chrisvoncsefalvay/vaers-outcomes huggingface dataset:
friend who cant even walk at all after receiving the COVID vaccine; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team, Program ID.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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: GAIT INABILITY (medically significant), outcome "unknown", described as "friend who cant even walk at all after receiving the COVID vaccine". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information, the reported serious event Gait Inability cannot be excluded for the suspect product BNT162b2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
12y/o F behind on vaccines came in to clinic to get MMR vaccine. Per Mom wants to do One injection every visit, decided to get the  MMR today only. MMR done while we were making the appointment for further vaccine noted patient collapsed on the floor facing down (Pt hit side of face). After getting  the patient up with the help made her sit on the chair, initial assessment done. Patient looked pale on her skin, no initial signs of injury noted at this time, As per patient no lunch today, Mother stated had to rush on there schedule unable to check if she eat or not. AT 4/28 MD visit, it was noted that the patient was not able to open mouth well and had pain over the side of the face. No HA, no dizziness. Mom also with hx of vasovagal syncope. 4/29 X-ray showed nondisplaced fracture of the left mandibular body. This injury approximated the mental foramen but appears to spare the alveoli the teeth. 5/3 Face is swollen and assymetric and pt unable to open her mouth wider than 1 finger breadth. 5/5 Pt underwent closed reduction of the right subcondylar fracture and application of arch bars with intermaxillary fixation.
pt fainted, lost LOC x 20 sec according to mom, upon arrival pt was awake, alert, clamy and pale, HR=85, laid pt in supine position, monitored HR x 15 mins, pt awake and alert, oriented, described a syncopal episode, stated he hadn't eaten yet today, engaged in conversation, then sat pt in sitting upright position x 15 mins, HR=85, gave pt juice = 50gms carb, pt continued stated he felt much better, still appeared pale, then 15 mins pt able to ambulate without dificulty, HR=85, mom refused to go to emergency room as counseled. mom states he has a history of syncopal episodes with blood draws, or getting shots.
Had a racing heart on Tuesday, February 16th in the morning, heart rate went up to 135 when I was just sitting. Went to the emergency room around 4pm and had been diagnosed with Supraventricular tachycardia.   Had to be given medicine to stop my heart for a second to slow it down. The only thing different in my life was the week before I had my second COVID-19 vaccine. I have been following up with a cardiologist office and all tests came back ok.  Now on medication daily to keep hear rate low.
LITTLE HEADACHE; EXHAUSTION; SORENESS IN ARM; DEHYDRATION; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included migraine, sinus, tension headaches, seasonal allergy, non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient did had history of marijuana edibles as drug abuse or illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 11:00 for prophylactic vaccination. Concomitant medications included ibuprofen for tension headache, and rizatriptan benzoate for tension headache. On APR-2021, the subject experienced dehydration. On 08-APR-2021, the subject experienced soreness in arm. On 09-APR-2021, the subject experienced little headache. On 09-APR-2021, the subject experienced exhaustion. Laboratory data (dates unspecified) included: COVID-19 virus test negative (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little headache, and exhaustion on 11-APR-2021, was recovering from soreness in arm, and the outcome of dehydration was not reported. This report was non-serious.
Pregnancy resulted in stillbirth at 36 weeks, 6 days gestation.  IVF Pregnancy with PGT-A testing. Unremarkable pregnancy with the exception of placenta previa (which resolved at 32 weeks gestation) and slightly elevated MSAFP (3.58 MOM).
Extreme muscle soreness and weakness especially in the lower back, the groin, and the leg with the orthopaedic knee, which has not had any pain for several months.  Pain , which was so severe I could not lie down, sleep or walk, has progressed for seven days.   Per the ER doctor, there is a bulging disc and arthritis in my lower back.  My daily routine is to walk three miles and work out at the gymn even though there was a bulging disc and arthritis.  I believe the pain is related to the shingrix shot and the fact that I have an orthopaedic knee, because the pain started within three hours of the shot and has concentrated in my lower back, groin, and the leg with the orthopaedic knee.
About 3 days after the shot, the left side of my body had pins and needles/ tingling in Foot, leg, torso and arm. Also, I have felt more off balance on my left side.  It has been 4 months and symptoms are better but I still have tingling/pins and needles feeling in my foot and lower leg , especially after walking a lot. Also sometime in my torso.
Flu like symptoms,fatigue, fever,really bad chills from 430 pm till the next am
She felt like someone hit her head with a bat. Called her Dr and was told to take 4 ibuprofen. Did not help and went to ER. At the ER was asked if she was in an accident because her head was swollen. She said no. They gave her a shot on the skull. Was not admitted to the hospital. Was sent home with muscle relaxer for the pain. She was home 3 days with pain and her husband had to stay home from work to help. No health insurance. Shot-CELESTONE 6mg-1 ML, MARCAINE 30 ML. Prescription=FLEXERIL-5 mg tab. Took 4 days to feel better. Took all muscle relaxer, 4 day on medication. Developed-a lump on the left wrist a week later.
The patient was given expired Daptacel; Initial information received on 25-Oct-2019 regarding an unsolicited valid non-serious case received from another health professional.  This case involves a 1-year-old male patient who was administered expired diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel] (PT: expired product administered)  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other concomitant vaccines were given. Only Flu vaccine of unknown brand given.  On 25-Oct-2019, the patient received 1 dose of expired Diphtheria-15/Tetanus/5 AC Pertussis vaccine (lot number: lot C5307AA; expiry date: 23-Oct-2019) in right thigh, for immunization (PT: expired product administered).  It was a case of actual medication error due to expired vaccine used.  Information on the batch number is available.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), on 21Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in left 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's relevant medical history included: "Recurrent sinus infections" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: Anti viral details: Product for COVID 19 Treatment, brand was Paxlovid, treatment start date was13Jul2022 and treatment stop date was 22Jul2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recvd 1st & 2nd dose of Hep B vax JAN89 & FEB89 & following 2nd vax devel hep-like illness characterized by elevated GGT, inc bilirubin, sx of myalgia & fever from 101 to 102; pt was ill for approx 1 month & missed @ least 1 wk of work;
40 watery blisters on back, chest, abdomen, arms itches no fever.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021 at 3:57 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Oct-2021 at 3:57 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial moved from freezer to refrigerator, it was a day when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer/refrigerator or maintained at room temperature.  The reporter stated that total 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions was reported. Total 280 patients received Moderna Covid 19 stored at minus 82 degrees Fahrenheit.  No treatment medications were provided.   This case was linked to MOD-2021-402935 (Patient Link).
After ZOSTAVAX vaccine, I had approximately 2x3 inch raised red rash day after. Second day after, moderate swelling and tenderness around this site approximately 6x10 inches. Hard lump beneath injection site.
PATIENT HAD PFIZER VACCIINE ON 12/22/2020 & 01/12/2020, AND TESTED POSITIVE TO COVID.
PT received TD and Varicella vaccine on 10/23/02 at 15:40. On 10/25/02, 9 a.m., c/o fever, severe headache, bodyaches, and lethargy noted by case worker. Taken to a medical center, treated & discharged to home.
STOMACH PAIN; VOMITING; DIARRHEA; NAUSEA; CHILLS; FEVER; MUSCLE ACHES; This spontaneous report received from a parent concerned a 20 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included 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, intramuscular, batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid.  On 26-MAY-2021, the subject experienced chills. On 26-MAY-2021, the subject experienced fever. On 26-MAY-2021, the subject experienced muscle aches. Treatment medications included: paracetamol. On 27-MAY-2021, the subject experienced stomach pain. On 27-MAY-2021, the subject experienced vomiting. On 27-MAY-2021, the subject experienced diarrhea. On 27-MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, and muscle aches on 26-MAY-2021, had not recovered from stomach pain, vomiting, and diarrhea, and the outcome of nausea was not reported. This report was non-serious.
left arm pain- pain at injection site with local edema, nausea, lower R and L LQ abd pain with palpation
mom reports that child became lethargic poss had sz;this child had DTP 1994, 1995 & DTAP 1997 w/no rxn;no rxn to MMR in 1994;pt was taken to ER & fully recovered;
Chills, rashes and swelling on my face. I took benadryl 50 mg and tylenol by mouth once only. Chills disappeared after few hours but rashes and swelling on my face takes days to disappeared. Over all felt better.
Progressive muscle weakness in upper and lower extremities starting 11 days after receiving mass immunizations. Also associated with facial weakness. Admitted to hospital on Dec. 22, 2015 - underwent workup including imaging, LP, EMG, lab work with diagnosis of GBS - treated with 5 day course of IVIG.
After the first vaccine I had a rapid heart rate and dizziness for days. I had a fever and extreme fatigue as well. On January 1, 2021 I went for a short hike with my family. When I was done I had a sudden feeling I couldn't breath and chest pain. Every time to tried to take a deep breath in I couldn't. The pain was sharp and hurt more as I inhaled for a deep breath. My heart felt like it was pounding out of my chest. After several minutes I could breath normally again. I should have gone to the hospital but I after it subsided I figured I was ok. I did tell my gynecologist about it that week because I was a little nervous after. I thought it was a PE after thinking about it, but she didn't have any recommendations for me at the time. With the second vaccine I had a 103 fever for over 48 hours. I had swollen lymph node with both vaccines. The second vaccine was in my right arm and ended up having lymph node biopsy. After the second vaccine I had a terrible time with rapid heart rate, dizziness and severe fatigue. There were times I almost fainted at work. I would have to sit down for a while until the dizziness subsided. I later found out that was POTS syndrome from my neurologist. On March 25th my right eye became inflamed and painful. It felt like daggers shooting through my eye. I went to the doctor and was referred to eye specialist. He diagnosed me with uveitis. I was sent to two eye specialists. A retina and glaucoma specialists. My eye pressures were so hight I had to have a trabeculoplasty surgery on both eyes in May. The eye pain and inflammation has persisted since March. I had several bouts of shingles. My headaches got so back with the eye pain I was then referred to a neurologist. They did a brain MRI and lots of blood work. I was also referred to a rheumatologist. The headaches were so bad it felt like my right side of my head would go numb when I sleep on it. My whole right side has neuropathy. This has lasted the whole time. I can barely pick things up with my right hand and I have a right foot drop. I have lost 50 percent of vision in my right eye since the vaccine.  I take Neurontin, prednisone, valtrex now since the vaccine.
Patient stated that she felt an immediate sting during administration, but she has swelling and bruising of her entire arm within 2 days, 9/26. She had a photo of the affected arm with bruising on the lower half of the arm near, just above the elbow.
SUPER SENSITIVE IN THE CENTER OF ARM PIT OF RIGHT ARM; ARM PIT OF RIGHT ARM SWOLLEN; 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, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced super sensitive in the center of arm pit of right arm, and arm pit of right arm swollen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the super sensitive in the center of arm pit of right arm and arm pit of right arm swollen was not reported. This report was non-serious.
Narrative:  COID infection following COVID vaccine series 08/04, Pfizer, dose #1 09/08, Pfizer dose #2 12/21 COVID swab, result: detected 12/17 pt cc: cough, fatigue, loss of taste or smell, myalgia, rhinorrhea, sore throat exposure: unknown
Patient was  inadvertently administered Pfizer for 2nd dose instead of Moderna  Contact Moderna vaccination for report and Pfizer to report and confirm no additional doses needed.
Patient reported rash at injection site about 2 by 4 inches that was warm and slightly itchy on 6.24. as of 6.26, rash was slightly larger per patient, but less red and itchy per patient report.
taste was affected for several hours; blood pressure has been high and yesterday it was 166/78; This is a spontaneous report from a contactable consumer (patient) reported an 89-year-old female patient received dose 1 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 included high blood pressure, lymphoma, and allergic to aspirin. Concomitant medications were not reported. On an unspecified date after the first dose of the vaccine the patient experienced taste was affected for several hours then subsided. Her blood pressure had been high and yesterday (24Apr2021) it was 166/78 but she did not recall what her pulse was. The patient had a history of high blood pressure and lymphoma so the high blood pressure was not new and she did not think it was related to the vaccine. The outcome of taste was affected was recovered. The outcome of blood pressure had been high was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: Based on the current available information, the event Blood pressure high is most likely related to an intercurrent or underlying condition which is not related to the suspected drug. Medical history of high blood pressure may provide an explanation for the event.
Patient got dizzy and had a tonic clonic seizure after about 10 mins. It lasted about 1 min and patient became alert again.
Patient had NO adverse effect, patient received Moderna Vaccine 1 st dose 3/31/21 no adverse effect then 2nd dose 4/28/21 given off-label. Patient's parents gave consent for patient to receive off-label
Reported hives occurring approximately 6 hours after vaccination. Self-treated with BENADRYL 50 mg x 1. Also took ZYRTEC 10 mg the following morning(takes as maintenance for allergies). Hives resolved within 24 hours of vaccination.
Symptoms started 3-3.5 hours after vaccination.  Mild headache, mild warmth (not sure if fever), body aches, mild disorientation.  By 8:25pm I was very achy & went to bed.  I awoke @ 12:40am & I could not move- my muscle were so tight all I could do was turn my head.  I did not panic (although it was very scary) because my pharmacist/friend had told me that this happened to her overnite after her first dose.  By morning  my mild headache & warmth went away & I was able to move but was extremely sore with muscle aches throughout my body.  I was unable to do anything all day & night.  I was better the next morning but still somewhat achy & my aches proceeded to continue over the next few days but decreased daily.
Fever starting 12 hours post-vaccination, lasting until 36 hours post-vaxx.  Body aches, lethargy.  Swollen lymph node (under left armpit) noted approx. 45 hours post-vaxx.
This case was reported by a consumer via call center representative and described the occurrence of injection site stinging in a female patient who received SHINGRIX for prophylaxis. On 11th March 2019, the patient received the 1st dose of SHINGRIX (subcutaneous). On 11th March 2019, immediately after receiving SHINGRIX, the patient experienced injection site stinging and intramuscular formulation administered by other route. In March 2019, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site stinging, injection site erythema, injection site swelling and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site stinging, injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The case was reported by the patient for herself who stated that she got her 1st Shingrix dose at doctor's office but had a reaction to it. The patient had redness and swelling at the injection site, the area was red and swollen and it was stinging and it stung when the vaccine was administered. The patient stated that her pharmacist said they gave her the shot in the wrong spot because they gave it to her behind her arm and not in the muscle (subcutaneously), which led to and intramuscular formulation administered by other route. The patient asked if she was supposed to repeat the dose and she was advice to speak with her healthcare provider as they will determine right treatment plan for her. The patient inquired whether the shot would not be effective since it was given at the wrong site. The patient was less concerned with the side effects and more concerned with the shot effectiveness and she asked to refer her to someone at a company who could help her. The patient insisted to talk with medical information department.
Rectal T 105.8 /win 48 hrs vax admin, APAP-white count inc 22.1->did blood culture but no growth.Gave 1 dose IM Rocephin.
Pt developed a suspected sterile abscess on right deltoid area with 3" of redness, warmth, tenderness and inflammation at site.