chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tonsils were swollen, enlarged/ tonsils were touching each other; couldn't swallow; did a strep test and it was positive; This is a spontaneous report from a contactable consumer (patient's mother) via Pfizer Sponsored Program. A 18-year old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via unspecified route of administration on 09Apr2021 at single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On 10Apr2021 he was taken to urgent care because his tonsils were swollen, enlarged, he couldn't swallow and his tonsils were touching each other. In the urgent care a strep test was made and it was positive so they prescribed him amoxicillin and he finished the course of antibiotics and then on 04May2021 his tonsils were swollen again and he went to convenient care and he was prescribed azithromycin (ZITHROMYCIN) and methylprednisolone. He finished the course of those antibiotics and medications as well. The patient had not had any other symptoms such as a cough, fever, or tiredness. He is a healthy student athlete with no underlying conditions and no history of having tonsillitis or strep. The consumer stated that this issue has been going on for a month. The consumer stated: "I have not provided her any information that can help him and hopefully he doesn't die she will just have to figure it out." The outcome of the events was unknown.   Information about lot/batch number has been requested requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021550844 Same patient, different vaccine dose number and different event.
high fever; Initial information received on 18-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 months old patient who experienced high fever (pyrexia), while received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a first  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious high fever (pyrexia) (Unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  (Other relevant tests included no lab data.) Final diagnosis was high fever.  It was not reported if the patient received a corrective treatment.  On an unknown date, the event outcome is reported as Recovered for high fever.  Information on the batch number was requested.  Documents held by sender: none.
C/O pain in (L) shoulder - persistent w/some loss of motion. Subacromial injection f/u - physical therapy and anti inflammatory meds.
Left ear started ringing around 4pm on April 12th and got progressively worse until it matched the intensity of what I had heard in my right ear right when I woke up on March 24th following my first dose of the vaccine on March 19th.
Reported by spouse, pt began experiencing left arm pain and weakness which has continued to grow in intensity. Moved for treatment. Can only be contacted by e-mail.
Severe pain in legs; Severe pain back; Patient couldn't walk for four to five day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Severe pain in legs), BACK PAIN (Severe pain back) and WALKING DISABILITY (Patient couldn't walk for four to five day) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (Severe pain in legs), BACK PAIN (Severe pain back) and WALKING DISABILITY (Patient couldn't walk for four to five day). On 22-Feb-2021, PAIN IN EXTREMITY (Severe pain in legs), BACK PAIN (Severe pain back) and WALKING DISABILITY (Patient couldn't walk for four to five day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication information was reported.
I initially some discomfort in both arms (shingles vaccine in left arm was less painful, flu vaccine in right arm was more painful - injection was more challenging for that one, so not surprised), followed by general malaise and an oncoming feeling of chills.  I had a difficult time standing to change clothing and brush my teeth, needing to lay down to avoid passing out.  I then experienced nausea, very bad chills, shaking, and aching for at least a few hours overnight.  I felt sick throughout the night and weak into the next morning.  I felt better as the day progressed, with lessening of arm pain.  The most challenging side effects were the extremely strong chills and weakness to the point of shaking and almost fainting.  This was the first time that I have received the shingles vaccine and I believe these symptoms were related to that injection.  I have had the flu vaccine many times before with minimal issues, usually only a little arm pain.  This was far worse.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 30Jan2021 as dose 1, single (Batch/Lot number: unknown), on 20Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 03Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Prostate cancer" (unspecified if ongoing); "prostate removed" (unspecified if ongoing). Concomitant medication(s) included: SILDENAFIL, start date: 30Oct2022, stop date: 30Oct2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19. COVID 19 Treatment included Paxlovid from 03Nov2022 to 08Nov2022  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Patient had syncopal episode immediately following vaccination.  Patient drank some juice and felt better.  He was released to home.
Case number PHEH2013US019374, is an initial spontaneous report from the health care professional received on 13 Sep 2013, and with a follow up report received on 18 Aug 2014. This report refers to a 24-year-old female pregnant patient. Her last menstrual date was not provided. This pregnant patient was vaccinated with FLUVIRIN (batch number: 13394P) via intramuscular route on 12 Sep 2013. No adverse event reported following FLUVIRIN vaccination. Multiple attempts were made to obtain follow-up information and outcome of pregnancy event but it was without success. This case was considered lost to follow-up. Follow up report received on 18 Aug 2014. Lost to follow up updated.
Dizzy, light headed after 5 mins.  No bfast, tends not to eat.  BP. 150/102. P82. Pulse ox 98%  Felt better after H20 and sitting
2yr old pt vax dtp/opv/hib and ex fever and convulsions, seizures less than one minute.
After received the shot about 5 min later patient start to have dizziness and hard time of breathing.  We called the paramedics and paramedic took patient after accessment
Mother reports that 2 days, post vax, child began having hallucinations which lasted for about 1 month. He seen and heard things and would cry and run. He was afraid all the time. Seen MD, who felt it could be immunizations.
Brought into the ER on 1/07/2022 with worsening mentation and hypoxia. Was intubated. Found to be COVID positive. Had superimposed bacterial pneumonia as well and developed septic shock with multiorgan system failure. Despite care she continued to decline and after discussion with her family she was made a DNR. Overnight on 1/11/22she continued to decline further and she ultimately passed away at 8:08am on 1/12/22.
2nd dose- Headache, bodyaches pain at injection site and bruising; symptoms lasted for 24hrs then resolved. Pain and tenderness persist at injection site. 1st dose - no reported adverse events
Patient started breaking out in hives on Tuesday Dec. 5th, 8 days after vaccination. I took her into the clinic that evening and the doctor thought she might be having an allergic reaction to her AUGMENTIN. He prescribed ZYRTEC every 12 hr. and it did not help at all. I had to keep taking her back to the clinic several times as her condition kept worsening. She was swollen all over her body, her joints, her face, her ear, hands and feet. She had a fever, severe hives, and was in immense pain and vomiting & nothing was helping. They finally gave her a shot of dexamethasone, which did help for 2 days. She started breaking out again on Friday evening, requiring one more steroid shot on Saturday. Our doctor referred us to an immunologist who said she was having an autoimmune response to her vaccines. Prescribes ZANTAC & ZYRTEC and said this could last up to 3 months.
SHE COMPLAINED OF BEING ANXIOUS AFTER RECEIVING THE VACCINE. ON SITE EMS RESPONDED. VITALS LISTED BELOW. SHE WAS MONITORED AND RELEASED TO HOME
This spontaneous report was received from a medical student concerning a patient of unknown age and gender who on 18-JAN-2013 was vaccinated with a dose of live ZOSTAVAX (lot number H011331 ,expiration date 08-SEP-2013) (route not provided) that was exposed to 20F for 360 hours. No adverse event reported. This is one of several reports received from the same source (Other MAARS number 1302USA001216, 1302USA000400, 1302USA001214). Additional information has been requested.
No systemic reaction; moderate swelling of soft tissue & tenderness lt arm @  or about site of DPT; no heat, no redness;
Area around injection site got very itchy, sore with a bump in it and a rash formed. Happened before I went to bed and I had a restless sleep. No fever in morning and symptoms disappeared as day went on. Rash lasted two days
Severe Reaction; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 61 year-old male patient received bnt162b2 (BNT162B2) (Lot number: Unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for covid-19 immunization; Bnt162b2 (dose 2), for covid-19 immunization. The following information was reported: DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Severe Reaction"; IMMUNISATION (non-serious), outcome "unknown", described as "Booster".  Additional information: Reporter stated that she couldn't tell between the 2 Pfizer vaccines, if it's Comirnaty or the Pfizer Covid BioNTech Vaccine. Reporter stated that with patient's booster, he had been having more severe reaction. Lot and Expiry were Unknown for patient's booster vaccine, reporter thought since he got it at the same office as she did that the Lot number could be the same. Reporter stated that her (Reporter) and her brother (Patient) are the same age, they were twins being 10 months apart. RA Communication reported as Report 2 of 2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected
Initial tingling in right arm.  Injection was provided in right lateral deltoid.  Approximately 40 minutes after vaccine was provided, employee had nausea and localized rash.  Employee escorted to ED for further assessment. Employee then experience hot flash and right side headache.
ER visit for swollen legs, upon admit to ER pt in SVT, given adenosine x 2, pt remains in the ICU
Local reaction immediately after getting flu vac. Reddness, swelling, itching. 5 days later started breaking out in hives all over body and throat closing up
headache at 4pm on 17th,  progressively tired.  Slept at 8pm and awake at midnight,  fever, HA and chills.  Temp 102.9 and temp broke 8am on 18 and considerable better by 4pm and now just tired. alternated ibuprofen and tylenol starting 6am on 18th.
Pain in left arm; chills; fever of 100 degrees; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received first dose of BNT162B2 (Pfizer- BioNTech COVID 19, solution for injection, lot number: unknown) via an unspecified route of administration on 05Feb2021 at 02:30 PM on left arm as single dose for COVID-19 immunization. Patient had other Medical history included Known allergies. Concomitant medications was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 06Feb2021 at 02:00 PM Patient experienced pain in left arm, chills and fever of 100 degrees after vaccination. No treatment was given. Outcome of the event was not recovered.  Information on the lot/batch number has been requested.
On 8/31/01, pt's fever was 102.8F and was pulling at left ear and throwing up. Pt was taken to PCP. Pt had ear and throat infection. Still sick on 9/4/01.
Itchy red and swollen knot at the site of injection; Itchy red and swollen knot at the site of injection; Itchy red and swollen knot at the site of injection; Fever; hot on the face; sore arm; Rash/rash on her face; This spontaneous case was reported by a health care professional and describes the occurrence of PYREXIA (Fever), SKIN WARM (hot on the face), PAIN IN EXTREMITY (sore arm), RASH (Rash/rash on her face) and VACCINATION SITE ERYTHEMA (Itchy red and swollen knot at the site of injection) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product CAMPHOR, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC OXIDE (BENADRYL [CAMPHOR;DIPHENHYDRAMINE HYDROCHLORIDE;ZINC OXIDE]) for an unknown indication.    Concurrent medical conditions included Penicillin allergy.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started CAMPHOR, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC OXIDE (BENADRYL [CAMPHOR;DIPHENHYDRAMINE HYDROCHLORIDE;ZINC OXIDE]) (unknown route) at an unspecified dose. On 03-Feb-2021, the patient experienced PYREXIA (Fever), SKIN WARM (hot on the face), PAIN IN EXTREMITY (sore arm) and RASH (Rash/rash on her face). On 10-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Itchy red and swollen knot at the site of injection), VACCINATION SITE PRURITUS (Itchy red and swollen knot at the site of injection) and VACCINATION SITE SWELLING (Itchy red and swollen knot at the site of injection). At the time of the report, PYREXIA (Fever), SKIN WARM (hot on the face), PAIN IN EXTREMITY (sore arm), VACCINATION SITE ERYTHEMA (Itchy red and swollen knot at the site of injection) and VACCINATION SITE SWELLING (Itchy red and swollen knot at the site of injection) had not resolved and RASH (Rash/rash on her face) and VACCINATION SITE PRURITUS (Itchy red and swollen knot at the site of injection) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2021: No specific follow-up information recorded.
Persistent rectal bleeding and passing blood and blood clots for 7 days since vaccination.  Bleeding occurs with stool and throughout the day, requiring the use of pads.
fever; This is a spontaneous report from a contactable Physician via Pfizer sales representative. This Physician reported for a 27-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number : Not reported), via an unknown route of administration on an unknown date as dose 1, single for covid-19 immunisation. On an unspecified date, the patient experienced fever. It was reported that patient in the healthcare field received both Pfizer COVID 19 vaccine doses. Patient did not have any reaction after second dose. 1 month after second dose of the vaccine, patient experienced fever with no other symptoms for several days. Symptoms have since resolved but she wished to report the adverse symptoms in case they may be related to taking the vaccine. Event took place after use of product. The clinical outcome of event was recovered on unspecified date.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
5 square inch round red spot at injection site. The spot is itchy, hot to touch, sore to touch. Spot was small after initial injection, went away after 3 days. Came back on 9/4/21 larger than the original spot. Continues to get larger each day.
Rheumatoid arthritis flare up; Face rash/neck rash; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 19-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 01-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant). In 2021, the patient experienced RASH (Face rash/neck rash). In 2021, RASH (Face rash/neck rash) had resolved. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) had resolved.            No concomitant products were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine trial.   No treatment information was reported by the reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.  Company Comment:  This spontaneous concerns a 63-year-old male patient with concurrent Rheumatoid arthritis, who experienced the unexpected, serious  (medically significant) adverse event of special interest Rheumatoid arthritis (Rheumatoid arthritis flare up) 13 days after receiving the first dose of mRNA-1273 vaccine.  Patient was treated with Upadacitinib (Rinvoq).  Outcome of the event was reported as resolved. Patient subsequently received a 2nd dose of mRNA-1273 vaccine  28 days after the first dose.  The concurrent Rheumatoid arthritis remains a confounder as the disease itself is known to result in flares. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous concerns a 63-year-old male patient with concurrent Rheumatoid arthritis, who experienced the unexpected, serious  (medically significant) adverse event of special interest Rheumatoid arthritis (Rheumatoid arthritis flare up) 13 days after receiving the first dose of mRNA-1273 vaccine.  Patient was treated with Upadacitinib (Rinvoq).  Outcome of the event was reported as resolved. Patient subsequently received a 2nd dose of mRNA-1273 vaccine  28 days after the first dose.  The concurrent Rheumatoid arthritis remains a confounder as the disease itself is known to result in flares. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
PATIENT RECEIVED 0.3ML DOSE AT 7 YEARS OLD. SHOULD HAVE RECEIVED 0.2ML DOSE. PER CDC, DOSE DOESN'T HAVE TO BE REPEATED.
Began with pain under vaccinated arm with pain into lymph nodes across chest and breast bilaterally.
lethargic; diarrhea; fever; fatigue; muscle pain; This spontaneous case was reported by a patient and describes the occurrence of LETHARGY (lethargic), DIARRHOEA (diarrhea), PYREXIA (fever), FATIGUE (fatigue) and MYALGIA (muscle pain) in a 63-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer on 26-Mar-2021, Pfizer on 16-Apr-2021, Pfizer on 22-Oct-2021 and Flu shot on 25-Sep-2023. Past adverse reactions to the above products included No adverse event with Flu shot, Pfizer, Pfizer and Pfizer.    On 02-Oct-2023 at 4:00 PM, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 03-Oct-2023 at 4:00 PM, the patient experienced PYREXIA (fever), FATIGUE (fatigue) and MYALGIA (muscle pain). On 04-Oct-2023, the patient experienced LETHARGY (lethargic). 04-Oct-2023, the patient experienced DIARRHOEA (diarrhea). On 04-Oct-2023, DIARRHOEA (diarrhea) had resolved. At the time of the report, LETHARGY (lethargic), PYREXIA (fever), FATIGUE (fatigue) and MYALGIA (muscle pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.3 F. On an unknown date, SARS-CoV-2 test: it was clear.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication were not reported by the reporter. It was reported that patient had second episode of fever on 04-OCT-2023. The treatment medication were not reported by the reporter.   Reporter did not allow further contact
VACCINE ALMOST KILLED SON; This spontaneous report received from a consumer via a company representative 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced vaccine almost killed son. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine almost killed son was not reported. This report was non-serious.
Documentation must have been delayed (website for documenting Vaccine)  because when looked out on 3/19, there was no record of her getting the vaccine.  On 3/31/31 she was given Moderna as an initial dose to find out she already received J&J on 3-19-21. so she received 1 J&J and 1 Moderna.