chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Little bit distressed; This is a spontaneous report from a Pfizer-sponsored program COVAX US SUPPORT. A contactable female consumer (patient) reported that: 77-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL9265), via an unspecified route of administration on 01Feb2021 (at the age of 77-year-old) as single dose for covid-19 immunisation. Medical history included lymphoma from an unknown date and unknown if ongoing. Consumer stated, I am in remission from lymphoma. Stage 2 lymphoma remission and I am finished with chemo. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. Patient reported that she received her first Pfizer vaccine dose on 01Feb2021 and was scheduled to receive her second dose 3 weeks later on 22Feb2021. Patient reported that today she received a "surprise phone call" and was told that she was scheduled to receive her second dose today (16 days after her first) because there was no appointment on 22Feb. Patient reported that she is very concerned and scared. She reported that she tried to speak with a supervisor, but they wouldn't let her, she was provided a number for the company coordinating the vaccine clinic, but the number was not a working number. And asks, what is the efficacy if I get the vaccine today. Patient reported that she is calling because she wanted Pfizer's recommendation, and "Pfizer would be liable if something happens if I go and they recommended it. Patient was little bit distressed on an unspecified date. Patient was not performed any lab test in past 2 weeks. The patient underwent lab tests and procedures which included blood test: normal on an unspecified date Lab work: I get blood work on a regular basis and everything was normal. No therapeutic measures were taken as a result of the event. The outcome of the event was reported as unknown.   No follow up attempts are possible. No further information is expected.
My arm has been hurting since my second dose of Moderna.  From injection site up to the tip of my shoulder blade.  It burns & stings, especially with certain range of motions.  It is very uncomfortable, it has been 4 months!!!
It started with joint pain and ringing in my ears. I had a low-grade fever and scratchy throat for 3 days. I also developed some congestion and a cough. I took an at-home COVID-19 rapid antigen on 02/12/2023 which came back negative; so I woke and retested on 02/13/2023, and that one came back positive for COVID-19. I contacted my doctor, and I was prescribed PAXLOVID and took it from 02/15/2023-02/19/2023. Since then, I'm doing better and don't have any residual symptoms or anything currently.
I am not sure if there was an adverse reaction. I am reporting because the immunizations were so close to date of death.
Bilateral knee swelling and pain (severely limiting mobility to the point of being unable to walk due to pain/swelling), rash (c/f erythema nodosum) for 2-3 weeks (presented on 6/18/21). Concerning for flare of JIA vs other autoimmune etiology (infectious studies mostly negative, though some studies pending). Diagnostics ongoing.
URI developed 3 days s/p booster, Shingles development Left Lower Forearm and Hand 7 days post booster.
DIZZINESS; PAIN IN ARM; TIREDNESS; MUSCLE ACHES; NAUSEA; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 in right arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced dizziness. On MAR-2021, the subject experienced pain in arm. On MAR-2021, the subject experienced tiredness. On MAR-2021, the subject experienced muscle aches. On MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tiredness, pain in arm, muscle aches, nausea and dizziness was not reported. This report was non-serious.
Most of my symptoms was gastrointestinal. I had motion sickness/car sickness. I had diarrhea, vomiting, and stomach cramping. I had a headache and sensitive to light. My body was sore all over. These symptoms lasted until now. I went to see more than one doctor about this. They did blood work, pregnancy test, and PCP exam, all came back normal.
Moderna on 3/19 and 4/16. Positive on 9/9 admitted 9/9 to current
gotten sick was the years when got a flu shot; Initial information received on 26-Dec-2022 regarding an unsolicited valid  non-serious Social Media case received from consumer/non-hcp.  This case involves an unknown age and unknown gender patient who was diagnosed with gotten sick was the years when got a flu shot while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer (dose, strength, frequency, formulation, route, batch number, expiry date: unknown) in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient diagnosed with a non-serious gotten sick was the years when got a flu shot (illness) (unknown latency) following the administration of influenza vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown.
Facial and eyelid edema and redness at 11:00pm. Treated 11/20/2009 with Medrol Pak and Atarax 25 mg at HS.
periods of constant crying 2-4 hrs for 2 days p/vax; tx APAP & Pediaprophen;
pt recvd vax;rt arm hurting at ppv site;felt exhausted few days later; gen weakness, tired & sleepy, resp problems; coughing, tightness in chest, SOB;dx pneumonia;
Vaccine was expired on 26-FEB-2023 and the vial was initially stored in the refrigerator on 14-MAR-2023; No adverse event; She had expired vaccine that was administered on March 15,2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine was expired on 26-FEB-2023 and the vial was initially stored in the refrigerator on 14-MAR-2023) and NO ADVERSE EVENT (No adverse event) in a 42-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 26-FEB-2023 and the vial was initially stored in the refrigerator on 14-MAR-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine was expired on 26-FEB-2023 and the vial was initially stored in the refrigerator on 14-MAR-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023) and PRODUCT STORAGE ERROR (Vaccine was expired on 26-FEB-2023 and the vial was initially stored in the refrigerator on 14-MAR-2023).    No concomitant medications were reported.  This lot number 060B22A of vaccine was administered to patients with a count of in between 75 and 125.  It was also reported that there was potentially a second lot number of vials that had expired on 28-Feb-2023 and was administered to patients on 03-Mar-2023, but the healthcare provider did not have any details of that event at that time.  The vial size was reported as 10 dose vial.  The vial had not undergone any temperature excursions.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
Instant pain in arm which continues.  Limited motion in arm - serious pain when stretching arm upward, outward, behind back or any other strain.  Also nearly constant dull pain which goes into hand.  Burning sensation at sight of injection.  On a scale of 1-10, most pain is 8 but when moving as noted above, becomes 11.
Within hours - became ill with temp of 101, body aches - local reaction, diarrhea - still having problems with muscle pain and weakness - taking ALEVE since 9/30.
Short 5-6 second generalized seizure <24 hours after received below immunizations.
Patient received influenza immunization on 9/15/20, patient  reports to vomiting few hours later after having received the flu vaccine. Patient  reported to medical office on 9/17/20 and described the reactions as, possible allergic reaction with nerve sensitivities, feels like "burning" on back, arms, and legs. As per medical provider, possible neuritis from the flu shot (unsure). On 9/18/20, patient reported to hospital, after being referred by provider at medical office, with joint pains and malaise since receiving the flu vaccine. Patient was advised upon admission evaluation for observation in the hospital for symptomatic relief and for follow-up on blood work but patient declined and signed out against medical advice.
A day after vaccination, patient noticed lymph node had become swollen, and tender. Day 2 and 3 after vaccination was the worse swelling  wise .  On Day 4 patient noticed more pain on inner bicep and pain that has been travelling down to elbow and is painful to touch.  If lift arm up can fell pain in arm pit area/ node area.  Still swollen but not as much as day 2 and 3.
My injection site was red swollen and warm to the touch. My doctor advised that I take some Benadryl and ice the area. It was the size of the palm of your hand. It took two days of Benadryl and ice before the area went away. I had the second shot in the same arm and did not have the same symptoms.
Multiple blood clots in the left leg had to be submitted to the Emergency Room at the hospital for immediate treatment; This is a spontaneous report from a non-contactable consumer. A 40-years-old male patient received 1 dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE) lot number: ER2613 via an unspecified route of administration, in arm left on 12Apr2021 at the age of 40 years as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient experienced multiple blood clots in the left leg and he had to be submitted to the emergency room at the hospital for immediate treatment on 16Apr2021 12:00 with outcome of recovering. The patient was hospitalized for 2 days and was treated with unspecified treatment. Covid test post vaccination: Nasal Swab on 20Apr2021 result Negative  No follow-up attempts are possible. No further information is expected.
Around 3:00 am experienced excruciating headache and chills and muscle pain throughout my body as though I had a severe case of the flu. Also very very tired and weak.   Took temperature and it was 101.8.  Approximately 6:00 am took ibuprofen and clear liquids.  Unable to eat due to fever, chills and loss of appetite.  Temperature subsided to 99.8 but muscle pain persisted.  Took ibupropen that night.  Next morning temperature was 99 , muscle pain and headache had subsided.
Admin shot on 10/16 into deltoid via 1 inch needle. 10 mins after admin, pt has slight red rash size of quarter about 3in from admin site. Upon visit of pharmacy 10/17/14, rash was 3 in in diameter, warm, tender to touch.
Fever for more than 4 days after second dose.; Change in menstrual cycle after both first and second dose/period occurred 5 days after the 2nd dose.; Acute headache and eye pain persisting 5 days after the 2nd dose.; Acute headache and eye pain persisting 5 days after the 2nd dose.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Aug2021 15:15 (Lot number: FC3182) at the age of 42 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single, lot number: FC3180, administration time 13:00, vaccine location: Left arm), administration date: 08Aug2021, when the patient was 42 years old, for COVID-19 immunisation, reaction(s): "Change in menstrual cycle after both first and second dose". The following information was reported: PYREXIA (non-serious) with onset 30Aug2021 01:00, outcome "not recovered", described as "Fever for more than 4 days after second dose."; MENSTRUAL DISORDER (non-serious) with onset 30Aug2021 01:00, outcome "not recovered", described as "Change in menstrual cycle after both first and second dose/period occurred 5 days after the 2nd dose."; HEADACHE (non-serious), EYE PAIN (non-serious) all with onset 30Aug2021 01:00, outcome "not recovered" and all described as "Acute headache and eye pain persisting 5 days after the 2nd dose.". Therapeutic measures were not taken as a result of pyrexia, menstrual disorder, headache, eye pain.  Additional information: Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was Unknown Prior to vaccination, was the patient diagnosed with COVID-19 and not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.
Couple weeks after injection, started to get rash on my back - attributed it to a tag on shirt - but then got itchy pimples and rash on arms - upper arms - upper legs and all over my back. Called dr. told me to take BENADRYL for the itching.
Headache, chills, cough, congestion, pain in shoulder/arm where shot was administered, muscle weakness and fever. She was treated at hospital on 12/17/2011 for walking pneumonia.
Vaccination was at 9:17am. Injection site arm pain and stiffness was noticeable by 12pm, and gradually worsened to incredibly painful by 8 pm, especially in muscles between left  shoulder blade and spine. Chills began around 9:30pm at which point I took one 500mg Tylenol and went to sleep. I woke up with severe chills around 1:45 am and pushed off taking more 500mg Tylenol until 2:45 am. Afterwards I began to feel heartburn and slight nausea but was able to fall back to sleep. I woke up around 3:45 am to vomit. Afterwards, the nausea subsided and I was able to go back to sleep until 6:45am. I woke up with a headache which got worse and I took one Aleve at 9 am. By late afternoon I was feeling much better.
First Dose: 02Mar2021; Second dose: 20May2021; First Dose: 02Mar2021; Second dose: 20May2021; Inflammatory bowel disease; Urgent diarrhea; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4426825-00 (Company).  A 45-year-old female patient received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 20May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 43 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for crohn's disease. The patient's relevant medical history was not reported. Concomitant medication(s) included: AMITRIPTYLINE. The following information was reported: OFF LABEL USE (medically significant), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (medically significant), outcome "unknown" and all described as "First Dose: 02Mar2021; Second dose: 20May2021"; INFLAMMATORY BOWEL DISEASE (medically significant), outcome "not recovered"; DIARRHOEA (non-serious), outcome "not recovered", described as "Urgent diarrhea". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "inflammatory bowel disease" and "urgent diarrhea" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the event (s) of URGENT diarrhea and inflammation in digestive tract and bowels was not provided.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information and known profile of the Comirnaty vaccine  ,the reported events of  diarrhoea  were assessed as related to the  Comirnaty vaccine . Based on the information provided by the reporter, it appears unlikely that suspect drug contributed to the reported events inflamamatory bowel disease.
Myalgia over entire body, but more severe in arm that was injected.  Developed itching on upper back and scalp.  Areas were visually inspected by me on 10/8/19.  No rash observed, other than one small colorless bump on back of skull.  Areas on back appeared pink and irritated, but pattern suggested that it was due to her scratching the area, rather than rash.  Patient reported taking Tylenol for the pain. Patient was advised to do a 24 hour trial of oral Benadryl & topical hydrocortisone, and to seek medical attention if no significant relief.
DIFFUSE VESICULAR RASH, INITIALLY ASYMPTOMATIC ONLY ON TRUNK BUT EVENTUALLY SPREAD TO ENTIRE BODY.
This spontaneous report as received from a nurse concerning unknown number of male patients of unknown age was vaccinated IM with 0.5 ml GARDASIL on month 0, 2, 6. The nurse reported that syncope occurs more in girls than boys. The patients sought unspecified medical attention. This is one of several reports received from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
1st dose 50 days ago; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (1st dose 50 days ago) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (1st dose 50 days ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (1st dose 50 days ago) had resolved.        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 medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: On 09-Jun-2021, follow up document was attached which contains no new information.
This spontaneous report received from a patient via other company concerned a 6 decade old adult female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe adult crohn's disease. The patient received Covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, intramuscular, batch number and expiry date were not reported) dose was not reported, 1 total administered on 25-MAR-2021 for Covid-19 prophylaxis. The batch number was not reported. Age at time of vaccination 6 decade old. The Company is unable to perform follow-up to request batch/lot numbers. The patient received non-company suspect drugs Humira (adalimumab), (solution for injection in pre-filled pen, subcutaneous, batch number and expiry date were not reported) dose, frequency, and therapy dates were not reported for moderate to severe adult crohn's disease. No concomitant medications were reported. On an unspecified date, the patient experienced headache (Dose number in series 1). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. On 10-MAR-2022, the patient also received booster dose of Moderna Covid-19 vaccine (elasomeran), (Dose number in series 2), (Intramuscular, form of admin, batch number and expiry date were not reported) dose was not reported, administered for Covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination (Dose number in series 2). The outcome of headache was not reported. This report was non-serious.
Case number PHEH2015US020307, is an initial spontaneous report from a nurse on 08 Oct 2015. This report refers to a 54-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUVIRIN (batch number: 1515701) 0.5 ml intramuscular on 07 Oct 2015. It was reported that the patient received FLUVIRIN MDV that was out of temperature range of 47 F before administration. No adverse event was reported.
Patient came in on 11-21-19 for Low grade fever and frequent urinating. Flu shot was administered on Left arm Yesterday. Mother states that patient got high fever @ home. Patient came in the next day 11-22-19 with 104.1 fever.
This spontaneous prospective pregnancy report as received from a physician via a company representative refers to a female patient of unknown age. Information on patient's concurrent condition and pertinent medical history was not provided. On an unknown date, the patient was vaccinated with GARDASIL (dose, route and lot number not provided). The physician reported that the unspecified patient became pregnant at unspecified time after receiving the unspecified dose of GARDASIL (maternal exposure before pregnancy). The Last Menstrual Period (LMP) date and Estimated Date of Delivery (EDD) were not reported). The outcome of pregnancy was not reported. No further details were noted. Additional information has been requested.
Hives, redness on face/neck and site of injection, shortness of breath, swelling on face and lips, dizziness
4-5 cm area of erythema, warmth & induration without discrete fluctuance (L) upper arm.
Patient was given Zostavax in error instead of the second dose of Varivax. Patient had no adverse effects to this error and CDC stated that there were no contraindications and that the Zostavax does count as a valid dose of Varicella.
Patient called 5/20 with complaints of hot, swelling & itchiness to the area; has tried BENEDRYL & Hydrocortisone creams & topical ice application. Got vaccine 5/17 - first day of complaint 5/19.