chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Covid test and it's showing positive; Covid test and it's showing positive; Booster; Had a cold; This is a spontaneous report received from a contactable reporter. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (Lot number: FE3594) 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. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2021, outcome unknown and all described as Covid test and it's showing positive; IMMUNISATION (non-serious) with onset 2021, outcome unknown, described as Booster; NASOPHARYNGITIS (non-serious) with onset 2021, outcome unknown, described as Had a cold. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Fever,chills, nausea,vometing,muscle pain ,body aches,high pulse rate.
This spontaneous report as received from a consumer reporting on her 67 years old husband with immune system of 3 year old and lymphoma. Pertinent medical history included radiation, chemotherapy and stem cell transplant who was vaccinated by error with a dose of live ZOSTAVAX (dose, route and lot # not provided) instead of live VARIVAX (Merck) on 30-JAN-2013. No other co-suspects were reported. No concomitant medications were reported. The patient's wife stated that on 30-JAN-2013, the evening after live ZOSTAVAX her husband was sweating profusely although his temperature was 96 F. There was no treatment given for the events. The patient called the physician. The outcome of sweating profusely was reported as not recovered/not resolved. The relatedness for sweating profusely and patient received ZOSTAVAX when supposed to received VARIVAX was unknown for live ZOSTAVAX was unknown. Additional information has been requested.
Injection site soreness shortly after administration. Fever started by 7:30 a.m. on 3/21/21, Fever reduced after taking Advil. By 7:00 p.m. 3/21/21, fever returned and achiness and respiratory distress started. Asthma medication administered, but only helped for a couple minutes at a time. An additional dose of Mucinex also administered. Respiratory distress increased if lying down. Respiratory distress eased by 8:00 a.m.. on 3/22/21.
Patient saw MD on 9/11/20 for follow up and showed bruising of arm. Patient stated that MD said they were not worried about bruising on arm, but to show pharmacy. Patient presented to pharmacy to pick up medications and show bruising of arm.
Redness at injection site, small hive at injection site, small knot at injection site, pain at injection site. Gave patient BENADRYL.
This spontaneous report was received from a nurse concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On an unknown date, the patient was vaccinated with VARIVAX intramuscularly, lot # N022980 with expiration date of 23-AUG-2019, (dose and anatomical location were not reported) for prophylaxis. No adverse effects were reported.
Initial unsolicited report received from a consumer on 28 Sep 2016. This case involves a 60-year-old female patient who was vaccinated with a dose of Fluzone QIV (Batch number, expiration date, dose and dose in series were not reported) intramuscularly in the left deltoid on 14 Sep 2016. Patient's medical history was reported that Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was none. Illness at the time of vaccination was also reported as no. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 14 Sep 2016, same day following the vaccination, the patient developed bruising at the left deltoid, soreness, and a red, raised patch of about 2.5 inches in diameter. The patient stated that arm was very sore and could not sleep on her left side. Laboratory investigations were reported as none. Corrective treatment was not reported. The patient recovered from the events on an unknown date (reported as symptoms took about two weeks to be resolved). List of documents held by sender: none.
DIARRHEA/WATERY STOOLS/LOOSE STOOLS; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (DIARRHEA/WATERY STOOLS/LOOSE STOOLS) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for an unknown indication.    No Medical History information was reported.   On 01-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced DIARRHOEA (DIARRHEA/WATERY STOOLS/LOOSE STOOLS). The patient was treated with LOPERAMIDE HYDROCHLORIDE (LOMOTIL [LOPERAMIDE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (DIARRHEA/WATERY STOOLS/LOOSE STOOLS) had resolved.            No concomitant medication was reported. Patient reported that she had watery, loose stools for about 5 days after her first injection. She had no other symptoms or other complaints of issues. She states that the diarrhea went away. Treatment information was not provided. 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.
Case previously recorded as MA2009-4536. Case report received from a registered nurse, on 10 NOV 2009. 35-year-old female pregnant patient was vaccinated with an overdose of 1 mL FLUVIRIN (batch no. 98468P1) i.m.. No adverse effect was reported. Reference no.:NA09-007809. Follow up report received on 26 Apr 2010: There was an twice attempt to contact reporter, but no response received so far. Therefore the case was closed with a consideration as a lost to follow up.
Moderate injection site/arm pain Nausea  Diarrhea Loss of appetite Abdominal pain Chills
Dizziness, Headache, Arthralgia, NauseaVomiting, Loss of appetite, loss of energy Narrative:
This spontaneous report was received from a pharmacist referring to an approximately 71 year-old female patient. Pertinent medical history, concurrent conditions and concomitant therapies were not provided. Approximately in 2014 (reported as "about 2 years ago"), the patient was vaccinated with ZOSTAVAX 19400 plaque forming units (PFU). Route, dose, dose number, lot # and anatomical location were not reported. The pharmacist stated that the patient experienced muscle weakness from her neck to her calves since administrations of ZOSTAVAX "about 2 years ago". The reporter also stated that the patient had difficulty bearing weight on her legs. The patient was evaluated by an unspecified physician in the office; however there was not diagnosis or treatment provided. It was not a product quality complaint involved. At the time of reporting the outcome of muscular weakness and weight bearing difficulty was reported as not recovered. The causality assessment between the events and the suspect therapy was not provided. Additional information is not expected due there is not consent of follow-up.
The pt states she woke up the following day with hives covering chest and shortness of breath, beginning at 12:00. The pt is taking Benadryl this afternoon.
I wear a Dexcom 6 Glucose transmitter. Never had any allergic reactions before. 24 hours after both Pfizer '||CHR(38)||' Influenza vaccinations, large blisters formed around G6 patch on stomach area.; other vaccine 4weeks product: Influenza; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old male patient received bnt162b2 (BNT162B2), administered in leg left, administration date 03Nov2021 13:30 (Lot number: FF2589) at the age of 57 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA), administered in arm left, administration date 03Nov2021 (Batch/Lot number: unknown). Relevant medical history included: "Addison''s Disease" (unspecified if ongoing), notes: Relevant medical history and concurrent conditions: Addison's Disease, Diabetes type 2; "Diabetes type 2" (unspecified if ongoing), notes: Relevant medical history and concurrent conditions: Addison's Disease, Diabetes type 2; "Fish and heavy dosages of aspirin" (unspecified if ongoing), notes: Fish and heavy dosages of aspirin; "Fish and heavy dosages of aspirin" (unspecified if ongoing), notes: Fish and heavy dosages of aspirin. The patient's concomitant medications were not reported. Past drug history included: Fish and heavy dosages of aspirin, reaction(s): "Allergy"; Fish and heavy dosages of aspirin, reaction(s): "Aspirin: allergy", notes: Fish and heavy dosages of aspirin. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EM9810, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 24Feb2021 and and Bnt162b2 (Dose Number: 1 Batch/Lot No: EN6502, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM),administration date: 24Feb2021 when the patient was 56 years old, for COVID-19 immunization. The following information was reported: BLISTER (non-serious) with onset 04Nov2021 14:30, outcome "recovering", described as "I wear a Dexcom 6 Glucose transmitter. Never had any allergic reactions before. 24 hours after both Pfizer '||CHR(38)||' Influenza vaccinations, large blisters formed around G6 patch on stomach area."; PRODUCT USE ISSUE (non-serious) with onset 03Nov2021, outcome "unknown", described as "other vaccine 4weeks product: Influenza". Therapeutic measures were not taken as a result of blister.  Additional information:Other vaccine 4weeks product included Influenza on 03Nov2021(Left Arm) as dose 1.Covid prior vaccination was reported as yes. Covid tested post vaccination was reported as no.Prior to vaccination the patient was diagnosed with COVID-19.Since the vaccination the patient had not been tested for COVID-19.No treatment was receive for the adverse event.  No follow-up attempts are possible. No further information is expected.
This is a spontaneous report received from a noncontactable consumer or other non-HCP. A female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient experienced anxiety disorder, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
joint pain whole body/ joint pain in limbs and trunk; muscle pain whole body/ severe muscle pain in limbs and trunk; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 12Feb2021 as dose 1, single (Lot number: EN6201) at the age of 65 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "irregular heartbeat" (unspecified if ongoing); "Hypothyroidism" (ongoing); "Sarcoidosis dermatological", start date: 09Feb2020, stop date: Aug2020; "Hepatitis C", stop date: Aug2006, notes: Onset Date: Prior to Sep1990; "Graves' disease", stop date: 1988, notes: Onset Date: prior to Sep1980, Treated with radioactive iodine 1988. Concomitant medication(s) included: ATENOLOL oral taken for heart rate irregular (ongoing); LEVOTHYROXINE oral taken for hypothyroidism (ongoing). Past drug history included: Radioactive iodine, start date: 1988, for Graves' disease. The following information was reported: ARTHRALGIA (medically significant) with onset 17Feb2021, outcome "recovered" (Feb2021), described as "joint pain whole body/ joint pain in limbs and trunk"; MYALGIA (medically significant) with onset 17Feb2021, outcome "recovered" (Feb2021), described as "muscle pain whole body/ severe muscle pain in limbs and trunk". Therapeutic measures were not taken as a result of arthralgia, myalgia.  Clinical Course: The patient reported that approximately 5 days after receiving the initial dose of Covid vaccine, she experienced severe muscle plus join pain in her limbs and trunk, but that lasted only about 24 hours. The patient also reported that given the symptoms and timing, it appeared that her symptoms were triggered by the vaccine. The patient has no family medical history relevant to the adverse events.; Sender's Comments: Considering the plausible drug-event temporal association and known safety profile, there is a reasonable possibility that reported events arthralgia and myalgia were related to suspect vaccine administration.,Linked Report(s) : US-PFIZER INC-PV202200115403 Same patient, same reporter, same product, different dose, different events;US-PFIZER INC-202300117872 Same patient, Same reporter, Different product, Different events;
Monthly cycle has been heavy bleeding, defibrilating cramps, and unpredictable. Spotting moments after the vaccine.  Chest pain, and pins and needle sensation in legs.
tested positive greater than 14 days after fully vaccinated Narrative: tested positive greater than 14 days post vaccination
About 4 hours after the HIGH DOSE shot, she began to experience a persistent cough, aches, shooting pain, and extreme chills. This lasted with slowly lessening severity, for about 4 days. She has had the flu shot before, but this is the first time that she got the HIGH-DOSE.
As soon as the vaccine was given, the patient began experiencing shortness of breath and chest pain. Patient has a history of asthma and fainting with previous vaccinations. 9-1-1 was contacted. Therapy was discussed with patient; patient refused service from paramedics and drove herself home
the vaccine given was 2 weeks past its beyond use date. The beyond use date on the label was 1/20/23 and the vaccine was give on 2/3/23. The administration error was not noticed until after the vaccine was given.  THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THE ADMINISTRATION OF THE VACCINE.
20 weeks pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of   in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details were reported. No treatment medication details was reported.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this unidentified female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
COAGULOPATHY, UNSPECIFIED TYPE 8/3/2021 EDEMA    MITRAL VALVE REGURGITATION  ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 8/3/2021 EDEMA    MITRAL VALVE REGURGITATION  COAGULOPATHY, UNSPECIFIED TYPE 8/3/2021 ANEMIA  ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 8/3/2021 ANEMIA
Pt was found unresponsive and limp by mother. Twin had same vaccines on same day. Twin was admitted to ER for observation but had no signs and symptoms of distress. Autopsy findings report inguinal lymph node had a subacute lymadenitis with peripheral fibrosis and the spleen is slightly lymphocyte depleted; this infant had atelectasis, a desquamative interstitial pneumonitis and acute and chronic tracheitis.
Pain in left arm. redness and swelling that is 4 inches by 3 inches.below the injection site. had headache on day of injection. also slight fever.  feeling cold. Took 1 aleve yesterday and today.
expired dose administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 1-year-old male patient who received Hib (Hiberix) (batch number TF4EB, expiry date 26th September 2021) for prophylaxis.   On 1st October 2021, the patient received the 4th dose of Hiberix. On 1st October 2021, unknown after receiving Hiberix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional information was provided as follows: The patient received an expired dose of Hiberix vaccine. The reporter consented to follow up. The case was linked with US2021207017, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021207017:Same reporter
p/recv vax pt thumb devel a twitch (uncontrollable) 3 to 7 days post vax;day 1 to 14 p/vax pt exp large warm lump in upper forearm, pain in lump;
Dermal filler (Juvederm) hypersensitivity facial adema treated with prednisone (10 mg twice a day for 7 days 11/29/21-12/05/21, medrol dose pack 12/14/21, medrol dose pack 12/24/21)
Throat pain - felt like it was closing. Chills, headache, shakes from chills. BENADRYL prescribed. Taken at 6:30 PM. Fell asleep at 9 PM and felt fine the next day.
The patient called us and said she received her COVID vaccine of Pfizer on 5-21-21. She said when she received her vaccine she bleed and the person administering the vaccine wiped up the blood twice after administering the vaccine. She said he has a bruise from the shot.
No additional AE reported.; GARDASIL 9 was inadvertently administered to a 15 month old; This spontaneous report was received referring to a 15 months old patient of unknown gender. The patient's pertinent medical history, drug reactions/ allergies and concomitant medication were not reported.  On 01-FEB-2021, the patient was inadvertently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 ml, route, lot# and expiration date were not reported) for prophylaxis (inappropriate age at vaccine administration). No other adverse event was reported. The outcome of the event was unknown.
Shot was painless the first. Next day was severe enough to limit movement for the next 2 days. Eventually shoulder pain s as me shooting pain down my arms. 3 weeks later noticing pain in all my joints, especially shoulder that was injected and my knees and hips. 4 weeks later all pain persists and the site of injection still is sore.
Information has been received from a physician and a consumer concerning herself, a 75 year old white female with diabetes, hypertension, asthma, penicillin allergy, sulfa allergy, arteriosclerotic heart disease, hyperthyroidism and colitis ulcerative who on 29-MAY-2008 was vaccinated subcutaneously in her left deltoid with the first dose of zoster vaccine live (Oka/Merck) (LOT# 659409/0409X). Concomitant therapy included GLIPIZIDE, insulin. Additional information has been requested. This is one of several reports from the same source.
Lost power the next day in the middle of the day at 12:00 PM.; No adverse event; Vaccine went tempearture excursion and was adminstered between 02-MAR-2023 to 28-MAR-2023.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Lost power the next day in the middle of the day at 12:00 PM.), POOR QUALITY PRODUCT ADMINISTERED (Vaccine went tempearture excursion and was adminstered between 02-MAR-2023 to 28-MAR-2023.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In March 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In March 2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine went tempearture excursion and was adminstered between 02-MAR-2023 to 28-MAR-2023.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Lost power the next day in the middle of the day at 12:00 PM.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Lost power the next day in the middle of the day at 12:00 PM.), POOR QUALITY PRODUCT ADMINISTERED (Vaccine went tempearture excursion and was adminstered between 02-MAR-2023 to 28-MAR-2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Lost power the next day in the middle of the day at 12:00 PM.) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine went tempearture excursion and was adminstered between 02-MAR-2023 to 28-MAR-2023.).    It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications were reported.  Temperature excursion occurred due to lost power in the middle of the day at 12:00 PM. Had placed all vaccine into a frozen bag. Booster vaccines were then transported to another clinic. On 02-Mar-2023 to 28-Mar-2023, vaccines were administered to 26 Patients at facility. No reported symptoms.  No treatment medications was reported.  This case was reported for Patient 12 out of 26 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-718370 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718370:
p/vax pt exp chickenpox w/approx 20 lesions;pt was treated w/DPH & Zovirax;pt chickenpox persisted;
7 days after received vaccine noted redness swelling, heat, itching to right upper arm. base ball sized redness. took benadryl symptoms resolving on 1/11/21
1 minute after injection, her right leg had many red blotchy spots including on the bottom of her right foot, and her leg had a purple appearance. It lasted for about 5 minutes and then quickly resolved.
Tested positive for Covid/contracted covid after receiving the vaccine; This is a spontaneous report from a contactable consumer (patient) received from Pfizer Sponsored Program. A female patient of an unspecified age (Age: 42, Units: Unspecified) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 09Jul2021 as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 20Jul2021, 11 days after vaccination, the patient contracted COVID-19 and tested positive for COVID-19. It was reported that patient missed the appointment for her second dose which scheduled on 30Jul2021, and did not received it because she tested positive for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 20Jul2021. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Injection received 9/16/10 in (L) deltoid. Patient indicated muscle remains very sore below injection site on 10/11/10. Patient states she saw doctor on 10/14/10 and he prescribed heat & ibuprofen.