chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At around 9:25 am on Thursday, June 17th, 2021, a fifteen-year-old patient walked into the vaccination site. She was accompanied by two guardians, along with 14 other minors. The minors came in for their 2nd shot of Pfizer Covid-19 vaccines.  Patient signed all necessary consent forms and pre-vaccination checklist requirements with guardian and entered the vaccination section at approx. 9:38 am. The Pfizer vaccine was administered at 9:45 am.  Patient was one of the first minor patients of the group that complained of a severe headache to observation nurse. Observation nurse gave Gatorade to the patient and she took a sip of Gatorade and was calm afterward. One of the patient?s guardians instructed her to head back to the van with the rest of the group.  At approximately 10:33 am observation nurse notified charge nurse that another minor patient was having a reaction to the vaccine in the parking lot area.   One of our site specialists was the first to attend to patient. Site specialist stated that she saw the patient walking with one of her guardians in the parking lot and looked like she was about to faint.   Charge nurse hooked up patient to the pulse oximetry and called 911 at approx. 10:34 am. The patient?s O2 level was 83 with a pulse of 107. The charge nurse observed that the patient was under a lot of stress and was hyperventilating and unable to verbalize how she was feeling. Shortly after, the patient fainted due to hyperventilation. Observation nurse advised the patient to calm down and take deep breaths but the patient did not comply and continued rapid breathing. The patient started to vomit and made some gurgling sounds in her mouth and the charge nurse with the help of site specialist laid the patient on her left side. Shortly after, the patient stopped breathing.   Observation nurse administered the epi-pen on the patient?s right thigh. Immediately after administering the epi-pen, patient started to breathe again with an O2 level of 98 with a pulse of 110; but the patient was still unconscious and unresponsive. At approx. 10:36 am first responder paramedics arrived at the scene and took the patient to hospital for further evaluation.
Leg that DTaP, HIB, IPV given became red and swollen, hot to touch from top of thigh to top of knee.
Rash/eczema appearing on both palms and some fingers, 2 rash spots on right thigh.  Also high fever both times 101.3 and 101.9 which required a day off and bed rest.
Patient received J&J vaccine at 15:01, approximately 10 min later patient reported she felt her tongue was swelling and her face was getting red and hot.  Following the reaction protocol patient received 0.5mg of epinephrine IM at 15:26 and was moved to a stretcher.  EMS was called, again per protocol.  EMS recommended patient be transported to hospital but patient refused.            Patient ambulated out of clinic independently and drove home.
Asked patient if this is his first covid vaccine and he said yes so I gave him the 1st dose of the Pfizer vaccine.  Later after processing the prescription it was discovered he had already gotten the Janssen vaccine in  April 2021. I called him to verify that and told him I will not be able to give him the second dose of the Pfizer since he was not recommended to get the first one.
tightness in my jaw; feeling shaky, tense, muscle spasms, and back pain; feeling shaky, tense, muscle spasms, and back pain; feeling shaky, tense, muscle spasms, and back pain; feeling shaky, tense, muscle spasms, and back pain; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 25Jan2021 09:30 (at the age of 37-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. Patient reported that shortly after receiving the vaccine, he felt tightness in his jaw (25Jan2021). Within a few hours he was feeling shaky, tense, muscle spasms, and back pain (25Jan2021). These issues had persisted for two weeks now. His provider and the ER did blood work which was normal, and were saying it could be lingering side effects or just anxiety and stress. He would like to know if similar symptoms had been reported and could be related. Patient visited doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care for adverse events. Patient received treatment for adverse events was unknown. The patient underwent lab tests and procedures which included blood work: normal. The clinical outcome of events was unknown.  Follow-up attempts completed. No further information expected.
ACHE MOSTLY ON THE FACE AREA; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and non-alcoholic, and other pre-existing medical conditions included the patient had no known allergies, no drug abuse or illicit drug use. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced ache mostly on the face area. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced fever. Laboratory data (dates unspecified) included: Pain scale (NR: not provided) 5/10. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ache mostly on the face area, chills, headache, and fever on 08-APR-2021. This report was non-serious.
( L ) forearm 4.25" x 2.25" ( L ) anterior deltoid. Erythema, warmth, induration occurred 24 hrs post injection. Injection given 5/3/2010 @ 4:30 pm. Had 1 temp 101 F @ 6 pm that night & dizziness at 2 pm on 5/4/2010. Both have resolved. Treated with Trimethoprim Sulfamethoxazole for possible cellulitis.
little red bump & itching on arms & neck appeared on neck p/vax;saw MD itching persisted;required 1 shot claritin;rash & itching went away p/vax;
Immediate symptoms were the classic ones - fatigue and my arm was there and I had brain fog that cleared up by the end of the day after the vaccine. I don't know if this vaccine caused the other things. I was diagnosed with Hashimoto's Disease of Thyroid (April or May was the diagnosis)  - I was experiencing symptoms but I wasn't aware of it. I was having body weight changes and was feeling lethargic and I had a severe Vit D deficiency.  I am on Levothyroxine  for it.  I also have some nerve damage in my shoulder area on my right had side - the right upper chest - where the collarbone goes to shoulder bone - that indent area is where I have some pain and it spans over the top of my shoulder and down to my upper back; so it's horrible pain. I am SSNRI to help with the nerve damage and the pain and also for depression - Duloxetine . I started noticing the symptoms the end of March and into early April.   I made a doctor's appt and did some x-rays. I wake up with the pain and it's always there nagging throughout the day - sometimes it's worse and sometimes it's better. We aren't sure what is causing that. It isn't really going away and so we need to address this again after the medication is in my body for 9 weeks - it's been six. My thyroid - did follow up bloodwood after being on the Levothyroxine for a month and my numbers were in normal range. I'll stay on that. I believe I'm on the road of recovery - symptoms are being managed and treatment is ongoing for both conditions.
Employee calling to report a reaction after receiving a COVID-19 vaccine.  Vaccine Name -  Pfizer Vaccine Date - ?  08/26/2021 Is this your first or second dose- 1st Date of symptom onset - ? 08/27/2021 Symptoms - ? Fever of 102.7, chills, headache, congestion, sore throat, and shortness of breath when talking. Last day of work and shift - ? 09/01/2021 Home remedies- Motrin for fever and headache. Any improvement- Motrin did help with the fever. It has resolved. Recommendation- Advised employee to continue taking Motrin/Tylenol per package instructions for fever and headache. Advised employee to leave work and schedule COVID testing due to symptoms. Employee voiced understanding Employee of information ? Yes  Employee voiced any concerns ? No  Employee?s questions answered to employee?s satisfaction -Yes
Extreme increase in neuropathic pain refractory to medications that continues to this day.  Other myalgias, fatigue related to second dose have resolved.
Patient received 1st of moderna vaccine ~4pm and was monitored for ~15 mins after the vaccination with no issues. The patient called the pharmacy around ~5pm while on the road driving home with complaints of mild tongue/throat swelling and a severe headache. Patient was told to go to the ER/hospital to get checked out as soon as possible.
PATIENT HAD FEVER, CHILLS, ACHES, AND DIARRHEA FOR SEVERAL DAYS.  SYMPTOMS STARTED BY DAY AFTER SHOT.  PHARMACY GAVE HER INJECTION THINKING IT WAS HER FIRST SHOT IN SERIES. FOUND OUT FEW DAYS LATER FROM DR'S OFFICE THAT SHE HAD RECIEVED 2 INJECTIONS AT THEIR OFFICE IN 2019.
This spontaneous prospective pregnancy report as received from a consumer refers to a 30 year old female patient. On 12-JUL-2017 the patient was vaccinated with VARIVAX, .5 ml for prophylaxis. The patient became pregnant. The LMP and EDD is not known. The patient delivered a {Enter Gender} infant. The pregnancy outcome was outcome pending. On an unknown date the patient experienced exposure during pregnancy. The outcome of exposure during pregnancy is unknown.
Around the injection site, it's little warmth; Around the injection site, it's still red; Around the injection site, it's still itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Around the injection site, it's little warmth), VACCINATION SITE ERYTHEMA (Around the injection site, it's still red) and VACCINATION SITE PRURITUS (Around the injection site, it's still itchy) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Around the injection site, it's little warmth), VACCINATION SITE ERYTHEMA (Around the injection site, it's still red) and VACCINATION SITE PRURITUS (Around the injection site, it's still itchy). At the time of the report, VACCINATION SITE WARMTH (Around the injection site, it's little warmth), VACCINATION SITE ERYTHEMA (Around the injection site, it's still red) and VACCINATION SITE PRURITUS (Around the injection site, it's still itchy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: TCR-event outcome, Patient endorsed she was feeling fine, and  didn't want no  further follow up
Immediate myalgias after injection. On 6/24/09 (6 d after inj). Woke up itchy, indurated, local injection site 4 x 8cm. (B) wrist edema. Hurt with arthralgias and myalgias. Fever 100 degrees F. orally on 6/24/09.
Dizziness/vertigo, nausea, vomiting, chills started at about 7:30 am  on 2/20/2021.  This was the day after I received the vaccine.  Nausea and vomiting subsided around noon.  Chills were ongoing through out the day.  On and off vertigo episodes continued through 2/23/2021.  All symptoms subsided by 2/23/2021.  Also had a very sore left arm.
UNABLE TO TALK; NOT FEELING WELL; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 24-SEP-2021, the patient experienced unable to talk. On 24-SEP-2021, the patient experienced not feeling well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the unable to talk and not feeling well was not reported. This report was non-serious.
PAIN IN HAMSTRINGS; PAIN IN BUTT; This spontaneous report received from a consumer concerned a male 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced pain in hamstrings, and pain in butt. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in hamstrings and pain in butt was not reported. This report was non-serious. This case, from the same reporter is linked to 20210510142.
Administrated with only the adjuvant; Administrated with only the adjuvant; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 3G33K, expiry date 10th July 2023) for prophylaxis.   On 13th September 2022, the patient received Shingrix. On 13th September 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 15-September 2022 Reporter's comment: No adverse event was reported. The reporter consented to follow-up. Additional supportive information:  The patient was administered with only the adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Patient was given a dose of Pfizer-BioNTech COVID vaccine after first receiving a Moderna vaccine 28 days prior. Patient reports no adverse events as of the time of reporting
Escorted to ED for further evaluation. Moderna COVID-19 Vaccine EUA Diarrhea, HYPERtension, Tachycardia & edema of face (eyelids), feeling faint, numbness tingling of extremities
10 minutes after injection "passed out in vehicle", unsure for how long.  Then regained consciousness and passed out 2 more times.  RN came to vehicle and took BP and was normal.  Pt  given crackers and juice and was able to stay alert and oriented and then able to drove home.  Later that pm about 8:00 states passed out again for about 1 hr.  No other symptoms present other than continued sore arm.
Diffuse, itchy rash developed 2 weeks after 1st Moderna vaccination.  Improved, then worsened dramatically after 2nd vaccination.
I got the vaccine on Thursday and by Friday morning  my SVT flared  up and down 187 beats per min off an on all day I stayed in bed after that day I was having headaches and feeling like my blood pressure was elevated as went back to work that week my blood pressure was high and now I am prescribed Lisinopril 10mg QD
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at an unspecified dose and frequency. On 19-Mar-2021, HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test: positive (Positive) tested positive for COVID in December..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Extreme body ache, headache, nausea, swelling of arm administered in, fever, chills, poor regulation of temperature, flu-like symptoms >48 hours.
I started with a tingling and pain around my waist, and I thought it was shingles. I never got a rash but then I had tingle ling down my left leg. I did take some medication that's usually taken for the shingles virus Acyclovir. During this time, I started having tingle ling and numbness down the right side. I did reach out to my pcp and he said it wasn't shingles. I was then referred to a neurologist. I saw the neurologist and he ordered a MRI and blood test. Then on January 23, I followed up and he found that the MRI showed inflammation of the spinal cord. I also did a scan of the brain to rule out MS. I was also prescribed Prednisone and then I followed up on Feb 6. I was told the MRI scans were all normal. It took a while, but all symptoms did decrease, and the neurologist wants a follow up to double check the affected area.   Myelitis Or Inflammation of the spinal cord of unknown cause    The symptoms appeared a few months after the vaccine, and I am not 100% sure if it's related to the vaccine this is what I experienced.
panniculitis; severe induration; This case was reported by a nurse via sales rep and described the occurrence of panniculitis in a female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced panniculitis (serious criteria GSK medically significant) and induration. On an unknown date, the outcome of the panniculitis and induration were unknown.   It was unknown if the reporter considered the panniculitis and induration to be related to Boostrix.  Linked case(s) involving the same patient: US2022AMR083315   Additional Information: GSK Receipt Date: 23-MAY-2022 Reporter's Comment: The reporter reported that, the patient received Boostrix and very soon after developed severe induration. She stated that, the patient later developed panniculitis. No further details were provided. The reporter consented to follow up. Additional Supportive Information: For tolerance of 2nd dose of Boostrix, refer case US2022AMR083315.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR083315:Same reporter
Cardiac tamponade; very weak; A spontaneous report was received from a consumer concerning a female patient of unknown age who, experienced cardiac tamponade, and very weak.   The patient's medical history was not provided.  Concomitant product use was not provided/unknown by the reporter.   On 21JAN2021, approximately 4days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number:039L20A) intramuscularly for prophylaxis of COVID-19 infection.  Caregiver-patient's daughter called to report that her mother potentially experienced an adverse reaction to the vaccine. Patient received the first dose of the vaccine on 21JAN2021, and 4 days later the patient developed cardiac tamponade and was very week. Patient went to the doctor's office where they were directed to wait for the second dose of the vaccine. Caller/caregiver wants to know how long they can wait for the second dose of the vaccine.  Treatment information was not provided/unknown.    Action taken with mRNA-1273 in response to the event was not provided/unknown.  The outcome of the events was unknown/not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
myasthenia gravis symptoms began 3 weeks after the second dose.  Severe weakness in chewing muscles and neck.  Inability to chew.  Inability to speak without slurring.  Severe weakness in shoulders, neck, chest, and legs.  Two weeks after adverse event, problems breathing were added to list of issues.   Blood work concluded elevated antibodies related to myasthenia gravis.  Follow up CT scan did not show any abnormal Thymus gland as is common in patients.
Vaccination failure; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17May2023 at 16:00 as dose 5 (booster), single (Lot number: AS7165B), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 19Mar2021 at 14:00 as dose 1, single (Lot number: 04GA21A), in left arm, on 22Apr2021 at 13:00 as dose 2, single (Lot number: 039B21A), in left arm, on 12Nov2021 at 13:00 as dose 3 (booster), single (Lot number: 033F21A), in left arm and on 09Sep2022 at 16:00 as dose 4 (booster), single (Lot number: AS7143C), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Overweight 50 lbs" (unspecified if ongoing); "anxiety disorder" (unspecified if ongoing), notes: long term Lexapro generic; "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: nickel metal" (unspecified if ongoing); "in recovery alcoholic/addict sober since 1984", start date: 1984 (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE, start date: 02Oct2022, stop date: 08Jul2023; LEXAPRO taken for anxiety disorder. The following information was reported: COVID-19 (medically significant) with onset 2023, outcome "unknown", described as "COVID 19"; VACCINATION FAILURE (medically significant) with onset 2023, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive, notes: Day 12 since original onset of Covid symptoms still testing POSITIVE. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 07Jul2023 to 12Jul2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300251995 same patient, different drug/event;
Patient given PCV13 in our office on right arm and then present to emergency department on 09/13/2017 with rash and upper arm soft tissue pain. Prescribed cellulitis. In primary care office on 09/15/2017 with improved rash after Keflex but still tender to palpation. Patient's rash on the inner arm and not at site of injection.
Complaints of  diarrhea, sweating, weakness suffered sudden cardiac arrest. CPR, AED, Lucas device applied ACLS protocol initiated by EMS. Efforts terminated. Patient pronounced deceased at 1003am.
After receiving the vaccine as patient stood up and got ready to leave clinic became dizzy, clammy to touch / pale, and nauseous. Patient was sat down in chair with feet elevated, a cool cloth was given for neck and forehead, and after nausea passed  a snack was given. After a minute are two patients color returned to patient's face was alert and oriented and was able to leave clinic.