right deltoid, 0.5ml, of Gardasil. Concomitant therapy included Valtrex and hormonal contraceptives (unspecified). Immediately after the injection (approximately 16-APR-2007), the patient's arm was sore. On 30-APR-2007, two weeks later, the nurse confirmed the soreness continued and the patient complained her arm with any pressure applied; in addition, a small lump was present under the skin at the injection site. At the time of this report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
He received PNEUMOVAX23 and he had sore arm, had a headahce last night and couldn't sleep well; He received PNEUMOVAX23 and he had sore arm, had a headahce last night and couldn't sleep well; He received PNEUMOVAX23 and he had sore arm, had a headahce last night and couldn't sleep well; This spontaneous was received from a male company representative regarding himself. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions, and allergies were not provided.   On 19-JAN-2022, he was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (dose, route of administration, lot number, and expiration date were not provided). Therefore, on the same date, he had sore arm (pain in extremity), he had headache, and could not sleep (poor quality sleep).   The outcome of the events pain in extremity, headache, and poor-quality sleep was not provided.   The causal relationship between the events pain in extremity, headache, and poor-quality sleep and vaccine Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) was not provided.
10-17-09: swelling in both eyes; 10-18-09:bursted blood vessel in right eye; swollen gland left side of neck; 10-19-09: stiffness, pain in left shoulder and neck; right eye was better, left eye was very blurry. Treated 10-26-09 and diagnosed 10-29-09 with keratosis due to flu vaccine nasal spray by Dr. Prescribed Prednisolone Acetate 1% and told to report this and return in 1 week for follow-up.
I did not have adverse effect from vaccine booster, but I did contract COVID afterwards and was asked by VSafe to provide details of my experience. On 12/27/2021, I had lower back pain and scratchy throat, which progressed to a mild cough with minimal chest congestion, low-grade fever (99.6)., some reduction in sense of smell and taste,  and sore throat. These symptoms started out mild, worsened for about 3 days, then tapered off so that by day 7 most symptoms were gone. Since that time, I have very mild leftover effects of slightly reduced sense of smell and taste, slight sore throat, and some fatigue. Otherwise, I feel fine.
Redness, swelling, pain from shoulder to elbow. Pt given 6 day prednisone.
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose number unknown (booster), single (Lot number: gj5342) for covid-19 immunisation; BNT162b2 (BNT162B2), in May2022 as dose number unknown, single (Lot number: fk9893) for covid-19 immunisation. The patient's relevant medical history included: "hypertension"; "osteoporosis"; "hypothyroid"; "known allergies: SULFA"; "known allergies: cyanoacrylate glue". The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  No follow-up attempts are possible. No further information is expected.
at times brain almost feels like a limited oxygen level to it; Having brain fog issues/strange feelings; forgetful; have no motivation to exercise; Very tired; hard to concentrate; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: Er8737) at the age of 45-year-old, via an unspecified route of administration in the left arm on 03Apr2021 at 10:45, as dose 2, single for COVID-19 immunisation. Medical history included hypothyroidism, cutaneous lupus erythematosus (cutaneous lupus), and sulfonamide allergy (known allergies: sulfa (rashes, heated)). The patient was not pregnant at the time of vaccination. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN) and hydroxychloroquine. The patient previously received the first dose of BNT162B2 (Lot Number: EN6208), via an unspecified route of administration in the left arm on 13Mar2021 at 10:15 (at the age of 45-year-old) as a single dose for COVID-19 immunisation and thought something was wrong with lympnodes in neck area or thyroid but went for ultrasound, very small nodule, this started after first vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 13:00, the patient experienced having brain fog issues, forgetful, at times brain almost feels like a limited oxygen level to it, no motivation to exercise, very tired, hard to concentrate and strange feelings. It was reported that patient experienced brain "fog" issues, forgetful and at times brain almost felt like a limited oxygen level to it, never had this prior to vaccine, the patient was healthy and active yet had no motivation to exercise since vaccine, very tired, hard to concentrate yet there were moments of clarity where patient felt that was so keen of thinking almost OCD perfect, very strange feelings, this started after second vaccine. No therapeutic measures were taken for the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events was not recovered at the time of report.
5-7 hr p/vax pt devel 101.4T, chills,aching upper back, left shoulder & neck, difficulty sleeping. Eval @ immed care facility & tx symptomatically. Is 1 of 2 pt from site to have adverse rxn p/vax w/different lot #'s of tetanus & diphtheria
Symmetrical rash on back of both hands.; This is a spontaneous report from a non-contactable consumer (patient). A 65-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via an unspecified route of administration on 11Feb2021 12:00 single dose for covid-19 immunisation. Medical history included covid prior to vaccination from an unspecified date to an unspecified date. The patient had no known allergies. The patient did not receive other vaccine in four weeks. Concomitant medication included levothyroxine (MANUFACTURER UNKNOEN). The patient experienced symmetrical rash on back of both hands on 12Feb2021. As a result, the patient had a doctor/clinic visit and was given an unspecified topical cream as treatment for the event. The patient had not tested positive for covid post vaccination. Outcome of symmetrical rash on back of both hands was not recovered at the time of the report.   No follow-up attempts are possible. No further information is expected.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a 60-year-old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry date : Unknown) dose was not reported, 1 total administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 20-APR-2021, the patient had negative quantitative antibody test (spike protein test) (confirmed immunological vaccine failure). Laboratory data included: Semi Quantitative spike protein Antibody test (NR: not provided) as Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. . The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210457869.; Sender's Comments: V0:20210525044 covid-19 vaccine ad26.cov2.s - Confirmed immunological vaccine failure.This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically:SPECIAL SITUATIONS
Patient received vaccine at 10:39am and was in the observation area. At about 3 minutes (10:42 am) she began to feel  " a tingly sensation in my tongue"  and felt warm. She also had localized redness and swelling at the site of injection (Right deltoid). She denied any symptoms of chest pain, SOB, palpitations, difficulty swallowing, drooling,  nausea/vomiting, dizziness or light-headed or near syncope. Patient was observed by provider for a course of one hour. We recommended to be taken by EMS to ER for further observation, she refused. Patient drove herself and was not able to take Benadryl.  Initial vital signs taken 10:54am 177/114; HR 92; O2 98% RA; RR 18 -sitting position Second vitals 11:35am 134/96; HR 79; O2 100% RA ; RR 16- sitting position Patient was observed for an hour and decided to drive home. Recommend hydration and call 911 if needed.
About 8 days after Covid vax, left arm started to itch a bit in the afternoon.  As the day wore on, area around the injection site got warm, turned reddish and hardened. The next day, the reddish area grew larger to about 7 inches measured at greatest spread.  It is not too uncomfortable, with the itching subsiding.  My left ear is also now warm, but no pain.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old male patient who received SHINGRIX for prophylaxis. On 20th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 20th March 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 22nd March 2018, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were received as follows: The patient received SHINGRIX on the left arm. The patient experienced pain in his left arm after vaccination with SHINGRIX. The patient reported that in March 2018, the pain lasted for approximately 2 days. The patient had denied permission to contact their physician.
Aside from the usual, I had sudden weight loss, intense itching, and was out f breath easily and sometimes dizzy. It now has been diagnosed as hyperthyroid. I am undergoing more diagnosis now.
Patient received immunes on 1/2/08, patient taken to ER by mom for rash on both thighs where immunes were given on 1/4/08.  ER report states hives on both thighs.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 13th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema and injection site pain. On an unknown date, the outcome of the injection site erythema and injection site pain were recovered/resolved. It was unknown if the reporter considered the injection site erythema and injection site pain to be related to SHINGRIX. Additional details were received as follows: The patient received SHINGRIX in the right arm and experienced redness and soreness at the injection site for a week. The patient did not consent to follow up. For tolerance to 2nd dose, refer case US2018GSK228978.
Narrative:  80 yo male with COPD, history of HTN and BPH, presented to the Emergency Department on 8/27/2021 with worsening dyspnea, fatigue, fever, and weakness. He tested positive for COVID despite being fully vaccinated with Pfizer's Covid vaccine on 2/1/2021 and 2/22/2021. Vital signs were stable and he was given 2-3L O2 via nasal cannula. He was not a remdesivir candidate. He was diagnosed with COVID 19 pneumonia and acute hypoxic respiratory failure and admitted to the hospital. He was treated as above, showed improvement and was discharged on 8/31/2021.
1/13/21 Noon, very itchy injection site pea size knot. Today 1/14/21  knot increased sized to half dollar coin size, very red, hot to touch, itchy and painful.