chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had COVID infection 10 days after the getting the vaccine; Had COVID infection 10 days after the getting the vaccine; This is a spontaneous report from a contactable physician. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730), intramuscular in right arm on 24Dec2020 09:00 at a single dose for Covid-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to Covid vaccine. The patient was not diagnosed with Covid-19 prior to vaccination. Patient has no allergies to medications, food, or other products. Physician would like to know if her patient can receive second dose of vaccine. Patient received vaccine 10 days ago. On 05Jan2021, the patient had Covid infection 10 days after the getting the vaccine. No treatment was received for the event. Patient tested positive for Covid after receiving vaccine. The patient underwent lab test  which included nasal swab: positive on 04Jan2021. The outcome of the event was recovering.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported COVID 19 infection based on the known safety profile. However the short duration of 10 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.
Hot ears; Heat and flushing; Heat and flushing; Diarrhea; This spontaneous case  was received on 23-Sep-2020 from other health professional (nurse) via agency (reference number: SEQW20-02108) and concerned a 30-year-old, female patient.  The patient had no relevant medical history and was not taking any concomitant medications.  On 21-Sep-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: deltoid, and route of administration: intramuscular) for influenza prophylaxis. The batch number reported was 283848 and expiry date was 30-Jun-2021.  On the same day, after receiving Flucelvax QIV, the patient developed hot ears, heat and flushing, then four hours later diarrhea that lasted for four hours.   On the same day, the patient recovered from the events.   The reporter did not provide a causality assessment to Flucelvax QIV.  The reporter assessed the events as non-serious.  This case is linked to cases 202004667, 202004665, 202004663, 202004664 and 202004610 due to the same reporter.  Company comment: The patient developed skin warm, flushing, feeling hot and diarrhea on the same day after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. No information about concomitant medications and medical history was provided. Considering all information above, causal relationship for all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed skin warm, flushing, feeling hot and diarrhea on the same day after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. No information about concomitant medications and medical history was provided. Considering all information above, causal relationship for all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).
MODERNA VACCINE IS NOT AUTHORIZED IN THIS AGE GROUP TEEN PREGNANCY GONORRHEA,CHLAMYDIA POSITIVE GA 15 WEEKS EDD 12/15/2021
Janssen COVID-19 Vaccine EUA  Swollen lymph node on collarbone on same side (left) as injection arm, lasting 10 days at time of report and continuing.  Patient will seek medical consult if condition persists for more than 7 more days
Devel t103 R about 8 hrs p/vax; Pt seen in ER 9PM 6MAY91 fever & usual crying; ran fever 3 days & was OK x/for hoarseness; well 1 1/ wks seen by MD 28MAY91 w/ear infect;
I noticed that there was discoloration on the tips of my toes. They turned out looking like red dots, but over time they got bigger and turned a purple color. They were very sensitive to touch and it was very hard to wear shoes. The sensitivity lasted a couple of weeks. The discoloration lasted much longer. I did a video visit with my PCP. They said that there was nothing they could do for it, but I wanted to let them know about it. I wanted it noted in my chart.
seizure; Initial information regarding an unsolicited valid serious case from a pharmacist via Regulatory Authority (Reference number- 00663747) and transmitted to Sanofi on 30-Jun-2021.  This case involves a 17-years old female patient who experienced seizure, while she received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported, and patient received no concomitant vaccines.  On 30-Jun-2021, the patient received 0.5 ml total (once) dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number: U6828AB and expiration date: 09-Jan-2022) via intramuscular route in the left deltoid muscle for prophylactic vaccination.  On 30-Jun-2021, the patient developed a serious, seizure, same day following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Seriousness criteria was assessed as medically significant as per important medical event Regulatory Authority list.  It was reported "pharmacist ask about seizure as a potential side effect".  It was unknown if there were lab data/results available.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of the event was unknown.; Sender's Comments: This case concerns a 17-years old female patient who had seizure same day following vaccination with MENACTRA. The time to onset is compatible. However, patient's medical condition at the time of vaccination and lab tests were not reported. Based upon the reported information, the role of vaccine cannot be assessed.
At day 31 I was driving, and I started feeling tingling on left side of my face and lips and I looked in mirror tried to smile, my face was drooping I went the rest the way home. When I got home, I checked my BP, pulse and then we drove to emergency.  At ER they took me into triage right away, they did blood work and CT which came back normal. They kept me overnight to do an MRI the next day.  They thought I had Bell's Palsy except I still could move my eyebrow so they could not diagnose me with Bell's Palsy. The symptoms kept getting worse and by the morning the neurologist diagnosed me with Bell's Palsy. They put me on steroids and an antiviral and eye drops. I still have no control over my left eye, and I have intermittently felt tingling around my cheeks and lips.
Monday-inflamation began;Tues swelling @ 1" very sore ice/Ibuprofin shrank swelling;Wed swelling migrated towards lower inner arm
I have been dizzy ever since I got the first dose, it feels like I am on a boat all day. It is hard to focus and read.  I am dizzy all throughout the day and nothing seems to help. I can't look at a screen long or my eyes begin to burn. It has been 16 days and I see little to no improvement.
Intense stabbing pain at injection site whenever I move my arm. Pain has persisted over past 18 days. Ice provides some relief. Ibiprofen and heat do not provide any relief. Pain is more intense at night.
Head starting hurting 30 mins after vaccine , Light headed ,  nauseated for almost 24 hour
3 nosebleeds since her booster dose with one as recently as this morning; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (3 nosebleeds since her booster dose with one as recently as this morning) and MYALGIA (Body aches) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced EPISTAXIS (3 nosebleeds since her booster dose with one as recently as this morning) and MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) in December 2021 for Myalgia, at an unspecified dose and frequency. In December 2021, MYALGIA (Body aches) had resolved. At the time of the report, EPISTAXIS (3 nosebleeds since her booster dose with one as recently as this morning) outcome was unknown.            No concomitant medication were reported by the reporter.   This case was linked to MOD-2021-419496, MOD-2021-419500 (Patient Link).
The patient's mother noted swelling and warmth along the patient's right thigh on 06/23/2005 where she had received a DTAP vaccine on 06/21/2005.  Doctor saw the patient back in his office on 06/24/2005 at which time there was a 6 x 6.5 cm area of mild erythema and induration along the lateral aspect of her right thigh which radiated slightly increased warmth.  Patient's gait is normal and she does not appear to have any tenderness at the site.  The patient is a little fussy according to her mother and she is not febrile.
-I was 19 weeks pregnant at time of vaccine.  -Immediately following vaccine (same day) symptoms of headache, fatigue, and sore arm.  -2 days following vaccine my symptoms of hives (which I have an ongoing history of) returned including new hives appearing on body.  -7 days after vaccine symptoms of hives are recurrent and much worse than they were before I received vaccine.
inc swelling @ inj site w/small contusion;9JUL96 call to mom swelling & contusion have dec;checked by MD 1JUL96;
Developed a rash 5 cm diameter around the injection site and less confluent rash up to 6 1/2 cm from site. Started > 1 1/2d after the vaccine. Shot 1/16 AM. Woke up with rash 1/18/13. Rash was around site of KINRIX.
Within 1 minute of administration, pt noted with redness, heat to injection site (R arm). Pt was given PO liquids and 50 mg PO benadryl. She was monitored for 15 minutes, and was noted with rash to B/L LE and chest. Denies difficulty breathing. With assessment from provider, pt was escorted to ED triage at entrance with RN for further evaluation.
From September 2021 to May 20, 2022 Clinica adult patient?s received a diluted dose of the Covid 19 vaccine. The LVN that was overseeing the Covid Clinics, during that period, instructed the medical assistants (MA?s) involved in the clinics to add 1.8 milliliters (ml?s) of normal saline to the Pfizer, gray top vial, therefore resulting in a diluted dose. At the onset of Covid, Pfizer initially distributed a purple top vial that required a dilution of 1.8 ml of normal saline. However in September of 2021 Pfizer developed and distributed a Covid 19, gray top vial, vaccine that no longer required dilution. The LVN overlooked and possibly disregarded the vials label top which warned to ?Do Not Dilute?, and continued to instruct the MA?s to dilute with the same 1.8 ml?s of normal saline.  It is estimated that approximately 3,900, adult patients only, were vaccinated with the diluted dose. We have since implemented a corrective action plan. Pfizer, CDC, local DPH and HRSA have all been notified and are aware of our corrective action plan. Steps taken: The LVN resigned in lieu of being terminated, we have identified the adult patients affected and have mailed out a letter informing them of the discrepancy and instructing them to call the clinic and speak with the clinical staff, including the Medical Director and Clinical RN.  We have also implemented walk-in Covid 19 vaccine Clinics at two sites, with dates and times of operation.  All clinical staff have been trained on the appropriate dosing and CDC?s & DPH?s Covid vaccination protocol. Covid 19 vaccines are in locked areas/refrigeration and only designated staff have access to handle the vaccine. We continue to train, update and monitor staff on vaccination best practices.
Depression in skin near injection site 3 cm x 1 cm. Noticed 1-2 days after H1N1 vaccination.
states experienced fatigue and painful arm in 1-2 days after vaccine(1/5/2021) and also non pruritic blisters on arms and inner thighs on day 11-12, resolving as of 1/20/2021 Narrative:
fever; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) and PYREXIA (fever) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 17-Jun-2020 and the estimated date of delivery was 23-Mar-2021. On 30-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 27-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (fever). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-second week of the pregnancy.  The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 30-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. On 28-Feb-2021, PYREXIA (fever) had resolved.            No concomitant medication details was reported.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-033824 (Patient Link).
Pt. states after given the injection, had severe arm and neck pain on the side of injection-states also upper arm and shoulder was red and swollen.
Moderna on 1/12 and 2/5. Positive on 8/24 admitted 8/28 to current
This spontaneous consumer report (initial receipt 08-Oct-2015) concerns a patient (unknown demographics). On 17-Sep-2015, the patient received AFLURIA (batch number U59508) 0.5mL once via the intramuscular route. AFLURIA was stored correctly and indication for use was approved as per the Product Information leaflet. On 21-Sep-2015, the patient experienced shingles which persisted to date (at the time of reporting). Action taken with AFLURIA was discontinued. The outcome was not yet recovered. Reporter's comments: The reporter assessed the event as non-serious.
03/31 started getting dizzy and tired.  04/01 was really dizzy, fatigued, heart rate elevated, and lymph nodes in right armpit swollen 04/02 started getting chills along with other symptoms. 04/04 fever was 103, had chills, fatigue, headache everything continued for a few days 04/09 heart rate really elevated rushed to the hospital, CT scan revealed enlarged spleen from side effects of Moderna
Information has been received from a registered nurse concerning two female patients who on unknown dates, were vaccinated with a dose of GARDASIL. The nurse reported that the patients fainted after receiving HPV vaccine. It is unknown if the patients sought medical attention. Follow up information received on 20-SEP-2009 from a health care professional indicated that the patient was a 15 year old female student, who on 28-JUL-2009 at 11:57 was vaccinated with a first dose of GARDASIL intramuscularly into the left deltoid. On 28-JUL-2009 at 11:58 the patient was in a sitting position. Gave immunization. About one minute later she saw the patient on the floor. The patient was pulled by legs out of corner of the room. The patient awoke from fainting about one minute later. The physician advised. The patient recovered on 28-JUL-2009. No further information is available.
ITCHINESS ALL OVER BODY; BRUISING; RASH ON ARM, SPREAD TO BACK LEFT, SHOULDER; CHILLS; LACK OF ENERGY; HEADACHE; FEVER; LACK OF APPETITE/COULD NOT EAT; COULD NOT GET OFF THE COUCH; EXTREME BACKACHE; This spontaneous report received from a patient concerned a 33 year old female. The patient's height, and weight were not reported. The patient's past medical history included cold, flu, meningitis, and petechiae, and concurrent conditions included alcohol use, and non smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no known allergies. the patient had no history of drug abuse/illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: 13-JUN-2021) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. Concomitant medications included levonorgestrel. On 03-APR-2021, the subject experienced extreme backache. On 04-APR-2021, the subject experienced lack of appetite/could not eat. On 04-APR-2021, the subject experienced could not get off the couch. On 04-APR-2021, the subject experienced chills. On 04-APR-2021, the subject experienced lack of energy. On 04-APR-2021, the subject experienced headache. On 04-APR-2021, the subject experienced fever. On 16-APR-2021, the subject experienced itchiness all over body. On 16-APR-2021, the subject experienced bruising. On 16-APR-2021, the subject experienced rash on arm, spread to back left, shoulder. On 17-APR-2021, Laboratory data included: Coagulation test (NR: not provided) NORMAL, Full blood count (NR: not provided) NORMAL, Platelet count (NR: not provided) Lower end of normal, Urine analysis (NR: not provided) NORMAL, and WBC count (NR: 4 - 11) Normal. Treatment medications (dates unspecified) included: fexofenadine hydrochloride, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extreme backache, lack of appetite/could not eat, could not get off the couch, chills, lack of energy, headache, and fever on 05-APR-2021, had not recovered from rash on arm, spread to back left, shoulder, and itchiness all over body, and the outcome of bruising was not reported. This report was non-serious.
pt called & reported to have react to pneumovax which was given 19DEC94 sx were fever 103, nausea & erythema 10 cm x 6 1/2cm, swollen lesion of rt arm;
fever; nausea; vomiting; diarrhea; mild arm soreness; mild swelling at injection site; mild to moderate chills; mild to moderate muscle aches; This is a spontaneous report from a Pfizer Colleague from a contactable pharmacist (patient parent). A 15-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number and expiry date were not reported via an unspecified route of administration on 04Jun2021 (at the age of 15-years-old) as single dose for COVID-19 immunization. Patient did not have known drug allergies. Patient did not have any chronic medical conditions. Patient's medical history included the first dose of bnt162b2 vaccine. The patients concomitant medications were not reported. In Jun2021, patient experienced mild arm soreness, mild swelling at injection site, mild to moderate chills, mild to moderate muscle aches, and having a slight temp the day after her vaccine. On 07Jun2021, the patient started experiencing fever, nausea, vomiting, and diarrhea. The clinical outcome of all events was unknown.  Information about batch/lot number has been requested
My son 20 years old was not ill, no symptoms of flu nothing. Never had covid yet, got the injection and two days later:Passed out for a while suddenly, got heartbeats serious ones got shaking cold feather.Went to hospital, no doctor available, went home and got to dr the next day, Blood pressure and examine was diagnose with side affects due to vaccine, he is having nor a Mild Covid?got meds and went home. He is still scared this will happen again? Must he get the 2nd Vaccine when its time? Will this happen again?
Information has been received from a healthcare professional concerning a 4 year old male pt who on 6/17/97, 8/4/97 and 4/17/98 was vaccinated with the 1st (lot 621000/1554D), 2nd (lot 620758/1402D) and 3rd (lot 622790/1036E) doses of Hep-B vaccine recombinant (yeast), respectively. It was noted that on 11/18/99, the pt was vaccinated with 1 dose of MMR (lot 628004/1173H). On 6/3/01, the pt was dx'd with autism. It was noted that no current medications have been prescribed by the PCP. The pt's mother indicated that her son was a normal child until he received these 4 shots. Additionally, it was reported that the parents expressed concerns about the thimerosal content in the vaccine because of the mental delays experienced by their son. FOLLOW-UP information has been received from a physician who reports that the patient has autism and the mother is checking into all his vaccines as a possible cause the physician does not feel that there is any connection. Upon internal review, autism was determined to be an "Other Important Medical Event". No further information is availble.
Patient had received the Typhoid vaccine first. Then she was administered the Hep. A. As soon as the Hep, A was removed the nurse, patient slumped over as of she fainted, then stiffened as if in a mild seizure, shaking head and kicking, then came out of it. She was very pale, pulse was racing and disoriented for a few minutes.
S:  is a 52 y/o female on the floor on presentation after receiving Moderna vaccine  1st dose. Nurse  reports holding her to the floor did not hit her head.  O: 10:47 1st blood pressure 150/100. HR 104 Oxygen saturation  97 Resp. 17 2nd Blood pressure 140/ 80 No signs of trauma. No hematoma of the head. No bleeding. No acute distress noted. Talking a/o x4.   Integumentary: normal dry, Intact skin, neg abrasion or lacerations. Resp. Normal . No rapid breathing, neg wheezing or shortness of breath Cardio:  Tachycardia, neg for murmur, positive for syncope neuro: Negative for slurring, negative facial drop, negative for weakness, negative for numbness and tingling  Assessment  Syncope Monitored for 20
No adverse effects & no treatment. Pharmacist administered FLUZONE ID to pediatric patient but it is only indicated for patients 18-64 years of age. The advertising of it being painless & good for anyone who is afraid, prompted pharmacist to administer it.
Child was being watched by grandmother who reported that the child was shaking earlier in the evening. Child was put in his crib on his back and later was found on his stomach; blue around the mouth but still warm. SIDS suspected.
For two weeks following the initial Covid Vaccine, I experienced extreme emotional distress and an inability to regulate those emotions, I was unable to work for several days due to the amount of anxiety I was experiencing. I was incredibly anxious, depressed, and generally overwhelmed. I had many thoughts that were passively suicidal, and many emotions of self-hate and deprecation. I was able to gradually cope with these emotions and after nearly two weeks, the symptoms were gone.  I thought that this was due to stress buildup until i got my booster shot last Thursday (11/18/2021), Immediately after, my energy was completely drained, and the next day I was even more exhausted and started to feel incredibly anxious, and I decided to go to sleep as i was likely just tired. The next morning, I woke up to extreme fears of my friends leaving me along with a deep feeling of depression. The thoughts of self hate returned, but they only lasted a few days... I am still dealing with these symptoms but they have gotten better the last two days.
PATIENT COMPLAINED OF TIGHTNESS ACROSS CHEEK AND HEADACHE. 11:35 BP 121/81, HR 70, RR 16 11:40 BP 122/68, HR 69, RR 16 11:45 BP 121/78, HR 70, RR 16 11:55 PATIENT LEFT SITE IN STABLE CONDITION