chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Night sweat; Discoloration stool; fever; fatigue; Chills; Discoloration urine; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 61-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EN6202), via an unspecified route of administration, administered in arm left on 13Mar2021 at 12:06 PM (at the age of 61-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were reported as none. Patient did not receive any other vaccine prior vaccinations within 4 weeks. On 16Mar2021, the patient experienced fever, fatigue, chills, discoloration urine. On 17Mar2021, the patient experienced discoloration stool. On 18Mar2021, the patient experienced night sweat. Patient reporting he had some really adverse reactions to the vaccine. Adds he had fever; night sweats; chills; fatigue and his stool was discolored and his urine has been discolored. Clarifies he received the first dose of the Pfizer COVID 19 vaccine on 13Mar2021 at 12:06PM in the left arm. His side effects didn't really start until Tuesday night, then continued Wednesday and Thursday. By Saturday he thought he was better and then last night was horrible again. Adds his urine is dark and his stool looks light colored. He is scheduled for the second dose on 03Apr2021. He is asking what to do; he can't take much more of this; wants to know if this in normal. Product: Pfizer COVID 19 vaccine; treatment first dose 13Mar2021; provides lot number from vaccination card but does not see NDC or expiration date. Outcome of all the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Information has been received from a consumer concerning her 20 year old daughter with asthma and allergic reactions to BIAXIN, AUGMENTIN, atarax, CECLOR, NORBID, erythromycin, penicillin, ADVAIR who on 03-MAY-2009 and 06-JUL-2009 was vaccinated with the first and second doses of GARDASIL. Concomitant therapy included LOESTRIN. On approximately 20-JUL-2009, "2 weeks after the second dose", the patient experienced chest pain, shortness of breath and nodules on her neck. The patient was seen by the physician. X-Ray, EKG and ultrasound were performed with unspecified results. At the time of the report, the patient had not recovered. Follow-up information has been received from a physician who reported that she did not give the patient the GARDASIL. The patient described the symptoms to her after starting therapy with LOESTRIN. Additional information is not expected.
chills; Malaise; Achiness; Headache; Dizziness; Diarrhea; Lymph nodes under arm and groin; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), MALAISE (Malaise), PAIN (Achiness), HEADACHE (Headache) and DIZZINESS (Dizziness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced CHILLS (chills), MALAISE (Malaise), PAIN (Achiness), HEADACHE (Headache), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea) and LYMPHADENOPATHY (Lymph nodes under arm and groin). At the time of the report, CHILLS (chills), MALAISE (Malaise), PAIN (Achiness), HEADACHE (Headache), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea) and LYMPHADENOPATHY (Lymph nodes under arm and groin) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.    This case was linked to MOD21-028609 (E2B Linked Report). This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Feb-2021 and was forwarded to Moderna on 12-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), MALAISE (Malaise), PAIN (Achiness), HEADACHE (Headache) and DIZZINESS (Dizziness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced CHILLS (chills), MALAISE (Malaise), PAIN (Achiness), HEADACHE (Headache), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea) and LYMPHADENOPATHY (Lymph nodes under arm and groin). At the time of the report, CHILLS (chills), MALAISE (Malaise), PAIN (Achiness), HEADACHE (Headache), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea) and LYMPHADENOPATHY (Lymph nodes under arm and groin) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.    This case was linked to MOD21-028609 (E2B Linked Report).; Sender's Comments:  MOD21-028609:
Also five days 20AUG89 after receiving the second dose of vaccine experienced arthralgia and fever lasting for 2 days.
not able to receive dose 2 within the recommended time frame; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (not able to receive dose 2 within the recommended time frame) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (not able to receive dose 2 within the recommended time frame). At the time of the report, PRODUCT DOSE OMISSION ISSUE (not able to receive dose 2 within the recommended time frame) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       .No concomitant medications were reported.  Treatment medications were not provided by the reporter.
Complaint: Nausea approximately 5 minutes after COVID vaccine administration.  Treatment: None. Observed 30 minutes. Symptoms subsided
Swelling of throat, dizziness, confusion, light headed, blurry  vision, rash & hives around neck and cheeks. Itchiness and hot feeling around neck and face.
Right upper arm red, swollen and painful, localized to deltoid. Treated with Bentra 10mg bid. Benadryl prn.
Patient received 2 50mcg doses (2 half doses) of the Moderna shot instead of receiving the flu shot.
pt recvd vax w/1992 fluogen on 1OCT93 & was asymptomatic as of 8OCT93;
Somnolence Diarrhea Cold sweats  Aches and pains all over body Weakness
Swelling and itching in eyes for almost 4 days. Swollen and extremely sore  and itching on arm for up to 3 days.  After swelling in eyes went down I'm still experiencing itching and same in the location of injection.  Day 6 injection site was still red swollen and itchy and the site was hot to the touch for almost 7 days.  Today, 04-13-21 site is still sore to touch and seems to have a lump. Warm to the touch.  Eyelids still irritating.
7 days too early; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (7 days too early) in a 31-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 040C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jul-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (7 days too early). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (7 days too early) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.; Sender's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273,
Information has been received from a consumer concerning his 12 year old grandson who in approximately August 2003, was vaccinated with a second dose of hepatitis B virus vaccine rHBsAg (yeast).  The reporter noted that the first two doses of hepatitis B virus vaccine rHBsAg (yeast) were administered over the last five weeks.  On 08/05/03, a physical exam was done that included blood work that showed thrombocytopenia.  On 08/06/03 and on 08/07/03, the pt was re-tested and each test showed a further decrease in blood platelets.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been requested.
This spontaneous report as received from a physician refers to a 60 year old female patient. Her concurrent conditions included an unspecified blood pressure disorder and increased level of blood cholesterol. The patient had no known drug reactions or allergies. On 11-OCT-2016, the patient was vaccinated subcutaneously with a dose of ZOSTAVAX injection (dose, lot # and expiration date were not reported). Concomitant medications included an unspecified blood pressure and cholesterol lowering medications. On 12-OCT-2016 (reported as on the following day), the patient developed a hot rash on her left arm and pain. The patient did not develop a fever, denied chills and had not developed any pus at the injection site. The patient sought an unspecified type of medical attention but no treatment was given for the adverse events and no lab diagnostics studies were performed. The outcome of the adverse events was reported as not recovered/not resolved. The relatedness between the adverse events and ZOSTAVAX was not provided. The reporter considered the event of pain to be serious, as it caused a significant disability. Additional information has been requested.
Body ache; Fever; A spontaneous report was received from a consumer concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events body ache, fever.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 2 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 4 Mar 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: Unknown)  for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events body ache, fever.  Treatment details included none.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of events, body ache, fever was unknown.
soreness at injection site that over next 8 hours radiated down left arm to elbow, up into shoulder, upper chest and shoulder blade. extremely painful at about 24 hours post injection . Pain lessened somewhat after 48 hours. But moderate pain still 5 days post injection and counting
Patient was administered an expired COVID Moderna bivalent vaccine. Patient was stable and no treatment was necessary. I contact Moderna to determine the viability of the vaccine.  They said "The vaccine administered on June 29, 2023 from lot number 042H22A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration." No other doses were given to this patient.
Extreme nausea and headache with in 20 minutes of receiving the vaccine. Within an hour difficulty focusing and extreme fatigue symptoms have not lessened and its been over 5 hours since shot was received.
Red rash on arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash on arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced RASH ERYTHEMATOUS (Red rash on arm). At the time of the report, RASH ERYTHEMATOUS (Red rash on arm) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.   Treatment was not specified.   This case was linked to MOD-2021-015381 (Patient Link).
Patient was provided a Moderna vaccine, instead of providing a Pfizer vaccine.  NO reactions with mixing both vaccines.
PATIENT RECEIVED VACCINATION 10/22.  CALLED 10/24 WITH COMPLAINS OF REDNESS, SWELLING, AND PAIN EXTENDING FROM SHOULDER TO ELBOW.  PAIN WAS GREAT ENOUGH THAT MOVEMENT WAS LIMITED FOR A TIME, BUT HAS GOTTEN BETTER NOW.  -PATIENT IS NOT GOING TO SEEK IMMEDIATE MEDICAL ATTENTION, BUT IS GOING TO MONITOR FOR ANY WORSENING AND WILL TAKE IBUPROFEN, APPLY ICE PACKS AND BENADRYL.  PATIENT IS GOING TO CALL US IN A FEW DAYS TO FOLLOW UP WITH ANY WORSENING OR GETTING BETTER.  IN OPPOSITE ARM, PATIENT RECEIVED ADACEL AND FLUCELVAX, NO REACTION ON THE ARM RECEIVING THOSE VACCINATIONS.
Initial unsolicited case received from a health care professional on 26 June 2015. A 30 year old female patient, whose medical history was none and concomitant medications was not reported, had received a dose of YF VAX (batch number: UI106AA, expiry date: 26-SEP-2016, site of administration was not reported) via intramuscular route and received a dose of IMOVAX (batch number: K1079-1, expiry date: 14-FEB-2016, site of administration was not reported) via intramuscular route on 2 June 2015. It was also reported that the patient received a dose of TYPHIM VI (batch number: K1200-1, expiry date: 15-APR-2016, site of administration was not reported) via intramuscular route and also received a dose of HAVRIX (batch number: Y4R59, expiry date was unknown, manufacturer was GSK, site of administration was not reported) via intramuscular route on 2 June 2015. On 2 June 2015, (same day after vaccination) it was reported that the patient experienced injection site where patient received YF vaccine and it was bruising and vaccination site erythema. Laboratory investigations were none and corrective treatments were not reported. At the time of this report, the patient outcome from the events was not recovered. Documents held by sender: none.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown demographics. On an unknown date the patients were vaccinated with LIQUID PEDVAXHIB that were stored improperly for an unknown indication. No adverse effect reported. Additional information has been requested.
Fever 101, headache,  joints ache, tired. Injection site red and hot and swollen
A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning a seven-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
Feverish 5 hours after injection and at 3am mom noticed injection site right leg was red, warm and hard, size of nickel. Baby irritable. 12/08 12:30 baby still irritable, spot turning blue/purple.
Starting 07/11/2022, I had a dry cough. I have sinus issues so I wasn't too concerned but it seemed more than normal. The next day, 07/12/2022, I started having body aches and my temp was 99.6 and I was still coughing. I took the at-home test that day and it was negative. I took another test the next day (07/13/2022) which was positive. I started becoming more tired, having more body aches and the cough worsened. Also, I felt nauseated and lost my appetite. I messaged my doctor that day and she prescribed me PAXLOVID which I started that same day. The morning after taking the first dose of PAXLOVID I woke up with diarrhea and took IMODIUM. On 07/14/2022, I could not work (I work at home) because I was becoming lightheaded and more fatigued upon sitting up. I ended up sleeping the whole day. After that, my symptoms started to lessen. Each day I felt slightly better and, as of today, I am finally feeling normal. I took a test today, 07/22/2022, which was negative.
Pt's L leg swollen from upper thigh down to the knee. No redness. Warm to the touch.
First dose 4-5 months ago, no second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First dose 4-5 months ago, no second dose) in a patient of an unknown age and gender 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 PRODUCT DOSE OMISSION ISSUE (First dose 4-5 months ago, no second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (First dose 4-5 months ago, no second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment and concomitant medication information was provided.   Reporter did not allow further contact
Rash at the injection site that spread to trunk. Feeling hot and a sore throat.
Fine the day of the shot (5/6/2021), woke up the next day (5/7/2021) with headache, joint pain, muscle aches, fever, nausea, dizziness and what felt like severe heartburn, frequent urination and stomach pain. As of 5/8/2021 all symptoms have subsided except for let arm still being a little tender, a little sore in left neck and that's it. Everything seems to be fine now
Information has been received from an RN concerning a female in her 30's who on 2/18/02 was vaccinated with a dose of MMRII, which was reconstituted with 0.5ml diluent instead of 0.7ml. The pt developed a bruise at the injection site, "but had no complaints". The pt did not seek medical attention. Additional info has been requested.
covid vaccine breakthrough case  dose 1 Pfizer  1/19/21  EL3249 dose 2 Pfizer  2/9/21  EL9265 dose 3 Pfizer  12/16/21  33130BA
Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Mild, Additional Details: PT FELT DIZZY FEW MINS AFTER INJECTION AND VOMITTING LIGHTLY. 5 TO 10 MINS LATER FELT OK AND WENT HOME WITH HER HUSBAND
patient was given a menquadfi vaccine before the actually due date by accident no symptoms or anything occurred.
Dizziness, increase heart rate, hives, and shortness of breath.  Treatment, vital signs and epinephrine 0.3 mg, EMS called and soldier transported to hospital via stretcher.
She reports fainting 12 hours later "fell to the floor; Currently thinking about getting the Pfizer COVID 19 Vaccine as her 2nd dose. It's been 6 months since the 1st dose is it going to help. fell to the floor; She was also "very fatigued for 2 months after that "I had to take naps."; She also reports her "arm still hurts where the vaccine was given; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (She reports fainting 12 hours later "fell to the floor) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In July 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (She reports fainting 12 hours later "fell to the floor) (seriousness criterion medically significant). an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Currently thinking about getting the Pfizer COVID 19 Vaccine as her 2nd dose. It's been 6 months since the 1st dose is it going to help.), FALL (fell to the floor), FATIGUE (She was also "very fatigued for 2 months after that "I had to take naps.") and VACCINATION SITE PAIN (She also reports her "arm still hurts where the vaccine was given). At the time of the report, SYNCOPE (She reports fainting 12 hours later "fell to the floor), PRODUCT ADMINISTRATION INTERRUPTED (Currently thinking about getting the Pfizer COVID 19 Vaccine as her 2nd dose. It's been 6 months since the 1st dose is it going to help.), FALL (fell to the floor), FATIGUE (She was also "very fatigued for 2 months after that "I had to take naps.") and VACCINATION SITE PAIN (She also reports her "arm still hurts where the vaccine was given) outcome was unknown.            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.  Company comment: This spontaneous case concerns a female patient of unknown age, with no reported medical history, who experienced the unexpected serious (medically significant) event of Syncope, about 12 hours after receiving a dose with mRNA-1273 vaccine in the COVID-19 vaccination series. No information on risk factors, co morbidities, clinical course, management of the event and outcome was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of unknown age, with no reported medical history, who experienced the unexpected serious (medically significant) event of Syncope, about 12 hours after receiving a dose with mRNA-1273 vaccine in the COVID-19 vaccination series. No information on risk factors, co morbidities, clinical course, management of the event and outcome was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.