chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PT felt hot and sweaty with dimming vision after injection. brought to Med obs 1 via wc. PT reports not eating anything prior to vaccination. vitals monitored 1655 LYING - BP: 116/76, HR: 79, O2: 100 1705 LYING - BP: 116/80, HR: 84, O2: 100 1710 Standing - BP: 113/74, HR: 83, O2: 98
1st covid vaccine in July: fatigue, fever for 4 days.   2nd dose of covid vaccine: itchy throat, burning paresthesias of arms, swelling of hands x 2 weeks. Improved on ibuprofen and acetaminophen. Can't sleep due to her paresthesias.
AFTER RECEIVING THE HPV VACCINE THE PATIENT INDICATED THAT IT HURT. AFTER RECEIVING THE OTHER VACCINE IN THE OTHER ARM THE PATIENT LOST CONSCIOUSNESS FOR A FEW SECONDS. THE DOCTOR INDICATED THE MOTHER TO TAKE HER SON TO THE HOSPITAL.
Patient reported to the office on 09/22/21 with redness to right upper arm that started at bottom injection site.  redness extended about 6 inches from injections site and wrapped around arm about 7 inches not touching under the arm  the area is swollen and warm to touch.  there was pain per the patient on 09/21/21. no pain in elbow, or shoulder or neck. pt is being treated for cellulitis with antibiotic.
Irregular heart beat developed  few hours after injection of the vaccine.; This is a spontaneous report received from a contactable consumer, the patient. A 85-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: ER8730) via an unspecified route of administration in the left arm on 19Mar2021 at 13:00 (at the age of 85-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, type 2 diabetes, gout and glaucoma. Concomitant medication included High blood pressure medicines and Diabetic medicine. The patient previously took quinidine and diamox for unknown indication and experienced an drug allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 19Mar2021, the patient experienced Irregular heart beat developed few hours after injection of the vaccine. The patient did not receive any treatment for the adverse events. The clinical outcome of the event Irregular heart beat was recovering.   No follow-up attempts are needed. No further information is expected.
High and low swings to my blood sugar levels. Low blood sugars to the point of seizure requiring emergency attention .
18 cm area of redness and induration on L thigh w/swelling of L knee, itchy, warm, no pain. Ambulating okay.
A week later had redness around injection site, warm to touch, sore, and tender to touch. A little bit of swelling.
pt recvd vax & devel h/a, sore throat, fever, swollen lymph nodes & spots on trunk & face;2APR95 exp fine, red non-pruritic, macular rash, sore throat & h/a;
I received a flu shot in my left shoulder at a drive in clinic.  The next day, that shoulder was painful and hard to move.  The pain increased over the next several days.  I had to stop using it and could not sleep on that side.  I have a bruise on the back of my arm where the injection was.  I have photographed it.  My husband is a physical therapist and said it was injected in the wrong place and may have gone through the bursa.  I have attempted to contact Clinic repeatedly to report the event with no success as there phone is unanswered and they transferring me to phone numbers that are not answered.  I am attempting to make an appointment or at least reach someone by phone to report this.  I do not know what version of the flu shot I was given, nor did I receive a handout and I was not offered a handout on what vaccine I was given.  I just picked one above so I could submit this.
Fully vaccinated in Mar2021 and contracted COVID-19 in Aug2021. Acquired two PCR to rule out a false positive from PCR test #1.; Fully vaccinated in Mar2021 and contracted COVID-19 in Aug2021. Acquired two PCR to rule out a false positive from PCR test #1.; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received the second dose and first dose of BNT162B2, second dose via an unspecified route of administration in Mar2021, first dose via intramuscular on the left arm on 09Mar2021 at 10:00 AM (Lot Number: EL3247), both at the age of 60-year-old as single dose for COVID-19 immunization. Medical history was none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient didn't received other vaccines within 4 weeks prior to the COVID vaccine. known allergies was none. Concomitant medication was not reported. On 25Aug2021 at 02:15 PM, the patient fully vaccinated in Mar2021 and contracted COVID-19 in Aug2021. Acquired two PCR to rule out a false positive from PCR test #1. COVID test (PCR, Nasal Swab) post vaccination on 25Aug2021 and result was positive. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received. The outcome of events was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Unevaluable event; This case was received via FDA VAERS on 27-Jul-2021 and was forwarded to Moderna on 27-Jul-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of UNEVALUABLE EVENT (Unevaluable event) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 010A21A) for COVID-19 vaccination.     The patient's past medical history included Lymphoma. Concurrent medical conditions included Type II diabetes mellitus. Concomitant products included BENDAMUSTINE from 04-Feb-2021 to 05-Feb-2021 and RITUXIMAB from 04-Feb-2021 to 05-Feb-2021 for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jul-2021, the patient experienced UNEVALUABLE EVENT (Unevaluable event) (seriousness criterion hospitalization). The patient was hospitalized on 12-Jul-2021 due to UNEVALUABLE EVENT. At the time of the report, UNEVALUABLE EVENT (Unevaluable event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  Patient stated that he is positive on 09JUL2021 for unknown lab test reported.  Company comment: Very limited information regarding these events have been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding these events have been provided at this time. No further information is expected.
Presented to emergency department with chief complaints of: myalgia, fever (101.2 F), chills, and malaise for 2 days. Reports an episode of emesis significant for red blood. Left deltoid significant for edema and significant thrombotic thrombocytopenic purpura. IV fluids, APAP PRN for fever and empiric Unasyn ordered on 11/09/2018 for presumed sepsis due to cellulitis of left upper extremity. Fever resolved (97.5 F), WBC normalized (7.3), and improved left upper extremity erythema on 11/11/2018. IV fluids discontinued on 11/11/2018. Unasyn discontinued on 11/12/2018 and replaced by Augmentin in preparation for discharge.
Client noted redness of the L deltoid the day following the injection. The site was sore to touch & tender. The redness increased, site was very warm to touch & painful. Involved area of redness/pain measured: approximately 6" L x 3" W 10/27/10.
11/15/07-pt told to come into office 11/5/07 (L) arm warm to wrist, swelling above elbow and Tx'd warmth around injection site. Had c/o off and on (L) finger numbness decreased this RN noted she need to go to medical department. 11/1/07: She c/o bilateral knee achiness
Per records, Varicella vaccine given 12/30/98. Today, seen in office w/Varicella.
soreness in her arm; tinge of a headache; she got up in the middle of the night because of really bad chills that felt like ice; stomach up; nausea; diarrhea; food poisoning; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (67; unit: unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route, on 27Feb2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took flu shots and experienced chills. On an unspecified date, after the vaccination the patient experienced soreness in her arm, tinge of a headache which lasted for a day, she got up in the middle of the night because of really bad chills that felt like ice and stomach up. Also experienced diarrhoea, low level nausea. She mentioned that this might be attributed to food poisoning as she had a cup of 3 oyster shooters 2 days ago, and another 4 oyster shooters 3 days ago. She also mentioned that she and her husband had black cod in the refrigerator for dinner. She found it odd because her husband did not experience these symptoms. And She was asking if her symptoms have been reported with the vaccine or if this is more associated with food poisoning. She was also asking how long these side effects usually last. The reporter assessed all events as non-serious. The outcome of the event headache (PT) was recovered on unspecified date, nausea was not recovered, and outcome related to soreness in her arm, chills, abdominal discomfort (PT), diarrhoea and food poisoning was unknown.  No follow-up attempts possible. No further information expected.
No adverse effect; Patient was administered an improperly stored dose of VARIVAX; This spontaneous report was received from a physician regarding a patient of unknown demographics. The patient's relevant medical history, concurrent condition were not reported. Concomitant therapy included a sterile diluent (well stored). On 24-MAY-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) data logger (lot # R029519/ expiration date:14-OCT-2020) with a well stored diluent diluted for prophylaxis. The vaccine was stored at a temperature of - 14 degrees centigrade to - 10 degree centigrade for a timeframe of 4 hours and 5 minutes. The previous temperature excursion was reported as no. On an unknown date, the reporter informed that the patient administered an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (improper storage of product in use). No other adverse effects (no adverse event) were reported. This case does not involve a product quality complaint. The outcome of the event was unknown.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with (Oka/Merck) VARIVAX dose 1, (dose, lot # and expiry date unknown) On 01-DEC-2011, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX dose 2,(dose unknown)  from lot # 669601/0138AA with expiry date of 26-JAN-2013. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review of records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provided 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Within about 30 mins my arm started swelling and became very itchy at the injection site.  I was advised to take benadryl, but I've had a bad response to benadryl in the past so I didn't want to take it. 2 hours later, a swollen rash the size of an inch began to develop. I felt very tired and went to bed early. By the next morning the rash was still swollen and painful and doubled in size. Today, day 3, the hot and swollen rash is 4 inches in size. I also have chills, diarrhea and fatigue. My arm feels weak and sore in the bone (if that makes sense). I'm not sure if this is the worse of it. I consulted a telemedicine dr and was advised to wait it out. I have documented with photos.
The patient received a vaccine and seven days after receiving it the patient began sneezing and developed a hive on her wrist.  By midnight she had hives all over her whole body so she took Benadryl. The patient then developed more hives, so she went to see her doctor; where she was treated this was 25 hours after she received her vaccine. The patient went to the ER 35 hours after receiving the vaccine to be treated because the hives continued to develop. The patient was treated with Benadryl, Solu-Medrol, Zantac, Epinephrine, Albuterol nebulized inhalation, Prednisone, Ranitidine, and Zyrtec.
Swollen, tense red left arm below vaccine site. All the way to the elbow onset 24 hours after vaccination. Lasted 3 days.
Next morning noticed swelling to the front of her chest, over collar bone, that has been spreading up to her left neck and left axillary area, very tender no itching no rash.
Experienced loss of appetite; mild nausea; headache; very mild body aches; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection; lot number: EL3247; expiry date: unknown) via an unspecified route of administration in the left arm, on 28Jan2021 at 09:15, at a single dose, for COVID 19 immunization. The patient had no relevant medical history and had no known allergies. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI 24 FE). It was unknown if the patient is pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the workplace clinic. On 28Jan2021, at 18:00, the patient experienced loss of appetite/mild nausea, headache, and very mild body aches. The events were considered non-serious. The patient did not receive treatment for the events. Outcome of the events was recovering/resolving. The patient has not been tested for COVID-19 since vaccination.
Difficulty breathing with hives and rash began 5 minutes after administration of the vaccine. Faintness and dizziness also occurred at the same time. 20 mL (50 mg) liquid Benadryl was administered and was effective within 10 min. 50 mg of Benadryl was taken for 24 hours after vaccine. Additional allergic reaction consisting of difficulty breathing and swallowing, hives, and heart pounding on 4/4/2021 at 2:30 am. Methylprednisole and EpiPen was prescribed at clinic.
PSA levels were detected to be 3 times the level it was before the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 Immunization. The following information was reported: PROSTATIC SPECIFIC ANTIGEN INCREASED (non-serious), outcome "unknown", described as "PSA levels were detected to be 3 times the level it was before the vaccine". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller stated he was calling on behalf of his patient. Caller stated his patient was vaccinated twice with the Pfizer COVID-19 vaccine and within two months of being vaccinated twice his PSA levels were detected to be 3 times the level it was before the vaccine. Caller stated the level was only 6 at the beginning of the year noting (name) pays for yearly checks and now is 18. Caller stated he reported this finding to agent. Caller stated the CDC shows 44 ongoing studies on the effect of the vaccine on PSA levels. Caller stated his personal HCP found information on the internet about the vaccine increasing PSA levels. Caller stated the vaccines are destroying cancer markers. Caller disconnected before survey could be offered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Staff member received her first dose of the Covid vaccine.  Immediately after injection staff member felt anxious with a "warm feeling" in her chest and a "prickly feeling" in her mouth.  Staff member was wheeled to vestibule area in Helfaer. Within 2 minutes symptoms subsided. Staff member was very anxious prior to getting vaccine and stated she is always anxious. She has a diagnosis of POTS and her heart rate is always elevated.  Staff member was monitored. VS: 1032 BP  145/80 HR  122  (Staff member states this is not unusual and that she takes a beta blocker daily) Sp02 100%  on room air  VS: 1037 BP  137/85 HR  108   Sp02 100%  on room air  VS: 1042 BP  128/83 HR  101   Sp02 100%  on room air  VS: 1052 BP  121/75 HR  94   Sp02 100%  on room air  Staff member left via ambulatory to home with no further symptoms. Staff member encouraged to contact primary care physicians/EMS with any further concerns.
vaccine_brand_other=Moderna, vaccine_dose_number=1, 2; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA 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: "Diabetes" (unspecified if ongoing); "asthma" (unspecified if ongoing); "obesity" (unspecified if ongoing). There were no concomitant medications, also reported as no other medication in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "vaccine_brand_other=Moderna, vaccine_dose_number=1, 2". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid, Treatment start date was 12Nov2022 and stop date was 16Nov2022.  Clinical course: Patient had no known allergies. Reported that, Patient had rebound of symptoms 7 days after finishing Paxlovid treatment included Headache, Running nose, body aches, tired. Tested positive again after testing negative after completing treatment. Rebound events onset was reported as 24Nov2022 at 20:00. Patient not received any treatment for symptoms and not recovered from symptoms.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Itchy rash on both outer forearms, from elbow to wrist, lasting 4+ days.
Intense Headache, muscle aches, weakness, tired, very sore arm. Chills. Flushed.
My son contracted covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (My son contracted covid) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (My son contracted covid). At the time of the report, COVID-19 (My son contracted covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
Patient stopped in our pharmacy wanting a Hep A&B vaccination. We entered his info into computer and ran TWINRIX thru on our Standing Order. I reviewed standing order questionnaire, then reviewed with patient. He stated he felt fine and had no fever. I then administered vaccination. I reviewed possible side effects he could possibly expect and it was recommended he wait around in pharmacy area or store for around 20 minutes, then patient proceeded to leave but then asked if he could just sit in IMZ area, I said yes. I came back in pharmacy to finish paperwork, then after 2 to 3 minutes I was giving paperwork to technician to enter into service admin, I glanced out at patient, which I noticed he was collapsing and sliding out of chair onto the floor. I ran out of pharmacy toward patient to assist, which I noticed patient being stiff, eyes rolled back, I had my technician call 911, then grabbed patient and shook he, calling out his name. After about 10-15 seconds, patient came to and EMTs arrived, assessing the patient.
Patient had developed a rash on extremities and upper torso.  She reported that the rash was in groups.  Patient went to ER and was given Benadryl and a topical steroid cream.
Patient was very anxious before receiving vaccine. Administered vaccine and patient's anxiety continued. Vaccine was also administered to patient's sister who had a slight fainting episode which increased this patient's anxiety. Approximately 10-15 minutes later patient stated that her hands were stiff and tingling.  She was breathing rapidly and crying. After sitting with patient's father and myself for 5-10 minutes, she said she started to feel better. Patient then left with her sister and father.
Soreness in left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in left arm) 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 PAIN IN EXTREMITY (Soreness in left arm). At the time of the report, PAIN IN EXTREMITY (Soreness in left arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment information was not provided.   Reporter did not allow further contact
Information regarding PREVNAR 13 was received from a healthcare professional regarding a 4month old male patient who experienced hard knot appeared (size of a nickel). At 4 months of age, the patient received the second in Oct 2010. Relevant medical history was not provided. Indication for PREVNAR 13 was immunisation. Product was administered in Oct 2010. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. The patient experienced hard knot which was the (size of a nickel) in Oct 2010. Outcome was not provided. No additional information was available at the time of this report.