chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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.  A 61-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Sep2023 at 13:15 as dose 1, single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lyme disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 Immunisation; Covid-19 vaccine (Dose 2, Manufacturer unknown), for COVID-19 Immunisation; Covid-19 vaccine (Dose 3 (Booster), Manufacturer unknown), for COVID-19 Immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid from 11oct2023 to 15Oct2023. Clinical course: The patient did not had any Known allergies.  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: Linked Report(s) : US-PFIZER INC-202300335740 same patient, different product, different event;
headache; fever; hands hurts; knee hurts/joint pain all over; This case was reported by a consumer via call center representative and described the occurrence of headache in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th June 2019, the patient received the 1st dose of Shingrix (intramuscular). On 26th June 2019, 1 days after receiving Shingrix, the patient experienced headache, fever, pain in hand and joint pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the headache, fever, pain in hand and joint pain were recovering/resolving.   It was unknown if the reporter considered the headache, fever, pain in hand and joint pain to be related to Shingrix.  Additional details were provided as follows: The batch number for Shingrix was not reported. The patient received Shingrix on right arm. The patient experienced headache, fever of 101 degrees, hands hurt, knees hurt, joint pain all over.  The patient contacted their doctor who recommended Tylenol and the patient's symptoms were getting bit better. The reporter did not consent to follow up.
We got one of your shots on the last monday and we've been sick the whole week/sickness/we've been sick every day since then; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (We got one of your shots on the last monday and we've been sick the whole week/sickness/we've been sick every day since then) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Unknown.     On 09-Jan-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced ILLNESS (We got one of your shots on the last monday and we've been sick the whole week/sickness/we've been sick every day since then). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ILLNESS (We got one of your shots on the last monday and we've been sick the whole week/sickness/we've been sick every day since then) had not resolved.        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.   No concomitant medicine were reported. It was reported that the patient received three shots with Pfizer. No treatment medicine were reported.   Reporter did not allow further contact
LT THIGH BECAME RED, SWOLLEN AND WARM TO TOUCH ON 6/13/23 . PATIENT WAS SEEN IN OUR OFFICE ON 6/14/23.
This spontaneous report as received from a nurse refers to a multiple unspecified 6 month old patients of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, during measles outbreak, the patients were vaccinated with M-M-R II injection (dose, frequency, site of administration, route of administration, lot # and expiration date were not reported) for prophylaxis. No adverse effects were reported.
A hive like rash on back of neck; moderate pain and swelling at injection site and a premature start of menstral cycle.
received a dose of Moderna vial after vial had been punctured 20 times already; received a dose of Moderna vial after vial had been punctured 20 times already.; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (received a dose of Moderna vial after vial had been punctured 20 times already) and PRODUCT ADMINISTRATION ERROR (received a dose of Moderna vial after vial had been punctured 20 times already.) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021 at 4:15 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (received a dose of Moderna vial after vial had been punctured 20 times already) and PRODUCT ADMINISTRATION ERROR (received a dose of Moderna vial after vial had been punctured 20 times already.). On 10-Nov-2021, ACCIDENTAL UNDERDOSE (received a dose of Moderna vial after vial had been punctured 20 times already) and PRODUCT ADMINISTRATION ERROR (received a dose of Moderna vial after vial had been punctured 20 times already.) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ACCIDENTAL UNDERDOSE (received a dose of Moderna vial after vial had been punctured 20 times already) and PRODUCT ADMINISTRATION ERROR (received a dose of Moderna vial after vial had been punctured 20 times already.) to be not related.    No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-385918, MOD-2021-392369, MOD-2021-392379 (Patient Link).
She still has issues of bouts of coughing; feeling unwell; slight fever; surprisingly the effects were milder, resolved within 24 hours; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (surprisingly the effects were milder, resolved within 24 hours), COUGH (She still has issues of bouts of coughing), MALAISE (feeling unwell) and PYREXIA (slight fever) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in October 2020.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (surprisingly the effects were milder, resolved within 24 hours), MALAISE (feeling unwell) and PYREXIA (slight fever). an unknown date, the patient experienced COUGH (She still has issues of bouts of coughing). At the time of the report, VACCINATION COMPLICATION (surprisingly the effects were milder, resolved within 24 hours) had resolved and COUGH (She still has issues of bouts of coughing), MALAISE (feeling unwell) and PYREXIA (slight fever) had not resolved.            No concomitant medications reported. The patient was treated with steroids for 1 week after each dose. She also recalled getting a CXR (chest x-ray).   This case was linked to MOD-2021-017375, MOD-2021-256794 (Patient Link).
Per report on 6/28/21 patient began to suffer with acute onset pleuritic, left sided chest and shoulder pain. Was able to go for a walk but was suffering shortness of breath. CT angiogram showed bilateral pulmonary emboli with no evidence of right heart strain, or bibasilar atelectasis. Patient was initiated on a heparin drip and changed to rivaroxaban 15 mg PO BID for three weeks followed by maintenance dose of 20 mg daily on 6/30/21.
Recurrence of HPV; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Jan2022 as dose 3 (booster), single (Lot number: 33130BA) at the age of 31 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Allergies" (unspecified if ongoing), notes: Allergies; "Asthma" (unspecified if ongoing); "Soy allergy" (unspecified if ongoing); "Egg allergy" (unspecified if ongoing); "HPV" (unspecified if ongoing), notes: Had a recurrence of HPV which had been dormant for over 10 years prior to booster. Concomitant medication(s) included: ALLEGRA D; SINGULAIR; NUVARING; OMEPRAZOLE. Vaccination history included: pfizer (DOSE NUMBER; 2, Batch/Lot No: FC3180, Location of injection: Arm Left), administration date: 22Aug2021, for COVID-19 immunization; pfizer (DOSE NUMBER: 1, Batch/Lot No: EW0181, Location of injection: Arm Right), administration date: 31Jul2021, for COVID-19 immunization. The following information was reported: PAPILLOMA VIRAL INFECTION (non-serious) with onset 25Jan2022, outcome "recovering", described as "Recurrence of HPV". The event "recurrence of hpv" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of papilloma viral infection.  Additional information: No any other vaccine in four weeks. Patient did not experience COVID prior vaccination. If COVID tested post vaccination: Yes. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination,patient been tested for COVID-19. Device date: 16Jun2022.
This spontaneous case, initially received from other health professional (pharmacist) on 25-Sep-2018, concerns a 59-year-old, adult male patient. On 24-Sep-2018, the suspect vaccine, FLUCELVAX QIVc was left in the cooler and the temperature reached 34.4-degree F. The average of the incident was about 35.4-degree F for a period for 45 minutes. This was the first-time excursion. On 24-Sep-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252657 and expiry date: 31-May-2019) which underwent temperature excursion. The patient did not experience any adverse event after the vaccination. The reporter assessed the case as non-serious. This case was linked to case number: 201804054 (original case) due to same reporter. Follow-up report received from the reporter on 25-Oct-2018: The reporter confirmed that, the vaccine was administered on 24-Sep-2018 and temperature excursion also occurred on 24-Sep-2018. The narrative was amended accordingly.
patient has rash on stomach; vaccine was given to 17 year old; A spontaneous report was received from a healthcare professional concerning a 17-year old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced rash on his stomach/rash and vaccine was given to 17 year old/inappropriate age at vaccine administration.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (Batch: Unknown) via unknown route for prophylaxis of COVID-19 infection.  Someone had followed up prior to the patient receiving the vaccine and due to the patient being close to 18 years of age, the okay was given. On an unknown date, a vaccine was given to 17 year old patient. Patient had a rash on the stomach. Treatment information was not provided  Action taken with mRNA-1273 in response to the events was not reported.  The event, vaccine was given to 17 year old, was considered resolved. The outcome of rash on his stomach was not reported.; Reporter's Comments: This case concerns a 17-year-old patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age with associated adverse event. Based on the current available information and temporal association between the use of the product and the onset date of the rash, a causal relationship cannot be excluded.
off label use; Interchange of vaccine products; Treatment of COVID-19; Treatment of 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 male patient received BNT162b2 (BNT162B2), on 01Nov2021 as dose 3 (booster), single (Lot number: EW0173) at the age of 67 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 02Aug2022 as dose 4 (booster), single (Lot number: 044C22A) for covid-19 immunisation; coviD-19 vaccine (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 had no relevant medical history. Concomitant medication(s) included: DOXYCYCLINE; CETIRIZINE. The following information was reported: OFF LABEL USE (medically significant), outcome "not recovered"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "not recovered"; DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: rapid test. Therapeutic measures were taken as a result of off label use, interchange of vaccine products, drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201173813 Same patient, different product and event;
Pt complained of itching, redness of both arms and feeling that the tongue is thick. Felt light headed but no SOB. Pt got the new Flu shot Afluria 1 hour ago. Dr in to assess pts' condition. Epi 0.3 given IM. Zyrtec 10 mg po and Prednisone 40 mg po. Observed for 1 hour. Taught use of twinject and recognition of anaphylaxis.
Patient had raised 4 inch red area on left leg, tender, mild swelling; cellulitis.
pt recv vax & sustained a T-fracture & had back surgery w/placement of titanium rods in OCT96;pre-op CBC revealed a platelet count of 117,000;post op count was 122,000;pt seen by MD FEB97 gen not feeling well;platelet count 97,000;
9/6/08, 6:00 p.m., Patient began complaining of feeling dizzy.  The next morning the dizziness was increased, he complained of a severe headache and right arm numbness [the arm in which the MMR was given], and he exhibited memory loss and confusion when trying to read.  He also reported that his right arm had been swollen at some time in the night.  On physical exam, the MD noted significantly enlarged lymph nodes in his neck.  Patient felt warm to me, despite a normal oral temperature.  He had spent the night with a friend, and because I had not been with him to observe the development of his complaints, and because of the complaint of severe headache and arm numbness, I called the on-call pediatric office, who referred us to the ER.
Patient phoned on 3/1/21 to report that starting on Feb 24, 2021 he had body aches and extreme fatigue
joint pain; fatigue; headache; sore arm; This is a spontaneous report from a contactable pharmacist (patient). A 27-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EH9899), via an unknown route of administration on 22Dec2020 09:00 AM in left arm at single dose for COVID-19 immunization. The COVID-19 vaccine was administered at hospital. The patient's medical history and concomitant medications were unknown. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced joint pain, fatigue, headache, sore arm on 23Dec2020 09:00 AM. The patient received Ibuprofen as treatment. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of events was unknown.
redness; small amount of swelling at the injection site; fever; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  An elderly female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single dose (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ERYTHEMA (non-serious), outcome "recovered", described as "redness"; VACCINATION SITE SWELLING (non-serious), outcome "recovered", described as "small amount of swelling at the injection site"; PYREXIA (non-serious), outcome "recovered", described as "fever". Additional information: Patient called clinic after receiving Prevnar 20 experiencing redness, small amount of swelling at the injection site and fever. Symptoms resolved within 48 hours. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PT DESCRIBES PAIN WHEN MOVING ARM. NO BRUISING OR SWELLING. NOTICED A LIMITED RANGE IN MOTION. WILL F/U W/DOCTOR
Patient complained of mid sternium chest pain after vaccination. Pain radiated down arm. Onsite EMS called HR 77 BP 130/79, patient stated at 4:17 pm pain was resolved and went home.
COVID-19 Pfizer VACCINE WAS DRAWN UP ON 02/22/2022 1036, accidently left out and not discarded and given to the patient on 02/23/2022 at 1329.
Sore muscle up to neck and unable to turn neck. No fever, red and sore no other symptoms.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: patient stayed for 1.5 hours post vaccination. symptoms resolved well enough for her to feel confident to leave. denied receiving paramedics help
Fatigue, nausea, no appetite, dizziness, diarrhea, and fever.
Upon the delivery of PFIZER gray cap vaccine on 2/15/2022, pharmacy has kept the vaccine in the freezer (average temperature at -23.9 C) for 38 days before the administration. There were no adverse reactions reported after the administration.
FEELING WEAK; MUSCLE ACHE; FEVER  (101.4 F); FLU-LIKE SYMPTOMS; ACHY BODY; PAIN IN ARM; 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 pre-existing medical conditions included patient had no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced flu-like symptoms. On 08-APR-2021, the subject experienced achy body. On 08-APR-2021, the subject experienced pain in arm. On 08-APR-2021, the subject experienced fever (101.4 f). Laboratory data included: Body temperature (NR: not provided) 101.4 F. On 09-APR-2021, the subject experienced feeling weak. On 09-APR-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever (101.4 f) on 09-APR-2021, had not recovered from pain in arm, flu-like symptoms, achy body, and feeling weak, and the outcome of muscle ache was not reported. This report was non-serious.
fatigue small Fever Loss of appetite weakness inability to stay awake Dehydration (feeling of cotton mouth) arythmia episodes leading to a check in of 240 bpm GI problems involving inability to process certain foods and having immense bloating
A week or 2 after her 2nd dose of the vaccine, she presented with a petechial rash all over body. She has abd pain and headache. After seeing 3 doctors we got the diagnoses of HSP.
Dizziness many times.  Unable to walk.  Had to sit each time.  Dizziness started on Thursday, March 18th and continues to today..  I spoke to Dr. who prescribed the Gabapentin and he advised to not take the Gabapentin until the dizziness fully stopped.    Dizziness  is still active.  Not taking anything for it.
had the flu; Initial information regarding this unsolicited valid non-serious social media case received from a consumer (patient) on 12-Nov-2020.  This case involves a patient with unknown demographics who had the flu (Influenza), when received vaccine influenza vaccine (Flu shot).  Relevant medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date in 1993, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, 7 days after administration of influenza vaccine, the patient had the flu (Influenza) for 8-10 days. Since then the patient had not received flu shot and had not the flu either.  Relevant laboratory test was not reported.  It was not reported if corrective treatment was administered.  On an unknown date, the patient had recovered from the event.  There will be no information available on batch number for this case.
After several hours, the pain started in my right arm which spread to my underarm. At approximately 9:30pm I started shivering and developed a headache. The shivering was so intense that it woke my husband. I also noticed that I was unusually parched. I couldn't get enough water.   The shivering has since subsided, though I didn't get any sleep. My headache still exists as does the arm and underarm pain, and need for excessive water intake.
Uncontrollable shaking( more than just chills). Fever of 102. Joint pain.  Resting heart rate of 130 while sleeping
COVID positive 4/17/20221 w/ Covid pneumonia present, remains in hospital at time of report
Patient received her vaccinations at 3:30pm. She stood beside her mom who was holding her 2 month old brother. She watched his vaccines being given. After the last vaccine given, (3:45pm)she fell to the floor. Very pale, shallow breathing, good pulse, not responding. 1 minute after falling she started to cry and said her head hurt. Rescue squad was called at 3:46pm. She continued to cry. Color improving. Alert and oriented. BP at 3:50 was 110/64. Normal respirations and breathing. No bruising on head or injury to tongue, teeth or mouth. She squeezed hands without difficulty. Followed the command of sticking out her tongue. At 3:57 the rescue squad arrived.  Parent carried her to the rescue squad who transported her to the ER.
PER PT, AFTER RECEIVING FLU SHOT ON MONDAY, STARTED EXPERIENCING SWELLING OF EYES, NOSE AND CHEECKS. NO SWELLING OF LIPS, TONGUE, THROAT ON WEDNESDAY. HAD DIFFICULTY BREATHING THROUGH NOSE, BUT NOT THE MOUTH. TOOK ANTIHISTAMINE, FELT BETTER WITHIN 24 HOURS STARTING THURSDAY/FRIDAY, SYMPTOMS COMPLETELY WENT AWAY SATURDAY AM. DENIES TAKING/TOUCHING ANYTHING ELSE NEW/UNUSUAL
Patients Guardian was notified of incorrect dose and agreed to appointment to re-vaccinate 10/17/2023
Patient fell face down, hit chin, vitals wnl. Gauze applied to lower chin.