chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever Saturday 101.2 - Sunday 100.2 - Purpura rash developed 11/11/09 800AM - 11/12/09 joint swelling rash - Dx: Henoch-Schonlein purpura. 11/13/2009 ED record for 11/11/2009. Dx skin rash-Henoch-Schonlein purpura  patient with c/o's fever, rash, itching and joint swelling. Tx: steroids, benadryl.  11/25/09:  ED Records recieved for date of service 11/12/09, no new information.
reports that he started to notice changes in his mood. he went to get pizza and salad for his family, and his wife found his keys in the styrofoam salad in the refrigerator (has never done anything like that before). his son found his wallet and dollar bills were scattered on the floor. after that, reports that he started to experience bouts of increased irritability that were atypical for him. These bouts of increased irritability were intermittent and lasting for several days, including currently still experiencing 2 wk later.
Client had Pneumonia and Flu vaccine on 10-25-07.  Site of Pneumonia vaccine (R) arm became painful and swollen that evening.  Over the weekend Oct 27 &28 states it hurt to move her arm and red streaks were coming from the area where shot was given.  Today has temp of 97.9 and edema to deltoid area and upper arm. Some limitation of movement due to pain and edema. Advised to see MD for evaluation.  Use cool compresses and APAP as needed.
During vaccine administration the syringe and needle separated. It is unknown how much of the vaccine the patient received as some liquid came out of the syringe.
Felt like face w swollen, hot, and tired. No facial swelling noted after thirty minute observation,  no rash, no SOB.
Guillain-Barré syndrome (GBS) - tingling and pain throughout body. Mostly in the legs. Difficulty when walking. Feeling of lightheadedness and unstable on feet. Rapid heartbeat, difficulty breathing, headaches, blurred vision, unable to focus/foggy brain, inability to drive or perform everyday activities. Lasted over four months.
Have been getting dizzy spells, blood pressure is lower than normally is, seems to be when I get up and stand up, reaching under the sink to get something, tying my shoe, working at the computer and walking away. dizziness has been going on for weeks after the first phizer shot. I have heard of a few other people having this issue. Hoping it goes away. Need some guidance on whether or not I should get the second shot.
expired vaccine was administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 72-year-old male patient who received HAB (Twinrix adult) (batch number 2KE55, expiry date 22-SEP-2023) for prophylaxis.   On 26-SEP-2023, the patient received the 1st dose of Twinrix adult. On 26-SEP-2023, an unknown time after receiving Twinrix adult, the patient experienced expired vaccine used (Verbatim: expired vaccine was administered).  The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-SEP-2023 The reporter stated that an expired Twinrix was administered which led to expired vaccine used. The reporter consented to follow up via postal The vaccine administration facility is the same as primary reporter.
No adverse event; 1 patient received a 0.5ml bivalent booster that was given as a primary series dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (1 patient received a 0.5ml bivalent booster that was given as a primary series dose) and NO ADVERSE EVENT (No adverse event) in a 37-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062f22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Dec-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 08-Dec-2022,  after starting , the patient experienced WRONG PRODUCT ADMINISTERED (1 patient received a 0.5ml bivalent booster that was given as a primary series dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (1 patient received a 0.5ml bivalent booster that was given as a primary series dose) 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 WRONG PRODUCT ADMINISTERED (1 patient received a 0.5ml bivalent booster that was given as a primary series dose).    No concomitant medication was provided by reporter. It was reported that HCP wanted to know which the guidance or steps was to take after the following administration error 1 patient received a 0.5ml bivalent booster that was given as a primary series dose lot #062f22a as a first dose Date of administration 8Dec 2022. No treatment medication was provided by reporter.
76-year-old female  presents to the emergency department with shortness of breath.  Shortness of breath began earlier this morning.   She tested positive for COVID-19 5 days ago.  Has been doing well and only complaining some very mild flu-like symptoms leading up to the weekend.  Her shortness of breath gradually got worse over the weekend and this morning was most significant prompting her to come to the emergency department.  Has not been diagnosed with COVID-19 prior to this.  Denies any sick contacts.  Denies any nausea, vomiting, diarrhea.  Denies any difficulty speaking or swallowing.  Does not require supplemental oxygen at baseline.   Admitted 2/21/22 - 2/23/22.  PReviously vaccinated Moderna 2/4/21, 3/8/21, Booster 8/24/21
Five Days later after Booster developed Jaundice abdominal pain nausea urine brown required to go to ER.
He lost his sense of taste and is complaining favorite foods taste bad. Peanut butter and macaroni and cheese have been some notable ones. I have post covid taste distortions and recognized he is having the same symptoms after being vaccinated.
Left eyelid swollen and red; Burning sensation; Left eyelid swollen and red; Dry cough; Uncomfortable feeling in body; Myalgia from shoulder to elbow; This case was received on 02-Sep-2020 from other non-health professional (consumer) via agency (reference number: SEQW20-01159) and concerned a 59-year-old, female patient.  The patient's concurrent conditions included unspecified thyroid disorder and alpha gal allergy.  The patient's concomitant medications included levothyroxine for unreported indication.   On 31-Aug-2020, the patient was vaccinated with Flucelvax QIV [influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route od administration: intramuscular and anatomical location: not reported] for influenza prophylaxis. The batch number reported was 276533, the expiration date reported was 05-Jun-2021.  On the same day, immediate after receiving Flucelvax QIV, the patient developed myalgia from shoulder to elbow, uncomfortable feeling in body and burning sensation. Her left eyelid was swollen and red and she developed dry cough at night.  On an unspecified date in 2020, the patient was treated with Benadryl (diphenhydramine hydrochloride).  At the time of initial reporting, on 02-Sep-2020, the patient was recovering. She was better that the previous day, but still was very red.  The reporter assessed the events to be related to Flucelvax QIV. The patient stated this is the first time she has a reaction to a flu shot.  Company comment: The patient developed all events on the same day after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. No alternative aetiology was provided. Based on provided information, causal relationship between the suspect product and all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).; Reporter's Comments: This is the first time she has a reaction to a flu shot.; Sender's Comments: The patient developed all events on the same day after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. No alternative aetiology was provided. Based on provided information, causal relationship between the suspect product and all events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).
Vial was stored in refrigerator on 02-Jun-2022 and administered on 06-Jul-2022; Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 02-Jun-2022 and administered on 06-Jul-2022) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059M21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Coronary artery disease since 27-Aug-2015, Hypertension since 02-Mar-2016, Hyperlipidemia since 04-Oct-2018, Allergic rhinitis since 07-Oct-2021 and BPH since 07-Oct-2021. Concomitant products included CETIRIZINE from 07-Oct-2021 to an unknown date for Allergic rhinitis, FINASTERIDE from 07-Oct-2021 to an unknown date for BPH, ACETYLSALICYLIC ACID (ASPIRIN 81) from 27-Aug-2013 to an unknown date for Coronary artery disease, PRAVASTATIN from 27-Aug-2015 to an unknown date for Hyperlipidemia and Coronary artery disease, METOPROLOL TARTRATE from 15-Mar-2018 to an unknown date for Hypertension and Coronary artery disease.    On 06-Jul-2022 at 8:57 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 02-Jun-2022 and administered on 06-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 02-Jun-2022 and administered on 06-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vial was initially stored on refrigerator on 02-Jun-2022. The vial did not undergo any temperature excursion.  No adverse events were reported. Treatment medication was not provided by the reporter.
Severe chills; waves of chills, shaking; Severe chills; waves of chills, shaking; Headache; Feeling tired; Nausea; Feeling unwell; Injection site pain; I am feeling so weak; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 18Feb2021 14:30 (lot number was unknown as patient card was in the bedroom, he couldn't go, he was feeling so weak so he was not going up to bring that) at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 in right shoulder on an unspecified date for COVID-19 immunization and experienced little soreness in shoulder. The patient experienced severe chills, waves of chills, shaking; headache; feeling tired; nausea; feeling unwell; injection site pain; was feeling so weak; all on 18Feb2021. Event details: No treatment received. But patient visited hospital on18Feb2021 because he did have severe chills accompanied with headache, feeling tired, some nausea, there was an unwell feeling, little bit of fever was not actual fever but the injection site pain. There were waves of chills, shaking, he shook for about an hour, it went away for a while, in half an hour or 45 minutes it returned again. He never had shaking with chills in his entire life, he was surprised with the reaction, by 2:30 (19Feb2021) after 24 hours of that he was back to hundred percent again, he was recovering very nicely but he did have injection site pain in shoulder but that's not a big deal. The patient stated there are various different variants of this Covid virus, he asked if this vaccine it is been effective against every other. Patient weight was reported as about 178. The outcome of the events was recovering.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021293277 similar report from same reporter
arm got red, swollen, warm;became 6" diameter;saw MD 4 days p/inj & put on med;
Soreness in left arm-red and swollen, nausea, chills, slept 10-12 hours, 12 by 6 cm erythema left deltoid.
pt recvd 3 doses of Engerix-B & exp no medical problems or reactions; titer test result indicated no antibody conversion;
Patient described right arm injection site symptoms as itching and swelling that is beginning to resolve. Initially it was a raised area about the size of nickel and now described as a "marble sized" knot in her arm.
has Covid; has Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 89-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Jun2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose number unknown, 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "has Covid". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course was reported as follows: Caller states she currently has Covid and is on a different antiviral (not Paxlovid) that she finished taking today. She has has 6 or 7 Pfizer shots, those when first available and then the boosters. Caller states she got her last booster in June, she was scheduled for the new shot but then she came down with Covid. The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300331404 same patient, different dose/event;
First night shivering, fever, pain, diarrhea. The left arm is still sore. Treated with Aspirin and Ibuprofen  On day2 and day3 nausea, tireness and pain in the arm, treated with ibuprofen but effects continued. On day4 the arm still aches terribly, treated with ibuprofen. I don't think the pain leaves tomorrow on the 5th day after vaccination
Pain at injection site immediately.  Flu like symptoms that evening and next day.  Muscle pain throughout body and joint pain in bearing joints on the second day following
Received DTAP, HIB, MMR 8/15/2008. 2 days later had fever and seizure - Mom was told by Dr. was febrile seizure. ? cause never told to mom.
Rt thigh red raised warm to the touch, itchy, 1 1/2-1 1/2 inches.
Had side effects from the 2nd moderna vaccine. Side effects started the first day of the vaccine were fatigue, slight headache muscle pain, nausea. The following day the symptoms were worse with fatigue nausea, joint and muscle pain, and fever of 99.8. and  headache that comes and goes, just feeling unwell. I plan to take tylenol to get through this. As of right now at 2 in the afternoon nothing has eased up yet. I know that you can experience side effects for 1 to 3 days but felt I should report these.
developed rash on both arms, chest , upper abdomen and back .  vital signs monitored, Benadryl 50 mgs given.
Vaccination adverse reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a 36-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, 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 25-Jan-2023, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.      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.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Contacted clinic day after vaccine given with report of local reaction to (L) arm and then continued to develop progressive symptoms of malaise, fatigue, arthralgias, myalgias.
Received 2 dose of Pfizer vaccine same place on Thursday June 17th-2021.. On Friday late afternoon, suddenly, started feeling  sluggish, then had a fever of 102,, right now  as of the June 19th-2021 so far temperature is down..
Within one hour post vax, the pt experienced shaking, chills, myalgias, headache, and severe injection site pain. The symptoms lasted 3-4 days.
Fainted/totally fainted; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainted/totally fainted) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced SYNCOPE (Fainted/totally fainted) (seriousness criterion medically significant). On 18-Feb-2021, SYNCOPE (Fainted/totally fainted) had resolved.            Concomitant medications were not reported. Treatment information was not provided.  The patient fainted 20 minutes after receiving the vaccine. A doctor was called to assess her at the vaccination facility. He waved something under her nose and she woke up immediately. The patient's husband would like for her to receive the next dose of the vaccine at a facility that also has a doctor like the first dose.  Company Comment:  Very limited information regarding this event has been provided at this time. The reporter declined further follow-up, so no further information is expected.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time. The reporter declined further follow-up, so no further information is expected.
I started getting stiffness in the right wrist and fingers; Effecting his writing; Bilateral wrist and finger pain mostly in his joints; Feeling lethargic; Pain at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LETHARGY (Feeling lethargic), MUSCULOSKELETAL STIFFNESS (I started getting stiffness in the right wrist and fingers), DYSGRAPHIA (Effecting his writing), VACCINATION SITE PAIN (Pain at injection site) and ARTHRALGIA (Bilateral wrist and finger pain mostly in his joints) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced LETHARGY (Feeling lethargic) and VACCINATION SITE PAIN (Pain at injection site). On 26-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (I started getting stiffness in the right wrist and fingers), DYSGRAPHIA (Effecting his writing) and ARTHRALGIA (Bilateral wrist and finger pain mostly in his joints). The patient was treated with DICLOFENAC SODIUM (VOLTAREN [DICLOFENAC SODIUM]) at an unspecified dose and frequency. On 22-Feb-2021, LETHARGY (Feeling lethargic) and VACCINATION SITE PAIN (Pain at injection site) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (I started getting stiffness in the right wrist and fingers) outcome was unknown and DYSGRAPHIA (Effecting his writing) and ARTHRALGIA (Bilateral wrist and finger pain mostly in his joints) had not resolved.            Action taken with mRNA-1273 in response to the events was  not applicable.  No concomitant products were reported.  Other treatment information provided included moist heat, a heating pad.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow up received on 15-JUN-2021. Patient contact information has been updated.
large area of erythema w/swelling 6-8 hrs p/& worsened area next few days;
Under eye swelling/puffiness; Diarrhea; Nausea; Headache; Low grade temperature; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02May2021 at 12:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, spondylosis of neck (cervical spondylosis), sciatica, low back pain and anxiety depression. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included hydrocodone (MANUFACTURER UNKNOWN), gabapentin (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN) and paroxetine (MANUFACTURER UNKNOWN); all taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously received naproxen (MANUFACTURER UNKNOWN) and experienced nauseous. On 03May2021 at 04:30, the patient experienced under eye swelling/puffiness, diarrhea, nausea, headache and low-grade temperature. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of nausea which included treatment with nausea medication called in by her primary care doctor.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events under eye swelling/puffiness, diarrhea, nausea, headache and low-grade temperature was unknown at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.