chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 4/24/2023. I was on a trip when I became terribly ill. I had a fever and extreme fatigue, and all I wanted to do was sleep. When we got home, I went straight to bed and did not get up until sometime on 4/27/2023. I took a home antigen test on 4/26/2023 and got a positive result. On 4/26/2023, I spoke to my doctor. My doctor didn't prescribe anything right away, as he was concerned about the blood value of one of my kidneys. However, on 4/27/2023, he did prescribe me Paxlovid. My symptoms began improving by 4/28/2023. I finished the medicine, but I still had fatigue for another week afterwards. I took another home antigen test on 5/1/2023, and the result was negative. At the time of this writing, I am digging a ditch in my yard, so I think I'm doing okay.
Headache, Myalgia, Fever, fatigue Narrative:  Employee reported mild fever 02/05/21 until 02/06/21, severe headaches 02/06/21 and 02/07/2021, moderated muscle pain 02/05/2021 until 02/07/21, moderate to severe fatigue 02/06/21 and 02/07/21. Resulted in unable to work 02/06/21. Did not seek medical attention for the symptoms.
Patient with 5 days of irritability/fussy. No fever, rash, redness (not sure where to give shot)
gout; nausea; This is a spontaneous report from a contactable nurse. An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced gout and nausea on an unspecified date. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Initial unsolicited report received from a non- healthcare professional on 27 January 2016. This case involves a 64-year-old female patient who was vaccinated with a first dose of ADACEL (batch number: U5263AA, expiry date: 21 January 2016, dose and route of administration was not reported) in the left deltoid on 22 January 2016. Illness at time of vaccination was None and Pre-existing physician diagnosed allergies, birth defects, medical conditions concomitant medications includes arthritis, hypertension and had no known allergies. On 23 January 2016, one day following the vaccination the patient had pain and redness at the injection site. Patient came into the office to be evaluated on 27 January 2016 and was diagnosed with an infection and a lump, which was red and hot. Patient required doctor visit. Lab data was reported none. Corrective treatment was reported unknown. The outcome of the event was not recovered. List of documents held by sender: none/yes.
Client became dizzy/lightheaded about 5 minutes after vaccine administration. Client has a history of vasovagal reactions with blood draws. Vaccine was administered sitting down on the ground to prevent any falls out of chair. Once client became dizzy he was laid down flat on back with legs raised. BP, pulse, and O2 sats taken shortly afterward and all were normal. Consciousness was never lost. Client was able to leave site safely with no issues.
By Thursday, I got allergic reaction everywhere, I had not done anything different. No new shampoos or medication. I noticed my feet a beet red and swollen and I had hives up to my neck. I got a dexamethasone injection, dose pack of steroid and over the counter antihistamines Benadryl, I took it every day for 3 weeks. I couldn't stop itching.
Fever; Chills; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced fever and chills. On an unknown date, the outcome of the fever and chills were recovered/resolved.   It was unknown if the reporter considered the fever and chills to be related to Shingrix.  Additional details were provided as follows: The patient demographic details were not provided. The reporter stated that, the patient had fever and chills, that lasted for 1 week. The reporter did not consent to follow up. This case has been linked with case US2019166363, reported by the same reporter.
He had a "cold" starting on Thursday.  Treated with Alka-Seltzer.  Noted he was having increasing crackles with breathing and started to have some increasing confusion off of his baseline dementia.  Wife stated his senses did not make sense are were irrelevant.  Patient has had a history of TIAs in the past but she said that was not exactly the same.  Otherwise has not been ill recently. In the emergency department was found to be hypoxic requiring 2 L of oxygen.  a chest x-ray was obtained and read as an infiltrate.  Was started on ceftriaxone and azithromycin.  With fluids and antibiotics the patient's mental status improved.  Following this however his COVID-19 testing returned positive.  Of note he does have lym phopenia on his CBC.  Admitted for further cares.  Patient admitted to GHS for observation on 05/21/2022 due to Acute respiratory failure with hypoxia, secondary to COVID-19 pneumonia and possibly secondary bacterial pneumonia.
Received a 0.25mL dose of the Moderna Covid19 Bivalent vaccine instead of a 0.5mL; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received a 0.25mL dose of the Moderna Covid19 Bivalent vaccine instead of a 0.5mL) and NO ADVERSE EVENT (No adverse event) in a 75-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Received a 0.25mL dose of the Moderna Covid19 Bivalent vaccine instead of a 0.5mL) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received a 0.25mL dose of the Moderna Covid19 Bivalent vaccine instead of a 0.5mL) 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 assessment was provided for ACCIDENTAL UNDERDOSE (Received a 0.25mL dose of the Moderna Covid19 Bivalent vaccine instead of a 0.5mL).    No concomitant drug was reported. Reporter stated that they mistakenly provided patients with 0,25 mL doses of the Moderna Covid 19 Bivalent. No treatment drug was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-646299, US-MODERNATX, INC.-MOD-2022-646302 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-646299:Patient 1 US-MODERNATX, INC.-MOD-2022-646302:Patient 3
Pt. complains of soreness in arm daily ever since the shot was administered, about 2 weeks now. Patient had taken Lortab with no relief. And she is unable to take ASA or NSAIDs per patient. Told to follow up with MD
didn't feel right; soreness on his arm; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (didn't feel right), PAIN IN EXTREMITY (soreness on his arm) and FATIGUE (tiredness) in a male patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (didn't feel right), PAIN IN EXTREMITY (soreness on his arm) and FATIGUE (tiredness). At the time of the report, MALAISE (didn't feel right), PAIN IN EXTREMITY (soreness on his arm) and FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient mentioned that her husband for 4-5 days after vaccination didn't feel right and experienced soreness on his arm and tiredness No concomitant treatment was provided. No treatment medication was provided.
No adverse event; A dose of M-M-R II was reconstituted with a sterile diluent that is used to reconstitute Act HIB; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Pertinent medical history, drug reactions/allergies and concomitant therapies were not reported.    On 03-MAR-2022, a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (rHA) (lot # U011149,  expiration date: 08-APR-2023) was reconstituted with a sterile diluent used to reconstitute ActHIB and administered to the patient (0.5 milliliter, unknown route) for prophylaxis. No additional adverse events were reported.
This patient has severe joint pain (disabling), swollen Joints, severe headache, muscle pain, rib and chest soreness, fever (100), neck stiff and painful to move, poor balance, ache all over, flu like symptoms, generalized ill feeling, extreme fatigue. There were three episodes lasting 1 week to 10 days (06/29/00, 08/01/00, 11/23/00). Currently taking Tetracycline.
Vaccine improperly stored in the freezer. Pfizer determined the vaccine was not viable. Informed patient's parent.
Inadvertent administration of COVID-19 lot number past the 30-day Use by Date & past expiration date of 3/27/22.
Patient temporarily passed out and looked pale. He was supplied with water and felt better after 15 minutes of sitting.
CoughWheeze Fatigue, shortness of breath Narrative:  Symptoms MAY be Covid; will test for Covid
Rash on both arms. Started in elbow bend and progressed up and down both arms. Also rash on chest and thigh area. Extremely itchy, some are pustular.
Around 5pm I notice that my arm was getting very sore and there was a small red spot a injection site.  The follow morning-2/12/16 there was swelling and a larger red area above the site of the injection.  I was also feeling achy, etc.  Started running a low grade fever.  Took 800mg Ibuprofen.  By 5pm the redness had moved even further up my body.  It advanced across my collar bone and up my neck to my hairline.  The redness in that area was sensitive to touch.  By this time my fever was around 102 and I really felt lousy.  I took a 25mg Benadryl and 800mg of ibuprofen and went to bed.  Had fever all night.  By 2/13/16 I felt better.  The redness up my neck and collar bone was diminishing.  The top of my shoulder and in injection site were still red.  Still had fever around 100.  On 2/15/16 the redness at the top of my shoulder had diminished.  There was still a knot a little smaller than a golf ball at the injection site with the redness now going down under the injection site.  As of 2/16/16 there is still the knot that is tender to the touch and slight redness.
Shot was extremely painful when injected. Created large zone of redness with heat and could not move my left shoulder. That zone has now spread to my collarbone, chest and under arm areas that are extremely sore and painful.  Initial symptoms were high fever for 48 hours straight with no breaks, body aches and pains. Those side effects were disclosed. What I am reporting (not disclosed) is the injection pain site spreading throughout the rest of my body.  The site of injection seemed to be very high on my shoulder so I am not sure if that is the cause.
Went to get up immediately after receiving immunizations, slumped forward and had a seizure for approximately 30 seconds. No prior hx of seizures: healthy that day.
6cm in diameter area of erythema and edema. Advised guardian to give benedryl.
Expired Pediarix administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 2-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 9X3T5, expiry date 05-MAR-2023) for prophylaxis.   On 07-MAR-2023, the patient received the 1st dose of Pediarix. On 07-MAR-2023, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: Expired Pediarix 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: 7-Mar-2023 Information for the adverse event was collected and the medical information was read. They did not wish to receive the information via only means. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The patient received an expired dose of Pediarix, which led to expired vaccine used.
Nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 53-year-old 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 23Aug2021 at 19:00 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. The patient's relevant medical history was not reported and had no known allergies. 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 duloxetine hydrochloride (CYMBALTA), cetirizine hydrochloride (ZYRTEC) and esomeprazole sodium (NEXIUM); all for an unknown indication from an unknown date and unknown if ongoing. On 24Aug2021 at 02:00, the patient experienced nausea. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event nausea was resolved on 24Aug2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 3/07/2021 and 3/28/2021. Covid + 1/4/22 had exhibited symptoms from 12/28/21, Presented to ED 1/8/22 c/o SOB and dyspnea. Exposed to COVID-19 by brother during Christmas. Hypoxic in ED to 81%. CXR with pneumonia. Treated with remdesivir, corticosteroids, Vancomycin, and Cresemba. Admitted to MICU with epistaxis and COVID pneumonia lead to worsening hypoxemia with intubation occuring on 1/25/22. Renal function worsened requiring CRRT. On 1/27 CXR showed large R pneumothorax and chest tube was placed. DNR Status.  Patient expired on 1/28/2022.
Information has been received from a 61 year old female RN who in the early afternoon of 10/18/02 (previously reported as 10/22/02) was vaccinated IM with a first dose of PNEUMOVAX 23 (643251/0445M). On 11/26/02 it was reported by a health professional that the pt had subsequently developed a local reaction which was diagnosed as erythema nodosum to the medial aspect of her humerus. No intervention was reported and the reaction had dissipated with no visible reaction. Unspecified medical attention was sought. On 3/2/03, the pt reported that on 10/18/02 her arm had swollen up 2x the normal size and was very hard and painful. The pain lasted for 3 days. The pt reported that she had recovered on 10/23/02. It was also reported that one other nurse was vaccinated with PNEUMOVAX 23 and also developed an adverse reaction (WAES0211USA02568). No further info is expected.
That night I had fatigue and fever. My temp went up to 102.7. I alternated Tylenol and Motrin every two hours during the night and my fever finally broke the next morning. I had about 12 hours total of fever. I also had a headache and brain fog.  For about two days after, I still had the brain fog along with chilling and sweating and a headache. Four days after my dose, on 24th, I noticed that my left side of my neck was swollen as well as my axilla - and it was swollen all the way up to my jaw line. It was diffuse swelling but in the middle of that I had a hard knot on the middle clavicle. I called my doctor (January). I saw her seven or eight days after vaccine. At the time, there wasn't really any reports of swollen lymph nodes yet. Dr. felt like it was lymph nodes inflamed from vaccine. She decided to wait four weeks and re-check. (March 2 was follow-up.) The diffuse swelling is gone and the tenderness is gone now - but the hard knot is still there on middle of clavicle. They did an ultrasound - 9 mm sub clavicular knot - lymph node. An enlarged lymph node.   I went back four weeks after that visit for the my annual exam  (April 12) and they lymph node is still there - enlarged sitting on top of my clavicle. It is hard. It's non tender at this time. Dr. told me it could be there for a long time.
Injection site sore and stiff, felt nausea, inflamed/swelling at injection site.
chest pain/tightness, tough to take deep breath, racing heart, out of breath more easily, constant fatigue
fever 101; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever 101) and PAIN (body aches) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03ZHZUA) for COVID-19 vaccination.     The patient's past medical history included No adverse event (product used for unknown indication).    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PYREXIA (fever 101) and PAIN (body aches). At the time of the report, PYREXIA (fever 101) and PAIN (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant medication and treatment provided
After 3.5 hours, the injection site got sore.  By the next day, it was painful and swollen.  By the following day, it was 80 % better.  After that, it seemed fine.  About ten days later, I noticed that the injection site had become dense and a little sore.  Within a few more days, I started having pectoralis muscle spasms, and I can no longer raise my right hand to my mouth, to my opposite shoulder or overhead.  Trying to make those motions causes me to cry out in pain.  I can't sleep on that shoulder, and need help getting dressed.  I get acute pain from moving it in other ways, too.
This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (Severe headache) 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 HEADACHE (Severe headache). At the time of the report, HEADACHE (Severe headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment medications were reported. Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested
The day after immunization given, tender erythematous wheals to injection sites. BENADRYL administered at clinic. Presented to ER with fever 102, given MOTRIN and discharged. Presented to another ER and admitted for fevers and Dx = cellulitis.
got covid and she was vaccinated; got covid and she was vaccinated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (173415). The reporter is the parent.  A 19-year-old female patient received 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 "got covid and she was vaccinated".  Event Description: I am not thrilled about the vaccine even though I've had both doses of Pfizer vaccine. Then my 19-year-old daughter got covid and she was vaccinated, so I guess I considered that one of the rare breakthrough cases and then I got covid. Also had very little symptoms, but it seems like now it wasn't just rare breakthrough cases, it was everybody's getting covid whether you're vaccinated or not."  ADDITIONAL CASE INFORMATION: Other medications (Including over-the-counter medications, nutritional and herbal supplements, etc. was Unknown. Family History was Unknown. Social History (Including occupational history, use of alcohol, tobacco, or recreational drugs was Unknown. Other relevant information, use this space to include any additional information that may be relevant, including any additional Events or Suspect Products Unwas known  No follow-up attempts are possible, batch or lot number is not available. No further information is expected
The vial was initially stored in the refrigerator on 31-Jan-2022 and administered to the patient on 16-Mar-2022; Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-Jan-2022 and administered to the patient on 16-Mar-2022) in an 80-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-Jan-2022 and administered to the patient on 16-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-Jan-2022 and administered to the patient on 16-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that date the vial was initially stored in the refrigerator was on 31-Jan-2022. The vial did not undergo any temperature excursions.  No treatment medications were reported.   This case was linked to MOD-2022-525860 (Patient Link).
seen 6FEB92 in ER, rt eye swollen closed, also rash on neck & forehead;
Seen on 10/12/07 in our office for nurse only visit for Dtap & Ipol.  Mom called 10/13/07 with arm red, tight and swollen.  Refferd to ED (after hours) Diagnosed with cellulitis.
Vaccine was stored in freezer for 16 days instead of 14 days. It was supposed to be moved to the fridge on 5/27, but it was not and was still given to the patient on 5/29.