chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID infection/test:Positive; COVID infection/test:Positive; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  An adult female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "ehlers danlos" (unspecified if ongoing); "inflammatory bowel disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID infection/test:Positive". The event "covid infection/test:positive" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Therapeutic measures were taken as a result of covid-19.  Patient had prolonged hypoglycemia, developed POTS (diagnosed by clinician) and also had right sided weakness post -COVID vaccine. However, patient also developed these symptoms after COVID infection all occurring after she received vaccine administration (2 doses and 1 booster). Patient also reported severe dizziness with 1st dose of vaccine.  Patient did not experienced covid prior to vaccination. Patient was tested for covid post vaccination and found positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report, a causal relationship between reported events drug ineffective, covid-19 and suspect BNT162B2 cannot be excluded.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Mar2023) Positive; (06Mar2023) Positive; (07Mar2023) Positive; (08Mar2023) Positive; (09Mar2023) Positive; (10Mar2023) Positive; (11Mar2023) Positive; (12Mar2023) Negative; (13Mar2023) Negative; (14Mar2023) Positive; (15Mar2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was treated with paxilovid for COVID-19 from 05Mar2023 to 09Mar2023.  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.
12 hours after injection I couldn't lift my arm above my head, I had a fever (99.3), I had chills and sweating and joint and muscle pain in my elbows, knees, and thighs. I developed a headache and sore throat. Symptoms persisted for 16 hours.
Patient discharged after 3 days hospitalization. Patient is a 61 y.o. male presented with shortness of breath on exertion along with cold sweats, cough, right-sided chest pain, worsened when taking a deep breaths. Patient also had diarrhea, loss of taste and smell. He was vaccinated against with Pfizer but did not receive booster dose. Workup in the emergency department significant for sodium 127 and creatinine 2.42 (previous 1.7). X-ray showing COVID pneumonia and patient had wheezing. Patient was admitted for acute kidney injury, COVID pneumonia. AKI resolved with IV fluids. Due to elevated procalcitonin, patient was started on IV ceftriaxone and oral doxycycline and was transitioned to oral Ceftin and Doxy for total 5 days of treatment. Due to AKI, lisinopril, Lasix and Aldactone were held. Due to history of low EF, Lasix was resumed at discharge after AKI is resolved. Patient was advised to monitor blood pressure and blood sugar levels closely at home and follow up with PCP. Due to low blood sugars, Lantus dose was decreased. Patient is on warfarin for A. Fib and was supratherapeutic with INR. Patient was advised to hold warfarin and check INR at home and follow up with anticoagulation clinic for further recommendations regarding warfarin dosing. Patient was discharged to Home without services in stable condition.
Fainted at home 2hs after the shot; A spontaneous report was received from a consumer who reported on behalf of her seventy-eight-years old husband who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced the event fainted at home 2hs after the shot.  The consumer's medical history was not provided. No relevant concomitant medications were reported.  The consumer received the first of two planned doses of mRNA-1273 on 22-JAN-2021 (Batch# 029L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 22-JAN-2021, the consumer experienced the event fainted at home 2hs after the shot.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the event was unknown.  The assessment for the event was not provided.; Reporter's Comments: This case concerns a 78-year-old male who experienced a medically significant and serious unexpected event of syncope.  Event onset occurred at home about 2 hours after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Symptoms began at 2200 hours on 03/01 with chills.  By 0230 on the morning of 03/02, I was vomiting, had chills, had hot flashes, had motion sickness with any movement.  At approximately 0230 I lost consciousness on the floor of my bathroom.  My husband, witnessed this event and indicated that he saw me stop breathing for a period of about 15 seconds.  I revived on my own, no intervention was needed.  More vomiting, chills, and hot flashes occurred after this event.  This event subsided at about 0300 hours and I was able to get some rest.  I have a skin rash that developed after the vaccine but is undocumented when it began.  It is still persisting today, one week after the vaccination.  The symptoms of this rash are it is widespread across my torso and it is itching and has small red dots.
A week of extreme weakness, dizziness, aches and pains, headaches. Just couldn?t get out of bed. After a week I have weakness and dizziness.
By Day #3 after 2nd dose, Swollen lymph node, above right collar bone - size of marble. Shot was in right arm.   23 days post 2nd dose, painful swollen lymph node behind left ear, base of skull.  Both node still swollen 18 days post 2nd dose.
STROKE IN RIGHT EYE; This spontaneous report received from a patient through other manufacturer (Novartis) concerned a female of unspecified age, race and ethnicity. 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, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient suffered an eye stroke in right eye. Patient got blind with her right eye. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke in right eye was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220604242-COVID-19 VACCINE AD26.COV2.S-stroke in right eye. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Information had been received from a physician and a Registered Nurse concerning a 16 year old female who was sexually active. In August 2006, the patient was vaccinated with the first dose of Gardasil, at the end of November 2006 with the second dose. She received the vaccination at the pediatrician's office. The patient was tested for syphilis " a couple of days" later. The patient's Rapid Plasma Reagin (RPR) test titers were 1-256 (high), with a negative Fluorescent Antibody Absorption (FTA) test.  The patient was tested again approximately one week later and the RPR titers were still high but lower. The physician mentioned that the patient underwent other antibody tests such as serum antinuclear antibodies (ANA) test, and Lyme disease test. The results were normal for those tests. The physician stated that the patient had not been sick with the flu nor mononucleosis, and that the patient had tested negative for other sexually transmitted diseases. Additional information has been requested.
The patient came in to the pharmacy, asking to receive his fourth COVID-19 vaccination, and he wanted the Moderna vaccine. The vaccine was administered. Upon further examination of his COVID vaccination card, it was noted that the patient had already received a fourth vaccination, so the patient had a fifth COVID-19 vaccination.  The administration of the fifth vaccine is also closer together than the recommended 4 months between booster doses. The patient appeared to be otherwise fine.
Lump; Redness; Swelling; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (Lump), INJECTION SITE ERYTHEMA (Redness), INJECTION SITE SWELLING (Swelling) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0121120) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced INJECTION SITE MASS (Lump), INJECTION SITE ERYTHEMA (Redness), INJECTION SITE SWELLING (Swelling) and FATIGUE (Fatigue). At the time of the report, INJECTION SITE MASS (Lump), INJECTION SITE ERYTHEMA (Redness), INJECTION SITE SWELLING (Swelling) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Next day woke up with hives on leg and had fever for 101.5 that day  Yesterday woke up fine and today he woke up with some hives dispersed all over the body  Mom gave zyrtec and rash went away both times  Nothing new that mom can think of other than the vaccines
Patient stated that after she received her vaccination, she began to feel warm.  Patient also reported dizziness.  Patient does report a history of fainting after vaccinations. Reports no food was consumed this morning.   Patient was hydrated, vital signs were taken.  Patient reports feeling better and vitals and everything was good and patient was able to go home.
Pain in ears, face, and joints; Pain in ears, face, and joints; Pain in palate of mouth; pain in mouth; Difficulty breathing; sensitivity; Pain in ears, face, and joints; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (Pain in ears, face, and joints), FACIAL PAIN (Pain in ears, face, and joints), ORAL PAIN (Pain in palate of mouth; pain in mouth), DYSPNOEA (Difficulty breathing) and HYPERAESTHESIA TEETH (sensitivity) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced EAR PAIN (Pain in ears, face, and joints), FACIAL PAIN (Pain in ears, face, and joints), ORAL PAIN (Pain in palate of mouth; pain in mouth), DYSPNOEA (Difficulty breathing), HYPERAESTHESIA TEETH (sensitivity) and ARTHRALGIA (Pain in ears, face, and joints). At the time of the report, EAR PAIN (Pain in ears, face, and joints), FACIAL PAIN (Pain in ears, face, and joints), ORAL PAIN (Pain in palate of mouth; pain in mouth), DYSPNOEA (Difficulty breathing), HYPERAESTHESIA TEETH (sensitivity) and ARTHRALGIA (Pain in ears, face, and joints) had resolved.            Concomitant medications were not reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jul-2021: Outcome updated from unknown to resolved.
Severe back pain; This is a spontaneous report from a contactable nurse (patient). This 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Dec2020 14:15 at single dose for COVID-19 immunization. Medical history included exercise induced asthma and COVID. No known allergies. Concomitant medications were not reported. Patient was not pregnant. Facility type of vaccine was hospital. No other vaccine received in four weeks. Prior to vaccination, the patient was diagnosed with COVID. Since the vaccination, the patient hasn't been tested for COVID. On 31Dec2020 07:00, patient experienced severe back pain that started the day after receiving the vaccine when she had never had back pain in the past. Woke her up through the night for about 5 days after receiving the vaccine. It has been 10 days and the back pain was easing up but still clearly present. No treatment received for the adverse event. Outcome of the event was not recovered.  Information of lot/batch number has been requested.
Developed pin dot rash on arms that was noticeable on 06/06/2021.  Sought medical treatment with doctor on 06/10/2021.  Labs drawn and rash identified as Petechiae.  Labs showed very low platelets and  WBC.  Spent day in ED  on 06/11/2021 based on lab results.  Labs were redrawn evening of 06/10/2021 to confirm initial lab results.  Labs repeated on 06/11/2021 in ED.  Another set of labs drawn on 06/14/2021.  Appt with Outpatient Hematology on 06/16/2021 and more labs drawn.  This is an ongoing issue and I am not sure if related to vaccine, but timing seems concerning.  New labs drawn today and awaiting those results.  She is still under medical care.
1 of 4 pts vaxed from the same DTP lot# who had adverse event; this pt recvd DTP/OPV on 17OCT94;brought to MD office 20OCT94 pt had fever 100.9, & 5cm area w/formed edge (not hive-like) surrounding inj site appearing like ringworm;
Itchy rash on side and down on lower portion of left arm. No treatment because he just woke up with it today.
Husband almost he died from covid; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Husband almost he died from covid) in an 88-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunocompromised and Cancer (Takes medicine for cancer).    On an unknown date, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In August 2022, the patient experienced COVID-19 (Husband almost he died from covid). At the time of the report, COVID-19 (Husband almost he died from covid) was resolving.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   It was reported that wife called in on behalf of her husband. Patient already had 5 shots. Her husband almost died from COVID so an AE needs to be done he had COVID last august he got it from his wife and he almost died it lasted for a long time but he was a lot better from what he was. No treatment medication was provided.
headache; very tired; pain and tenderness at injection site; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient experienced headache, very tired and pain and tenderness at injection site on an unspecified date. Outcome of the events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
pt presented from assisted living home with hypoxia (87% on RA); tested positive 6 days prior for COVID and tested positive again in the ED; hyponatremic; started on remdesivir and Decadron; A Fib and GI bleed occurred during hospitalization; increased renal insufficiency and hyperkalemia; pt died in the hospital
On 9-15-06, four hours after the vaccinations were given, the client experience 'chills, fever, shivering and aching all over'. By the next day, 9-16, the above symptoms had increased and her 'stomach and back hurt'. Also her 'arm really hurt, I couldn't move it'. Except for the sore and very stiff arm, symptoms subsided by about 2 pm on the follwoing day, 9-17. On 9-18, the two injection sites were reddened and raised, one approximately 1 3/4 inches, the other 1 1/2 by 2 1/2 inches.
Patient received vaccine on her left arm and was instructed to stay for 15 minutes per protocol. After 5 minutes, patient complained of left arm numbness that radiated from injection area. patient was brought in to Minute Clinic for evaluation and after period of 10 minutes, complained of left leg numbness. Patient has history of high blood pressure, and high cholesterol. Minute clinic personel consulted with their MD after examination and patient was prefered to ER to rule out stroke. Physician assistant at Minute Clinic verified that shot was in proper placement. Pt was taken to ER by son.
pt recv vax 11SEP96 & 12SEP93 pt was brought to the clinic w/a swollen lt upper arm that was warm & firm in the area;mom could not raise arm w/o problems;pt appeared in no distress & had full use of arm;mom instructed to apply warm compress
Asthmatic pt recvd DTP in lt deltoid; whole arm (shoulder to wrist) doubled in size; arm became cyanotic (mottled); had wheezing which improved w/Proventil MDI; pt also recvd MMR/PPD/OPV;
Blackout; Muscle twitching; Tingling; Cramps legs; Facial spasm; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Blackout) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0011321A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Blackout) (seriousness criterion medically significant), MUSCLE TWITCHING (Muscle twitching), PARAESTHESIA (Tingling), MUSCLE SPASMS (Cramps legs), FACIAL SPASM (Facial spasm) and MYALGIA (Myalgia). At the time of the report, LOSS OF CONSCIOUSNESS (Blackout), MUSCLE TWITCHING (Muscle twitching), PARAESTHESIA (Tingling), MUSCLE SPASMS (Cramps legs), FACIAL SPASM (Facial spasm) and MYALGIA (Myalgia) outcome was unknown.            Concomitant product use was not provided.  At the time of the report, the patient is awaiting results of a magnetic resonance imaging test.  Treatment information was not provided.  This case concerns a female of unknown age with a serious unexpected event of loss of consciousness, and nonserious muscle twitching, paraesthesia, muscle spasms, facial spasm, and myalgia. Event latency 4 weeks after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a female of unknown age with a serious unexpected event of loss of consciousness, and nonserious muscle twitching, paraesthesia, muscle spasms, facial spasm, and myalgia. Event latency 4 weeks after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Vaccine given at 1pm; pt developed chills, shakes & fever at 4p - T-102.4 - max. 103.3 on 12/9/10 with severe H/A, weakness, lethargy; given TYLENOL 2 q 4 hours & Ibuprofen, ice packs to groin & bilat axilla; cool compress to neck & forehead; use of Incentive Spirometer & increased fluids; contacted Dr. x 3.
Redness, swelling, hardness, and warm to the touch at injection site 1 week after injection. Has not tried to self treat yet.
Headache & Myalgia Narrative:  Employee woke up this morning with a severe headache. He state that he took one capsule of Tylenol and went back to bed sleeping for 5 hours. He states that he feels much better.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. In 2013 (reported as: one year ago) the patient was vaccinated with PNEUMOVAX 23 (dose 1; route, dosage and lot number unknown) for prevention. In October 2014 the patient inadvertently received a second dose of PNEUMOVAX 23 (dose 2, lot # K009809 EXP 16-MAY-2015; route and dosage unknown) for prevention. By the third day post second injection, patient reported to pharmacist that their arm hurt due swelling and redness. The outcome of the events was reported as resolved (unknown date). Additional information has been requested.
A total of 8 pts had local reactions following immun; 6 of these 8 pts exp inject site reactions which included erythema, hot to touch, pain & swelling w/in 15 mins of immunization; dx allergic topical reaction;
Participant reported to having symptoms of nausea and felt weak. His nurse requested to see & elevate the participant. 0855 participant entered the room awake, alert, and oriented x 3. Steady gait. Note injection was given at 0714 and tolerated well. Current c/o felt nauseated, weak, and tired. Note pulse 82, slightly tacky skin, no per-fused sweating or diaphoresis noted. Pt denies difficulty breathing. Resp 16, even and unlabored. No urticarias or rash noted. Pt appeared tired. Hydrated pt with 200 mL H20. Pt admits didn't sleep well last night and any drinking etch consumption. Advised to allow pt to do light duty or go home with no contact with machinery today. Safety office and HR agreed for safety office to drive pt home. No acute distress. Pt left facility @ 0915.