chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ANXIETY; SWOLLEN ARMS AND FINGERS; BLOATED STOMACH; BODY ACHES; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. 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, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 13-APR-2021 06:50 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced body aches. On 13-APR-2021, the subject experienced chills. On 13-APR-2021, the subject experienced fever. On 13-APR-2021, the subject experienced headache. On 16-APR-2021, the subject experienced swollen arms and fingers. On 16-APR-2021, the subject experienced bloated stomach. On an unspecified date, the subject experienced anxiety. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from body aches, chills, fever, and headache on 14-APR-2021, was recovering from swollen arms and fingers, and bloated stomach, and the outcome of anxiety was not reported. This report was non-serious.
Patient was extremely nervous and has always been nervous about needles. The parents let me know that he had passed out in the past from vaccinations. Patient received the vaccine fine and was sitting in our waiting area. I was standing in front of him when he suddenly felt sick and passed out. I used cold compresses and gave him a cold bottle of water when he was able to drink.  My staff called 911 and they checked him out. He able to stand and walk out  after about 15 minutes.
pt recvd vax 11APR94 & high fver 104, listless x 2 days & screaming;
I took Paxlovoid after getting COVID 19; I took Paxlovoid after getting COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "I took Paxlovoid after getting COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: tested positive again; (2022) Positive, notes: tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
HEART RACING; FEVER; NAUSEA; HEADACHE; UNCONTROLLABLE SHAKING; UNABLE TO EAT ALL DAY; This spontaneous report received from a patient concerned female of unspecified age.. The patient's height, and weight were not reported. The patient's concurrent conditions included migraines, and other pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805012, and batch number: 1805012 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 15:40 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced unable to eat all day. On 10-MAR-2021, the subject experienced uncontrollable shaking. On 10-MAR-2021, the subject experienced headache. Laboratory data included: Heart rate (NR: not provided) 100 laying down and sitting down in the 90s, normally in the 50s. On 10-MAR-2021 23:00, the subject experienced heart racing. On 10-MAR-2021 23:00, the subject experienced fever. On 10-MAR-2021 23:00, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from uncontrollable shaking on 11-MAR-2021, and fever on MAR-2021, was recovering from headache, and nausea, had not recovered from heart racing, and the outcome of unable to eat all day was not reported. This report was non-serious.  Version created to amend previously reported information on 11-Mar-2021. Upon review the following information was amended: Latest received date (ICH) was corrected.; Sender's Comments: Medical assessment comment not required as per standard procedure as the case is assessed as Non-serious. .
shingles; This is a spontaneous report from a contactable consumer (patient). An 83-year-old male patient received the first dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EL0140), via an unspecified route of administration, administered in Arm Left on 13Jan2021 (received at the age of 83-years-old) at 0.3 mL, single for COVID-19 immunisation. Medical history included pacemaker and atrial fibrillation. There were no concomitant medications. The patient had his first Pfizer vaccine shot on 13Jan2021 and was scheduled for the second on Wednesday, 03Feb2021.  Six or seven days after getting the first dose, in Jan2021, he noticed little red spots. He came down with shingles and his doctor has prescribed him valcyclovir.  It's an antiviral medication and he just want to be sure he'll still be able to get the second dose of the vaccine. His physician gave him a miracle medicine for it, Valacyclovir, an antiviral medication, he gathers, and it has done a great job. He has taken it for 3-4 days; the shingles are now leaving. However, he has his next shot, his second shot of the vaccine is this coming Wednesday, and he wondered if anyone at Pfizer can say whether this antiviral for shingles, a pill, is in any way perhaps going to interfere with the COVID second shot. He further stated, "I tell you, that first shot went in like a hot knife through butter!" Outcome of the event was recovering.
felt fainty; sweaty; Burning where i was injected; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (felt fainty), HYPERHIDROSIS (sweaty) and VACCINATION SITE PAIN (Burning where i was injected) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (felt fainty), HYPERHIDROSIS (sweaty) and VACCINATION SITE PAIN (Burning where i was injected). At the time of the report, DIZZINESS (felt fainty), HYPERHIDROSIS (sweaty) and VACCINATION SITE PAIN (Burning where i was injected) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.  Company Comment: Very limited information regarding these non serious events has been provided at this time.  Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: report contained no new information; Sender's Comments: Very limited information regarding these non serious events has been provided at this time.  Further information has been requested.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 28-JAN-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength: 0.5ml)(lot # L036245, expiration date 09-FEB-2018). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion for one time. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (refrigerator/freezer)(R/F) were 16, 29 and R. The storage criteria was R. This is one of several reports received from the same source. Additional information has been requested.
Redness on the place where I have the vaccine and a lot of pain. Itching on that arm and all over the arm and suddenly all my body itch and I have hives all over my body, head, arms, hands tang, inside my mouth. I got fever and chills.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 5 (bivalent), single (Lot number: GH9694) at the age of 73 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 06Apr2021 as dose 2, single (Lot number: ER8733), in left arm, on 06Oct2021 as dose 3 (booster), single (Lot number: FF2587), in left arm and on 06May2022 as dose 4 (booster), single (Lot number: FJ4989), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Atrial fibrillation" (unspecified if ongoing); "Known allergies : Pollen" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Eighteen month old boy given Varivax on 10/29/2001. Presented 11/13/2001 with redness/puffiness at site of Varivax and left inguinal node. Skin with blanching erythema, not indurated, not tender; left inguinal node about 1.5cm in diameter, mobile; given Augmentin as unable to rule out early cellulitis/edemitis.
Onset anxiety, tics, OCD behavior, worsened with increasing obsessive thoughts for 7 days, then gradually back to baseling by 10 days. No treatment except Zithromax for elevated mycoplasma Ig6. IgM at 7 days out.
Where i got my shot it turned hot; Where i got my shot it turned itchy; Where i got my shot it swelkled up; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Where i got my shot it turned hot), VACCINATION SITE PRURITUS (Where i got my shot it turned itchy) and VACCINATION SITE SWELLING (Where i got my shot it swelkled up) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Where i got my shot it turned hot), VACCINATION SITE PRURITUS (Where i got my shot it turned itchy) and VACCINATION SITE SWELLING (Where i got my shot it swelkled up). At the time of the report, VACCINATION SITE WARMTH (Where i got my shot it turned hot), VACCINATION SITE PRURITUS (Where i got my shot it turned itchy) and VACCINATION SITE SWELLING (Where i got my shot it swelkled up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.
Possible febrile seizure at 920 AM the morning following the immunizations child had single 15 sec "post shaking, eyes rolled up" witnessed my mother of child, seen in clinic. Sent to ER for further evaluation.
Pt sitting in observation area after Pfizer vaccination.  Felt hot, got up and then eased to the floor and laid down.  Hx of vasovagal syncope with injections and blood draws.  No LOC.  Vitals taken at time- HR remained 70s-110, BP at first in 90s/60s.  Pt laid down with feet up, cool compress, able to converse easily.  Eased to sitting position, then to sitting in chair and then standing.  BP when leaving was 110s/80s, patient reported feeling fine.  This was comparable to all previous syncopal events with blood draws/ vaccinations.
Received flu vaccine on 11/16/2001. One hour and a half later began sweating, swelling in armpit (size of baseball), shaking, no pain, indigestion, weakness, laying on floor. Called doctor 3 hours after receiving vaccine was in hospital for heart attack.
around 2130 the night of the vaccine I started to have muscle spasms in my back, glute (right side), chest muscle and arms.  I felt ill when I went to bed.  I woke up to my Apple watch having "high heart rate" alerts (3 alerts) saying my sleeping heart rate was from 140-155 bpm (normal is 50-57).  When I woke up the morning after my vaccine I was sore and in pain in every muscle in my body.   It hurt to speak because my jaw was so sore all the way to the insides of my feet and everything in between was in pain (6/10) and sore.  I took 800mg Ibuprofen which brought my pain down to a 2/10 and I stayed in bed all day, into the night and part of the day after.    Since then I have been having PVC's (caught on ECG and my apple watch) and palpitations in my chest where my heart will race and I have a stabbing pain in the center of my chest.  My fingers and hands have been cold (and finger tips are turning purple some days) and I am finding it difficult to get warm which has never been a problem for me.  I notice a drastic brain fog, which has partially dissipated over the past few months.  I have a few swollen lymph nodes in my neck as well which are new to me.    As someone who is fit I am unable to run more then 100 yards without my pulse going into the 150's during moderate intensity.  This is also VERY abnormal.
Increased swelling, itching and redness of left leg area to which injections were given, symptoms were 3x as bad on Sunday morning when grandma took pt to ER. Pt given Atarax Rx recheck on tues with improvement.
pt devel unspecified sx following vax; MD reported 3 pts; The pts were assigned WAES94030368 through 94030370; No further details were provided;
I had pain in the arm and a low grade fever. Months later I tested positive for COVID at the end of December, first of January 2022. I had to go to the doctor because I got very sick and I rarely get sick. I started with a bad headache and with some gastro issues and itching throat and fever that started first. My lower back started hurting and I started running fever, diarrhea and starting throwing up and my calf of my legs started hurting. I just laid down and took Tylenol and drunk plenty of water for about 6 days. I had to quarantine for about 5 days and I had to wear a mask for 5 days. I am a paramedic. I did have to go to the quick care, they did a PCR and the nurse went to far and I started bleeding from that and I cough up blood.  Here I am 5 weeks later I am sick again but I don't think I have COVID with this.  All of these symptoms are from the COVID, not the vaccine. I will not get another shot.
I did not know where I was or why I was where I was/I did not recognize my own dog; I did not know where I was or why I was where I was/I did not recognize my own dog; fever of 104.2; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 10Apr2021 as dose 2, single (Lot number: EW0158) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19: Yes. Concomitant medication(s) included: CRESTOR; LISINOPRIL. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: ER2613, Location of injection: Arm Left), administration date: 20Mar2021, when the patient was 61-year-old, for COVID-19 Immunization, reaction(s): "fever of 102.5", "Soreness at shot location". The following information was reported: PYREXIA (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "fever of 104.2"; DISORIENTATION (non-serious), COGNITIVE DISORDER (non-serious) all with onset 20Apr2021, outcome "unknown" and all described as "I did not know where I was or why I was where I was/I did not recognize my own dog". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: It was reported that within 24 hours of the first dose, a fever of 102.5 developed and lasted about 12 hours and within 12 hours of second shot, a fever of 104.2 developed and lasted about 60 hour. I did not know where I was or why I was where I was. I did not recognize my own dog. My doctor is not sure if I should even think about getting a booster shot because of reaction to first two shots. Patient received the treatment. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient has not been tested for COVID-19. No known allergies was reported.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200996478 Same patient, same vaccine in different dose, partial same event;
Pt. was screened twice about allergic reations any medical conditions/immunocomprimsed etc. Pt. responded no to all of the above questions. He was vaccinated IM on left arm. Pt. was educated about post care. Pt. was alert. I moved on to the next two cars and on the third car and about three minutes after his female partener called out for help and said that the Pt. passed out. Thats when the other nurse ran to the car to check on him and told me he was having a seizure. I ran to the lead to explain what happend and to call the medical team right away. The other nure was stablizing the patient. The patient was going in and out of consciousness for about ten seconds. The medical team arrived and took vitals.
Lymph nodes under both arms and in breasts achy, burning and sore for a month
Pt recvd vax @ 1PM t101.6 R; Pt recvd APAP; cont to check temp throughout the day & given APAP each time, taken to MD's ofc; pt also exp diarrhea, pulling lt ear, cough, ear w/sign of infect;
Pt has slight swelling/rash @ site the day of vaccine within hours of vaccine. Then pt was sent to summer camp. Pt returned home on 08/02/2002 from summer camp and left shoulder has become increasingly more swollen, the size of a tennis bball. Pt states she has itching.
broke her back; This is a spontaneous report from a contactable nurse via the Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient was hospitalized since she broke her back. The patient was scheduled for her second dose on 18Apr2021 but missed it since the patient was in the hospital. The reporter queried whether the patient could get the second dose or start over. The nurse stated that the patient "was admitted to the hospital had nothing to do with the vaccine, patient was in the hospital since she broke her back". The clinical outcome of "broke her back" was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The event "broke her back" is attributed to an intercurrent medical condition and assessed Unrelated to BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE).
I had another episode of weakness; slurred speech; unable to drink; couldn't walk; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (I had another episode of weakness), DYSARTHRIA (slurred speech), DYSPHAGIA (unable to drink) and GAIT INABILITY (couldn't walk) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In February 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jul-2022, the patient experienced ASTHENIA (I had another episode of weakness), DYSARTHRIA (slurred speech), DYSPHAGIA (unable to drink) and GAIT INABILITY (couldn't walk). At the time of the report, ASTHENIA (I had another episode of weakness), DYSARTHRIA (slurred speech), DYSPHAGIA (unable to drink) and GAIT INABILITY (couldn't walk) outcome was unknown.            No concomitant medication was reported. Patient reported that prior to this episode it had been at least 6 months since the last episode. No treatment information was reported.   This case was linked to MOD-2021-101864, MOD-2021-101869 (Patient Link).
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 10-OCT-2013, the patient was administered with a dose of VARIVAX (Merck) (Lot # J004162, expiry date 08-APR-2015) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Client complained of feeling drowsy and having perception of things being slow 15 minutes after receiving Bexsero vaccine on 10-25-2019. Client reported that she had the same perception when she received vaccines one month ago. Client did not report complaint during screening for contraindications and precautions. Client was advised to follow up with PCP for evaluation.  On follow up - Client reported that she did not see PCP due to symptoms resolved. Client was advised to report episode to PCP on next visit. Client verbalized understanding.
Information has been received from a 66 year old male with no pertinent medical history or allergies who about 2 months ago (in approximately June 2008), was vaccinated with a 0.65mL dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included [therapy unspecified]. The next day after getting shot (in approximately June 2008), the patient experienced warmth, pain and itchiness at injection site. At the time of the reporting, the patient had recovered (about 5 days after being vaccinated). Medical attention was not sought. Additional information is not expected.