chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I experienced headaches, nausea, diarrhea, chills.  I felt very weak. On the second day, my symptoms were the same. On the third day i started to feel itchy and was super red. On Monday morning, I woke up with the rash all over my body and feeling very dizzy. I went to urgent care and he checked me that I had an allergic reaction to the J&J vaccine. I also experienced vaginal bleeding, uncontrollably and he did the exams and I was told it was my menstrual cycle which lasted one week.  I have not gotten my menstrual cycle since the J&J vaccine.  I do not have my lot # at the moment.
In the evening lots of pain in left arm. during night chills including teeth chattering, pain all over, no sleep but slept through most of the next day, ate nothing.  Was quite concerning but did not call doctor although I sure thought about it. I was wondering if I was actually infected with Covid- 19. Shot was Tuesday 2: 30 PM, felt a bit better by Thursday but arm still hurt even on Friday arm was red and swollen down to my elbow. Saturday fine. I thought someone should know about this as lost of my friends also had difficult reactions. But this was the first time I saw an opportunity to respond.
Fever 102-103 f lethargy alt with irritability Loss of appetite- solid/formula/pedialyte. Emesis 3X. Not moving right leg injection area. No swelling  no redness, mild induration at injection site. Baby very clingy "not herself" Rx: Motrin/tylenol prn 12/23/ infant seened slightly better. Last night, drank formula and pedilyte. Urinating fine, but very tired, somnolent, clingy today. Definitely not her usual self.Rx given for STAT Labs. CBC, c-Reactive protein Amalyse. 12/24 Labs normal. SI increase, CRP . Infant much improved. Eating drinking, more active, less irritable! Systomnsresolving on day 4.  12/26/2022 Infant back to normal.
"dry scalp, white flakes fall on my blouse."; "Itchy scalp"; "dry areas on arms, skin on arm have looked and felt bad"; "For the last few days, I've bee having signs of cystitis."; This spontaneous case was reported by a consumer and describes the occurrence of DRY SKIN ("dry scalp, white flakes fall on my blouse."), PRURITUS ("Itchy scalp"), DRY SKIN ("dry areas on arms, skin on arm have looked and felt bad") and CYSTITIS-LIKE SYMPTOM ("For the last few days, I've bee having signs of cystitis.") in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 013L20A) for COVID-19 vaccination.     No medical history were reported.  Concomitant products included ALPRAZOLAM (XANAX), SERTRALINE HYDROCHLORIDE (ZOLOFT), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), THIAMINE and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced CYSTITIS-LIKE SYMPTOM ("For the last few days, I've bee having signs of cystitis."). On an unknown date, the patient experienced DRY SKIN ("dry scalp, white flakes fall on my blouse."), PRURITUS ("Itchy scalp") and DRY SKIN ("dry areas on arms, skin on arm have looked and felt bad"). At the time of the report, DRY SKIN ("dry scalp, white flakes fall on my blouse."), PRURITUS ("Itchy scalp"), DRY SKIN ("dry areas on arms, skin on arm have looked and felt bad") and CYSTITIS-LIKE SYMPTOM ("For the last few days, I've bee having signs of cystitis.") had not resolved. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable Patient medical history were not reported.  Concomitant medication also includes thyroid medication, vitamin B, calcium with vitamin D and  multivitamin. Treatment medicines were not reported.
feeling achy; His joints are a little sore; feeling tired.; This is a spontaneous report from a Pfizer sponsored program. A non-contactable Male consumer (patient). A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 11Jun2021 as dose 2, single dose for covid-19 immunization.The patient medical history and concomitant medications were not reported.  It was reported that he called in because he got the 2nd dose of the vaccine the previous day on 11Jun2021.On an unspecified date, patient said he was feeling achy. His joints were a little sore and he was feeling tired. He wanted to know if it was safe for him to take Tylenol. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
First time flu shot - denies allergy to eggs. Raised red welts - applies topical cortisone, BENADRYL. No change in condition.
MD H&P: Patient with recent exposure then diagnosis of Covid.  This started about 10 days ago.  Her O2 sats was checked by her daughter yesterday and was found to be under 90.  Because of that she was directed to emergency room.  She was admitted for further treatment.  Since admission patient been treated with Decadron oxygen supplementation and Has needed breathing treatments.
Redness to site with warmth. Tender to palpation full range of motion. No fever chills or vomiting. Redness localized to injection site with no streaking
coughing, quivering, shaking, turned blue, to ER, cold extremities, crying, tachycardic;given 02;
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient evaluated by PCP who determined she had an infection and started on antibiotics, but didn't think related to the vaccine injection per mother's report.
This report describes the occurrence of flu-like symptoms in an unidentified subject who was vaccinated with hep B vaccine recombinant (Engerix B) for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On an unspecified date, the subject received an injection of Engerix B (5379A4). Subsequently, the subject experienced flu-like symptoms. The outcome of the events was unknown. Comment: The reporter indicated that 11 subjects experienced flu-like symptoms after receiving Engerix B (5379A4). However, they are not presently identifiable.
Approximately 3 hours after the vaccination my eyes were burning, felt like they had sandpaper in them and felt swollen. Approximately 4 hours after the vaccination in addition to previously described eye problems, my chest felt on fire and while I wasn't in breathing distress felt like I had an upper respiratory cold (chest felt tight and burned). Approximately 19 hours (next morning) my eyes were bright red and swollen, my lungs felt compromised and my face was swollen (Oculo-respiratory syndrome describes symptoms). Approximately 29 hours after the vaccination, my eyes are still red but not as swollen, my chest is starting to feel normal and the edema in my face is lessening.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration 09-Nov-2021) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis. No Medical History information was reported. On 11-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration 09-Nov-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration 09-Nov-2021) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant product use was reported. Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 168 doses. Dates of administration of vaccine were reported as 10-Nov-2021 and 11-Nov-2021. The vial did not undergo any temperature excursions. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received contains non significant information.
Localized adverse reaction to drug-- swelling, warmth. Required MD visit in office 2 days post injection.
Hours after receiving the vaccine, I became dizzy, and nearly fainted several times. This was resolved once j was able to lay down and elevated my legs. I had no adverse effects in the first 15 minutes after the vaccine, the fainting spells were several hours after I was vaccinated.
Mom observed fever after 4 month HMV immunizations were given the child exhibited severe pallor, lethargy and hypotonia.  This resolved in several hours .  Doctor spoke with associates who had counseled er evaluation, by the time Mom considered this patient was becoming more alert.  No know past allergies.
I was at the airport getting ready to fly home so I had to take a test to get on my flight home. I tested positive but had no symptoms at the time. I  went back to my host's apartment and the next day I was taken to the quarantine center the next day. I developed a sore throat and was very fatigued. I have a chronic cough so I did have a cough but I do not notice it from covid. The next day I was so exhausted I could not walk and had to be in a wheel chair- I was fighting to breath. My pulse and blood pressure were both high. I had started the meds for treatment after I arrived to the treatment center. I had my first negative test on April 8th and I was then able to travel home.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Medium, Systemic: Shakiness-Medium
vasovagal episode, monitored VS, rested on exam table, drank water, friend drove home
I feel vertigo when going from lying in standing, and when rotating my head while in the lying position.  Symptoms were internal.  Most recent incident was external.
Eyes were red; Raised from shoulder to elbow; Left arm was red; Itching; Lymph n odes on both side of her neck were swollen; Tired; several Asthma attacks; Arm was sore; A spontaneous report was received from a Reporter like HCP  concerning a 40 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events such as sore left arm, Tired, Reaction to the vaccine, very tired, several asthma attacks, swollen lymph nodes on both side of her neck, Red eyes, Red and raised left arm from shoulder to elbow, itching left arm from shoulder to elbow, extremely tired.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 15-01-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 batch no:027L20A  intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection.  On 5th, 15th and 20th , The patient experienced the events such as sore left arm, Tired, Reaction to the vaccine, very tired, several asthma attacks, swollen lymph nodes on both side of her neck, Red eyes, Red and raised left arm from shoulder to elbow, itching left arm from shoulder to elbow, extremely tired.  Laboratory details are not provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The events are still not resolved.
Hives on thighs occurring about 10 hours post vaccine.  Hives lasted 48-60 hours
pt exp hot flashes, blurred vision, faint feeling & nausea then devel h/a;pt got out of car & sat on trunk until felt more lucid;when pt arrived home went to sleep until arrived home 5:40;
Hours after vaccines - c/o pain (R) leg -> refusal to walk negative redness or induration
On 04/01/16, pt started to notice redness and swelling at the injection site. +itching and burning to site.  Over the next two days, redness and swelling spread across the whole upper arm and down to the elbow with reports of increased "burning and itching."  DENIES fever, wheezing, SOB, swelling to lips/tongue/throat.
Rash all over his body, elevated bumps with red borders, itchy, he couldn't stop scratching. Runny nose. Cough. Doctor said he had hives due to the vaccine.
Couldnt breathe : red blood cells count went down to three. had to have three units of red blood.
Administration error: 46-year-old patient with a diagnosis of Rheumatoid Arthritis and Osteogenesis Imperfecta Type 1, which is categorized as an immunocompromised patient, receives a booster dose of 0.5 mL of the Moderna vaccine.
Patient reports she developed fever and chills overnight Friday into Saturday after 2nd dose of Covid vaccine on Friday.  On Saturday morning states she became dizzy and fell in her bathroom against the tub, reports she thinks she lost consciousness, as she woke on the bathroom floor to her husband yelling her name.   Denies that she was seen in the ER for the fall and loss of consciousness, states "I had a fever and did not feel like going anywhere".  States she has no idea how long she may have been out.
Sore arm the next day from elbow to shoulder, red swollen site for a couple days. Now 9 days later the red, swollen area has reappeared and it warm to touch as well. Headaches and bowel pressure with heartburn feeling since the day of the vaccine.
pt recv vax 14APR98 & awoke next AM had generalized macular papular blanching rash, very pruritic, no resp sx, sl dec intensity w/time;rx DPH;
Pt recvd 1 dose of Engerix-B on 10JUN92 & exp abdo pain, no appetite, rt lung pain & liver swelling; treated w/extra-strength APAP for pain; appetite has returned;
Drug ineffective; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  An adult male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information and the known product safety profile, a causal relationship between the reported events drug ineffective, COVID-19 and BNT162B2, BNT162B2 OMI BA.4-5 is considered possible.,Linked Report(s) : US-PFIZER INC-PV202300112100 different patient, same drug/ event;
Approx 5 minutes after vaccine administered, Pt became dizzy, itchy, and noted dry mouth & palpitations. BP approx. 160 / 100, HR 99. There were hives on the left arm. Lungs were clear. Administered 50mg Benadryl IM approx. 10 minutes after vaccine. Approx 15-20 minutes after vaccine, Pt fell out of her chair and became tachypneic and unresponsive. EpiPen administered and EMS called. Pt transported to hospital.
Information has been received from a physician and a healthcare worker referring to unspecified number of patients of unknown ages and gender. On unspecified dates since 05-FEB-2015 the patients were vaccinated with improperly stored doses of M-M-R II (lot #, strength, dosage and route unspecified), which were exposed to temperatures outside of the recommended range. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Swollen lymph nodes in right side of neck, and very painful rigid neck pain - continuous - hard to move, sleep. Massage and ibuprofen  did not resolve issue.  Doctor has prescribed muscle relaxant and PT.
skin crawling sensation; This case was reported by a consumer via call center representative and described the occurrence of crawling sensation of skin in a 64-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced crawling sensation of skin. On an unknown date, the outcome of the crawling sensation of skin was recovered/resolved.   It was unknown if the reporter considered the crawling sensation of skin to be related to Influenza vaccine Quadrivalent unspecified season.  Additional case details were reported as follows: The age at vaccination was not reported. Several years ago the patient had a reaction to a flu vaccine that caused a skin crawling sensation.  This lasted for almost one year before resolving.  At that time the patient thought it might be due to the thimerosal in the vaccine. The reporter did not consent to follow up. This case had been linked to the case US2019166421, reported for same patient.
Pt broke out in systemic rash at onset of injection and pt seen by provider and Benadryl given .
Temp 102- 2-11-21- Took Tylenol Temp 104.2 2-12-21  To ER vomiting & diarrhea Gave her IV Fluids. Took Her in Twice. Treated with ZOFRAN. Better on 2-14-21
He got his vaccine, had no reaction at first other than arm pain.  Starting his BP has been high and has remained high all year long.  Because of her doctors reaction he thinks he feels it is due to the vaccine, which he feels is happening to a lot of people and his doctor does not feel it should be treated.  He went to the ER on 11/12/22, and they told him that he had high blood pressure and they gave him BP medicine.  They did an EKG which he thought was OK.
Patient received the flu shot, and was conscious after the injection. The patient proceeded to see a friend receive a Flu shot and approximately 10 minutes after her injection the patient fainted at the sight of injection. After fainting to the ground the patient had a detectable  pulse and a heart rate. Paramedics were called to the scene right away. Patient woke up 1-2 minutes later and was drowsy but alert, and stated she had not ate this morning. Paramedics arrived and patient was much more co-operative and not as drowsy. She was breathing fine at this point and was sent to the local hospital for follow up.
3-4 days p/2nd vax pt devel bilat loss of vision; dx= acute retinitis; in hosp for evaluation & treatment  Annual follow-up received on 9/11/00 states loss of retinal junction has stablized.
stools are black, crying like there are pains in stomach cries constant unless held & legs are straight;problems w/sleeping;eating OK.  couple weeks p/vax started to throw up;problems have gotten worse last 2wk;
The child had a syncopal event within 5 minutes after being vaccinated; fell to floor and hit forehead on the floor. Child regained consciousness within 10 seconds. Staff laid the child on the couch. Child alert and oriented to person, place, and time immediately. Staff had child lie on couch for approximately 10 minutes and then sit at side of couch for approximately 5 more minutes. The family stated that he had not eaten and he was given juice and crackers. The mother decided to keep the child home from school to observe. Mother advised to call her physician if child started to feel increasingly worse, nauseous, dizzy, etc. Family left clinic approximately 20 minutes after incident with instructions to monitor child on walk to car.
At 1641 Tdap, and polio, in that order, were administered to the LD.  Pt did not shows signs of distress nor did she make any complaints. This nurse moved to the rt side and administered the Menveo, Havrix and Gardasil 9.  Bandages were applied.  Pt then started to droop her head and nurse moved to protect her from falling.  She then lost consciousness for approx 5 seconds  when she regained consciousness.  Face was flushed and pt had been observed to have urinated. Nurse was joined by BSN.  Pt was moved to the bed at 1643 and bed head was at 45 degrees.  She was alert, given water, a sucker and a granola bar.  Her  vitals were taken at 1646 BP 111/79, P 88, and Temp 97 degrees F.  Pt does not complain of dizziness or light-headedness.  Color is returning to normal.  BP 112/76 and pulse 88 at 1650. HOB was increased to 90 degrees, no complaints or dizziness or light-headedness BP 104/70 and P 80.  1652 BP 106/70 P 94. 1655 Pt stood, no complaints BP 106/70 P 94 at 1655.  Instructions were given to seek medical advice from dr if questions or concerns arose after hours and to contact this office tomorrow for any further questions.  Mom stated understanding and felt comfortable taking her daughter home.
Immediately pain in arm after shot with stinging, then started feeling fingers getting real numb, tightness in fingers to arm with tightness, feeling funny, then rose to her neck with tightness.  Headache, little confusion.  Went home and rested and resolved through the night.  On 1/10/21, called her PCP as her arm swelled up and felt sick, nausea, feeling of vomiting, numb fingers, redness.  On 1/12/21 but gave her antibiotics. Out of work for 10 days due to feeling like she had the flu.  Arm swelled up like a balloon with achiness, hot to touch and felt like she had an infection in it.  Went for FU on 1/14, arm redness faded away.  Went to work on 1/15 as Hospice person, fatigued, exhausted.  This morning 1/19/21, not feeling good, and injection arm swelled up again, this time at injection site is swollen and raised area with large ring around it, swollen, bullseye area.  Now out of work for another week.
LOSS OF MOVEMENT FROM SHOULDER TO ELBOW WITHOUT PAIN. PAIN AND TINGLING/BURNING SENSATION WITHOUT MOVEMENT.
Thought I couldn't walk because my body hurt bad; Every joint in my body hurt; Really bad headache; Had chills like I never had before; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Thought I couldn't walk because my body hurt bad), ARTHRALGIA (Every joint in my body hurt), HEADACHE (Really bad headache) and CHILLS (Had chills like I never had before) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced GAIT DISTURBANCE (Thought I couldn't walk because my body hurt bad), ARTHRALGIA (Every joint in my body hurt), HEADACHE (Really bad headache) and CHILLS (Had chills like I never had before). On 04-Apr-2021, GAIT DISTURBANCE (Thought I couldn't walk because my body hurt bad), ARTHRALGIA (Every joint in my body hurt), HEADACHE (Really bad headache) and CHILLS (Had chills like I never had before) had resolved.
Information has been received from a physician concerning a 2 month old male who was vaccinated with Rotateq Lot # 658379/1388U 2 mL PO. The physician reported that the patient was given 2 mL doses of Rotateq threes times in one day. The first time, the patient "spit it up" and had a seizure. The same thing happened when the second dose was given. The third time the patient spit up pure stomach acid and had another seizure. It was reported that getting three doses in one day could potentially be an overdose. The patient sought unspecified medical attention. There was no product quality complaint. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested. This is an amended report.  This is in follow-up to report(s) previously submitted on 3/14/2008. A code of overdose was added. This is a corrected report, as amended.