chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bacterial eye infection; shingles; pain in injection arm; fever; chills; redness at injection site; A spontaneous report  was received from a consumer concerning a unknown age, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever, chills, pain in injection arm, redness at injection site, shingles and bacterial eye infection.  The patient's medical history was not provided by the reporter. Concomitant medications included duloxetine hydrochloride and heart medications.  On 3 Feb 2021, approximately a few hours after prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   On 3 Feb 2021, prior to receiving mRNA-1273, the patient felt fever, chills, pain in injection arm, redness at injection site. on 23 Feb 2021, shingles, bacterial eye infection. Treatment for the events included eye medications and antibiotics.  The event of bacterial eye infection was considered to be serious with criteria of important medical event.  Action taken with mRNA-1273 in response to the events was not reported.   The events, fever, chills, pain in injection arm, redness at injection site were considered resolved on 10 Feb 2021.  The outcome of events shingles and bacterial eye infection were unknown.; Reporter's Comments: This case concerns a 51-year-old female who had serious unexpected events of eye infection bacterial along with nonserious unexpected herpes zoster, pain in extremity and expected pyrexia, chills, vaccination site erythema.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment with antibiotics. Based on 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.
Left armpit swollen, presumably lymph nodes (lymphadenopathy), as noted on the FDA's website.
she fell asleep; sick; Didn't receive the 2nd dose 1 month after the 1st (>35 days); Head Hurt; arms hurt/Legs Hurt; but felt as if she couldn't get up; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arms hurt/Legs Hurt), MOBILITY DECREASED (but felt as if she couldn't get up), SOMNOLENCE (she fell asleep), ILLNESS (sick) and HEADACHE (Head Hurt) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011DZ1A and 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, the patient experienced PAIN IN EXTREMITY (arms hurt/Legs Hurt), MOBILITY DECREASED (but felt as if she couldn't get up) and HEADACHE (Head Hurt). On an unknown date, the patient experienced SOMNOLENCE (she fell asleep), ILLNESS (sick) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Didn't receive the 2nd dose 1 month after the 1st (>35 days)). On 15-Jun-2021, PAIN IN EXTREMITY (arms hurt/Legs Hurt), MOBILITY DECREASED (but felt as if she couldn't get up) and HEADACHE (Head Hurt) had resolved. At the time of the report, SOMNOLENCE (she fell asleep), ILLNESS (sick) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Didn't receive the 2nd dose 1 month after the 1st (>35 days)) outcome was unknown.            The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable. No concomitatnt medication was mentioned. No treatment medication was mentioned.   This case was linked to MOD-2021-228448 (Patient Link).
I have had a period  since my first shot on 2/12/22. I had a full period followed by spotting for a few days then  another full period and then again.  I received my second shot today 3/12/22 and am still on my period.   My right eye has also been twitching daily since 2/12/22.
Oth complications following immunization, NEC, init on 2017-07-15.
(1) Severe heart  palpitations for 24 hours following vaccination. (2) Severe body rash: numerous small red, raised, itchy bumps all over.
Redness (about 5 x 6 cm) beginning on day 2 and lasting about 3 days, and itching beginning on day 2 and lasting up to 10 days after vaccination .
14APR93 recvd phone call from mom; pt has a red rash on abdo & thighs, some pustules also swelt areas around eyes; fever over weekend but not now; advised to call pvt MD; MD prescribed DPh; 19APR93 no rash sx;
Patient received a expired product on 9/2 and it was administered with no AE; Initial information was received on 05-Nov-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional via the Regulatory Authority (Regulatory Authority Number-00845512).  This case involves a patient of (unknown demographics) who was vaccinated with an expired dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (Expired product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other concomitant vaccines were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was reported "yesterday stating that they received a shipment of expired Fluzone High Dose on 9/2 and he reported that a dose was administered. I do not have further details.Is dose not used or not available. Whether product is available for return o If the customer says no then advise them that if this happens again to retain the product for return to better assist in the investigation. o If the customer states picture(s) are available, ask to send us the picture(s). No broken vials or syringes with needles can be returned. Information to be gathered on the type of needle that was used by the end-user (example gauge size) Is the reporter the one who found it? Was he/she the one who opened & checked the shipment? Do they insist it actually arrived in the shipment with the new product? If found by someone in the fridge verses  shipment, state that also. Do they have the original packaging that is carton and is the info on the carton the same as the label?"  It was a case of an actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event reported.  Event outcome was unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
Extreme heavy menstrual bleeding for 5  months. 2 breakthrough bleeding events where blood poured out of me and soaked up many tampons before stopping mid cycle. Very scary amount of blood. The periods were so heavy I was very worried and went to my OB for testing.
Rash on eyelids, mouth, nose, and gums.  Rash blistered, scabbed, and is currently healing.....slowly.
Round two: nausea; fatigue; fever; chills; This is a spontaneous report from a non-contactable consumer (patient). A 69-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6201), via an unspecified route of administration, administered in right arm on 15Mar2021 at 03:00 PM (at the age of 69-years-old) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included alprazolam (MANUFACTURER UNKNOWN). The patient previously took barium and had allergy (allergies: barium). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6201), via an unspecified route of administration, administered on 18Feb2021 at 02:00 PM (at the age of 69-years-old) as dose 1, single for COVID-19 immunisation and experienced felt stoned, bad headache for 3 days, chills, fever and nausea. The patient had not taken other vaccine in four weeks. The patient not had covid prior vaccination. The events fever, chills and nausea were still there since first dose. On an unspecified date, after second dose of vaccine, the patient experienced round two: nausea, fatigue, fever, chills, day 5 all continue. The patient had not received any treatment for events. The patient was not tested for covid post vaccination. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
DIZZINESS; RACING HEARTBEAT; SORENESS IN THE ARM; HEADACHE (PAIN : 7/10); FATIGUE; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was on no medication and was a healthy individual. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced soreness in the arm. On 12-APR-2021, the subject experienced headache (pain : 7/10). On 12-APR-2021, the subject experienced fatigue. On 15-APR-2021, the subject experienced dizziness. On 15-APR-2021, the subject experienced racing heartbeat. Treatment medications included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness in the arm, and fatigue on 14-APR-2021, and had not recovered from headache (pain : 7/10), dizziness, and racing heartbeat. This report was non-serious.
This is a spontaneous report from a contactable consumer reported for herself. A 25-year-old (non-pregnant) female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not available), at the vaccination age of 25, via an unspecified route, left arm, on Feb 12, 2021, at 12:45, single dose, for COVID-19 immunization. The patient's medical history not reported. Concomitant medication included Aldactone (spironolactone). No known allergies reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. On Feb 12, 2021, at 12:45, patient experienced a low-grade fever from 100.3 to 99, every day since the vaccination and would like to understand why. Therapeutic measures taken as a result of the event included Tylenol/Advil. The patient underwent lab test and procedure, which included fever from 100.3 to 99 on Feb 12, 2021. The clinical outcome of the event: not recovered. No follow-up attempts possible. Information about lot/batch number cannot been obtained.
Fever and hallucinations on first night after dose. From injection onwards constant headache and eye issues such as focusing and photophobia, fatigue, tiredness.
Rt upper arm red, swollen, warm to touch. Size of lemon. Grandmom stated pt. c/o next day arm hurt. Ice applied and BENADRYL ordered.
Pain the evening of the QUAD Flu vaccine on left side.  Stronger pain by the next night.  SHINGLES ERUPTIONS by the third night.
Swelling, redness, Hives, burning and itchy. took Benadryl and within 20 min hives were gone.
Pfizer - BioNTech COVID-19 Vaccine EUA  Within the first 10 minutes I felt the first symptom which was itchiness on various parts of my body and especially on my face + head. (This was my first indication I was reacting.)  Then my tongue started to tingle. Over a period of another five minutes the tingling spread to my lips, within another few minutes the tingling spread to the rood of my mouth.  As I sat in my car the tingling intensified and the innerside of my lower lip and my tongue felt denser, as if they were swelling. However, this swelling was not visible; yet, it was very much there from my experience.  The nurse at the site kept coming around to check on me throughout this time period. I believe I waited 30-45 minutes so that I could be monitored. Finally the nurse and I agreed it would be okay for me to go home.  My daughter-in-law drove me home. I took a Benadryl and within 1.5 hours the sensations were completely gone. I was symptom free the rest of the day except for some slight sensation at the injection site.  This reaction to the 1st dose has me quite concerned about taking the 2nd dose.  My body is severely sensitive to a wide range of substances.  In 2016 I was receiving desensitization shots for environmental allergens. I had returned to the shots after stopping them for about 5 months due to severe asthma. When I returned to the shots, I was started on a reduced dose/potency + had a mild anaphylactic shock reaction. We waited 2 weeks + tried again and I had a slightly more serious A.S. reaction.  Then we waited 1-1 1/2 month + redid testing for allergens.  I had slightly stronger reactions to those.. At that point the doctor + I agreed the testing + injections would be completely stopped.  It is because of these experiences + the mild reaction to the 1st Covid vaccine that a 2nd injection is inadvisable for me. My primary care doctor and pulmonologist agree with me. I have gotten a written statement from my primary care to this effect
HEART PROBLEMS; PSORIASIS; SO SICK; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced heart problems, psoriasis, and so sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from psoriasis, and the outcome of so sick and heart problems was not reported. This report was non-serious.; Sender's Comments: V0; Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Pt developed hives, within 48 hours, post vax. He was seen in ER. Per mother, no treatment was given.
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. No pertinent medical history and drug reactions/allergies were reported. On unspecified dates the unspecified number of patients were vaccinated with improperly stored doses (incorrect product storage) of VAQTA (lot # M002268 and expiry date 20-SEP-2017) (dosing regimen and route of administration were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint (PQC) was filed. This is one of several reports received from the same reporter. Additional information has been requested.
Woke to profound chills and shaking despite no appreciable moisture present on skin. This subsided in appx. 30 minutes however I suffered a very poor night?s sleep. Following day, Feb 20, 2012, I felt as though I had a very mild virus with achiness in neck and shoulders primarily with lesser discomfort in back and legs. Was a mildly fatigued with mild headache as well. Did not check temp but never felt feverish.  On 2/21/2021 I felt symptom free until evening when a slight trace of achiness returned. I slept very well that night and woke symptom free, encountering  no further reactive symptoms.
Aprox 5 minutes after vaccine was given, patient stated he was not feeling well, asked for water and stated he was  having trouble breathing. Was then assisted to clinic treatment room, vitals were taken: 08:45 B/P 171/110, HR 84, R 28 O2 97.  EMS was activated. At 0900 158/94 HR 84 R 24 O2 97. Patient then voice he was having tightness in his throat. Epi Pen 0.3mg administered at 0900. At 0904 EMS arrived and patient taken to the nearest hospital.
Migraine - Lights and sounds made worse; Knee pain while standing; Cold sweats; This is a spontaneous report from a contactable consumer (patient). A 30-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0170, Expiration date was not reported), via an unspecified route of administration in arm left on 21Apr2021 at 17:45 (at the age of 30-years-old) as a dose 2, single for COVID-19 immunization. The patient's medical history included was none. The patient had no known allergies. The patient's concomitant medications in two weeks was reported as no. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8730, Expiration date was not reported), via an unspecified route of administration in arm left on 27Mar2021 at 14:30 (at the age of 30-years-old) as a dose 1, single for COVID-19 immunization. Other vaccine in four weeks was reported as no. No covid prior vaccination and no covid tested post vaccination. On 22Apr2021 at 11:00, the patient experienced migraine - lights and sounds made worse, knee pain while standing and cold sweats. Ibuprofen only prevented pain for about 30 minutes. Treatment was received for the events migraine - lights and sounds made worse, knee pain while standing and treatment was not received for cold sweats. The outcome of the events was recovering.  No follow-up attempts are required. No further information is expected.
Fever, chills and shaky muscles the night of my second dose. Three days later, I had swollen lips and lymph nodes as well as body aches and a closed throat. Took Benadryl and symptoms went away within a week.
patient received vaccine beyond the BUD. BUD was 7/1/22 and patient received on 7/17/22
This spontaneous report received from a patient concerned a patient of unspecified age and gender. No medical history, height, weight, concomitant medications or concurrent conditions reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch/lot#: not reported), dose, start therapy date: not reported, for immunization. Per procedure, no follow-up requested for this case. On an unspecified date, patient's mouth was sore inside; neck sore and shoulder sore. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The outcome of shoulder sore, mouth sore inside and neck sore: not reported.
4/14/21 Patient is a 58 y.o. male who presented for confusion, fatigue and dizziness since the past couple of days. Patient was getting lost on the train and forgetting his work duties.  4/14/21Neurologic exam: MS - awake, alert, oriented to name, -age, hospital, -time, speech fluent and without dysarthria, naming & repetition intact, follows commands, attention and concentration are impaired, clock drawing is impaired and shows L sided neglect, line bisection test is impaired, remote and recent memory and fund of knowledge are impaired CN - PERRL, EOMI and without nystagmus, visual fields are intact to confrontation but there is extinction on the L to double simultaneous stimulation, facial sensation is intact to PP V1V2V3, no facial droop, hearing is intact to finger rub B, palate is not well visualized due to his palate/tongue anatomy, head turn is 5/5 B, tongue protrudes symmetrically.  Fundoscopy is deferred due to the COVID-19 pandemic and need for PPE which precludes exam. Motor - Normal bulk/tone, 5/5 B UE and LE, curling of the L fingers on pronator drift testing Sens - Pinprick is intact B UE and LE.  There is extinction to double simultaneous stimulation on the L DTR's - 1/4 B bi/tri/BR and patellar/ankles.  No clonus.  No Hoffman's.  Babinski is down B. Coord - finger-to-nose is without dysmetria B, there is dysmetria of the L leg on heel-to-shin
Pt called on 12/28/18 reporting an adverse reaction to her PREVNAR and flu vaccines. She reports at 6pm on 12/27/18, her left arm started to swell and she started having nausea and vomiting and leg cramps. She used ice packs and swelling has gone down. Denied any shortness of breath, throat or mouth swelling. Still was complaining of body aches.
Information has been received from a consumer concerning his 12 month old son with no pertinent medical history and no drug reactions allergies who was vaccinated with a single dose of MMR II (Lot # not reported). Concomitant therapy include "all childhood vaccines". When the patient was 18 months old he started to have repetitive behavior, stemming and lack of eye contact and was then diagnosed with autism. The reporter was unsure if MMR II had caused his child's autism. On unspecified date blood work was performed (results not reported). The patient sought unspecified medical attention. Upon internal review, autism was determined to be an other important medical event. No further information is available.
DEVELOPED ELEVATED BLOOD PRESSURE (181/106) AND TACHYCARDIA (125), SOB, FAINTNESS, NAUSEA, RED EYES. GAVE BENADRYL 25MG PO AT 0940. BP DECREASED TO 143/88 AND PULSE 99.
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PHARYNGEAL SWELLING (Throat swelled up), DIZZINESS (Dizziness), ILLNESS (I was a sick sick puppy yesterday, chills were the worst, couldn't get warm), ASTHENIA (Weakness) and LYMPHADENOPATHY (Lymph nodes under the left arm were swollen) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PHARYNGEAL SWELLING (Throat swelled up), DIZZINESS (Dizziness), ILLNESS (I was a sick sick puppy yesterday, chills were the worst, couldn't get warm), ASTHENIA (Weakness), LYMPHADENOPATHY (Lymph nodes under the left arm were swollen), NAUSEA (Nausea), ARTHRALGIA (Joint pain), FATIGUE (Feeling really tired), HEADACHE (Head ache) and CHILLS (chills were the worst,). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. At the time of the report, PHARYNGEAL SWELLING (Throat swelled up), DIZZINESS (Dizziness), ILLNESS (I was a sick sick puppy yesterday, chills were the worst, couldn't get warm), ASTHENIA (Weakness), LYMPHADENOPATHY (Lymph nodes under the left arm were swollen), NAUSEA (Nausea), ARTHRALGIA (Joint pain), FATIGUE (Feeling really tired), HEADACHE (Head ache) and CHILLS (chills were the worst,) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were not provided. Treatment with Aleve and Benadryl were provided.
9/24 5pm onset rash on face and trunk. 9pm swelling of face, chest with local swelling of LA (where Varivax was given). 9/25 improved post Benadryl-now fine.
PATIENT STATED HE HAD SHOT IN THE MORNING, BY EVENING LEFT ARM STARTED TO SWELL AND HAVE PAIN IN HIS ELBOW. HE STATED HE ALSO HAD FEVER. PATIENT WAS ADMITTED TO HOSPITAL FOR CELLULITIS.