chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Systemic: Fainting / Unresponsive-Mild, Additional Details: vaccine was administered and then a few minutes later he fainted. Patient fell out of chair bite his lip and hit head on privacy screen.  He did not want me to call ambulance and refused to go to ER.  His wife came to pick him up to ensure he is ok.
Left upper extremity redness, warmth, swelling, mild itching approximately 7cm area.
severe pain in arm, shoulder, neck.  Then my arm, where the injection was given, swelled up to the size of a orange. Was very hard to work for the 7 days the symptoms lasted.
Administered MMR and TB on 8/24. Fever 101-102 degrees 3 days on 9/2-4/04. Red, profuse rash on cheeks, neck, front and back torso, vagina and buttocks; upper thigh and top of feet from 9/5  - 9/4.
the second dose was accidentally administered 18 days after the 1st dose, instead of 28 days. patient's grand daughter stated that she fainted 2 times after receiving the dose earlier than recommended.
Patient communicated over the weekend with the doctor on 3/2021 that she was told that she had rotator cuff injury because of the influenza vaccine that was administered on September 10 2020. She had called the office on September 22nd 2020, to report she had pain at the injection site. The doctor called her and instructed to ice, take ibuprofen as needed.  Since then there was no communication with the doctor. She just informed the doctor that she continued to have pain after six months of the vaccine and  in last few months she has started physical therapy and was told that this injury is because of influenza vaccine. The doctor does not have any records available.  However, the doctor recommended her to see a shoulder orthopedist,  and follow-up with her as needed.
Pain in upper arm and neck for close to a week.  Got shot on Wednesday and felt sore throughout body especially around upper arm and neck.  By Friday had biting pain around neck.  Could barely move it on Saturday and Sunday.  Monday the biting pain left and neck pain started to let up.  Tuesday seems like pain is getting better.
After MMR Vaccine on May 22, 2021: Was in bed for a week, with fever, malaise; Could not walk very well; Had joint pain and aches; After patient reports his back was covered in hives afterwards, huge large welts; Did not go anywhere new or consume any new foods; Patient reports the vaccine was the only new thing.
Have taken the shot, now shingles/ suspected vaccination failure; shingles/Have taken the shot, now shingles; Pain is muchless; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved and the outcome of the pain was recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-SEP-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient experiencing Shingles now and certainly glad to have taken the shot a few years past. The patient would not want to have not taken the shot, the pain was much less now. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not possible, as no contact details were available.
Inconsolable crying x 1 hour started about 3 hours after shots: better now: Tylenol .8cc q 4 hours. Right leg sensitive to motion more so than left leg.
A couple hours after the COVID vaccine I developed a headache which lasted 3 days. Over the next couple of days I developed a deep aching in my shoulders, hips, spine, and ankles. At 11 pm on the 20th I awake with the most horrible headache. It felt like my brain was wrapped around the outside of my head, and my neck was very stiff. I became dizzy and nauseated and vomited several times. I had a fever of 102.1 and was feverish for the next 6 hours. For these symptoms I took 325mg of ASA, and 50 mg of Benadryl.  After my fever broke my headache and neck pain began to resolve. My bone aching remained. My headache returned the following day along with my neck stiffness and another fever. I again took ASA, and Benadryl. My fever broke after a couple of hours and my symptoms began to resolve. My bone aching remained. On the 21st the aching in my shoulders and ankles resolved, but remained in my spine and in my hips. It felt like I was bruised from the inside of my bones. Today 9/22/2021 my spine aching has mostly resolved, I have no headache or neck stiffness, but I still have bone aching in my hips. It is about 3/4 less than it was at it's worst. The only medication I have taken for it is ASA and Benadryl. I do have a known Allergy to PEG and was advised that I might have a cross sensitivity reaction to the polysorbate in the J and J, which is why I took the Benadryl and ASA. My arm in which I received the injection was never sore.
vomiting; shortness of breath; coughing spell; This is a spontaneous report from a contactable consumer (patient). A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration on 15Apr2021 as SINGLE DOSE for covid-19 immunization. Patient medical history and concomitant medications were not reported. After taking the 1st dose of the Pfizer Covid 19 vaccine on 15Apr2021, the patient experienced shortness of breath and vomiting, and wanted to know if this a common side effect and how long would it last. While reporting the events via phone she was unable to continue talking and hold phone due to coughing spell. Outcome of the events was unknown.
Pt. reported experiencing headaches described as "odd, throbbing"headaches that decrease when laying down; This is a spontaneous report from a contactable other health professional and a consumer (patient) via a Pfizer sponsored program Optum Xeljanz Program. A 40-year-old female patient received BNT162B2 (reported as "COVID-19 VACCINE"), via an unspecified route of administration on an unspecified date, at an unspecified age, as unknown dose number as single dose (Batch/Lot number was not reported) for covid-19 immunisation; tofacitinib citrate (XELJANZ XR), via an unspecified route of administration from 16Jun2021, at 11 mg for an unspecified indication. The patient medical history included eye surgery on an unspecified date. Concomitant medications were not reported. The patient reported experienced headaches described as "odd, throbbing" headaches that decrease when laying down on an unspecified date. The patient reported received COVID vaccine and underwent eye surgery prior to starting Xeljanz stated those may contribute to headaches. The action taken for tofacitinib citrate was unknown. The outcome of event was unknown.  Pfizer is a marketing authorization holder of COVID vaccine in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of COVID vaccine has submitted the same report to the regulatory authorities.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.
got her first Moderna COVID19 vaccination on Wednesday 03/10/2021. She had no immediate problems with the shot such as arm pain or any other concerns, but by the next day 03/11/2021 she woke feeling very exhausted. They were having tests, and she is one of the main people in charge of this, so she just wrote it off as a reaction to stress. However as the day went on she was feeling worse including low-grade chronic headache, nausea, intermittent palpitations and waves of dizziness. She even had a little anxiety attack, thus she went home Thursday afternoon. She forced herself to go back to school the next day, knowing that if she could get through that day, she'd have a whole week off for spring break. Unfortunately, despite decreased stress, she continued to feel poorly. She has a feeling of profound fatigue, constant headache at the base of the skull that Tylenol really doesn't touch, nausea, stomach rumbling, intermittent dizziness, and intermittent palpitations.  Not surprisingly, her anxiety has increased, so she started sertraline 25 mg one half tab on Tuesday 03/16/2021, and on Saturday 03/20/2021 she increased it to a full tab. Now taking PharmaGABA at night to keep the anxiety and heart racing down.
Syncopal episode after receiving covid vaccine.  He became acutely lightheaded, describes tunneling of his vision, then his head rolled back and his eyes fluttered.  Event was witnessed by his mother.  Did not fall to ground.  No injury.  Taken to ER no further care required and symptoms resolved. Has happened before with blood draws and other vaccinations.
Injection site is irritated; injection site is becoming hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE IRRITATION (Injection site is irritated) and VACCINATION SITE WARMTH (injection site is becoming hot) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE IRRITATION (Injection site is irritated) and VACCINATION SITE WARMTH (injection site is becoming hot). At the time of the report, VACCINATION SITE IRRITATION (Injection site is irritated) and VACCINATION SITE WARMTH (injection site is becoming hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided by the reporter  No treatment medication were provided by the reporter
Had a similar experience with 1st dose of vaccine see e-confirmation number 296929. The 2nd time she vomited about 4 times large amounts, ran a high fever and became listless. The symptoms lasted about 48 hours. I also called the doctor's office as well, I was told to try and keep her hydrated and if she got worse to take her to the ER. I also called the ER as well.
Completed the 2 dose Covid vaccine series on 2/18/21, then was hospitalized for Covid on 8/15/21.
Severe headache, flu like symptoms and fatigue the day after the vacinne.  Followed by muscle aches and low grade fever for several days.    Slowly started feeling better without a fever.  7 days after vacinne I begin feeling flu like symptoms with a 102 and 103 fever.
Pfizer vaccine was stored incorrectly, it was placed in the regular freezer instead of the sub-zero freezer. I contacted the mom of the parent and informed her of the situation. She will converse with her husband to see if they would like to re-vaccinate pt.
Was feeling fine the day I received the shot, albeit some pain at the injection site. I woke up early the next morning and my left jaw was sore, my left knee was swollen and hurt to move/walk, and the bottom of my left foot felt strange. There is also a very, very dull wave-like ache across the bottom of my front teeth.
The night of the second dose of my Pfizer Covid vaccine, my face began to feel hot and tight. The next day, I began with the expected flu like symptoms of the vaccine, accompanied by a red, fine bumpy rash with some swelling on my face where it had felt hot and tight the evening prior. The flu like symptoms lasted about 24 hours. The facial rash persisted and I began oral antihistamines - diphenhydramine and famotidine. The rash continued for one full week, only improving after beginning to use topical hydrocortisone on my face at the suggestion of a friend who is a nurse practitioner. After improvement in the rash I stopped hydrocortisone and antihistamines. The rash reappeared about 5 days later, and continues to randomly reappear about once a week to every 10 days. Flares only last about 24-36 hours now and will go away without medication but it does clear faster with hydrocortisone and antihistamines. The rash only flares at night, and no triggers like heat, alcohol or certain foods seem to bring it out.  I have been consistently taking famotidine and cetirizine daily since the last flare of the rash, and have not experienced a flare again yet.
Heavy and weird tongue feeling; sore arm; not feeling good; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (Heavy and weird tongue feeling), PAIN IN EXTREMITY (sore arm), MALAISE (not feeling good) and FATIGUE (fatigue) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA ORAL (Heavy and weird tongue feeling), PAIN IN EXTREMITY (sore arm), MALAISE (not feeling good) and FATIGUE (fatigue). At the time of the report, PARAESTHESIA ORAL (Heavy and weird tongue feeling), PAIN IN EXTREMITY (sore arm), MALAISE (not feeling good) and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was not provided by reporter Treatment medicines were not reported
This spontaneous report as received from a Registered Nurse refers to a 1 day old female patient. On 14-JUN-2014 he patient was vaccinated with an improperly stored RECOMBIVAX HB lot # J012520 dose 1, intramuscular. No adverse symptoms reported. The patient did not seek medical attention. Also it was reported that vaccine storage temperature dipped to 0 to 1 grade in 18 different episodes according to min/max. All recorded temperatures were within 2 to 8 grade. This is one of several reports received from the same source. Additional information is not expected. All follow ups requested to complete the case were received.
This spontaneous report as received from a physician refers to a 14 year old male patient. The patient's pertinent medical history was not reported. On an unspecified date in October 2013 the patient was vaccinated with second dose of GARDASIL. The patient's mother brought the patient in for a follow up exam on an unspecified date in March 2014 and stated that after the second dose of GARDASIL, the patient experienced slow speech, loss of appetite and was not acting like himself on an unspecified date. The physician examined the patient and did not find anything outside of the "normal". The outcome of the events was unknown. The causality was not reported. Additional information has been requested.
A non-serious spontaneous report of inadvertently administered expired FLUMIST was received from a health professional concerning a nine-year-old female. Neither the patient's past medical history nor any concomitant medications were reported. The product expired on 15-Dec-2010. The patient received the expired FLUMIST on 22-Dec-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Pt complaint of redness, swelling, warm to touch at injection site. 4 days after receiving injection. Pt seen by Dr 8/10/10. Instructed localized reaction to vaccine. To F/U 8/11/10 or sooner.
Shortness of breath; This spontaneous case was received on 18-Sep-2020 from a pharmacist via agency (reference number: SEQW20-01973) and concerned a 36-year-old male patient.  The patient's medical history and concomitant medication were not reported.  On an unknown date, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; indication, dose, anatomical location and route of administration: not reported). The batch number was not reported.  On the same day, after receiving Flucelvax QIV, the patient experienced shortness of breath. The patient went to medical doctor (MD) and was tested for flu and COVID-19, which came back negative. MD said it was a reaction to the vaccine (did not specify) and patient was sent home with Benadryl (diphenhydramine hydrochloride).   The outcome of shortness of breath was not reported.  The reporter did not provide a causality assessment to Flucelvax QIV, however the was MD said it a reaction to the vaccine (did not specify).   The reporter assessed the event as non-serious.   This case is linked to case 202004569 due to the same reporter.  Company comment: The patient developed dyspnea on the same day after receiving the suspect product, Flucelvax QIV. Chronology is suggestive. No information about concomitant medications and medical history was provided. Based on provided information, causal relationship is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).; Reporter's Comments: MD said it was a reaction to the vaccine (did not specify).; Sender's Comments: The patient developed dyspnoea on the same day after receiving the suspect product, Flucelvax QIV. Chronology is suggestive. No information about concomitant medications and medical history was provided. Based on provided information, causal relationship is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).
Patient developed a hard lump about 2" wide and redness about 5 1/2" long around the injection site when I measured it 11/13/15 approximately 1pm. She also experienced whole body itchiness for the past few days. She went seen employees medical team and was advised to take BENADRYL. She has been using it ever since and when I called her today, she said the rash is more contained.
Swollen and painful lymph nodes around collar bone and neck lasting for 2 weeks and ongoing
This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Dec2021 as dose 1, 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", described as "Covid-19 infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: The patient got Covid-19 infection. Clinical Course: The nurse calling for the Pfizer Covid-19 vaccine 5-11 years old.  She states that the patient received their first dose in Dec2021 and did not comeback. The patient got Covid-19 infection and was just never scheduled. The nurse would like to know if there is a deadline or should the patient need to restart the primary series. 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 limited information in the case, a possible causal association between the reported events Drug ineffective, Covid 19 and the suspect drug cannot be excluded.
Friday, Oct 2, approx 5:19pm, Occupational Health Manager received a call from Occupational Health nurse administering flu vaccine to employees at Hospital. OccHealth nurse stated she went to inpatient pharmacy and requested Fluzone preservative free influenza vaccine for Occupational (Employee) Health to administer to employees. Stated the pharmacy tech handed her the doses from a refrigerator without pharmacist checking before dispensed. After 4th dose administered, nurse noted on the box it was high dose influenza vaccine and returned them to pharmacy. States doses were administered between approximately 1:30pm-2:30pm, Oct 2. OccHealth Manager contacted pharmacy director, Clinical Occupational Health Director, and Occupational Health Medical Director of the incident between 6pm-7pm Oct 2. Employees were to receive Fluzone, but received high-dose vaccine in error from occupational health nurse.  Occupational health nurse received incorrect product from inpatient pharmacy.
pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) in a 33-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 016M20A) for COVID-19 vaccination.     The patient's past medical history included Artificial insemination (IUI). Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for Anxiety, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-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 04-Jul-2020 and the estimated date of delivery was 09-Apr-2021. On 06-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-first week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, Glucose tolerance test: normal (normal) normal. In 2020, Ultrasound scan: normal (normal) normal. On 31-Jul-2021, Pregnancy test: positive (Positive) Positive.         Treatment information was not provided. Estimated date of conception was on 17 Jul 2021. It was reported that there was maternal history of subfertility wherein intrauterine insemination was performed.
diarrhea, soft stools 4-8x a day began 1wk p/vax & cont for about 6wk afterward;pt rear end was so raw, it bled;now it is scar red;
right ear itching and burning and then the skin started to crack; right ear itching and burning and then the skin started to crack; right ear itching and burning and then the skin started to crack; her other ear was burning, red, felt hot and started cracking again; her other ear was burning, red, felt hot and started cracking again; This is a spontaneous report received from a contactable consumer or other non-health care professional. This is the report 2 of 5 regarding callers sons wife's father. A male patient of an unspecified age received dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced right ear itching and burning and then the skin started to crack, burning, red, felt hot and started cracking again. The outcome of the events was reported as unknown.  Information on lot/Batch number has been requested
Nausea, vomiting, dizziness, fainting, cold sweats, heat flashes, weakness. Pain.