chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tested positive for covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for covid) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included METFORMIN for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced COVID-19 (tested positive for covid). At the time of the report, COVID-19 (tested positive for covid) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, SARS-CoV-2 test: positive (Positive) POSITIVE.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Mar-2021: Therapy details and outcome of the event updated.
Information has been received from a physician concerning a 64 year old female with no known allergies and no recent exposures to chickenpox or shingles, who on 07-SEP-2007 was vaccinated with zoster vaccine live (Oka/Merck) (lot no. "3073U"). Concomitant therapy included included atorvastatin calcium (LIPITOR). In September 2007, the patient developed erythema at the injection site of th L arm. On 14-SEP-2007 the patient developed a herpes zoster macular rash on the R leg. Additional information has been requested.
This spontaneous report as received from a pharmacy technician refers to a 1 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 16-MAR-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
Redness and warmth 1 inch by 4 inch that developed 9 days post vaccine. Treated for cellulite with keflex 500 mg 4x faily
Patient received a dose of improperly stored MMR-II and Varivax; No adverse event; This spontaneous case was received from and healthcare professional regarding to a patient of unknown age, gender and ethnicity. The patient's concurrent conditions, medical history, drug allergies and concomitant therapies were not reported.   On 26-FEB-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # S039316 with expiration date reported as 04-DEC-2021) 0.5 mL and improperly store varicella virus vaccine live (oka/merck)(VARIVAX) (lot # T024285 with expiration date reported as 15-JUL-2022) 0.5 mL (route of administration and anatomical location of vaccine were not reported) for prophylaxis. The vaccine was exposed to a temperature between 5.0 °F and 8.0 °F for 8 hours and 40 minutes. A previous temperature excursion was reported. No adverse effect was reported.  Albumin status has been verified for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # S039316) to be recombinant human albumin (rHa).  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2103USA003425:
Flu shot given 10/27/2005.  Patient developed red raised itchy rash in the morning 10/28/2005.  Patient also on IV Levaquin and Clindamycin 10/23-10/25.  Started on antibiotics on 10/26/2005.
Arm with baseball sized, raised, painful, itchy, red welt. Not sure if it was due to the vaccine or the fact that the shot was not given in the appropriate spot. It was given lower in my arm and not in the delt
Patient had the adverse reaction that evening at home several hours later at 10 pm. She had swelling of the face, neck, eyes, and arms. She had a weird feeling in her head and balance issues. She saw a doctor for this issues. She reported to us the reaction a few weeks after the fact. most everything has resolved except the balance issues and pressure feeling in head.
Vaccine expired 11/5/21, given 11/9/21 no adverse events reported.
herpes zoster; Information has been received regarding a case in litigation from a lawyer, an female patient of unknown age, and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 20-NOV-2016, at age 69, the patient was administered the zoster vaccine live (ZOSTAVAX) by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from her zoster vaccine live (ZOSTAVAX) use: Herpes zoster. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. The outcome of the Herpes zoster is unknown.  Additional information has been requested.
Terrible flu like symptom; Shingles; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Terrible flu like symptom) and HERPES ZOSTER (Shingles) in a 41-year-old male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Terrible flu like symptom) and HERPES ZOSTER (Shingles). At the time of the report, INFLUENZA LIKE ILLNESS (Terrible flu like symptom) and HERPES ZOSTER (Shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided.  No treatment medication provided.   This case was linked to MOD-2021-209810 (Patient Link).
Pt. was found dead in the crib at daycare the following afternoon. 2/18/09-autopsy report received-COD Sudden Infant Death Syndrome.
Total body pain, severe "felt like body was shattering", about 18 hours, after receiving day 7 shot and lasted for  about 1 day.
Received the smallpox vaccine on 5/4/2011. Two weeks later he developed scatter pustules on arms, legs and trunk and one in scalp. He had one enlarged submandibular node. Some drained clear fluid and a few were large; 1-2 cm. Two on his knee were foul smelling. I&D was performed on these lesions and he began antibiotics. He has a history of boils occasionally. There were no other symptoms such as fever, headache, SOB or chest pain. He felt well that day, but the next day he returned for dressing change and c/o LUQ pain (5/10) x 4 days. His WBC which had been normal the day before was 12k. He was then transferred out for further evaluation.
having side affect; hot; tired; flushed in his face; A spontaneous report was received from a  concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events having side affect, hot, tired, flushed in his face.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) having side affect, hot, tired, flushed in his face.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), having side affect, hot, tired, flushed in his face was unknown.
THROW UP; NAUSEA; FATIGUE; This spontaneous report received from a consumer concerned a 60 year old female. The patient's height, and weight were not reported. The patient's past medical history included: stage 4 kidney disease, small clot, bipolar depression, rectal prolapse surgery, surgery for broken knee cap, and surgery for leak in spinal fluid, and concurrent conditions included: smoker, and non alcohol user, and other pre-existing medical conditions included: Patient had no known allergies and no drug abuse or illicit drug usage. The patient was previously treated with warfarin sodium for small clot. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 24-AUG-2021 for prophylactic vaccination. Concomitant medications included apixaban for small clot. On an unspecified date, the patient experienced throw up, nausea, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, fatigue and throw up was not reported. This report was non-serious. This case, from the same reporter is linked to 20210908699.
Adverse event: Shingles Treatment- Antivirals (valcyclovir) topical steroids (TAC), NSAID. Time course: Still have rash and pain currently as reporting.  Signs and symptoms: Dermatomal rash to the left chest, upper back, and arm  with grouped vesicles and erythema. Hypersensitivity to the left side and down the arm.  Intermittent fevers and lethargy.  I previously had chicken pox as a child.
No adverse event; HCP calling and stated they gave 4 expired vaccines to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP calling and stated they gave 4 expired vaccines to patient) and NO ADVERSE EVENT (No adverse event) in a 56-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7185B) for COVID-19 prophylaxis.     It was reported that HCP did not report any medical history or condition for the patient. Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (031H21A) on 11-Dec-2021 and Moderna COVID-19 Vaccine (059A22A) on 12-Jun-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 10-Jun-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 10-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP calling and stated they gave 4 expired vaccines to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP calling and stated they gave 4 expired vaccines to patient) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP calling and stated they gave 4 expired vaccines to patient).    No concomitant information was reported. It was reported that the vaccine been expired about 8 or more days. Patient was not aware that she received an expired dose. No treatment information was provided.   This case was linked to MOD-2023-731713, MOD-2023-731685, MOD-2023-731650, US-MODERNATX, INC.-MOD-2023-731713, US-MODERNATX, INC.-MOD-2023-732157 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD-2023-731713:Same reporter, Same product, Same Batch lot/number MOD-2023-731685:Same reporter, Same product, Same Batch lot/number MOD-2023-731650:Same reporter, Same product, Same Batch lot/number US-MODERNATX, INC.-MOD-2023-731713:Same reporter (Patient 1) US-MODERNATX, INC.-MOD-2023-732157:Monovalent case
pt vaxed w/MMR 15JUL93 & 17JUL93 devel a fever, cervical adenopathy & exp aching joints; over the following two days, pt sx worsened; pt was dx w/infectious mononucleosis; No further details were provided;
Pt reported "itching" several hours after receiving....self-admin diphenhydramine..similar symtoms 09/28/2014, plus "shaking"  took diphenhydramine...went to local ER..no additional therapy/effects.
Patient was given 0.2 mL of undiluted Pfizer COVID-19 2023-2024 vaccine for 6m to <5y. CDC contacted and clinic notified to monitor patient, do not repeat dose, and given next dose as scheduled. Patient without symptoms of adverse reaction when leaving clinic. Lot: HH3252 EXP: 7/2024.
Patient received Pfizer COVID-19 Bivalent Booster vaccine which was beyond the manufacturer recommended use time of 10 weeks at the refrigerated temperature.  Staff has been in direct contact with the vaccine manufacturer regarding this issue. Pfizer has data to support the stability of the vaccine up to 45 days at refrigerated temperatures. The vaccine given was within this range which is supported by the above data. Clinically, the patient is considered to have adequate protection against COVID-19 from this vaccine dose compared to if the dose was administered within 10 weeks. Thus, there are no additional clinical recommendations at this time. Patient should continue to receive the recommended COVID-19 vaccination doses on the usual schedule.
The pt recvd 1st Engerix-B dose on 18JUN91 for Hep B prophylaxis; 4 days later pt devel a rash on lower extremities, few on torso, very itchy; given DPH
Pt experienced a rash over entire face since 3/2/00. Pt is currently afebrile but states may have had low grade fever on 3/2/00.
Patient came in today and said that she had a one in a million reaction to the vaccine given to her on 10/2/16. She said she had a fever, malaise and her lymph nodes swelled for 2 days. She said she went to the doctors and they told her to keep an eye on it and if it lasted more than 2 days they would have to report to the FDA but it only lasted 2 days with no remaining side effects so they did not report.
Child complained of an itchy arm. Mom says arm in area of varicella vaccine is red, hot, itchy, swollen and is about "golf ball sized". Child has a history of allergies. No previous reactions to vaccines. Mom gave child BENADRYL & will give ice pack.
I tested positive for Covid 19; I tested positive for Covid 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 5 (booster), single (Lot number: GH9694) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Oct2022, outcome "not recovered" and all described as "I tested positive for Covid 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Oct2022) Positive; (15Oct2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
COVID vaccine 1 was completed 1/6/2021. Day 12 post injection, my injection site on my left arm became red, splotchy, warm to the touch and painful after having no reaction like this on any of the days prior to this. It stayed like this for 2 days and then the redness and warmth went away but it was then itchy for 2 days. This would be days 14 and 15 post injection. I did not consult a doctor but did consult a nurse who I work with. Drew a circle around it to make sure it did not get larger. It did not spread from the initial size and I did report the reaction.
Pt complaint of headache, anxious. Pt taken into medical bay and vitals at 3:15 were blood pressure of 150/101 and pulse of 86. Patient evidently only took 1/2 of prescribed doses of her blood pressure medications the morning before the vaccine. Pt refused to ER. Last set of vitals were at 3:58 with a blood pressure of 160/101 and pulse of 90. Headache improved and resolved.
Wife gets covid 11May2023; Wife gets covid 11May2023; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA).  A 69-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Dec2022 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11May2023, outcome "unknown" and all described as "Wife gets covid 11May2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11May2023) Wife gets covid, notes: Wife gets covid 11May2023. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient took got 2nd Pfizer booster 29Dec2022. Got covid 11May2023, with fever, headache & body aches at pain level 8.75. Took Paxlovid early 12May & on 13May is out of bed with no fever, minimal headache.  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.
Hives /rash trunk,upper arms x 3 days. chicken pox like pimples  on right shoulder and a few here and there. , low grade temp, fatigue,itchiness,
arm pain; slight headache; a little bit of the chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), HEADACHE (slight headache) and CHILLS (a little bit of the chills) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm pain), HEADACHE (slight headache) and CHILLS (a little bit of the chills). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm pain), HEADACHE (slight headache) and CHILLS (a little bit of the chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No medical history was reported   Reporter did not allow further contact
Redness and swelling of 3/4 of upper left arm. Dizziness.
her right leg turns purple due to her heart; her right leg turns purple due to her heart; affected it kidneys and heart after getting Omicron; affected it kidneys and heart after getting Omicron; She felt like passing out; wanted to sleep and sleep and sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 44-year-old female patient 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. The patient's relevant medical history included: "EDS" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 Immunization. The following information was reported: CONTUSION (hospitalization), CARDIAC DISORDER (hospitalization), outcome "unknown" and all described as "her right leg turns purple due to her heart"; RENAL DISORDER (hospitalization), CARDIAC DISORDER (hospitalization), outcome "unknown" and all described as "affected it kidneys and heart after getting Omicron"; LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "She felt like passing out"; SOMNOLENCE (non-serious), outcome "unknown", described as "wanted to sleep and sleep and sleep". The patient underwent the following laboratory tests and procedures: Blood test: put a damper on her heart and kidneys, notes: Omicron put a damper on her heart and kidneys that showed up on bloodwork. Therapeutic measures were taken as a result of contusion, cardiac disorder.  Clinical course: During the report caller stated that the patient had a lot of problems. The patient had kidney and heart problems and having 4 kids. The patient got Omicron variety and had gotten all her shots except the 2nd booster. Omicron put a damper on patient's heart and kidneys that showed up on bloodwork. The reporter originally called and asked why it would bother her kidneys so bad, it made her hurt more. The patient had the Pfizer Covid 19 vaccines but not the last one because they told her to wait. The reporter did not know if it was because she got Covid. The patient had so much built up and she had Omicron really bad. The patient felt like passing out and wanted to sleep and sleep and sleep. The patient's right leg turns purple due to her heart, and they did blood work. The patient went to the hospital when she had Covid and the tests found it was affecting her heart and kidneys and showed damage to both heart and kidneys. Caller does not have Pfizer Covid 19 vaccine details to include dates, NDC, lot or expiry but she reported those previously.  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-202201246575 same patient, different vaccine dose/events;